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The Value of AAHRPP Accreditation

The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research.

The benefits of AAHRPP’s comprehensive approach extend beyond participants to the research enterprise as a whole. Perhaps the greatest value is to those organizations that earn the privilege of displaying the AAHRPP seal. For them, attaining AAHRPP accreditation has proved to be both the right and the smart thing to do. The vast majority find that AAHRPP accreditation provides an excellent return on their investment. Equally important, the value of AAHRPP accreditation endures and is reinforced through reaccreditation.

Hear from AAHRPP-accredited organizations.

Adults unable to consent (0)

All (132)

Children (0)

Conduct exempt review - limited IRB review (4)

Conduct exempt review - non-US (11)

Conduct exempt review - non-US + follows US DHHS (1)

Conduct exempt review - US (11)

Conduct exempt review - US + follows US DHHS (1)

Conduct exempt review - US + follows US DOE (1)

Conducts or reviews research within the Bureau of Prisons (5)

Conducts, sponsors, or manages transnational research (3)

DHHS (9)

DHHS - internal IRB/EC + outside US (0)

DHHS + based in the US (4)

DHHS + based outside US (0)

DHHS + Unregulated (1)

DHHS- independent IRB + reviews research involving prisoners (2)

DHHS- independent IRB + reviews research with pregnant individuals, fetuses, or neonates (3)

DHHS- internal IRB + reviews research involving prisoners (2)

DHHS-adults unable to provide consent (1)

DHHS-children (2)

DHHS-independent IRB (12)

DHHS-independent IRB + reviews research with children (4)

DHHS-internal IRB (12)

DHHS-internal IRB + reviews research with children (4)

DHHS-internal IRB + reviews research with pregnant individuals, fetuses, or neonates (3)

DoD (12)

DOD + transnational research (1)

DoD facility with internal IRB (16)

DoD- independent IRB that reviews research involving children (1)

DoD- independent IRB that reviews research involving prisoners (2)

DoD- independent IRB that reviews research with pregnant individuals, fetuses, or neonates (2)

DoD- internal IRB that reviews research involving children (1)

DoD- internal IRB that reviews research involving prisoners (2)

DoD- internal IRB that reviews research with pregnant individuals, fetuses, or neonates (2)

DOE (9)

DOE facility with internal IRB (7)

DoJ (6)

DoJ facility with internal IRB (3)

ED (3)

ED-independent IRB (1)

ED-internal IRB (1)

EPA (3)

EPA - independent IRB + reviews research with children (1)

EPA - independent IRB + reviews research with pregnant individuals (1)

EPA - internal IRB + reviews research with children (1)

EPA - internal IRB + reviews research with pregnant individuals (1)

EPA - IRB + reviews research with children (0)

EPA - IRB that reviews research with pregnant individuals (0)

FDA-adults unable to provide consent (1)

FDA-children (2)

FDA-independent IRB (10)

FDA-independent IRB + reviews research with children (3)

FDA-internal IRB (10)

FDA-internal IRB + reviews research with children (3)

ICH-GCP - independent IRB/EC (6)

ICH-GCP - internal IRB/EC (3)

ICH-GCP all (15)

ICH-GCP sponsor request (12)

Investigational devices (4)

Investigational drug + device (0)

Investigational drugs (4)

IRB EC + reviews research involving pregnant individuals, fetuses, or neonates (2)

IRB EC + reviews research involving prisoners (2)

IRB EC + reviews transnational research (3)

IRB/EC + reviews DoD research (16)

IRB/EC + reviews DOE research (7)

IRB/EC + reviews DoJ research (3)

IRB/EC + reviews ED research (2)

IRB/EC + reviews research involving adults unable to consent (2)

IRB/EC + reviews research involving children (2)

NIH + Rely on External IRB/EC (1)

Non-US + emergency research (2)

Non-US + emergency research + independent IRB (1)

Non-US + emergency research + internal IRB (1)

Non-US independent IRB (21)

Non-US internal IRB (172)

Non-US no IRB (17)

Not DHHS (0)

Not DHHS + Not DoD + Not DOE + Not DoJ + Not ED + Not EPA + Not VA (2)

Not DoD (0)

Not DOE (0)

Not DoJ (0)

Not ED (0)

Not EPA (0)

Not independent IRB/EC (14)

Not VA (0)

NSF (1)

Org is DoD (0)

Org is DOE (3)

Org is DoJ (1)

Org is independent IRB/EC (166)

Org is VA (44)

Org is VA + transnational research (1)

Org is VA with internal IRB (27)

Org is VA with NO internal IRB (1)

Outside US (7)

Outside US + investigational devices (7)

Outside US + investigational drugs (7)

Outside US + investigational drugs + devices (1)

Permits expedited review - non-US + internal IRB (1)

Permits expedited review - non-US independent IRB (1)

Prisoners (0)

Relies on external IRB/EC (8)

Serves as a IRB for external organizations (11)

Serves as an IRB for DoD organizations (19)

Serves as an IRB for DOE organizations (9)

Serves as an IRB for DoJ research (1)

Serves as an IRB for ED organization (0)

Serves as an IRB for VA facilities or non-VA IRB that reviews VA research (31)

Serves as an IRB for VA facilities or non-VA IRB that reviews VA research + transnational research (0)

Sponsors or manages transnational research (0)

US + emergency research + independent IRB (1)

US + emergency research + internal IRB (1)

US based (2)

US based + emergency research (3)

US based + investigational devices (7)

US based + investigational drugs (7)

US based + investigational drugs + devices (0)

US based independent IRB (30)

US based independent IRB that reviews unregulated research (2)

US based internal IRB (187)

US based internal IRB + not a VA org (4)

US based internal IRB that reviews unregulated research (0)

US based no IRB (21)

US based no IRB + not a VA org (1)

US FDA (15)

US FDA + based in the US (0)

VA (11)

Benefits of being an AAHRPP-accredited organization

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Earn the respect and meet the expectations of their peers.

Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Increasingly, organizations that have not earned AAHRPP accreditation are being asked, “Why not?”

Play a leadership role in collaborative efforts.

AAHRPP accreditation instills trust among research partners and, therefore, is becoming a requirement for collaboration. AAHRPP-accredited organizations often insist that accreditation status be a determining factor in decisions on external IRB review. Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Increasingly, organizations that have not earned AAHRPP accreditation are being asked, “Why not?”

Gain a competitive edge with sponsors and other funders.

Sponsors and funders recognize that AAHRPP-accredited organizations have more efficient operations, provide more comprehensive protections, and produce high-quality data. Virtually all sponsors require independent IRBs to be AAHRPP accredited. Some sponsors also consider accreditation status when choosing investigative sites.

Reduce the risk of noncompliance.

AAHRPP accreditation signifies that an organization has built the necessary infrastructure for a quality human research protection program (HRPP). AAHRPP-accredited organizations tend to have more streamlined, effective policies and procedures. These organizations also typically keep better records and are more likely to avoid costly shutdowns and problematic inspections.

Enhance their standing with U.S. federal agencies.

Regulatory agencies are more likely to target non-accredited organizations for inspections. Federal agencies have begun seeking AAHRPP accreditation for their own HRPPs.

Benefit from a common commitment to continuous quality improvement.

AAHRPP-accredited organizations share innovative practices and collect data to help establish benchmarks and assess quality improvement. AAHRPP compiles and distributes these data to aid organizations, sponsors, government agencies, and participants in identifying and promoting high-quality practices.

Evaluation Instrument for Accreditation

Jan 19, 2022, 16:59 PM

Resources: For Accreditation - Evaluation Instrument

INTRODUCTION

USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION

THE FIVE SECTIONS OF ELEMENTS AND STANDARDS

LIST OF STANDARDS AND ELEMENTS

GLOSSARY OF TERMS

SUMMARY OF REVISIONS

DOMAIN I: ORGANIZATION

STANDARD I-1

ELEMENT I.1.A. ELEMENT I.1.B. ELEMENT I.1.C. ELEMENT I.1.D. ELEMENT I.1.E. ELEMENT I.1.F. ELEMENT I.1.G. ELEMENT I.1.H.

STANDARD I-2

STANDARD I-3

STANDARD I-4

ELEMENT I.4.A. ELEMENT I.4.B. ELEMENT I.4.C.

STANDARD I-5

ELEMENT I.5.A. ELEMENT I.5.B. ELEMENT I.5.C. ELEMENT I.5.D.

STANDARD I-6

ELEMENT I.6.A. ELEMENT I.6.B.

STANDARD I-7

ELEMENT I.7.A. ELEMENT I.7.B. ELEMENT I.7.C.

STANDARD I-8

ELEMENT I.8.A. ELEMENT I.8.B. ELEMENT I.8.C. ELEMENT I.8.D. ELEMENT I.8.E.

STANDARD I-9

DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE

STANDARD II-1

ELEMENT II.1.A. ELEMENT II.1.B. ELEMENT II.1.C. ELEMENT II.1.D. ELEMENT II.1.E.

STANDARD II-2

ELEMENT II.2.A. ELEMENT II.2.B. ELEMENT II.2.C. Element II.2.D. Element II.2.E. Element II.2.F. Element II.2.G. Element II.2.H. Element II.2.I.

STANDARD II-3

ELEMENT II.3.A. ELEMENT II.3.B. ELEMENT II.3.C. ELEMENT II.3.D. ELEMENT II.3.E. ELEMENT II.3.F. ELEMENT II.3.G.

STANDARD II-4

ELEMENT II.4.A. ELEMENT II.4.B. ELEMENT II.4.C.

STANDARD II-5

ELEMENT II.5.A. ELEMENT II.5.B.

DOMAIN III: RESEARCHER AND RESEARCH STAFF

STANDARD III-1

ELEMENT III.1.A. ELEMENT III.1.B. ELEMENT III.1.C. ELEMENT III.1.D. ELEMENT III.1.E. ELEMENT III.1.F. ELEMENT III.1.G.

STANDARD III-2

ELEMENT III.2.A. ELEMENT III.2.B. ELEMENT III.2.C. ELEMENT III.2.D.

TABLES

TABLE II.2.A.1.

TABLE II.2.C.1.

TABLE II.2.F.1.

TABLE II.3.F.1.

TABLE II.3.G.1

TABLE II.3.G.2.

INTERNATIONAL ADDENDA

Country-Specific Addenda

DOMAIN III: RESEARCHER AND RESEARCH STAFF

The environment in which researchers and research staff conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate, and responsible researchers and research staff provide the best possible protection for human research participants. This Domain of Standards sets forth requirements for researchers and research staff involved in research using human participants. As part of its Human Research Protection Program, an organization can improve its protection of research participants if it has arrangements ascertaining and enhancing the competence of researchers and research staff.

Proceed To: STANDARD III-1

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 "title": "Essential requirementsThe organization has a policy with the following definition of research or an equivalent definition: Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. In addition, policies and procedures include examples of activities that meet the definition of research.GUIDANCEMake sure examples provided are relevant to the type of research conducted at the organization. For example:<ul dir=\"ltr\"><li>Universities and hospitals should define when classroom activities and case studies constitute research involving human participants.</li><li>In general, do not include requests to clarify when an activity is research when reviewing independent IRBs, unless they provide the service of making non-human participant research determinations. </li></ul> For organizations outside the US:<ul dir=\"ltr\"><li>Check the Addendum to see if there is a country-specific definition. In many countries, research and human subjects only apply to clinical investigations. AAHRPP requires that policies include the broader definition of research in the Evaluation Instrument (something similar to the definitions in the Common Rule.)</li><li>If the organization follows US DHHS regulations, ensure the following definition is included for any research that must comply with these regulations: Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.</li></ul>",
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 "type": "question/review-assessment",
 "key": "guidance-to-researchers",
 "title": "Essential requirementsThe organization’s written materials include:<ul><li dir=\"ltr\">Guidance to researchers and IRBs/ECs concerning activities that sometimes are or are not overseen by the HRPP at the organization. Examples of activities that an organization may not consider to be research include but are not limited to:<ul><li>Research involving non-living persons. </li><li>Case reports.</li><li>Classroom activities. </li><li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, which focus directly on the specific individuals about whom the information is collected.</li><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.</li><li>The collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. </li><li>Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.<ul><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul></li><li>Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. </li><li>Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.</li></ul></li></ul>GUIDANCE These examples are based on DHHS criteria – for organizations that do not follow DHHS criteria, adapt as appropriate.<ul dir=\"ltr\"><li>Do NOT for contract research organizations or sponsors.</li><li>For hospitals, contract research organizations, sponsors, or organizations that indicate they only conduct biomedical research, DO NOT INCLUDE: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, which focus directly on the specific individuals about whom the information is collected. </li><li>For organizations that are not public health authorities (e.g., most universities, independent IRBs/ECs, contract research organizations, and industry sponsors) DO NOT include: <ul><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance. </li><li>The collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. <ul><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul></li></ul></li><li>For organizations that are not government criminal justice organizations (e.g., CROs, industry sponsors, and most universities) DO NOT include: Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.</li><li>Unless policies explicitly indicate the organization reviews for these types of agencies, do not include for organizations other than these federal agencies – in general do not include CROs, industry sponsors, and most universities.</li></ul>",
 "description": "",
 "keywords": "not-an-independent-irb-ec",
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 {
 "type": "text/review-assessment-snippet",
 "key": "guidance-to-researchers",
 "title": "Add to or describe in written materials <page xx or elsewhere>:<ul><li dir=\"ltr\">Guidance to researchers and IRBs/ECs concerning activities that sometimes are or are not overseen by the HRPP at the organization. Examples of activities that an organization may not consider to be research include but are not limited to: <ul><li>Research involving non-living persons</li><li>Case reports</li><li>Classroom activities.</li><li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, which focus directly on the specific individuals about whom the information is collected.</li><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.</li><li>The collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.</li><li>Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.<ul><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul></li><li>Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.</li><li>Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "guidance-to-researchers--independent-irbs-ecs",
 "title": "Essential requirementsThe organization’s written materials include:<ul><li dir=\"ltr\">Guidance to researchers and IRB/EC staff concerning activities that sometimes are or are not overseen by an HRPP. Examples of activities that an organization may not consider to be research include but are not limited to:<ul><li>Research involving non-living persons. </li><li>Case reports.</li><li>Classroom activities. </li><li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, which focus directly on the specific individuals about whom the information is collected.*</li><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.</li><li>The collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.</li><li>Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.<ul><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul></li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.**</li></ul></li></ul>GUIDANCE *For independent IRBs/ECs that indicate they only conduct biomedical research, DO NOT INCLUDE: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, which focus directly on the specific individuals about whom the information is collected.  ** Unless policies explicitly indicate the organization reviews for these types of agencies, do not include for organizations other than these federal agencies – in general do not include most independent IRBs/ECs.",
 "description": "",
 "keywords": "org-is-independent-irb-ec",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "guidance-to-researchers--independent-irbs-ecs",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>Guidance to researchers and IRB/EC staff concerning activities that sometimes are or are not overseen by an HRPP. Examples of activities that an organization may not consider to be research include but are not limited to:</li><ul type=\"disc\"><li>Research involving non-living persons. </li><li>Case reports.</li><li>Classroom activities. </li><li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, which focus directly on the specific individuals about whom the information is collected.</li><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.</li><li>The collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.</li><li>Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.</li><ul type=\"disc\"><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul><li>Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.</li></ul></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "process-to-track-open-studies",
 "title": "Essential requirementsWritten materials include a description of the process the organization uses to track all open studies, even if ongoing review by an IRB/EC is not required or they are reviewed by an external IRB/EC.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "description-of-process",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A description of the process the organization uses to track all open studies, even if ongoing review by an IRB/EC is not required or the studies are reviewed by an external IRB/EC.<div> </div>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "process-for-registering-irbs-ecs",
 "title": "Essential requirementsWritten materials include a description of the process for registering IRBs/ECs, when required by regulatory agencies.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "description-of-process",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A description of the process for registering IRBs/ECs, when required by regulatory agencies.<div> </div>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "process-to-determine-regulations",
 "title": "Essential requirementsA process to identify what regulations an organization needs to comply with. This process might include, for example:<ul dir=\"ltr\"><li>Who is responsible for knowing what regulations the organization must follow.</li><li>Who is responsible for documenting the regulations the organization must follow, and how documentation is updated.</li><li>How relevant persons in the HRPP are educated or trained so they are aware of what regulations the organization must follow.</li></ul>",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "regulations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A process to identify what regulations an organization needs to comply with. This process might include, for example:<ul dir=\"ltr\"><li>Who is responsible for knowing what regulations the organization must follow.</li><li>Who is responsible for documenting the regulations the organization must follow, and how documentation is updated.</li><li>How relevant persons in the HRPP are educated or trained so they are aware of what regulations the organization must follow.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "policies-and-procedures-dhhs",
 "title": "When following DHHS requirements, written materials include a description of whether the organization:<ul><li dir=\"ltr\">Applies the same policies and procedures regardless of whether research is covered by DHHS regulations or the Common Rule. </li></ul>OR<ul><li dir=\"ltr\">Applies different but equivalent policies and procedures for some or all research not covered by regulations.</li></ul>",
 "description": "",
 "keywords": "dhhs",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "written-materials",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization applies the same policies and procedures regardless of whether research is covered by DHHS regulations or the Common Rule. ",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--different-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization applies different but equivalent policies and procedures for some or all research not covered by regulations. ",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "clinical-trial-definition",
 "title": "When following DHHS requirements, written materials describe that <a data-sf-ec-immutable=\"\">clinical trial means a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.</a> <div><div><div id=\"_com_1\"> </div></div></div>",
 "description": "",
 "keywords": "dhhs---based-in-the-us,us-fda",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "clinical-trials-definition",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Clinical trial means a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.<div><div id=\"_com_1\"> </div></div>",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "research-for-prophylactic-protective-or-other-peaceful-purposes",
 "title": "When following DoD requirements, written materials are clear whether or not the organization conducts research for prophylactic, protective, or other peaceful purposes involving:<ul><li dir=\"ltr\">Chemical agents (a chemical substance that is intended for use in military operations to kill, seriously injure, or incapacitate a person through its physiological effects. Excluded from consideration are riot control agents, chemical herbicides, smoke, and flame). (Section 1520a of Title 50, United States Code (U.S.C.)).</li><li dir=\"ltr\">Biological agents (the term “biological agent” means any micro-organism (including bacteria, viruses, fungi, rickettsia, or protozoa), pathogen, or infectious substance, and any naturally occurring, bioengineered, or synthesized component of any such micro-organism, pathogen, or infectious substance, whatever its origin or method of production, that is capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; or deterioration of food, water, equipment, supplies, or materials of any kind; or deleterious alteration of the environment. (DoD Directive 5210.65)</li></ul> GUIDANCE If the application and written materials are unclear, clarify whether the organization conducts research for prophylactic, protective, or other peaceful purposes involving:<ul><li dir=\"ltr\">Chemical agents (a chemical substance that is intended for use in military operations to kill, seriously injure, or incapacitate a person through its physiological effects. Excluded from consideration are riot control agents, chemical herbicides, smoke, and flame). (Section 1520a of Title 50, United States Code (U.S.C.)).</li><li dir=\"ltr\">Biological agents (the term “biological agent” means any micro-organism (including bacteria, viruses, fungi, rickettsia, or protozoa), pathogen, or infectious substance, and any naturally occurring, bioengineered, or synthesized component of any such micro-organism, pathogen, or infectious substance, whatever its origin or method of production, that is capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; or deterioration of food, water, equipment, supplies, or materials of any kind; or deleterious alteration of the environment. (DoD Directive 5210.65)</li></ul>",
 "description": "",
 "keywords": "dod",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "conducts-research-for",
 "title": "Add to or describe in written materials <page xx or elsewhere>, if your organization conducts research for prophylactic, protective, or other peaceful purposes involving:<ul><li dir=\"ltr\">Chemical agents (a chemical substance that is intended for use in military operations to kill, seriously injure, or incapacitate a person through its physiological effects. Excluded from consideration are riot control agents, chemical herbicides, smoke, and flame). (Section 1520a of Title 50, United States Code (U.S.C.)).</li><li dir=\"ltr\">Biological agents (the term “biological agent” means any micro-organism (including bacteria, viruses, fungi, rickettsia, or protozoa), pathogen, or infectious substance, and any naturally occurring, bioengineered, or synthesized component of any such micro-organism, pathogen, or infectious substance, whatever its origin or method of production, that is capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; or deterioration of food, water, equipment, supplies, or materials of any kind; or deleterious alteration of the environment. (DoD Directive 5210.65)</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "chemical-or-biological-agents",
 "title": "Add to or describe in written materials <page xx or elsewhere>:<ul><li dir=\"ltr\">Human participant research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving human participant research can begin, the DoD component seeking to conduct such research must obtain explicit written approval from the DoD Office for Human Research Protections (DOHRP).</li><ul><li dir=\"ltr\">The organization permits research involving chemical or biological agents under an exception.</li><li dir=\"ltr\">Describe who in the organization is responsible for obtaining approval from DoD and the process they go through.</li></ul></ul>",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "alternative-text-(not-allowed)",
 "title": "Add to or describe in written materials <page xx or elsewhere>, if research for prophylactic, protective, or other peaceful purposes involving chemical or biological agents is NOT allowed:The organization does not allow research involving chemical or biological agents, including research for prophylactic, protective, or other peaceful purposes involving chemical or biological agents.<div> </div>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "research-involving-experimental-subjects-(dod)",
 "title": "When following DoD requirements, written materials are clear whether or not the organization conducts research involving “experimental subjects”. GUIDANCE If the application and written materials are unclear, clarify whether the organization conducts research involving “experimental subjects”. Research involving an “experimental subject” is an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving “experimental subjects” is a subset of research involving human participants. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of 32 CFR 219.<div> </div>",
 "description": "",
 "keywords": "dod",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "experimental-subjects",
 "title": "Add to or describe in written materials [page xx or elsewhere], if your organization conducts research involving “experimental subjects”:<ul dir=\"ltr\"><li>A description of the process to ensure “research involving a human being as an experimental subject” is conducted in accordance with 10 USC 980, as implemented by DoDI 3216.02, section 3.11.</li><li>A definition of research involving an “experimental subject” as an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving “experimental subjects” is a subset of research involving human participants. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of 32 CFR 219.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "no-experimental-subjects",
 "title": "If your organization DOES NOT conduct research involving “experimental subjects”, add to or describe in written materials {page xx or elsewhere], The organization does not conduct research involving experimental subjects.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dod-personnel",
 "title": "Written materials are clear that if the human subjects research (HSR) involves DoD-affiliated personnel, the key investigator must receive approval from the DoD-affiliated personnel’s command or DoD Component to conduct the research. If the HSR takes place on a DoD facility, the key investigator must also receive approval from the command or DoD Component responsible for the facility.  GUIDANCE If the application and written materials are unclear, clarify whether human subjects research can involve DoD-affiliated personnel or could take place on a DoD facility. DoD-affiliated personnel are considered to be Service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors.",
 "description": "",
 "keywords": "dod",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "research-involving-dod-personnel",
 "title": "Add to or describe in written materials [page xx or elsewhere], if your organization conducts research involving DoD-affiliated personnel or a DoD facility:If the human subjects research (HSR) involves DoD-affiliated personnel, the key investigator must receive approval from the DoD-affiliated personnel’s command or DoD Component to conduct the research.  If the HSR takes place on a DoD facility, the key investigator must also receive approval from the command or DoD Component responsible for the facility.",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "no-dod-personnel",
 "title": "Add to or describe in written materials [page xx or elsewhere], if your organization DOES NOT conduct research involving DoD-affiliated personnel or a DoD facility:The organization does not conduct research involving DoD-affiliated personnel or DoD facilities.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "classified-research-(dod)",
 "title": "When following DoD requirements, written materials are clear whether the organization conducts classified research. GUIDANCE If the application and written materials are unclear, clarify whether the organization conducts classified research.",
 "description": "",
 "keywords": "dod",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "classified-research",
 "title": "Add to or describe in written materials [page xx or elsewhere], if your organization conducts classified research:<ul dir=\"ltr\"><li>DoD-conducted or DoD-supported human subjects research (HSR) is considered classified HSR when: (1) Classified information is required for IRB review and oversight of the research. (2) Classified information must be provided to human subjects, or their guardians, during the HSR recruitment or informed consent process in order to achieve fully effective legal consent.  (3) Classified information is provided to, or by, research subjects.</li><li>Describe who in the organization is responsible for obtaining approval for such research and the process they go through.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "no-classified-research",
 "title": "Add to or describe in written materials [page xx or elsewhere], if your organization DOES NOT conduct classified research:The organization does not conduct classified research.<div> </div>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "follow-doe-requirements",
 "title": "Written materials are clear that when following DOE requirements:<ul dir=\"ltr\"><li>DOE requirements apply to all research conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research. </li><li>When research involves contractors, DOE “Contractor Requirements Document” describing contractor responsibilities for protecting human research participants must be included in contracts.</li><li>Research that uses social media data must be submitted to the appropriate IRB/EC for human participant research review and determination. (DOE O 443.1C, Section 4(a)(5))</li><li>Research that involves the study of humans in a systematically modified environment must be submitted to the appropriate IRB/EC for HSR review and determination.</li><li>Classified and unclassified human participant research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB-Classified.</li><li>Human Terrain Mapping (HTM) is managed as research involving human participants. <ul><li>Whether the organization engages in DOE human terrain mapping research.</li></ul></li></ul>",
 "description": "",
 "keywords": "doe",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "written-materials",
 "title": "Add to or describe in written materials <page xx or elsewhere>:<ul><li>DOE requirements apply to all research conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research. </li><li>When research involves contractors, DOE “Contractor Requirements Document” describing contractor responsibilities for protecting human research participants must be included in contracts.</li><li>Research that uses social media data must be submitted to the appropriate IRB/EC for human participant research review and determination. (DOE O 443.1C, Section 4(a)(5))</li><li>Research that involves the study of humans in a systematically modified environment must be submitted to the appropriate IRB/EC for HSR review and determination.</li><li>Classified and unclassified human participant research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB-Classified.</li><li>Human Terrain Mapping (HTM) is managed as research involving human participants. </li><ul><li dir=\"ltr\">Whether the organization engages in DOE human terrain mapping research.</li></ul></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "classified-research-(doe)",
 "title": "When following DOE requirements, written materials are clear whether the organization conducts classified research. GUIDANCE If the application and written materials are unclear, clarify whether the organization conducts classified research.",
 "description": "",
 "keywords": "doe",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "classified-research",
 "title": "Add to or describe in written materials [page xx or elsewhere], if your organization conducts classified research:<ul dir=\"ltr\"><li>All information related to classified human subjects research (HSR) must be managed in accordance with applicable DOE directives and other requirements (Executive Orders, laws, regulations).</li><li>HSR that is classified, in whole or in part, must not be initiated without IRB approval, which must be followed by DOE Institutional Official (IO) approval. The DOE IO, in consultation with the Human Subjects Protection (HSP) Program Managers, will determine whether he/she will approve/disapprove the project or brief the Secretary about the project prior to his/her approval/disapproval.</li><li>Information on each HSR project that is classified must be submitted annually, or in accordance with the directions and schedules provided by the appropriate Human Subjects Protection (HSP) program manager. </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 },
 {
 "type": "text/review-assessment-snippet",
 "key": "no-classified-research",
 "title": "If your organization DOES NOT conduct classified research, add to written materials [page xx or elsewhere]:The organization does not conduct classified research.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "bureau-of-prisons-(doj)",
 "title": "Written materials are clear that for research conducted within the Bureau of Prisons, implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.",
 "description": "",
 "keywords": "conducts-or-reviews-research-within-the-bureau-of-prisons",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "written-materials",
 "title": "Add to or describe in written materials [page xx or elsewhere]:For research conducted within the Bureau of Prisons: Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--scope-of-guideline",
 "title": "When following the ICH-GCP (E6) guideline, written materials specify that ICH-GCP (E6) applies to\nclinical trials of investigational products intended to be submitted to\nregulatory authorities in support of marketing authorization applications.",
 "description": "",
 "keywords": "ich-gcp-all,ich-gcp-sponsor-request",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "ich-gcp--scope-of-guideline",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline, written materials specify that ICH-GCP (E6) applies to clinical trials of investigational products intended to be submitted to regulatory authorities in support of marketing authorization applications.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va-requirements",
 "title": "Written materials are clear that when following VA requirements:<ul dir=\"ltr\"><li>VA research is research that is conducted by researchers serving on VA compensated, without compensation (WOC), or interagency personnel agreement (IPA) appointments while on VA time or on VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have Research and Development (R&D) Committee approval before it is considered VA Research and before it can be initiated. All research activities approved by the R&D Committee are considered VA Research.</li><li>VA-affiliated nonprofit research and education corporations (NPC) are authorized by Congress under 38 U.S.C. 7361-7366 to provide flexible funding mechanisms for the conduct of research and education at one or more VA facilities. Research approved by a facility R&D Committee and education approved by the facility Education Committee are considered to be a VA research project or a VA education activity respectively, regardless of the source of funding, the entity administering the funds, or the research or education site.</li><li>VA research includes VA-approved research conducted at international sites not within the United States, its territories, or Commonwealths; and includes any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data outside the United States.</li><li>The VA does not conduct classified research involving human participants. Classified research is research that is considered restricted or secret by the Federal government, sponsor, or any third party. For example, research for the Federal government that is considered sensitive or would affect national security.</li></ul>",
 "description": "",
 "keywords": "va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "written-materials",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul dir=\"ltr\"><li>VA research is research that is conducted by researchers serving on VA compensated, without compensation (WOC), or interagency personnel agreement (IPA) appointments while on VA time or on VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have Research and Development (R&D) Committee approval before it is considered VA Research and before it can be initiated. All research activities approved by the R&D Committee are considered VA Research.</li><li>VA-affiliated nonprofit research and education corporations (NPC) are authorized by Congress under 38 U.S.C. 7361-7366 to provide flexible funding mechanisms for the conduct of research and education at one or more VA facilities. Research approved by a facility R&D Committee and education approved by the facility Education Committee are considered to be a VA research project or a VA education activity respectively, regardless of the source of funding, the entity administering the funds, or the research or education site.</li><li>VA research includes VA-approved research conducted at international sites not within the United States, its territories, or Commonwealths; and includes any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data outside the United States.</li><li>The VA does not conduct classified research involving human participants. Classified research is research that is considered restricted or secret by the Federal government, sponsor, or any third party. For example, research for the Federal government that is considered sensitive or would affect national security.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-i-1-b",
 "title": "ELEMENT I.1.B.",
 "description": "The organization delegates responsibility for the Human Research Protection Program to an\nofficial with sufficient standing, authority, and independence to ensure implementation and\nmaintenance of the program.",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name]</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "hrpp-responsibilities",
 "title": "Essential requirements\nWritten materials describe the responsibilities of the organizational official, and specify the unique responsibilities of each individual that relate to the HRPP if more than one person is designated as an organizational official.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "organizational-official-responsibilities",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The responsibilities of the organizational official.If more than one person is designated as an organizational official, specify the unique responsibilities of each individual that relate to the HRPP.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "doe-requirements",
 "title": "Written materials describe that when following DOE requirements:<ul><li>No human participant research conducted with DOE funding at DOE institutions (regardless of funding source), or by DOE or contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research, may be initiated without both a Federalwide Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) and approval by the cognizant IRB/EC in accordance with 10 CFR Part 745.103.</li><li>The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) must be notified in writing prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt HSR as outlined in 10 CFR Part 745.104, that involves (DOE 0 443.1C, section 4(d)):<ul><li>An institution without an established IRB.</li><li>A foreign country.</li><li>A potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups).</li><li>Research subjects in a protected class (prisoners, children, individuals with impaired decision making, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue influence to participate) that is outside of the reviewing IRB’s/EC’s typical range/scope.</li><li>The generation or use of classified information.</li></ul></li></ul>GUIDANCENational Nuclear Security Administration (NNSA) is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science.",
 "description": "",
 "keywords": "doe,org-is-doe",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "doe-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DOE requirements:<ul><li>No human participant research conducted with DOE funding at DOE institutions (regardless of funding source), or by DOE or contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research, may be initiated without both a Federalwide Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) and approval by the cognizant IRB/EC in accordance with 10 CFR Part 745.103.</li><li>The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) must be notified in writing prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt HSR as outlined in 10 CFR Part 745.104, that involves (DOE 0 443.1C, section 4(d)):<ul><li>An institution without an established IRB.</li><li>A foreign country.</li><li>A potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups).</li><li>Research subjects in a protected class (prisoners, children, individuals with impaired decision making, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue influence to participate) that is outside of the reviewing IRB’s/EC’s typical range/scope.</li><li>The generation or use of classified information.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va-organizations",
 "title": "When an organization is a VA facility, written materials describe the responsibilities of the VA medical facility director and how they are implemented:<ul><li>Serving as the organizational official for the medical facility. The organizational official is the individual legally authorized as signatory official to commit an institution to an FWA.</li><li>Overseeing the facility’s research program. The organizational official is responsible for the creation and implementation of an HRPP for research involving human participants. </li><li>Ensuring that the institution’s HRPP functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human participants.</li><li>Overseeing the R&D Committee, IRB, and other applicable subcommittees of the R&D Committee, facility research office, and all VA researchers and VA research staff who conduct human participants research at that facility.</li><li>Delegating authority in writing for respective roles and responsibilities for the HRPP. This delegation of authority must provide the organizational structure and ensure leadership for oversight activities for all human participants research conducted at or by the facility.</li><li>Ensuring provision of adequate resources to support the operations of the HRPP.</li><li>Ensuring independence of the IRB.</li><li>Appointing VA voting members to an IRB/EC in writing. Appointment procedures for ex officio, non-voting members are made according to local SOPs and any other applicable VA requirements. Voting members of VA IRBs/ECs and VA representatives to external IRB(s) of Record are appointed for a period of up to three years. They may be re-appointed to new terms of up to three years without a break in service at the end of each term.</li><li>Appointing the chair and, when applicable, co-chair(s) or vice chair(s) for a term of up to three years when the VA facility operates its own IRB.</li><li>Serving as the official representative of the institution to external agencies and oversight bodies, and providing all written communication with external departments, agencies, and oversight bodies.</li><li>Ensuring that a procedure is in place to review and approve recruiting media, including documents, flyers, and advertisements for research that is not VA research prior to being posted or distributed in any form within or on the premises of a VA facility. Posting or distributing may include announcing, distributing, publishing, or advertising the study either electronically, by hard copy, or other means to anyone, including Veterans, clinicians, or other staff.</li><li>Ensuring that a documented procedure is in place for determining when a research activity approved by the IRB, prior to January 21, 2019, can transition to the 2018 Requirements, if applicable. The documented procedure must list what individuals or groups are designated to make the determinations. Researchers may not make a determination that their studies can be transitioned to the 2018 Requirements.</li><li>Ensuring appropriate documentation of required actions and responsibilities pertaining to review, approval, conduct and oversight of research conducted at that facility.</li><li>Ensuring all research subject to VHA Directive 1200.05 is reviewed and approved by an IRB/EC and will be subject to oversight by the IRB. (Research that meets the exempt categories is not subject to IRB/EC review unless it is determined to meet one of the exempt categories requiring limited IRB review. All exempt research must be reviewed and approved by the R&D Committee.)</li><li>Ensuring that any IRB/EC operated by the VA facility is established in accordance with the requirements of VHA Directive 1200.05 and registered through VA Office of Research Oversight (ORO) with OHRP.<ul><li>The facility’s IRB(s) of Record may include the facility’s own IRB(s), VHA Central Office IRB (VA Central IRB), an IRB/EC of another VA facility, the IRB(s) of a medical or dental school, or the IRB/EC of another Federal agency. A facility may also use an IRB/EC for multi-site protocols that has been specifically designated by VA Office of Research & Development (ORD) as an IRB/EC that may serve as a multi-site IRB/EC for VA facilities. (See Standard I-9)</li><li>VA will permit use of a commercial IRB/EC as an IRB/EC of Record for VA facilities if it has been specifically designated by ORD as a commercial IRB/EC that may serve as an IRB/EC for cooperative research. (See Standard I-9)</li><li>A VA facility’s own IRB, also known as an internal IRB, and the VA Central IRB, cannot serve as an IRB/EC of Record for any non-VA entity except a Department of Defense (DoD) facility, Department of Energy laboratory, or a VA-affiliated nonprofit research and education corporation (NPC).</li></ul></li><li>When the facility engages the services of another entity’s IRB/EC as its IRB/EC of Record, the organizational official is responsible for:<ul><li>Establishing and signing a Memorandum of Understanding (MOU) or Authorizing Agreement with other VA facilities or external organization(s) providing IRB/EC services.</li><li>Ensuring that external IRBs/ECs of Record used by the VA facility hold current IRB/EC registrations with FDA/OHRP and provide updates to membership. </li></ul></li><li>Requesting VA Chief Research & Development Officer (CRADO) approval when the VA facility wants to establish a new HRPP, change its IRB(s) of Record, or wants its internal IRB/EC to serve as an IRB/EC of Record for a non-VA entity.</li><li>Submitting waiver requests electronically to the CRADO for approval of research involving prisoners conducted by VA researchers while on official VA duty.</li><li>Approving VA participation in proposed research that includes pregnant women, neonates, or children as described in VHA Directive 1200.05.</li></ul>",
 "description": "",
 "keywords": "org-is-va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va-organizations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The responsibilities of the VA medical facility director and how they are implemented:<ul><li>Serving as the organizational official for the medical facility. The organizational official is the individual legally authorized as signatory official to commit an institution to an FWA.</li><li>Overseeing the facility’s research program. The organizational official is responsible for the creation and implementation of an HRPP for research involving human participants.</li><li>Ensuring that the institution’s HRPP functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human participants.</li><li>Overseeing the R&D Committee, IRB, and other applicable subcommittees of the R&D Committee, facility research office, and all VA researchers and VA research staff who conduct human participants research at that facility.</li><li>Delegating authority in writing for respective roles and responsibilities for the HRPP. This delegation of authority must provide the organizational structure and ensure leadership for oversight activities for all human participants research conducted at or by the facility.</li><li>Ensuring provision of adequate resources to support the operations of the HRPP.</li><li>Ensuring independence of the IRB.</li><li>Appointing VA voting members to an IRB/EC in writing. Appointment procedures for ex officio, non-voting members are made according to local SOPs and any other applicable VA requirements. Voting members of VA IRBs/ECs and VA representatives to external IRB(s) of Record are appointed for a period of up to three years. They may be re-appointed to new terms of up to three years without a break in service at the end of each term.</li><li>Appointing the chair and, when applicable, co-chair(s) or vice chair(s) for a term of up to three years when the VA facility operates its own IRB.</li><li>Serving as the official representative of the institution to external agencies and oversight bodies, and providing all written communication with external departments, agencies, and oversight bodies.</li><li>Ensuring that a procedure is in place to review and approve recruiting media, including documents, flyers, and advertisements for research that is not VA research prior to being posted or distributed in any form within or on the premises of a VA facility. Posting or distributing may include announcing, distributing, publishing, or advertising the study either electronically, by hard copy, or other means to anyone, including Veterans, clinicians, or other staff.</li><li>Ensuring that a documented procedure is in place for determining when a research activity approved by the IRB, prior to January 21, 2019, can transition to the 2018 Requirements, if applicable. The documented procedure must list what individuals or groups are designated to make the determinations. Researchers may not make a determination that their studies can be transitioned to the 2018 Requirements.</li><li>Ensuring appropriate documentation of required actions and responsibilities pertaining to review, approval, conduct and oversight of research conducted at that facility.</li><li>Ensuring all research subject to VHA Directive 1200.05 is reviewed and approved by an IRB/EC and will be subject to oversight by the IRB. (Research that meets the exempt categories is not subject to IRB/EC review unless it is determined to meet one of the exempt categories requiring limited IRB review. All exempt research must be reviewed and approved by the R&D Committee.)</li><li>Ensuring that any IRB/EC operated by the VA facility is established in accordance with the requirements of VHA Directive 1200.05 and registered through VA Office of Research Oversight (ORO) with OHRP.<ul><li>The facility’s IRB(s) of Record may include the facility’s own IRB(s), VHA Central Office IRB (VA Central IRB), an IRB/EC of another VA facility, the IRB(s) of a medical or dental school, or the IRB/EC of another Federal agency. A facility may also use an IRB/EC for multi-site protocols that has been specifically designated by VA Office of Research & Development (ORD) as an IRB/EC that may serve as a multi-site IRB/EC for VA facilities. (See Standard I-9)</li><li>VA will permit use of a commercial IRB/EC as an IRB/EC of Record for VA facilities if it has been specifically designated by ORD as a commercial IRB/EC that may serve as an IRB/EC for cooperative research. (See Standard I-9)</li><li>A VA facility’s own IRB, also known as an internal IRB, and the VA Central IRB, cannot serve as an IRB/EC of Record for any non-VA entity except a Department of Defense (DoD) facility, Department of Energy laboratory, or a VA-affiliated nonprofit research and education corporation (NPC).</li></ul></li><li>When the facility engages the services of another entity’s IRB/EC as its IRB/EC of Record, the organizational official is responsible for:<ul><li>Establishing and signing a Memorandum of Understanding (MOU) or Authorizing Agreement with other VA facilities or external organization(s) providing IRB/EC services.</li><li>Ensuring that external IRBs/ECs of Record used by the VA facility hold current IRB/EC registrations with FDA/OHRP and provide updates to membership.</li></ul></li><li>Requesting VA Chief Research & Development Officer (CRADO) approval when the VA facility wants to establish a new HRPP, change its IRB(s) of Record, or wants its internal IRB/EC to serve as an IRB/EC of Record for a non-VA entity.</li><li>Submitting waiver requests electronically to the CRADO for approval of research involving prisoners conducted by VA researchers while on official VA duty.</li><li>Approving VA participation in proposed research that includes pregnant women, neonates, or children as described in VHA Directive 1200.05.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va-organizations--r-d-committee-responsibilities",
 "title": "When an organization is a VA facility, written materials describe the responsibilities of the Research and Development Committee (R&D Committee) and how they are implemented:<ul><li>Assisting the medical facility Director in fulfilling responsibilities for the facility’s research program by making recommendations regarding personnel, space, and other resource needs of the research program.</li><li>Reviewing research proposals:<ul><li>Approving the research, requiring modifications to obtain approval, or disapproving the research. The R&D Committee can disapprove research approved by the IRB/EC or another one of its subcommittees, but is not permitted to approve research that has been disapproved by an IRB/EC or other appropriate subcommittee.</li><li>Suspending or terminating a research protocol.</li><li>Suspending a researcher’s or a research staff member’s privilege to conduct research pending appropriate investigation and decision by the medical facility Director.</li><li>Require the implementation of additional safeguards related to the safety of human participants.</li></ul></li><li>Ensuring the effective operation of the facility research program through oversight of all R&D Committee subcommittees and the facility’s research portfolio.</li><li>Ensuring that all research in which the facility is engaged is consistent with the VA mission and complies with all applicable statutory and regulatory requirements.</li><li>Establishing appropriate subcommittees to review and oversee human participants research.</li><li>Ensuring Information System Security Officer (ISSO) review of studies that involve the collection, processing, storage, and transmission of research data and Privacy Officer (PO) review of studies using human data are complete before a study is given final approval.</li><li>Determining whether the facility should participate in a study and ensuring that the appropriate Institutional Review Board (IRB) agreements are in place.</li><li>Establishing procedures to ensure that all research in which the facility is to be engaged has been reviewed and approved for high scientific quality, the protection of human participants and research staff, the welfare of animal participants, the safety of all involved in research, and the security of VA data and sensitive information.</li><li>Ensuring that classified research is not conducted as VA research.</li><li>Reviewing the operations of all research-related committees and subcommittees as an ongoing function.</li></ul>",
 "description": "",
 "keywords": "org-is-va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va-organizations--r-d-committee-responsibilities",
 "title": "Add to or describe in written materials [page xx or elsewhere]: <ul type=\"disc\"><li>Assisting the medical facility Director in fulfilling responsibilities for the facility’s research program by making recommendations regarding personnel, space, and other resource needs of the research program.</li><li>Reviewing research proposals:</li><ul type=\"disc\"><li>Approving the research, requiring modifications to obtain approval, or disapproving the research. The R&D Committee can disapprove research approved by the IRB/EC or another one of its subcommittees, but is not permitted to approve research that has been disapproved by an IRB/EC or other appropriate subcommittee.</li><li>Suspending or terminating a research protocol.</li><li>Suspending a researcher’s or a research staff member’s privilege to conduct research pending appropriate investigation and decision by the medical facility Director.</li><li>Require the implementation of additional safeguards related to the safety of human participants.</li></ul><li>Ensuring the effective operation of the facility research program through oversight of all R&D Committee subcommittees and the facility’s research portfolio.</li><li>Ensuring that all research in which the facility is engaged is consistent with the VA mission and complies with all applicable statutory and regulatory requirements.</li><li>Establishing appropriate subcommittees to review and oversee human participants research.</li><li>Ensuring Information System Security Officer (ISSO) review of studies that involve the collection, processing, storage, and transmission of research data and Privacy Officer (PO) review of studies using human data are complete before a study is given final approval.</li><li>Determining whether the facility should participate in a study and ensuring that the appropriate Institutional Review Board (IRB) agreements are in place.</li><li>Establishing procedures to ensure that all research in which the facility is to be engaged has been reviewed and approved for high scientific quality, the protection of human participants and research staff, the welfare of animal participants, the safety of all involved in research, and the security of VA data and sensitive information.</li><li>Ensuring that classified research is not conducted as VA research.</li><li>Reviewing the operations of all research-related committees and subcommittees as an ongoing function.</li></ul> ",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-i-1-c",
 "title": "ELEMENT I.1.C.",
 "description": "The organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in protecting research participants. ",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-authority",
 "title": "Essential requirementsWritten materials describe that the organization grants the IRB/EC, whether internal or external to the organization, the authority:<ul><li>To approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organization.</li><li>To suspend or terminate IRB/EC approval of research not being conducted in accordance with the IRB’s/EC’s requirements or that had been associated with unexpected serious harm to participants.</li><li>To observe, or have a third party observe, the consent process and the conduct of the research.</li></ul>",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "irb-ec-authority",
 "title": "Add to or describe in written materials [page xx or elsewhere]: The organization grants the IRB/EC, whether internal or external to the organization, the authority:<ul><li>To approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organization.</li><li>To suspend or terminate IRB/EC approval of research not being conducted in accordance with the IRB’s/EC’s requirements or that had been associated with unexpected serious harm to participants.</li><li>To observe, or have a third party observe, the consent process and the conduct of the research</li></ul><div><div><div id=\"_com_1\"></div></div></div>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "how-ensure-research-commences-after-required-approvals",
 "title": "Essential requirementsWritten materials describe the steps the organization takes to ensure that research involving human participants does not commence until the research has received all approvals required by the organization.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "how-ensure-research-commences-after-required-approvals",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The steps the organization takes to ensure that research involving human participants does not commence until the research has received all approvals required by the organization.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "prohibiting-approval-when-irb-ec-disapproves",
 "title": "Essential requirementsWritten materials state that officials of the organization may not approve research that has not been approved by the IRB/EC.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "prohibiting-approval-when-irb-ec-disapproves",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Officials of the organization may not approve research that has not been approved by the IRB/EC.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-undue-influence",
 "title": "Essential requirementsWritten materials identify: <ul><li>To whom IRB/EC members and staff report undue influence.</li><li>The organization’s response to attempts to unduly influence the IRB/EC.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,us-based-internal-irb",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "undue-influence-irb-ec",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>To whom IRB/EC members and staff report undue influence.</li><li>The organization’s response to attempts to unduly influence the IRB.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va---independent-irb-function",
 "title": "When an organization is a VA facility, written materials describe:<ul><li>The facility director is responsible for ensuring that the IRB/EC functions independently.</li><li>An IRB-approved research activity may be disapproved by the facility director or the R&D Committee. If a research activity is disapproved by the IRB, or modifications to the research are required by the IRB, the disapproval or need for modification cannot be overruled by any other authority (e.g., facility director or R&D Committee).</li><li>The R&D Committee must provide the final approval before the research can be initiated. VA research cannot be initiated by the researcher until written notification is received from the Associate Chief of Staff/Research & Development (ACOS/R&D) that all required approvals have been obtained.</li></ul>",
 "description": "",
 "keywords": "org-is-va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va-orgs",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The facility director is responsible for ensuring that the IRB/EC functions independently.</li><li>An IRB-approved research activity may be disapproved by the facility director or the R&D Committee. If a research activity is disapproved by the IRB, or modifications to the research are required by the IRB, the disapproval or need for modification cannot be overruled by any other authority (e.g., facility director or R&D Committee).</li><li>The R&D Committee must provide the final approval before the research can be initiated. VA research cannot be initiated by the researcher until written notification is received from the Associate Chief of Staff/Research & Development (ACOS/R&D) that all required approvals have been obtained.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-i-1-d",
 "title": "ELEMENT I.1.D.",
 "description": "The organization has and follows written policies and procedures setting forth the ethical standards and practices of the Human Research Protection Program. Relevant policies and procedures are made available to sponsors, researchers, research staff, research participants, and the Institutional Review Board or Ethics Committee, as appropriate. ",
 "keywords": "all",
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 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "ethical-principles-governing-research-internal-irb-ec",
 "title": "Essential requirementsWritten materials describe:<ul><li>The ethical principles that the organization follows to govern the conduct of research involving human participants.</li><li>The ethical obligations and expectations of:<ul><li>Researchers and research staff, including students involved in the conduct of research.</li><li>IRB/EC members and chairs.</li><li>IRB/EC staff.</li><li>The organizational official.</li><li>Employees.</li><li>Students.</li></ul></li></ul>GUIDANCEWhen reviewing teaching hospitals and academic institutions, include students in the list above.",
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 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "ethical-principles",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The ethical principles that the organization follows to govern the conduct of research involving human participants.</li><li>The ethical obligations and expectations of:<ul><li>Researchers and research staff, including students involved in the conduct of research.</li><li>IRB/EC members and chairs.</li><li>IRB/EC staff.</li><li>The organizational official.</li><li>Employees.</li><li>Students. </li></ul></li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "ethical-principles-governing-research--no-internal-irb-ec",
 "title": "Essential requirementsWritten materials describe:<ul type=\"disc\"><li>The ethical principles that the organization follows to govern the conduct of research involving human participants.</li><li>The ethical obligations and expectations of:</li><ul type=\"disc\"><li>Researchers and research staff, including students involved in the conduct of research.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The organizational official.</li><li>Employees.</li><li>Students.</li></ul></ul>GUIDANCE<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">When reviewing teaching hospitals and academic institutions, include students in the list above.",
 "description": "",
 "keywords": "non-us-no-irb,us-based-no-irb",
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 "key": "ethical-principles-governing-research--no-internal-irb-ec",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The ethical principles that the organization follows to govern the conduct of research involving human participants.</li><li>The ethical obligations and expectations of:</li></ul><ul type=\"disc\"><ul type=\"disc\"><li>Researchers and research staff, including students involved in the conduct of research.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The organizational official.</li><li>Employees.</li><li>Students.</li></ul></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "policy-procedure-dissemination",
 "title": "Essential requirementsWritten materials describe:<ul><li>The mechanism for communicating or making available the policies and procedures of the HRPP to all individuals.</li><li>The mechanism for communicating changes in policies and procedures to all individuals.</li></ul>",
 "description": "",
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 "key": "policy-procedure-dissemination",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The mechanism for communicating or making available the policies and procedures of the HRPP to all individuals.</li><li>The mechanism for communicating changes in policies and procedures to all individuals.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "hrpp-coordination",
 "title": "Essential requirementsWritten materials describe:<ul><li>The roles and responsibilities for each of the entities.</li><li>The relationships among the entities.</li><li>A description of the ways the entities of the organization communicate and work together to protect participants.</li></ul>",
 "description": "",
 "keywords": "all",
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 "key": "hrpp-coordination",
 "title": "Add to or describe in written materials [page xx or elsewhere]:All entities that are involved with human research protection, including:<ul><li>The roles and responsibilities for each of the entities.</li><li>The relationships among the entities.</li><li>A description of the ways the entities of the organization communicate and work together to protect participants.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "equivalent-protections-us-organizations",
 "title": "Essential requirementsWritten materials describe equivalent protections for participants for human participants research that does not fall under any Federal regulatory requirements (e.g., research that is not federally supported and not FDA-regulated).",
 "description": "",
 "keywords": "dhhs-unregulated",
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 "key": "equivalent-protections",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Equivalent protections for participants in research that does not fall under any Federal regulatory requirements (e.g., research that is not federally supported and not FDA-regulated).",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "equivalent-protections--non-us-organizations",
 "title": "Essential requirementsWritten materials describe equivalent protections for participants in research that does not fall under any law or other regulatory requirements.",
 "description": "",
 "keywords": "outside-us",
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 "key": "equivalent-protections--outside-us",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Equivalent protections for participants in research that does not fall under any law or other regulatory requirements.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "doj",
 "title": "When following DoJ requirements, written materials describe for research conducted within the Bureau of Prisons that the organization, IRB, and researchers and research staff must follow the requirements of 28 CFR 512, including:<ul><li>The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.</li><li>The research design must be compatible with both the operation of prison facilities and protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted.</li><li>Any researcher who is a non-employee of the Bureau must sign a statement in which the researcher agrees to adhere to the provisions of 28 CFR 512.</li><li>All research proposals will be reviewed by the Bureau Research Review Board.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:For research conducted within the Bureau of Prisons, the organization, IRB, and researchers and research staff must follow the requirements of 28 CFR 512, including:<ul><li>The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.</li><li>The research design must be compatible with both the operation of prison facilities and protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted.</li><li>Any researcher who is a non-employee of the Bureau must sign a statement in which the researcher agrees to adhere to the provisions of 28 CFR 512.</li><li>All research proposals will be reviewed by the Bureau Research Review Board.</li></ul>",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "epa",
 "title": "When following EPA requirements, written materials describe the following:<ul><li>EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.</li><li>EPA requires application of 40 CFR 26 Subparts C and D to provide additional protections to pregnant women and children as participants in observational research, i.e., research that does not involve intentional exposure to any substance.</li><li>EPA requires submission of IRB/EC determinations and approval to the EPA research involving human participants review official for final review and approval before the research can begin.</li><li>For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:<ul><li>EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.</li><li>EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.</li></ul></li></ul>",
 "description": "",
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 "key": "epa",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.</li><li>EPA requires application of 40 CFR 26 Subparts C and D to provide additional protections to pregnant women and children as participants in observational research, i.e., research that does not involve intentional exposure to any substance.</li><li>EPA requires submission of IRB/EC determinations and approval to the EPA research involving human participants review official for final review and approval before the research can begin.</li><li>For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:<ul><li>EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.</li><li>EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
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 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp",
 "title": "When following ICH GCP (E6) guidelines, written materials state: <ul><li>Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and the applicable regulatory requirements.</li><li>Clinical trials should be designed and conducted in ways that ensure the rights, safety, and well-being of participants.</li><li>The rights, safety, and well-being of participants are the most important considerations and should prevail over interests of science and society.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline:<ul><li>Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and the applicable regulatory requirements.</li><li>Clinical trials should be designed and conducted in ways that ensure the rights, safety, and well-being of participants.</li><li>The rights, safety, and well-being of participants are the most important considerations and should prevail over interests of science and society.</li></ul>",
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 {
 "type": "section/element",
 "key": "element-i-1-e",
 "title": "ELEMENT I.1.E.",
 "description": "The organization has an education program that contributes to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants. ",
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 "type": "question/applicant-documents",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
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 },
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 "type": "question/review-assessment",
 "key": "educational-activities",
 "title": "Essential requirementsWritten materials describe educational activities designed to contribute to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "educational-activities",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Educational activities designed to contribute to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants.",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "monitoring-education-internal-irb-independent-irb",
 "title": "Essential requirementsWritten materials describe:<ul><li>Initial education requirements and timeframes for researchers and research staff; IRB/EC staff, IRB/EC chairs, and members; and others. </li><li>Monitoring of education requirements.</li><li>Continuing education requirements and time frames.</li><li>Actions the IRB/EC or the organization takes if education requirements are not fulfilled.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "monitoring-education",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Initial education requirements, including timeframes, for researchers and research staff; IRB/EC staff, IRB/EC chairs, and members; and others. Include:<ul><li>Monitoring of education requirements.</li><li>Continuing education requirements and time frames.</li><li>Actions the IRB/EC or the organization takes if education requirements are not fulfilled.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "monitoring-education--no-internal-irb-ec-and-not-independent-irb-ec",
 "title": "Essential requirementsWritten materials describe:<ul type=\"disc\"><li>Initial education requirements and timeframes for researchers and research staff and others.</li><li>Monitoring of education requirements.</li><li>Continuing education requirements and time frames.</li><li>Actions the organization takes if education requirements are not fulfilled.</li></ul>",
 "description": "",
 "keywords": "non-us-no-irb,us-based-no-irb",
 "components": [
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 "key": "monitoring-education--no-internal-irb-ec-and-not-independent-irb-ec",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>Initial education requirements and timeframes for researchers and research staff and others.</li><li>Monitoring of education requirements.</li><li>Continuing education requirements and time frames.</li><li>Actions the organization takes if education requirements are not fulfilled.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-internal-irb",
 "title": "When the organization is a VA facility, written materials describe: <ul><li>Policies describe training and education of the IRB/EC chair, voting members, and alternates in human participants protections, ethics, and regulatory requirements.</li><li>All individuals involved in conducting VA human participants research are required to complete training in ethical principles which apply to research conducted on human participants as specified by ORD.</li><li>The R&D Committee ensures successful completion of all relevant research-related training requirements prior to approving research.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Training and education of the IRB chair, voting members, and alternates in human participants protections, ethics, and regulatory requirements.</li><li>All individuals involved in conducting VA human participants research are required to complete training in ethical principles which apply to research conducted on human participants as specified by ORD.</li><li>The R&D Committee ensures successful completion of all relevant research-related training requirements prior to approving research.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-organization--no-internal-irb",
 "title": "When the organization is a VA facility, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">All individuals involved in conducting VA human participants research are required to complete training in ethical principles which apply to research conducted on human participants as specified by ORD.</li><li>The R&D Committee ensures successful completion of all relevant research-related training requirements prior to approving research.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>All individuals involved in conducting VA human participants research are required to complete training in ethical principles which apply to research conducted on human participants as specified by ORD.</li><li>The R&D Committee ensures successful completion of all relevant research-related training requirements prior to approving research.</li></ul>",
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 },
 {
 "type": "section/element",
 "key": "element-i-1-f",
 "title": "ELEMENT I.1.F.",
 "description": "The organization has and follows written policies and procedures for reviewing the scientific or scholarly validity of a proposed research study. Such procedures are coordinated with the ethics review process.",
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 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
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 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "scientific-validity",
 "title": "Essential requirementsWritten materials describe the organization’s evaluation of proposed research for scientific validity:<ul><li>The individuals or entities that are responsible for scientific review.</li><li>Scholarly or scientific review of proposed research addresses the following issues, at a minimum:</li></ul><ul style=\"margin-left: 30px\"><li>The research uses procedures consistent with sound research design.</li><li>The research design is sound enough to yield the expected knowledge.</li><li>The process for documenting and communicating the review to the IRB/EC when the review is conducted by someone other than the IRB/EC.</li></ul><div><div><div id=\"_com_1\"></div></div></div>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s evaluation of proposed research for scientific validity:<ul><li>The individuals or entities that are responsible for scientific review.</li><li>Scholarly or scientific review of proposed research addresses the following issues, at a minimum:<ul><li>The research uses procedures consistent with sound research design.</li><li>The research design is sound enough to yield the expected knowledge.</li><li>The process for documenting and communicating the review to the IRB/EC when the review is conducted by someone other than the IRB/EC.</li></ul></li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "dod",
 "title": "When following DoD requirements, written materials describe:<ul><li>When an IRB/EC at a non-DoD institution reviews DoD-supported research, the IRB/EC must consider the scientific merit of the research.</li><li>The IRB/EC may rely on outside experts to provide an evaluation of the scientific merit.</li></ul>",
 "description": "",
 "keywords": "dod-facility-with-internal-irb,irb-ec---reviews-dod-research,serves-as-an-irb-for-dod-organizations",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>When an IRB/EC at a non-DoD institution reviews DoD-supported research, the IRB/EC must consider the scientific merit of the research.</li><li>The IRB/EC may rely on outside experts to provide an evaluation of the scientific merit.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "doj",
 "title": "When following DoJ requirements, written materials describe that when research is conducted within the Bureau of Prisons, the project must have an adequate research design and contribute to the advancement of knowledge about corrections.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp",
 "title": "When following the ICH-GCP (E6) guideline, written materials describe:<ul><li>The available nonclinical and clinical information on an investigational product is adequate to support the proposed clinical trial.</li><li>Clinical trials should be scientifically sound and reflect the state of knowledge and experience with the investigational product(s), including, if applicable,<ul><li>the condition to be treated, diagnosed or prevented; </li><li>the current understanding of the underlying biological mechanism (of both the condition and the investigational product); and </li><li>the population for which the investigational product is intended.</li></ul></li><li>There should be periodic review of current scientific knowledge and approaches to determine whether modifications to the trial are needed, since new or unanticipated information may arise once the trial has begun.</li><li>The scientific goal and purpose should be carefully considered so as not to unnecessarily exclude particular participant populations.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline:<ul><li>The available nonclinical and clinical information on an investigational product is adequate to support the proposed clinical trial.</li><li>Clinical trials should be scientifically sound and reflect the state of knowledge and experience with the investigational product(s), including, if applicable,<ul><li>the condition to be treated, diagnosed or prevented;</li><li>the current understanding of the underlying biological mechanism (of both the condition and the investigational product); and</li><li>the population for which the investigational product is intended.</li></ul></li><li>There should be periodic review of current scientific knowledge and approaches to determine whether modifications to the trial are needed, since new or unanticipated information may arise once the trial has begun.</li><li>The scientific goal and purpose should be carefully considered so as not to unnecessarily exclude particular participant populations.</li></ul>",
 "description": "",
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 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va-organization",
 "title": "When an organization is a VA facility, written materials specify that:<ul><li>The R&D Committee is responsible for ensuring the scientific merit of the research proposal.</li><li>If the protocol has been peer reviewed by a VA merit review committee, a National Institutes of Health (NIH) study section, or other Federal peer review committee, the R&D Committee or IRB/EC may rely on that peer review if the findings of the peer review committee are submitted with the protocol.</li></ul>",
 "description": "",
 "keywords": "org-is-va",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The R&D Committee is responsible for ensuring the scientific merit of the research proposal.</li><li>If the protocol has been peer reviewed by a VA merit review committee, a National Institutes of Health (NIH) study section, or other Federal peer review committee, the R&D Committee or IRB/EC may rely on that peer review if the findings of the peer review committee are submitted with the protocol.</li></ul>",
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 },
 {
 "type": "section/element",
 "key": "element-i-1-g",
 "title": "ELEMENT I.1.G.",
 "description": "The organization has and follows written policies and procedures that identify applicable laws in the localities where it conducts human research, takes them into account in the review and conduct of research, and resolves differences between federal or national law and local laws.  ",
 "keywords": "all",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "application-of-laws",
 "title": "Essential requirementsWritten materials describe the organization’s application of laws relevant to research involving humans as participants, when the research is conducted:<ul><li>In the jurisdiction where the organization resides.</li><li>Outside the jurisdiction where the organization resides.</li></ul>",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "application-of-laws",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The application of laws relevant to research involving humans as participants, when the research is conducted:<ul><li>In the jurisdiction where the organization resides.</li><li>Outside the jurisdiction where the organization resides.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "resolving-conflicts-in-law",
 "title": "Essential requirementsWritten materials describe the organization’s process to resolve conflicts between federal or national law and other applicable laws.",
 "description": "",
 "keywords": "all",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "resolving-conflicts-in-law",
 "title": "Add to or describe in written materials [page xx or elsewhere}:The process to resolve conflicts between federal or national law and other applicable laws.",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "adults-unable-to-consent",
 "title": "When following DHHS requirements, written materials describe the organization’s process to determine who is a “legally authorized representative” as defined by DHHS requirements when research involves adults unable to provide consent.GUIDANCEDHHS definition: Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research.",
 "description": "",
 "keywords": "dhhs-adults-unable-to-provide-consent",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to determine who is a “legally authorized representative” as defined by DHHS when research involves adults unable to provide informed consent.",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "us-fda--adults-unable-to-provide-consent",
 "title": "When following FDA requirements, written materials describe the organization’s process to determine who is a “legally authorized representative” as defined by the FDA when research involves adults unable to provide consent.GUIDANCEFDA definition: Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.",
 "description": "",
 "keywords": "fda-adults-unable-to-provide-consent",
 "components": [
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 "key": "us-fda--adults-unable-to-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to determine who is a “legally authorized representative” as defined by the FDA when research involves adults unable to provide consent.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "children",
 "title": "When following DHHS requirements, written materials describe the organization’s process to determine who is a “child” as defined by DHHS requirements.",
 "description": "",
 "keywords": "dhhs-children",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to determine who is a “child” as defined by DHHS.",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "us-fda--children---definition",
 "title": "When following FDA requirements, written materials describe the organization’s process to determine who is a “child” as defined by FDA requirements.",
 "description": "",
 "keywords": "fda-children",
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 "type": "text/review-assessment-snippet",
 "key": "us-fda--children---definition",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to determine who is a “child” as defined by FDA requirements. ",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "children---guardian",
 "title": "Written materials describe the organization’s decision about or process to determine who is a “guardian” as defined by DHHS and FDA requirements.",
 "description": "",
 "keywords": "dhhs-children,fda-children",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "children---guardian",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s decision about or process to determine who is a “guardian” as defined by DHHS and FDA requirements.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
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 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-i-1-h",
 "title": "ELEMENT I.1.H.",
 "description": "The organization has and follows written policies and procedures specifically designed to protect the rights and welfare of research participants during an emergency. ",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "plan",
 "title": "Essential requirementsWritten materials describe an emergency preparedness and response plan, which addresses how continuity of operations will be maintained to ensure human participant protections during an emergency.",
 "description": "",
 "keywords": "all",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "plan",
 "title": "Add to or describe in written materials [page xx or elsewhere]:An emergency preparedness and response plan, which addresses how continuity of operations will be maintained to ensure human participant protections during an emergency.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "evaluating-response",
 "title": "Essential requirementsWritten materials describe the organization’s process to evaluate its emergency preparedness and response plan for the HRPP. GUIDANCEThe description may include, for example:<ul><li>Who is responsible for conducting the evaluation.</li><li>How frequently such an evaluation will occur.</li><li>The process for using the results, when necessary, to make adjustments to the plan to ensure continuity of operations.</li></ul>",
 "description": "",
 "keywords": "all",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "evaluating-response",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to evaluate its emergency preparedness and response plan for the HRPP.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "education",
 "title": "Essential requirementsWritten materials describe the organization’s process to provide education about the organization’s emergency response and preparedness plan for HRPP staff, IRB/EC members and staff, and researchers.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "education",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to provide education about the organization’s emergency response and preparedness plan for HRPP staff, IRB/EC members and staff, and researchers.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "education--no-internal-irb-ec-and-not-an-independent-irb-ec",
 "title": "Essential requirementsWritten materials describe the organization’s process to provide education about the organization’s emergency response and preparedness plan for HRPP staff and researchers.",
 "description": "",
 "keywords": "non-us-no-irb,us-based-no-irb",
 "components": [
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 "key": "education--no-internal-irb-ec-and-not-an-independent-irb-ec",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The organization’s process to provide education about the organization’s emergency response and preparedness plan for HRPP staff and researchers.<div> </div>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/standard",
 "key": "standard-i-2",
 "title": "STANDARD I-2",
 "description": "The organization ensures that the Human Research Protection Program has resources sufficient\nto protect the rights and welfare of research participants for the research activities that the\norganization conducts or oversees. \n",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Standard.",
 "description": "",
 "keywords": "all",
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 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "maintain-hrpp-resources",
 "title": "Essential requirementsWritten materials describe the process by which the organization maintains adequate resources for support of the operations of the HRPP, including but not limited to administrative resources including space and personnel, in order to meet the accreditation standards.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "maintain-hrpp-resources",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process by which the organization maintains adequate resources for support of the operations of the HRPP, including but not limited to administrative resources including space and personnel, in order to meet the accreditation standards.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "resource-evaluation",
 "title": "Essential requirementsWritten materials describe the plan to evaluate resources needed for the HRPP, including but not limited to:<ul><li>Space</li><li>Personnel</li><li>HRPP education program</li><li>Legal counsel</li><li>Conflict of interest</li><li>Quality improvement plan</li><li>Community outreach</li><li>IRBs/ECs</li></ul>",
 "description": "",
 "keywords": "all",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "resource-evaluation",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The plan to evaluate resources needed for the HRPP, including but not limited to:<ul><li>Space</li><li>Personnel</li><li>HRPP education program</li><li>Legal counsel</li><li>Conflict of interest</li><li>Quality improvement plan</li><li>Community outreach</li><li>IRBs/ECs<span style=\"background-color: initial; color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"> </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "shared-responsibilities",
 "title": "Essential requirementsIf the organization relies on the services or entities of another organization, written materials describe the steps followed (e.g., criteria, evaluation, or monitoring) to evaluate whether the service or entities meets the relevant accreditation standards and the MOU or agreement describes how responsibilities are divided between the organization and vendor (e.g., noncompliance, education, reporting).GUIDANCE If an organization relies on an independent IRB/EC or other IRB, policies must require that there will be some type of formal agreement (including but not limited to a memorandum of understanding) that describes the responsibilities of each party in writing. For the VA, if the MOU between the VA and its academic affiliate is not included, contact AAHRPP staff. ",
 "description": "",
 "keywords": "all",
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 "key": "evaluation-of-the-external-entity-or-service",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When the organization relies on the services or entities of another organization, the steps followed (e.g., criteria, evaluation, or monitoring) to evaluate whether the service or entities meets the relevant accreditation standards.",
 "description": "",
 "keywords": "",
 "components": []
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 {
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 "key": "division-of-responsibilities",
 "title": "Add to or describe in written materials [page xx or elsewhere]:How responsibilities are divided between the organization and vendor (e.g., noncompliance, education, reporting) in the MOU or agreement used when the organization relies on the services or entities of another organization.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dod",
 "title": "When following DOD requirements, written materials describe: <ul><li>The process to confirm approval by the appropriate DoD component prior to research starting, including who is responsible and the process they go through. DoD component-level administrative review (CLAR) must be conducted when:<ul><li>Human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.</li><li>The research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b).</li><li>The research is fetal research, as described in 42 USC 289g-289g-2.</li><li>Large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSGD includes data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. (See definition in DoDI 3216.02 G.2 Definitions) </li><li>The research constitutes classified research involving human participants. (DoDI 3216.02 section 3.13)</li><li>The research is required to be approved by the DOHRP (in addition to the COHRP) in accordance with DoDI 3216.02. </li></ul></li><li>Component review includes review of reliance agreements.</li></ul><div><div><div id=\"_com_1\"> </div></div></div>",
 "description": "",
 "keywords": "dod",
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 "key": "dod",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The process to confirm approval by the appropriate DoD component prior to research starting, including who is responsible and the process they go through. DoD component-level administrative review (CLAR) must be conducted when:</li><li>Human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.</li><li>The research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b).</li><li>The research is fetal research, as described in 42 USC 289g-289g-2.</li><li>Large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSGD includes data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. (See definition in DoDI 3216.02 G.2 Definitions)</li><li>The research constitutes classified research involving human participants. (DoDI 3216.02 section 3.13)</li><li>The research is required to be approved by the DOHRP (in addition to the COHRP) in accordance with DoDI 3216.02. </li><li>Component review includes review of reliance agreements</li></ul><div><div id=\"_com_1\"></div></div>",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "va-organization",
 "title": "When following VA requirements, written materials describe that the VA medical Facility Director is responsible for ensuring provision of adequate resources to support the operations of the HRPP.",
 "description": "",
 "keywords": "org-is-va",
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 "description": "",
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 },
 {
 "type": "section/standard",
 "key": "standard-i-3",
 "title": "STANDARD I-3",
 "description": "The organization’s transnational research activities are consistent with the ethical principles set forth\nin its Human Research Protection Program and meet equivalent levels of participant protection as\nresearch conducted in the organization’s principal location while complying with local laws and\ntaking into account cultural context. ",
 "keywords": "conducts-transnational-research,irb-ec---reviews-transnational-research",
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 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Standard.",
 "description": "",
 "keywords": "conducts-transnational-research,irb-ec---reviews-transnational-research",
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 {
 "type": "question/review-assessment",
 "key": "review-of-transnational-research",
 "title": "Essential requirementsWhen reviewing transnational research, written materials describe the procedures for:<ul><li>Ensuring appropriate expertise and knowledge of the country(ies) either through IRB/EC members or consultants.</li><li>Ensuring knowledge of local laws.</li><li>Ensuring knowledge of cultural context.</li><li>Confirming the qualifications of the researchers and research staff for conducting research in that country.</li><li>Initial review, continuing review, and review of modifications to previously approved research.</li><li>Handling complaints, noncompliance, and unanticipated problems involving risk to participants or others.</li><li>The consent process and document and other language issues.</li><li>Coordinating and communicating with local IRBs/ECs when appropriate.</li></ul>GUIDANCESome examples of ways of ensuring knowledge of the laws of other countries might include:<ul><li>Relying upon an IRB/EC in the country.</li><li>Using a consultant with expertise in the country.</li><li>Partnering with an organization such as a not-for-profit that regularly works in the country.</li></ul>Verify that policies and procedures applied to research conducted domestically are applied to research conducted in other countries, when applicable.",
 "description": "",
 "keywords": "irb-ec---reviews-transnational-research",
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 "key": "review-of-transnational-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When reviewing transnational research, how the IRB/EC:<ul><li>Ensures appropriate expertise and knowledge of the country(ies) either through IRB/EC members or consultants.</li><li>Ensures knowledge of local laws.</li><li>Ensures knowledge of cultural context.</li><li>Confirms the qualifications of the researchers and research staff for conducting research in that country.</li><li>Conducts initial review, continuing review, and review of modifications to previously approved research.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Handles complaints, noncompliance, and unanticipated problems involving risk to participants or others.</li><li>Assesses the consent process and document and other language issues.</li><li>Coordinates and communicates with local IRBs/ECs when appropriate.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "sponsoring--managing-or-conducting-transnational-research",
 "title": "Essential requirementsWhen sponsoring, managing, or conducting transnational research, witten materials describe the procedures for:<ul type=\"disc\"><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Ensuring knowledge of local laws.</li><li>Ensuring knowledge of cultural context.</li><li>Confirming the qualifications of the researchers and research staff for conducting research in that country.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Post-approval monitoring.</li><li>Handling of complaints, noncompliance, and unanticipated problems involving risk to participants or others.</li><li>Consent process and document and other language issues.</li><li>Coordination and communication with local IRBs/ECs when appropriate.</li></ul>GUIDANCEVerify that policies and procedures applied to research conducted domestically are applied to research sponsored, managed, or conducted in other countries, when applicable.",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>Ensuring knowledge of local laws.</li><li>Ensuring knowledge of cultural context.</li><li>Confirming the qualifications of the researchers and research staff for conducting research in that country.</li><li>Post-approval monitoring.</li><li>Handling of complaints, noncompliance, and unanticipated problems involving risk to participants or others.</li><li>Consent process and document and other language issues.</li><li>Coordination and communication with local IRBs/ECs when appropriate.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dod",
 "title": "When following DoD requirements, written materials are clear that the organization conducts or reviews DoD research conducted in countries other than the US.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">",
 "description": "",
 "keywords": "dod-transnational-research,serves-as-an-irb-for-dod-organizations",
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 "key": "dod",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A statement about that your organization conducts and/or reviews DoD research conducted in countries other than the US. I<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">f this type of research is not allowed, include a statement that the organization does not conduct or review DoD research in countries other than the US.If the organization does conduct or review DoD research outside the US include <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">a description of the process to confirm approval by the appropriate DoD component prior to research starting when human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens. Include who is responsible and the process they go through to obtain approval.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va-organizations",
 "title": "When the organization is a VA facility, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">VA international research is defined as any VA-approved research conducted at international sites (i.e., not within the United States (U.S.), its territories, or Commonwealths), any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data out of the U.S. This definition applies regardless of the funding source (funded or unfunded) and to research conducted through any mechanism of support including MOUs, Cooperative Research and Development Agreements (CRADAs), grants, contracts, or other agreements. Research conducted at U.S. military bases, ships, or embassies is not considered international research.</li><li>Sending specimens or data to individuals with VA appointments at international sites (e.g., a without compensation (WOC) appointment, a VA researcher on sabbatical at an international site) is considered international research. Remote use of data that is maintained on VA computers within the U.S. or Puerto Rico and U.S. territories accessed via a secure connection is not considered international research.</li><li>International research includes multi-site trials involving non-U.S. sites where VA is the study sponsor, a VA researcher is the overall study-wide PI, VA holds the Investigational New Drug (IND), or the VA manages the data collection and the data analyses.</li><li>International research does not include studies in which VA is only one of multiple participating sites where the overall study-wide principal researcher is not a VA researcher (i.e., the PI for the study as a whole is not a VA researcher).</li><li>Before approving international research involving human participants research, the IRB/EC must ensure that human participants outside of the U.S. who participate in research projects in which VA is a collaborator receive equivalent protections as research participants inside the U.S. if the activity involves human participants research requiring IRB/EC approval or limited IRB review.</li><li>All international research must also be approved explicitly in a document signed by the VA medical facility Director, except for Cooperative Studies Program activities which must be approved by the Chief Research and Development Officer (CRADO).</li></ul>",
 "description": "",
 "keywords": "org-is-va-transnational-research",
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 "title": "Add to or describe in written materials <page xx or elsewhere>:<ul><li>VA international research is defined as any VA-approved research conducted at international sites (i.e., not within the United States (U.S.), its territories, or Commonwealths), any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data out of the U.S. This definition applies regardless of the funding source (funded or unfunded) and to research conducted through any mechanism of support including MOUs, Cooperative Research and Development Agreements (CRADAs), grants, contracts, or other agreements. Research conducted at U.S. military bases, ships, or embassies is not considered international research.</li><li>Sending specimens or data to individuals with VA appointments at international sites (e.g., a without compensation (WOC) appointment, a VA researcher on sabbatical at an international site) is considered international research. Remote use of data that is maintained on VA computers within the U.S. or Puerto Rico and U.S. territories accessed via a secure connection is not considered international research.</li><li>International research includes multi-site trials involving non-U.S. sites where VA is the study sponsor, a VA researcher is the overall study-wide PI, VA holds the Investigational New Drug (IND), or the VA manages the data collection and the data analyses.</li><li>International research does not include studies in which VA is only one of multiple participating sites where the overall study-wide principal researcher is not a VA researcher (i.e., the PI for the study as a whole is not a VA researcher).</li><li>Before approving international research involving human participants research, the IRB/EC must ensure that human participants outside of the U.S. who participate in research projects in which VA is a collaborator receive equivalent protections as research participants inside the U.S. if the activity involves human participants research requiring IRB/EC approval or limited IRB review.</li><li>All international research must also be approved explicitly in a document signed by the VA medical facility Director, except for Cooperative Studies Program activities which must be approved by the Chief Research and Development Officer (CRADO).</li></ul>",
 "description": "",
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 }
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 },
 {
 "type": "section/standard",
 "key": "standard-i-4",
 "title": "STANDARD I-4",
 "description": "The organization responds to the concerns of research participants. ",
 "keywords": "all",
 "components": [
 {
 "type": "section/element",
 "key": "element-i-4-a",
 "title": "ELEMENT I.4.A.",
 "description": "The organization has and follows written policies and procedures that establish a safe,\nconfidential, and reliable channel for current, prospective, or past research participants\nor their designated representatives that permits them to discuss problems, concerns, and\nquestions; obtain information; or offer input with an informed individual who is unaffiliated\nwith the specific research protocol or plan. ",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: <ul><li>[document name] </li></ul>",
 "description": "",
 "keywords": "",
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 },
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 "type": "question/review-assessment",
 "key": "informed-consent-contact",
 "title": "Essential requirementsTemplate consent documents include contact information for an individual who is unaffiliated with a specific research study to:<ul><li>Discuss problems, concerns, and questions.</li><li>Obtain information.</li><li>Offer input.</li></ul>",
 "description": "",
 "keywords": "all",
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 "key": "informed-consent-contact",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Contact information for an individual who is unaffiliated with a specific research study to:<ul><li>Discuss problems, concerns, and questions.</li><li>Obtain information.</li><li>Offer input.</li></ul>",
 "description": "",
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 "type": "question/review-assessment",
 "key": "response-to-contacts",
 "title": "Essential requirementsWritten materials describe the steps followed when the organization responds to contacts from participants or others.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "response-to-contacts",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The steps followed when the organization responds to contacts from participants or others.",
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 "type": "section/element",
 "key": "element-i-4-b",
 "title": "ELEMENT I.4.B.",
 "description": "The organization conducts activities designed to enhance understanding of human research by participants, prospective participants, or their communities, when appropriate. These activities are evaluated on a regular basis for improvement.",
 "keywords": "all",
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 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: [document name] ",
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 "type": "question/review-assessment",
 "key": "enhancing-participant-understanding",
 "title": "Essential RequirementsWritten materials describe the plan and methods for enhancing the understanding of participants, prospective participants, and communities, including a description of:<ul><li>who is responsible for enhancing the understanding of participants, prospective participants, and communities</li><li>how understanding is enhanced (e.g., what materials, tools, worksheets, websites are used), and</li><li>when these activities occur.</li></ul>",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "enhancing-participant-understanding",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The plan and methods for enhancing the understanding of participants, prospective participants, and communities, including a description of:<ul><li>who is responsible for enhancing the understanding of participants, prospective participants, and communities</li><li>how understanding is enhanced (e.g., what materials, tools, worksheets, websites are used), and</li><li>when these activities occur.</li></ul>",
 "description": "",
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 "type": "question/review-assessment",
 "key": "evaluating-outreach-activities",
 "title": "Essential requirementsWritten materials describe who is responsible for evaluating outreach activities, when this occurs (e.g., annually, quarterly, monthly), the tools used (e.g., checklists, worksheets), and the review of results, and how this is documented.GUIDANCECouncil has not established a minimum period – this could be annual or every other year, for example, but policies must indicate how often it occurs.",
 "description": "",
 "keywords": "all",
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 "key": "evaluating-outreach-activities",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A description of who is responsible for evaluating outreach activities, when this occurs (e.g., annually, quarterly, monthly), the tools used (e.g., checklists, worksheets), and the review of results, and how this is documented.",
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 "type": "section/element",
 "key": "element-i-4-c",
 "title": "ELEMENT I.4.C.",
 "description": "The organization promotes the involvement of community members, when appropriate, in the design and implementation of research and the dissemination of results. ",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review: [document name] ",
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 "type": "question/review-assessment",
 "key": "community-involvement-in-research",
 "title": "Essential requirementsWritten materials describe how the organization supports mechanisms that allow researchers to involve community members in the research process, including the design and implementation of research and the dissemination of results, when appropriate. The description might include the following, among other information:<ul><li>Resources to provide support to researchers where there may be challenges recruiting due to community attitudes toward researchers or stigma about the research topic.</li><li>Education or information for researchers on how to identify relevant community members. This could include lists of local community resources with expertise in hard-to-reach populations.</li><li>Periodic evaluation of racial or ethnic demographic characteristics of participants enrolled in research to evaluate whether participation in research reflects the demographics of the community, when appropriate.</li></ul> GUIDANCEThis element refers to activities such as community engagement conducted by the organization to support researchers to involve community members in the design and conduct of research, when appropriate. This can include identifying relevant community contacts and providing educational materials for researchers. Although applications may not include a description of this, organizations with Clinical Translational Science Awards (CTSA) are expected to conduct these activities as part of the CTSA grant. This requirement is broader than just the specialized research method called “community-based participatory research” that specially focuses on inclusion of community members in the design and conduct of the research. Engaging community members in the design and conduct of research can be appropriate for research involving hard-to-reach populations, but it is also relevant for ensuring that the organization’s research reflects the demographics of the community, when appropriate.",
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 "key": "community-involvement-in-research",
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 "type": "question/review-assessment",
 "key": "additional-review-considerations",
 "title": "Essential requirementsWritten materials describe additional considerations for reviewing research that involves community members in the research process, including the design and implementation of research and the dissemination of results. The description might include the following, among other information:<ul><li>Education of IRB/EC members in community based participatory research.</li><li>Inclusion of IRB/EC members with expertise in community based participatory research.</li><li>Inclusion of consultants to the IRB/EC with expertise in community based participatory research.</li><li>Inclusion of information on IRB/EC applications concerning community-based research.</li><li>IRB/EC experience with this type of research.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "review-considerations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Additional considerations for reviewing research that involves community members in the research process, including the design and implementation of research and the dissemination of results. The description might include the following, among other information:<ul><li>Education of IRB/EC members in community based participatory research.</li><li>Inclusion of IRB/EC members with expertise in community based participatory research.</li><li>Inclusion of consultants to the IRB/EC with expertise in community based participatory research.</li><li>Inclusion of information on IRB/EC applications concerning community-based research.</li><li>IRB/EC experience with this type of research.</li></ul>",
 "description": "",
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 "type": "section/standard",
 "key": "standard-i-5",
 "title": "STANDARD I-5",
 "description": "The organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.  ",
 "keywords": "all",
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 "type": "section/element",
 "key": "element-i-5-a",
 "title": "ELEMENT I.5.A.",
 "description": "The organization conducts audits or surveys or uses other methods to assess compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization makes improvements to increase compliance, when necessary.",
 "keywords": "all",
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 "type": "question/review-assessment",
 "key": "test",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "key": "sample-snippet",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name] ",
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 },
 {
 "type": "question/review-assessment",
 "key": "qi-plan",
 "title": "Essential RequirementsWritten materials describe a quality improvement plan that periodically assesses the effectiveness of the HRPP’s compliance program, which should include:<ul><li>Who is responsible for developing and maintaining a plan, including:</li><li>Defining at least one objective to achieve or maintain compliance.</li><li>Defining at least one measure of compliance.</li><li>When objectives and measures are developed (e.g., annually in a certain month)</li><li>Who is responsible for reviewing results and making improvements.</li><li>When results are reviewed and improvements are made (e.g., annually in a certain month).</li><li>How the results of the quality improvement evaluation are documented (e.g., worksheets, meeting minutes, or other records demonstrating the organization follows its process)</li></ul>",
 "description": "",
 "keywords": "all",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:A quality improvement plan that periodically assesses the effectiveness of the HRPP’s compliance program, which should include:<ul><li>Who is responsible for developing and maintaining a plan, including:</li><li>Defining at least one objective to achieve or maintain compliance.</li><li>Defining at least one measure of compliance.</li><li>When objectives and measures are developed (e.g., annually in a certain month)</li><li>Who is responsible for reviewing results and making improvements.</li><li>When results are reviewed and improvements are made (e.g., annually in a certain month).</li><li>How the results of the quality improvement evaluation are documented (e.g., worksheets, meeting minutes, or other records demonstrating the organization follows its process)</li></ul>",
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 "type": "question/review-assessment",
 "key": "qi-goals-and-measures",
 "title": "Essential requirementsWritten materials describe examples of the types of goals and measures that might be adopted by the organization in the quality improvement plan with respect to achieving and maintaining compliance. GUIDANCEPolicies do not need to include the exact goals and measures in policies per se, just examples.",
 "description": "",
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 "type": "question/review-assessment",
 "key": "va-organizations",
 "title": "Written materials describe that the VA facility Director is responsible for:<ul><li>Notifying the appropriate Office of Research Oversight (ORO) workgroup(s) of the initiation of a research program or the substantial alteration of an existing research program that is related to the implementation, suspension, or termination of an HRPP.</li><li>Notifying, or designating an individual to notify, the appropriate ORO workgroup(s) within five (5) business days after receiving written notification of any situation that is reportable to ORO under VHA Directive 1058.01. NOTE: The VA medical facility director’s report is required regardless of whether the situation has been resolved at the time of the report.</li><li>Appointing at least one full-time Research Compliance Officer (RCO) to conduct research informed consent and regulatory audits unless the VA Office of Research and Development (ORD) and ORO jointly approve a waiver to permit appointing of a part-time RCO. The RCO, or a lead RCO if one is designated in instances where a VA medical facility employs more than one RCO, must report directly to and be supervised by either the VA medical facility Director or a senior individual who reports directly to and is supervised by the VA medical facility Director and whose primary responsibilities at the VA medical facility pertain directly to compliance.<ul><li>RCO activities must not be determined or managed by the Associate Chief of Staff for Research and Development (ACOS/R&D) or any other individual or research review committee in a VA medical facility’s Research Service.</li><li>The VA medical facility director must ensure that the RCO(s) has the necessary expertise, through education or experience, to fulfill the duties of the RCO position.</li><li>The VA medical facility director must ensure that the RCO(s) has ready access to research program and study documentation so that the RCO can effectively fulfill the responsibilities of the position. This includes access to documentation (e.g., research review committee meeting minutes, study approval letters, researcher study documentation) necessary to fulfill requirements related to auditing of informed consents and study protocols. NOTE: In situations where the VA medical facility relies upon a research review committee operated by a non-VA entity, the VA medical facility director must ensure that agreements to rely on such committees or other documents (e.g., the committee’s SOPs) require that the VA medical facility’s RCO has access to the committee’s records to the extent necessary for the RCO to fulfill research auditing requirements.</li></ul></li><li>Ensuring that all research compliance reports from any state or federal oversight entity (including ORO), as well as research accreditation reports/determinations, are provided to the ACOS/R&D, the R&DC, any other relevant research review committees, and the RCO within five (5) business days after receipt.</li></ul>Written materials describe that the VA Associate Chief of Staff for Research and Development (ACOS/R&D) is responsible for:<ul><li>Promptly reviewing and reporting events as specified in VHA Directive 1058.01.</li><li>Alerting, or designating an individual to alert, the VA medical facility Director and ORO by email or telephone within one business day after receiving the initial oral notification of a local research death of a human participant or a human death associated with VA animal or laboratory research and providing relevant information requested.</li></ul>Written materials describe that the VA Research Compliance Officer (RCO) is responsible for:<ul><li>Auditing VA medical facility research projects including performing annual informed consent and triennial regulatory audits of approved study protocols and other post-approval monitoring activities as specified by ORO. <ul><li>RCO audits must be conducted in accordance with a written audit plan or SOP that describes the RCO’s auditing process, including procedures for planning and executing audits, procedures for soliciting study researcher’s responses to preliminary audit findings and timelines for providing all audit results (regardless of findings) to the relevant research review committees, including the Research and Development (R&D) Committee.</li></ul></li><li>Informing the VA medical facility Director and applicable research review committees about research compliance concerns.</li><li>Performing additional research oversight duties assigned by his or her supervisor, including assisting in compliance education to researchers, research staff and research committee staff/members; accreditation activities; the completion of the VA medical facility Director’s Certification of Research Oversight; and ad hoc audits of individual studies or programs. Such duties must not conflict with or delay completion of the RCO’s research audit responsibilities.</li></ul>Written materials describe that the VA Research and Development (R&D) Committee Chair is responsible for:<ul><li>Ensuring the committee’s prompt review and reporting of events as required by VHA Directive 1058.01 and applicable federal regulations and policies pertaining to VA research.</li><li>Within one (1) business day after receiving written notification of the local research death of a human participant, assessing and documenting whether any actions are warranted to eliminate apparent immediate hazards to participants or others and, if so, initiating those actions. This may be delegated to another qualified committee voting member. </li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The VA facility Director is responsible for:<ul><li>Notifying the appropriate Office of Research Oversight (ORO) workgroup(s) of the initiation of a research program or the substantial alteration of an existing research program that is related to the implementation, suspension, or termination of an HRPP.</li><li>Notifying, or designating an individual to notify, the appropriate ORO workgroup(s) within five (5) business days after receiving written notification of any situation that is reportable to ORO under VHA Directive 1058.01. NOTE: The VA medical facility director’s report is required regardless of whether the situation has been resolved at the time of the report.</li><li>Appointing at least one full-time Research Compliance Officer (RCO) to conduct research informed consent and regulatory audits unless the VA Office of Research and Development (ORD) and ORO jointly approve a waiver to permit appointing of a part-time RCO. The RCO, or a lead RCO if one is designated in instances where a VA medical facility employs more than one RCO, must report directly to and be supervised by either the VA medical facility Director or a senior individual who reports directly to and is supervised by the VA medical facility Director and whose primary responsibilities at the VA medical facility pertain directly to compliance.<ul><li>RCO activities must not be determined or managed by the Associate Chief of Staff for Research and Development (ACOS/R&D) or any other individual or research review committee in a VA medical facility’s Research Service.</li><li>The VA medical facility director must ensure that the RCO(s) has the necessary expertise, through education or experience, to fulfill the duties of the RCO position.</li><li>The VA medical facility director must ensure that the RCO(s) has ready access to research program and study documentation so that the RCO can effectively fulfill the responsibilities of the position. This includes access to documentation (e.g., research review committee meeting minutes, study approval letters, researcher study documentation) necessary to fulfill requirements related to auditing of informed consents and study protocols. NOTE: In situations where the VA medical facility relies upon a research review committee operated by a non-VA entity, the VA medical facility director must ensure that agreements to rely on such committees or other documents (e.g., the committee’s SOPs) require that the VA medical facility’s RCO has access to the committee’s records to the extent necessary for the RCO to fulfill research auditing requirements.</li></ul></li><li>Ensuring that all research compliance reports from any state or federal oversight entity (including ORO), as well as research accreditation reports/determinations, are provided to the ACOS/R&D, the R&DC, any other relevant research review committees, and the RCO within five (5) business days after receipt.</li></ul>",
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 "description": "The organization conducts audits or surveys or uses other methods to assess the quality, efficiency, and effectiveness of the Human Research Protection Program. The organization identifies strengths and weaknesses of the Human Research Protection Program and makes improvements, when necessary, to increase the quality, efficiency, and effectiveness of the program.",
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 "type": "question/review-assessment",
 "key": "hrpp-qi-plan",
 "title": "Essential RequirementsWritten materials describe a quality improvement plan that periodically assesses the quality, efficiency and effectiveness of the HRPP, which should include:<ul><li>Who is responsible for developing and maintaining a plan, including:</li><li>Defining at least one objective to assess the quality, efficiency, and/or effectiveness of the HRPP.</li><li>Defining at least one measure of quality, efficiency, and/or effectiveness.</li><li>When objectives and measures are developed (e.g., annually in a certain month)</li><li>Who is responsible for reviewing results and making improvements.</li><li>When results are reviewed and improvements are made (e.g., annually in a certain month).</li><li>How the results of the quality improvement evaluation are documented (e.g., worksheets, meeting minutes, or other records demonstrating the organization follows its process)</li></ul>",
 "description": "",
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 },
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 "type": "question/review-assessment",
 "key": "examples-of-goals",
 "title": "Essential RequirementsWritten materials describe examples of the types of goals and measures that might be adopted by the organization in the quality improvement plan with respect to achieving and maintaining compliance. Policies do not need to include the exact goals and measures in policies per se, just examples.",
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 "type": "question/review-assessment",
 "key": "va-organizations",
 "title": "Written materials for the VA facility describe:<ul><li>The VA facility Director is responsible for:<ul><li>Ensuring that the VA medical facility’s research review and oversight programs function effectively, and that the VA medical facility provides the resources necessary to comply with all requirements applicable to the responsible conduct of research.</li></ul></li><li>The VA Research and Development (R&D) Committee is responsible for:<ul><li>Assisting the medical facility director in fulfilling responsibilities for the facility’s research program by making recommendations regarding personnel, training, space, equipment, and other resource needs of the research program.</li><li>Reviewing all research related committees and subcommittees at least annually in part by: reviewing the minutes of each subcommittee that reviews VA research protocols; by close communication with the subcommittees; and through Quality Assurance and Quality Improvement activities.<ul><li>When a VA facility uses an IRB/EC other than its own internal IRB, such as, but not limited to, the VACO IRB, the IRB/EC of another Federal agency, or a non-VA academic institution’s IRB, the role of the R&D Committee is to review and evaluate facility-specific aspects of these relationships, rather than the subcommittee itself, to ensure the obligations as detailed in the MOU are being met. For example, review of an external committee would include evaluation of the number of projects handled by the committee, communication between entities, changes in MOUs or other agreements, change in processes, and challenges. A summary of these reviews and evaluations must be sent to the medical facility director annually.</li></ul></li></ul></li></ul>",
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 "title": "Add to written materials [page xx or elsewehere]:<ul><li>The VA facility Director is responsible for:<ul><li>Ensuring that the VA medical facility’s research review and oversight programs function effectively, and that the VA medical facility provides the resources necessary to comply with all requirements applicable to the responsible conduct of research.</li></ul></li><li>The VA Research and Development (R&D) Committee is responsible for:<ul><li>Assisting the medical facility director in fulfilling responsibilities for the facility’s research program by making recommendations regarding personnel, training, space, equipment, and other resource needs of the research program.</li><li>Reviewing all research related committees and subcommittees at least annually in part by: reviewing the minutes of each subcommittee that reviews VA research protocols; by close communication with the subcommittees; and through Quality Assurance and Quality Improvement activities.<ul><li>When a VA facility uses an IRB/EC other than its own internal IRB, such as, but not limited to, the VACO IRB, the IRB/EC of another Federal agency, or a non-VA academic institution’s IRB, the role of the R&D Committee is to review and evaluate facility-specific aspects of these relationships, rather than the subcommittee itself, to ensure the obligations as detailed in the MOU are being met. For example, review of an external committee would include evaluation of the number of projects handled by the committee, communication between entities, changes in MOUs or other agreements, change in processes, and challenges. A summary of these reviews and evaluations must be sent to the medical facility director annually.</li></ul></li></ul></li></ul>",
 "description": "",
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 {
 "type": "section/element",
 "key": "element-i-5-c",
 "title": "ELEMENT I.5.C.",
 "description": "The organization has and follows written policies and procedures so that researchers and research staff may bring forward to the organization concerns or suggestions regarding the Human Research Protection Program, including the ethics review process. ",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 {
 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 "type": "question/review-assessment",
 "key": "hrpp-suggestions",
 "title": "Essential RequirementsWritten materials describe the process for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the HRPP. Common types of materials include, but are not limited to, phone numbers for feedback, organization’s website, approval letters, posters, and customer satisfaction surveys. ",
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 "key": "hrpp-suggestions",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the HRPP. Common types of materials include, but are not limited to, phone numbers for feedback, organization’s website, approval letters, posters, and customer satisfaction surveys. ",
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 {
 "type": "section/element",
 "key": "element-i-5-d",
 "title": "ELEMENT I.5.D.",
 "description": "The organization has and follows written policies and procedures for addressing allegations and findings of non-compliance with Human Research Protection Program requirements. The organization works with the Institutional Review Board or Ethics Committee, when appropriate, to ensure that participants are protected when non-compliance occurs. Such policies and procedures include reporting these actions, when appropriate.  ",
 "keywords": "all",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name] ",
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 "type": "question/review-assessment",
 "key": "noncompliance-definitions",
 "title": "Essential RequirementsWritten materials include definitions of:<ul><li>Noncompliance.</li><li>Serious noncompliance.</li><li>Continuing noncompliance.</li></ul>",
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 "key": "noncompliance-definitions",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Noncompliance.</li><li>Serious noncompliance.</li><li>Continuing noncompliance.</li></ul> ",
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 {
 "type": "question/review-assessment",
 "key": "informing-irb-ec",
 "title": "Essential RequirementsWritten materials describe mechanisms for informing the organization or IRB/EC of noncompliance:<ul><li>Reporting requirements for researchers, staff, and employees.</li><li>Consideration of complaints and protocol deviations.</li><li>Results of audits.</li><li>Describe in written materials (page XX):</li><li>The organization’s process to decide whether each allegation of noncompliance has a basis in fact.</li><li>The organization’s process to decide whether each incident of noncompliance is serious or continuing.</li></ul>",
 "description": "",
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 "type": "text/review-assessment-snippet",
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 "title": "Add to or describe in written materials page xx or elsewhere]:Mechanisms for informing the organization or IRB/EC of noncompliance:<ul><li>Reporting requirements for researchers, staff, and employees.</li><li>Consideration of complaints and protocol deviations.</li><li>Results of audits.</li><li>Describe in written materials (page XX):</li><li>The organization’s process to decide whether each allegation of noncompliance has a basis in fact.</li><li>The organization’s process to decide whether each incident of noncompliance is serious or continuing.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "not-serious-not-continuing-noncompliance",
 "title": "Essential RequirementsWritten materials describe the process to manage noncompliance that is neither serious nor continuing.",
 "description": "",
 "keywords": "all",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "not-serious-not-continuing-noncompliance",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process to manage noncompliance that is neither serious nor continuing. ",
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 {
 "type": "question/review-assessment",
 "key": "review-by-convened-irb-ec",
 "title": "Essential RequirementsThe process for management of serious or continuing noncompliance by the convened IRB/EC, including the documents distributed to primary reviewers. ",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "review-by-convened-irb-ec",
 "title": "For organizations that have primary reviewersAdd to or describe in written materials [page xx or elsewhere]:The process for management of serious or continuing noncompliance by the convened IRB/EC, including:<ul><li>Documents distributed to primary reviewers. </li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Documents distributed to all IRB/EC members.</li><li>The range of possible actions considered by the IRB:<ul><li>Required actions:<ul><li>Suspension of IRB/EC approval of the research.</li><li>Termination of IRB/EC approval of the research.</li><li>Notification of current participants when such information might relate to participants’ willingness to continue to take part in the research.</li></ul></li><li>Optional actions:<ul><li>Modification of the protocol.</li><li>Modification of the information disclosed during the consent process.</li><li>Providing additional information to past participants.</li><li>Requiring current participants to re-consent to participation.</li><li>Modification of the continuing review schedule.</li><li>Monitoring of the research.</li><li>Monitoring of the consent process.</li><li>Referral to other organizational entities. </li></ul></li></ul></li></ul>",
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 "type": "text/review-assessment-snippet",
 "key": "review-by-convened-irb-ec---no-primary-reviewers",
 "title": "For organizations that do not have primary reviewersAdd to or describe in written materials [page xx or elsewhere]:The process for management of serious or continuing noncompliance by the convened IRB/EC, including:<ul><li>Documents distributed to all IRB/EC members.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li><li>The range of possible actions considered by the IRB:<ul><li>Required actions:<ul><li>Suspension of IRB/EC approval of the research.</li><li>Termination of IRB/EC approval of the research.</li><li>Notification of current participants when such information might relate to participants’ willingness to continue to take part in the research.</li></ul></li><li>Optional actions:<ul><li>Modification of the protocol.</li><li>Modification of the information disclosed during the consent process.</li><li>Providing additional information to past participants.</li><li>Requiring current participants to re-consent to participation.</li><li>Modification of the continuing review schedule.</li><li>Monitoring of the research.</li><li>Monitoring of the consent process.</li><li>Referral to other organizational entities. </li></ul></li></ul></li></ul><ul style=\"margin-left: 30px\"></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "reporting",
 "title": "Written materials describe the reporting of serious or continuing noncompliance, including:<ul><li>Distribution of the report to:<ul><li>Specific organizational officials.</li><li>Other agencies when the research is overseen by those agencies.</li></ul></li><li>The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements (not more than 30 days).</li></ul>",
 "description": "",
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 "key": "reporting",
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs-ohrp-reporting",
 "title": "When following DHHS requirements, written materials describe the reporting of serious or continuing noncompliance\nto OHRP.",
 "description": "",
 "keywords": "dhhs",
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 "type": "text/review-assessment-snippet",
 "key": "dhhs-ohrp-reporting",
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 {
 "type": "question/review-assessment",
 "key": "dod",
 "title": "When following DoD requirements, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Who is responsible and the process used to promptly (AAHRPP defines “promptly” as within 30 days) report to the Component Office of Human Research Protections (COHRP).<ul><li>Reports of audits of DoD-conducted or DoD-supported human participant research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government.</li><li>Allegations of serious or continuing noncompliance related to research involving human participants that are substantiated by investigation, and subsequent actions taken based on the findings.</li><li>Substantiated allegations related to classified HSR must be reported immediately.</li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Who is responsible and the process used to promptly (AAHRPP defines “promptly” as within 30 days) report to the Component Office of Human Research Protections (COHRP).</li></ul><ul style=\"margin-left: 30px\"><li>Reports of audits of DoD-conducted or DoD-supported human participant research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government.</li><li>Allegations of serious or continuing noncompliance related to research involving human participants that are substantiated by investigation, and subsequent actions taken based on the findings.</li><li>Substantiated allegations related to classified HSR must be reported immediately.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "doe",
 "title": "When following DOE requirements, written materials describe that the HSP Program Manager at DOE or NNSA must be notified within 48 hours, with a description of corrective actions taken, of any known or potential incidents of noncompliance.",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The HSP Program Manager at DOE or NNSA must be notified within 48 hours, with a description of corrective actions taken, of any known or potential incidents of noncompliance.",
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 {
 "type": "question/review-assessment",
 "key": "us-fda",
 "title": "When following US FDA regulations, written materials describe the reporting of serious or continuing noncompliance to\nFDA.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va",
 "title": "When following VA requirements, written materials describe:The following definitions, procedures, and timeframes:<ul><li>Serious noncompliance is any failure to adhere to requirements for conducting human research that may reasonably be regarded as: <ul><li>Presenting a genuine risk of substantive harm to the safety, rights, or welfare of human research participants, research staff, or others, including the rights to privacy and confidentiality of identifiable private information.</li><li>Presenting a genuine risk of substantive harm to the safety, rights, or welfare of research personnel who conduct research.</li><li>Presenting a genuine risk of substantive reputational harm to VA.</li><li>Substantively compromising a VA facility’s HRPP or research information security processes.</li></ul></li><li>Continuing noncompliance means repeated instances of noncompliance with applicable laws, regulations, policies, agreements, or determinations of a research review committee or the prolonged persistence of noncompliance occurring after its identification, awareness, or implementation of a corrective action intended to effectively resolve the noncompliance.<ul><li>The determination that noncompliance is “serious” or “continuing” rests with the IRB.</li></ul></li><li>Apparent serious or continuing noncompliance:<ul><li>VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent serious and/or continuing noncompliance with applicable laws, regulations, policies, and agreements pertaining to non-exempt human participants research. This includes, but is not limited to, serious or continuing noncompliance with the Common Rule, local VA medical facility policies and SOPs related to human participants research, if developed, IRB-approved protocols, and the requirements or determinations of the IRB.</li><li>In response to the written notification, the IRB/EC must:<ul><li>Review the written notification at its next convened meeting, not to exceed 30 calendar days after the date of written notification. NOTE: Incidents covered by this paragraph may call for immediate attention and require the IRB/EC to convene an emergency session prior to its next scheduled meeting.</li></ul></li><li>Determine and document within 60 calendar days of the convened IRB’s/EC’s initial review:<ul><li>Whether or not serious or continuing noncompliance actually occurred; and if so,</li><li>What, if any, remedial actions are needed to resolve present noncompliance or prevent future noncompliance.</li></ul></li><li>If the IRB/EC determines that serious or continuing noncompliance actually occurred, it must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.</li></ul></li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The following definitions, procedures, and timeframes:<ul><li>Serious noncompliance is any failure to adhere to requirements for conducting human research that may reasonably be regarded as:<ul><li>Presenting a genuine risk of substantive harm to the safety, rights, or welfare of human research participants, research staff, or others, including the rights to privacy and confidentiality of identifiable private information.</li><li>Presenting a genuine risk of substantive harm to the safety, rights, or welfare of research personnel who conduct research.</li><li>Presenting a genuine risk of substantive reputational harm to VA.</li><li>Substantively compromising a VA facility’s HRPP or research information security processes.</li></ul></li><li>Continuing noncompliance means repeated instances of noncompliance with applicable laws, regulations, policies, agreements, or determinations of a research review committee or the prolonged persistence of noncompliance occurring after its identification, awareness, or implementation of a corrective action intended to effectively resolve the noncompliance.<ul><li>The determination that noncompliance is “serious” or “continuing” rests with the IRB.</li></ul></li><li>Apparent serious or continuing noncompliance:<ul><li>VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent serious and/or continuing noncompliance with applicable laws, regulations, policies, and agreements pertaining to non-exempt human participants research. This includes, but is not limited to, serious or continuing noncompliance with the Common Rule, local VA medical facility policies and SOPs related to human participants research, if developed, IRB-approved protocols, and the requirements or determinations of the IRB.</li><li>In response to the written notification, the IRB/EC must:<ul><li>Review the written notification at its next convened meeting, not to exceed 30 calendar days after the date of written notification. NOTE: Incidents covered by this paragraph may call for immediate attention and require the IRB/EC to convene an emergency session prior to its next scheduled meeting.</li></ul></li><li>Determine and document within 60 calendar days of the convened IRB’s/EC’s initial review:<ul><li>Whether or not serious or continuing noncompliance actually occurred; and if so,</li><li>What, if any, remedial actions are needed to resolve present noncompliance or prevent future noncompliance.</li></ul></li><li>If the IRB/EC determines that serious or continuing noncompliance actually occurred, it must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
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 "title": "Written materials describe that the VA facility Director is responsible for:<ul><li>Ensuring timely implementation of remedial actions to address research noncompliance identified by VA medical facility personnel, VA Office of Research Oversight (ORO), and other entities.</li><li>Notifying, or designating an individual to notify, the appropriate ORO workgroup(s) within five business days of becoming aware of the issuance of a research-related citation or determination of noncompliance by a state or federal entity (including the VA Office of Inspector General) or an accrediting organization, pertaining to an event(s) within the scope of this directive.</li><li>Ensuring timely implementation of remedial actions to address research noncompliance identified by VA medical facility personnel, ORO, and other entities.</li><li>Remedial actions to correct noncompliance identified by ORO or that is otherwise required to be reported to ORO must be completed within 180 calendar days after any determination of noncompliance, except where extenuating circumstances exist (e.g., remediation requires substantial renovation or fiscal expenditure, hiring, or legal negotiations).</li><li>Where remedial actions cannot be completed in 180 calendar days, the VA medical facility Director must provide the appropriate ORO workgroup(s) with written justification and a reasonable timeline for completion.</li></ul>",
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 "type": "section/standard",
 "key": "standard-i-6",
 "title": "STANDARD I-6",
 "description": "The organization has and follows written policies and procedures to ensure that research is conducted so that financial conflicts of interest are identified, managed, and minimized or eliminated. ",
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 "description": "The organization has and follows written policies and procedures to identify, manage, and minimize or eliminate financial conflicts of interest of the organization that could influence the conduct of the research or the integrity of the Human Research Protection Program.  ",
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 {
 "type": "question/review-assessment",
 "key": "managing-icoi",
 "title": "Essential RequirementsWritten materials describe procedures for recognizing and managing organizational conflict of interest.GUIDANCEReview of organizational conflicts of interest is different from review of researcher and research staff conflicts of interest:The IRB/EC does not need to review organizational conflicts of interest, nor does it need to be informed of the management plan.Check that the organizational conflict of interest policy is approved - if not approved, add a note in the general requirements section that this policy must be approved to move to Step 2.",
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 {
 "type": "question/review-assessment",
 "key": "defining-icoi",
 "title": "Essential RequirementsWritten materials define organizational financial conflict of interest, including: <ul><li>Licensing, technology transfer, and patents.</li><li>Investments of the organization.</li><li>Gifts, when the donor has an interest in the research.</li><li>Financial interests of senior administrators.</li><li>Other financial interests.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "identifying-icoi",
 "title": "Essential RequirementsWritten materials describe the process to identify or disclose financial conflicts of interest of the organization. ",
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 "keywords": "all",
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 "type": "text/review-assessment-snippet",
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 },
 {
 "type": "question/review-assessment",
 "key": "evaluate-icoi",
 "title": "Essential RequirementsWritten materials describe the process that the organization uses to evaluate organizational financial conflict of interest. ",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The process that the organization uses to evaluate organizational financial conflict of interest.",
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 },
 {
 "type": "question/review-assessment",
 "key": "entity-who-manages-icoi",
 "title": "Essential RequirementsWritten materials describe the committee or individual(s) and process that the organization uses to evaluate and manage organizational financial conflict of interest and included examples of management strategies.",
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 "key": "entity-who-manages-icoi",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The committee or individual(s) and process that the organization uses to evaluate and manage organizational financial conflict of interest. Include examples of management strategies.",
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 "type": "section/element",
 "key": "element-i-6-b",
 "title": "ELEMENT I.6.B.",
 "description": "The organization has and follows written policies and procedures to identify, manage, and minimize or eliminate individual financial conflicts of interest of Researchers and research staff that could influence the conduct of the research or the integrity of the Human Research Protection Program. The organization works with the Institutional Review Board or Ethics Committee in ensuring that financial conflicts of interest are managed and minimized or eliminated, when appropriate. ",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 {
 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name] ",
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 "type": "question/review-assessment",
 "key": "definition-of-coi",
 "title": "Essential RequirementsWritten materials define the financial interests of researchers and research staff for which the organization requires disclosure:<ul><li>Financial interests of researchers and research staff.</li><li>Financial interests of immediate family members.</li><li>Immediate family members at a minimum include the spouse and each dependent child.</li><li>“Financial Interest Related to the Research” means financial interest in the sponsor, product, or service being tested. </li></ul>GUIDANCEThe definition the organization provides can be equivalent or stricter.Evaluate the disclosure threshold and the threshold for defining a financial conflict of interest that requires management. If the organization adopts different disclosure thresholds to comply with different requirements, confirm the thresholds for management comply with different regulatory requirements. Independent IRBs/ECs also must define disclosure thresholds. However, it is acceptable to AAHRPP for independent IRBs/ECs to use an attestation form where the researcher attests they will disclose financial interests per the disclosure thresholds defined by the independent IRB.",
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 "key": "coi-definition",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A definition of the financial interests of researchers and research staff for which the organization requires disclosure:<ul><li>Financial interests of researchers and research staff.</li><li>Financial interests of immediate family members.</li><li>Immediate family members at a minimum include the spouse and each dependent child.</li><li>“Financial Interest Related to the Research” means financial interest in the sponsor, product, or service being tested. </li></ul>",
 "description": "",
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 "type": "question/review-assessment",
 "key": "dhhs-requirements",
 "title": "When following DHHS requirements, significant financial interest means:<ul><li>A financial interest consisting of one or more of the following interests of the Researcher (and those of the researcher’s spouse and dependent children) that reasonably appears to be related to the researcher’s institutional responsibilities:<ul><li>With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. (For purposes of this definition, remuneration includes salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest as determined through reference to public prices or other measures of fair market value).</li><li>With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000 or when the researcher (or the researcher’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);</li><li>Intellectual property rights and interest (e.g., patents, copyrights), upon receipt of income related to such rights and interests.</li><li>Researchers must also disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the researcher and not reimbursed to the researcher so that the exact monetary value might not be readily available) related to the institutional responsibilities; provided, however, that this disclosure does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C.1001(a), an academic teaching hospital, or a research institute that is affiliated with an institution of higher education.</li></ul></li></ul>",
 "description": "",
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 "key": "dhhs-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements, significant financial interest means:<ul><li>A financial interest consisting of one or more of the following interests of the Researcher (and those of the researcher’s spouse and dependent children) that reasonably appears to be related to the researcher’s institutional responsibilities:<ul><li>With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. (For purposes of this definition, remuneration includes salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest as determined through reference to public prices or other measures of fair market value).</li><li>With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000 or when the researcher (or the researcher’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);</li><li>Intellectual property rights and interest (e.g., patents, copyrights), upon receipt of income related to such rights and interests.</li><li>Researchers must also disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the researcher and not reimbursed to the researcher so that the exact monetary value might not be readily available) related to the institutional responsibilities; provided, however, that this disclosure does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C.1001(a), an academic teaching hospital, or a research institute that is affiliated with an institution of higher education.</li></ul></li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "nsf",
 "title": "When following NSF requirements, written materials describe that the financial interests of the researcher or research staff, or their immediate family means:<ul><li>Ownership interest, stock options, or other financial interest related to the research unless it:</li><li>Does not exceed $10,000 when aggregated for the immediate family.</li><li>Is publicly traded on a stock exchange.</li><li>Compensation related to the research unless it does not exceed $10,000 in the past year when aggregated for the immediate family. </li><li>Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright, or licensing agreement.</li></ul>",
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 "key": "nsf",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following NSF requirements, financial interests of the researcher or research staff, or their immediate family means:<ul><li>Ownership interest, stock options, or other financial interest related to the research unless it:</li><li>Does not exceed $10,000 when aggregated for the immediate family.</li><li>Is publicly traded on a stock exchange.</li><li>Compensation related to the research unless it does not exceed $10,000 in the past year when aggregated for the immediate family. </li><li>Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright, or licensing agreement.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "us-fda",
 "title": "When following US FDA requirements, written materials describe the financial interests of the researcher or research staff, or their immediate family means:<ul><li>Ownership interest, stock options, or other financial interest related to the research unless it meets four tests:</li><li>Does not exceed $50,000 when aggregated for the immediate family.</li><li>Publicly traded on a stock exchange.</li><li>No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research. </li><li>Does not exceed 5% interest in any one single entity when aggregated for the immediate family. </li><li>Compensation related to the research unless it meets two tests:</li><li>Does not exceed $25,000 in the past year when aggregated for the immediate family. </li><li>No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.</li><li>Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.</li></ul>",
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 "key": "us-fda",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following US FDA requirements, the financial interests of the researcher or research staff, or their immediate family means:<ul><li>Ownership interest, stock options, or other financial interest related to the research unless it meets four tests:</li><li>Does not exceed $50,000 when aggregated for the immediate family.</li><li>Publicly traded on a stock exchange.</li><li>No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research.</li><li>Does not exceed 5% interest in any one single entity when aggregated for the immediate family.</li><li>Compensation related to the research unless it meets two tests:</li><li>Does not exceed $25,000 in the past year when aggregated for the immediate family.</li><li>No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.</li><li>Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "non-us",
 "title": "Essential RequirementsFor organizations outside the US, written materials describe that the financial interests of the researcher or research staff, or their immediate family means:<ul><li>Ownership interest, stock options, or other financial interest related to the research unless it meets four tests:</li><li>Does not exceed $50,000 when aggregated for the immediate family.</li><li>Publicly traded on a stock exchange.</li><li>No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research. </li><li>Does not exceed 5% interest in any one single entity when aggregated for the immediate family. </li><li>Compensation related to the research unless it meets two tests:</li><li>Does not exceed $25,000 in the past year when aggregated for the immediate family. </li><li>No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.</li><li>Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.</li></ul> GUIDANCEOrganizations outside the US that are not required to follow US regulatory requirements must have equivalent researcher and research staff conflict of interest disclosure requirements and processes. Check the Addendum, and if not included in the Addendum indicate in your assessment the page number(s) of written materials on researcher and research staff conflicts of interest, or where the above information could be added or needs to be added.",
 "description": "",
 "keywords": "outside-us",
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 "key": "non-us",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The financial interests of the researcher or research staff, or their immediate family means:<ul><li>Ownership interest, stock options, or other financial interest related to the research unless it meets four tests:</li><li>Does not exceed $50,000 when aggregated for the immediate family.</li><li>Publicly traded on a stock exchange.</li><li>No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research.</li><li>Does not exceed 5% interest in any one single entity when aggregated for the immediate family.</li><li>Compensation related to the research unless it meets two tests:</li><li>Does not exceed $25,000 in the past year when aggregated for the immediate family.</li><li>No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.</li><li>Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "disclosure-forms",
 "title": "Essential RequirementsDisclosure forms have individuals involved in the design, conduct, or reporting of the research disclose the financial interests that require disclosure under regulation.GUIDANCEConfirm that disclosure forms and policy are consistent and include disclosures required by the requirements the organization follows:<ul><li>For organizations that must follow Public Health Service (PHS) and FDA requirements: Both PHS and FDA regulations.</li><li>For organizations that must follow only FDA requirements: FDA requirements.</li><li>For organizations that must follow PHS and National Science Foundation (NSF) requirements: Both PHS and NSF requirements.</li><li>For organizations that must follow only PHS research: PHS requirements.</li><li>For organizations that must follow only NSF regulations: NSF requirements.</li><li>For organizations that are not required to follow FDA, NSF, or PHS regulations: Disclosures equivalent to FDA, NSF, or PHS requirements.</li><li>Others, including organizations outside the US: Evaluate to confirm equivalent protections</li></ul>Disclosure threshold can vary, depending on funding or regulatory oversight, so long as the organization has the ability to track different disclosure requirements.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "disclosure-forms",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Individuals involved in the design, conduct, or reporting of the research disclose the financial interests that require disclosure under regulation.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "research-team-education",
 "title": "Essential RequirementsWritten materials describe the process to\neducate researchers and research staff about disclosures and responsibilities\nrelated to financial conflict of interest. <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Education is required of each individual initially and at least every four years.<ul><li>Education is required immediately when:</li><li>Financial conflict of interest policies are revised in a manner that changes researcher requirements.</li><li>A researcher is new to the organization.</li><li>A researcher is noncompliant with financial conflict of interest policies and procedures.</li></ul>",
 "description": "",
 "keywords": "not-an-independent-irb-ec",
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 "key": "research-team-education",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process to\neducate researchers and research staff about disclosures and responsibilities\nrelated to financial conflict of interest. <ul><li>Education is required of each individual initially and at least every four years.</li><li>Education is required immediately when:</li><li>Financial conflict of interest policies are revised in a manner that changes researcher requirements.</li><li>A researcher is new to the organization.</li><li>A researcher is noncompliant with financial conflict of interest policies and procedures.</li></ul>",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "obtaining-disclosures",
 "title": "Essential RequirementsWritten materials describe the process to obtain financial disclosures from researchers and researcher staff to require:<ul><li>Minimum of annual disclosure.</li><li>Update new significant financial interests within 30 days of acquisition or discovery.</li></ul>",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "obtaining-disclosures",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process to obtain financial disclosures from researchers and researcher staff to require:<ul><li>Minimum of annual disclosure.</li><li>Update new significant financial interests within 30 days of acquisition or discovery. </li></ul>",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "evaluating-and-managing-coi",
 "title": "Essential RequirementsWritten materials describe the process to evaluate and manage financial interests.<ul><li>The organizational official(s) or committee designated to evaluate and manage financial interests.</li><li>The definition of significant financial interest.</li><li>The inclusion of relatedness to research in the definition of significant financial interest.</li><li>Examples of strategies to manage financial conflicts of interest.</li></ul>",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "evaluating-and-managing-coi",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Add to or describe in written materials [page xx or elsewhere]:The process to evaluate and manage financial interests:<ul><li>The organizational official(s) or committee designated to evaluate and manage financial interests.</li><li>The definition of significant financial interest.</li><li>The inclusion of relatedness to research in the definition of significant financial interest.</li><li>Examples of strategies to manage financial conflicts of interest.</li></ul>",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "coi-monitoring-enforcement",
 "title": "Essential RequirementsWritten materials describe:<ul><li>The monitoring and enforcement mechanisms for management plans and the provision of employee sanctions or other administrative actions to ensure researcher compliance.</li><li>Examples of sanctions or other administrative actions.</li></ul>",
 "description": "",
 "keywords": "not-an-independent-irb-ec",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "coi-monitoring-enforcement",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The monitoring and enforcement mechanisms for management plans and the provision of employee sanctions or other administrative actions to ensure researcher compliance.</li><li>Examples of sanctions or other administrative actions.</li></ul> ",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "coi-management-outside-irb-ec",
 "title": "Essential RequirementsWritten materials describe that i<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">f a committee or individual other than the IRB/EC evaluates and manages financial interests of researchers and research staff, policies and procedures describe:<ul><li>The process to inform the IRB/EC of the results of this evaluation, including any management plan.</li><li>The process that allows the IRB/EC to have the final authority to decide whether the interest and its management, if any, allows the research to be approved.</li></ul>",
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 "key": "coi-management-outside-irb-ec",
 "title": "Add to or describe in written materials [page xx or elsewhere]:If a committee or individual other than the IRB/EC evaluates and manages financial interests of researchers and research staff, policies and procedures describe:<ul><li>The process to inform the IRB/EC of the results of this evaluation, including any management plan.</li><li>The process that allows the IRB/EC to have the final authority to decide whether the interest and its management, if any, allows the research to be approved.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "coi-record-maintenance",
 "title": "Essential RequirementsWritten materials describe the plan to maintain records related to disclosures and management of financial conflicts of interest for at least three years from completion of the research. ",
 "description": "",
 "keywords": "not-an-independent-irb-ec",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "coi-record-maintenance",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The plan to maintain records related to disclosures and\nmanagement of financial conflicts of interest for at least three years from\ncompletion of the research. ",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "phs-requirements",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">When following PHS requirements, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">The process the organization uses to obtain disclosures from researchers and research staff of institutional responsibilities related to significant financial interests. </li><li>A definition of the institutional responsibilities.</li><li>The process the organization uses to obtain disclosures from researchers and research staff of reimbursed or sponsored travel related to institutional responsibilities.</li><li>A definition of what reimbursed or sponsored travel is required to be reported.</li><li>At a minimum, travel disclosures will include the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration.</li></ul>GUIDANCEPHS requirements are found at 42 CFR 50.601-607 (especially 42 CFR 50.604, “Responsibilities of Institutions Regarding Investigator Financial Conflicts of Interest”).PHS agencies include:<ul><li>NIH – National Institutes of Health</li><li>CDC – Centers for Disease Control and Prevention</li><li>HRSA – Health Resources & Services Administration</li><li>FDA – Food & Drug Administration</li><li>SAMHSA – Substance Abuse & Mental Health Services</li><li>IHS – Indian Health Services</li><li>ATSDR – Agency for Toxic Substances & Disease Registry</li><li>AHRQ - Agency for Health Care Research and Quality</li><li>Office of the Secretary</li></ul>In addition, organizations may follow PHS requirements as part of their policy. ",
 "description": "",
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 "type": "text/review-assessment-snippet",
 "key": "phs-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The process the organization uses to obtain disclosures from researchers and research staff of institutional responsibilities related to significant financial interests. </li><li>A definition of the institutional responsibilities.</li><li>The process the organization uses to obtain disclosures from researchers and research staff of reimbursed or sponsored travel related to institutional responsibilities.</li><li>A definition of what reimbursed or sponsored travel is required to be reported.</li><li>At a minimum, travel disclosures will include the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va",
 "title": "Written materials for the VA facility describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">VA facilities are not required to follow PHS requirements, even when research is funded by a PHS agency (e.g., NIH).</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Affiliates that serve as IRBs/ECs of record for VA facilities must use the VA financial conflict of interest form, and may not create, redraft, or change this form.</li></ul>GUIDANCEThe PHS requirements do not apply to the VHA. Although the PHS requirements state they are applicable to “each institution that is applying for, or that receives, PHS research funding ...,” (42 CFR 50.601), the definition of “institution” excludes federal agencies (42 CFR 50.603).  ",
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 "key": "va-organization",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>VA facilities are not required to follow PHS requirements, even when research is funded by a PHS agency (e.g., NIH).</li><li>Affiliates that serve as IRBs/ECs of record for VA facilities must use the VA financial conflict of interest form, and may not create, redraft, or change this form.</li></ul>",
 "description": "",
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 },
 {
 "type": "section/standard",
 "key": "standard-i-7",
 "title": "STANDARD I-7",
 "description": "The organization has and follows written policies and procedures to ensure that the use of any investigational or unlicensed test article complies with all applicable legal and regulatory requirements.  ",
 "keywords": "outside-us-investigational-devices,outside-us-investigational-drugs,us-based-investigational-devices,us-based-investigational-drugs,us-fda",
 "components": [
 {
 "type": "section/element",
 "key": "element-i-7-a",
 "title": "ELEMENT I.7.A.",
 "description": "When research involves investigational or unlicensed test articles, the organization confirms that the test articles have appropriate regulatory approval or meet exemptions for such approval.  ",
 "keywords": "investigational-devices,investigational-drugs",
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 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "outside-us-investigational-devices,outside-us-investigational-drugs,us-based-investigational-devices,us-based-investigational-drugs,us-fda",
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 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name] ",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "requirements-for-investigational-test-articles",
 "title": "Essential RequirementsWritten materials describe the legal and regulatory requirements that apply to the use of investigational test articles (e.g., drugs, devices, biologics), including when they require regulatory agency approval, such as by the US FDA or other country equivalent FDA.GUIDANCEOrganizations outside the US are not required to follow US FDA requirements, provided they follow country-specific law and country-specific GCP, or follow ICH-GCP (E6). <ul><li>If you see US FDA requirements in policies, contact AAHRPP staff. </li><li>Use the Addendum to confirm policies meet requirements of country-specific laws.</li></ul> ",
 "description": "",
 "keywords": "investigational-devices,investigational-drugs",
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 "type": "text/review-assessment-snippet",
 "key": "legal-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:T<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">he legal and regulatory requirements that apply to the use of investigational test articles (e.g., drugs, devices, biologics), including when they require regulatory agency approval, such as by the US FDA or other country equivalent FDA.",
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 },
 {
 "type": "question/review-assessment",
 "key": "us-fda---confirming-ind",
 "title": "OPTION 1: When research involves the use of a drug other than the use of a marketed drug in the course of medical practice, written materials describe who confirms the IND is valid and how they confirm the IND is valid, either by:<ul><li>Confirming the IND is listed on the protocol, or </li><li>Requiring the researcher to provide a letter from the FDA confirming an IND is not required.</li></ul>OR<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">OPTION 2:When research involves the use of a drug other than the use of a marketed drug in the course of medical practice, the process to determine the regulatory status of the drug by:<ul><li>Confirming the drug has an IND for its proposed use in the research.</li><li>The process to obtain approvals from regulatory bodies such as a clinical trial certificate or an IND.</li><li>The protocol meets one of the FDA exemptions from the requirement to have an IND.<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">IND Exemption 1<ul><li>The drug product is lawfully marketed in the United States.</li><li>The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug.</li><li>If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product.</li><li>The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.</li><li>The investigation is conducted in compliance with 21 CFR 50 and 56.</li><li>The investigation is conducted in compliance with the requirements of 21 CFR 312.7.</li></ul></li><li>IND Exemption 2<ul><li>A clinical investigation is for an in vitro diagnostic biological product that involves one or more of the following:<ul><li>Blood grouping serum.</li><li>Reagent red blood cells.</li><li>Anti-human globulin.</li></ul></li><li>The diagnostic test is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure.</li><li>The diagnostic test is shipped in compliance with 21 CFR 312.160.</li></ul></li><li>IND Exemption 5<ul><li>A clinical investigation involving use of a placebo if the investigation does not otherwise require submission of an IND.</li></ul></li></ul></li></ul>GUIDANCE<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Organizations can adopt different processes to verify\nthe IND and can require researchers obtain a determination from the\nFDA or make a determination internally. For an organization such as a regional\nhospital or university that mainly conducts industry-sponsored research and\ndoes not frequently conduct investigator-initiated research or have the\ninfrastructure to evaluate internally, then Option 1 above (asking the FDA) is\nacceptable, although we also will <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">accept an internal review. Option 1 may also be\nrelevant for an independent IRB/EC that only works with industry sponsors and\ndoes not review investigator-initiated research. In contrast, if an\norganization does not require the researcher obtain a determination from the\nFDA, such as an academic medical center that makes its own determinations of\nwhen an IND is required, then all of the criteria in Option 2 are required. For\nquestions, contact AAHRPP staff.</li><li>For FDA-regulated research involving an investigational drug conducted outside of the US, an IND is not required provided the research is conducted under the Declaration of Helsinki (1989) and Good Clinical Practice guidelines.</li><li>Independent IRBs/ECs must have a mechanism to verify the IND. </li><li>Validation can occur by confirming the IND number on the sponsor protocol, communication from the sponsor with the IND linked to the specific protocol, or communication from the FDA. In the cases of researchers who hold the IND, validation can occur by confirming the number on the communication from the FDA. Investigator’s brochures should not be used to validate an IND because one investigator’s brochure may be used for multiple INDs.</li></ul>",
 "description": "",
 "keywords": "us-based-investigational-drugs",
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 "type": "text/review-assessment-snippet",
 "key": "us-fda---confirming-ind",
 "title": "IF THE ORGANIZATION FOLLOWS OPTION 1:Add to or describe in written materials [page xx or elsewhere]:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">When research involves the use of a drug other than the use of a marketed drug in the course of medical practice, who confirms the IND is valid, either by:<ul><li>Confirming the IND is listed on the protocol, or</li><li>Requiring the researcher to provide a letter from the FDA confirming an IND is not required.<ul><li>For FDA-regulated research involving an investigational drug conducted outside of the US, an IND is not required provided the research is conducted under the Declaration of Helsinki (1989) and Good Clinical Practice guidelines.</li></ul></li></ul>",
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 "key": "us-fda---determining-if-ind-needed---option-2",
 "title": "IF THE ORGANIZATION FOLLOWS OPTION 2:Add to or describe in written materials [page xx or elsewhere]:<div>When research involves the use of a drug other than the use of a marketed drug in the course of medical practice, the process to determine the regulatory status of the drug by:</div><ul><li>Confirming the drug has an IND for its proposed use in the research.</li><li>The process to obtain approvals from regulatory bodies such as a clinical trial certificate or an IND.</li><li>The protocol meets one of the FDA exemptions from the requirement to have an IND.<ul><li>IND Exemption 1<ul><li>The drug product is lawfully marketed in the United States.</li><li>The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug.</li><li>If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product.</li><li>The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.</li><li>The investigation is conducted in compliance with 21 CFR 50 and 56.</li><li>The investigation is conducted in compliance with the requirements of 21 CFR 312.7.</li></ul></li><li>IND Exemption 2<ul><li>A clinical investigation is for an in vitro diagnostic biological product that involves one or more of the following:<ul><li>Blood grouping serum.</li><li>Reagent red blood cells.</li><li>Anti-human globulin.</li></ul></li><li>The diagnostic test is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure.</li><li>The diagnostic test is shipped in compliance with 21 CFR 312.160.</li></ul></li><li>IND Exemption 5<ul><li>A clinical investigation involving use of a placebo if the investigation does not otherwise require submission of an IND.</li></ul></li></ul></li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "non-us---ind-confirmation",
 "title": "Written materials describe, when research involves the use of a drug other than the use of a marketed drug in the course of medical practice, who confirms required regulatory approval is in place in order to conduct research involving an experimental drug, or the drug meets an exemption from regulatory approval when appropriate. If regulatory agency issues permission, policies describe how this is determined to be valid.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">GUIDANCEUse the Addendum to confirm policies meet requirements of country-specific laws.",
 "description": "",
 "keywords": "outside-us-investigational-drugs",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "non-us---determining-regulatory-requirements-for-drugs",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When research involves the use of a drug other than the use of a marketed drug in the course of medical practice, who confirms required regulatory approval is in place in order to conduct research involving an experimental drug, or the drug meets an exemption from regulatory approval when appropriate. If regulatory agency issues permission, policies describe how this is determined to be valid.",
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 {
 "type": "question/review-assessment",
 "key": "us-fda---confirming-ide",
 "title": "OPTION 1:When research is conducted to determine the safety or effectiveness of a device, written materials describe who determines whether:<ul><li>there is a valid IDE</li><li>the study meets requirements for an abbreviated IDE, or </li><li>is exempt from requirements to have an IDE, </li></ul>and how they make that determination either by:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">Confirming the IDE is listed on the protocol, or</li><li data-list=\"0\" data-level=\"1\">Requiring the researcher to provide a letter from the FDA confirming an IDE is not required, or that an abbreviated IDE is not required, or that the protocol is exempt from requirements to have an IDE.</li></ul>OROPTION 2:When research is conducted to determine the safety or effectiveness of a device, written materials describe who determines:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The device is not a banned device.</li><li>The device meets one of these requirements:<ul><li>The device has an IDE issued by the FDA.</li><li>The device fulfills the requirements for an abbreviated IDE and the IRB/EC determines whether or not the device is a significant risk device.</li><li>The device fulfills one of the IDE exemption categories:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.</li><li>A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.</li><li>A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing:<ul><li>Is noninvasive.</li><li>Does not require an invasive sampling procedure that presents significant risk.</li><li>Does not by design or intention introduce energy into a participant.</li><li>Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.</li><li>A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put participants at risk.</li><li>A custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.</li></ul></li></ul></li></ul></li></ul>GUIDANCE<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Organizations can adopt different processes to verify the IDE and can require researchers obtain a determination from the FDA or make a determination internally. For an organization such as a regional hospital or university that mainly conducts industry-sponsored research and does not frequently conduct investigator-initiated research or have the infrastructure to evaluate internally, then Option 1 above (asking the FDA) is acceptable, though we will also accept an internal review. Option 1 may also be relevant for an independent IRB/EC that only works with industry sponsors and does not review investigator-initiated research. In contrast, if an organization does not require the researcher obtain a determination from the FDA, such as an academic medical center that makes its own determinations of when an IDE is required, then all of the criteria in Option 2 are required. For questions, contact AAHRPP staff.</li><li>Independent IRBs/ECs must have a mechanism to verify the IDE.</li><li>If an IDE has been issued, validation of the IDE can occur by confirming the IDE number on the sponsor protocol, communication from the sponsor with the IDE linked to the specific protocol, or communication from the FDA. In the cases of researchers who hold the IDE, validation can occur by confirming the number on the communication from the FDA. </li></ul>",
 "description": "",
 "keywords": "us-based-investigational-devices",
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 "key": "us-confirming-ide",
 "title": "FOR ORGANIZATIONS THAT FOLLOW OPTION 1:Add to or describe in written materials <page xx or elsewhere>:When research is conducted to determine the safety or effectiveness of a device, written materials describe who determines whether:<ul><li>there is a valid IDE</li><li>the study meets requirements for an abbreviated IDE, or </li><li>is exempt from requirements to have an IDE, </li></ul>and how they make that determination either by:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">Confirming the IDE is listed on the protocol, or</li><li data-list=\"0\" data-level=\"1\">Requiring the researcher to provide a letter from the FDA confirming an IDE is not required, or that an abbreviated IDE is not required, or that the protocol is exempt from requirements to have an IDE.</li></ul> FOR ORGANIZATIONS THAT FOLLOW OPTION 2:Add to or describe in written materials <page xx or elsewhere>:When research is conducted to determine the safety or effectiveness of a device, describe who determines:<ul><li>The device is not a banned device.</li><li>The device meets one of these requirements:<ul><li>The device has an IDE issued by the FDA.</li><li>The device fulfills the requirements for an abbreviated IDE and the IRB/EC determines whether or not the device is a significant risk device.</li><li>The device fulfills one of the IDE exemption categories:<ul><li>A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.</li><li>A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.</li><li>A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing:<ul><li>Is noninvasive.</li><li>Does not require an invasive sampling procedure that presents significant risk.</li><li>Does not by design or intention introduce energy into a participant.</li><li>Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.</li><li>A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put participants at risk.</li><li>A custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.</li></ul></li></ul></li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "non-us---ide-confirmation",
 "title": "Written materials describe, when research involves the use of a device other than the use of a marketed device in the course of medical practice, who confirms required regulatory approval is in place in order to conduct research involving an experimental device, or the device meets an exemption from regulatory approval when appropriate. If a regulatory agency issues permission, policies describe how this is determined to be valid.GUIDANCEOrganizations outside the US are not required to follow US FDA requirements, provided they follow country-specific law and country-specific GCP, or follow ICH-GCP (E6).<ul><li>If you see US FDA requirements in policies, contact AAHRPP staff.</li><li>Use the Addendum to confirm policies meet requirements of country-specific laws.</li></ul>",
 "description": "",
 "keywords": "outside-us-investigational-devices",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "xx",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When research involves the use of a device other than the use of a marketed device in the course of medical practice, who confirms required regulatory approval is in place in order to conduct research involving an experimental device, or the device meets an exemption from regulatory approval when appropriate. If a regulatory agency issues permission, policies describe how this is determined to be valid. ",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "us---confirming-ind",
 "title": "Witten materials describe the mechanism the organization uses to ensure that when the research requires an IND or an IDE, the research must not begin until a valid IND or IDE is in effect. This includes recruiting, obtaining consent, and screening participants for a specific study that is subject to the IND or IDE.Written materials also describe that the IND or IDE goes into effect 30 days after the FDA receives the application for an IND or IDE, unless the sponsor receives earlier notice from the FDA. GUIDANCE<ul><li>Note: If an organization only conducts research involving investigational drugs, delete references to IDEs; and if an organization only conduct research involving investigational devices, delete references to INDs.</li><li>Sites have options about how to implement this “30-day rule”:  <ul><li>If someone other than the IRB/EC verifies the IND or IDE is valid, the IRB/EC can approve the protocol and inform the sponsor or CRO and site not to begin until there is a valid IND or IDE, or </li><li>The IRB/EC can withhold IRB/EC approval until the IND or IDE goes into effect, or</li><li>The IRB/EC can approve the trial but delay sending the approval letter until the IND or IDE goes into effect.</li></ul></li></ul>",
 "description": "",
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 "key": "us-confirming_ind_or_ide",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Describe the mechanism the organization uses to ensure that when the research requires an IND or an IDE, the research must not begin until a valid IND or IDE is in effect. This includes recruiting, obtaining consent, and screening participants for a specific study that is subject to the IND or IDE.Describe that the IND or IDE goes into effect 30 days after the FDA receives the application for an IND or IDE, unless the sponsor receives earlier notice from the FDA. ",
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 {
 "type": "question/review-assessment",
 "key": "non-us---ensuring-ind-ide-in-place-before-research-begins",
 "title": "Witten materials describe the mechanism the organization uses to ensure that when the research requires regulatory agency approval that the research must not begin until a such approval is obtained. This includes recruiting, obtaining consent, and screening participants for a specific study that is subject to the regulatory agency approval.",
 "description": "",
 "keywords": "outside-us-investigational-devices,outside-us-investigational-drugs",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "non-us---ensuring-ind-ide-in-place-before-research-begins",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Describe the mechanism the organization uses to ensure that when the research requires regulatory agency approval that the research must not begin until a such approval is obtained. This includes recruiting, obtaining consent, and screening participants for a specific study that is subject to the regulatory agency approval.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "us---sponsor-investigator-holding-ind",
 "title": "Written materials describe that if a researcher may serve as a sponsor-investigator for a study involving an IND:<ul><li>In addition to the responsibilities of an investigator, the sponsor investigator fulfills the responsibilities of a sponsor.</li><li>The sponsor-investigator is responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. </li><li>The sponsor-investigator follows Good Clinical Practice, including obtaining IRB/EC approval of the investigation, and complies with FDA regulations about human participants protections, including related to informed consent.</li><li>The sponsor-investigator selects qualified investigators based on training and experience. </li><li>The sponsor-investigator maintains complete and accurate records showing any financial interest in paid to clinical investigators by the sponsor of the covered study and all other financial interests of investigators as required by FDA regulations. </li><li>The sponsor-investigator maintains adequate records showing the receipt, shipment, or other disposition of the investigational drug.  </li><li>The sponsor-investigator shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated.</li></ul>",
 "description": "",
 "keywords": "us-based-investigational-drugs",
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 "type": "text/review-assessment-snippet",
 "key": "us---sponsor-investigator-holding-ind",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>In addition to the responsibilities of an investigator, the sponsor investigator fulfills the responsibilities of a sponsor.</li><li>The sponsor-investigator is responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. </li><li>The sponsor-investigator follows Good Clinical Practice, including obtaining IRB/EC approval of the investigation, and complies with FDA regulations about human participants protections, including related to informed consent.</li><li>The sponsor-investigator selects qualified investigators based on training and experience. </li><li>The sponsor maintains complete and accurate records showing any financial interest in paid to clinical investigators by the sponsor of the covered study and all other financial interests of investigators as required by FDA regulations. </li><li>The sponsor-investigator maintains adequate records showing the receipt, shipment, or other disposition of the investigational drug.  </li><li>The sponsor-investigator shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "us---sponsor-investigator-holding-ide",
 "title": "Written materials describe if a researcher may serve as a sponsor-investigator that:<ul><li>The sponsor labels the device in accordance with 21 CFR 812.5.<ul><li>The sponsor obtains IRB/EC approval of the investigation after presenting the reviewing IRB/EC with a brief explanation of why the device is not a significant risk device, and maintains such approval.</li><li>The sponsor ensures that each researcher participating in an investigation of the device obtains from each participant under the researcher’s care, consent under 21 CFR 50 and documents it, unless documentation is waived.</li><li>The sponsor complies with the requirements of 21 CFR 812.46 with respect to monitoring investigations;</li><li>The sponsor maintains the records required under 21 CFR 812.140(b) (4) and (5) and makes the reports required under 21 CFR 812.150(b) (1) through (3) and (5) through (10);</li><li>The sponsor ensures that participating researchers maintain the records required by 21 CFR 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and</li><li>The sponsor complies with the prohibitions in 21 CFR 812.7 against promotion and other practices.</li></ul></li></ul>",
 "description": "",
 "keywords": "us-based-investigational-devices",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "us---sponsor-investigator-holding-ide",
 "title": "Add to or describe in written materials [page xx or elsewhere]:I<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">f a researcher may serve as a sponsor-investigator that:<ul><li>The sponsor labels the device in accordance with 21 CFR 812.5.<ul><li>The sponsor obtains IRB/EC approval of the investigation after presenting the reviewing IRB/EC with a brief explanation of why the device is not a significant risk device, and maintains such approval.</li><li>The sponsor ensures that each researcher participating in an investigation of the device obtains from each participant under the researcher’s care, consent under 21 CFR 50 and documents it, unless documentation is waived.</li><li>The sponsor complies with the requirements of 21 CFR 812.46 with respect to monitoring investigations;</li><li>The sponsor maintains the records required under 21 CFR 812.140(b) (4) and (5) and makes the reports required under 21 CFR 812.150(b) (1) through (3) and (5) through (10);</li><li>The sponsor ensures that participating researchers maintain the records required by 21 CFR 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and</li><li>The sponsor complies with the prohibitions in 21 CFR 812.7 against promotion and other practices.</li></ul></li></ul>",
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 {
 "type": "section/element",
 "key": "element-i-7-b",
 "title": "ELEMENT I.7.B.",
 "description": "The organization has and follows written policies and procedures to ensure that the handling of investigational or unlicensed test articles conforms to legal and regulatory requirements.",
 "keywords": "investigational-devices,investigational-drugs",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "outside-us-investigational-devices,outside-us-investigational-drugs,us-based-investigational-devices,us-based-investigational-drugs",
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 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name] ",
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 {
 "type": "question/review-assessment",
 "key": "drug-control",
 "title": "Essential RequirementsWritten materials describe the process to control\ninvestigational drugs so that they are used only in approved research studies and under the direction of approved researchers. In the case of independent IRBs/ECs, written materials describe the process to ensure the storage, handling, and dispensing of drugs\nconforms to regulatory requirements. One approach is for the researcher to\nprovide an attestation that drugs will be stored in a secure area, and that\nrecords are maintained.",
 "description": "",
 "keywords": "outside-us-investigational-drugs,us-based-investigational-drugs",
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 "key": "drug-control---independent-irb-ec",
 "title": "ORGANIZATIONS THAT ARE INDEPENDENT IRBS/ECS<div>Add to or describe in written materials [page xx or elsewhere]:</div>Describe the process to ensure the storage, handling, and dispensing of drugs conforms to regulatory requirements.<div> </div>",
 "description": "",
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 },
 {
 "type": "text/review-assessment-snippet",
 "key": "drug-control",
 "title": "ORGANIZATIONS THAT ARE NOT INDEPENDENT IRBS/ECSAdd to or describe in written materials [page xx or elsewhere]:Describe the process to control investigational drugs so that they are used only in approved research protocols and under the direction of approved researchers. ",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "device-control",
 "title": "Essential RequirementsWritten materials describe the process to control investigational devices so that they are used only in approved research studies and under the direction of approved researchers.In the case of independent IRBs/ECs, written materials describe the process to ensure the storage, handling, and dispensing of devices conforms to regulatory requirements. One approach is for the researcher to provide an attestation that devices will be stored in a secure area, and that records are maintained.",
 "description": "",
 "keywords": "outside-us-investigational-devices,us-based-investigational-devices",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "device-control",
 "title": "ORGANIZATIONS THAT ARE NOT INDEPENDENT IRBS/ECSAdd to or describe in written materials [page xx or elsewhere]:Describe the process to control investigational devices so that they are used only in approved research protocols and under the direction of approved researchers.",
 "description": "",
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 {
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 "key": "device-control-independent-irbs-ecs",
 "title": "ORGANIZATIONS THAT ARE INDEPENDENT IRBS/ECS<div>Add to or describe in written materials [page xx or elsewhere]:</div>Describe the process to ensure the storage, handling, and dispensing of devices conforms to regulatory requirements.",
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 "type": "question/review-assessment",
 "key": "ich-gcp-sponsor-investigators",
 "title": "When following the ICH-GCP (E6) guideline, written materials describe: If the researcher serves as a sponsor-investigator, t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">he researcher is responsible for ensuring manufacturing, handling, and storage in accordance with applicable good manufacturing practice.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline, if the researcher serves as a sponsor-investigator, the researcher is responsible for ensuring manufacturing, handling, and storage in accordance with applicable good manufacturing practice.",
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 "key": "ich-gcp-investigational-article-management",
 "title": "When following the ICH-GCP (E6) guideline, written materials describe: <ul><li>Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol.</li><li>Responsibility for investigational product(s) management, including accountability, handling, dispensing, administration and return, rests with the investigator/institution.</li><li>When the investigator/institution delegates some or all of their activities for investigational product(s) management to a pharmacist or another individual in accordance with local regulatory requirements, the delegated individual should be under the oversight of the investigator/institution. </li><li>The investigator/institution and/or a pharmacist or other appropriate individual should maintain records of the product’s delivery, the inventory, the use by each participant (including documenting that the participants were provided the doses specified by the protocol) and the return to the sponsor and destruction or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable) and the unique code numbers assigned to the investigational product(s) and trial participants. For authorized medicinal products, alternative approaches to the aforementioned may be considered, in accordance with local regulatory requirements.</li><li>The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).</li><li>The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol.</li><li>Where applicable, the investigator or a person designated by the investigator/institution should explain the correct use of the investigational product(s).</li><li>The investigational product may be shipped to the participant’s location or supplied to/dispensed at a location closer to the participant (e.g., at a local pharmacy or a local healthcare center).</li><li>The investigational product may be administered at the participant’s location by investigator site staff, the participant themselves, a caregiver or a healthcare professional. </li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline:<ul><li>Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol.</li><li>Responsibility for investigational product(s) management, including accountability, handling, dispensing, administration and return, rests with the investigator/institution.</li><li>When the investigator/institution delegates some or all of their activities for investigational product(s) management to a pharmacist or another individual in accordance with local regulatory requirements, the delegated individual should be under the oversight of the investigator/institution.</li><li>The investigator/institution and/or a pharmacist or other appropriate individual should maintain records of the product’s delivery, the inventory, the use by each participant (including documenting that the participants were provided the doses specified by the protocol) and the return to the sponsor and destruction or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable) and the unique code numbers assigned to the investigational product(s) and trial participants. For authorized medicinal products, alternative approaches to the aforementioned may be considered, in accordance with local regulatory requirements.</li><li>The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).</li><li>The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol.</li><li>Where applicable, the investigator or a person designated by the investigator/institution should explain the correct use of the investigational product(s).</li><li>The investigational product may be shipped to the participant’s location or supplied to/dispensed at a location closer to the participant (e.g., at a local pharmacy or a local healthcare center).</li><li>The investigational product may be administered at the participant’s location by investigator site staff, the participant themselves, a caregiver or a healthcare professional.</li></ul>",
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 "title": "ELEMENT I.7.C.",
 "description": "The organization has and follows written policies and procedures for compliance with legal and regulatory requirements governing emergency use of an investigational or unlicensed test article.    ",
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 "key": "us-fda",
 "title": "When following US FDA requirements, written materials describe that:<ul><li>The emergency use of a test article, other than a medical device, is a clinical investigation, the patient is a participant, and the FDA may require data from an emergency use to be reported in a marketing application.<ul><li>DHHS regulations do not permit data obtained from patients to be classified as research involving human participants, nor permit the outcome of such care to be included in any report of a research activity subject to DHHS regulations. </li></ul></li><li>In order to use a test article in a life-threatening situation without prior IRB/EC review:<ul><li>The participant is in a life-threatening or severely debilitating situation.</li><li>No standard acceptable treatment is available.</li><li>There is not sufficient time to obtain IRB/EC approval.</li><li>The use is reported to the IRB/EC within five working days.</li><li>Any subsequent use of the test article is subject to IRB/EC review. </li><li>Consent will be obtained in accordance with FDA regulations, or the circumstances meet the exception to the requirement for consent in FDA regulations.</li><li>If the research involves an investigational drug, the FDA has issued an IND.</li><li>If the research involves an unapproved medical device, the physician has obtained authorization from the IDE sponsor if an IDE exists for the device. </li></ul></li><li>Informed consent is sought from each prospective participant or the participant’s legally authorized representative, in accordance with and to the extent required by 21 CFR 50 and informed consent is appropriately documented, in accordance with and to the extent required by 21 CFR 50.27.</li><li>Prospective Informed consent before the use of the test article is not required when both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The participant is confronted by a life-threatening situation necessitating the use of the test article.</li><li>Informed consent cannot be obtained from the participant because of an inability to communicate with, or obtain legally effective consent from, the participant.</li><li>Time is not sufficient to obtain consent from the participant’s legal representative.</li><li>No alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the participant.</li><li>If, in the investigator's opinion, immediate use of the test article is required to preserve the subject's life, and if time is not sufficient to obtain an independent physician's determination that the four conditions above apply, the clinical investigator should make the determination and, within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. </li></ul></li><li>The investigator must notify the IRB/EC within 5 working days after the use of the test article. </li><li>Any subsequent use of the test article at the institution is subject to IRB/EC review.</li></ul>GUIDANCE<ul><li>Emergency use of a test article is different from planned emergency research; see Element II.4.C.  Not all organizations conduct emergency use of a test article – for example, organizations that do not have a hospital, such as universities primarily with social science research programs, likely do not need to address this in their policies.</li><li>This Element may not be applicable for independent IRBs/ECs because not all review.</li><li>Confirm the consent process includes all required and appropriate additional elements of consent disclosure.</li><li>The consent process needs to be documented in writing using the long or short form of consent documentation.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The emergency use of a test article, other than a medical device, is a clinical investigation, the patient is a participant, and the FDA may require data from an emergency use to be reported in a marketing application.</li><li><ul><li>DHHS regulations do not permit data obtained from patients to be classified as research involving human participants, nor permit the outcome of such care to be included in any report of a research activity subject to DHHS regulations.</li></ul></li><li>In order to use a test article in a life-threatening situation without prior IRB/EC review:<ul><li>The participant is in a life-threatening or severely debilitating situation.</li><li>No standard acceptable treatment is available.</li><li>There is not sufficient time to obtain IRB/EC approval.</li><li>The use is reported to the IRB/EC within five working days.</li><li>Any subsequent use of the test article is subject to IRB/EC review.</li><li>Consent will be obtained in accordance with FDA regulations, or the circumstances meet the exception to the requirement for consent in FDA regulations.</li><li>If the research involves an investigational drug, the FDA has issued an IND.</li><li>If the research involves an unapproved medical device, the physician has obtained authorization from the IDE sponsor if an IDE exists for the device.</li></ul></li><li>Informed consent is sought from each prospective participant or the participant’s legally authorized representative, in accordance with and to the extent required by 21 CFR 50 and informed consent is appropriately documented, in accordance with and to the extent required by 21 CFR 50.27.</li><li>Prospective Informed consent before the use of the test article is not required when both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:<ul><li>The participant is confronted by a life-threatening situation necessitating the use of the test article.</li><li>Informed consent cannot be obtained from the participant because of an inability to communicate with, or obtain legally effective consent from, the participant.</li><li>Time is not sufficient to obtain consent from the participant’s legal representative.</li><li>No alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the participant.</li><li>If, in the investigator's opinion, immediate use of the test article is required to preserve the subject's life, and if time is not sufficient to obtain an independent physician's determination that the four conditions above apply, the clinical investigator should make the determination and, within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. </li></ul></li><li>The investigator must notify the IRB/EC within 5 working days after the use of the test article.</li><li>Any subsequent use of the test article at the institution is subject to IRB/EC review.</li></ul> ",
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 "key": "us---review-of-emergency-use-reports",
 "title": "Written materials describe w<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">ho reviews five-day reports of the emergency use of a test article and the exception to the requirement to obtain consent to determine whether the circumstances met FDA regulations.",
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 "type": "question/review-assessment",
 "key": "non-us-emergency-use",
 "title": "Written materials describe whether prior authorization to use an investigational drug or device is required in an emergency when there is not time to obtain authorization.  If prior authorization, such as from a government agency, is not required, written materials describe this process, such as when an emergency use without prior IRB/EC review is allowed, who conducts any applicable review in lieu of the IRB/EC (e.g., an IRB/EC chair), any reporting requirements to the IRB/EC after the use has occurred, and how the organization confirms the use met the criteria for an emergency use.  GUIDANCEOrganizations outside\nthe US do not need to follow US FDA requirements. This Element may not be\nrelevant to many organizations outside the US. However, the laws of some\ncountries outside the US provide for emergency use – check the Addendum. ",
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 "title": "When following VA requirements, written materials describe that any emergency use of a test article does not require R&D Committee approval but is VA research.",
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 "description": "The organization works with public, industry, and private sponsors to apply the requirements of the Human Research Protection Program to all participants.",
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 "key": "providing-and-paying-for-care",
 "title": "Essential RequirementsWritten materials, such as contracts or other funding agreements, indicate who will provide care and who is responsible to pay for it.",
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 "title": "When the organization is a VA facility, written materials describe:<ul><li>The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:</li><li>The industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>The industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>The VA PI has substantially designed the protocol for clinical studies.</li></ul>",
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 "description": "<div>In studies where sponsors conduct research site monitoring visits or conduct monitoring activities remotely, the organization has a written agreement with the sponsor that the sponsor promptly reports to the organization findings that could affect the safety of participants or influence the conduct of the study.</div> ",
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 "key": "reporting-findings---not-independent-irbs-ecs",
 "title": "Essential RequirementsWritten materials, such as <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">contracts or other funding agreements, require the sponsor to promptly, or in a timely manner, appropriate to the level of risk involved, report to the organization any findings that could:<ul><li>Affect the safety of participants.</li><li>Influence the conduct of the study.</li></ul>GUIDANCEAAHRPP does not require that organizations define “promptly” as less than 30 days; instead, organizations may use language similar to what appears above.",
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 "type": "question/review-assessment",
 "key": "reporting-findings---independent-irbs-ecs",
 "title": "Essential RequirementsWritten materials, such as service contracts with sponsors, contract research organizations, or other funding agreements, require the sponsor to promptly, or in a timely manner, appropriate to the level of risk involved, report to the organization any findings that could: <ul><li>Affect the safety of participants.</li><li>Influence the conduct of the study or alter the IRB’s/EC’s approval to continue the study.</li></ul>GUIDANCEAAHRPP does not require that organizations define “promptly” as less than 30 days; instead, organizations may use language similar to what appears above.",
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 "title": "Add to or describe in w<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">ritten materials, such as service contracts with sponsors, contract research organizations, or other funding agreements [page xx or elsewhere]:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">The sponsor is required to promptly, or in a timely manner, appropriate to the level of risk involved, report to the organization any findings that could:<ul type=\"disc\"><li>Affect the safety of participants.</li><li>Influence the conduct of the study or alter the IRB’s/EC’s approval to continue the study.</li></ul>",
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 "title": "Essential RequirementsWritten materials describe that the researcher or contract research organization provides an attestation or other written statement that contracts obligate the sponsor to promptly, or in a timely manner, appropriate to the level of risk involved, report any findings of study monitors that could affect the safety of participants or influence the conduct of the study to the researcher or organization conducting the research. Researchers or the organization conducting the research are required to promptly, or in a timely manner, appropriate to the level of risk involved, forward this information to the IRB/EC.GUIDANCEAAHRPP does not require that organizations define “promptly” as less than 30 days; instead, organizations may use language similar to what appears above.",
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 "title": "Written materials describe for VA facilities that the appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:<ul><li>the industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>the industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>the VA PI has substantially designed the protocol for clinical studies.</li></ul>",
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 "description": "When the sponsor has the responsibility to conduct data and safety monitoring, the organization has a written agreement with the sponsor that addresses provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the organization.    ",
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 "type": "question/review-assessment",
 "key": "data-and-safety-monitoring-plans---not-independent-irbs-ecs",
 "title": "Essential RequirementsWritten materials, such as contracts or other funding agreements, require the sponsor\nto send data and safety monitoring plans and reports to the organization.\nContracts or other funding agreements specify the time frame for providing\nroutine and urgent data and safety monitoring reports to the organization as\nindicated in the data and safety monitoring plan approved by the IRB/EC.",
 "description": "",
 "keywords": "not-an-independent-irb-ec",
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 "key": "data-and-safety-monitoring-plans---not-independent-irbs-ecs",
 "title": "Add to or describe in contracts or other funding agreements [page xx or elsewhere]:<ul><li>Sponsors are required to send data and safety monitoring plans and reports to the organization.\n</li><li>Sponsors are required to specify the time frame in which they are required to provide\nroutine and urgent data and safety monitoring reports to the organization as\nindicated in the data and safety monitoring plan approved by the IRB/EC.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "data-and-safety-monitoring-plans---independent-irbs-ecs",
 "title": "Written materials, such as service contracts with sponsors, contract research organizations or other funding agreements, require the sponsor\nto send data and safety monitoring plans and reports to the organization.\nService contracts or other funding agreements specify the time frame for providing routine and urgent data and safety monitoring reports to the organization.",
 "description": "",
 "keywords": "org-is-independent-irb-ec",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "data-and-safety-monitoring-plans---independent-irbs-ecs",
 "title": "Add to or describe in service contracts with sponsors, contract research organizations or other funding agreements [page xx or elsewhere]:<ul><li>Sponsor are required to send data and safety monitoring plans and reports to the organization. </li><li>Sponsors are required to specify the time frame for providing routine and urgent data and safety monitoring reports to the organization.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "attestation-from-orgs---independent-irbs-ecs",
 "title": "Written materials describe that the researcher or contract research organization provides an attestation or other written statement that contracts obligate the sponsor to send routine and urgent data and safety monitoring reports to the researcher or organization conducting the research. <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Researchers or the organization conducting the research are required to forward this information to the IRB/EC.",
 "description": "",
 "keywords": "org-is-independent-irb-ec",
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 "key": "attestation-from-orgs---independent-irbs-ecs",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The researcher or contract research organization provides an attestation or other written statement that contracts obligate the sponsor to send routine and urgent data and safety monitoring reports to the researcher or organization conducting the research. Researchers or the organization conducting the research are required to forward this information to the IRB/EC.",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facilities",
 "title": "Written materials describe for the VA facility that the appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:<ul><li>the industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>the industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>the VA PI has substantially designed the protocol for clinical studies.</li></ul> ",
 "description": "",
 "keywords": "org-is-va",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:<ul><li>the industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>the industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>the VA PI has substantially designed the protocol for clinical studies. </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
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 }
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 },
 {
 "type": "section/element",
 "key": "element-i-8-d",
 "title": "ELEMENT I.8.D.",
 "description": "Before initiating research, the organization has a written agreement with the sponsor about plans for disseminating findings from the research and the roles that researchers and sponsors will play in the publication or disclosure of results.     ",
 "keywords": "not-an-independent-irb-ec",
 "components": [
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-documents",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "provide-documents",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "requiring-publication-of-findings",
 "title": "Essential RequirementsWritten materials describe that contracts or other funding agreements require the sponsor\nto follow the organization’s policies and procedures regarding the publication\nof findings from sponsored research. GUIDANCENot applicable if the organization has no such policy. ",
 "description": "",
 "keywords": "not-an-independent-irb-ec",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "publication-of-findings",
 "title": "Add to or describe in contracts or other funding agreements [page xx or elsewhere]:The organization’s policies and procedures regarding the publication of findings from sponsored research. ",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facilities",
 "title": "Written materials for the VA facility describe:The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:<ul><li>the industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>the industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>the VA PI has substantially designed the protocol for clinical studies.</li></ul>",
 "description": "",
 "keywords": "org-is-va",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:<ul><li>the industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>the industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>the VA PI has substantially designed the protocol for clinical studies.</li></ul>",
 "description": "",
 "keywords": "",
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 }
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 }
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 }
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 },
 {
 "type": "section/element",
 "key": "element-i-8-e",
 "title": "ELEMENT I.8.E.",
 "description": "When participant safety could be directly affected by study results after the study has ended, the organization has a written agreement with the sponsor that the researcher or organization will be notified of the results in order to consider informing participants.",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
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 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "closure-language-in-contracts",
 "title": "Essential RequirementsWritten materials describe the process to ensure contracts or other funding agreements include the steps followed to promptly, or in a timely manner, appropriate to the level of risk involved, communicate findings from a closed research study to the researcher or organization when those findings directly affect participant safety. Written materials have contracts or other funding agreements specify a time frame after closure of the study during which the sponsor will communicate such findings:<ul><li>The time frame may be a specific time period (for example, two years). </li><li>The time frame may be based on a specific triggering event (such as completion of data analysis).</li><li>The time frame may be left open-ended or the requirement can be included or referred to in a survivor clause.</li></ul>GUIDANCEAAHRPP does not require the use of a two-year time period and accepts other time periods.",
 "description": "",
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 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "closure-language-in-contracts",
 "title": "Add to or describe in written materials [page xx or elsewhere]: <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">The process to ensure contracts or other funding agreements identify the steps followed to promptly, or in a timely manner, appropriate to the level of risk involved, communicate findings from a closed research study to the researcher or organization when those findings directly affect participant safety. ",
 "description": "",
 "keywords": "",
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 "key": "closure-language-in-contracts---timeframe",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A specific time frame after closure of the study during which the sponsor will communicate such findings:<ul type=\"disc\"><li>The time frame may be a specific time period (for example, two years).</li><li>The time frame may be based on a specific triggering event (such as completion of data analysis).</li><li>The time frame may be left open-ended or the requirement can be included or referred to in a survivor clause.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "independent-irbs-ecs--closure-language-in-contracts",
 "title": "Essential RequirementsWritten materials describe:<ul><li>The steps followed to communicate findings from a closed research study to the researcher or organization when those findings directly affect participant safety for service contracts (work orders, or master agreement) with sponsors, contract research organizations, or other funding agreements. </li><li>That service contracts (work orders, master agreements) or other funding agreements reference a time frame after closure of the study during which the sponsor will communicate such findings. The time frame may be specified (e.g., two years); left open-ended; or included or referred to in a survivor clause.</li><li>That the researcher or contract research organization must provide an attestation or other written statement that contracts:<ul><li>Obligate the sponsor to notify the researcher or organization conducting the research of any study results after the study has ended that could directly affect participant safety.</li><li>Reference a time frame, based on the appropriate timeframe for each individual study, after closure of the study during which the Sponsor will communicate such findings (e.g., two years).</li></ul></li><li>Researchers or the organization conducting the research are required to forward any study results after the study has ended that could directly affect participant safety communicated to them by the sponsor.</li></ul>",
 "description": "",
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 "type": "text/review-assessment-snippet",
 "key": "independent-irbs--closure-language-in-contracts",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>The steps followed to communicate findings from a closed research study to the researcher or organization when those findings directly affect participant safety for service contracts (work orders, or master agreement) with sponsors, contract research organizations, or other funding agreements.</li><li>That service contracts (work orders, master agreements) or other funding agreements reference a time frame after closure of the study during which the sponsor will communicate such findings. The time frame may be specified (e.g., two years); left open-ended; or included or referred to in a survivor clause.</li><li>That the researcher or contract research organization must provide an attestation or other written statement that contracts:</li><ul type=\"disc\"><li>Obligate the sponsor to notify the researcher or organization conducting the research of any study results after the study has ended that could directly affect participant safety.</li><li>Reference a time frame, based on the appropriate timeframe for each individual study, after closure of the study during which the Sponsor will communicate such findings (e.g., two years).</li></ul><li>Researchers or the organization conducting the research are required to forward any study results after the study has ended that could directly affect participant safety communicated to them by the sponsor.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va--closure-language-in-contracts",
 "title": "Written materials for the VA facility describe:<ul><li>The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:</li><li>the industry Sponsor holds the FDA investigational device exemption (IDE).</li><li>the industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.</li><li>the VA PI has substantially designed the protocol for clinical studies.</li></ul>",
 "description": "",
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 },
 {
 "type": "section/standard",
 "key": "standard-i-9",
 "title": "STANDARD I-9",
 "description": "The organization has written policies and procedures to ensure that, when sharing oversight of research with another organization, the rights and welfare of research participants are protected. ",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Standard.GUIDANCEOrganizations do not need to create\na separate policy on single IRB/EC review if the information is provided in\nother materials. Information may be found in other documents, such as reliance\nagreements or memoranda of understanding, researcher or staff manuals, or\nwebsites, as well as policies. ",
 "description": "",
 "keywords": "all",
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 "key": "provide-written-materials",
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 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "reliance-agreements--exclusive-use-of-the-smart-irb-agreement",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">For organizations that exclusively follow the SMART IRB agreement, written materials describe whether the organization follows the SMART IRB Agreement exclusively, or allows other types of agreements. ",
 "description": "",
 "keywords": "us-based-independent-irb,us-based-internal-irb,us-based-no-irb",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "reliance-agreements--exclusive-use-of-the-smart-irb-agreement",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Whether the organization follows the SMART IRB Agreement exclusively, or allows other types of agreements.</li><li>The staff person or staff role who serves as the contact for researchers needing to rely upon another organization’s IRB/EC, or who want other organizations to rely upon their organization’s IRB/EC for a study.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "reliance-arrangements--agreement-terms",
 "title": "Essential RequirementsWhen sharing oversight of research, a written agreement or other written materials describe the respective responsibilities of each organization, including which organization is responsible for:  <ul><li>Providing education to researchers and research staff.</li><li>Conducting scientific review.</li><li>Reviewing potential noncompliance, including complaints, protocol deviations, and results of audits:<ul><li>Identifying which organization is responsible for deciding whether each allegation of noncompliance has a basis in fact.</li><li>Identifying which organization’s process is used to decide whether each incident of noncompliance is serious or continuing.</li></ul></li><li>Obtaining management plans for researcher and research staff conflicts of interest. <ul><li>If the relying organization maintains responsibility for this issue, the management plan must be provided to the IRB/EC in a timely manner prior to the decision by the IRB/EC.</li></ul></li><li>Managing organizational conflict of interest related to the research.</li><li>Ensuring that, should termination of a reliance agreement occur, one of the parties clearly is responsible for continued oversight of active studies until closure or a mutually agreed upon transfer of the studies.</li></ul>GUIDANCEIf the organization exclusively uses the SMART IRB agreement, that agreement addresses the terms above. If the organization indicates it follows other agreements, or other agreements in addition to the SMART IRB agreement, then make sure everything above is addressed.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,relies-on-external-irb-ec,serves-as-a-irb-for-external-organizations",
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 "title": "Add to or describe in a template written agreement or other written materials [page xx or elsewhere]:When sharing oversight of research, the respective responsibilities of each organization, including which organization is responsible for: <ul type=\"disc\"><li>Providing education to researchers and research staff.</li><li>Conducting scientific review.</li><li>Reviewing potential noncompliance, including complaints, protocol deviations, and results of audits:<ul type=\"disc\"><li>Identifying which organization is responsible for deciding whether each allegation of noncompliance has a basis in fact.</li><li>Identifying which organization’s process is used to decide whether each incident of noncompliance is serious or continuing.</li></ul></li><li>Obtaining management plans for researcher and research staff conflicts of interest.</li><ul type=\"disc\"><li>If the relying organization maintains responsibility for this issue, the management plan must be provided to the IRB/EC in a timely manner prior to the decision by the IRB/EC.</li></ul><li>Managing organizational conflict of interest related to the research.</li><li>Ensuring that, should termination of a reliance agreement occur, one of the parties clearly is responsible for continued oversight of active studies until closure or a mutually agreed upon transfer of the studies.</li></ul> ",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--addition-of-research-sites",
 "title": "Essential RequirementsWritten materials describe the process to review the addition of research sites to previously approved protocols. Organizations may:<ul><li>Review requests to add research sites as modifications to previously approved research.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Review requests to add research sites as separate studies or protocols.</li></ul>When adding sites as modifications, written materials specify the criteria for when the addition of an investigative site is considered to be a minor modification.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The process to review the addition of research sites to previously approved protocols, such as:<ul type=\"disc\"><li>Review requests to add research sites as modifications to previously approved research.</li><li>Review requests to add research sites as separate studies or protocols. </li></ul>",
 "description": "",
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 "key": "reviewing-irb-ec--addition-of-research-sites---adding-sites-as-modifications",
 "title": "If the organization permits adding sites as modificationsAdd to or describe in written materials [page xx or elsewhere]:The specific criteria for when the addition of a research site is considered to be a minor modification.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--applicable-laws-applied",
 "title": "Essential RequirementsIRB/EC applications or other materials contain a description of any laws relevant to the study being reviewed by the IRB/EC, when research is conducted in another state or country.GUIDANCEInformation about relevant laws may be provided in a memorandum of understanding, research site agreement, local context form, or other ways.This language should be included in the organization's written materials regardless of whether the organization exclusively uses the SMART IRB agreement.",
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 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
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 "title": "Add to or describe in IRB/EC applications or other written materials [page xx or elsewhere]:A description of any laws relevant to the study being reviewed by the IRB/EC, when research is conducted in another state or country.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--obtaining-coi-management-plans",
 "title": "Essential RequirementsWritten materials describe the process for the reviewing IRB/EC to obtain conflict of interest management plans. ",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
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 "type": "text/review-assessment-snippet",
 "key": "reviewing-irb-ec--obtaining-coi-management-plans",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process for the reviewing IRB/EC to obtain conflict of interest management plans. ",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--reportable-events",
 "title": "Essential RequirementsWritten materials describe reporting requirements and timelines for possible unanticipated problems, participant complaints, protocol deviations, and other events, so the IRB/EC obtains information necessary to make required determinations for unanticipated problems involving risks to participants or others.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "reviewing-irb-ec--reportable-events",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Reporting requirements and timelines for possible unanticipated problems, participant complaints, protocol deviations, and other events, so the IRB/EC obtains information necessary to make required determinations for unanticipated problems involving risks to participants or others.",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--suspension-termination-communication",
 "title": "Essential RequirementsWritten materials describe the process for the IRB/EC to communicate suspension or termination of IRB/EC approval to the researcher and researcher’s organization.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "reviewing-irb-ec--suspension-termination-communication",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process for the IRB/EC to communicate suspension or termination of IRB/EC approval to the researcher and researcher’s organization. ",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--decision-notification",
 "title": "Essential RequirementsWritten materials describe how the IRB/EC will notify the researcher, and if applicable the researcher’s organization, of its decisions.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "reviewing-irb-ec--decision-notification",
 "title": "Add to or describe in written materials [page xx or elsewhere]:How the IRB/EC will notify the researcher, and, if applicable, the researcher’s organization of its decisions.",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--record-availability",
 "title": "Essential RequirementsWritten materials describe how the IRB/EC will make available relevant IRB/EC records, including but not limited to minutes, approved protocols, consent documents, and other records that document the IRB’s/EC’s determinations to the relying organization upon request.GUIDANCEIf the organization exclusively uses the SMART IRB agreement, that agreement addresses record IRB/EC availability and thus this language does not need to appear in other written materials.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
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 "type": "text/review-assessment-snippet",
 "key": "reviewing-irb-ec--record-availability",
 "title": "Add to or describe in written materials [page xx or elsewhere]:How the IRB/EC will make available relevant IRB/EC records, including but not limited to minutes, approved protocols, consent documents, and other records that document the IRB’s/EC’s determinations to the relying organization upon request.",
 "description": "",
 "keywords": "",
 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--providing-policies",
 "title": "Essential RequirementsWritten materials describe how the IRB/EC will provide relevant policies to the relying organization, including HRPP staff, and researchers and research staff, and the mechanism for communicating to the organization when policies are updated, as appropriate.GUIDANCEIf the organization exclusively uses the SMART IRB agreement, that agreement addresses making policies available and thus this language does not need to appear in other written materials.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "reviewing-irb-ec--providing-policies",
 "title": "Add to or describe in written materials [page xx or elsewhere]:How the IRB/EC will provide relevant policies to the relying organization, including HRPP staff, and researchers and research staff, and the mechanism for communicating to the organization when policies are updated, as appropriate.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "reviewing-irb-ec--contacting-the-irb-ec",
 "title": "Essential RequirementsWritten materials describe how researchers can contact the IRB/EC, by providing contact information for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the IRB/EC.",
 "description": "",
 "keywords": "org-is-independent-irb-ec,serves-as-a-irb-for-external-organizations",
 "components": [
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 "title": "Add to or describe in written materials [page xx or elsewhere]:H<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">ow researchers can contact the IRB/EC, by providing contact information for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the IRB/EC.",
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 "type": "question/review-assessment",
 "key": "relying-organization--study-eligibility-for-single-irb-review",
 "title": "Essential RequirementsWritten materials describe which studies are eligible for review by another organization’s IRB/EC, and the mechanism for making the determination. ",
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 "type": "question/review-assessment",
 "key": "relying-organization--additional-reviews-by-the-organization",
 "title": "Essential RequirementsWritten materials describe the additional reviews (such as scientific review or conflict of interest review) that must be conducted by the organization prior to review by the external IRB/EC, and when appropriate, the process to communicate the results of this review to the external reviewing IRB/EC.",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:Additional reviews (such as scientific review or conflict of interest review) that must be conducted by the organization prior to review by the external IRB/EC, and when appropriate, the process to communicate the results of this review to the external reviewing IRB/EC.",
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 {
 "type": "question/review-assessment",
 "key": "relying-organization--local-requirements",
 "title": "Essential RequirementsWritten materials describe how the organization will provide the reviewing IRB/EC with requested information about local requirements or local research context issues relevant to the IRB’s/EC’s determination, prior to IRB/EC review.",
 "description": "",
 "keywords": "relies-on-external-irb-ec",
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 {
 "type": "question/review-assessment",
 "key": "relying-organization--coi-disclosures",
 "title": "Essential RequirementsWritten materials describe the process for researchers and research staff to disclose conflicts of interest according to the process agreed upon between the researcher’s organization and the reviewing IRB/EC. If the researcher’s organization is responsible for reviewing conflicts of interest disclosures and developing management plans, then policies must describe the mechanism for providing conflict of interest management plans to the reviewing IRB/EC.",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]: The mechanism for providing conflict of interest management plans to the reviewing IRB/EC.",
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 "type": "question/review-assessment",
 "key": "relying-organization--reporting",
 "title": "Essential RequirementsWritten materials describe the process and timelines for reporting to the external IRB/EC possible unanticipated problems, participant complaints, protocol deviations, and other events, so the IRB/EC obtains information necessary to make required determinations for unanticipated problems involving risks to participants or others.",
 "description": "",
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 "key": "relying-organization--feedback",
 "title": "Essential RequirementsWritten materials describe a contact person (by title or role) at the researcher’s organization for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions when using an external IRB/EC for review.",
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 "type": "question/review-assessment",
 "key": "dhhs--additional-requirements-for-reliance",
 "title": "When non-exempt human participants research is funded by DHHS or conducted by a DHHS Agency or Department, written materials define the responsibilities of the relying organization and reviewing IRB/EC for, including but not limited to:<ul><li>Determining which organization is responsible for obtaining any additional approvals from DHHS when the research involves pregnant women, fetuses, and neonates; or children; or prisoners.</li></ul>",
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 "type": "question/review-assessment",
 "key": "nih--additional-requirements-for-reliance",
 "title": "When following the NIH policy on single IRB/EC review, written materials describe:<ul><li>The process for entering into an “authorization agreement” or “reliance agreement” which documents respective authorities, roles, responsibilities, and communication between an organization providing the ethical review and a participating organization relying on a reviewing IRB.</li><li>Who is responsible for managing authorization agreements (by title or role).</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The process to ensure IRB/EC approval is obtained when the organization is responsible for a multi-site research study outside the United States that is not required to follow requirements for single IRB review. (See Standard I-3)</li><li>The process used by the awardee organization to ensure authorization agreements are in place, and that documentation is maintained.</li><li>Which organization is responsible for meeting additional certification requirements, such as Certificates of Confidentiality or the NIH Genomic Data Sharing Policy.</li></ul>GUIDANCEOrganizations that utilize the SMART IRB agreement meet this requirement. If there is another agreement, please contact staff. ",
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 "type": "question/review-assessment",
 "key": "relying-on-non-accredited-irb-ec",
 "title": "Essential RequirementsWhen relying upon an IRB/EC that is not AAHRPP-accredited, w<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">ritten materials describe:<ul><li>The process to evaluate whether research is being reviewed appropriately and complies with applicable laws and regulations.</li><li>Criteria describing the extent of the review to confirm compliance with the organization’s ethical standards and with applicable laws and regulations. </li><li>The extent of the review of the non-accredited IRB/EC can vary, depending upon the level of risk to participants in the research. </li></ul>GUIDANCEContact AAHRPP Staff if you have questions about an organization’s policies on relying upon non-accredited IRBs/ECs.",
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 "type": "question/review-assessment",
 "key": "additional-reviews-by-external-organization",
 "title": "Essential RequirementsWhen additional reviews relevant to the HRPP are conducted by an external organization, including but not limited to biosafety review, radiation safety review, recombinant DNA research review, human stem cell research review, and conflict of interest review, w<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">ritten materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">How the review is documented and communicated to the IRB/EC or other relevant part of the HRPP.</li><li>The process for the relying organization to inform the external organization of circumstances when the external review must take into account additional regulatory requirements, for example, those of DoD or DoJ.</li><li>Education for researchers when using these additional reviews.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">How the review is documented and communicated to the IRB/EC or other relevant part of the HRPP.</li><li>The process for the relying organization to inform the external organization of circumstances when the external review must take into account additional regulatory requirements, for example, those of DoD or DoJ.</li><li>Education for researchers when using these additional reviews.</li></ul><ul></ul>",
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 "type": "question/review-assessment",
 "key": "dod--serving-as-a-reviewing-irb-ec",
 "title": "Written materials describe whether the organization allows its IRB/EC to serve as the reviewing IRB/EC for DoD-covered research studies.",
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 "type": "question/review-assessment",
 "key": "dod--when-serving-as-a-reviewing-irb",
 "title": "When serving as the reviewing IRB/EC for a DoD-covered research study, written materials (including a reliance agreement) define the responsibilities of the DoD organization and non-DoD reviewing IRB/EC, including all requirements in Standard I-9 for IRBs/ECs serving as reviewing IRBs/ECs.Written materials also describe:<ul><li>The process for serving as a reviewing IRB/EC for DoD institutions collaborating with non-DoD institutions, including who is responsible and the process 24to obtain DoD approval for a non-DoD institution to be designated to review for DoD research, including ensuring the following conditions are met (DoDI 3216.02 section 3.5): </li><li>Each institution engaged in non-exempt human participant research must have a current federal assurance of compliance. </li><li>The non-DoD institution’s IRB/EC is registered in accordance with Subpart E of 45 CFR 46.</li><li>The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.</li><li>The DoD institution, non-DoD institution, and the non-DoD institution’s IRB/EC have a written agreement defining the responsibilities and authorities of each institution in complying with all legal requirements. This agreement must specify that the non-DoD IRB/EC will apply the DoD requirements specified in DoDI 3216.02, including but not limited to non-DoD institutional responsibilities defined under DoDI 3216.02 section 3.6(b).</li><li>If the research constitutes classified human participant research, the COHRP must approve the agreement to rely on the non-DoD institution’s IRB/EC.</li></ul>",
 "description": "",
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 "key": "dod--when-serving-as-a-reviewing-irb---process",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>The process for serving as a reviewing IRB/EC for DoD institutions collaborating with non-DoD institutions, including who is responsible and the process 24to obtain DoD approval for a non-DoD institution to be designated to review for DoD research, including ensuring the following conditions are met (DoDI 3216.02 section 3.5):</li><li>Each institution engaged in non-exempt human participant research must have a current federal assurance of compliance.</li><li>The non-DoD institution’s IRB/EC is registered in accordance with Subpart E of 45 CFR 46.</li><li>The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.</li><li>The DoD institution, non-DoD institution, and the non-DoD institution’s IRB/EC have a written agreement defining the responsibilities and authorities of each institution in complying with all legal requirements. This agreement must specify that the non-DoD IRB/EC will apply the DoD requirements specified in DoDI 3216.02, including but not limited to non-DoD institutional responsibilities defined under DoDI 3216.02 section 3.6(b).</li><li>If the research constitutes classified human participant research, the COHRP must approve the agreement to rely on the non-DoD institution’s IRB/EC.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "doe--reviewing-irb-requirements-for-multisite-doe-research",
 "title": "Written materials for the DOE entity describe that research involving human participants involving\nmultiple DOE sites (e.g., members of the research team from more than one DOE\nsite and/or data or human subjects from more than one DOE site) must be\nreviewed and approved by one of the Central DOE IRBs/ECs prior to initiation,\nunless review by another appropriate IRB/EC of record is authorized by the DOE\nand/or NNSA HSP Program Manager. ",
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 {
 "type": "question/review-assessment",
 "key": "doe--authorization-of-non-doe-reviewing-irbs",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Written materials describe that, if authorized by the DOE and/or NNSA HSP Program\nManager, research may be reviewed by other appropriate IRB/EC of record. In all\ncases, an IRB/EC Authorization Agreement (IAA) or Memorandum of Understanding\n(MOU) must be in place between the organization(s) conducting the HSR and the\norganization responsible for IRB/EC review.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:If authorized by the DOE and/or NNSA HSP Program Manager, research may be reviewed by other appropriate IRB/EC of record. In all cases, an IRB/EC Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the organization(s) conducting the HSR and the organization responsible for IRB/EC review.",
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 "type": "question/review-assessment",
 "key": "doe--non-doe-reviewing-irbs",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Written materials describe that the IRB must be authorized by the DOE and/or NNSA HSP Program\nManager to review research for a DOE entity. In all\ncases, an IRB/EC Authorization Agreement (IAA) or Memorandum of Understanding\n(MOU) must be in place between the organization(s) conducting the HSR and the\norganization responsible for IRB/EC review.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facilities--permitted-irbs",
 "title": "Written materials for the VA facility describe the requirements for relying upon other IRB(s)/EC(s):<ul><li>The VA facility’s IRB/EC of record may include:<ul><li>The facility's own IRB(s)</li><li>VHA Central Office IRB (VA Central IRB)</li><li>An IRB/EC of another VA facility</li><li>The IRB(s) of a medical or dental school</li><li>The IRB/EC of another Federal agency</li><li>An IRB/EC for multi-site protocols that has been specifically designated by VA Office of Research and Development (ORD) as an IRB/EC that may serve as a multi-site IRB/EC for VA facilities</li><li>A commercial IRB/EC if it has been specifically designated by ORD as a commercial IRB/EC that may serve as an IRB/EC for cooperative research</li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The requirements for relying upon other IRB(s)/EC(s):<ul type=\"disc\"><li>The VA facility’s IRB/EC of record may include:</li><ul type=\"disc\"><li>The facility's own IRB(s)</li><li>VHA Central Office IRB (VA Central IRB)</li><li>An IRB/EC of another VA facility</li><li>The IRB(s) of a medical or dental school</li><li>The IRB/EC of another Federal agency</li><li>An IRB/EC for multi-site protocols that has been specifically designated by VA Office of Research and Development (ORD) as an IRB/EC that may serve as a multi-site IRB/EC for VA facilities</li></ul></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facilities--reliance-responsibilities",
 "title": "Written materials for the VA facility include documentation specifying the responsibilities that the VA facility and an organization operating as the VA facility's IRB/EC of Record each will undertake to ensure compliance with the requirements of VHA Directive 1200.05, such as a Memorandum of Understanding (MOU) or an IRB/EC Authorization Agreement or IRB/EC reliance agreement.",
 "description": "",
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 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facilities--use-of-a-non-va-research-review-committee",
 "title": "Written materials describe that the VA medical facility Director is responsible for ensuring that documents (e.g., standard operating procedures (SOPs) or memoranda of understanding (MOUs)) establishing the role of a non-VA operated research review committee in the oversight of a VA medical facility’s research address the non-VA operated committee's procedures for the review and reporting (including to VA medical facility personnel) of events described in this directive, including timeframes. If the procedures of the non-VA operated committee differ from, or the timeframes exceed those of, VHA Directive 1058.01, the Director must consult with VA ORD and the appropriate VA Office of Research Oversight (ORO) workgroup (as specified on ORO's website) as to the adequacy of those procedures to protect the interests of VA and those involved in VA research.",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The VA medical facility Director is responsible for ensuring that documents (e.g., standard operating procedures (SOPs) or memoranda of understanding (MOUs)) establishing the role of a non-VA operated research review committee in the oversight of a VA medical facility’s research address the non-VA operated committee's procedures for the review and reporting (including to VA medical facility personnel) of events described in this directive, including timeframes. If the procedures of the non-VA operated committee differ from, or the timeframes exceed those of, VHA Directive 1058.01, the Director must consult with VA ORD and the appropriate VA Office of Research Oversight (ORO) workgroup (as specified on ORO's website) as to the adequacy of those procedures to protect the interests of VA and those involved in VA research.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facilities--limitations-of-use-of-va-irbs",
 "title": "Written materials describe that a VA facility’s own internal IRB and the VA Central IRB cannot serve as an IRB/EC of record for any non-VA entity except a DoD facility, DOE Laboratory, or a VA-affiliated Nonprofit Research and Education Corporation (VA NPC). interests of VA and those involved in VA research.",
 "description": "",
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 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va--serving-as-a-reviewing-irb-for-va",
 "title": "When serving as a reviewing IRB/EC for VA research, written materials describe<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">IRBs/ECs overseeing VA human participants research must meet all the IRB/EC requirements described in 38 CFR Part 16.</li><li>When the IRB/EC of Record is directly operated and supported by a non-VA entity, the policies and procedures related to the review of VA research by the non-VA entity must be consistent with VHA Directive 1200.05, 1005.01, and all requirements applicable to VA research.</li><li>IRBs/ECs of Record used by a VA facility must hold current IRB/EC registrations with FDA/OHRP and provide updates to membership as required by VHA Handbook 1058.03.</li><li>IRBs/ECs should consider including a Veteran or Veteran's representative.</li></ul>",
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 "key": "va--serving-as-a-reviewing-irb-for-va",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When serving as a reviewing IRB/EC for VA research:<ul><li>All IRBs/ECs overseeing VA human participants research must meet all the IRB/EC requirements described in 38 CFR Part 16. </li><li>When the IRB/EC of Record is directly operated and supported by a non-VA entity, the policies and procedures related to the review of VA research by the non-VA entity must be consistent with VHA Directive 1200.05, 1005.01, and all requirements applicable to VA research.</li><li>IRBs/ECs of Record used by a VA facility must hold current IRB/EC registrations with FDA/OHRP and provide updates to membership as required by VHA Handbook 1058.03.</li><li>IRBs/ECs should consider including a Veteran or Veteran's representative.</li></ul>",
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 "type": "section/domain",
 "key": "domain-ii-irbandec",
 "title": "DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE",
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 "type": "section/standard",
 "key": "standard-ii-1",
 "title": "STANDARD II-1",
 "description": "The structure and composition of the IRB or EC are appropriate to the amount and nature of the research reviewed and in accordance with requirements of applicable laws, regulations, codes, and guidance.",
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 "key": "element-ii-1-a",
 "title": "ELEMENT II.1.A.",
 "description": "The IRB or EC membership permits appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster. The IRB or EC has one or more unaffiliated members; one or more members who represent the general perspective of participants; one or more members who do not have scientific expertise; one or more members who have scientific or scholarly expertise; and, when the IRB or EC regularly reviews research that involves vulnerable participants, one or more members who are knowledgeable about or experienced in working with such participants.",
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 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "irb-ec-rosters",
 "title": "Essential RequirementsIRB/EC rosters include the following information:<ul><li>Names.</li><li>Earned degrees.</li><li>Representative capacities.</li><li>Scientific/nonscientific status.</li><li>Affiliation status (whether the IRB/EC member or an immediate family member of the IRB/EC member is affiliated with the organization).</li><li>Indications of experience sufficient to describe each IRB/EC member’s chief anticipated contributions.</li><li>Employment or other relationship between each IRB/EC member and the organization.</li><li>Alternate members.</li><li>The primary members or class of primary members for whom each alternate member can substitute.</li></ul>",
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 "key": "irb-ec-rosters",
 "title": "Add to or describe in IRB/EC rosters written materials [page xx or elsewhere]:<ul><li>Names.</li><li>Earned degrees.</li><li>Representative capacities.</li><li>Scientific/nonscientific status.</li><li>Affiliation status (whether the IRB/EC member or an immediate family member of the IRB/EC member is affiliated with the organization).</li><li>Indications of experience sufficient to describe each IRB/EC member’s chief anticipated contributions.</li><li>Employment or other relationship between each IRB/EC member and the organization.</li><li>Alternate members.</li><li>The primary members or class of primary members for whom each alternate member can substitute.</li></ul>",
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 "type": "question/review-assessment",
 "key": "irb-ec-membership",
 "title": "Essential RequirementsWritten materials describe:<ul><li>Each IRB/EC has at least five members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization.</li><li>No IRB/EC has members of a single gender.</li><li>No IRB/EC has members who represent a single profession.</li><li>Each IRB/EC has at least one member whose primary concerns are in scientific areas.</li><li>Each IRB/EC has at least one member whose primary concerns are in nonscientific areas.</li><li>Each IRB/EC has at least one member who is not otherwise affiliated with the organization and who is not part of the immediate family of a person who is affiliated with the organization.</li><li>Each IRB/EC has at least one member who represents the perspective of research participants.</li></ul>GUIDANCEThe unaffiliated member, the member representing the general perspective of participants, and the non-scientific member may be the same person, or they may be represented by two or three different persons.",
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 "key": "va--non-va-irb-serving-as-an-irb-for-a-va-facility",
 "title": "When providing IRB/EC review for a VA facility or VA research, written materials describe:<ul><li>VA representation on external IRBs, such as academic IRBs, is optional and at the discretion of the organizational official and the external IRB.</li><li>IRBs/ECs serving VA should consider including a Veteran or Veteran's representative.</li><li>VA facility research office staff including, but not limited to, the ACOS/R&D, the AO for R&D, and IRB/EC administrative staff may not serve as members of the IRB. They may serve as ex officio attendees.</li><li>Research Compliance Officers (RCOs) may act as consultants to the IRB, but may not serve as members of the IRB. RCOs may attend IRB/EC meetings when requested by the IRB/EC or as specified by the IRB’s/EC’s SOPs. RCOs must be aware of and manage any potential, actual, apparent, or perceived conflicts of interest that arise because of their role.</li><li>Facility Directors, their administrative staff, COS, other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and NPC Administrative Staff may observe IRB/EC meetings, but may not serve as members of the IRB.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>VA representation on external IRBs, such as academic IRBs, is optional and at the discretion of the organizational official and the external IRB.</li><li>IRBs/ECs serving VA should consider including a Veteran or Veteran's representative.</li><li>VA facility research office staff including, but not limited to, the ACOS/R&D, the AO for R&D, and IRB/EC administrative staff may not serve as members of the IRB. They may serve as ex officio attendees.</li><li>Research Compliance Officers (RCOs) may act as consultants to the IRB, but may not serve as members of the IRB. RCOs may attend IRB/EC meetings when requested by the IRB/EC or as specified by the IRB’s/EC’s SOPs. RCOs must be aware of and manage any potential, actual, apparent, or perceived conflicts of interest that arise because of their role.</li><li>Facility Directors, their administrative staff, COS, other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and NPC Administrative Staff may observe IRB/EC meetings, but may not serve as members of the IRB.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va-facility--irb-requirements",
 "title": "Written materials for the VA facility describe:<ul><li>VA facilities must maintain accurate membership rosters for their designated IRB(s) of Record and submit the roster(s) to the VA Office of Research Oversight (ORO) as required by VHA Handbook 1058.03.</li><li>The Privacy Officer (PO) and the Information System Security Officer (ISSO) serve in an advisory capacity to the facility’s IRB/EC as either non-voting members or as consultants.</li><li>Each IRB/EC must include at least one voting member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.<ul><li>Members whose training, background, and occupation are within a behavioral or biomedical research discipline should be considered a scientist.</li><li>Members whose training, background, and occupation are outside of a behavioral or biomedical research discipline should be considered a nonscientist.</li></ul></li><li>Each IRB/EC must include at least one voting member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. Retired VA employees who are receiving VA retirement benefits are considered affiliated for purposes of VA IRB/EC membership. Veterans who receive their care at the facility, but have never been employed by VA, would not be considered affiliated.</li><li>VA facility research office staff including, but not limited to, the Associate Chief of Staff/R&D (ACOS/R&D), the Administrative Officer (AO) for R&D, and IRB/EC administrative staff may not serve as voting members of the facility’s IRB. They may serve as ex officio, non-voting members or attendees; however, they and the IRB/EC must be sensitive to any potential, actual, apparent, or perceived conflicts of interest and appropriately manage such conflicts.</li><li>Research Compliance Officers (RCOs) may act as consultants to the facility’s IRB, but may not serve as members of the IRB. RCOs may attend IRB/EC meetings when requested by the IRB/EC or as specified by the IRB’s/EC’s SOPs. RCOs must be aware of and manage any potential, actual, apparent, or perceived conflicts of interest that arise because of their role.</li><li>The Privacy Officer (PO) and the Information System Security Officer (ISSO) serve in an advisory capacity to the facility’s IRB/EC as either non-voting members or as consultants.</li><li>Facility Directors, their administrative staff, Chief of Staff (COS), other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and VA-affiliated nonprofit research and education corporation (NPC) Administrative Staff may observe IRB/EC meetings, but may not serve as members of the facility’s IRB.</li><li>Alternate members are appointed to the facility’s IRB, the IRB’s/EC’s written procedures must describe the appointment and function of alternate members, and the IRB/EC membership roster must identify by name the primary member(s) for whom each alternate member may substitute.<ul><li>The alternate members must have similar member qualification(s) of the primary member they replace.</li></ul></li><li>The organizational official appoints VA voting members to an IRB/EC in writing. Appointment procedures for ex officio, non-voting members are made according to local SOPs and any other applicable VA requirements. Voting members of VA IRBs/ECs and VA representatives to external IRB(s) of Record and the VA Central IRB are appointed for a period of up to three years. They may be re-appointed to new terms of up to three years without a break in service at the end of each term.</li><li>The chair, co-chair(s), and vice chair(s) of an internal VA IRB/EC (e.g., an IRB/EC that is managed by the VA Facility or by a VA Program Office such as the VHA Central Office IRB) must be paid VA employees (i.e., not holding a without compensation (WOC) or interagency personnel agreement (IPA) appointment at VA).<ul><li>There may be one IRB/EC chair, co-chairs, or a chair and vice chair(s). Each may serve as a voting member of the IRB/EC pursuant to IRB/EC SOPs.</li><li>The chair and, when applicable, co-chair(s) or vice chair(s), are appointed by the organizational official for a term of up to three years, and may be re-appointed indefinitely.</li></ul></li></ul>",
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 "key": "va-facility--irb-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>VA facilities must maintain accurate membership rosters for their designated IRB(s) of Record and submit the roster(s) to the VA Office of Research Oversight (ORO) as required by VHA Handbook 1058.03.</li><li>The Privacy Officer (PO) and the Information System Security Officer (ISSO) serve in an advisory capacity to the facility’s IRB/EC as either non-voting members or as consultants.</li><li>Each IRB/EC must include at least one voting member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.<ul><li>Members whose training, background, and occupation are within a behavioral or biomedical research discipline should be considered a scientist.</li><li>Members whose training, background, and occupation are outside of a behavioral or biomedical research discipline should be considered a nonscientist.</li></ul></li><li>Each IRB/EC must include at least one voting member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. Retired VA employees who are receiving VA retirement benefits are considered affiliated for purposes of VA IRB/EC membership. Veterans who receive their care at the facility, but have never been employed by VA, would not be considered affiliated.</li><li>VA facility research office staff including, but not limited to, the Associate Chief of Staff/R&D (ACOS/R&D), the Administrative Officer (AO) for R&D, and IRB/EC administrative staff may not serve as voting members of the facility’s IRB. They may serve as ex officio, non-voting members or attendees; however, they and the IRB/EC must be sensitive to any potential, actual, apparent, or perceived conflicts of interest and appropriately manage such conflicts.</li><li>Research Compliance Officers (RCOs) may act as consultants to the facility’s IRB, but may not serve as members of the IRB. RCOs may attend IRB/EC meetings when requested by the IRB/EC or as specified by the IRB’s/EC’s SOPs. RCOs must be aware of and manage any potential, actual, apparent, or perceived conflicts of interest that arise because of their role.</li><li>The Privacy Officer (PO) and the Information System Security Officer (ISSO) serve in an advisory capacity to the facility’s IRB/EC as either non-voting members or as consultants.</li><li>Facility Directors, their administrative staff, Chief of Staff (COS), other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and VA-affiliated nonprofit research and education corporation (NPC) Administrative Staff may observe IRB/EC meetings, but may not serve as members of the facility’s IRB.</li><li>Alternate members are appointed to the facility’s IRB, the IRB’s/EC’s written procedures must describe the appointment and function of alternate members, and the IRB/EC membership roster must identify by name the primary member(s) for whom each alternate member may substitute.<ul><li>The alternate members must have similar member qualification(s) of the primary member they replace.</li></ul></li><li>The organizational official appoints VA voting members to an IRB/EC in writing. Appointment procedures for ex officio, non-voting members are made according to local SOPs and any other applicable VA requirements. Voting members of VA IRBs/ECs and VA representatives to external IRB(s) of Record and the VA Central IRB are appointed for a period of up to three years. They may be re-appointed to new terms of up to three years without a break in service at the end of each term.</li><li>The chair, co-chair(s), and vice chair(s) of an internal VA IRB/EC (e.g., an IRB/EC that is managed by the VA Facility or by a VA Program Office such as the VHA Central Office IRB) must be paid VA employees (i.e., not holding a without compensation (WOC) or interagency personnel agreement (IPA) appointment at VA).<ul><li>There may be one IRB/EC chair, co-chairs, or a chair and vice chair(s). Each may serve as a voting member of the IRB/EC pursuant to IRB/EC SOPs.</li><li>The chair and, when applicable, co-chair(s) or vice chair(s), are appointed by the organizational official for a term of up to three years, and may be re-appointed indefinitely.</li></ul></li></ul>",
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 "type": "section/element",
 "key": "element-ii-1-b",
 "title": "ELEMENT II.1.B.",
 "description": "The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.",
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 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "irb-member-appointments",
 "title": "Essential RequirementsWritten materials describe the appointment of:<ul><li>IRB/EC members.</li><li>IRB/EC chairs and vice chairs when appropriate.</li><li>Alternate IRB/EC members.</li></ul>",
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 "key": "alternate-irb-ec-members",
 "title": "Essential RequirementsWritten materials describe the\nfunction of alternate members.",
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 "type": "question/review-assessment",
 "key": "irb-ec-member-feedback",
 "title": "Essential RequirementsWritten materials describe the periodic assessment and feedback provided to:<ul><li>IRB/EC members.</li><li>IRB/EC chairs, and vice chairs when appropriate.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The periodic assessment and feedback provided to:<ul><li>IRB/EC members.</li><li>IRB/EC chairs, and vice chairs when appropriate.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--experienced-member-definition",
 "title": "When following DHHS requirements, written materials describe:<ul><li>That an “experienced” IRB/EC member means the member has adequate professional competence. </li><li>The organization’s criteria to determine whether an IRB/EC member has adequate professional competence.</li></ul>",
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 "key": "dhhs--experience-irb-member-definition",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>That an “experienced” IRB/EC member means the member has adequate professional competence. </li><li>The organization’s criteria to determine whether an IRB/EC member has adequate professional competence.</li></ul>",
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 "key": "element-ii-1-c",
 "title": "ELEMENT II.1.C.",
 "description": "The organization has and follows written policies and procedures to separate competing business interests from ethics review functions.   ",
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 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "separation-of-business-and-ethics-interests",
 "title": "Essential RequirementsWritten materials describe: <ul><li>Individuals who are responsible for business development are prohibited from:</li><li>Serving as members or ex-officio members on the IRB/EC.</li><li>Carrying out day-to-day operations of the review process.</li><li>IRB/EC members are prohibited from owning equity in the organization, if appropriate.</li></ul>GUIDANCEThe last bullet only applies to organizations where employees may hold an equity stake, e.g., stock options or other ownership interests (for example, researchers who own companies spun off from universities). ",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>Individuals who are responsible for business development are prohibited from:</li><li>Serving as members or ex-officio members on the IRB/EC.</li><li>Carrying out day-to-day operations of the review process.</li><li>IRB/EC members are prohibited from owning equity in the organization, if appropriate.</li></ul>",
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 "type": "section/element",
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 "title": "ELEMENT II.1.D.",
 "description": "The IRB or EC has and follows written policies and procedures so that members and consultants do not participate in the review of research protocols or plans in which they have a conflict of interest, except to provide information requested by the IRB or EC.   ",
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 "type": "question/review-assessment",
 "key": "conflicts-of-interest",
 "title": "Essential RequirementsWritten materials describe:IRB/EC members and consultants do not participate in any review in which they have a conflict of interest, except to provide information requested by the IRB/EC.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:IRB/EC members and consultants do not participate in any review in which they have a conflict of interest, except to provide information requested by the IRB/EC.",
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 "title": "Essential RequirementsWritten materials define when an IRB/EC member has a conflict of interest. The definition must:<ul><li>Consider financial issues.</li><li>Consider non-financial issues.</li><li>Be at least as stringent as the level of a researcher’s financial interest that requires evaluation as a possible conflict of interest.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:A definition of when an IRB/EC member has a conflict of interest. The definition must:<ul type=\"disc\"><li>Consider financial issues.</li><li>Consider non-financial issues.</li><li>Be at least as stringent as the level of a researcher’s financial interest that requires evaluation as a possible conflict of interest.</li></ul> ",
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 "type": "question/review-assessment",
 "key": "identification-of-irb-ec-member-cois",
 "title": "Written materials describe the process to identify IRB/EC members and consultants with a conflict of interest. These policies cover each type of review, such as:<ul><li>Review by a convened IRB.</li><li>Review by the expedited procedure.</li><li>Review of unanticipated problems involving risks to participants or others.</li><li>Review of noncompliance with regulations or laws or the requirements of the IRB/EC.IRB/EC members or consultants are defined when they have a conflicting interest as follows:  </li></ul><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">In addition, written materials include a definition of an IRB/EC members or consultant conflict of interest that: <ul type=\"disc\"><li>Considers non-financial issues.</li><li>Is at least as stringent as the level of a researcher’s financial interest that requires evaluation as a possible conflict of interest.</li><li>Identifies the involvement of the IRB/EC member, consultant, or their immediate family in the design, conduct, or reporting of the research as a conflict of interest. </li><li>Addresses:</li><ul type=\"disc\"><li>“Immediate Family” means spouse and dependent children. [May be equivalent or stricter.]</li><li>“Financial Interest Related to the Research” means financial interest in the sponsor, product, or service being tested. [May be equivalent or stricter.</li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></ul></ul>GUIDANCELook for a definition rather than disclosure requirements.   ",
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 "key": "identification-of-irb-ec-member-cois",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process to identify IRB/EC members and consultants with a conflict of interest for the following type(s) of review:<ul type=\"disc\"><li>Review by a convened IRB.</li><li>Review by the expedited procedure.</li><li>Review of unanticipated problems involving risks to participants or others.</li><li>Review of noncompliance with regulations or laws or the requirements of the IRB/EC.</li></ul>Include a definition of an IRB/EC members or consultant conflict of interest that: <ul type=\"disc\"><li>Considers non-financial issues.</li><li>Is at least as stringent as the level of a researcher’s financial interest that requires evaluation as a possible conflict of interest.</li><li>Identifies the involvement of the IRB/EC member, consultant, or their immediate family in the design, conduct, or reporting of the research as a conflict of interest. </li><li>Addresses:</li><ul type=\"disc\"><li>“Immediate Family” means spouse and dependent children. [May be equivalent or stricter.]</li><li>“Financial Interest Related to the Research” means financial interest in the sponsor, product, or service being tested. [May be equivalent or stricter.]</li></ul></ul>",
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 "type": "question/review-assessment",
 "key": "addressing-irb-ec-member-cois",
 "title": "Essential RequirementsWritten materials describe that IRB/EC members and consultants with a conflict of interest:<ul><li>Are excluded from discussion except to provide information requested by the IRB/EC.</li><li>Are excluded from voting except to provide information requested by the IRB/EC.</li><li>Leave the meeting for discussion and voting.</li><li>Are not counted towards quorum.</li><li>IRB/EC members with a conflict are documented in the minutes as being absent with an indication that a conflict of interest was the reason for the absence.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:IRB/EC members and consultants with a conflict of interest:<ul type=\"disc\"><li>Are excluded from discussion except to provide information requested by the IRB/EC.</li><li>Are excluded from voting except to provide information requested by the IRB/EC.</li><li>Leave the meeting for discussion and voting.</li><li>Are not counted towards quorum.</li><li>IRB/EC members with a conflict are documented in the minutes as being absent with an indication that a conflict of interest was the reason for the absence.</li></ul>",
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 "type": "question/review-assessment",
 "key": "irb-ec-consultants",
 "title": "Essential RequirementsWritten materials describe whether consultants with a conflict of interest:<ul><li>Are allowed to provide information to the IRB/EC, and the process to manage the conflict of interest. Acceptable methods of managing the conflict include disclosing the existence of the conflict to IRB/EC members. Consultants with a conflict must not be present for the discussion and vote. </li><li>Are not allowed to provide information to the IRB/EC. </li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:Whether consultants with a conflict of interest:<ul><li>Are allowed to provide information to the IRB/EC, and the process to manage the conflict of interest. Acceptable methods of managing the conflict include disclosing the existence of the conflict to IRB/EC members. Consultants with a conflict must not be present for the discussion and vote.</li><li>Are not allowed to provide information to the IRB/EC.</li></ul>",
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 "title": "ELEMENT II.1.E.",
 "description": "The IRB or EC has and follows written policies and procedures requiring research protocols or plans to be reviewed by individuals with appropriate scientific or scholarly expertise and other expertise or knowledge as required to review the research protocol or plan.   ",
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 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "ensuring-scientific-review-of-a-study",
 "title": "Essential RequirementsWritten materials describe the process so that at\nleast one person with appropriate scientific or scholarly expertise conducts an\nin-depth review of the protocol.",
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 "type": "question/review-assessment",
 "key": "ensuring-other-expertise-for-irb-review",
 "title": "Essential RequirementsWritten materials describe the process to\ndetermine whether other types of expertise or knowledge are required in order\nto conduct an in-depth review of the protocol.",
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 "type": "question/review-assessment",
 "key": "process-for-addressing-lack-of-expertise",
 "title": "Written materials describe that the IRB/EC defers to\nanother meeting, cedes review to another IRB/EC, or obtains consultation if there is not at least one\nperson on the IRB/EC with appropriate scientific or scholarly expertise or\nother expertise or knowledge to conduct an in-depth review of the protocol.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC defers to another meeting, cedes review to another IRB/EC, or obtains consultation, if there is not at least one person on the IRB/EC with appropriate scientific or scholarly expertise or other expertise or knowledge to conduct an in-depth review of the protocol.",
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 "type": "question/review-assessment",
 "key": "use-of-consultants",
 "title": "Essential RequirementsWritten materials describe:<ul><li>Who evaluates each protocol to determine whether a consultant is needed.</li><li>The process to obtain consultants.</li><li>Consultants do not vote with IRB/EC members.</li><li>How the information provided by consultants is documented.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Who evaluates each protocol to determine whether a consultant is needed.</li><li>The process to obtain consultants.</li><li>Consultants do not vote with IRB/EC members.</li><li>How the information provided by consultants is documented.</li></ul>",
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 "type": "section/standard",
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 "title": "STANDARD II-2",
 "description": "<div>The IRB or EC evaluates each research protocol or plan to ensure the protection of participants.</div>",
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 "type": "section/element",
 "key": "element-ii-2-a",
 "title": "ELEMENT II.2.A.",
 "description": "The IRB or EC has and follows written policies and procedures for determining when activities are exempt from applicable laws and regulations, when permitted by law or regulation and exercised by the IRB or EC. Such policies and procedures indicate that exemption determinations are not to be made by researchers or others who might have a conflict of interest regarding the studies.  ",
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 "type": "question/review-assessment",
 "key": "exemption-reviewers",
 "title": "Essential RequirementsWritten materials describe that the entity or individuals who are authorized to make exemption determinations, and the requirement that no conflict of interest regarding the studies exists for those making the determinations. GUIDANCEExemption determinations may not be made solely by the researcher or someone with a conflict of interest in the research.NOTE: Organizations outside the US generally do not\nhave legal authority to grant exempt determinations (country law does not allow\nexemptions). If you see policies on exempt determinations, contact AAHRPP\nstaff.",
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 "type": "question/review-assessment",
 "key": "research-that-qualifies-for-exemption",
 "title": "Essential RequirementsWritten materials describe which research studies\ninvolving human participants are exempt.",
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 "type": "question/review-assessment",
 "key": "requesting-exemption-determinations",
 "title": "Essential RequirementsWritten materials describe the process to inform researchers:<ul><li>Whom to ask for an authoritative decision about whether research involving human participants is exempt from regulation.</li><li>What information to submit.</li></ul>",
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 "type": "question/review-assessment",
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 "title": "Essential RequirementsWritten materials describe the process to provide determinations about whether research involving human participants is exempt from regulation that includes:<ul><li>Specific titles of persons or offices authorized to make determinations.</li><li>Criteria used to make determinations.</li><li>The process used to communicate determinations.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--exemption-categories",
 "title": "Written materials indicate that when following DHHS requirements, the criteria allowing exemption are:Category 1<ul><li>The research is conducted in established or commonly accepted educational settings.</li><li>The research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction, such as:<ul><li>Research on regular and special education instructional strategies.</li><li>Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.</li></ul></li><li>The research does not involve prisoners as participants, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul>Category 2<ul><li>The research only involves interactions involving one or more of the following:<ul><li>Educational tests (cognitive, diagnostic, aptitude, achievement). </li><li>Survey procedures.</li><li>Interview procedures.</li><li>Observation of public behavior (including visual or auditory recording).</li></ul></li><li>One of the following conditions are met:<ul><li>The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li></ul><ul><li>Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB/EC conducts a limited IRB/EC review of the research.<ul><li>This condition cannot be applied when research is subject to Subpart D. </li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The research is not regulated by the FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul>Category 3 (<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">For Category 3, written materials must define benign behavioral interventions, consistent with the organization’s research portfolio.)<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection.<ul><li>Benign behavioral interventions are:</li><li>Brief in duration.</li><li>Harmless.</li><li>Painless.</li><li>Not physically invasive.</li><li>Not likely to have a significant adverse lasting impact on participants.</li></ul></li><li>The researcher has no reason to think the participants will find the interventions offensive or embarrassing.</li><li>At least one of the following criteria is met:<ul><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or</li><li>Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or</li><li>If the information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB/EC conducts a limited IRB review.</li></ul></li><li>If the research involves deception of participants regarding the nature or purposes of the research:<ul><li>The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.* </li></ul>Category 4<ul><li>Secondary research uses of identifiable private or identifiable biospecimens, if at least one of the following criteria are met:<ul><li>The identifiable private information or identifiable biospecimens are publicly available, or </li><li>The research involves only information collection and analysis, that either:<ul><li>Involves the researcher’s use of identifiable health information when that use is regulated under HIPAA for the purposes of ‘‘health care operations,’’ or “research” or public health activities and purposes as defined in HIPAA. </li><li>Involves research conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C. 552a.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul></li></ul>Category 5<ul><li>The project is a research or demonstration project.</li><li>The research is conducted by or subject to the approval of a US federal government Department or Agency head.</li><li>The research is designed to study, evaluate, improve, or otherwise examine a program that delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act) and includes one or more of the following:<ul><li>Procedures for obtaining benefits or services under those programs.</li><li>Possible changes in or alternatives to those programs or procedures.</li><li>Possible changes in methods or levels of payment for benefits or services under those programs.</li></ul></li><li>The research is conducted pursuant to specific statutory authority of the US federal government.</li><li>There is no statutory requirement that an IRB/EC review the research.</li><li>The research does not involve significant physical invasions or intrusions upon the privacy of participants.</li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul>Category 6<ul><li>The research involves taste and food quality evaluation or is a consumer acceptance study.</li><li>Either of the following is true:<ul><li>Wholesome foods without additives are consumed.</li><li>If a food is consumed that contains a food ingredient or an agricultural chemical or environmental contaminant, the food ingredient or agricultural chemical or environmental contaminant is at or below the level and for a use found to be safe by one of the following:<ul><li>The Food and Drug Administration.</li><li>The Environmental Protection Agency.</li><li>The Food Safety and Inspection Service of the Department of Agriculture.</li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul>Category 7<ul><li>Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, if the research has undergone limited IRB/EC review. For purposes of conducting the limited IRB/EC review, the IRB/EC must determine:<ul><li>Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained:<ul><li>The researcher obtains the legally effective broad consent of the participant or the participant's legally authorized representative.</li><li>The researcher must provide the prospective participant or legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.</li><li>The information that is given to the participant or the legally authorized representative must be in language understandable to the participant or the legally authorized representative.</li><li>The prospective participant or legally authorized representative must be provided with the information a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.</li><li>No broad consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the researcher, the sponsor, the organization, or its agents from liability for negligence.</li><li>Broad consent must include the following information:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>When appropriate, a statement that the participant's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>When appropriate, for research involving biospecimens, a statement indicating whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).</li><li>A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.</li><li>A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens.</li><li>A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite).</li><li>Unless the participant or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.</li><li>Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant.</li><li>An explanation of whom to contact for answers to questions about the participant’s rights and about storage and use of the participant's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.</li></ul></li><li>Documentation of broad consent or waiver of documentation of consent is obtained. (See Elements II.3.F. and II.3.G.)</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Elements II.3.D. and II.3.E.)</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul></li></ul></li></ul>Category 8<ul><li>Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met:<ul><li>Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.</li><li>Documentation of consent or waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.)</li><li>The research has undergone limited IRB review by an IRB/EC member, who determines:<ul><li>There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data </li><li>The research to be conducted is within the scope of the broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate.</li></ul></li><li>The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the laws of that country do not prohibit an exemption.*</li></ul></li></ul>GUIDANCECheck what types of participants are allowed in research conducted by the organization, to be sure that exemption policies / worksheets include all required determinations. For example, if the organization does not conduct research involving children, then the Subpart D requirements are not applicable.*See AAHRPP Addenda for discussion of country-specific laws.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements, the criteria allowing exemption are:Category 1<ul><li>The research is conducted in established or commonly accepted educational settings.</li><li>The research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction, such as:<ul><li>Research on regular and special education instructional strategies.</li><li>Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.</li></ul></li><li>The research does not involve prisoners as participants, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li></ul>Category 2<ul><li>The research only involves interactions involving one or more of the following:<ul><li>Educational tests (cognitive, diagnostic, aptitude, achievement).</li><li>Survey procedures.</li><li>Interview procedures.</li><li>Observation of public behavior (including visual or auditory recording).</li></ul></li><li>One of the following conditions are met:<ul><li>The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li></ul><ul><li>Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB/EC conducts a limited IRB/EC review of the research.<ul><li>This condition cannot be applied when research is subject to Subpart D. </li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li></ul>Category 3 (For Category 3, written materials must define benign behavioral interventions, consistent with the organization’s research portfolio.)<ul><li>Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection.<ul><li>Benign behavioral interventions are:</li><li>Brief in duration.</li><li>Harmless.</li><li>Painless.</li><li>Not physically invasive.</li><li>Not likely to have a significant adverse lasting impact on participants.</li></ul></li><li>The researcher has no reason to think the participants will find the interventions offensive or embarrassing.</li><li>At least one of the following criteria is met:<ul><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or</li><li>Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or</li><li>If the information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB/EC conducts a limited IRB review.</li></ul></li><li>If the research involves deception of participants regarding the nature or purposes of the research:<ul><li>The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul>Category 4<ul><li>Secondary research uses of identifiable private or identifiable biospecimens, if at least one of the following criteria are met:<ul><li>The identifiable private information or identifiable biospecimens are publicly available, or</li><li>The research involves only information collection and analysis, that either:<ul><li>Involves the researcher’s use of identifiable health information when that use is regulated under HIPAA for the purposes of ‘‘health care operations,’’ or “research” or public health activities and purposes as defined in HIPAA.</li><li>Involves research conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C. 552a.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul>Category 5<ul><li>The project is a research or demonstration project.</li><li>The research is conducted by or subject to the approval of a US federal government Department or Agency head.</li><li>The research is designed to study, evaluate, improve, or otherwise examine a program that delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act) and includes one or more of the following:<ul><li>Procedures for obtaining benefits or services under those programs.</li><li>Possible changes in or alternatives to those programs or procedures.</li><li>Possible changes in methods or levels of payment for benefits or services under those programs.</li></ul></li><li>The research is conducted pursuant to specific statutory authority of the US federal government.</li><li>There is no statutory requirement that an IRB/EC review the research.</li><li>The research does not involve significant physical invasions or intrusions upon the privacy of participants.</li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul>Category 6<ul><li>The research involves taste and food quality evaluation or is a consumer acceptance study.</li><li>Either of the following is true:<ul><li>Wholesome foods without additives are consumed.</li><li>If a food is consumed that contains a food ingredient or an agricultural chemical or environmental contaminant, the food ingredient or agricultural chemical or environmental contaminant is at or below the level and for a use found to be safe by one of the following:<ul><li>The Food and Drug Administration.</li><li>The Environmental Protection Agency.</li><li>The Food Safety and Inspection Service of the Department of Agriculture.</li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li></ul>Category 7<ul><li>Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, if the research has undergone limited IRB/EC review. For purposes of conducting the limited IRB/EC review, the IRB/EC must determine:<ul><li>Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained:<ul><li>The researcher obtains the legally effective broad consent of the participant or the participant's legally authorized representative.</li><li>The researcher must provide the prospective participant or legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.</li><li>The information that is given to the participant or the legally authorized representative must be in language understandable to the participant or the legally authorized representative.</li><li>The prospective participant or legally authorized representative must be provided with the information a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.</li><li>No broad consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the researcher, the sponsor, the organization, or its agents from liability for negligence.</li><li>Broad consent must include the following information:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>When appropriate, a statement that the participant's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>When appropriate, for research involving biospecimens, a statement indicating whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).</li><li>A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.</li><li>A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens.</li><li>A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite).</li><li>Unless the participant or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.</li><li>Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant.</li><li>An explanation of whom to contact for answers to questions about the participant’s rights and about storage and use of the participant's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.</li></ul></li><li>Documentation of broad consent or waiver of documentation of consent is obtained. (See Elements II.3.F. and II.3.G.)</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Elements II.3.D. and II.3.E.)</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul></li></ul>Category 8<ul><li>Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met:<ul><li>Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.</li><li>Documentation of consent or waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.)</li><li>The research has undergone limited IRB review by an IRB/EC member, who determines:<ul><li>There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data</li><li>The research to be conducted is within the scope of the broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate.</li></ul></li></ul><ul><li>The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul>",
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 "title": "Written materials indicate that when following VA requirements, the criteria allowing exemption are:Category 1<ul><li>The research is conducted in established or commonly accepted educational settings.</li><li>The research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. <ul><li>This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.</li></ul></li><li>The research does not involve prisoners as participants, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li></ul>Category 2<ul><li>The research only involves interactions involving one or more of the following:<ul><li>Educational tests (cognitive, diagnostic, aptitude, achievement).</li><li>Survey procedures.</li><li>Interview procedures.</li><li>Observation of public behavior (including visual or auditory recording).</li></ul></li><li>One of the following conditions are met:<ul><li>The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li></ul><ul><li>Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB/EC conducts a limited IRB/EC review of the research.<ul><li>This condition cannot be applied when research is subject to Subpart D.</li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li></ul>Category 3 (For Category 3, written materials must define benign behavioral interventions, consistent with the organization’s research portfolio.)<ul><li>Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection.<ul><li>Benign behavioral interventions are:</li><li>Brief in duration.</li><li>Harmless.</li><li>Painless.</li><li>Not physically invasive.</li><li>Not likely to have a significant adverse lasting impact on participants.</li></ul></li><li>The researcher has no reason to think the participants will find the interventions offensive or embarrassing.</li><li>At least one of the following criteria is met:<ul><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or</li><li>Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or</li><li>If the information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB/EC conducts a limited IRB review.</li></ul></li><li>If the research involves deception of participants regarding the nature or purposes of the research:<ul><li>The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul>Category 4<ul><li>Secondary research uses of identifiable private or identifiable biospecimens, if at least one of the following criteria are met:<ul><li>The identifiable private information or identifiable biospecimens are publicly available, or</li><li>Information, which may include information about biospecimens, is recorded by \nthe investigator in such a manner that the identity of the human subjects cannot readily \nbe ascertained directly or through identifiers linked to the subjects, the investigator does \nnot contact the subjects, and the investigator will not re-identify subjects; or</li><li>The research involves only information collection and analysis, that either:<ul><li>Involves the researcher’s use of identifiable health information when that use is regulated under HIPAA for the purposes of ‘‘health care operations,’’ or “research” or public health activities and purposes as defined in HIPAA.</li><li>Involves research conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C. 552a.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul>Category 5<ul><li>The determination of exempt status for research and demonstration projects meeting the criteria for exempt Category 5 must be made by the Under Secretary for Health on behalf of the Secretary of VA, after consultation with Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of General Counsel (OGC), and other experts, as appropriate.</li><li>The project is a research or demonstration project.</li><li>The research is conducted by or subject to the approval of a US federal government Department or Agency head.</li><li>The research is designed to study, evaluate, improve, or otherwise examine a program that delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act) and includes one or more of the following:</li><li>Procedures for obtaining benefits or services under those programs.</li><li>Possible changes in or alternatives to those programs or procedures.</li><li>Possible changes in methods or levels of payment for benefits or services under those programs.</li><li>The research is conducted pursuant to specific statutory authority of the US federal government.<ul><li>There is no statutory requirement that an IRB/EC review the research.</li><li>The research does not involve significant physical invasions or intrusions upon the privacy of participants.</li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li></ul></li><li>The research is not regulated by the US FDA.</li></ul>Category 6<ul><li>The research involves taste and food quality evaluation or is a consumer acceptance study.</li><li>Either of the following is true:<ul><li>Wholesome foods without additives are consumed.</li><li>If a food is consumed that contains a food ingredient or an agricultural chemical or environmental contaminant, the food ingredient or agricultural chemical or environmental contaminant is at or below the level and for a use found to be safe by one of the following:<ul><li>The Food and Drug Administration.</li><li>The Environmental Protection Agency.</li><li>The Food Safety and Inspection Service of the Department of Agriculture.</li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li></ul>Category 7<ul><li>Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, if the research has undergone limited IRB/EC review. For purposes of conducting the limited IRB/EC review, the IRB/EC must determine:<ul><li>Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained:<ul><li>The researcher obtains the legally effective broad consent of the participant or the participant's legally authorized representative.</li><li>The researcher must provide the prospective participant or legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.</li><li>The information that is given to the participant or the legally authorized representative must be in language understandable to the participant or the legally authorized representative.</li><li>The prospective participant or legally authorized representative must be provided with the information a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.</li><li>No broad consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the researcher, the sponsor, the organization, or its agents from liability for negligence.</li><li>Broad consent must include the following information:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>When appropriate, a statement that the participant's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>When appropriate, for research involving biospecimens, a statement indicating whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).</li><li>A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.</li><li>A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens.</li><li>A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite).</li><li>Unless the participant or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.</li><li>Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant.</li><li>An explanation of whom to contact for answers to questions about the participant’s rights and about storage and use of the participant's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.</li></ul></li><li>Documentation of broad consent or waiver of documentation of consent is obtained. (See Elements II.3.F. and II.3.G.)</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Elements II.3.D. and II.3.E.)</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul></li></ul>Category 8<ul><li>Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met:<ul><li>Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.</li><li>Documentation of consent or waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.)</li><li>The research has undergone limited IRB review by an IRB/EC member, who determines:<ul><li>There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data</li><li>The research to be conducted is within the scope of the broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate.</li></ul></li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>The investigator does not include returning individual research results to subjects \nas part of the study plan. This provision does not prevent an investigator from abiding \nby any legal requirements to return individual research results</li></ul></li></ul>GUIDANCEVA exemption categories are almost identical to DHHS categories of exemption.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:Category 1<ul><li>The research is conducted in established or commonly accepted educational settings.</li><li>The research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. <ul><li>This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.</li></ul></li><li>The research does not involve prisoners as participants, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li></ul>Category 2<ul><li>The research only involves interactions involving one or more of the following:<ul><li>Educational tests (cognitive, diagnostic, aptitude, achievement).</li><li>Survey procedures.</li><li>Interview procedures.</li><li>Observation of public behavior (including visual or auditory recording).</li></ul></li><li>One of the following conditions are met:<ul><li>The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li></ul><ul><li>Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB/EC conducts a limited IRB/EC review of the research.<ul><li>This condition cannot be applied when research is subject to Subpart D.</li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the FDA.</li></ul>Category 3 (For Category 3, written materials must define benign behavioral interventions, consistent with the organization’s research portfolio.)<ul><li>Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection.<ul><li>Benign behavioral interventions are:</li><li>Brief in duration.</li><li>Harmless.</li><li>Painless.</li><li>Not physically invasive.</li><li>Not likely to have a significant adverse lasting impact on participants.</li></ul></li><li>The researcher has no reason to think the participants will find the interventions offensive or embarrassing.</li><li>At least one of the following criteria is met:<ul><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or</li><li>Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or</li><li>If the information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB/EC conducts a limited IRB review.</li></ul></li><li>If the research involves deception of participants regarding the nature or purposes of the research:<ul><li>The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul>Category 4<ul><li>Secondary research uses of identifiable private or identifiable biospecimens, if at least one of the following criteria are met:<ul><li>The identifiable private information or identifiable biospecimens are publicly available, or</li><li>Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; or</li><li>The research involves only information collection and analysis, that either:<ul><li>Involves the researcher’s use of identifiable health information when that use is regulated under HIPAA for the purposes of ‘‘health care operations,’’ or “research” or public health activities and purposes as defined in HIPAA.</li><li>Involves research conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C. 552a.</li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul>Category 5<ul><li>The determination of exempt status for research and demonstration projects meeting the criteria for exempt Category 5 must be made by the Under Secretary for Health on behalf of the Secretary of VA, after consultation with Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of General Counsel (OGC), and other experts, as appropriate.</li><li>The project is a research or demonstration project.</li><li>The research is conducted by or subject to the approval of a US federal government Department or Agency head.</li><li>The research is designed to study, evaluate, improve, or otherwise examine a program that delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act) and includes one or more of the following:</li><li>Procedures for obtaining benefits or services under those programs.</li><li>Possible changes in or alternatives to those programs or procedures.</li><li>Possible changes in methods or levels of payment for benefits or services under those programs.</li><li>The research is conducted pursuant to specific statutory authority of the US federal government.<ul><li>There is no statutory requirement that an IRB/EC review the research.</li><li>The research does not involve significant physical invasions or intrusions upon the privacy of participants.</li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li></ul></li><li>The research is not regulated by the US FDA.</li></ul>Category 6<ul><li>The research involves taste and food quality evaluation or is a consumer acceptance study.</li><li>Either of the following is true:<ul><li>Wholesome foods without additives are consumed.</li><li>If a food is consumed that contains a food ingredient or an agricultural chemical or environmental contaminant, the food ingredient or agricultural chemical or environmental contaminant is at or below the level and for a use found to be safe by one of the following:<ul><li>The Food and Drug Administration.</li><li>The Environmental Protection Agency.</li><li>The Food Safety and Inspection Service of the Department of Agriculture.</li></ul></li></ul></li><li>Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li></ul>Category 7<ul><li>Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, if the research has undergone limited IRB/EC review. For purposes of conducting the limited IRB/EC review, the IRB/EC must determine:<ul><li>Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained:<ul><li>The researcher obtains the legally effective broad consent of the participant or the participant's legally authorized representative.</li><li>The researcher must provide the prospective participant or legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.</li><li>The information that is given to the participant or the legally authorized representative must be in language understandable to the participant or the legally authorized representative.</li><li>The prospective participant or legally authorized representative must be provided with the information a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.</li><li>No broad consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the researcher, the sponsor, the organization, or its agents from liability for negligence.</li><li>Broad consent must include the following information:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>When appropriate, a statement that the participant's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>When appropriate, for research involving biospecimens, a statement indicating whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).</li><li>A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.</li><li>A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens.</li><li>A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite).</li><li>Unless the participant or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.</li><li>Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant.</li><li>An explanation of whom to contact for answers to questions about the participant’s rights and about storage and use of the participant's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.</li></ul></li><li>Documentation of broad consent or waiver of documentation of consent is obtained. (See Elements II.3.F. and II.3.G.)</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Elements II.3.D. and II.3.E.)</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li></ul></li></ul></li></ul>Category 8<ul><li>Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met:<ul><li>Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.</li><li>Documentation of consent or waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.)</li><li>The research has undergone limited IRB review by an IRB/EC member, who determines:<ul><li>There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data</li><li>The research to be conducted is within the scope of the broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate.</li></ul></li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results</li></ul></li></ul>",
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 "title": "Written materials describe that all exempt research subject to VA regulations must be \nreviewed and approved by the R&D Committee.For VA facilities, written materials also describe that <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">research determined to be exempt also requires continuing review by the R&D Committee unless it is under the oversight of another subcommittee (e.g., Safety Review Subcommittee).",
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 "title": "Written materials describe that the investigator may not self-certify that a study is exempt. ",
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 "title": "Written materials describe that for VA research exempt determinations may be made by the IRB/EC chair, an experienced IRB/EC member, or qualified administrative staff with expertise in applying human research exempt regulations.",
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 "title": "For organizations that are not VA facilities but review research for VA facilitiesAdd to or describe in written materials [page xx or elsewhere]: <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Exempt determinations for VA research may be made by the IRB/EC chair, an experienced IRB/EC member, or qualified administrative staff with expertise in applying human research exempt regulations. <div> </div><div> </div> <div> </div>",
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 "title": "Written materials describe:<ul><li>If an exempt activity requires a limited IRB review, the limited IRB review must be \ncompleted prior to approval by the R&D Committee.</li><li>Limited IRB review for applicable exempt activities may be done by the convened \nIRB, the IRB Chair, or delegated to one or more experienced reviewers from among \nvoting IRB members.\n</li></ul>  ",
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 "title": "Essential RequirementsWritten materials describe:<ul><li>The research holds out no more than minimal risk to participants.</li><li>Selection of participants is equitable.</li><li>If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.</li><li>If there are interactions with participants, someone with appropriate qualifications and expertise should determine whether there should be a consent process that will disclose such information as:<ul><li>That the activity involves research.</li><li>A description of the procedures.</li><li>That participation is voluntary.</li><li>Name and contact information for the researcher.</li><li>There are adequate provisions to maintain the privacy interests of participants.</li></ul></li></ul>",
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 "title": "Written materials describe that for VA exempt research activities involving the investigator interacting with human \nsubjects or obtaining information by educational tests, survey or interview procedures, \nor behavioral interventions, the following information must be given to the prospective \nhuman subject as applicable in writing or orally:\n<ul><li>The activity is research;\n</li><li>Participation is voluntary;\n</li><li>Permission to participate can be withdrawn;\n</li><li>Permission for use of data can be withdrawn for exempt research activities \ninvolving the collection and use of identifiable data; and\n</li><li>Contact information for the VA Investigator.</li></ul>",
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 "title": "For organizations that conduct IRB review for VA facilitiesAdd to or describe in written materials [page xx or elsewhere]:Written materials describe that for VA exempt research activities involving the investigator interacting with human subjects or obtaining information by educational tests, survey or interview procedures, or behavioral interventions, the following information must be given to the prospective human subject as applicable in writing or orally:<ul type=\"disc\"><li>The activity is research;</li><li>Participation is voluntary;</li><li>Permission to participate can be withdrawn;</li><li>Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data; and</li><li>Contact information for the VA Investigator.</li></ul>",
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 "title": "Written materials describe:<ul><li>A description of what research is eligible for limited IRB review.<ul><li>Eligible research is deemed to be no more than minimal risk.</li><li>Eligible research meets one or more expedited categories 2, 3, 7, or 8.</li><li>If an IRB/EC member reviewing the research finds that research is greater than minimal risk, the reviewer must document the rationale for this determination and the rationale for review by the convened IRB/EC. </li></ul></li><li>Written materials specify the information that researchers must submit for limited IRB review, including:<ul><li>The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.</li><li>Proposed consent document.</li></ul></li><li>Written materials specify that IRB/EC members conducting limited IRB review may not disapprove research.</li><li>Written materials specify the required determinations when conducting limited IRB/EC review.<ul><li>For exemption Categories 2 and 3, there are adequate protections for privacy interests of participants and the confidentiality of identifiable data.</li><li>For exemption Category 7, broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained.</li><li>For exemption Category 8, broad consent is appropriately documented, or a waiver of documentation is appropriate.</li></ul></li><li>Written materials describe the evaluation of exempt research under limited IRB review to determine whether it fulfills the organization’s ethical standards.</li><li>Written materials specify that continuing review is not required for studies that qualify for a limited review.</li><li>Written materials specify that the organization retains the authority to suspend or terminate IRB/EC approval of research approved with a limited review.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>A description of what research is eligible for limited IRB review.<ul><li>Eligible research is deemed to be no more than minimal risk.</li><li>Eligible research meets one or more expedited categories 2, 3, 7, or 8.</li><li>If an IRB/EC member reviewing the research finds that research is greater than minimal risk, the reviewer must document the rationale for this determination and the rationale for review by the convened IRB/EC.</li></ul></li><li>Written materials specify the information that researchers must submit for limited IRB review, including:<ul><li>The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.</li><li>Proposed consent document.</li></ul></li><li>Written materials specify that IRB/EC members conducting limited IRB review may not disapprove research.</li><li>Written materials specify the required determinations when conducting limited IRB/EC review.<ul><li>For exemption Categories 2 and 3, there are adequate protections for privacy interests of participants and the confidentiality of identifiable data.</li><li>For exemption Category 7, broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained.</li><li>For exemption Category 8, broad consent is appropriately documented, or a waiver of documentation is appropriate.</li></ul></li><li>Written materials describe the evaluation of exempt research under limited IRB review to determine whether it fulfills the organization’s ethical standards.</li><li>Written materials specify that continuing review is not required for studies that qualify for a limited review.</li><li>Written materials specify that the organization retains the authority to suspend or terminate IRB/EC approval of research approved with a limited review.</li></ul>",
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 "title": "Written materials describe that when conducting limited IRB review, research must meet Category 2, 3, 7, or 8:Category 2: <ul><li>The research has undergone limited IRB review by an IRB/EC member.</li><li>The research only involves interactions involving one or more of the following:<ul><li>Educational tests (cognitive, diagnostic, aptitude, achievement).</li><li>Survey procedures.</li><li>Interview procedures.</li><li>Observation of public behavior (including visual or auditory recording).</li></ul></li><li>One of the following conditions are met:<ul><li>The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB/EC conducts a limited IRB/EC review of the research. (See Element II.2.C.)<ul><li>This condition cannot be applied when research is subject to Subpart D.</li></ul></li></ul></li></ul>Category 3: <ul><li>Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection:<ul><li>The research must receive limited IRB review by an IRB/EC member.<ul><li>Benign behavioral interventions are:</li><li>Brief in duration.</li><li>Harmless.</li><li>Painless.</li><li>Not physically invasive.</li><li>Not likely to have a significant adverse lasting impact on the participants.</li></ul></li><li>The researcher has no reason to think the participants will find the interventions offensive or embarrassing.<ul><li>At least one of the following criteria is met:</li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or</li><li>Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or</li><li>If the information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB/EC conducts a limited IRB review.</li></ul></li><li>If the research involves deception of participants regarding the nature or purposes of the research:<ul><li>The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.</li></ul></li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the research is eligible for an exemption under the laws of that country. (See AAHR PP Addenda for discussion of country-specific laws.)</li></ul></li></ul>Category 7: <ul><li>Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use:<ul><li>The research must receive limited IRB review by an IRB/EC member.</li><li>The researcher plans to obtain broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, including the following disclosures:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li></ul></li><li>Whether the participant will or will not share in any commercial profit.</li><li>For research involving biospecimens: whether the research will (if known) or might include whole genome sequencing. </li><li>One of the following statements:<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or the legally authorized representative, if this might be a possibility; or</li><li>A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>The researcher does not plan to provide individual research results to participants, unless otherwise required by law.</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data.</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the research is eligible for an exemption under the laws of that country. (See AAHRPP Addenda for discussion of country-specific laws)</li></ul></li></ul>Category 8<ul><li>Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:<ul><li>The research must receive limited IRB review by an IRB/EC member.</li><li>The researcher plans to obtain broad consent (See Table II.2.C.2.) for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, including the following disclosures:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li></ul></li><li>Whether the participant will or will not share in any commercial profit.</li><li>For research involving specimens: Whether the research will (if known) or might include whole genome sequencing. </li><li>One of the following statements:<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or the legally authorized representative, if this might be a possibility; or</li><li>A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>Documentation of consent or waiver of consent is obtained.</li><li>The researcher does not plan to provide individual research results to participants, unless otherwise required by law.</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Element II.3.E.)</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the research is eligible for an exemption under the laws of that country. (See AAHRPP Addenda for discussion of country-specific laws.) </li></ul></li></ul>GUIDANCEFor organizations in other countries, check AAHRPP Addenda to confirm exemptions are not prohibited under country-specific laws.<ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul>",
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 "key": "dhhs--limited-irb-review-categories",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When conducting limited IRB review, research must meet Category 2, 3, 7, or 8:Category 2:<ul><li>The research has undergone limited IRB review by an IRB/EC member.</li><li>The research only involves interactions involving one or more of the following:<ul><li>Educational tests (cognitive, diagnostic, aptitude, achievement).</li><li>Survey procedures.</li><li>Interview procedures.</li><li>Observation of public behavior (including visual or auditory recording).</li></ul></li><li>One of the following conditions are met:<ul><li>The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.<ul><li>When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the researcher(s) do not participate in the activities being observed.</li></ul></li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB/EC conducts a limited IRB/EC review of the research. (See Element II.2.C.)<ul><li>This condition cannot be applied when research is subject to Subpart D.</li></ul></li></ul></li></ul>Category 3:<ul><li>Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection:<ul><li>The research must receive limited IRB review by an IRB/EC member.<ul><li>Benign behavioral interventions are:</li><li>Brief in duration.</li><li>Harmless.</li><li>Painless.</li><li>Not physically invasive.</li><li>Not likely to have a significant adverse lasting impact on the participants.</li></ul></li><li>The researcher has no reason to think the participants will find the interventions offensive or embarrassing.<ul><li>At least one of the following criteria is met:</li><li>The information obtained is recorded by the researcher in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or</li><li>Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or</li><li>If the information obtained is recorded by the researcher in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB/EC conducts a limited IRB review.</li></ul></li><li>If the research involves deception of participants regarding the nature or purposes of the research:<ul><li>The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.</li></ul></li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the research is eligible for an exemption under the laws of that country. (See AAHR PP Addenda for discussion of country-specific laws.)</li></ul></li></ul>Category 7:<ul><li>Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use:<ul><li>The research must receive limited IRB review by an IRB/EC member.</li><li>The researcher plans to obtain broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, including the following disclosures:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li></ul></li><li>Whether the participant will or will not share in any commercial profit.</li><li>For research involving biospecimens: whether the research will (if known) or might include whole genome sequencing.</li><li>One of the following statements:<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or the legally authorized representative, if this might be a possibility; or</li><li>A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>The researcher does not plan to provide individual research results to participants, unless otherwise required by law.</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data.</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the research is eligible for an exemption under the laws of that country. (See AAHRPP Addenda for discussion of country-specific laws)</li></ul></li></ul>Category 8<ul><li>Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:<ul><li>The research must receive limited IRB review by an IRB/EC member.</li><li>The researcher plans to obtain broad consent (See Table II.2.C.2.) for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, including the following disclosures:<ul><li>A description of any reasonably foreseeable risks or discomforts to the participant.</li><li>A description of any benefits to the participant or to others that may reasonably be expected from the research.</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li></ul></li><li>Whether the participant will or will not share in any commercial profit.</li><li>For research involving specimens: Whether the research will (if known) or might include whole genome sequencing.</li><li>One of the following statements:<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or the legally authorized representative, if this might be a possibility; or</li><li>A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>Documentation of consent or waiver of consent is obtained.</li><li>The researcher does not plan to provide individual research results to participants, unless otherwise required by law.</li><li>If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Element II.3.E.)</li><li>When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li><li>The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.</li><li>The research is not regulated by the US FDA.</li><li>For organizations located outside the US, the research is eligible for an exemption under the laws of that country. (See AAHRPP Addenda for discussion of country-specific laws.)</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "va--limited-irb-review-requirements",
 "title": "Written materials describe for limited IRB review of VA exempt research activities falling under requirements for limited IRB review:<ul><li>If the exempt activities involve the researcher interacting with human participants or obtaining information by educational tests, survey or interview procedures, or behavioral interventions, the following information must be given to the prospective human participant as applicable in writing or orally:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The activity is research.</li><li>Participation is voluntary.</li><li>Permission to participate can be withdrawn.</li><li>Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data.</li><li>Contact information for the VA researcher.</li></ul></li><li>If an exempt activity requires a limited IRB review, the limited IRB review must be completed prior to approval by the R&D Committee.</li><li>Research that has undergone limited IRB review and determined to be exempt requires approval by the R&D Committee and requires continuing review by the R&D Committee unless it is under the oversight of another subcommittee (e.g., Safety Review Subcommittee). </li></ul>",
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 "key": "va--limited-irb-review-requirements",
 "title": "Written materials describe for limited IRB review of VA exempt research activities falling under requirements for limited IRB review:<ul><li>If the exempt activities involve the researcher interacting with human participants or obtaining information by educational tests, survey or interview procedures, or behavioral interventions, the following information must be given to the prospective human participant as applicable in writing or orally:<ul><li>The activity is research.</li><li>Participation is voluntary.</li><li>Permission to participate can be withdrawn.</li><li>Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data.</li><li>Contact information for the VA researcher.</li></ul></li><li>If an exempt activity requires a limited IRB review, the limited IRB review must be completed prior to approval by the R&D Committee.</li><li>Research that has undergone limited IRB review and determined to be exempt requires approval by the R&D Committee and requires continuing review by the R&D Committee unless it is under the oversight of another subcommittee (e.g., Safety Review Subcommittee). </li></ul>",
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 "type": "section/element",
 "key": "element-ii-2-d",
 "title": "Element II.2.D.",
 "description": "The IRB or EC has and follows written policies and procedures to conduct meetings by the convened IRB or EC.",
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 "key": "q1",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 "type": "question/review-assessment",
 "key": "scheduling-convened-irb-meetings",
 "title": "Essential RequirementsWritten materials describe:<ul><li>The timing and scheduling of IRB/EC meetings.</li><li>The timing of document distribution before convened IRB/EC meetings.</li><li>Limits placed on the number of items on the agenda, if any.</li><li>Other functions of the agenda, if any, e.g., informing IRB/EC members of research protocols approved using the expedited process.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "scheduling-convened-irb-meetings",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The timing and scheduling of IRB/EC meetings.</li><li>The timing of document distribution before convened IRB/EC meetings.</li><li>Limits placed on the number of items on the agenda, if any.</li><li>Other functions of the agenda, if any, e.g., informing IRB/EC members of research protocols approved using the expedited process.</li></ul>",
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 "type": "question/review-assessment",
 "key": "quorum-at-convened-irb-meeting",
 "title": "Essential RequirementsWritten materials describe that at convened meetings:<ul><li>A majority of IRB/EC members must be present.</li><li>At least one member whose primary concerns are in non-scientific areas must be present.</li><li>For research to be approved it must receive the approval of a majority of members present at the meeting.</li><li>If quorum is lost during a meeting, the IRB/EC cannot take votes until the quorum is restored.</li><li>When the convened IRB/EC reviews research involving prisoners, the prisoner representative is present.</li></ul>",
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 "key": "quorum-at-a-convened-irb-meeting",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>A majority of IRB/EC members must be present.</li><li>At least one member whose primary concerns are in non-scientific areas must be present.</li><li>For research to be approved it must receive the approval of a majority of members present at the meeting.</li><li>If quorum is lost during a meeting, the IRB/EC cannot take votes until the quorum is restored.</li><li>When the convened IRB/EC reviews research involving prisoners, the prisoner representative is present.</li></ul>",
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 "type": "question/review-assessment",
 "key": "unaffiliated-member-at-convened-board-meetings",
 "title": "Essential RequirementsWritten materials describe attendance requirements for the member who represents the unaffiliated member. This might be accomplished by one of the following:<ul><li>Requiring the members as part of quorum.</li><li>Placing an attendance requirement on the member (e.g., attend 10 of 12 meetings per year).</li></ul>",
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 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "unaffiliated-member-at-convened-board-meetings",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Attendance requirements for the member who represents the unaffiliated member. This might be accomplished by one of the following:<ul><li>Requiring the members as part of quorum.</li><li>Placing an attendance requirement on the member (e.g., attend 10 of 12 meetings per year).</li></ul>",
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 "type": "question/review-assessment",
 "key": "member-who-represents-general-perspective-of-participants-at-convened-board-meetings",
 "title": "Essential RequirementsWritten materials describe attendance requirements for the member who represents the general perspective of participants.<ul><li>This might be accomplished by one of the following:<ul><li>Requiring the members as part of quorum.</li><li>Placing an attendance requirement on the member (e.g., attend 10 of 12 meetings per year).</li><li>If the IRB/EC reviews research that involves categories of participants vulnerable to coercion or undue influence, one or more individuals who are knowledgeable about or experienced in working with such participants are present.</li></ul></li></ul>",
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 "key": "member-who-represents-general-perspective-of-participants-at-convened-board-meetings",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Attendance requirements for the member who represents the general perspective of participants.<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">This might be accomplished by one of the following:</li><ul type=\"disc\"><li data-list=\"0\" data-level=\"2\">Requiring the members as part of quorum.</li><li data-list=\"0\" data-level=\"2\">Placing an attendance requirement on the member (e.g., attend 10 of 12 meetings per year).</li><li data-list=\"0\" data-level=\"2\">If the IRB/EC reviews research that involves categories of participants vulnerable to coercion or undue influence, one or more individuals who are knowledgeable about or experienced in working with such participants are present.</li></ul></ul>",
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 {
 "type": "question/review-assessment",
 "key": "who-determines-quorum-established",
 "title": "Essential RequirementsWritten materials describe who determines\nquorum is established and how it is documented.",
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 "key": "who-determines-quorum-established",
 "title": "Add to or describe in written materials [page xx or elsewhere]:Who determines quorum is established and how it is documented.<div> </div>",
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 "type": "question/review-assessment",
 "key": "losing-quorum-during-a-meeting",
 "title": "Essential RequirementsWritten materials describe: <ul><li>If quorum is lost during a meeting, the IRB/EC cannot take votes until the quorum is restored.</li><li>If required members (e.g., non-scientific members) leave the room and quorum is lost, votes cannot be taken until the quorum is restored, even if half of the members are still present.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "losing-quorum-during-a-meeting",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">If quorum is lost during a meeting, the IRB/EC cannot take votes until the quorum is restored.</li><li data-list=\"0\" data-level=\"1\">If required members (e.g., non-scientific members) leave the room and quorum is lost, votes cannot be taken until the quorum is restored, even if half of the members are still present.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "technology-supporting-convened-meetings",
 "title": "Essential RequirementsWritten materials describe the use of any materials or technology used to conduct meeting or meet regulatory requirements. For example, describe whether all members have laptop computers to access materials; handouts, posters, or projections contain the criteria for approval; or meetings are conducted over the Internet.<div> </div>",
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 "key": "technology-supporting-convened-meetings",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The use of any materials or technology used to conduct meeting or meet regulatory requirements. For example, describe whether all members have laptop computers to access materials; handouts, posters, or projections contain the criteria for approval; or meetings are conducted over the Internet.",
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 {
 "type": "question/review-assessment",
 "key": "convened-board-voting",
 "title": "Essential RequirementsWritten materials describe how votes are\ntaken and documented, and what constitutes approval.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "convened-board-voting",
 "title": "Add to or describe in written materials [page xx or elsewhere]:How votes are taken and documented, and what constitutes approval.<div> </div>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "role-of-irb-chair-and-vice-chair",
 "title": "Essential RequirementsWritten materials describe the role of the chair and vice chair, if there are vice chairs, including:<ul><li>Voting responsibilities.</li><li>Role of the chair and vice chair prior to, during, and after the meeting.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "role-of-irb-chair-and-vice-chair",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The role of the chair and vice chair, if there are vice chairs, including:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">Voting responsibilities.</li><li data-list=\"0\" data-level=\"1\">Role of the chair and vice chair prior to, during, and after the meeting.</li></ul>",
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 },
 {
 "type": "section/element",
 "key": "element-ii-2-e",
 "title": "Element II.2.E.",
 "description": "<div>The IRB or EC has and follows written policies and procedures to conduct reviews by the convened IRB or EC.</div><ul><li>Element II.2.E.1. – Initial review</li><li>Element II.2.E.2. – Continuing review</li><li>Element II.2.E.3. – Review of proposed modifications to previously approved research</li></ul>",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 {
 "type": "question/review-assessment",
 "key": "convened-board-review-process",
 "title": "Essential RequirementsWritten materials describe the process the IRB/EC uses to review research for initial review, continuing review, and review of modifications to previously approved research:<ul><li>The primary reviewer system used, if any.</li><li>The process used to supplement the IRB’s/EC’s review.</li><li>The range of possible actions that the IRB/EC is allowed to take.</li><li>If the IRB/EC approves research with conditions:<ul><li>Substantive changes or requirements, requests for more information for IRB/EC consideration, and other issues related to the criteria for approval require review and approval by the convened IRB.</li><li>Minor or prescriptive changes or requirements may be reviewed for approval by the IRB/EC chair, or designated IRB/EC member.</li><li>The date of approval is the date the conditions were determined to be met.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li></ul></li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">A process for the IRB/EC to determine which protocols need review more often than annually.</li><li>For initial review of research by a convened IRB, when they are scheduled to attend an IRB/EC meeting, all members (including attending alternate members) are provided and review:<ul><li>The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.</li><li>Proposed consent document.</li><li>Recruitment materials.</li><li>At least one member is provided and reviews the investigator’s brochure (when one exists).</li></ul></li><li>For continuing review of research by a convened IRB/EC when they are scheduled to attend an IRB/EC meeting, all IRB/EC members (including alternate members) are provided and review:<ul><li>The full protocol, application, or a protocol summary containing the relevant information necessary to determine whether the proposed research continues to fulfill the criteria for approval.</li><li>The current consent document.</li><li>Any newly proposed consent document.</li><li>A status report on the progress of the research.</li></ul></li><li>For continuing review of research by a convened IRB: <ul><li>At least one IRB/EC member is provided and reviews the complete protocol including any protocol modifications previously approved by the IRB.</li><li>The status report on the progress of the research includes:<ul><li>The number of participants accrued.</li><li>A summary since the last IRB/EC review of:<ul><li>Adverse events and adverse outcomes experienced by participants.</li><li>Unanticipated problems involving risks to participants or others.</li><li>Participant withdrawals.</li><li>The reasons for withdrawals.</li><li>Complaints about the research.</li><li>Amendments or modifications.</li><li>Any relevant recent literature.</li><li>Any interim findings.</li></ul></li><li>Any relevant multi-center trial reports.</li><li>The researcher’s current risk-potential benefit assessment based on study results.</li></ul></li></ul></li></ul>GUIDANCEIf an organization uses the term “Effective Date” have them describe in their policies how they use that term and check that it conforms to OHRP Guidance.",
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 "key": "convened-board-review-process",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process the IRB/EC uses to review research for initial review, continuing review, and review of modifications to previously approved research:<ul><li>The primary reviewer system used, if any.</li><li>The process used to supplement the IRB’s/EC’s review.</li><li>The range of possible actions that the IRB/EC is allowed to take.</li><li>If the IRB/EC approves research with conditions:<ul><li>Substantive changes or requirements, requests for more information for IRB/EC consideration, and other issues related to the criteria for approval require review and approval by the convened IRB.</li><li>Minor or prescriptive changes or requirements may be reviewed for approval by the IRB/EC chair, or designated IRB/EC member.</li><li>The date of approval is the date the conditions were determined to be met.</li></ul></li><li>A process for the IRB/EC to determine which protocols need review more often than annually.</li><li>For initial review of research by a convened IRB, when they are scheduled to attend an IRB/EC meeting, all members (including attending alternate members) are provided and review:<ul><li>The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.</li><li>Proposed consent document.</li><li>Recruitment materials.</li><li>At least one member is provided and reviews the investigator’s brochure (when one exists).</li></ul></li><li>For continuing review of research by a convened IRB/EC when they are scheduled to attend an IRB/EC meeting, all IRB/EC members (including alternate members) are provided and review:<ul><li>The full protocol, application, or a protocol summary containing the relevant information necessary to determine whether the proposed research continues to fulfill the criteria for approval.</li><li>The current consent document.</li><li>Any newly proposed consent document.</li><li>A status report on the progress of the research.</li></ul></li><li>For continuing review of research by a convened IRB:<ul><li>At least one IRB/EC member is provided and reviews the complete protocol including any protocol modifications previously approved by the IRB.</li><li>The status report on the progress of the research includes:<ul><li>The number of participants accrued.</li><li>A summary since the last IRB/EC review of:<ul><li>Adverse events and adverse outcomes experienced by participants.</li><li>Unanticipated problems involving risks to participants or others.</li><li>Participant withdrawals.</li><li>The reasons for withdrawals.</li><li>Complaints about the research.</li><li>Amendments or modifications.</li><li>Any relevant recent literature.</li><li>Any interim findings.</li></ul></li><li>Any relevant multi-center trial reports.</li><li>The researcher’s current risk-potential benefit assessment based on study results.</li></ul></li></ul></li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "applying-criteria-for-irb-approval",
 "title": "Essential RequirementsWritten materials describe the IRB/EC uses the\nrequired criteria for approval for all reviews of research, including initial\nreview, continuing review, and review of a modification to previously approved\nresearch when the modification affects a criterion for approval.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC uses the required criteria for approval for all reviews of research, including initial review, continuing review, and review of a modification to previously approved research when the modification affects a criterion for approval.",
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 {
 "type": "question/review-assessment",
 "key": "continuing-review-more-often-than-annually",
 "title": "Essential RequirementsWitten materials describe the process the IRB/EC follows to determine whether continuing review should occur at an interval less than one year.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "continuing-review-more-often-than-annually",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process the IRB/EC follows to determine whether continuing review should occur at an interval less than one year.",
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 },
 {
 "type": "question/review-assessment",
 "key": "oversight-of-open-studies",
 "title": "Essential RequirementsWritten materials describe the process the IRB/EC uses to maintain oversight of all open studies, even where laws, codes, and regulations do not require the IRB/EC to conduct continuing review:<ul><li>The circumstances when continuing review by the convened IRB/EC or an IRB/EC member is no longer required.</li><li>The mechanism for maintaining ongoing oversight of all open studies. <ul><li>Written materials must describe an alternate process, such as staff review, for the organization to maintain oversight over the research initially reviewed using the expedited procedure, as long as the research is ongoing.</li></ul></li><li>When the IRB/EC is not required to conduct continuing review, records must provide a rationale for any decisions to conduct continuing review of research otherwise eligible for review using the expedited procedure.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "oversight-of-open-studies",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The process the IRB/EC uses to maintain oversight of all open studies, even where laws, codes, and regulations do not require the IRB/EC to conduct continuing review:<ul><li>The circumstances when continuing review by the convened IRB/EC or an IRB/EC member is no longer required.</li><li>The mechanism for maintaining ongoing oversight of all open studies.<ul><li>Written materials must describe an alternate process, such as staff review, for the organization to maintain oversight over the research initially reviewed using the expedited procedure, as long as the research is ongoing.</li></ul></li><li>When the IRB/EC is not required to conduct continuing review, records must provide a rationale for any decisions to conduct continuing review of research otherwise eligible for review using the expedited procedure.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "expiration-dates",
 "title": "Essential RequirementsWritten materials describe:<ul><li>Whether the expiration date is the last date that the study is approved or the first date that the study is no longer approved.</li><li>The method of calculating the expiration date.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "expiration-dates",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Whether the expiration date is the last date that the study is approved or the first date that the study is no longer approved.</li><li>The method of calculating the expiration date.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "approval-with-conditions",
 "title": "Essential RequirementsWritten materials describe: <ul><li>If the IRB/EC approves research with conditions:<ul><li>Substantive changes or requirements, requests for more information for IRB/EC consideration, and other issues related to the criteria for approval require review and approval by the convened IRB/EC.</li><li>Minor or prescriptive changes or requirements may be reviewed for approval by the IRB/EC chair or designated IRB/EC member.</li><li>The date of approval is the date the conditions were determined to be met. </li><li>If the research expires before the conditions are reviewed and approved, all research activities must stop until approval is obtained.</li></ul></li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "approval-with-conditions",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>If the IRB/EC approves research with conditions:<ul><li>Substantive changes or requirements, requests for more information for IRB/EC consideration, and other issues related to the criteria for approval require review and approval by the convened IRB/EC.</li><li>Minor or prescriptive changes or requirements may be reviewed for approval by the IRB/EC chair or designated IRB/EC member.</li><li>The date of approval is the date the conditions were determined to be met.</li><li>If the research expires before the conditions are reviewed and approved, all research activities must stop until approval is obtained.</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "addition-of-sites",
 "title": "Essential RequirementsWritten materials describe: <ul><li>The procedure for reviewing the addition of investigative sites to previously approved protocols. </li><li>The criteria for when the addition of an investigative site is considered to be a “minor modification.\"</li></ul>GUIDANCEWhen reviewing independent IRBs/ECs\nand other organizations that provide review services (e.g., a university\nserving as the single IRB) – When adding investigative sites to previously\napproved protocols, the independent IRB/EC may decide to review these additions\nas separate protocols or as modifications to previously approved research, and\nthey may decide to handle such modifications using the expedited procedure\nrather than the convened IRB/EC for review. ",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "addition-of-sites",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The procedure for reviewing the addition of investigative sites to previously approved protocols.</li><li>The criteria for when the addition of an investigative site is considered to be a “minor modification.\"</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "notification-of-irb-actions",
 "title": "Essential RequirementsWritten materials describe: <ul><li>The organizational offices and officials who are notified of the findings of the IRB/EC and the method of notification.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The process the IRB/EC uses for reporting its findings and actions to researchers in writing, including:<ul><li>The decision to approve, disapprove, or require modifications to secure approval.</li><li>Any modifications or clarifications required by the IRB/EC as a condition for IRB/EC approval.</li><li>If an IRB/EC decides to disapprove a research activity, a statement of the reasons for its decision and giving the researcher an opportunity to respond in person or in writing.</li></ul></li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "notification-of-irb-actions",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The organizational offices and officials who are notified of the findings of the IRB/EC and the method of notification.</li><li>The process the IRB/EC uses for reporting its findings and actions to researchers in writing, including:<ul><li>The decision to approve, disapprove, or require modifications to secure approval.</li><li>Any modifications or clarifications required by the IRB/EC as a condition for IRB/EC approval.</li><li>If an IRB/EC decides to disapprove a research activity, a statement of the reasons for its decision and giving the researcher an opportunity to respond in person or in writing.</li></ul></li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "organization-approval",
 "title": "Essential RequirementsWritten materials describe the person or office that is responsible for further approval or disapproval of research that is approved by the IRB/EC.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-review-of-responses",
 "title": "Essential RequirementsWritten materials describe IRB/EC review of researchers’ responses.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "key": "irb-ec-review-of-responses",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC review of researchers’ responses.",
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 },
 {
 "type": "question/review-assessment",
 "key": "continuing-review--irb-ec-determinations",
 "title": "Essential RequirementsWritten materials describe for continuing review of research the IRB/EC determines:<ul><li>Whether the protocol needs verification from sources other than the researchers that no material changes had occurred since previous IRB/EC review.</li><li>The current consent document is still accurate and complete.</li><li>Any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation will be provided to participants.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "key": "continuing-review--irb-ec-determinations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:For continuing review of research the IRB/EC determines:<ul><li>Whether the protocol needs verification from sources other than the researchers that no material changes had occurred since previous IRB/EC review.</li><li>The current consent document is still accurate and complete.</li><li>Any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation will be provided to participants.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "continuing-review--expiration",
 "title": "Written materials describe if a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:<ul><li>All research activities stop.</li><li>Interventions and interactions on current participants stop, unless the IRB/EC finds an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating.</li><li>New enrollment of participants may not occur.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "continuing-review--expired",
 "title": "Add to or describe in written materials [page xx or elsewhere]:If a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:<ul><li>All research activities stop.</li><li>Interventions and interactions on current participants stop, unless the IRB/EC finds an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating.</li><li>New enrollment of participants may not occur.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "modifications-to-previously-review-research",
 "title": "Essential RequirementsWritten materials describe for review of\nmodifications to previously approved research by a convened IRB, when they are\nscheduled to attend a meeting, all members (including alternate members)\nreceive and review all modified documents.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "text/review-assessment-snippet",
 "key": "modifications-to-previously-reviewed-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:For review of modifications to previously approved research by a convened IRB, when they are scheduled to attend a meeting, all members (including alternate members) receive and review all modified documents.",
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 {
 "type": "question/review-assessment",
 "key": "modifications--irb-ec-review",
 "title": "Essential RequirementsWritten materials describe:<ul><li>The IRB/EC uses the criteria to approve modifications to previously approved research when the modifications affect one or more criteria.</li><li>The IRB/EC determines that any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation are provided to participants.</li><li>Changes in approved research that are initiated without IRB/EC approval to eliminate apparent immediate hazards to the participant:<ul><li>Are promptly (no longer than within 30 days) reported to the IRB.</li><li>Are reviewed by the IRB/EC to determine whether each change was consistent with ensuring the participants’ continued welfare.</li></ul></li><li>Researchers report to the IRB/EC proposed changes in a research study.</li><li>Researchers report to the IRB/EC the premature completion of a study.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "modifications--irb-ec-review",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The IRB/EC uses the criteria to approve modifications to previously approved research when the modifications affect one or more criteria.</li><li>The IRB/EC determines that any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation are provided to participants.</li><li>Changes in approved research that are initiated without IRB/EC approval to eliminate apparent immediate hazards to the participant:<ul><li>Are promptly (no longer than within 30 days) reported to the IRB.</li><li>Are reviewed by the IRB/EC to determine whether each change was consistent with ensuring the participants’ continued welfare.</li></ul></li><li>Researchers report to the IRB/EC proposed changes in a research study.</li><li>Researchers report to the IRB/EC the premature completion of a study. </li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "ensuring-modifications-to-previously-reviewed-research-are-not-initiated-without-irb-ec-approval",
 "title": "Essential RequirementsWritten materials describe the actions taken to\nensure that proposed changes in approved research during the period for which\nIRB/EC approval had already been given cannot be initiated without IRB/EC\napproval.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "ensuring-modifications-to-previously-reviewed-research-are-not-initiated-without-irb-ec-approval",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The actions taken to ensure that proposed changes in approved research during the period for which IRB/EC approval had already been given cannot be initiated without IRB/EC approval.<div> </div>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "dod--review-of-surveys-performed-on-dod-personnel",
 "title": "Written materials indicate whether the organization conducts research on DoD personnel, and if such research is allowed, describe who in the organization is responsible for obtaining approval and the process they go through.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If the organization DOES review surveys conducted on DoD personnel, written materials describe the following:<ul><li>Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB. </li><li>When a survey crosses DoD components, additional review is required.</li></ul><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">GUIDANCEClarify whether the organization conducts or reviews surveys on DoD personnel.",
 "description": "",
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 "title": "For all organizations [DoD facilities or organizations that provide IRB review for DoD facilities]Add to or describe in written materials [page xx or elsewhere]:Whether the organization conducts research on DoD personnel, and if such research is allowed, describe who in the organization is responsible for obtaining approval and the process they go through.For IRBs/ECs that review surveys conducted on DoD personnel Add to or describe in written materials [page xx or elsewhere]:Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD components, additional review is required.",
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 },
 {
 "type": "question/review-assessment",
 "key": "dod--serving-as-a-reviewing-irb-for-dod-study",
 "title": "When serving as the reviewing IRB/EC for a DoD-covered research study, written materials include:<ul><li>The following must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP. (DoDI 3216.02 section 3.6)</li><li>When significant changes to the research protocol are approved by the IRB/EC:<ul><li>Changes to key investigators or institutions.</li><li>Decreased benefit or increased risk to participants in greater than minimal risk research.</li><li>Addition of vulnerable populations as participants.</li><li>Addition of DoD-affiliated personnel as participants.</li></ul></li><li>Change of reviewing IRB. </li><li>When the organization is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of an HRPP is under investigation for cause involving a DoD-supported research protocol.</li><li>Any problems involving risks to participants or others, suspension or termination of IRB/EC approval, or any serious or continuing noncompliance pertaining to DoD-supported human participant research.</li><li>The results of the IRB’s/EC’s continuing review, if required.</li><li>Change in status when a previously enrolled participant becomes pregnant, or when the researcher learns that a previously enrolled participant is pregnant, and the protocol was not reviewed and approved by the IRB/EC in accordance with 45 CFR 46, Subpart B.</li><li>Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB/EC in accordance with 32 CFR 219, Subpart C.</li><li>Closure of a DoD-supported study.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When serving as the reviewing IRB/EC for a DoD-covered research study:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">The following must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP. (DoDI 3216.02 section 3.6)</li><li data-list=\"0\" data-level=\"1\">When significant changes to the research protocol are approved by the IRB/EC:</li><ul type=\"disc\"><li data-list=\"0\" data-level=\"2\">Changes to key investigators or institutions.</li><li data-list=\"0\" data-level=\"2\">Decreased benefit or increased risk to participants in greater than minimal risk research.</li><li data-list=\"0\" data-level=\"2\">Addition of vulnerable populations as participants.</li><li data-list=\"0\" data-level=\"2\">Addition of DoD-affiliated personnel as participants.</li></ul><li data-list=\"0\" data-level=\"1\">Change of reviewing IRB.</li><li data-list=\"0\" data-level=\"1\">When the organization is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of an HRPP is under investigation for cause involving a DoD-supported research protocol.</li><li data-list=\"0\" data-level=\"1\">Any problems involving risks to participants or others, suspension or termination of IRB/EC approval, or any serious or continuing noncompliance pertaining to DoD-supported human participant research.</li><li data-list=\"0\" data-level=\"1\">The results of the IRB’s/EC’s continuing review, if required.</li><li data-list=\"0\" data-level=\"1\">Change in status when a previously enrolled participant becomes pregnant, or when the researcher learns that a previously enrolled participant is pregnant, and the protocol was not reviewed and approved by the IRB/EC in accordance with 45 CFR 46, Subpart B.</li><li data-list=\"0\" data-level=\"1\">Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB/EC in accordance with 32 CFR 219, Subpart C.</li><li data-list=\"0\" data-level=\"1\">Closure of a DoD-supported study.</li></ul>",
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 "key": "va--continuing-review-requirements",
 "title": "Written materials describe:<ul><li>If a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:</li><li>The researcher must stop all research activities including, but not limited to, enrollment of new participants, analysis of individually identifiable data, and research interventions or interactions with currently enrolled participants, except where stopping such interventions or interactions could be harmful to participants. </li><li>The researcher must immediately submit to the IRB/EC chair a list of research participants who could be harmed by stopping study procedures.</li><li>The IRB/EC chair, with appropriate consultation with the chief of staff, determines within two business days whether participants on the list may continue participating in the research interventions or interactions.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>If a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:</li><li>The researcher must stop all research activities including, but not limited to, enrollment of new participants, analysis of individually identifiable data, and research interventions or interactions with currently enrolled participants, except where stopping such interventions or interactions could be harmful to participants.</li><li>The researcher must immediately submit to the IRB/EC chair a list of research participants who could be harmed by stopping study procedures.</li><li>The IRB/EC chair, with appropriate consultation with the chief of staff, determines within two business days whether participants on the list may continue participating in the research interventions or interactions.</li></ul>",
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 "description": "<div>The IRB or EC has and follows written policies and procedures to conduct reviews by an expedited procedure, if such procedure is used.</div><ul><li>Element II.2.F.1. – Initial review</li><li>Element II.2.F.2. – Continuing review</li><li>Element II.2.F.3. – Review of proposed modifications to previously approved research</li></ul>",
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 "type": "question/review-assessment",
 "key": "expedited-irb-ec-review--process",
 "title": "Essential RequirementsWritten materials describe:<ul><li>Only experienced IRB/EC members may conduct reviews using the expedited procedure.<ul><li>“Experienced” is defined in terms of professional competence.</li></ul></li><li>A description of the conduct of:<ul><li>Initial review.</li><li>Continuing review.</li><li>Review of modifications using the expedited procedure.<ul><li>Modifications that are “minor” are defined.</li></ul></li></ul></li><li>A description of the information that researchers have to submit for review using the expedited procedure.</li><li>At least one reviewer receives and reviews the same materials that the convened IRB/EC receives for protocols reviewed by the convened IRB/EC.</li><li>A description of the evaluation by the reviewer undergoing initial review, modifications, and continuing review, when required by law or regulation, using the expedited procedure.<ul><li>The criteria for approval using the expedited procedure are the same as those for review by a convened IRB/EC, unless otherwise specified in law or regulation.</li><li>When using the expedited procedure, reviewers are prohibited from disapproving research.</li></ul></li><li>A description of the process for contingent approval of revisions by the chair or designated IRB/EC member without subsequent review by the convened IRB/EC.<ul><li>When the convened IRB/EC requests substantive clarifications or modifications that are directly relevant to the determinations required by the IRB, the protocol must return to the convened IRB/EC and not be approved by the expedited procedure.</li></ul></li><li>A description of the process for informing IRB/EC members about approvals by review using the expedited procedure, including:<ul><li>Initial review.</li><li>Continuing review, when required by law or regulation.</li><li>Review of modifications to previously approved research.</li></ul></li><li>When continuing review of research is required by law or regulation, at least one IRB/EC member is provided and reviews the complete protocol, including a status report and any protocol modifications previously approved by the IRB/EC.</li><li>The status report on the progress of the research includes:<ul><li>Number of participants accrued.</li><li>A summary since the last IRB/EC review of:<ul><li>Adverse events, untoward events, and adverse outcomes experienced by participants.</li><li>Unanticipated problems involving risks to participants or others.</li><li>Participant withdrawals.</li><li>The reasons for withdrawals.</li><li>Complaints about the research.</li><li>Amendments or modifications.</li><li>Any relevant recent literature.</li><li>Any interim findings.</li><li>Any relevant multi-center trial reports.</li></ul></li><li>The researcher’s current risk-potential benefit assessment based on study results.\\</li></ul></li></ul>GUIDANCE<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Laws governing organizations outside the US may not have provisions for expedited review. AAHRPP recognizes that expedited review may be used for minimal risk activities outside those covered in law, unless prohibited by the country law. See the Addendum for the country. If you see policies for expedited review, and the Addendum does not describe expedited review, contact AAHRPP staff.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Only experienced IRB/EC members may conduct reviews using the expedited procedure.<ul><li>“Experienced” is defined in terms of professional competence.</li></ul></li><li>A description of the conduct of:<ul><li>Initial review.</li><li>Continuing review.</li><li>Review of modifications using the expedited procedure.<ul><li>Modifications that are “minor” are defined.</li></ul></li></ul></li><li>A description of the information that researchers have to submit for review using the expedited procedure.</li><li>At least one reviewer receives and reviews the same materials that the convened IRB/EC receives for protocols reviewed by the convened IRB/EC.</li><li>A description of the evaluation by the reviewer undergoing initial review, modifications, and continuing review, when required by law or regulation, using the expedited procedure.<ul><li>The criteria for approval using the expedited procedure are the same as those for review by a convened IRB/EC, unless otherwise specified in law or regulation.</li><li>When using the expedited procedure, reviewers are prohibited from disapproving research.</li></ul></li><li>A description of the process for contingent approval of revisions by the chair or designated IRB/EC member without subsequent review by the convened IRB/EC.<ul><li>When the convened IRB/EC requests substantive clarifications or modifications that are directly relevant to the determinations required by the IRB, the protocol must return to the convened IRB/EC and not be approved by the expedited procedure.</li></ul></li><li>A description of the process for informing IRB/EC members about approvals by review using the expedited procedure, including:<ul><li>Initial review.</li><li>Continuing review, when required by law or regulation.</li><li>Review of modifications to previously approved research.</li></ul></li><li>When continuing review of research is required by law or regulation, at least one IRB/EC member is provided and reviews the complete protocol, including a status report and any protocol modifications previously approved by the IRB/EC.</li><li>The status report on the progress of the research includes:<ul><li>Number of participants accrued.</li><li>A summary since the last IRB/EC review of:<ul><li>Adverse events, untoward events, and adverse outcomes experienced by participants.</li><li>Unanticipated problems involving risks to participants or others.</li><li>Participant withdrawals.</li><li>The reasons for withdrawals.</li><li>Complaints about the research.</li><li>Amendments or modifications.</li><li>Any relevant recent literature.</li><li>Any interim findings.</li><li>Any relevant multi-center trial reports.</li></ul></li><li>The researcher’s current risk-potential benefit assessment based on study results.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "continuing-review-required",
 "title": "Essential RequirementsWritten materials describe that when continuing review of research is required by law or regulation, IRB/EC members determine:<ul><li>Whether the protocol needs verification from sources other than the researchers that no material changes had occurred since previous IRB/EC review.</li><li>The current consent document is still accurate and complete.</li><li>Any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation will be provided to participants.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When continuing review of research is required by law or regulation, IRB/EC members determine:<ul><li>Whether the protocol needs verification from sources other than the researchers that no material changes had occurred since previous IRB/EC review.</li><li>The current consent document is still accurate and complete.</li><li>Any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation will be provided to participants.</li></ul>",
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 "type": "question/review-assessment",
 "key": "continuing-review--expiration",
 "title": "Essential RequirementsWritten materials describe when continuing review is required by law or regulation, if a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:<ul><li>All research activities stop.</li><li>Interventions and interactions on current participants stop, unless the IRB/EC finds an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating.</li><li>Enrollment of new participants may not occur.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When continuing review is required by law or regulation, if a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:<ul><li>All research activities stop.</li><li>Interventions and interactions on current participants stop, unless the IRB/EC finds an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating.</li><li>Enrollment of new participants may not occur.</li></ul>",
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 "type": "question/review-assessment",
 "key": "oversight-of-open-research",
 "title": "Essential RequirementsWritten materials describe the process the IRB/EC uses to maintain oversight of all open studies, even where laws, codes, and regulations do not require the IRB/EC to conduct continuing review:<ul><li>When continuing review by an IRB/EC member is no longer required.</li><li>The mechanism for maintaining ongoing oversight of all open studies. </li><li>Written materials must describe an alternate process, such as staff review, for the organization to maintain oversight over the research initially reviewed using the expedited procedure, as long as the research is ongoing.</li><li>When the IRB/EC is not required to conduct continuing review, records must provide a rationale for any decisions to conduct continuing review of research otherwise eligible for review using the expedited procedure.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The process the IRB/EC uses to maintain oversight of all open studies, even where laws, codes, and regulations do not require the IRB/EC to conduct continuing review:<ul><li>When continuing review by an IRB/EC member is no longer required.</li><li>The mechanism for maintaining ongoing oversight of all open studies.</li><li>Written materials must describe an alternate process, such as staff review, for the organization to maintain oversight over the research initially reviewed using the expedited procedure, as long as the research is ongoing.</li><li>When the IRB/EC is not required to conduct continuing review, records must provide a rationale for any decisions to conduct continuing review of research otherwise eligible for review using the expedited procedure.</li></ul>",
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 "key": "other-expedited-review-categories",
 "title": "Essential RequirementsIf an organization has additional categories of expedited review when not following DHHS or FDA regulations, written materials describe the equivalent protections provided for this research.GUIDANCEIf an organization does not have additional expedited review categories for unregulated research, mark this requirement as not applicable.",
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 "title": "If an organization has additional categories of expedited review when not following DHHS or FDA regulations  Add to or describe in written materials [page xx or elsewhere]:The equivalent protections provided for additional categories of expedited review when not the research is not subject to Federal regulations (i.e., unregulated research).",
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 "type": "question/review-assessment",
 "key": "dhhs-or-us-fda--expedited-review-procedure",
 "title": "Written following DHHS or FDA requirements, materials describe the process for review using the expedited procedure:<ul><li>The designation by the IRB/EC chair of IRB/EC members who may conduct review using the expedited procedure.</li><li>The evaluation by the reviewer of whether research undergoing initial review using the expedited procedure:<ul><li>Does not involve more than minimal risk. </li><li>Research appearing on the list of expedited review categories is deemed to be no more than minimal risk. (DHHS only)</li><li>If a reviewer finds that research appearing on the expedited review list is greater than minimal risk, the reviewer must document the rationale for this determination and the rationale for review by the convened IRB/EC. (DHHS only)</li><li>Represents one or more approvable expedited review categories. </li><li>Does not include activities where identification of the participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.</li><li>Does not involve classified research.</li><li>When research involves vulnerable populations, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li></ul></li></ul>GUIDANCEOrganizations that apply equivalent protections can\nadd additional categories and examples when not following DHHS or FDA\nregulations, but these must offer equivalent protections.For reference: Expedited review categories for DHHS-regulated or FDA-regulated research: Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) is met.<ul><li>Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)</li><li>Research on medical devices for which:<ul><li>An investigational device exemption application (21 CFR Part 812) is not required; or </li><li>The medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.</li></ul></li></ul>Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:<ul><li>from healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or</li><li>from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.</li></ul>Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples:<ul><li>hair and nail clippings in a nondisfiguring manner; </li><li>deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; </li><li>permanent teeth if routine patient care indicates a need for extraction; </li><li>excreta and external secretions (including sweat); </li><li>uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; </li><li>placenta removed at delivery; </li><li>amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; </li><li>supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; </li><li>mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; </li><li>sputum collected after saline mist nebulization.</li></ul>Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)  Examples: <ul><li>physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy; </li><li>weighing or testing sensory acuity; </li><li>magnetic resonance imaging; </li><li>electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; </li><li>moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.</li></ul>Category 5: Research involving materials (data, documents, records, or specimens) that:<ul><li>have been collected for non-research purposes (such as medical treatment or diagnosis), or </li><li>will be collected solely for non-research purposes (such as medical treatment or diagnosis). </li></ul>(NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human participants.)Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.Category 7: Research on individual or group characteristics or behavior including, but not limited to:<ul><li>research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior, or</li><li>research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.</li></ul>Category 8: Continuing review of research previously approved by the convened IRB/EC as follows: <ul><li>the research is permanently closed to the enrollment of new participants;</li><li>all participants have completed all research-related interventions; and the research remains active only for long-term follow-up of participants; or</li><li>where no participants have been enrolled and no additional risks have been identified; or</li><li>where the remaining research activities are limited to data analysis.</li></ul>Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB/EC has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. ",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS or FDA requirements, the process for review using the expedited procedure:<ul><li>The designation by the IRB/EC chair of IRB/EC members who may conduct review using the expedited procedure.</li><li>The evaluation by the reviewer of whether research undergoing initial review using the expedited procedure:<ul><li>Does not involve more than minimal risk.</li><li>Research appearing on the list of expedited review categories is deemed to be no more than minimal risk. (DHHS only)</li><li>If a reviewer finds that research appearing on the expedited review list is greater than minimal risk, the reviewer must document the rationale for this determination and the rationale for review by the convened IRB/EC. (DHHS only)</li><li>Represents one or more approvable expedited review categories.</li><li>Does not include activities where identification of the participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.</li><li>Does not involve classified research.</li><li>When research involves vulnerable populations, additional safeguards have been included in the study to protect the rights and welfare of these participants.</li></ul></li></ul>",
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 "title": "When following DHHS requirements or applying equivalent protections to conduct review using the expedited procedure, written materials describe:<ul><li>Organizations are permitted, but not required, to eliminate the requirement for continuing review of research originally approved through expedited review. Written materials specify that continuing review by the IRB/EC or an expedited reviewer is not required when: <ul><li>Research meets one or more expedited review categories.</li><li>Research has progressed to the point that it involves only one or both of the following:<ul><li>Data analysis, including analysis of identifiable private information or identifiable biospecimens, or </li><li>Accessing follow-up clinical data from procedures that participants would undergo as part of clinical care. </li></ul></li></ul></li><li>The IRB/EC must justify the decision to conduct continuing review of research originally reviewed using the expedited procedure. </li><li>For organizations that eliminate the requirement for the IRB/EC to conduct continuing review of minimal risk research, written materials must describe an alternate process, such as staff review, for the organization to maintain oversight over the research initially approved using the expedited procedure, as long as the research is ongoing.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements or applying equivalent protections to conduct review using the expedited procedure:<ul><li>Organizations are permitted, but not required, to eliminate the requirement for continuing review of research originally approved through expedited review. Written materials specify that continuing review by the IRB/EC or an expedited reviewer is not required when:<ul><li>Research meets one or more expedited review categories.</li><li>Research has progressed to the point that it involves only one or both of the following:<ul><li>Data analysis, including analysis of identifiable private information or identifiable biospecimens, or</li><li>Accessing follow-up clinical data from procedures that participants would undergo as part of clinical care.</li></ul></li></ul></li><li>The IRB/EC must justify the decision to conduct continuing review of research originally reviewed using the expedited procedure.</li><li>For organizations that eliminate the requirement for the IRB/EC to conduct continuing review of minimal risk research, written materials must describe an alternate process, such as staff review, for the organization to maintain oversight over the research initially approved using the expedited procedure, as long as the research is ongoing.</li></ul>",
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 "title": "When following FDA requirements, written materials describe:<ul><li>Continuing review of research must occur at intervals appropriate to the degree of risk, but not less than once a year.</li><li>The IRB/EC must determine which clinical investigations require review more than annually.</li><li>The IRB/EC must determine which clinical investigations need verification from sources other than the clinical investigator that no material changes in the research have occurred since the previous IRB/EC review. The IRB/EC should consider:<ul><li>The nature of and any risks posed by the clinical investigation.</li><li>The degree of uncertainty regarding the risks involved.</li><li>The vulnerability of the participants.</li><li>The experience of the clinical investigator in conducting clinical research.</li><li>The IRB’s/EC’s previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher).</li><li>The projected rate of enrollment.</li><li>Whether the study involves novel therapies.</li></ul></li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following US FDA requirements:<ul><li>Continuing review of research must occur at intervals appropriate to the degree of risk, but not less than once a year.</li><li>The IRB/EC must determine which clinical investigations require review more than annually.</li><li>The IRB/EC must determine which clinical investigations need verification from sources other than the clinical investigator that no material changes in the research have occurred since the previous IRB/EC review. The IRB/EC should consider:<ul><li>The nature of and any risks posed by the clinical investigation.</li><li>The degree of uncertainty regarding the risks involved.</li><li>The vulnerability of the participants.</li><li>The experience of the clinical investigator in conducting clinical research.</li><li>The IRB’s/EC’s previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher).</li><li>The projected rate of enrollment.</li><li>Whether the study involves novel therapies.</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dod--review-of-surveys-performed-on-dod-personnel",
 "title": "Written materials indicate whether the organization conducts research on DoD personnel, and if such research is allowed, describe who in the organization is responsible for obtaining approval and the process they go through.If the organization DOES review surveys conducted on DoD personnel, written materials describe the following:<ul type=\"disc\"><li>Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD components, additional review is required.</li></ul>GUIDANCEClarify whether the organization conducts or reviews surveys on DoD personnel.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:Whether the organization conducts research on DoD personnel, and if such research is allowed, describe who in the organization is responsible for obtaining approval and the process they go through. If the organization DOES review surveys conducted on DoD personnelAdd to or describe in written materials [page xx or elsewhere]:Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD components, additional review is required.",
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 {
 "type": "question/review-assessment",
 "key": "dod--serving-as-a-reviewing-irb-for-dod-study",
 "title": "When serving as the reviewing IRB/EC for a DoD-covered research study, written materials include:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">The following must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP. (DoDI 3216.02 section 3.6)</li><li data-list=\"0\" data-level=\"1\">When significant changes to the research protocol are approved by the IRB/EC:</li><ul type=\"disc\"><li data-list=\"0\" data-level=\"2\">Changes to key investigators or institutions.</li><li data-list=\"0\" data-level=\"2\">Decreased benefit or increased risk to participants in greater than minimal risk research.</li><li data-list=\"0\" data-level=\"2\">Addition of vulnerable populations as participants.</li><li data-list=\"0\" data-level=\"2\">Addition of DoD-affiliated personnel as participants.</li></ul><li data-list=\"0\" data-level=\"1\">Change of reviewing IRB.</li><li data-list=\"0\" data-level=\"1\">When the organization is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of an HRPP is under investigation for cause involving a DoD-supported research protocol.</li><li data-list=\"0\" data-level=\"1\">Any problems involving risks to participants or others, suspension or termination of IRB/EC approval, or any serious or continuing noncompliance pertaining to DoD-supported human participant research.</li><li data-list=\"0\" data-level=\"1\">The results of the IRB’s/EC’s continuing review, if required.</li><li data-list=\"0\" data-level=\"1\">Change in status when a previously enrolled participant becomes pregnant, or when the researcher learns that a previously enrolled participant is pregnant, and the protocol was not reviewed and approved by the IRB/EC in accordance with 45 CFR 46, Subpart B.</li><li data-list=\"0\" data-level=\"1\">Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB/EC in accordance with 32 CFR 219, Subpart C.</li><li data-list=\"0\" data-level=\"1\">Closure of a DoD-supported study.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When serving as the reviewing IRB/EC for a DoD-covered research study:<ul type=\"disc\"><li data-list=\"0\" data-level=\"1\">The following must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP. (DoDI 3216.02 section 3.6)</li><li data-list=\"0\" data-level=\"1\">When significant changes to the research protocol are approved by the IRB/EC:</li><ul type=\"disc\"><li data-list=\"0\" data-level=\"2\">Changes to key investigators or institutions.</li><li data-list=\"0\" data-level=\"2\">Decreased benefit or increased risk to participants in greater than minimal risk research.</li><li data-list=\"0\" data-level=\"2\">Addition of vulnerable populations as participants.</li><li data-list=\"0\" data-level=\"2\">Addition of DoD-affiliated personnel as participants.</li></ul><li data-list=\"0\" data-level=\"1\">Change of reviewing IRB.</li><li data-list=\"0\" data-level=\"1\">When the organization is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of an HRPP is under investigation for cause involving a DoD-supported research protocol.</li><li data-list=\"0\" data-level=\"1\">Any problems involving risks to participants or others, suspension or termination of IRB/EC approval, or any serious or continuing noncompliance pertaining to DoD-supported human participant research.</li><li data-list=\"0\" data-level=\"1\">The results of the IRB’s/EC’s continuing review, if required.</li><li data-list=\"0\" data-level=\"1\">Change in status when a previously enrolled participant becomes pregnant, or when the researcher learns that a previously enrolled participant is pregnant, and the protocol was not reviewed and approved by the IRB/EC in accordance with 45 CFR 46, Subpart B.</li><li data-list=\"0\" data-level=\"1\">Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB/EC in accordance with 32 CFR 219, Subpart C.</li><li data-list=\"0\" data-level=\"1\">Closure of a DoD-supported study.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "doe--identification-of-reportable-events",
 "title": "Written materials describe that when serving as a reviewing IRB for DOE-funded research:  <ul><li>The HRP Program Manager at DOE or NNSA must be notified:<ul><li>Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.</li><li>Within 48 hours, with a description of corrective actions taken, of:<ul><li>Unanticipated problems.</li><li>Significant adverse events, and</li><li>Complaints about the research.</li></ul></li></ul></li></ul>",
 "description": "",
 "keywords": "doe-facility-with-internal-irb,irb-ec---reviews-doe-research,serves-as-an-irb-for-doe-organizations",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When serving as a reviewing IRB for DOE-funded research: <ul type=\"disc\"><li>The HRP Program Manager at DOE or NNSA must be notified:</li><ul type=\"disc\"><li>Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.</li><li>Within 48 hours, with a description of corrective actions taken, of:</li><ul type=\"disc\"><li>Unanticipated problems.</li><li>Significant adverse events, and</li><li>Complaints about the research.</li></ul></ul></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va--continuing-review-expiration",
 "title": "Written materials describe:<ul><li>If a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:<ul><li>The researcher must stop all research activities including, but not limited to, enrollment of new participants, analysis of individually identifiable data, and research interventions or interactions with currently enrolled participants, except where stopping such interventions or interactions could be harmful to participants. </li><li>The researcher must immediately submit to the IRB/EC chair a list of research participants who could be harmed by stopping study procedures.</li><li>The IRB/EC chair, with appropriate consultation with the chief of staff, determines within two business days whether participants on the list may continue participating in the research interventions or interactions.</li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>If a researcher does not provide continuing review information to the IRB/EC or the IRB/EC has not approved a protocol by the expiration date:<ul><li>The researcher must stop all research activities including, but not limited to, enrollment of new participants, analysis of individually identifiable data, and research interventions or interactions with currently enrolled participants, except where stopping such interventions or interactions could be harmful to participants.</li><li>The researcher must immediately submit to the IRB/EC chair a list of research participants who could be harmed by stopping study procedures.</li><li>The IRB/EC chair, with appropriate consultation with the chief of staff, determines within two business days whether participants on the list may continue participating in the research interventions or interactions.</li></ul></li></ul>",
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 {
 "type": "section/element",
 "key": "element-ii-2-g",
 "title": "Element II.2.G.",
 "description": "The IRB or EC has and follows written policies and procedures for addressing unanticipated problems involving risks to participants or others, and for reporting these actions, when appropriate.",
 "keywords": "ich-gcp-all,outside-us-internal-irb,org-is-independent-irb-ec,org-is-va,us-based-internal-irb",
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 "key": "q1",
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 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 "type": "question/review-assessment",
 "key": "unanticipated-problems--reporting",
 "title": "Essential RequirementsWritten materials describe the problems researchers have to report to the IRB/EC and the time frame for prompt reporting (within 30 days), including:<ul><li>Internal adverse events that are unexpected, involve new or increased risks, and are related to the research.</li><li>External adverse events that are unanticipated problems involving risks to participants or others.</li><li>Changes made to the research without prior IRB/EC approval in order to eliminate apparent immediate harm.</li><li>Other unanticipated information that is related to the research and when participants or others might be at increased risk of harm.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The problems researchers have to report to the IRB/EC and the time frame for prompt reporting (within 30 days), including:<ul><li>Internal adverse events that are unexpected, involve new or increased risks, and are related to the research.</li><li>External adverse events that are unanticipated problems involving risks to participants or others.</li><li>Changes made to the research without prior IRB/EC approval in order to eliminate apparent immediate harm.</li><li>Other unanticipated information that is related to the research and when participants or others might be at increased risk of harm.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "unanticipated-problems--definition",
 "title": "Essential RequirementsWritten materials include a definition of unanticipated\nproblems involving risks to participants or others.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:A definition of unanticipated problems involving risks to participants or others.",
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 "type": "question/review-assessment",
 "key": "unanticipated-problems--review-process",
 "title": "Essential RequirementsWritten materials describe:<ul type=\"disc\"><li>The process for review of problems reported by researchers.</li><li>The process for determination of whether each reported problem is an unanticipated problem involving risks to participants or others.</li></ul>",
 "description": "",
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 "type": "question/review-assessment",
 "key": "unanticipated-problems--minimal-risks",
 "title": "Essential RequirementsWritten materials describe the review process of\nunanticipated problems involving no more than minimal risks to participants or\nothers.",
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 {
 "type": "question/review-assessment",
 "key": "unanticipated-problems--more-than-minimal-risk",
 "title": "Essential RequirementsWritten materials describe that the convened IRB’s/EC’s review of unanticipated problems involving more than minimal risks to participants or others, including:<ul><li>Documents distributed to primary reviewers.</li><li>Documents distributed to all IRB/EC members.</li></ul>",
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 "type": "question/review-assessment",
 "key": "unanticipated-problems--potential-actions",
 "title": "Essential RequirementsWritten materials describe the range of actions considered by the IRB. Actions considered by the IRB/EC must include:<ul><li>Suspension of the research.</li><li>Termination of the research.</li><li>Notification of current participants when such information might relate to participants’ willingness to continue to take part in the research.</li></ul>Optional actions might include:<ul><li>Modification of the protocol.</li><li>Modification of the information disclosed during the consent process.</li><li>Providing additional information to past participants.</li><li>Requiring current participants to re-consent to participation.</li><li>Modification of the continuing review schedule.</li><li>Monitoring of the research.</li><li>Monitoring of the consent process.</li><li>Referral to other organizational entities.</li></ul>",
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 "type": "question/review-assessment",
 "key": "unanticipated-problems--external-reporting",
 "title": "Essential RequirementsWritten materials describe the reporting of problems determined to represent unanticipated problems involving risks to participants or others, including:<ul><li>The distribution of the report to:<ul><li>Specific organizational officials.</li><li>Regulatory agencies, when the research is overseen by those agencies, and they require separate reporting.</li><li>The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements</li></ul></li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The reporting of problems determined to represent unanticipated problems involving risks to participants or others, including:<ul><li>The distribution of the report to:<ul><li>Specific organizational officials.</li><li>Regulatory agencies, when the research is overseen by those agencies, and they require separate reporting.</li><li>The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--unanticipated-problems",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Written materials describe the process when following DHHS requirements <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">to report unanticipated problems involving risks to participants or others to OHRP, when the research is covered by DHHS regulations.When research is not covered by DHHS regulations, written materials specify that reports of unanticipated problems involving risks to participants or others are not to be reported to OHRP. GUIDANCEIf an organization has extended its Federalwide Assurance (FWA) to cover all of its research, then all non-exempt human participants research is considered to be covered by DHHS regulations. Consequently, the organization is required to report findings of unanticipated problems to OHRP regardless of the funding support for the research.",
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 "title": "When following DHHS requirementsAdd to or describe in written materials [page xx or elsewhere]:The process when following DHHS requirements to report unanticipated problems involving risks to participants or others to OHRP, when the research is covered by DHHS regulations.If an organization does not apply DHHS requirements to all of its human participants research<div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Add to or describe in written materials [page xx or elsewhere]:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">When research is not covered by DHHS regulations, written materials specify that reports of unanticipated problems involving risks to participants or others are not to be reported to OHRP. </div>",
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 "type": "question/review-assessment",
 "key": "us-fda--unanticipated-problems",
 "title": "When following FDA requirements, written materials describe that the report of unanticipated problems involving risks to participants or others be sent to the FDA, when the research is FDA-regulated.When research is not covered by FDA regulations, written materials specify that reports of unanticipated problems involving risks to participants or others are not to be reported to FDA.",
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 "title": "When following FDA requirementsAdd to or describe in written materials [page xx or elsewhere]:The report of unanticipated problems involving risks to participants or others be sent to the FDA, when the research is FDA-regulated.When research is not covered by FDA regulationsAdd to or describe in written materials [page xx or elsewhere]:<div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Reports of unanticipated problems involving risks to participants or others are not to be reported to FDA when research is not covered by FDA regulations.</div>",
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 "type": "question/review-assessment",
 "key": "dod--unanticipated-problems",
 "title": "When following DoD requirements, written materials describe:<ul><li>The following must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP:<ul><li>Unanticipated problems involving risks to participants or others and any subsequent actions taken based on the findings.</li><li>Include the person responsible and the process they go through to report unanticipated problems involving risks to participants.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "doe--unanticipated-problems",
 "title": "When following DOE requirements, written materials describe:<ul><li>The HSP Program Manager at DOE or NNSA must be notified within 48 hours, with a description of corrective actions taken, of:<ul><li>Suspensions of IRB/EC approval</li><li>Terminations of IRB/EC approval</li></ul></li></ul>",
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 "title": "When following the ICH-GCP (E6) guideline, written materials describe:Problems researchers have to report to the IRB/EC include:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Deviations from the protocol to eliminate immediate hazards to the trial participants.</li><li>Changes increasing the risk to participants and/or significantly affecting the conduct of the trial.</li><li>All suspected unexpected serious adverse reactions (SUSARs) in accordance with applicable regulatory requirements.</li><li>New information that may adversely affect the safety of the participants or the conduct of the trial. </li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline, problems researchers have to report to the IRB/EC include:<ul><li>Deviations from the protocol to eliminate immediate hazards to the trial participants.</li><li>Changes increasing the risk to participants and/or significantly affecting the conduct of the trial.</li><li>All suspected unexpected serious adverse reactions (SUSARs) in accordance with applicable regulatory requirements.</li><li>New information that may adversely affect the safety of the participants or the conduct of the trial.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va--unanticipated-problems",
 "title": "When following VA requirements, <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">written materials describe t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">he following definitions, procedures, and timeframes:<ul><li>An unanticipated problem involving risks to participants or others (UPIRTSO) in human participants research is an incident, experience, or outcome that is: unexpected; related or possibly related to participation in the research; and indicative of the research placing participants or others at substantively greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. (VHA Directive 1058.01 Section 3)<ul><li>The term “unexpected” refers to an incident, experience, or outcome that is new or greater than previously known in terms of nature, severity, or frequency, given the procedures described in protocol-related documents and the characteristics of the study population.</li><li>The phrase “related to participation in the research” means a logical sequence of cause and effect shows that the study procedures were the reason for the incident, experience, or outcome. </li><li>The phrase “possibly related to participation in the research” implies a lesser degree of certainty about causality and refers to an incident, experience, or outcome for which there is some evidence to reasonably suggest a causal relationship between study procedures and the incident, experience, or outcome. </li></ul></li><li>A serious adverse event (SAE) in human participants research is an untoward occurrence, whether or not considered related to a participant’ participation in research, that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome.<ul><li>An unexpected SAE that is related or possibly related to participation in human participants research constitutes a UPIRTSO. </li></ul></li><li>Within five (5) business days after receiving written notification of an apparent UPIRTSO, the IRB/EC chair or another qualified IRB/EC member must assess and document whether any actions are warranted to eliminate apparent immediate hazards to participants and, if so, initiate those actions.<ul><li>In response to the written notification, the IRB/EC must:<ul><li>Review the written notification, the immediate hazard assessment of the IRB/EC chair or other qualified IRB/EC member, and the actions taken to date at its next convened meeting, not to exceed 30 calendar days after the date of written notification. NOTE: Incidents covered by this paragraph may call for immediate attention and require the IRB/EC to convene an emergency session prior to its next scheduled meeting. (B) Determine and document within 30 calendar days of the convened IRB’s/EC’s initial review:<ul><li>Whether the incident, experience, or outcome was unexpected and related to or possibly related to participation in the research and indicative of the research placing participants or others at substantively greater risk of harm than was previously known or recognized (i.e., whether the incident, experience, or outcome constituted an actual UPIRTSO); and</li><li>What, if any, protocol or informed consent modifications are warranted. If modifications are warranted, the convened IRB/EC must determine and document whether or not researchers must notify or solicit renewed or revised consent from previously enrolled participants; and if so, when such notification or consent must take place and how it must be documented.</li></ul></li><li>If the IRB/EC determines that the incident, experience, or outcome constituted an actual UPIRTSO, it must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.</li><li>If the IRB/EC is unable to make a determination on the matter within 30 calendar days of the convened IRB’s/EC’s initial review due to insufficient information or due to a lack of sufficient time to complete its review, the IRB/EC must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing no later than five (5) business days after the determination was due.</li></ul></li></ul></li><li>Within one (1) business day after receiving written notification of the death, the IRB/EC chair or another qualified IRB/EC member must assess and document whether any actions are warranted to eliminate apparent immediate hazards to participants and, if so, initiate those actions.<ul><li>Determine and document within 30 calendar days of the convened IRB’s/EC’s initial review:</li><li>Whether the death was both unexpected and related or possibly related to participation in the research; and</li><li>What, if any, protocol or informed consent modifications are warranted. If modifications are warranted, the convened IRB/EC must determine and document whether or not researchers must notify or solicit renewed/revised consent from previously enrolled participants; and if so, when such notification or consent must take place and how it must be documented.</li></ul></li><li>The IRB/EC must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements, describe the following definitions, procedures, and timeframes:<ul><li>An unanticipated problem involving risks to participants or others (UPIRTSO) in human participants research is an incident, experience, or outcome that is: unexpected; related or possibly related to participation in the research; and indicative of the research placing participants or others at substantively greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. (VHA Directive 1058.01 Section 3)<ul><li>The term “unexpected” refers to an incident, experience, or outcome that is new or greater than previously known in terms of nature, severity, or frequency, given the procedures described in protocol-related documents and the characteristics of the study population.</li><li>The phrase “related to participation in the research” means a logical sequence of cause and effect shows that the study procedures were the reason for the incident, experience, or outcome.</li><li>The phrase “possibly related to participation in the research” implies a lesser degree of certainty about causality and refers to an incident, experience, or outcome for which there is some evidence to reasonably suggest a causal relationship between study procedures and the incident, experience, or outcome.</li></ul></li><li>A serious adverse event (SAE) in human participants research is an untoward occurrence, whether or not considered related to a participant’ participation in research, that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome.<ul><li>An unexpected SAE that is related or possibly related to participation in human participants research constitutes a UPIRTSO.</li></ul></li><li>Within five (5) business days after receiving written notification of an apparent UPIRTSO, the IRB/EC chair or another qualified IRB/EC member must assess and document whether any actions are warranted to eliminate apparent immediate hazards to participants and, if so, initiate those actions.<ul><li>In response to the written notification, the IRB/EC must:<ul><li>Review the written notification, the immediate hazard assessment of the IRB/EC chair or other qualified IRB/EC member, and the actions taken to date at its next convened meeting, not to exceed 30 calendar days after the date of written notification. NOTE: Incidents covered by this paragraph may call for immediate attention and require the IRB/EC to convene an emergency session prior to its next scheduled meeting. (B) Determine and document within 30 calendar days of the convened IRB’s/EC’s initial review:<ul><li>Whether the incident, experience, or outcome was unexpected and related to or possibly related to participation in the research and indicative of the research placing participants or others at substantively greater risk of harm than was previously known or recognized (i.e., whether the incident, experience, or outcome constituted an actual UPIRTSO); and</li><li>What, if any, protocol or informed consent modifications are warranted. If modifications are warranted, the convened IRB/EC must determine and document whether or not researchers must notify or solicit renewed or revised consent from previously enrolled participants; and if so, when such notification or consent must take place and how it must be documented.</li></ul></li><li>If the IRB/EC determines that the incident, experience, or outcome constituted an actual UPIRTSO, it must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.</li><li>If the IRB/EC is unable to make a determination on the matter within 30 calendar days of the convened IRB’s/EC’s initial review due to insufficient information or due to a lack of sufficient time to complete its review, the IRB/EC must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing no later than five (5) business days after the determination was due.</li></ul></li></ul></li><li>Within one (1) business day after receiving written notification of the death, the IRB/EC chair or another qualified IRB/EC member must assess and document whether any actions are warranted to eliminate apparent immediate hazards to participants and, if so, initiate those actions.<ul><li>Determine and document within 30 calendar days of the convened IRB’s/EC’s initial review:</li><li>Whether the death was both unexpected and related or possibly related to participation in the research; and</li><li>What, if any, protocol or informed consent modifications are warranted. If modifications are warranted, the convened IRB/EC must determine and document whether or not researchers must notify or solicit renewed/revised consent from previously enrolled participants; and if so, when such notification or consent must take place and how it must be documented.</li></ul></li><li>The IRB/EC must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va-facilities--unanticipated-problems",
 "title": "For VA facilities, written materials describe: <ul><li>In the event of any apparent UPIRTSO, VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent UPIRTSO involving a VA non-exempt human participants research study.<ul><li>An apparent UPIRTSO is an apparent incident, experience or outcome that is: unexpected and related or possibly related to participation in the research and indicative of the research placing participants or others at substantively greater risk of harm than was previously known or recognized.</li><li>The VA medical facility Director, or designee, must report the IRB’s/EC’s determinations to the appropriate ORO workgroup within five (5) business days after receiving the IRB’s/EC’s written notification.</li><li>The VA medical facility Director, or designee, must notify the appropriate ORO workgroup within five (5) business days after receiving the IRB’s/EC’s written notification that it is unable to make a UPIRTSO determination.</li></ul></li><li>In the event of a local research participant death:<ul><li>VA personnel must ensure that the appropriate IRB/EC of Record and VA ACOS/R&D are orally notified immediately (i.e., within one hour) upon becoming aware of any local research death of a human participant that is believed to be both unexpected and related or possibly related to a participant in a VA non-exempt human participant study.</li><li> VA personnel must also provide follow-up written notification to the IRB/EC within one (1) business day of becoming aware of such a death.</li><li>The ACOS/R&D, or designee, must alert the VA medical facility Director and appropriate ORO workgroup by email or telephone within one (1) business day after receiving the initial oral notification and provide relevant information as requested.</li><li>The VA medical facility Director, or designee, must report the IRB’s/EC’s determinations to the appropriate ORO workgroup within five (5) business days after receiving the IRB’s/EC’s written notification.</li><li>If the IRB/EC is unable to make a determination on the matter within 30 calendar days of the convened IRB’s/EC’s initial review due to insufficient information or due to a lack of sufficient time to complete its review, the IRB/EC must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing no later than five (5) business days after the determination was due.</li></ul></li></ul>",
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 "key": "va-facilities--unanticipated-problems",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">In the event of any apparent UPIRTSO, VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent UPIRTSO involving a VA non-exempt human participants research study.<ul><li>An apparent UPIRTSO is an apparent incident, experience or outcome that is: unexpected and related or possibly related to participation in the research and indicative of the research placing participants or others at substantively greater risk of harm than was previously known or recognized.</li><li>The VA medical facility Director, or designee, must report the IRB’s/EC’s determinations to the appropriate ORO workgroup within five (5) business days after receiving the IRB’s/EC’s written notification.</li><li>The VA medical facility Director, or designee, must notify the appropriate ORO workgroup within five (5) business days after receiving the IRB’s/EC’s written notification that it is unable to make a UPIRTSO determination.</li></ul></li><li>In the event of a local research participant death:<ul><li>VA personnel must ensure that the appropriate IRB/EC of Record and VA ACOS/R&D are orally notified immediately (i.e., within one hour) upon becoming aware of any local research death of a human participant that is believed to be both unexpected and related or possibly related to a participant in a VA non-exempt human participant study.</li><li> VA personnel must also provide follow-up written notification to the IRB/EC within one (1) business day of becoming aware of such a death.</li><li>The ACOS/R&D, or designee, must alert the VA medical facility Director and appropriate ORO workgroup by email or telephone within one (1) business day after receiving the initial oral notification and provide relevant information as requested.</li><li>The VA medical facility Director, or designee, must report the IRB’s/EC’s determinations to the appropriate ORO workgroup within five (5) business days after receiving the IRB’s/EC’s written notification.</li><li>If the IRB/EC is unable to make a determination on the matter within 30 calendar days of the convened IRB’s/EC’s initial review due to insufficient information or due to a lack of sufficient time to complete its review, the IRB/EC must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing no later than five (5) business days after the determination was due.</li></ul></li></ul>",
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 "type": "section/element",
 "key": "element-ii-2-h",
 "title": "Element II.2.H.",
 "description": "The IRB or EC has and follows written policies and procedures for suspending or terminating IRB or EC approval of research, if warranted, and for reporting these actions, when appropriate.",
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 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "key": "suspension-or-termination-of-irb-ec-approval",
 "title": "Essential RequirementsWritten materials describe<ul><li>Suspension of IRB/EC approval is defined as a temporary halt in IRB/EC approval of some or all research activities.</li><li>Termination of IRB/EC approval is defined as a permanent halt in IRB/EC approval of all research activities.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>Suspension of IRB/EC approval is defined as a temporary halt in IRB/EC approval of some or all research activities.</li><li>Termination of IRB/EC approval is defined as a permanent halt in IRB/EC approval of all research activities.</li></ul>",
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 "type": "question/review-assessment",
 "key": "suspension-or-termination-of-irb-ec-approval--when-it-can-occur",
 "title": "Essential RequirementsWritten materials describe that the IRB/EC can suspend or terminate approval of research that:<ul><li>Is not being conducted in accordance with the IRB’s/EC’s requirements.</li><li>Has been associated with unexpected serious harm to participants.</li></ul>",
 "description": "",
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 "key": "suspension-or-termination-of-irb-ec-approval--when-it-can-occur",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC can suspend or terminate approval of research that:<ul><li>Is not being conducted in accordance with the IRB’s/EC’s requirements.</li><li>Has been associated with unexpected serious harm to participants.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "suspension-or-termination-of-irb-ec-approval--who-can-take-the-action",
 "title": "Essential RequirementsWritten materials describe: <ul><li>Who is authorized to suspend or terminate research.</li><li>Who can suspend or terminate IRB/EC approval on an urgent basis.</li></ul>",
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 "key": "suspension-or-termination-of-irb-ec-approval--action-by-entity-other-than-irb-ec",
 "title": "Essential RequirementsWritten materials describe that suspensions and\nterminations by someone other than the convened IRB/EC must be reported to and\nreviewed by the convened IRB/EC.",
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 "type": "question/review-assessment",
 "key": "suspension-or-termination-of-irb-ec-approval--considerations",
 "title": "Essential RequirementsWritten materials describe when study approval is suspended or terminated, the IRB/EC or the person ordering the suspension or termination:<ul><li>Considers actions to protect the rights and welfare of currently enrolled participants.</li><li>Considers whether procedures for withdrawal of enrolled participants take into account their rights and welfare (e.g., making arrangements for medical care outside of a research study, transfer to another researcher, and continuation in the research under independent monitoring).</li><li>Considers informing current participants of the termination or suspension.</li><li>Considers requesting additional information, such as any adverse events or other information, be reported to the IRB/EC.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When study approval is suspended or terminated, the IRB/EC or the person ordering the suspension or termination:<ul><li>Considers actions to protect the rights and welfare of currently enrolled participants.</li><li>Considers whether procedures for withdrawal of enrolled participants take into account their rights and welfare (e.g., making arrangements for medical care outside of a research study, transfer to another researcher, and continuation in the research under independent monitoring).</li><li>Considers informing current participants of the termination or suspension.</li><li>Considers requesting additional information, such as any adverse events or other information, be reported to the IRB/EC.</li></ul>",
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 "type": "question/review-assessment",
 "key": "suspension-or-termination-of-irb-ec-approval--reporting",
 "title": "Essential RequirementsWritten materials describe:<ul><li>The prompt reporting of suspensions and terminations of IRB/EC approval (within 30 days).</li><li>The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements.</li><li>The distribution of the report to:<ul><li>Specific organizational officials.</li><li>Regulatory agencies when the research is overseen by those agencies, and they require reporting.</li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>The prompt reporting of suspensions and terminations of IRB/EC approval (within 30 days).</li><li>The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements.</li><li>The distribution of the report to:<ul><li>Specific organizational officials.</li><li>Regulatory agencies when the research is overseen by those agencies, and they require reporting.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "administrative-holds",
 "title": "Essential RequirementsFor organizations that adopt an “administrative hold” policy, written materials describe:<ul><li>An administrative hold is a voluntary interruption of research enrollments and ongoing research activities by the researcher. The researcher must notify the IRB/EC of the request to place a study under administrative hold.<ul><li>The definition of administrative hold must explain how it is different from a suspension or termination.</li></ul></li><li>An administrative hold does not apply to interruptions of research related to concerns regarding the safety, rights, or welfare of human research participants, researchers, research staff, or others. If there is an unanticipated problem involving risks to participants or others, the study is not eligible for an administrative hold.</li><li>An administrative hold must not be used to avoid reporting deficiencies or circumstances that otherwise require reporting by regulatory agencies.</li><li>Activities placed under administrative hold remain subject to continuing review and all organizational policies, such as policies on reporting problems.</li><li>An administrative hold cannot be used to extend IRB/EC approval beyond the expiration date of a protocol without IRB/EC approval of continuing review.</li><li>Policies should provide examples of when an administrative hold may be granted, such as when a researcher goes on sabbatical or takes a leave of absence.</li></ul>GUIDANCEIf “administrative hold” is used, policies need\nto explain the difference between a suspension or termination and an\nadministrative hold.",
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 "title": "For organizations that adopt an “administrative hold” policyAdd to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">An administrative hold is a voluntary interruption of research enrollments and ongoing research activities by the researcher. The researcher must notify the IRB/EC of the request to place a study under administrative hold.<ul><li>The definition of administrative hold must explain how it is different from a suspension or termination.</li></ul></li></ul><ul><li>An administrative hold does not apply to interruptions of research related to concerns regarding the safety, rights, or welfare of human research participants, researchers, research staff, or others. If there is an unanticipated problem involving risks to participants or others, the study is not eligible for an administrative hold.</li><li>An administrative hold must not be used to avoid reporting deficiencies or circumstances that otherwise require reporting by regulatory agencies.</li><li>Activities placed under administrative hold remain subject to continuing review and all organizational policies, such as policies on reporting problems.</li><li>An administrative hold cannot be used to extend IRB/EC approval beyond the expiration date of a protocol without IRB/EC approval of continuing review.</li><li>Policies should provide examples of when an administrative hold may be granted, such as when a researcher goes on sabbatical or takes a leave of absence.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--reporting-suspensions-and-terminations",
 "title": "When following DHHS requirements, written materials describe that suspensions and\nterminations of IRB/EC approval are promptly (no longer than within 30 days)\nreported to OHRP. ",
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 "type": "question/review-assessment",
 "key": "fda--reporting-suspensions-and-terminations",
 "title": "When following FDA requirements, written materials describe that suspensions and\nterminations of IRB/EC approval are promptly (no longer than within 30 days)\nreported to FDA.",
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 "type": "question/review-assessment",
 "key": "dod--reporting-suspensions-and-terminations",
 "title": "When following the DoD requirements, written materials describe that suspensions or terminations of IRB/EC approval and any subsequent actions taken based on the findings <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP. <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Written materials also include<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"> the person responsible and the process they go through to report unanticipated problems involving risks to participants.",
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 "title": "When following the DoD requirementsAdd to or describe in written materials [page xx or elsewhere]:<ul><li>Suspensions or terminations of IRB/EC approval and any subsequent actions taken based on the findings must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP.</li><li>The person responsible and the process they go through to report unanticipated problems involving risks to participants.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "ich-gcp--problems-reported-to-the-irb-ec",
 "title": "When following the ICH-GCP (E6) guideline, written materials include a definition of the problems researchers must report to the IRB/EC that includes:<ul><li>New information that might affect adversely the safety of the participants or the conduct of the clinical trial.</li><li>Any changes significantly affecting the conduct of the clinical trial or increasing the risk to participants.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va--reporting-suspensions-or-terminations",
 "title": "When following VA requirements, written materials describe that:<ul><li>The IRB/EC of Record must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing within five business days of the suspension or early termination of a non-exempt VA human research study by the IRB/EC or IO due to the study not being conducted in accordance with applicable regulations, policies, agreements, or IRB/EC requirements or due to concerns about the safety, rights, or welfare of human participants or others.</li><li>The notification of suspension or early termination of a non-exempt VA human research study by the IRB/EC must include a statement of the reason for the IRB's/EC’s action.</li></ul>",
 "description": "",
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 "key": "va--reporting-suspensions-or-terminations",
 "title": "When following VA requirementsAdd to or describe in written materials [page xx or elsewhere]:<ul><li>The IRB/EC of Record must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing within five business days of the suspension or early termination of a non-exempt VA human research study by the IRB/EC or IO due to the study not being conducted in accordance with applicable regulations, policies, agreements, or IRB/EC requirements or due to concerns about the safety, rights, or welfare of human participants or others.</li><li>The notification of suspension or early termination of a non-exempt VA human research study by the IRB/EC must include a statement of the reason for the IRB's/EC’s action.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va-facilities--who-can-suspend-other-than-the-irb-ec",
 "title": "For VA facilities, written materials include:<ul><li>The R&D Committee and VA facility Director have the authority to suspend or terminate their approval of research. This authority can be delegated by the organizational official to the Chief of Staff (COS). ORD has authority to suspend or terminate any research activity it is funding.</li><li>The notification of suspension or early termination of a non-exempt VA human research study by the VA IO must include a statement of the reason for the IO’s action.</li><li>The facility Director, or designee, must report the termination or suspension to the VA Office of Research Oversight (ORO) within five business days after receiving such notification.</li></ul>",
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 "type": "section/element",
 "key": "element-ii-2-i",
 "title": "Element II.2.I.",
 "description": "The IRB or EC has and follows policies and procedures for managing multi-site research by defining the responsibilities of participating sites that are relevant to the protection of research participants, such as reporting of unanticipated problems or interim results.",
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 "key": "provide-written-materials",
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 "type": "question/review-assessment",
 "key": "multi-site-research--information-management",
 "title": "Essential RequirementsWritten materials describe that when the researcher is the lead researcher of a multi-site study, applications include information about the management of information that is relevant to the protection of participants, such as:<ul><li>Unanticipated problems involving risks to participants or others.</li><li>Interim results.</li><li>Protocol modifications.</li></ul>",
 "description": "",
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 "description": "",
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 "type": "question/review-assessment",
 "key": "multi-site-research--irb-ec-review-of-information-management",
 "title": "Essential RequirementsWritten materials describe that when the researcher is the lead researcher of a multi-site study, the IRB/EC evaluates whether the management of information that is relevant to the protection of participants is adequate.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "dod--agreement-specifying-roles-and-responsibilities",
 "title": "When following DoD requirements, written materials describe the process to obtain a formal agreement between organizations when conducting multi-site research to specify the roles and responsibilities of each party.",
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 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va-facilities",
 "title": "For VA facilities, written materials describe):<ul><li>Each VA facility must retain a complete record of all data obtained during the VA portion of the research in accordance with privacy requirements, the Federal Records Act, and VHA Record Control Schedule 10-1.</li><li>A Material Transfer Agreement (MTA) must be used to transfer biospecimens from VA unless the biospecimens’ transfer is addressed in another agreement executed between VA and the receiving institution or party, such as a CRADA, subaward, or MOU. NOTE: If a CRADA is executed for a research study where the scope of work specifically describes analysis, retention, and disposal of biospecimens by a central laboratory, then an MTA is not required.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "va",
 "title": "When following VA requirements, written materials describe: <ul><li>Collaborative research is human participants research activities involving researchers from VA and at least one non-VA institution. <ul><li>Each institution is responsible for safeguarding the rights and welfare of human participants and providing oversight of the research activities conducted by that institution.</li><li>Each collaborating institution engaged in human participants research must obtain approval from its IRB/EC of Record and hold an FWA or another assurance acceptable to VA (e.g. DoD assurance).</li><li>VA researchers must submit a protocol or other documentation to their VA IRB/EC of Record and the R&D Committee that clearly delineates which research activities will be conducted as the VA portion of the overall Collaborative Research study (e.g., by VA researchers on VA time or VA property).</li><li>Each institution engaged in the Collaborative Research must use the informed consent document required by its respective institutional policies for participants recruited from that institution, or procedures requiring participation of the participants at that institution. The informed consent document may contain information on the project as a whole as long as the document clearly describes which procedures will be performed under VA’s auspices and which will be performed under a non-VA institution’s auspices.<ul><li>The VA informed consent document must clearly state when procedures conducted at other non-VA institutions are part of the VA’s portion of the study.</li></ul></li><li>The protocol, protocol addendum, and/or subcommittee application must describe the data (identifiable or de-identified) to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, the method of how the data are to be transmitted, and the person who will own or have responsibility for the disclosed copies of the data. This includes data developed directly from the research including the analytic data and the aggregate data.<ul><li>All disclosures and data transmission must meet privacy and security requirements per VHA Directive 1605.01 and VA Handbook 6500.</li></ul></li><li>The protocol, addendum, and/or subcommittee application must describe the applicable collection, use, transfer, and disposition of biospecimens obtained or collected.</li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li>Collaborative research is human participants research activities involving researchers from VA and at least one non-VA institution.</li><ul type=\"disc\"><li>Each institution is responsible for safeguarding the rights and welfare of human participants and providing oversight of the research activities conducted by that institution.</li><li>Each collaborating institution engaged in human participants research must obtain approval from its IRB/EC of Record and hold an FWA or another assurance acceptable to VA (e.g. DoD assurance).</li><li>VA researchers must submit a protocol or other documentation to their VA IRB/EC of Record and the R&D Committee that clearly delineates which research activities will be conducted as the VA portion of the overall Collaborative Research study (e.g., by VA researchers on VA time or VA property).</li><li>Each institution engaged in the Collaborative Research must use the informed consent document required by its respective institutional policies for participants recruited from that institution, or procedures requiring participation of the participants at that institution. The informed consent document may contain information on the project as a whole as long as the document clearly describes which procedures will be performed under VA’s auspices and which will be performed under a non-VA institution’s auspices.</li><ul type=\"disc\"><li>The VA informed consent document must clearly state when procedures conducted at other non-VA institutions are part of the VA’s portion of the study.</li></ul><li>The protocol, protocol addendum, and/or subcommittee application must describe the data (identifiable or de-identified) to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, the method of how the data are to be transmitted, and the person who will own or have responsibility for the disclosed copies of the data. This includes data developed directly from the research including the analytic data and the aggregate data.</li><ul type=\"disc\"><li>All disclosures and data transmission must meet privacy and security requirements per VHA Directive 1605.01 and VA Handbook 6500.</li></ul><li>The protocol, addendum, and/or subcommittee application must describe the applicable collection, use, transfer, and disposition of biospecimens obtained or collected.</li></ul></ul>",
 "description": "",
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 },
 {
 "type": "section/standard",
 "key": "standard-ii-3",
 "title": "STANDARD II-3",
 "description": "The IRB or EC approves each research protocol or plan according to criteria based on applicable laws, regulations, codes, and guidance. ",
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 "type": "section/element",
 "key": "element-ii-3-a",
 "title": "ELEMENT II.3.A.",
 "description": "The IRB or EC has and follows written policies and procedures for identifying and analyzing risks and identifying measures to minimize such risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to the potential benefits to participants and to society.",
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 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "risks-and-benefits--irb-ec-application",
 "title": "Essential RequirementsIRB/EC applications include information allowing the IRB/EC to conduct an analysis of the risks and potential benefits, such as:<ul><li>The purposes of the research.</li><li>The scientific or scholarly rationale.</li><li>The procedures to be performed.</li><li>A description of the procedures being performed already for diagnostic or treatment purposes.</li><li>The risks and potential benefits of the research to participants.</li></ul>",
 "description": "",
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 "title": "Add to or describe in IRB/EC applications [page xx or elsewhere]:Information allowing the IRB/EC to conduct an analysis of the risks and potential benefits, such as:<ul type=\"disc\"><li>The purposes of the research.</li><li>The scientific or scholarly rationale.</li><li>The procedures to be performed.</li><li>A description of the procedures being performed already for diagnostic or treatment purposes.</li><li>The risks and potential benefits of the research to participants. </li></ul>",
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 "type": "question/review-assessment",
 "key": "risk-benefit-assessment--irb-ec-review",
 "title": "Essential RequirementsWritten materials describe that in order to approve research, the IRB/EC determines:<ul><li>Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.</li><li>Risks to participants are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.</li><li>Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that might be expected to result.</li><li>Research studies have the resources necessary to protect participants:</li><li>Adequate time for the researchers to conduct and complete the research.</li><li>Adequate number of qualified staff.</li><li>Adequate facilities.</li><li>Access to a population that will allow recruitment of the necessary number of participants.</li><li>Availability of medical or psychosocial resources that participants might need as a consequence of the research.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:In order to approve research, the IRB/EC determines:<ul><li>Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.</li><li>Risks to participants are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.</li><li>Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that might be expected to result.</li><li>Research studies have the resources necessary to protect participants:</li><li>Adequate time for the researchers to conduct and complete the research.</li><li>Adequate number of qualified staff.</li><li>Adequate facilities.</li><li>Access to a population that will allow recruitment of the necessary number of participants.</li><li>Availability of medical or psychosocial resources that participants might need as a consequence of the research.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dod--risk-assessment",
 "title": "When following DoD requirements, written materials describe: <ul><li>The definition of minimal risk in 32 CFR 219 does not include the inherent occupational risks that certain participants face in their everyday life, such as those:</li><li>Encountered by Service members, law enforcement, or first responders while on duty.</li><li>Resulting from or associated with high-risk behaviors or pursuits.</li><li>Experienced by individuals whose medical conditions involve frequent tests or constant pain.</li></ul>",
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 "type": "section/element",
 "key": "element-ii-3-b",
 "title": "ELEMENT II.3.B.",
 "description": "The IRB or EC has and follows written policies and procedures for reviewing the plans for data and safety monitoring, when applicable, and determines that the data and safety monitoring plan provides adequate protection for participants. ",
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 "title": "Essential RequirementsWritten materials describe a requirement for researchers a description of provisions for monitoring data to ensure the safety\nof participants, when appropriate, to provide the IRB/EC.",
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 "type": "question/review-assessment",
 "key": "data-and-safety-monitoring--when-considered-by-the-irb-ec",
 "title": "Essential RequirementsWritten materials describe when the IRB/EC considers provisions for monitoring data to ensure the safety of participants to be appropriate.",
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 {
 "type": "question/review-assessment",
 "key": "data-and-safety-monitoring--irb-ec-considerations",
 "title": "Essential RequirementsWritten materials describe that, in order to approve research in which the IRB/EC considers provisions for monitoring data to ensure the safety of participants to be appropriate, the IRB/EC determines that the research plan makes adequate provisions. The IRB/EC might consider provisions such as:<ul><li>What safety information will be collected, including serious adverse events.</li><li>How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants). </li><li>The frequency of data collection, including when safety data collection starts.</li><li>The frequency or periodicity of review of cumulative safety data.</li><li>The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB/EC and the sponsor, including the frequency of reporting.</li><li>For studies that do not have or are not required to have a data monitoring committee and are blinded, have multiple sites, enter vulnerable populations, or employ high-risk interventions, the IRB/EC needs to carefully review the data and safety monitoring plan and determine whether a data monitoring committee is needed. </li><li>If not using a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring.</li><li>Provisions for the oversight of safety data (e.g., by a data monitoring committee).</li><li>Conditions that trigger an immediate suspension of the research, if applicable. </li></ul> GUIDANCEThe list above includes the types of issues that the IRB/EC should consider when reviewing monitoring plans. There is no requirement that the organization’s SOPs include all of the bullets above.<ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul><ul></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:In order to approve research in which the IRB/EC considers provisions for monitoring data to ensure the safety of participants to be appropriate, the IRB/EC determines that the research plan makes adequate provisions. The IRB/EC might consider provisions such as:<ul type=\"disc\"><li>What safety information will be collected, including serious adverse events.</li><li>How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants).</li><li>The frequency of data collection, including when safety data collection starts.</li><li>The frequency or periodicity of review of cumulative safety data.</li><li>The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB/EC and the sponsor, including the frequency of reporting.</li><li>For studies that do not have or are not required to have a data monitoring committee and are blinded, have multiple sites, enter vulnerable populations, or employ high-risk interventions, the IRB/EC needs to carefully review the data and safety monitoring plan and determine whether a data monitoring committee is needed.</li><li>If not using a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring.</li><li>Provisions for the oversight of safety data (e.g., by a data monitoring committee).</li><li>Conditions that trigger an immediate suspension of the research, if applicable. </li></ul>",
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 "type": "section/element",
 "key": "element-ii-3-c",
 "title": "ELEMENT II.3.C.",
 "description": "The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants.  ",
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 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "information-for-irb-ec-assessment-of-equitable-selection-of-participants",
 "title": "Essential RequirementsWritten materials, such as IRB/EC applications, collect information that allows the IRB/EC to determine whether selection of participants will be equitable, such as:<ul><li>The purposes of the research.</li><li>The setting in which the research will be conducted.</li><li>Whether prospective participants will be vulnerable to coercion or undue influence.</li><li>The selection (inclusion/exclusion) criteria.</li><li>Participant recruitment and enrollment procedures.</li><li>The amount and timing of payments to participants.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:Information that allows the IRB/EC to determine whether selection of participants will be equitable, such as:<ul type=\"disc\"><li>The purposes of the research.</li><li>The setting in which the research will be conducted.</li><li>Whether prospective participants will be vulnerable to coercion or undue influence.</li><li>The selection (inclusion/exclusion) criteria.</li><li>Participant recruitment and enrollment procedures.</li><li>The amount and timing of payments to participants.</li></ul>",
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 "type": "question/review-assessment",
 "key": "requirement-for-irb-ec-assessment-of-equitable-selection-of-participants",
 "title": "Essential Requirements<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Written materials require that, in order to approve research,\nthe IRB/EC determines that selection of participants is equitable.",
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 "type": "question/review-assessment",
 "key": "irb-ec-assessment-of-equitable-selection-of-participants",
 "title": "Essential RequirementsWritten materials describe that in making an assessment about whether selection of participants is equitable the IRB/EC take into account:<ul><li>The purposes of the research.</li><li>The setting in which the research will be conducted.</li><li>Whether prospective participants will be vulnerable to coercion or undue influence.</li><li>The selection (inclusion/exclusion) criteria.</li><li>Participant recruitment and enrollment procedures.</li><li>The influence of payments to participants.</li></ul>",
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 "type": "text/review-assessment-snippet",
 "key": "irb-ec-assessment-of-equitable-selection-of-participants",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">In making an assessment about whether selection of participants is equitable the IRB/EC take into account:<ul type=\"disc\"><li>The purposes of the research.</li><li>The setting in which the research will be conducted.</li><li>Whether prospective participants will be vulnerable to coercion or undue influence.</li><li>The selection (inclusion/exclusion) criteria.</li><li>Participant recruitment and enrollment procedures.</li><li>The influence of payments to participants.</li></ul>",
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 "type": "question/review-assessment",
 "key": "advertisements--irb-ec-considerations",
 "title": "Written materials describe that the IRB/EC reviews the following related to advertisements:<ul><li>The information contained in the advertisement.</li><li>The mode of its communication.</li><li>The final copy of printed advertisements.</li><li>The final audio or video taped advertisements.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC reviews the following related to advertisements:<ul><li>The information contained in the advertisement.</li><li>The mode of its communication.</li><li>The final copy of printed advertisements.</li><li>The final audio or video taped advertisements.</li></ul>",
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 "key": "advertisements--irb-ec-review-of-content",
 "title": "Essential RequirementsWritten materials describe that the IRB/EC reviews advertising to ensure that advertisements do not:<ul><li>State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.</li><li>Include exculpatory language.</li><li>Emphasize the payment or the amount to be paid, by such means as larger or bold type.</li><li>Promise “free treatment” when the intent is only to say participants will not be charged for taking part in the investigation.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC reviews advertising to ensure that advertisements do not:<ul><li>State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.</li><li>Include exculpatory language.</li><li>Emphasize the payment or the amount to be paid, by such means as larger or bold type.</li><li>Promise “free treatment” when the intent is only to say participants will not be charged for taking part in the investigation.</li></ul>",
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 "type": "question/review-assessment",
 "key": "advertisements--limitations",
 "title": "Essential RequirementsWritten materials describe that advertisements are limited to the information prospective participants need to determine their eligibility and interest, such as:<ul><li>The name and address of the researcher or research facility.</li><li>The purpose of the research or the condition under study.</li><li>In summary form, the criteria that will be used to determine eligibility for the study.</li><li>A brief list of benefits to participants, if any.</li><li>The time or other commitment required of the participants.</li><li>The location of the research and the person or office to contact for further information.</li></ul>",
 "description": "",
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 "title": "Add to the IRB/EC application or other written materials [page XX or elsewhere]:Advertisements are limited to the information prospective participants need to determine their eligibility and interest, such as:<ul><li>The name and address of the researcher or research facility.</li><li>The purpose of the research or the condition under study.</li><li>In summary form, the criteria that will be used to determine eligibility for the study.</li><li>A brief list of benefits to participants, if any.</li><li>The time or other commitment required of the participants.</li><li>The location of the research and the person or office to contact for further information.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "participant-payments--irb-ec-applications",
 "title": "Essential RequirementsIRB/EC applications include\nthe amount and schedule of all payments.",
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 {
 "type": "question/review-assessment",
 "key": "participant-payments--irb-ec-assessments",
 "title": "Essential RequirementsWritten materials describe that t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">he IRB/ECs review payments to determine that:<ul><li>The amount of payment and the proposed method and timing of disbursement neither is coercive nor presents undue influence.</li><li>Credit for payment accrues as the study progresses and not be contingent upon the participant completing the entire study.</li><li>Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.</li><li>All information concerning payment, including the amount and schedule of payments, is set forth in the consent document.</li></ul>",
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 {
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 "key": "participant-payments--irb-ec-assessments",
 "title": "Add to or describe in written materials [page xx or elsewhere]:T<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">he IRB/EC reviews payments to determine that:<ul type=\"disc\"><li>The amount of payment and the proposed method and timing of disbursement neither is coercive nor presents undue influence.</li><li>Credit for payment accrues as the study progresses and not be contingent upon the participant completing the entire study.</li><li>Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.</li><li>All information concerning payment, including the amount and schedule of payments, is set forth in the consent document.</li></ul>",
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 "type": "question/review-assessment",
 "key": "participant-payments--irb-ec-review-of-payment-arrangements",
 "title": "Essential RequirementsWritten materials describe acceptable and unacceptable payment arrangements for the sponsor, organization, researcher, and those referring research participants and address: <ul><li>The acceptability of payments in exchange for referrals of prospective participants (“finder’s fees” or “referral fees”).</li><li>Payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”).</li></ul>GUIDANCEFinder's fees and bonus payments are allowed provided the organization has policies and procedures that describe what are acceptable and unacceptable and the IRB/EC considers and adheres to these in practice.",
 "description": "",
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 "key": "participant-payments--irb-ec-review-of-payment-arrangements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:A<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">cceptable and unacceptable payment arrangements for the sponsor, organization, researcher, and those referring research participants and address:<ul type=\"disc\"><li>The acceptability of payments in exchange for referrals of prospective participants (“finder’s fees” or “referral fees”).</li><li>Payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”).</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dod--recruitment",
 "title": "When following DoD requirements written materials describe:<ul><li>DoD-affiliated personnel, military and civilian supervisors, officers, and others in the chain of command:<ul><li>Are prohibited from influencing their subordinates to participate in research involving human participants.</li><li>Must not be present at any human participant recruitment sessions or during the consent process for DoD-affiliated personnel.</li><li>May participate in separate human participant research recruitment sessions.</li></ul></li><li>For greater than minimal risk research involving DoD-personnel, when recruitment and consent occurs in a group setting, the IRB/EC must appoint an ombudsperson. The ombudsperson:<ul><li>Must not have a conflict of interest with the research or be a part of the research team.</li><li>Must be present during human participant recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.</li><li>Should be available to address DoD-affiliated personnel’s concerns about participation.</li></ul></li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements:<ul><li>DoD-affiliated personnel, military and civilian supervisors, officers, and others in the chain of command:<ul><li>Are prohibited from influencing their subordinates to participate in research involving human participants.</li><li>Must not be present at any human participant recruitment sessions or during the consent process for DoD-affiliated personnel.</li><li>May participate in separate human participant research recruitment sessions.</li></ul></li><li>For greater than minimal risk research involving DoD-personnel, when recruitment and consent occurs in a group setting, the IRB/EC must appoint an ombudsperson. The ombudsperson:<ul><li>Must not have a conflict of interest with the research or be a part of the research team.</li><li>Must be present during human participant recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.</li><li>Should be available to address DoD-affiliated personnel’s concerns about participation.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "dod--compensation",
 "title": "When following DoD regulations and <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">research involves U.S. military personnel, written materials describe <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">limitations on dual compensation:<ul><li>Prohibit an individual from receiving pay of compensation for research during duty hours.</li><li>U.S. military personnel may be compensated for research if the participant is involved in the research when not on duty.</li><li>Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood draw.</li><li>Non-federal persons may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB/EC according to local prevailing rates and the nature of the research.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul type=\"disc\"><li><ul type=\"disc\"></ul>When following DoD regulations and research involves U.S. military personnel, written materials describe limitations on dual compensation:<ul><li>Prohibit an individual from receiving pay of compensation for research during duty hours.</li><li>U.S. military personnel may be compensated for research if the participant is involved in the research when not on duty.</li><li>Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood draw.</li><li>Non-federal persons may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB/EC according to local prevailing rates and the nature of the research.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "doe--confidentiality",
 "title": "When following DOE requirements, written materials describe:<ul><li>Personally identifiable information collected and/or used during human participant research projects must be protected in accordance with the requirements of DOE Order 206.1, Department of Energy Privacy Program.</li><li>Any breach involving Personally Identifiable Information must be reported:<ul><li>Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable Information (PII) in printed or electronic form, the incident must be reported to the DOE-Cyber Incident Response Capability in accordance with the requirements of DOE O 206.1. </li><li>Within 48 hours the DOE or NNSA HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "us-fda--advertisements",
 "title": "When following FDA requirements, written materials describe that the IRB/EC reviews advertising to ensure that advertisements do not:<ul><li>Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.</li><li>Use terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that the test article is investigational.</li><li>Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA requirements, the IRB/EC reviews advertising to ensure that advertisements do not:<ul><li>Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.</li><li>Use terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that the test article is investigational.</li><li>Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.</li></ul>",
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 "type": "question/review-assessment",
 "key": "ich-gcp--equitable-selection-of-subjects",
 "title": "When following the ICH-GCP guideline, written materials describe:<ul><li>If the trial participants are compensated for their participation in the trial, the IRB/IEC should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence on the trial participants.</li><li>Payments to a participant should be timely, prorated and not wholly contingent on completion of the trial by the participant. </li><li>Reasonable reimbursement of expenses incurred by participants, such as for travel and lodging, is not coercive.</li><li>The IRB/IEC should ensure that information regarding payment to participants, including the methods, amounts and schedule of payment to trial participants, is set forth in the informed consent materials and any other information to be provided to participants.</li><li>The participant selection process should be representative of the population groups that the investigational product is intended to benefit, once authorized, to allow for generalizing the results across the broader population.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP guideline:<ul><li>If the trial participants are compensated for their participation in the trial, the IRB/IEC should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence on the trial participants.</li><li>Payments to a participant should be timely, prorated and not wholly contingent on completion of the trial by the participant.</li><li>Reasonable reimbursement of expenses incurred by participants, such as for travel and lodging, is not coercive.</li><li>The IRB/IEC should ensure that information regarding payment to participants, including the methods, amounts and schedule of payment to trial participants, is set forth in the informed consent materials and any other information to be provided to participants.</li><li>The participant selection process should be representative of the population groups that the investigational product is intended to benefit, once authorized, to allow for generalizing the results across the broader population.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va-facilities--recruitment",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Written materials describe that t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">he VA facility Director must ensure that a procedure is in place to review and approve recruiting media, including documents, flyers, and advertisements for research that is not VA research prior to being posted or distributed in any form within or on the premises of a VA facility. Posting or distributing may include announcing, distributing, publishing, or advertising the study either electronically, by hard copy, or other means to anyone, including Veterans, clinicians, or other staff.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The VA facility Director must ensure that a procedure is in place to review and approve recruiting media, including documents, flyers, and advertisements for research that is not VA research prior to being posted or distributed in any form within or on the premises of a VA facility. Posting or distributing may include announcing, distributing, publishing, or advertising the study either electronically, by hard copy, or other means to anyone, including Veterans, clinicians, or other staff.",
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 "type": "question/review-assessment",
 "key": "va--enrollment-of-non-veterans",
 "title": "Written materials describe that IRBs/ECs (even an internal VA IRB) do not have the authority to approve non-Veteran enrollment into VA studies. This must instead be done by the R&D Committee. ",
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 {
 "type": "section/element",
 "key": "element-ii-3-d",
 "title": "ELEMENT II.3.D.",
 "description": "The IRB or EC has and follows written policies and procedures to evaluate the proposed arrangements for protecting the privacy interests of research participants, when appropriate, during their involvement in the research.",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
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 "title": "Essential RequirementsWritten materials describe that the IRB/EC determines:<ul><li>The required disclosures will be provided to each participant or a legally authorized representative in accordance with legal and regulatory requirements. Required disclosures include:</li><li>A statement that the study involves research.</li><li>An explanation of the purposes of the research.</li><li>An explanation of the expected duration of the participant’s participation.</li><li>A description of the procedures to be followed.</li><li>Identification of any procedures that are experimental. (May be omitted if there are none.)</li><li>A description of any reasonably foreseeable risks or discomforts to the participant. (May be omitted if there are none.)</li><li>A description of any benefits to the participant or to others, which may reasonably be expected from the research. (May be omitted if there are none.)</li><li>A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant. (May be omitted if there are none.)</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>An explanation as to whether compensation is available if injury occurs. (May be omitted if the research involves no more than minimal risk.)</li><li>If compensation is available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.)</li><li>An explanation as to whether any medical treatments are available if injury occurs. (May be omitted if the research involves no more than minimal risk.)</li><li>If medical treatments are available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.)</li><li>An explanation of whom to contact for answers to pertinent questions about the research.</li><li>An explanation of whom to contact for answers to pertinent questions about the research participants’ rights.</li><li>An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more than minimal risk.)</li><li>Contact information for the research team for questions, concerns, or complaints.</li><li>Contact information for someone independent of the research team for problems, concerns, questions, information, or input.</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>If research involves the collection of identifiable information or identifiable biospecimens, an explanation of potential future use. (May be omitted if the research does not involve collection of identifiable information or identifiable biospecimens):<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or</li><li>A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>Whether additional disclosures are required for inclusion in the consent process.<ul><li>A statement that the particular treatment or procedure may involve risks to the participant, which are currently unforeseeable.</li><li>A statement that if the participant is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable.</li><li>Anticipated circumstances under which the participant’s participation may be terminated by the researcher without regard to the participant’s consent.</li><li>Any additional costs to the participant that may result from participation in the research.</li><li>A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.</li><li>The approximate number of participants involved in the study.</li><li>A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>The amount and schedule of all payments.</li><li>The consequences of a participant’s decision to withdraw from the research.</li><li>Procedures for orderly termination of participation by the participant.</li><li>A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to the participant, and if so, under what conditions.</li><li>For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.</li></ul></li><li>The consent process will be documented according to legal and regulatory requirements.</li></ul>",
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 "key": "informed-consent--disclosures",
 "title": "Add to or describe in written materials [page xx or elsewhere]:The IRB/EC determines:<ul><li>The required disclosures will be provided to each participant or a legally authorized representative in accordance with legal and regulatory requirements. Required disclosures include:</li><li>A statement that the study involves research.</li><li>An explanation of the purposes of the research.</li><li>An explanation of the expected duration of the participant’s participation.</li><li>A description of the procedures to be followed.</li><li>Identification of any procedures that are experimental. (May be omitted if there are none.)</li><li>A description of any reasonably foreseeable risks or discomforts to the participant. (May be omitted if there are none.)</li><li>A description of any benefits to the participant or to others, which may reasonably be expected from the research. (May be omitted if there are none.)</li><li>A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant. (May be omitted if there are none.)</li><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>An explanation as to whether compensation is available if injury occurs. (May be omitted if the research involves no more than minimal risk.)</li><li>If compensation is available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.)</li><li>An explanation as to whether any medical treatments are available if injury occurs. (May be omitted if the research involves no more than minimal risk.)</li><li>If medical treatments are available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.)</li><li>An explanation of whom to contact for answers to pertinent questions about the research.</li><li>An explanation of whom to contact for answers to pertinent questions about the research participants’ rights.</li><li>An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more than minimal risk.)</li><li>Contact information for the research team for questions, concerns, or complaints.</li><li>Contact information for someone independent of the research team for problems, concerns, questions, information, or input.</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>If research involves the collection of identifiable information or identifiable biospecimens, an explanation of potential future use. (May be omitted if the research does not involve collection of identifiable information or identifiable biospecimens):<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or</li><li>A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>Whether additional disclosures are required for inclusion in the consent process.<ul><li>A statement that the particular treatment or procedure may involve risks to the participant, which are currently unforeseeable.</li><li>A statement that if the participant is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable.</li><li>Anticipated circumstances under which the participant’s participation may be terminated by the researcher without regard to the participant’s consent.</li><li>Any additional costs to the participant that may result from participation in the research.</li><li>A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.</li><li>The approximate number of participants involved in the study.</li><li>A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>The amount and schedule of all payments.</li><li>The consequences of a participant’s decision to withdraw from the research.</li><li>Procedures for orderly termination of participation by the participant.</li><li>A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to the participant, and if so, under what conditions.</li><li>For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.</li></ul></li><li>The consent process will be documented according to legal and regulatory requirements.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--informed-consent-content",
 "title": "When following DHHS requirements written materials describe: <ul><li>The IRB/EC determines that the required and appropriate additional elements of disclosure are included in the consent process. </li><li>The consent document begins with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.</li><li>Written materials define for researchers what the organization considers “key information”.</li><li>Written materials specify what the organization considers a “concise” presentation of key information.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">The consent process and documentation as a whole presents information in sufficient detail, and facilitates the prospective participant’s or legally authorized representative’s understanding.</li></ul><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">GUIDANCEDo not apply bullet points 2-5 to policies that apply to research being reviewed under the prior (old) Common Rule, just check for policies that apply to new research.",
 "description": "",
 "keywords": "dhhs-independent-irb,dhhs-internal-irb",
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 "key": "dhhs--informed-consent-content",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements:<ul><li>The IRB/EC determines that the required and appropriate additional elements of disclosure are included in the consent process.</li><li>The consent document begins with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.</li><li>Written materials define for researchers what the organization considers “key information”.</li><li>Written materials specify what the organization considers a “concise” presentation of key information.</li><li>The consent process and documentation as a whole presents information in sufficient detail, and facilitates the prospective participant’s or legally authorized representative’s understanding.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--long-form-consent-documentation",
 "title": "When following DHHS requirements, written materials describe: To allow use of the long form of consent documentation, the IRB/EC determines:<ul><li>The consent document embodies the basic and required additional elements of disclosure, including required disclosures when the research involves private identifiable information or identifiable biospecimens.</li><li>The participant or the participant’s legally authorized representative will sign the consent document.</li><li>A copy of the consent document will be given to the person signing the consent document.</li><li>The researcher will give either the participant or the representative adequate opportunity to read the consent document before it is signed.</li></ul>",
 "description": "",
 "keywords": "dhhs-independent-irb,dhhs-internal-irb",
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 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--long-form-consent-documentation",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements, to allow use of the long form of consent documentation, the IRB/EC determines:<ul><li>The consent document embodies the basic and required additional elements of disclosure, including required disclosures when the research involves private identifiable information or identifiable biospecimens.</li><li>The participant or the participant’s legally authorized representative will sign the consent document.</li><li>A copy of the consent document will be given to the person signing the consent document.</li><li>The researcher will give either the participant or the representative adequate opportunity to read the consent document before it is signed.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--short-form",
 "title": "When following DHHS regulations, written materials describe:  To allow the use of the short form of consent documentation, the IRB/EC determines:<ul><li>The short form consent document states that the basic and appropriate additional elements of disclosure have been presented orally to the participant or the participant’s legally authorized representative, including required disclosures when the research involves private identifiable information or identifiable biospecimens.</li><li>A written summary embodies the basic and required additional elements of disclosure.</li><li>There will be a witness to the oral presentation.</li><li>For participants who do not speak English, the witness is conversant in both English and the language of the participant.</li><li>The participant or the participant’s legally authorized representative will sign the short form consent document.</li><li>The witness will sign both the short form consent document and a copy of the summary.</li><li>The person actually obtaining consent will sign a copy of the summary.</li><li>A copy of the signed short form consent document will be given to the participant or the legally authorized representative.</li><li>A copy of the signed summary will be given to the participant or the legally authorized representative.</li></ul>",
 "description": "",
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 "key": "dhhs--short-form",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations, to allow the use of the short form of consent documentation, the IRB/EC determines:<ul><li>The short form consent document states that the basic and appropriate additional elements of disclosure have been presented orally to the participant or the participant’s legally authorized representative, including required disclosures when the research involves private identifiable information or identifiable biospecimens.</li><li>A written summary embodies the basic and required additional elements of disclosure.</li><li>There will be a witness to the oral presentation.</li><li>For participants who do not speak English, the witness is conversant in both English and the language of the participant.</li><li>The participant or the participant’s legally authorized representative will sign the short form consent document.</li><li>The witness will sign both the short form consent document and a copy of the summary.</li><li>The person actually obtaining consent will sign a copy of the summary.</li><li>A copy of the signed short form consent document will be given to the participant or the legally authorized representative.</li><li>A copy of the signed summary will be given to the participant or the legally authorized representative.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--broad-consent",
 "title": "When following DHHS regulations, written materials describe:  To allow the use of the broad consent, the IRB/EC determines:<ul><li>The study is limited to the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens (collected for either research studies other than the proposed research, or non-research purposes).</li><li>The study has undergone limited IRB review and meets requirements for exempt Category 7 or Category 8.</li><li>Researchers must provide all required disclosures for broad consent to each participant or participant’s legally authorized representative:<ul><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>Information about future use of private identifiable information or identifiable biospecimens:<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or</li><li>A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens, such that a reasonable person would expect the broad consent would permit the types of research conducted.</li><li>A description of the identifiable private information or identifiable biospecimens that might be used in the research.</li><li>Whether sharing of identifiable private information or identifiable biospecimens might occur.</li><li>Unless the participant or legally authorized representative will be provided details about the specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might not have chosen to consent to some of those specific research studies.</li><li>Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results might not be disclosed to the participant.</li><li>For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.</li><li>An explanation of whom to contact for answers to pertinent questions about the research participant’s rights.</li><li>An explanation of whom to contact for answers to questions about storage and use of the participant’s identifiable information or biospecimens.</li><li>An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more than minimal risk.)</li><li>Contact information for the research team for questions, concerns, or complaints.</li><li>Contact information for someone independent of the research team for problems, concerns, questions, information, or input.</li></ul></li><li>If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.</li></ul>",
 "description": "",
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 {
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 "key": "dhhs--broad-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations, to allow the use of the broad consent, the IRB/EC determines:<ul><li>The study is limited to the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens (collected for either research studies other than the proposed research, or non-research purposes).</li><li>The study has undergone limited IRB review and meets requirements for exempt Category 7 or Category 8.</li><li>Researchers must provide all required disclosures for broad consent to each participant or participant’s legally authorized representative:<ul><li>A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)</li><li>A statement that participation is voluntary.</li><li>A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.</li><li>Information about future use of private identifiable information or identifiable biospecimens:<ul><li>A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or</li><li>A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.</li></ul></li><li>A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens, such that a reasonable person would expect the broad consent would permit the types of research conducted.</li><li>A description of the identifiable private information or identifiable biospecimens that might be used in the research.</li><li>Whether sharing of identifiable private information or identifiable biospecimens might occur.</li><li>Unless the participant or legally authorized representative will be provided details about the specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might not have chosen to consent to some of those specific research studies.</li><li>Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results might not be disclosed to the participant.</li><li>For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.</li><li>An explanation of whom to contact for answers to pertinent questions about the research participant’s rights.</li><li>An explanation of whom to contact for answers to questions about storage and use of the participant’s identifiable information or biospecimens.</li><li>An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more than minimal risk.)</li><li>Contact information for the research team for questions, concerns, or complaints.</li><li>Contact information for someone independent of the research team for problems, concerns, questions, information, or input.</li></ul></li><li>If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--posting-consent-documents",
 "title": "When following DHHS requirements, written materials describe the process for posting one IRB-approved consent form for each clinical trial conducted or supported by a federal department or agency on a website specified by the US federal government.<ul><li>Written materials specify the person or role responsible for posting the consent form.</li><li>The consent form must be posted on the website after the clinical trial is closed to recruitment, but no later than 60 days after the last study visit by any participant, as required by the protocol.</li><li>Written materials must describe the process to request from the federal funding agency an exception to the requirement to post the consent document, and the process to redact confidential commercial information from the consent form.</li></ul>",
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 "key": "dhhs--posting-consent-documents",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements, describe the process for posting one IRB-approved consent form for each clinical trial conducted or supported by a federal department or agency on a website specified by the US federal government.<ul><li>Written materials specify the person or role responsible for posting the consent form.</li><li>The consent form must be posted on the website after the clinical trial is closed to recruitment, but no later than 60 days after the last study visit by any participant, as required by the protocol.</li><li>Written materials must describe the process to request from the federal funding agency an exception to the requirement to post the consent document, and the process to redact confidential commercial information from the consent form.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "us-fda--long-form-consent-documentation",
 "title": "When following the FDA requirements, written materials describe: To allow use of the long form of consent documentation, the IRB/EC determines:<ul><li>The required and appropriate additional elements of disclosure are included in the consent process. </li><li>The consent document embodies the basic and required additional elements of disclosure. <ul><li>Additional disclosures for FDA-regulated research include: </li><li>There is a statement noting the possibility that the FDA may inspect the records that will be provided to each participant.</li><li>There is a statement that the results of the research will be posted on clinicaltrials.gov.<ul><li>“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”</li></ul></li></ul></li><li>The participant or the participant’s legally authorized representative will sign and date the consent document.</li><li>The researcher will give either the participant or the legally authorized representative adequate opportunity to read the consent document before it is signed.</li></ul>",
 "description": "",
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 "key": "us-fda--long-form-consent-documentation",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the FDA requirements, to allow use of the long form of consent documentation, the IRB/EC determines:<ul><li>The required and appropriate additional elements of disclosure are included in the consent process.</li><li>The consent document embodies the basic and required additional elements of disclosure.<ul><li>Additional disclosures for FDA-regulated research include:</li><li>There is a statement noting the possibility that the FDA may inspect the records that will be provided to each participant.</li><li>There is a statement that the results of the research will be posted on clinicaltrials.gov.<ul><li>“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”</li></ul></li></ul></li><li>The participant or the participant’s legally authorized representative will sign and date the consent document.</li><li>The researcher will give either the participant or the legally authorized representative adequate opportunity to read the consent document before it is signed.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "us-fda--short-form",
 "title": "When following US FDA regulations, written materials describe: To allow the use of the short form of consent documentation, the IRB/EC determines:<ul><li>The short form consent document states that the elements of basic and additional elements of disclosure required by regulations have been presented orally to the participant or the participant’s legally authorized representative.</li><li>A written summary embodies the basic and required additional elements of disclosure.</li><li>There will be a witness to the oral presentation.</li><li>For participants who do not speak English, the witness is conversant in both English and the language of the participant.</li><li>The participant or the participant’s legally authorized representative will sign the consent document.</li><li>The witness will sign both the short form and a copy of the summary.</li><li>The person actually obtaining consent will sign a copy of the summary.</li><li>A copy of the signed short form will be given to the participant or the legally authorized representative.</li><li>A copy of the signed summary will be given to the participant or the legally authorized representative.</li></ul>",
 "description": "",
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 "key": "us-fda--short-form",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following US FDA regulations, to allow the use of the short form of consent documentation, the IRB/EC determines:<ul><li>The short form consent document states that the elements of basic and additional elements of disclosure required by regulations have been presented orally to the participant or the participant’s legally authorized representative.</li><li>A written summary embodies the basic and required additional elements of disclosure.</li><li>There will be a witness to the oral presentation.</li><li>For participants who do not speak English, the witness is conversant in both English and the language of the participant.</li><li>The participant or the participant’s legally authorized representative will sign the consent document.</li><li>The witness will sign both the short form and a copy of the summary.</li><li>The person actually obtaining consent will sign a copy of the summary.</li><li>A copy of the signed short form will be given to the participant or the legally authorized representative.</li><li>A copy of the signed summary will be given to the participant or the legally authorized representative.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "us-fda--participant-withdrawal",
 "title": "When following US FDA regulations, written materials describe: When participants withdraw from a clinical trial, the IRB/EC determines: <ul><li>When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.</li><li>A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information. </li><li>The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB/EC must approve the consent document.</li><li>If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.</li></ul>",
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 "key": "us-fda--participant-withdrawal",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA regulations, when participants withdraw from a clinical trial, the IRB/EC determines:<ul><li>When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.</li><li>A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information.</li><li>The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB/EC must approve the consent document.</li><li>If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dod--informed-consent-requirements",
 "title": "When following DoD requirements, written materials describe: <ul><li>If the research involves DoD-affiliated personnel as participants, in addition to the basic and required consent disclosures, consent documents must include: <ul><li>If the research involves risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document (ICD) must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.</li><li>If applicable, a statement of potential risks for the revocation of clearance, credentials, or other privileged access or duty.</li><li>A statement that the DoD or a DoD organization is funding the study.</li><li>A statement that representatives of the DoD are authorized to review research records.</li></ul></li><li>The IRB/EC must determine that the disclosure includes that provisions for research-related injury follow the requirements of the DoD component.</li><li>For greater than minimal risk research, consent documents must include the disclosure that participants may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond participants’ participation in the study to such time after the study has ended. <ul><li>Written materials must document how organizations will care for participants with research-related injuries, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution. </li></ul></li><li>For greater than minimal risk research involving DoD-personnel, when recruitment and consent occur in a group setting, the IRB/EC must appoint an ombudsperson. The ombudsperson:<ul><li>Must not have a conflict of interest with the research or be a part of the research team.</li><li>Must be present during the HSR recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.</li><li>Should be available to address DoD-affiliated personnel’s concerns about participation.</li></ul></li><li>If the research involves a human being as an experimental subject and is supported by DoD-appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980.<ul><li>If the participant is unable to provide informed consent and consent will be obtained in advance from the participant’s legal representative, the research must be intended to benefit the individual participants.</li></ul></li></ul>",
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 "key": "dod--informed-consent-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements: <ul><li>If the research involves DoD-affiliated personnel as participants, in addition to the basic and required consent disclosures, consent documents must include:<ul><li>If the research involves risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document (ICD) must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.</li><li>If applicable, a statement of potential risks for the revocation of clearance, credentials, or other privileged access or duty.</li><li>A statement that the DoD or a DoD organization is funding the study.</li><li>A statement that representatives of the DoD are authorized to review research records.</li></ul></li><li>The IRB/EC must determine that the disclosure includes that provisions for research-related injury follow the requirements of the DoD component.</li><li>For greater than minimal risk research, consent documents must include the disclosure that participants may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond participants’ participation in the study to such time after the study has ended.<ul><li>Written materials must document how organizations will care for participants with research-related injuries, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution.</li></ul></li><li>For greater than minimal risk research involving DoD-personnel, when recruitment and consent occur in a group setting, the IRB/EC must appoint an ombudsperson. The ombudsperson:<ul><li>Must not have a conflict of interest with the research or be a part of the research team.</li><li>Must be present during the HSR recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.</li><li>Should be available to address DoD-affiliated personnel’s concerns about participation.</li></ul></li><li>If the research involves a human being as an experimental subject and is supported by DoD-appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980.<ul><li>If the participant is unable to provide informed consent and consent will be obtained in advance from the participant’s legal representative, the research must be intended to benefit the individual participants.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "doe--informed-consent-requirements",
 "title": "When following DOE requirements, written materials describe: <ul><li>In addition to the basic and required consent disclosures, when research is classified, consent documents must disclose:<ul><li>The identity of the sponsoring agency, unless the sponsor requests it not be done. The only acceptable reason for non-disclosure is that disclosure could compromise intelligence sources or methods. Additionally, the research must be no more than minimal risk to participants; and the IRB/EC must determine that not disclosing the identity will not adversely affect the participants.</li><li>That the project is classified, what it means for the purposes of the research project, and what part of the research that applies to.</li><li>The IRB/EC must determine if participants need access to classified information to make a valid consent decision.</li></ul></li><li>Consent documents must include additional DOE elements of disclosure. (See Table II.3.F.1.)</li></ul>",
 "description": "",
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 "key": "doe--informed-consent-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DOE requirements:<ul><li>In addition to the basic and required consent disclosures, when research is classified, consent documents must disclose:<ul><li>The identity of the sponsoring agency, unless the sponsor requests it not be done. The only acceptable reason for non-disclosure is that disclosure could compromise intelligence sources or methods. Additionally, the research must be no more than minimal risk to participants; and the IRB/EC must determine that not disclosing the identity will not adversely affect the participants.</li><li>That the project is classified, what it means for the purposes of the research project, and what part of the research that applies to.</li><li>The IRB/EC must determine if participants need access to classified information to make a valid consent decision.</li></ul></li><li>Consent documents must include additional DOE elements of disclosure. (See Table II.3.F.1.)</li></ul>",
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 "type": "question/review-assessment",
 "key": "doj--informed-consent-requirements",
 "title": "When following DoJ requirements, written materials describe: <ul><li>For National Institute of Justice (NIJ)-funded research the consent document must disclose: <ul><li>The name(s) of the funding agency(ies).</li></ul><ul></ul></li></ul>",
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 "key": "doj--informed-consent-requirements",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoJ requirements:<ul><li>For National Institute of Justice (NIJ)-funded research the consent document must disclose:<ul><li>The name(s) of the funding agency(ies).</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "doj--bureau-of-prisons-informed-consent-disclosure",
 "title": "When following DoJ requirements for research conducted within the Bureau of Prisons, written materials describe that <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">required elements of disclosure include:<ul><li>The identity of the researchers.</li><li>Anticipated uses of the results of the research.</li><li>The extent to which confidentiality of records identifying the participant will be maintained. For studies sponsored by NIJ, the participant should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the participants need to be explicitly notified. If the researcher intends to disclose any information, the participant needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The participant must be informed of any risks that might result from this disclosure and must explicitly provide written consent prior to participating in the research.</li><li>A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable).</li><li>A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the participant indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the participant is an inmate, indicates intent to leave the facility without authorization.</li><li>A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility.</li></ul>",
 "description": "",
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 "key": "doj--bureau-of-prisons-informed-consent-disclosure",
 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>For research conducted within the Bureau of Prisons required elements of disclosure include:<ul><li>The identity of the researchers.</li><li>Anticipated uses of the results of the research.</li><li>The extent to which confidentiality of records identifying the participant will be maintained. For studies sponsored by NIJ, the participant should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the participants need to be explicitly notified. If the researcher intends to disclose any information, the participant needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The participant must be informed of any risks that might result from this disclosure and must explicitly provide written consent prior to participating in the research.</li><li>A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable).</li><li>A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the participant indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the participant is an inmate, indicates intent to leave the facility without authorization.</li><li>A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility.</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "ich-gcp--informed-consent",
 "title": "When following the ICH-GCP (E6) guideline, written describe: <ul><li>The IRB/EC determines that the following consent disclosures are included:<ul><li>The approval or favorable opinion by the IRB.</li><li>The probability for random assignment to each treatment.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">What is expected of participants.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">When applicable, the reasonably foreseeable risks or inconveniences to the participant, the participant's partner (when applicable), an embryo, fetus, or nursing infant.</li><li>The important potential benefits and risks of the alternative procedures or courses of treatment that may be available to the participant.</li><li>When there is no intended clinical benefit to the participant, the participant should be made aware of this.</li><li>Any unanticipated prorated compensation to the participant for trial participation.</li><li>That by agreeing to participate in the trial, the participant or their legally acceptable representative allows direct access to source records, based on the understanding that the confidentiality of the participant’s medical record will be safeguarded. This access is limited for the purpose of reviewing trial activities and/or reviewing or verifying data and records by the regulatory authority(ies) and the sponsor’s representatives, for example, monitor(s) or auditor(s), and in accordance with applicable regulatory requirements, the IRB(s).</li><li>That records identifying the participant will be kept confidential and, to the extent permitted by the applicable regulatory requirements, will not be made publicly available.</li><li>A statement that if the results of the trial are published, the participant’s identity will remain confidential.</li></ul></li></ul><ul><li>Documentation of the consent process includes:<ul><li>The informed consent process should take into consideration relevant aspects of the trial, such as the characteristics of the participants, the trial design, the anticipated benefits and risks of medical intervention(s), the setting and context in which the trial will be conducted (e.g., trials in emergency situations), and the potential use of technology to inform participants (or their legally acceptable representatives) and obtain informed consent.</li><li>The information should be as clear and concise as possible, use simple language and avoid unnecessary volume and complexity.</li><li>For potential participants unable to provide informed consent, their legally acceptable representatives, acting in the participants’ best interest, should provide consent prior to clinical trial participation. These potential participants should be informed about the trial in a manner that facilitates their understanding and, if capable, the participant should sign and date the informed consent form or assent form as appropriate.</li><li>The process and information provided should be designed to achieve the primary objective of enabling potential trial participants to evaluate the benefits, risks and burden of participating in the trial and to make an informed decision on whether or not to participate in the trial. The information provided during the informed consent process should be clear and concise so as to be understandable by potential participants or legally acceptable representatives.</li><li>When computerized systems are used to obtain informed consent, trial participants may be given the option to use a paper-based approach as an alternative.</li><li>Whether the informed consent process takes place in person or remotely, the investigator should assure themselves of the identity of the participant (or legally acceptable representative) in accordance with applicable regulatory requirements.</li><li>Prior to a participant’s participation in the trial, the written consent document should be signed and personally dated by the participant or by the participant's legally acceptable representative.</li><li>Prior to a participant’s participation in the trial, the written consent document should be signed and personally dated by the investigator or delegated site investigator who conducted the informed consent discussion.</li><li>If a participant is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) during the entire informed consent discussion.<ul><li>After the written consent document and any other written information to be provided to participants is read and explained to the participant or the participant’s legally acceptable representative, and after the participant or the participant’s legally acceptable representative has orally consented to the participant’s participation in the trial and, if capable of doing so, has signed and personally dated the consent document, the witness should sign and personally date the consent document.</li><li>By signing the consent document, the witness attests that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant or the participant's legally acceptable representative, and that consent was freely given by the participant or the participant’s legally acceptable representative.</li></ul></li><li>Prior to participation in the trial, the participant or the participant's legally acceptable representative should receive a copy (paper or electronic) of the signed and dated written consent document and any other written information provided to the participants.</li></ul></li></ul>",
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 "key": "ich-gcp--informed-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline:<ul><li>The IRB/EC determines that the following consent disclosures are included:<ul><li>The approval or favorable opinion by the IRB.</li><li>The probability for random assignment to each treatment.</li><li>What is expected of participants.</li><li>When applicable, the reasonably foreseeable risks or inconveniences to the participant, the participant's partner (when applicable), an embryo, fetus, or nursing infant.</li><li>The important potential benefits and risks of the alternative procedures or courses of treatment that may be available to the participant.</li><li>When there is no intended clinical benefit to the participant, the participant should be made aware of this.</li><li>Any unanticipated prorated compensation to the participant for trial participation.</li><li>That by agreeing to participate in the trial, the participant or their legally acceptable representative allows direct access to source records, based on the understanding that the confidentiality of the participant’s medical record will be safeguarded. This access is limited for the purpose of reviewing trial activities and/or reviewing or verifying data and records by the regulatory authority(ies) and the sponsor’s representatives, for example, monitor(s) or auditor(s), and in accordance with applicable regulatory requirements, the IRB(s).</li><li>That records identifying the participant will be kept confidential and, to the extent permitted by the applicable regulatory requirements, will not be made publicly available.</li><li>A statement that if the results of the trial are published, the participant’s identity will remain confidential.</li></ul></li></ul><ul><li>Documentation of the consent process includes:<ul><li>The informed consent process should take into consideration relevant aspects of the trial, such as the characteristics of the participants, the trial design, the anticipated benefits and risks of medical intervention(s), the setting and context in which the trial will be conducted (e.g., trials in emergency situations), and the potential use of technology to inform participants (or their legally acceptable representatives) and obtain informed consent.</li><li>The information should be as clear and concise as possible, use simple language and avoid unnecessary volume and complexity.</li><li>For potential participants unable to provide informed consent, their legally acceptable representatives, acting in the participants’ best interest, should provide consent prior to clinical trial participation. These potential participants should be informed about the trial in a manner that facilitates their understanding and, if capable, the participant should sign and date the informed consent form or assent form as appropriate.</li><li>The process and information provided should be designed to achieve the primary objective of enabling potential trial participants to evaluate the benefits, risks and burden of participating in the trial and to make an informed decision on whether or not to participate in the trial. The information provided during the informed consent process should be clear and concise so as to be understandable by potential participants or legally acceptable representatives.</li><li>When computerized systems are used to obtain informed consent, trial participants may be given the option to use a paper-based approach as an alternative.</li><li>Whether the informed consent process takes place in person or remotely, the investigator should assure themselves of the identity of the participant (or legally acceptable representative) in accordance with applicable regulatory requirements.</li><li>Prior to a participant’s participation in the trial, the written consent document should be signed and personally dated by the participant or by the participant's legally acceptable representative.</li><li>Prior to a participant’s participation in the trial, the written consent document should be signed and personally dated by the investigator or delegated site investigator who conducted the informed consent discussion.</li><li>If a participant is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) during the entire informed consent discussion.<ul><li>After the written consent document and any other written information to be provided to participants is read and explained to the participant or the participant’s legally acceptable representative, and after the participant or the participant’s legally acceptable representative has orally consented to the participant’s participation in the trial and, if capable of doing so, has signed and personally dated the consent document, the witness should sign and personally date the consent document.</li><li>By signing the consent document, the witness attests that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant or the participant's legally acceptable representative, and that consent was freely given by the participant or the participant’s legally acceptable representative.</li></ul></li><li>Prior to participation in the trial, the participant or the participant's legally acceptable representative should receive a copy (paper or electronic) of the signed and dated written consent document and any other written information provided to the participants.</li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "va--informed-consent",
 "title": "When following VA requirements, written materials describe:<ul><li>The consent document must be signed and dated by the participant or legally authorized representative. The IRB/EC may waive the requirement for the signature of the person obtaining consent when there is no physical contact with the participant (e.g., where the only contact with the participant is through telephone or mail). A physical or electronic copy must be given or made available to the person signing the form. </li><li>The informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes; how the photographs, video, and/or audio recordings will be used for the research; and whether the photographs, video, and/or audio recordings will be disclosed outside VA.<ul><li>An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.</li><li>The consent for research does not give legal authority to disclose the photographs, video, and/or audio recordings outside VA.</li></ul></li><li>Consent documents must include additional VA elements of disclosure. (See Table II.3.F.)</li></ul>",
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 "key": "va--informed-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements:<ul><li>The consent document must be signed and dated by the participant or legally authorized representative. The IRB/EC may waive the requirement for the signature of the person obtaining consent when there is no physical contact with the participant (e.g., where the only contact with the participant is through telephone or mail). A physical or electronic copy must be given or made available to the person signing the form. </li><li>The informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes; how the photographs, video, and/or audio recordings will be used for the research; and whether the photographs, video, and/or audio recordings will be disclosed outside VA.<ul><li>An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.</li><li>The consent for research does not give legal authority to disclose the photographs, video, and/or audio recordings outside VA.</li></ul></li><li>Consent documents must include additional VA elements of disclosure. (See Table II.3.F.)</li></ul>",
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 "type": "section/element",
 "key": "element-ii-3-g",
 "title": "ELEMENT II.3.G.",
 "description": "The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation. ",
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 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "informed-consent--waivers-and-alterations",
 "title": "Essential RequirementsWritten materials describe that the IRB/EC is allowed\nto waive or alter the consent process by determining that the criteria for\nwaivers or alterations are met.Confirm that waiver criteria comply with the regulations the organization follows:<ul><li>When following DHHS requirements, waivers or alterations follow DHHS regulations.</li><li>When following FDA requirements, waivers or alterations follow FDA regulations.</li><li>When following both DHHS and FDA requirements, waivers or alterations are consistent with both regulations.</li><li>For organizations in other countries, waivers or alterations comply with country law (and any additional US regulatory requirements, if the organization conducts research funded or supported by the US government); see the country-specific Addendum.</li></ul>If you have questions, contact AAHRPP staff.",
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 "type": "question/review-assessment",
 "key": "informed-consent--waivers-alterations-for-unregulated-research",
 "title": "Essential RequirementsWhen research is not covered by any laws or regulations addressing consent requirements, written materials describe:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that equivalent protections to those in regulations are present.</li><li>When the IRB/EC considers waiving or altering the consent process, the IRB/EC must review a written description of the information that will be provided to participants, when appropriate.</li><li>The process for the IRB/EC to waive the requirement to document the consent process by determining that equivalent protections to those in regulations are present.</li><li>When the IRB/EC considers waiving the requirement to obtain written documentation of the consent process, the IRB/EC review a written description of the information that will be provided to participants.</li><li>The IRB/EC documents its findings justifying the waiver or alteration.</li></ul>GUIDANCEWhen research is not covered by any laws or regulations addressing consent requirements, organizations may develop equivalent protections to waive or alter the consent process, or to waive documentation of consent.",
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 "key": "informed-consent--waivers-alterations-for-unregulated-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When research is not covered by any laws or regulations addressing consent requirements:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that equivalent protections to those in regulations are present.</li><li>When the IRB/EC considers waiving or altering the consent process, the IRB/EC must review a written description of the information that will be provided to participants, when appropriate.</li><li>The process for the IRB/EC to waive the requirement to document the consent process by determining that equivalent protections to those in regulations are present.</li><li>When the IRB/EC considers waiving the requirement to obtain written documentation of the consent process, the IRB/EC review a written description of the information that will be provided to participants.</li><li>The IRB/EC documents its findings justifying the waiver or alteration.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--irb-assessment-of-waivers-alterations",
 "title": "When following DHHS requirements, written materials describe:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of the consent process are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the consent process by determining that the regulatory criteria for waivers are met.</li><li>If a broad consent procedure is used:<ul><li>An IRB/EC may not omit or alter any of the required elements of disclosure, and when appropriate, any of the additional elements of disclosure.</li><li>If a study requests broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, and refused to consent, an IRB/EC cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.</li></ul><ul></ul></li><li>The IRB/EC documents ifs findings justifying the waiver or alteration.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of the consent process are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the consent process by determining that the regulatory criteria for waivers are met.</li><li>If a broad consent procedure is used:<ul><li>An IRB/EC may not omit or alter any of the required elements of disclosure, and when appropriate, any of the additional elements of disclosure.</li><li>If a study requests broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, and refused to consent, an IRB/EC cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.</li></ul></li><li>The IRB/EC documents ifs findings justifying the waiver or alteration.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--criteria-for-informed-consent-waiver-alteration",
 "title": "When following DHHS requirements, written materials describe requirements to waive or alter the consent process:Waiver of Consent Process – Public Demonstration Project<ul><li>The research is conducted by or subject to the approval of state or local government officials.</li><li>The research or demonstration protocol is designed to study, evaluate, or otherwise examine:<ul><li>Public benefit or service programs.</li><li>Procedures for obtaining benefits or services under those programs.</li><li>Possible changes in or alternatives to those programs or procedures.</li><li>Possible changes in methods or levels of payment for benefits or services under those programs.</li></ul></li><li>The research cannot practicably be carried out without the waiver or alteration.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver or Alteration of Consent Process: Obtaining Consent not Practicable<ul><li>The research involves no more than minimal risk to the participants.</li><li>The research cannot practicably be carried out without the requested waiver or alteration.</li><li>If the research involves using identifiable private information or identifiable biospecimens, the research cannot practicably be carried out without using such information or biospecimens in an identifiable format.</li><li>The waiver or alteration will not adversely affect the rights and welfare of the participants.</li><li>When appropriate, the participants will be provided with additional pertinent information after participation.</li></ul>Waiver of Documentation of the Consent Process – Screening, Recruiting, and Determining Eligibility<ul><li>The researcher will obtain information through oral or written communication with the prospective participant or legally authorized representative, or</li><li>The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver of Documentation of the Consent Process – Confidentiality<ul><li>The only record linking the participant and the research will be the consent document.</li><li>The principal risk will be potential harm resulting from a breach of confidentiality.</li><li>Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC has determined whether the participant should be provided written information.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver of Documentation of the Consent Process: Consent normally not required outside the research context<ul><li>The research involves no procedures for which written documentation of the consent process is normally required outside of the research context.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC will determine whether the researcher should provide participants with a written statement regarding the research.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver of Documentation of the Consent Process: Distinct Cultural Groups<ul><li>The research presents no more than minimal risk of harm to participants.</li><li>The participants or legally authorized representatives are members of a distinct cultural group or community in which signing consent documents is not the norm.</li><li>There is an appropriate alternative mechanism for documenting that informed consent was obtained.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC will determine whether the researcher should provide participants with a written statement regarding the research.</li><li>The research is not regulated by the US FDA.</li></ul>",
 "description": "",
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 "key": "dhhs--criteria-for-informed-consent-waiver-alteration",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements, requirements to waive or alter the consent process are:Waiver of Consent Process – Public Demonstration Project<ul><li>The research is conducted by or subject to the approval of state or local government officials.</li><li>The research or demonstration protocol is designed to study, evaluate, or otherwise examine:<ul><li>Public benefit or service programs.</li><li>Procedures for obtaining benefits or services under those programs.</li><li>Possible changes in or alternatives to those programs or procedures.</li><li>Possible changes in methods or levels of payment for benefits or services under those programs.</li></ul></li><li>The research cannot practicably be carried out without the waiver or alteration.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver or Alteration of Consent Process: Obtaining Consent not Practicable<ul><li>The research involves no more than minimal risk to the participants.</li><li>The research cannot practicably be carried out without the requested waiver or alteration.</li><li>If the research involves using identifiable private information or identifiable biospecimens, the research cannot practicably be carried out without using such information or biospecimens in an identifiable format.</li><li>The waiver or alteration will not adversely affect the rights and welfare of the participants.</li><li>When appropriate, the participants will be provided with additional pertinent information after participation.</li></ul>Waiver of Documentation of the Consent Process – Screening, Recruiting, and Determining Eligibility<ul><li>The researcher will obtain information through oral or written communication with the prospective participant or legally authorized representative, or</li><li>The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver of Documentation of the Consent Process – Confidentiality<ul><li>The only record linking the participant and the research will be the consent document.</li><li>The principal risk will be potential harm resulting from a breach of confidentiality.</li><li>Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC has determined whether the participant should be provided written information.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver of Documentation of the Consent Process: Consent normally not required outside the research context<ul><li>The research involves no procedures for which written documentation of the consent process is normally required outside of the research context.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC will determine whether the researcher should provide participants with a written statement regarding the research.</li><li>The research is not regulated by the US FDA.</li></ul>Waiver of Documentation of the Consent Process: Distinct Cultural Groups<ul><li>The research presents no more than minimal risk of harm to participants.</li><li>The participants or legally authorized representatives are members of a distinct cultural group or community in which signing consent documents is not the norm.</li><li>There is an appropriate alternative mechanism for documenting that informed consent was obtained.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC will determine whether the researcher should provide participants with a written statement regarding the research.</li><li>The research is not regulated by the US FDA.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--research-involving-children---waivers-alterations",
 "title": "When following DHHS requirements and research involves children, written materials describe:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of parental permission are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the parental permission by determining that the regulatory criteria for waivers are met.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements and research involves children:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of parental permission are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the parental permission by determining that the regulatory criteria for waivers are met.</li></ul>",
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 "type": "question/review-assessment",
 "key": "fda--irb-assessment-of-waivers-alterations",
 "title": "When following FDA requirements, written materials describe:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of the consent process are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the consent process by determining that the regulatory criteria for waivers are met.<ul><li>When the IRB/EC considers waiving the requirement to obtain written documentation of the consent process, the IRB/EC must review a written description of the information that will be provided to participants.</li><li>When granting waivers of the requirement to obtain written documentation of the consent process, the IRB/EC considers requiring the researcher to provide participants with a written statement regarding the research.</li></ul></li><li>The IRB/EC documents\nits findings justifying the waiver or alteration.</li></ul>",
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 "key": "fda--irb-assessment-of-waivers-alterations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA requirements:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of the consent process are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the consent process by determining that the regulatory criteria for waivers are met.<ul><li>When the IRB/EC considers waiving the requirement to obtain written documentation of the consent process, the IRB/EC must review a written description of the information that will be provided to participants.</li><li>When granting waivers of the requirement to obtain written documentation of the consent process, the IRB/EC considers requiring the researcher to provide participants with a written statement regarding the research.</li></ul></li><li>The IRB/EC documents its findings justifying the waiver or alteration.</li></ul>",
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 "type": "question/review-assessment",
 "key": "fda--criteria-for-informed-consent-waiver-alteration",
 "title": "When following FDA requirements, written materials describe requirements to waive or alter the consent process:Waiver or Alteration of Consent Process: Obtaining Consent not Practicable<ul><li>The clinical investigation involves no more than minimal risk to the participants.</li><li>The research cannot practicably be carried out without the waiver or alteration.</li><li>The waiver or alteration will not adversely affect the rights and welfare of the participants.</li><li>When appropriate, the participants will be provided with additional pertinent information after participation.</li></ul>Waiver of Documentation of the Consent Process: Consent normally not required outside the research context<ul><li>The research presents no more than minimal risk of harm to participants.</li><li>The research involves no procedures for which written documentation of the consent process is normally required outside of the research context.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC has determined whether the researcher should provide participants with a written statement regarding the research.</li></ul>",
 "description": "",
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 "key": "fda--criteria-for-waivers-alterations-of-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA requirements, describe requirements to waive or alter the consent process:Waiver or Alteration of Consent Process: Obtaining Consent not Practicable<ul><li>The clinical investigation involves no more than minimal risk to the participants.</li><li>The research cannot practicably be carried out without the waiver or alteration.</li><li>The waiver or alteration will not adversely affect the rights and welfare of the participants.</li><li>When appropriate, the participants will be provided with additional pertinent information after participation.</li></ul>Waiver of Documentation of the Consent Process: Consent normally not required outside the research context<ul><li>The research presents no more than minimal risk of harm to participants.</li><li>The research involves no procedures for which written documentation of the consent process is normally required outside of the research context.</li><li>The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.</li><li>The IRB/EC has determined whether the researcher should provide participants with a written statement regarding the research.</li></ul>",
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 "type": "question/review-assessment",
 "key": "fda--waivers-alterations-for-research-involving-children",
 "title": "When following FDA requirements and research involves children, written materials describe<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of parental permission are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the parental permission by determining that the regulatory criteria for waivers are met.</li></ul>",
 "description": "",
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 "key": "fda--waivers-alterations-for-research-involving-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA requirements and research involves children:<ul><li>The IRB/EC is allowed to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of parental permission are met.</li><li>Written materials allow the IRB/EC to waive the requirement to document the parental permission by determining that the regulatory criteria for waivers are met.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dod--waivers-alterations-of-informed-consent",
 "title": "When following DoD requirements, written materials describe:<ul><li>The definition of \"experimental subject.\"</li><li>If non-exempt research is supported by DoD-appropriated funds and involves experimental subjects as defined in DODI 3216.02, consent must be obtained in advance, in accordance with 10 USC 980.<ul><li>An IRB/EC may waive or alter some elements of informed consent for research involving human beings as experimental subjects, so long as it preserves the informed consent of the participant (i.e., the consent indicates that participation in the research is voluntary, and the participant/representative is informed of research risks).</li></ul></li><li>DOHRP may waive the requirements for prospective consent for research involving human beings as “experimental subjects” when all of the following are met: <ul><li>The research is necessary to advance the development of a medical product for the Military Services. </li><li>The research may directly benefit the individual “experimental subject”.</li><li>The research is conducted in compliance with all other applicable laws and regulations. </li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements:<ul type=\"disc\"><li>The definition of \"experimental subject.\"</li><li>If non-exempt research is supported by DoD-appropriated funds and involves experimental subjects as defined in DODI 3216.02, consent must be obtained in advance, in accordance with 10 USC 980.</li><ul type=\"disc\"><li>An IRB/EC may waive or alter some elements of informed consent for research involving human beings as experimental subjects, so long as it preserves the informed consent of the participant (i.e., the consent indicates that participation in the research is voluntary, and the participant/representative is informed of research risks).</li></ul><li>DOHRP may waive the requirements for prospective consent for research involving human beings as “experimental subjects” when all of the following are met:</li><ul type=\"disc\"><li>The research is necessary to advance the development of a medical product for the Military Services.</li><li>The research may directly benefit the individual “experimental subject”.</li><li>The research is conducted in compliance with all other applicable laws and regulations.</li></ul></ul>",
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 "type": "question/review-assessment",
 "key": "ed--informed-consent-waivers-under-ferpa",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">When following ED requirements, written materials describe: \n\n<ul class=\"Bullet1ED\"><li>A description of the process to comply with the\nFamily Educational Rights and Privacy Act (FERPA).</li><li>The process to grant exceptions to\nparental/student consent to release student records for research. This\nresponsibility may be delegated to the IRB/EC or another individual or\ncomponent of the organization (e.g., a FERPA committee). </li><li>An educational agency or institution may\ndisclose personally identifiable information from an education record of a\nstudent without consent if the disclosure is to organizations conducting\nstudies for, or on behalf of, educational agencies or institutions to:<ul><li>Develop, validate, or administer predictive\ntests.</li><li>Administer student aid programs.</li><li>Improve instruction.</li></ul></li><li>A school district or postsecondary institution\nthat uses this exception is required to enter into a written agreement with the\norganization or researcher conducting the research that specifies:<ul><li>The determination of the exception.</li><li>The purpose, scope, and duration of the study.</li><li>The information to be disclosed.</li><li>That information from education records may only\nbe used to meet the purposes of the study stated in the written agreement and\nmust contain the current requirements in 34 CFR 99.31(a)(6) on re-disclosure\nand destruction of information.</li><li>That the study will be conducted in a manner\nthat does not permit personal identification of parents and students by anyone\nother than representatives of the organization with legitimate interests.</li><li>That the organization is required to destroy or\nreturn all personally identifiable information when no longer needed for the\npurposes of the study.</li><li></li></ul></li></ul>FERPA (Family Educational Rights and Privacy Act) does not apply to schools operated by the U.S. military or Department of Defense. This is because FERPA only applies to educational institutions that receive funding from the U.S. Department of Education, and military schools instead receive their funding through the Department of Defense.However, if a service member takes classes at a civilian college or university (including through tuition assistance or the GI Bill), those educational records would be protected by FERPA since those schools receive Department of Education funding.The key distinction is not whether the student is military personnel, but whether the school itself is a military institution or a civilian one.",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following ED requirements:<ul><li>A description of the process to comply with the Family Educational Rights and Privacy Act (FERPA).</li><li>The process to grant exceptions to parental/student consent to release student records for research. This responsibility may be delegated to the IRB/EC or another individual or component of the organization (e.g., a FERPA committee).</li><li>An educational agency or institution may disclose personally identifiable information from an education record of a student without consent if the disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to:<ul><li>Develop, validate, or administer predictive tests.</li><li>Administer student aid programs.</li><li>Improve instruction.</li></ul></li><li>A school district or postsecondary institution that uses this exception is required to enter into a written agreement with the organization or researcher conducting the research that specifies:<ul><li>The determination of the exception.</li><li>The purpose, scope, and duration of the study.</li><li>The information to be disclosed.</li><li>That information from education records may only be used to meet the purposes of the study stated in the written agreement and must contain the current requirements in 34 CFR 99.31(a)(6) on re-disclosure and destruction of information.</li><li>That the study will be conducted in a manner that does not permit personal identification of parents and students by anyone other than representatives of the organization with legitimate interests.</li><li>That the organization is required to destroy or return all personally identifiable information when no longer needed for the purposes of the study.</li><li></li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "ed--release-of-identifiable-information-without-consent",
 "title": "When following ED requirements, written materials describe:Education records may be released without consent under FERPA if all personally identifiable information has been removed including:<ul><li>Student’s name and other direct personal identifiers, such as the student’s social security number or student number. </li><li>Indirect identifiers, such as the name of the student’s parent or other family members; the student’s or family’s address, and personal characteristics or other information that would make the student’s identity easily traceable; date and place of birth and mother’s maiden name.</li><li>Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and handwriting. </li><li>Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following ED requirements:Education records may be released without consent under FERPA if all personally identifiable information has been removed including:<ul><li>Student’s name and other direct personal identifiers, such as the student’s social security number or student number.</li><li>Indirect identifiers, such as the name of the student’s parent or other family members; the student’s or family’s address, and personal characteristics or other information that would make the student’s identity easily traceable; date and place of birth and mother’s maiden name.</li><li>Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and handwriting.</li><li>Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty.</li></ul>",
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 "type": "question/review-assessment",
 "key": "doe--waiver-alteration-prohibition-for-classified-research",
 "title": "When following DOE requirements and conducting classified research (in whole or in part), written materials describe that:<ul><li>A waiver of informed consent may only be granted by the convened IRB/EC for minimal risk research that qualifies for exemption under 10 CFR §745.104.</li><li>Exemptions (as per 10 CFR §745.104) and expedited review cannot be used. If the research meets a particular exemption or expedited category it may be noted, but convened IRB/EC review is required. </li></ul>",
 "description": "",
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 "key": "doe--waiver-alteration-prohibition-for-classified-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DOE requirements and conducting classified research (in whole or in part):<ul><li>A waiver of informed consent may only be granted by the convened IRB/EC for minimal risk research that qualifies for exemption under 10 CFR §745.104.</li><li>Exemptions (as per 10 CFR §745.104) and expedited review cannot be used. If the research meets a particular exemption or expedited category it may be noted, but convened IRB/EC review is required.</li></ul>",
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 "type": "question/review-assessment",
 "key": "va--informed-consent-waivers",
 "title": "When following VA requirements, written materials describe:  <ul><li>The IRB/EC must document the reason when it waives the requirement to obtain written documentation of the consent process.</li><li>An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB/EC.</li></ul>",
 "description": "",
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 "key": "va--informed-consent-waivers",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements: <ul><li>The IRB/EC must document the reason when it waives the requirement to obtain written documentation of the consent process.</li><li>An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB/EC.</li></ul>",
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 "type": "section/standard",
 "key": "standard-ii-4",
 "title": "STANDARD II-4",
 "description": "The IRB or EC provides additional protections for individuals who are vulnerable to coercion or undue influence and participate in research.",
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 "type": "section/element",
 "key": "element-ii-4-a",
 "title": "ELEMENT II.4.A.",
 "description": "The IRB or EC has and follows written policies and procedures for determining the risks to prospective participants who are vulnerable to coercion or undue influence and ensuring that additional protections are provided as required by applicable laws, regulations, codes, and guidance. ",
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 "title": "The organization provided all documents relevant for the evaluation of this Element.",
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 "type": "question/review-assessment",
 "key": "information-for-the-irb-ec-to-assess-additional-protections",
 "title": "Essential RequirementsWritten materials describe the information the IRB/EC requires to evaluate the researcher’s additional safeguards to protect\nthe rights and welfare of vulnerable participants.",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:The information the IRB/EC requires to evaluate the researcher’s additional safeguards to protect the rights and welfare of vulnerable participants.",
 "description": "",
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 "type": "question/review-assessment",
 "key": "irb-ec-consideration-of-additional-safeguards-for-vulnerable-populations",
 "title": "Essential RequirementWritten materials describe that in order to approve\nresearch where some or all of the participants are likely to be vulnerable the IRB/EC\ndetermines whether additional safeguards have been included in the protocol or study plan to\nprotect their rights and welfare.",
 "description": "",
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 "key": "irb-ec-consideration-of-additional-safeguards-for-vulnerable-populations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:In order to approve research where some or all of the participants are likely to be vulnerable the IRB/EC determines whether additional safeguards have been included in the protocol or study plan to protect their rights and welfare.",
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 {
 "type": "question/review-assessment",
 "key": "protections-for-pregnant-individuals--fetuses--or-neonates",
 "title": "Essential requirements<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">For US based organizations:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If research involves pregnant individuals, fetuses, or neonates<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">, written materials describe that:<ul><li>The IRB/EC follows Subpart B of the DHHS regulations or equivalent protections as allowed by law. </li><li>When the organization or organizations relying on the IRB/EC choose not to apply Subpart B to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research. </li></ul>For organizations based outside the US:If research involves pregnant individuals, fetuses, or neonates, written materials describe that:<ul><li>The IRB/EC applies additional protections as required by applicable country laws or regulations. </li><li>If the country's laws or regulations do not specify additional protections for prisoners, the IRB/EC applies US DHHS Subpart B or equivalent protections when reviewing research involving pregnant women, fetuses, or neonates.</li></ul>",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-pregnant-women--fetuses--or-neonates",
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 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-pregnant-women--fetuses--or-neonates",
 "title": "For US based organizations:<div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Add to or describe in written materials [page xx or elsewhere]:</div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If research involves pregnant women, fetuses, or neonates:<ul><li>The IRB/EC follows Subpart B of the DHHS regulations or equivalent protections as allowed by law.</li><li>When the organization or organizations relying on the IRB/EC choose not to apply Subpart B to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research.</li></ul>",
 "description": "",
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 },
 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-pregnant-women--fetuses--or-neonates---non-us",
 "title": "For organizations based outside the US:<div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Add to or describe in written materials [page xx or elsewhere]:</div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If research involves pregnant women, fetuses, or neonates:<ul><li>The IRB/EC applies additional protections as required by applicable country laws or regulations.</li><li>If the country's laws or regulations do not specify additional protections for prisoners, the IRB/EC applies US DHHS Subpart B or equivalent protections when reviewing research involving pregnant women, fetuses, or neonates.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "protections-for-prisoners",
 "title": "Essential requirementsIf research involves prisoners as participants, written materials describe that the IRB/EC follows Subpart C of the DHHS regulations or equivalent protections as allowed by law.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">For US based organizations:If research involves prisoners as participants, written materials describe that:<ul><li>The IRB/EC follows Subpart C of the DHHS regulations or equivalent protections as allowed by law. </li><li>When the organization or organizations relying on the IRB/EC choose not to apply Subpart C to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research. </li><li>If the convened IRB/EC reviews research that involves prisoners, one or more individuals who are prisoners or prisoner representatives must be present at the meeting.</li></ul><div><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">For organizations based outside the US:</div>If research involves prisoners as participants, written materials describe that the IRB/EC applies additional protections as required by applicable country laws or regulations. If the country's laws or regulations do not specify additional protections for prisoners, the IRB/EC applies US DHHS Subpart C or equivalent protections when reviewing research involving prisoners.",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-prisoners",
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 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-prisoners",
 "title": "For US based organizations:Add to or describe in written materials [page xx or elsewhere]:<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If research involves prisoners as participants:<ul><li>The IRB/EC follows Subpart C of the DHHS regulations or equivalent protections as allowed by law. </li><li>When the organization or organizations relying on the IRB/EC choose not to apply Subpart C to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research. </li><li>If the convened IRB/EC reviews research that involves prisoners, one or more individuals who are prisoners or prisoner representatives must be present at the meeting.</li></ul>",
 "description": "",
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 },
 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-prisoners---non-us",
 "title": "For organizations based outside the US:Add to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">If research involves prisoners as participants, written materials describe that the IRB/EC applies additional protections as required by applicable country laws or regulations.</li><li>If the country's laws or regulations do not specify additional protections for prisoners, the IRB/EC applies US DHHS Subpart C or equivalent protections when reviewing research involving prisoners.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "additional-protections--a-research-participant-becomes-a-prisoner",
 "title": "When IRBs/ECs do not have written procedures for research involving prisoners and a research participant becomes a prisoner, written materials describe:The IRB/EC:<ul><li>Confirms that the participant meets the definition of a prisoner.</li><li>Decides whether it is in the best interests of the participant to remain in the study or to terminate enrollment.</li><li>Decides whether it is feasible for the participant to remain in the study.</li><li>[For organizations that review US DHHS-funded research or research conducted by a US DHHS Department or Agency] Determines whether Subpart C applies.<ul><li>If Subpart C applies:<ul><li>Finds an IRB/EC that can review the study or refer to the federal regulations and identify a prisoner representative so that your IRB/EC can review the study.</li></ul></li><li>If Subpart C does not apply:<ul><li>Finds an IRB/EC that can review the study or develop written procedures for providing equivalent protections.</li></ul></li></ul></li></ul>If a participant is incarcerated temporarily while enrolled in a study:<ul><li>If the temporary incarceration has no effect on the study, keep the participant enrolled</li><li>If the temporary incarceration has an effect on the study, handle according to the above guidance.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 {
 "type": "text/review-assessment-snippet",
 "key": "additional-protections--a-research-participant-becomes-a-prisoner",
 "title": "If Subpart C appliesAdd to or describe in written materials [page xx or elsewhere]:When a research participant becomes a prisoner, the IRB/EC:<ul><li>Confirms that the participant meets the definition of a prisoner.</li><li>Decides whether it is in the best interests of the participant to remain in the study or to terminate enrollment.</li><li>Decides whether it is feasible for the participant to remain in the study.</li><li>Determines whether Subpart C applies.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Finds an IRB/EC that can review the study or refer to the federal regulations and identify a prisoner representative so that the organization's IRB/EC can review the study.</li></ul>If a participant is incarcerated temporarily while enrolled in a study:<ul><li>If the temporary incarceration has no effect on the study, keep the participant enrolled</li><li>If the temporary incarceration has an effect on the study, handle according to the above guidance.</li></ul>",
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 {
 "type": "text/review-assessment-snippet",
 "key": "additional-protections--a-research-participant-becomes-a-prisoner---subpart-c-does-not-apply",
 "title": "If Subpart C does not applyAdd to or describe in written materials [page xx or elsewhere]:When a research participant becomes a prisoner, the IRB/EC:<ul><li>Confirms that the participant meets the definition of a prisoner.</li><li>Decides whether it is in the best interests of the participant to remain in the study or to terminate enrollment.</li><li>Decides whether it is feasible for the participant to remain in the study.</li><li>Determines whether Subpart C applies.</li><li>Finds an IRB/EC that can review the study or develop written procedures for providing equivalent protections.</li></ul>If a participant is incarcerated temporarily while enrolled in a study:<ul><li>If the temporary incarceration has no effect on the study, keep the participant enrolled</li><li>If the temporary incarceration has an effect on the study, handle according to the above guidance.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "protections-for-children",
 "title": "Essential requirementsFor US based organizations:If research involves children, written materials describe that the IRB/EC follows Subpart D of the DHHS regulations or equivalent protections as allowed by law. When the organization or organizations relying on the IRB/EC choose not to apply Subpart D to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research.For organizations based outside the US:If research involves children, written materials describe that the IRB/EC applies additional protections as required by applicable country laws or regulations. If the country's laws or regulations do not specify additional protections for children, the IRB/EC applies US DHHS Subpart D or equivalent protections when reviewing research involving children.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-children",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-children",
 "title": "For US based organizations:Add to or describe in written materials [page xx or elsewhere]:<ul><li>If research involves children, the IRB/EC follows Subpart D of the DHHS regulations or equivalent protections as allowed by law. </li><li>When the organization or organizations relying on the IRB/EC choose not to apply Subpart D to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research.</li></ul><ul></ul>",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-children---non-us",
 "title": "For organizations based outside the US:Add to or describe in written materials [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">If research involves children, the IRB/EC applies additional protections as required by applicable country laws or regulations. </li><li>If the country's laws or regulations do not specify additional protections for children, the IRB/EC applies US DHHS Subpart D or equivalent protections when reviewing research involving children.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "protections-for-adults-unable-to-provide-consent",
 "title": "Essential requirementsWritten materials describe that if research involves adults unable to consent, the IRB/EC considers specific criteria for approval of such research that provides additional safeguards to protect their rights and welfare.",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-adults-unable-to-consent",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-adults-unable-to-provide-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:If research involves adults unable to consent, the IRB/EC considers specific criteria for approval of such research that provides additional safeguards to protect their rights and welfare.",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "protections-for-other-vulnerable-populations",
 "title": "Essential requirementsWritten materials describe that if the IRB/EC\nregularly reviews research that involves other vulnerable populations (beyond pregnant women, fetuses, or neonates; prisoners; children; and adults unable to consent), the steps the IRB/EC follows to evaluate whether additional safeguards are\nincluded in research to protect the rights and welfare of these participants.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "protections-for-other-vulnerable-populations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:If the IRB/EC regularly reviews research that involves other vulnerable populations (beyond pregnant women, fetuses, or neonates; prisoners; children; and adults unable to consent), the steps the IRB/EC follows to evaluate whether additional safeguards are included in research to protect the rights and welfare of these participants.<div> </div>",
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--additional-protections-for-vulnerable-populations",
 "title": "When following DHHS regulations, written materials describe that the IRB/EC follows\nthe requirements specified in relevant Subparts for the populations the organization might enroll in research. GUIDANCEIf the organization uses equivalent criteria for non-DHHS regulated research, indicate this in the General Comment section. May omit any category not used. For reference:<ul><li>Subpart B applies to research involving pregnant women, fetuses, or neonates</li><li>Subpart C applies to research involving prisoners</li><li>Subpart D applies to research involving children.</li></ul>",
 "description": "",
 "keywords": "dhhs--independent-irb-reviews-research-involving-prisoners,dhhs--independent-irb-reviews-research-with-pregnant-individuals-fetuses-or-neonates,dhhs-internal-irb-research-involving-prisoners,dhhs-independent-irb---reviews-research-with-children,dhhs-internal-irb---reviews-research-with-children,dhhs-internal-irb-reviews-research-with-pregnant-individuals-fetuses-or-neonates",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--additional-protections-for-vulnerable-populations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations, the IRB/EC follows the requirements specified in Subpart B for research involving pregnant women, fetuses, or neonates; Subpart C for research involving prisoners; and Subpart D for research involving children.",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--additional-protections-for-pregnant-individuals--fetuses--or-neonates",
 "title": "When following DHHS regulations and research involves pregnant individuals, fetuses, or neonates, written materials describe that the IRB/EC follows the requirements specified in Subpart B.GUIDANCE<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Pregnant Women or Fetuses<ul><li>Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provided data for assessing potential risks to pregnant women and fetuses.</li><li>One of the following is true:<ul><li>The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus.</li><li>The risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means.</li></ul></li><li>Any risk is the least possible for achieving the objectives of the research.</li><li>For children who are pregnant, assent and permission are obtained in accordance with the regulations.</li><li>No inducements, monetary or otherwise, will be offered to terminate a pregnancy.</li><li>Individuals engaged in the research have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.</li><li>Individuals engaged in the research have no part in determining the viability of a neonate.</li></ul>Neonates of Uncertain Viability and Non-Viable Neonates<ul><li>Where scientifically appropriate, preclinical and clinical studies have been conducted and provided data for assessing potential risks to neonates.</li><li>Individuals engaged in the research have no part in determining the viability of a neonate.</li><li>For neonates of uncertain viability, until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:<ul><li>The IRB/EC determines whether the criteria for approval of research are met when research involves nonviable neonates. The IRB/EC determines and documents that:<ul><li>The research held out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective.</li><li>The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there is no added risk to the neonate resulting from the research.</li></ul></li></ul></li><li>After delivery a nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:<ul><li>Vital functions of the neonate are not artificially maintained.</li><li>The research will not terminate the heartbeat or respiration of the neonate.</li><li>There is no added risk to the neonate resulting from the research.</li><li>The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means.</li></ul></li></ul>",
 "description": "",
 "keywords": "dhhs--independent-irb-reviews-research-with-pregnant-individuals-fetuses-or-neonates,dhhs-internal-irb-reviews-research-with-pregnant-individuals-fetuses-or-neonates",
 "components": [
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 "key": "dhhs--additional-protections-for-pregnant-women--fetuses--or-neonates",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations, the IRB/EC may approve research involving pregnant women or fetuses under the following circumstances:<ul type=\"disc\"><li>Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provided data for assessing potential risks to pregnant women and fetuses.</li><li>One of the following is true:</li><ul type=\"disc\"><li>The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus.</li><li>The risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means.</li></ul><li>Any risk is the least possible for achieving the objectives of the research.</li><li>For children who are pregnant, assent and permission are obtained in accordance with the regulations.</li><li>No inducements, monetary or otherwise, will be offered to terminate a pregnancy.</li><li>Individuals engaged in the research have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.</li><li>Individuals engaged in the research have no part in determining the viability of a neonate.</li></ul>When following DHHS regulations, t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">he IRB/EC may approve research involving neonates of uncertain viability or non-viable neonates under the following circumstances:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">Where scientifically appropriate, preclinical and clinical studies have been conducted and provided data for assessing potential risks to neonates.</li><li>Individuals engaged in the research have no part in determining the viability of a neonate.</li><li>For neonates of uncertain viability, until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:</li></ul><ul type=\"disc\"><ul type=\"disc\"><li>The IRB/EC determines whether the criteria for approval of research are met when research involves nonviable neonates. The IRB/EC determines and documents that:</li><ul type=\"disc\"><li>The research held out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective.</li><li>The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there is no added risk to the neonate resulting from the research.</li></ul></ul><li>After delivery a nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:</li><ul type=\"disc\"><li>Vital functions of the neonate are not artificially maintained.</li><li>The research will not terminate the heartbeat or respiration of the neonate.</li><li>There is no added risk to the neonate resulting from the research.</li><li>The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means.</li></ul></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--additional-protections-for-prisoners",
 "title": "When following DHHS regulations and research involves prisoners, written materials describe that the IRB/EC follows the requirements specified in Subpart C.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">GUIDANCEIf another IRB/EC satisfies the requirements under Subpart C, the organization does not need to duplicate this review. If an organization does not conduct all types of research involving prisoners, policies may omit requirements for research it does not conduct.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Subpart C: Additional Protections for Prisoners<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">For the review of research involving prisoners:<ul><li>A majority of the IRB/EC (exclusive of prisoner members) have no association with the prison involved, apart from their membership on the IRB.</li><li>At least one IRB/EC member who is a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity is present at the meeting.</li><li>For prisoners, “minimal risk” means the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.</li><li>The IRB/EC determines whether the criteria for approval of research are met when research involves prisoners.<ul><li>The IRB/EC determines and documents that:<ul><li>The research represents one of the following categories:<ul><li>Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the participants.</li><li>Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the participants.</li><li>Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults).<ul><li>For DHHS-funded research, OHRP has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of its intent to approve such research.</li></ul></li><li>Research on practices, both innovative and accepted that has the intent and reasonable probability of improving the health or well-being of the participant.<ul><li>For DHHS-funded research which require the assignment of prisoners in a manner consistent with protocols approved by the IRB/EC to control groups which may not benefit from the research, the study may proceed only after OHRP has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of its intent to approve such research.</li></ul></li><li>Epidemiologic studies that meet the following criteria:<ul><li>The sole purposes are one of the following:<ul><li>To describe the prevalence or incidence of a disease by identifying all cases.</li><li>To study potential risk factor associations for a disease.</li><li>The research presents no more than minimal risk and no more than inconvenience to the prisoner-participants, and</li><li>Prisoners are not a particular focus of the research.</li></ul></li></ul></li></ul></li><li>Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.</li><li>The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.</li><li>Procedures for the selection of participants within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners.</li><li>Unless the principal investigator (PI) provides justification in writing for following some other procedures, control participants are selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.</li><li>Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole.</li><li>When there is a need for follow-up examination or care of participants after the end of their participation, adequate provisions are made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact.</li><li>For DHHS-funded research, indicate the individual (by title of position) who certifies to OHRP the duties of the IRB/EC have been fulfilled.</li></ul></li></ul></li><li>For research involving prisoners reviewed by the convened IRB/EC:<ul><li>The prisoner representative must be a voting member of the IRB/EC.</li><li>The prisoner representative may be listed as an alternative member who becomes a voting member when needed.</li><li>The prisoner representative must review research involving prisoners, focusing on the requirements in Subpart C or equivalent protections.</li><li>The prisoner representative must receive all review materials pertaining to the research (same as primary reviewer).</li><li>The prisoner representative must be present at a convened meeting when the research involving prisoners is reviewed. If the prisoner representative is not present, research involving prisoners cannot be reviewed or approved.</li><li>The prisoner representative may attend the meeting by phone, videoconference, or webinar, as long as the representative is able to participate in the meeting as if they were present in person at the meeting.</li><li>The prisoner representative must present his/her review either orally or in writing at the convened meeting of the IRB/EC when the research involving prisoners is reviewed.</li><li>Minor modifications to research may be reviewed using the expedited procedure described below, using either of the two procedures described based on the type of modification.</li><li>Modifications involving more than a minor change reviewed by the convened IRB/EC – must use the same procedures for initial review including the responsibility of the prisoner representative to review the modification and participate in the meeting (as described above).</li><li>Continuing review – must use the same procedures for initial review including the responsibility of the prisoner representative to review the continuing review materials and participate in the meeting (as described above).</li><li>If no participants have been enrolled, the research may receive continuing review using the expedited procedure under expedited category #8.</li></ul></li><li>For research involving prisoners reviewed by the expedited procedure, the organization may use the following two options:<ul><li>Research involving interaction with prisoners may be reviewed by the expedited procedure, if a determination is made that the research involves no greater than minimal risk for the prison population being studied.<ul><li>The prisoner representative must concur with the determination that the research involves no greater than minimal risk.</li></ul></li><li>The prisoner representative must review the research as a reviewer, designated by the chair, or consultant. This may be as the sole reviewer or in addition to another reviewer, as appropriate.</li><li>Review of modifications and continuing review must use the same procedures for initial review using this expedited procedure including the responsibility of the prisoner representative.</li></ul></li><li>For research that does not involve interaction with prisoners (e.g., existing data, record review) reviewed by the expedited procedure:<ul><li>Research that does not involve interaction with prisoners may be reviewed by the expedited procedure, if a determination is made that the research involves no greater than minimal risk for the prison population being studied.</li><li>Review by a prisoner representative is not required.</li><li>The prisoner representative may review the research as a reviewer or consultant if designated by the IRB/EC chair.</li><li>Review of modifications and continuing review must use the same procedures as initial review.</li></ul></li><li>If the organization uses the exempt procedure for research involving prisoners, it may use the following option:<ul><li>If Subpart C is applicable either by funding requirement or voluntarily (e.g., Subpart C box is checked on the FWA) research involving prisoners cannot be deemed exempt.</li><li>If Subpart C is not applicable:<ul><li>Research using data, samples, or materials that involves prisoners or that may involve prisoners but qualifies for an exemption may be granted an exemption. It must be determined that an exemption is appropriate for the prison population being studied.</li><li>The prisoner representative may be consulted for exempt determinations involving prisoners but is not required.</li><li>An exemption may not be granted if the research involves interaction with prisoners (including obtaining informed consent).</li></ul></li></ul></li><li>If a participant becomes a prisoner while enrolled in a research study that was not reviewed according to Subpart C:<ul><li>When Subpart C applies. the IRB/EC:<ul><li>Confirms that the participant meets the definition of a prisoner.</li><li>Terminates enrollment or review the research study under Subpart C if it is feasible for the participant to remain in the study.</li><li>Before terminating the enrollment of the incarcerated participant, the IRB/EC should consider the risks associated with terminating participation in the study.</li><li>If the participant cannot be terminated for health or safety reasons:<ul><li>Keeps the participant enrolled in the study and review the research under Subpart C.<ul><li>If some of the requirements of Subpart C cannot be met, but it is in the best interests of the participant to remain in the study, keep the participant enrolled and inform OHRP of the decision along with the justification.</li></ul></li><li>Removes the participant from the study and keep the participant on the study intervention under an alternate mechanism such as compassionate use, off label use, etc.</li></ul></li></ul></li><li>When Subpart C does not apply, and the organization has written procedures for providing equivalent protections, the IRB/EC:<ul><li>Confirms that the participant meets the definition of a prisoner.</li><li>Decides whether it is in the best interests of the participant to remain in the study or to terminate enrollment.</li><li>Decides whether it is feasible for the participant to remain in the study.</li><li>If it is in the best interests of the participant to remain in the study, keeps the participant in the study and review the research at the next meeting of the convened IRB/EC.</li></ul></li></ul><ul></ul></li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations for the review of research involving prisoners:<ul><li>A majority of the IRB/EC (exclusive of prisoner members) have no association with the prison involved, apart from their membership on the IRB.</li><li>At least one IRB/EC member who is a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity is present at the meeting.</li><li>For prisoners, “minimal risk” means the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.</li><li>The IRB/EC determines whether the criteria for approval of research are met when research involves prisoners.<ul><li>The IRB/EC determines and documents that:<ul><li>The research represents one of the following categories:<ul><li>Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the participants.</li><li>Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the participants.</li><li>Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults).<ul><li>For DHHS-funded research, OHRP has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of its intent to approve such research.</li></ul></li><li>Research on practices, both innovative and accepted that has the intent and reasonable probability of improving the health or well-being of the participant.<ul><li>For DHHS-funded research which require the assignment of prisoners in a manner consistent with protocols approved by the IRB/EC to control groups which may not benefit from the research, the study may proceed only after OHRP has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of its intent to approve such research.</li></ul></li><li>Epidemiologic studies that meet the following criteria:<ul><li>The sole purposes are one of the following:<ul><li>To describe the prevalence or incidence of a disease by identifying all cases.</li><li>To study potential risk factor associations for a disease.</li><li>The research presents no more than minimal risk and no more than inconvenience to the prisoner-participants, and</li><li>Prisoners are not a particular focus of the research.</li></ul></li></ul></li></ul></li><li>Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.</li><li>The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.</li><li>Procedures for the selection of participants within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners.</li><li>Unless the principal investigator (PI) provides justification in writing for following some other procedures, control participants are selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.</li><li>Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole.</li><li>When there is a need for follow-up examination or care of participants after the end of their participation, adequate provisions are made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact.</li><li>For DHHS-funded research, indicate the individual (by title of position) who certifies to OHRP the duties of the IRB/EC have been fulfilled.</li></ul></li></ul></li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations for the review by the convened IRB/EC of research involving prisoners:<ul><li>The prisoner representative must be a voting member of the IRB/EC.</li><li>The prisoner representative may be listed as an alternative member who becomes a voting member when needed.</li><li>The prisoner representative must review research involving prisoners, focusing on the requirements in Subpart C or equivalent protections.</li><li>The prisoner representative must receive all review materials pertaining to the research (same as primary reviewer).</li><li>The prisoner representative must be present at a convened meeting when the research involving prisoners is reviewed. If the prisoner representative is not present, research involving prisoners cannot be reviewed or approved.</li><li>The prisoner representative may attend the meeting by phone, videoconference, or webinar, as long as the representative is able to participate in the meeting as if they were present in person at the meeting.</li><li>The prisoner representative must present his/her review either orally or in writing at the convened meeting of the IRB/EC when the research involving prisoners is reviewed.</li><li>Minor modifications to research may be reviewed using the expedited procedure described below, using either of the two procedures described based on the type of modification.</li><li>Modifications involving more than a minor change reviewed by the convened IRB/EC – must use the same procedures for initial review including the responsibility of the prisoner representative to review the modification and participate in the meeting (as described above).</li><li>Continuing review – must use the same procedures for initial review including the responsibility of the prisoner representative to review the continuing review materials and participate in the meeting (as described above).</li><li>If no participants have been enrolled, the research may receive continuing review using the expedited procedure under expedited category #8.</li></ul>",
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 "key": "dhhs--additional-protections-for-prisoners---expedited-review",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations for the review by the expedited procedure of research involving prisoners, the organization may use the following two options: <ul><li>Research involving interaction with prisoners may be reviewed by the expedited procedure, if a determination is made that the research involves no greater than minimal risk for the prison population being studied.</li><ul type=\"disc\"><li>The prisoner representative must concur with the determination that the research involves no greater than minimal risk.</li></ul></ul>OR<ul><li>The prisoner representative must review the research as a reviewer, designated by the chair, or consultant. This may be as the sole reviewer or in addition to another reviewer, as appropriate.</li></ul> <ul><li>Review of modifications and continuing review must use the same procedures for initial review using this expedited procedure including the responsibility of the prisoner representative. </li></ul> ",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations for the review by the expedited procedure for r\\Research that does not involve interaction with prisoners (e.g., existing data, record review) reviewed by the expedited procedure:<ul type=\"disc\"><li>Research that does not involve interaction with prisoners may be reviewed by the expedited procedure, if a determination is made that the research involves no greater than minimal risk for the prison population being studied.</li><li>Review by a prisoner representative is not required.</li><li>The prisoner representative may review the research as a reviewer or consultant if designated by the IRB/EC chair.</li><li>Review of modifications and continuing review must use the same procedures as initial review.</li></ul>",
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 "key": "dhhs--additional-protections-for-prisoners---exempt-review---subpart-c-applies",
 "title": "If Subpart C is applicable either by funding requirement or voluntarily (e.g., Subpart C box is checked on the FWA)Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations for the review of research involving prisoners, if the organization uses the exempt procedure for research involving prisoners, research involving prisoners cannot be deemed exempt.",
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 "key": "dhhs--additional-protections-for-prisoners---exempt-review---subpart-c-does-not-apply",
 "title": "If Subpart C is not applicable either by funding requirement or voluntarily (e.g., Subpart C box is not checked on the FWA):Add to or describe in written materials [page xx or elsewhere]:For the review of research involving prisoners:<ul><li>Research using data, samples, or materials that involves prisoners or that may involve prisoners but qualifies for an exemption may be granted an exemption. It must be determined that an exemption is appropriate for the prison population being studied.</li></ul><ul><li>The prisoner representative may be consulted for exempt determinations involving prisoners but is not required.</li><li>An exemption may not be granted if the research involves interaction with prisoners (including obtaining informed consent).</li></ul>",
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 "key": "dhhs--additional-protections-for-prisoners---participant-becomes-prisoner---subpart-c-applies",
 "title": "If Subpart C is applicable either by funding requirement or voluntarily (e.g., Subpart C box is checked on the FWA)Add to or describe in written materials [page xx or elsewhere]:When following DHHS regulations for the review of research involving prisoners, if a participant becomes a prisoner while enrolled in a research study that was not reviewed according to Subpart C:<ul type=\"disc\"><li>Confirm that the participant meets the definition of a prisoner.</li><li>Terminate enrollment or review the research study under Subpart C if it is feasible for the participant to remain in the study.</li><li>Before terminating the enrollment of the incarcerated participant, the IRB/EC should consider the risks associated with terminating participation in the study.</li><li>If the participant cannot be terminated for health or safety reasons:</li><ul type=\"disc\"><li>Keep the participant enrolled in the study and review the research under Subpart C.</li><ul type=\"disc\"><li>If some of the requirements of Subpart C cannot be met, but it is in the best interests of the participant to remain in the study, keep the participant enrolled and inform OHRP of the decision along with the justification.</li><li>Remove the participant from the study and keep the participant on the study intervention under an alternate mechanism such as compassionate use, off label use, etc.</li></ul></ul></ul>",
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 "type": "text/review-assessment-snippet",
 "key": "dhhs--additional-protections-for-prisoners---participant-becomes-prisoner---subpart-c-does-not-apply",
 "title": "If Subpart C does not apply, and the IRB/EC has written procedures for providing equivalent protections Add to or describe in written materials [page xx or elsewhere]:If a participant becomes a prisoner while enrolled in a research study that was not reviewed according to Subpart C:<ul type=\"disc\"><li>Confirm that the participant meets the definition of a prisoner.</li><li>Decide whether it is in the best interests of the participant to remain in the study or to terminate enrollment.</li><li>Decide whether it is feasible for the participant to remain in the study.</li><li>If it is in the best interests of the participant to remain in the study, keep the participant in the study and review the research at the next meeting of the convened IRB/EC.</li></ul>",
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 "type": "question/review-assessment",
 "key": "dhhs--additional-protections-for-children",
 "title": "When following DHHS requirements for research involving children, written materials describe:<ul><li>The IRB/EC determines whether the criteria for approval of research are met when research involves children. In addition, the IRB/EC determines and documents which of the following categories apply to the research:<ul><li>Category 1:<ul><li>No greater than minimal risk to children is presented.</li></ul></li><li>Category 2:<ul><li>More than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual participant, or by a monitoring procedure that is likely to contribute to the participant’s well-being.</li><li>The risk is justified by the anticipated benefit to the participants.</li><li>The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.</li></ul></li><li>Category 3:<ul><li>More than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual participant, or by a monitoring procedure, which is not likely to contribute to the well-being of the participant.</li><li>The risk represents a minor increase over minimal risk.</li><li>The intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations.</li><li>The intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition which is of vital importance for the understanding or amelioration of the participants’ disorder or condition.</li></ul></li><li>Category 4:<ul><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.</li><li>The federal agency, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determined either (if not federally funded, the organization can substitute an equivalent mechanism):<ul><li>That the research fell into categories 1 through 3; or</li><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles.</li></ul></li></ul></li></ul></li><li>The IRB/EC determines whether the criteria for approval of research are met when research in Category 3 or 4 involves wards of the state or any other agency. The IRB/EC determines and documents that:<ul><li>The research is:<ul><li>Related to their status as wards; or</li><li>Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.</li></ul></li><li>The IRB/EC requires appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.<ul><li>The advocate is an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research.</li><li>The advocate is not associated in any way (except in the role as advocate or member of the IRB/EC) with the research, the researchers, or the guardian.</li></ul></li></ul></li></ul>GUIDANCEThe Common Rule Subpart D and FDA Subpart D are highly similar and primarily differ in terminology. An IRB/EC that reviews research funded or conducted by DHHS that is FDA-regulated must describe the need to apply both regulations to the research, including Subparts D when the research involves children.When reviewing an organization outside of the US, refer to the Addendum for any county-specific laws regarding research involving orphans, wards of the state, or other terms for children without legal guardians who are in custody of a government agency.",
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 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--additional-protections-for-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements for research involving children:<ul><li>The IRB/EC determines whether the criteria for approval of research are met when research involves children. In addition, the IRB/EC determines and documents which of the following categories apply to the research:<ul><li>Category 1:<ul><li>No greater than minimal risk to children is presented.</li></ul></li><li>Category 2:<ul><li>More than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual participant, or by a monitoring procedure that is likely to contribute to the participant’s well-being.</li><li>The risk is justified by the anticipated benefit to the participants.</li><li>The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.</li></ul></li><li>Category 3:<ul><li>More than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual participant, or by a monitoring procedure, which is not likely to contribute to the well-being of the participant.</li><li>The risk represents a minor increase over minimal risk.</li><li>The intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations.</li><li>The intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition which is of vital importance for the understanding or amelioration of the participants’ disorder or condition.</li></ul></li><li>Category 4:<ul><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.</li><li>The federal agency, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determined either (if not federally funded, the organization can substitute an equivalent mechanism):<ul><li>That the research fell into categories 1 through 3; or</li><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles.</li></ul></li></ul></li></ul></li><li>The IRB/EC determines whether the criteria for approval of research are met when research in Category 3 or 4 involves wards of the state or any other agency. The IRB/EC determines and documents that:<ul><li>The research is:<ul><li>Related to their status as wards; or</li><li>Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.</li></ul></li><li>The IRB/EC requires appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.<ul><li>The advocate is an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research.</li><li>The advocate is not associated in any way (except in the role as advocate or member of the IRB/EC) with the research, the researchers, or the guardian.</li></ul></li></ul></li></ul>",
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 "type": "question/review-assessment",
 "key": "us-fda--additional-protections-for-children",
 "title": "When following FDA requirements for research involving children, written materials describe:<ul><li>The IRB/EC determines whether the criteria for approval of research are met when research involves children. In addition, the IRB/EC determines and documents which of the following categories apply to the research:<ul><li>Category 1:<ul><li>No greater than minimal risk to children is presented.</li></ul></li><li>Category 2:<ul><li>More than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual participant, or by a monitoring procedure that is likely to contribute to the participant’s well-being.</li><li>The risk is justified by the anticipated benefit to the participants.</li><li>The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.</li></ul></li><li>Category 3:<ul><li>More than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual participant, or by a monitoring procedure, which is not likely to contribute to the well-being of the participant.</li><li>The risk represents a minor increase over minimal risk.</li><li>The intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations.</li><li>The intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition which is of vital importance for the understanding or amelioration of the participants’ disorder or condition.</li></ul></li><li>Category 4:<ul><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.</li><li>The federal agency, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determined either (if not federally funded, the organization can substitute an equivalent mechanism):<ul><li>That the research fell into categories 1 through 3; or</li><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles.</li></ul></li></ul></li></ul></li><li>The IRB/EC determines whether the criteria for approval of research are met when research in Category 3 or 4 involves wards of the state or any other agency. The IRB/EC determines and documents that:<ul><li>The research is:<ul><li>Related to their status as wards; or</li><li>Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.</li></ul></li><li>The IRB/EC requires appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.<ul><li>The advocate is an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research.</li><li>The advocate is not associated in any way (except in the role as advocate or member of the IRB/EC) with the research, the researchers, or the guardian.</li></ul></li></ul></li></ul>GUIDANCEThe Common Rule Subpart D and FDA Subpart D are highly similar and primarily differ in terminology. An IRB/EC that reviews research that is FDA-regulated and also funded or conducted by DHHS must describe the need to apply both regulations to the research, including Subparts D when the research involves children.When reviewing an organization outside of the US, refer to the Addendum for any county-specific laws regarding research involving orphans, wards of the state, or other terms for children without legal guardians who are in custody of a government agency.",
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 "keywords": "fda-independent-irb---reviews-research-with-children,fda-internal-irb---reviews-research-with-children",
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 {
 "type": "text/review-assessment-snippet",
 "key": "us-fda--additional-protections-for-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA requirements for research involving children:<ul><li>The IRB/EC determines whether the criteria for approval of research are met when research involves children. In addition, the IRB/EC determines and documents which of the following categories apply to the research:<ul><li>Category 1:<ul><li>No greater than minimal risk to children is presented.</li></ul></li><li>Category 2:<ul><li>More than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual participant, or by a monitoring procedure that is likely to contribute to the participant’s well-being.</li><li>The risk is justified by the anticipated benefit to the participants.</li><li>The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.</li></ul></li><li>Category 3:<ul><li>More than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual participant, or by a monitoring procedure, which is not likely to contribute to the well-being of the participant.</li><li>The risk represents a minor increase over minimal risk.</li><li>The intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations.</li><li>The intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition which is of vital importance for the understanding or amelioration of the participants’ disorder or condition.</li></ul></li><li>Category 4:<ul><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.</li><li>The federal agency, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determined either (if not federally funded, the organization can substitute an equivalent mechanism):<ul><li>That the research fell into categories 1 through 3; or</li><li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles.</li></ul></li></ul></li></ul></li><li>The IRB/EC determines whether the criteria for approval of research are met when research in Category 3 or 4 involves wards of the state or any other agency. The IRB/EC determines and documents that:<ul><li>The research is:<ul><li>Related to their status as wards; or</li><li>Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.</li></ul></li><li>The IRB/EC requires appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.<ul><li>The advocate is an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research.</li><li>The advocate is not associated in any way (except in the role as advocate or member of the IRB/EC) with the research, the researchers, or the guardian.</li></ul></li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dod--additional-protections-for-vulnerable-populations",
 "title": "When following DoD requirements, written materials describe that r<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">esearch involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D, except where modified by DoDI 3216.02.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">In addition, written materials describe that:<ul><li>Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of the command structure of the organization. Therefore, additional protections for DoD-affiliated personnel are required, as follows (DoDI 3216.02 section 3.9 (f)):<ul><li>If the research involves DoD-affiliated personnel as  participants and if the research includes any risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.</li><li>If the research involves DoD-affiliated personnel, the researcher must receive command or component approval to execute the research.</li><li>Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in research.</li><li>Military and civilian supervisors, officers, and others in the chain of command must not be present at any participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in the chain of command may participate in separate recruitment sessions, if applicable.</li><li>Service members and all Reserve component and National Guard members in a federal duty status are considered to be adults. If a Service member, Reserve component or National Guard member in federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB/EC must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.</li><li>In order to approve research involving DoD-affiliated personnel, the IRB/EC or component HRPO must determine whether the following requirements have been satisfied:<ul><li>The consent documentation must include, if applicable, potential risks for revocation of clearance, credentials, or other privileged access or duty.</li><li>For research involving recruitment of DoD-affiliated personnel in research determined to be greater than minimal risk, and when recruitment occurs in a group setting, the IRB/EC must appoint an ombudsperson. The ombudsperson:<ul><li>Must not have a conflict of interest with the research or be a part of the research team.</li><li>Must be present during the recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.</li><li>Should be available to address DoD-affiliated personnel’s concerns about participation.</li></ul></li><li>Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with 5 USC, with particular reference to Subparts G and H, with some exceptions for purposes consistent with 24 USC 30.</li></ul></li></ul></li></ul><ul type=\"disc\"><li>Research involving large-scale genomic data from DoD-affiliated personnel is subject to additional requirements:</li><ul type=\"disc\"><li>The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security; accordingly, written materials must describe administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of de-identified data or specimens.</li><li>All research involving large-scale genomic data collected from DoD-affiliated personnel must have a Certificate of Confidentiality from DHHS (Title 42, U.S.C., and Public Law 114-255).</li><li>Research involving large-scale genomic data collected from DoD-affiliated personnel is subject to DoD component security review to ensure the adequacy of the proposed administrative, technical, and physical safeguards, including the secondary use or sharing of de-identified data or specimens.</li></ul></ul><ul><li>DoD organizations must demonstrate to the senior designated official that the IRB/EC has fulfilled its duties in accordance with DHHS Subpart D, 45 CFR 46. 407 and 21 CFR 50.54.</li></ul>",
 "description": "",
 "keywords": "dod--independent-irb-that-reviews-research-involving-children,dod--independent-irb-that-reviews-research-involving-prisoners,dod--independent-irb-that-reviews-research-with-pregnant-individuals-fetuses-or-neonates,dod--internal-irb-that-reviews-research-involving-children,dod--irb-that-reviews-research-involving-prisoners,dod--internal-irb-that-reviews-research-with-pregnant-individuals-fetuses-or-neonates",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dod--additional-protections-for-vulnerable-populations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements:<ul><li>R<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">esearch involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D, except where modified by DoDI 3216.02.</li><li>Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of the command structure of the organization. Therefore, additional protections for DoD-affiliated personnel are required, as follows (DoDI 3216.02 section 3.9 (f)):<ul><li>If the research involves DoD-affiliated personnel as  participants and if the research includes any risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.</li><li>If the research involves DoD-affiliated personnel, the researcher must receive command or component approval to execute the research.</li><li>Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in research.</li><li>Military and civilian supervisors, officers, and others in the chain of command must not be present at any participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in the chain of command may participate in separate recruitment sessions, if applicable.</li><li>Service members and all Reserve component and National Guard members in a federal duty status are considered to be adults. If a Service member, Reserve component or National Guard member in federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB/EC must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.</li><li>In order to approve research involving DoD-affiliated personnel, the IRB/EC or component HRPO must determine whether the following requirements have been satisfied:<ul><li>The consent documentation must include, if applicable, potential risks for revocation of clearance, credentials, or other privileged access or duty.</li><li>For research involving recruitment of DoD-affiliated personnel in research determined to be greater than minimal risk, and when recruitment occurs in a group setting, the IRB/EC must appoint an ombudsperson. The ombudsperson:<ul><li>Must not have a conflict of interest with the research or be a part of the research team.</li><li>Must be present during the recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.</li><li>Should be available to address DoD-affiliated personnel’s concerns about participation.</li></ul></li></ul></li><li>Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with 5 USC, with particular reference to Subparts G and H, with some exceptions for purposes consistent with 24 USC 30.</li></ul></li></ul><ul type=\"disc\"><li>Research involving large-scale genomic data from DoD-affiliated personnel is subject to additional requirements:</li><ul type=\"disc\"><li>The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security; accordingly, written materials must describe administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of de-identified data or specimens.</li><li>All research involving large-scale genomic data collected from DoD-affiliated personnel must have a Certificate of Confidentiality from DHHS (Title 42, U.S.C., and Public Law 114-255).</li><li>Research involving large-scale genomic data collected from DoD-affiliated personnel is subject to DoD component security review to ensure the adequacy of the proposed administrative, technical, and physical safeguards, including the secondary use or sharing of de-identified data or specimens.</li></ul></ul><ul><li>DoD organizations must demonstrate to the senior designated official that the IRB/EC has fulfilled its duties in accordance with DHHS Subpart D, 45 CFR 46. 407 and 21 CFR 50.54.</li></ul>",
 "description": "",
 "keywords": "",
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 }
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 },
 {
 "type": "question/review-assessment",
 "key": "dod--additional-protections-for-pregnant-individuals--fetuses--and-neonates",
 "title": "When following DoD requirements, written materials describe:<ul><li>For purposes of applying Subpart B, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.”</li><li>The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.</li><li>Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.<ul><li>Research or experimentation may not be conducted, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation:<ul><li>May enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or</li><li>Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.</li></ul></li><li>The risk standard must be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.</li><li>For human participant research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, written approval from the DOHRP must be obtained through the COHPR prior to research starting.</li></ul></li></ul>",
 "description": "",
 "keywords": "dod--independent-irb-that-reviews-research-with-pregnant-individuals-fetuses-or-neonates,dod--internal-irb-that-reviews-research-with-pregnant-individuals-fetuses-or-neonates",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dod--additional-protections-for-pregnant-women--fetuses--and-neonates",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements:<ul type=\"disc\"><li>For purposes of applying Subpart B, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.”</li><li>The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.</li><li>Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.</li><ul type=\"disc\"><li>Research or experimentation may not be conducted, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation:</li><ul type=\"disc\"><li>May enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or</li><li>Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.</li></ul><li>The risk standard must be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.</li><li>For human participant research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, written approval from the DOHRP must be obtained through the COHPR prior to research starting.</li> </ul></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "dod--additional-protections-for-prisoners",
 "title": "When following DoD requirements, written materials describe: <ul><li>In addition to the categories of permissible human participant research involving prisoners identified in DHHS regulations Subpart C, two additional categories are permissible:</li><li><ul><li>Epidemiological research is permitted under the following conditions:<ul><li>Where the sole purpose of the research is to describe the prevalence or incidence of a disease by identifying all cases, or study potential risk factor associations for a disease.</li><li>The research presents no more than minimal risk.</li><li>The research involves no more than inconvenience to the prisoner-participants.</li><li>Prisoners are not a particular focus of the research.</li></ul></li><li>Human participant research involving prisoners that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB/EC and meet the requirements of Subpart C and DoDI 3216.02.</li></ul></li><li>DoD organizations conducting research involving prisoners must demonstrate to the senior designated official that the IRB/EC has fulfilled its duties in accordance with Subpart C.</li><li>When a previously enrolled human participant becomes a prisoner, and the protocol has not been reviewed and approved by the IRB/EC in accordance with Subpart C, the researcher must promptly notify the IRB/EC. <ul><li>For DoD-conducted research, the human protections director must notify the COHRP.</li><li>For DoD-supported research, the non-DoD organization must notify the DOHRP and other federal agencies.</li><li>The DOHRP must concur with the IRB/EC before the participant can continue to participate while a prisoner.</li></ul></li><li>Research involving a detainee or a prisoner of war as a human participant is prohibited:<ul><li>This prohibition does not apply to activities covered by investigational new drug or investigational device provisions of FDA regulations, when the purpose is for diagnosis or treatment of a medical condition in a patient.</li><li>Such treatment may be offered to detainees or prisoners of war with their informed consent when the medical products are subject to FDA regulations, and only when the same product may be available to DoD-affiliated personnel consistent with established medical practices.</li></ul></li></ul>",
 "description": "",
 "keywords": "dod--independent-irb-that-reviews-research-involving-prisoners,dod--irb-that-reviews-research-involving-prisoners",
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 {
 "type": "text/review-assessment-snippet",
 "key": "dod--additional-protections-for-prisoners",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements:<ul><li>In addition to the categories of permissible human participant research involving prisoners identified in DHHS</li><li>regulations Subpart C, two additional categories are permissible:<ul><li>Epidemiological research is permitted under the following conditions:<ul><li>Where the sole purpose of the research is to describe the prevalence or incidence of a disease by identifying all cases, or study potential risk factor associations for a disease.</li><li>The research presents no more than minimal risk.</li><li>The research involves no more than inconvenience to the prisoner-participants.</li><li>Prisoners are not a particular focus of the research.</li></ul></li><li>Human participant research involving prisoners that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB/EC and meet the requirements of Subpart C and DoDI 3216.02.</li></ul></li><li>DoD organizations conducting research involving prisoners must demonstrate to the senior designated official that the IRB/EC has fulfilled its duties in accordance with Subpart C.</li><li>When a previously enrolled human participant becomes a prisoner, and the protocol has not been reviewed and approved by the IRB/EC in accordance with Subpart C, the researcher must promptly notify the IRB/EC.<ul><li>For DoD-conducted research, the human protections director must notify the COHRP.</li><li>For DoD-supported research, the non-DoD organization must notify the DOHRP and other federal agencies.</li><li>The DOHRP must concur with the IRB/EC before the participant can continue to participate while a prisoner.</li></ul></li><li>Research involving a detainee or a prisoner of war as a human participant is prohibited:<ul><li>This prohibition does not apply to activities covered by investigational new drug or investigational device provisions of FDA regulations, when the purpose is for diagnosis or treatment of a medical condition in a patient.</li><li>Such treatment may be offered to detainees or prisoners of war with their informed consent when the medical products are subject to FDA regulations, and only when the same product may be available to DoD-affiliated personnel consistent with established medical practices.</li></ul></li></ul>",
 "description": "",
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 }
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 },
 {
 "type": "question/review-assessment",
 "key": "doe--additional-protections-for-vulnerable-populations",
 "title": "When following DOE requirements, written materials describe: <ul><li>DOE staff and DOE site contractors are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team), and that data collected about them is kept confidential.</li><li>The IRB/EC must consider if additional protections are required for research involving employees and contractors.</li></ul>",
 "description": "",
 "keywords": "doe-facility-with-internal-irb,irb-ec---reviews-doe-research,serves-as-an-irb-for-doe-organizations",
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 {
 "type": "text/review-assessment-snippet",
 "key": "doe--additional-protections-for-vulnerable-populations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DOE requirements:<ul type=\"disc\"><li>DOE staff and DOE site contractors are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team), and that data collected about them is kept confidential.</li><li>The IRB/EC must consider if additional protections are required for research involving employees and contractors.</li></ul> ",
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 },
 {
 "type": "question/review-assessment",
 "key": "doj--application-of-common-rule-subparts-b-d",
 "title": "When following DoJ requirements, written materials describe that <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">DoJ has not adopted the Common Rule Subparts. <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">GUIDANCE<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">For organizations\nthat ONLY apply DoJ requirements, evaluate for equivalent protections, but keep\nin mind that they are not required to follow Common Rule subparts, e.g.,\nSubpart C for review of research involving prisoners.",
 "description": "",
 "keywords": "doj-facility-with-internal-irb,irb-ec-reviews-doj-research,serves-as-an-irb-for-doj-research",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "doj--application-of-common-rule-subparts-b-d",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoJ requirements, the DoJ has not adopted the Common Rule Subparts.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "epa--additional-protections-for-pregnant-individuals",
 "title": "When following EPA requirements, written materials describe:<ul><li>Research involving intentional exposure of pregnant women to any substance is prohibited and not approved by the IRB.</li><li>For research intended for submission to the EPA, research involving intentional exposure of pregnant women to any substance is prohibited and not approved by the IRB/EC.</li><li>The IRB/EC must review observational research involving pregnant women and fetuses using 40 CFR 26 and 45 CFR 46 Subpart B.</li></ul>",
 "description": "",
 "keywords": "epa---independent-irb---reviews-research-with-pregnant-individuals,epa---internal-irb---reviews-research-with-pregnant-individuals",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "epa--additional-protections-for-pregnant-women",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following EPA requirements:<ul type=\"disc\"><li>Research involving intentional exposure of pregnant women to any substance is prohibited and not approved by the IRB.</li><li>For research intended for submission to the EPA, research involving intentional exposure of pregnant women to any substance is prohibited and not approved by the IRB/EC.</li><li>The IRB/EC must review observational research involving pregnant women and fetuses using 40 CFR 26 and 45 CFR 46 Subpart B.</li></ul>",
 "description": "",
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 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "epa--additional-protections-for-children",
 "title": "When following EPA requirements, written materials describe: <ul><li>Research involving intentional exposure of children to any substance is prohibited and not approved by the IRB.</li><li>For research intended for submission to the EPA, research involving intentional exposure of children to any substance is prohibited and not approved by the IRB/EC.</li><li>The IRB/EC must review and approve observational research involving children that does not involve greater than minimal risk only if the IRB/EC finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 26.406.</li><li>The IRB/EC may only approve observational research involving children that involves greater than minimal risk but presenting the prospect of direct benefit to the individual participants if the IRB/EC finds and documents that:</li><li>The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.</li><li>The risk is justified by the anticipated benefit to the participants.</li><li>The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.</li><li>Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 26.406. </li></ul>",
 "description": "",
 "keywords": "epa---independent-irb---reviews-research-with-children,epa---internal-irb---reviews-research-with-children",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "epa--additional-protections-for-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following EPA requirements:<ul><li>Research involving intentional exposure of children to any substance is prohibited and not approved by the IRB.</li><li>For research intended for submission to the EPA, research involving intentional exposure of children to any substance is prohibited and not approved by the IRB/EC.</li><li>The IRB/EC must review and approve observational research involving children that does not involve greater than minimal risk only if the IRB/EC finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 26.406.</li><li>The IRB/EC may only approve observational research involving children that involves greater than minimal risk but presenting the prospect of direct benefit to the individual participants if the IRB/EC finds and documents that:</li><li>The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.</li><li>The risk is justified by the anticipated benefit to the participants.</li><li>The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.</li><li>Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 26.406. </li></ul>",
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 "type": "question/review-assessment",
 "key": "va--additional-protections-for-pregnant-individuals--fetuses--and-neonates",
 "title": "When following VA requirements, written materials:<ul><li>For research involving pregnant individuals, fetuses, and neonates:<ul style=\"margin-left: 30px\"><li>Research that involves provision of in vitro fertilization services is permitted and can be conducted by VA researchers while on official VA duty, or at VA facilities, or at VA-approved off-site facilities.<ul><li>This includes prospective and retrospective research involving provision of or the enhancement of FDA-approved methods of in vitro fertilization for studies involving consenting participants, both male and female, undergoing or who have undergone in vitro fertilization for the treatment of certain forms of human infertility. In vitro fertilization is any fertilization of human ova that occurs outside the body of a female, either through a mixture of donor human sperm and ova or by any other means.</li></ul></li><li>Prospective and retrospective studies that enroll or include pregnant participants who conceived through in vitro fertilization or other artificial reproductive technologies are permitted.</li><li>Research that uses human fetal tissue or that focuses on either a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA researchers while on official VA duty, at VA facilities, or at VA-approved off-site facilities. Use of stem cells shall be governed by the policy set by NIH for recipients of NIH research funding. </li><li>Research involving the creation of a human embryo or embryos solely for research purposes or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498B of the Public Health Service Act (42 U.S.C. 289g(b)) cannot be conducted by VA researchers, at VA facilities, or at VA-approved off-site facilities.</li><li>Women who are known to be pregnant and their fetuses may be involved in research if all the following requirements are met and the VA medical facility Director certifies that the VA medical facility has sufficient expertise in women’s or reproductive health to conduct the proposed research if the research includes interventional studies or invasive monitoring of pregnant women as participants.</li><li>VA researchers cannot conduct interventions in research that include neonates while on official VA duty, at VA facilities, or at VA-approved off-site facilities. VA researchers may conduct research involving noninvasive monitoring of neonates if the research is determined by the IRB/EC to be minimal risk. Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted.<ul><li>The reviewing IRB/EC must have the appropriate expertise to evaluate any VA research involving neonates and must comply with the requirements of 45 CFR 46.205. The VA medical facility Director must certify that the medical facility has sufficient expertise in neonatal health to conduct the proposed research.</li></ul></li></ul></li></ul>",
 "description": "",
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 {
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 "key": "va--additional-protections-for-pregnant-women--fetuses--and-neonates",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements:<ul><li>For research involving pregnant women, fetuses, and neonates:<ul><li>Research that involves provision of in vitro fertilization services is permitted and can be conducted by VA researchers while on official VA duty, or at VA facilities, or at VA-approved off-site facilities.<ul><li>This includes prospective and retrospective research involving provision of or the enhancement of FDA-approved methods of in vitro fertilization for studies involving consenting participants, both male and female, undergoing or who have undergone in vitro fertilization for the treatment of certain forms of human infertility. In vitro fertilization is any fertilization of human ova that occurs outside the body of a female, either through a mixture of donor human sperm and ova or by any other means.</li></ul></li><li>Prospective and retrospective studies that enroll or include pregnant participants who conceived through in vitro fertilization or other artificial reproductive technologies are permitted.</li><li>Research that uses human fetal tissue or that focuses on either a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA researchers while on official VA duty, at VA facilities, or at VA-approved off-site facilities. Use of stem cells shall be governed by the policy set by NIH for recipients of NIH research funding.</li><li>Research involving the creation of a human embryo or embryos solely for research purposes or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498B of the Public Health Service Act (42 U.S.C. 289g(b)) cannot be conducted by VA researchers, at VA facilities, or at VA-approved off-site facilities.</li><li>Women who are known to be pregnant and their fetuses may be involved in research if all the following requirements are met and the VA medical facility Director certifies that the VA medical facility has sufficient expertise in women’s or reproductive health to conduct the proposed research if the research includes interventional studies or invasive monitoring of pregnant women as participants.</li><li>VA researchers cannot conduct interventions in research that include neonates while on official VA duty, at VA facilities, or at VA-approved off-site facilities. VA researchers may conduct research involving noninvasive monitoring of neonates if the research is determined by the IRB/EC to be minimal risk. Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted.<ul><li>The reviewing IRB/EC must have the appropriate expertise to evaluate any VA research involving neonates and must comply with the requirements of 45 CFR 46.205. The VA medical facility Director must certify that the medical facility has sufficient expertise in neonatal health to conduct the proposed research.</li></ul></li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "va--additional-protections-for-prisoners",
 "title": "When following VA requirements, written materials describe:<ul><li>For research involving prisoners:<ul><li>Research involving prisoners cannot be conducted by VA researchers while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the VA Chief Research and Development Officer (CRADO). (VHA Directive 1200.05)</li><li>Waiver requests, along with supporting documentation from the IRB, must be submitted to the CRADO by the VA medical facility Director stating support for the conduct of the VA study involving prisoners.</li><li>If such a waiver is granted, the research must comply with the requirements of 45 CFR 46.301 - 46.306.</li></ul></li></ul>",
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 "key": "va--additional-protections-for-prisoners",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements:<ul><li>For research involving prisoners:<ul><li>Research involving prisoners cannot be conducted by VA researchers while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the VA Chief Research and Development Officer (CRADO). (VHA Directive 1200.05)</li><li>Waiver requests, along with supporting documentation from the IRB, must be submitted to the CRADO by the VA medical facility Director stating support for the conduct of the VA study involving prisoners.</li><li>If such a waiver is granted, the research must comply with the requirements of 45 CFR 46.301 - 46.306.</li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "va--additional-protections-for-children",
 "title": "When following VA requirements, written materials describe:<ul><li>For research involving children:<ul><li>Research involving children as participants is not allowed unless a waiver has been granted by the VA medical facility director.</li><li>Research involving children may not pose greater than minimal risk to the child. (VHA Directive 1200.05 Section 21)</li><li>Biological specimens and data obtained from children is considered research involving children even if deidentified.</li></ul></li></ul>",
 "description": "",
 "keywords": "org-is-va-with-internal-irb,serves-as-an-irb-for-va-facilities",
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 "type": "text/review-assessment-snippet",
 "key": "va--additional-protections-for-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements:<ul><li>For research involving children:<ul><li>Research involving children as participants is not allowed unless a waiver has been granted by the VA medical facility director.</li><li>Research involving children may not pose greater than minimal risk to the child. (VHA Directive 1200.05 Section 21)</li><li>Biological specimens and data obtained from children is considered research involving children even if deidentified.</li></ul></li></ul>",
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 {
 "type": "section/element",
 "key": "element-ii-4-b",
 "title": "ELEMENT II.4.B.",
 "description": "The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question. ",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
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 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 {
 "type": "question/review-assessment",
 "key": "diminished-decision-making-capacity--consent-process-evaluation",
 "title": "Essential requirementsWritten materials describe that when a research study involves populations with diminished decision-making capacity not covered by specific policies and procedures, describe, in general, the steps followed by the IRB/EC to evaluate the consent process for these populations.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "diminished-decision-making-capacity--consent-process-evaluation",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When a research study involves populations with diminished decision-making capacity not covered by specific policies and procedures, describe, in general, the steps followed by the IRB/EC to evaluate the consent process for these populations.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "consent-process--research-involving-pregnant-women--fetuses--or-neonates",
 "title": "Essential RequirementsWritten materials describe that when research involves pregnant women, fetuses, or neonates, the IRB/EC follows Subpart B of the DHHS regulations or equivalent laws or regulations to approve an appropriate consent process.GUIDANCEIf the organization uses equivalent protections for non-regulated research, indicate this in the General Comment section.",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-pregnant-women--fetuses--or-neonates",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "consent-process--research-involving-pregnant-women--fetuses--or-neonates",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When research involves pregnant women, fetuses, or neonates, the IRB/EC follows Subpart B of the DHHS regulations or equivalent laws or regulations to approve an appropriate consent process.",
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 {
 "type": "question/review-assessment",
 "key": "consent-process--research-involving-prisoners",
 "title": "Essential RequirementsWritten materials describe that when research involves prisoners as participants, the IRB/EC follows Subpart C of the DHHS regulations or equivalent laws or regulations to approve an appropriate consent process that includes a determination that:<ul><li>The information will be presented in language that is understandable to prisoners.</li><li>Each prisoner will be informed in advance that participation in the research will have no effect on his or her parole.</li></ul>GUIDANCEIf the organization uses equivalent protections for non-regulated research, indicate this in the General Comment section.",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-prisoners",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "consent-process--research-involving-prisoners",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When research involves prisoners as participants, the IRB/EC follows Subpart C of the DHHS regulations or equivalent laws or regulations to approve an appropriate consent process that includes a determination that:<ul><li>The information will be presented in language that is understandable to prisoners.</li><li>Each prisoner will be informed in advance that participation in the research will have no effect on his or her parole.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "consent-process--research-involving-children",
 "title": "Essential RequirementsWritten materials describe that when research involves children as participants, the IRB/EC follows Subpart D of the DHHS or FDA regulations or equivalent laws or regulations to approve an appropriate assent process for children and consent process for parents or guardians.GUIDANCEIf the organization uses equivalent protections for non-regulated research, indicate this in the General Comment section.",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-children",
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 {
 "type": "text/review-assessment-snippet",
 "key": "consent-process--research-involving-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When research involves children as participants, the IRB/EC follows Subpart D of the DHHS or FDA regulations or equivalent laws or regulations to approve an appropriate assent process for children and consent process for parents or guardians.",
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 },
 {
 "type": "question/review-assessment",
 "key": "consent-process--adults-who-lack-the-ability-to-consent",
 "title": "Essential RequirementsWritten materials describe that when researchers are likely to approach adults who lack the ability to consent, the IRB/EC evaluates whether:<ul><li>The proposed plan for the assessment of the capacity to consent is adequate.</li><li>Assent of the participants is a requirement, and, if so, whether the plan for assent is adequate.</li></ul>",
 "description": "",
 "keywords": "irb-ec---reviews-research-involving-adults-unable-to-consent",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "consent-process--research-involving-adults-who-lack-the-ability-to-consent",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When researchers are likely to approach adults who lack the ability to consent, the IRB/EC evaluates whether:<ul><li>The proposed plan for the assessment of the capacity to consent is adequate.</li><li>Assent of the participants is a requirement, and, if so, whether the plan for assent is adequate.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs---consent-process--research-involving-pregnant-women--fetuses--or-neonates",
 "title": "When following DHHS requirements, written materials (page XX):<ul><li>When research involves pregnant women, the IRB/EC determines that the consent of the pregnant women is required if the research holds out:<ul><li>The prospect of direct benefit to the pregnant woman.</li><li>The prospect of direct benefit both to the pregnant woman and the fetus.</li><li>No prospect of benefit for the woman or the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means.</li></ul></li><li>When research involves pregnant women, the IRB/EC determines that the consent of the pregnant woman and the father is required, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest if the research holds out the prospect of direct benefit solely to the fetus.</li><li>When the research involves neonates of uncertain viability, the IRB/EC determines that the consent of either parent of the neonate is required or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective consent of either parent’s legally authorized representative is required, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.</li><li>When the research involves non-viable neonates, the IRB/EC determines that the consent of both parents is required, except:<ul><li>If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the consent of one parent is required.</li><li>If the pregnancy resulted from rape or incest the consent of the father need not be obtained.</li></ul></li><li>When the research involves non-viable neonates, the IRB/EC is not allowed to approve the consent of a legally authorized representative.</li></ul>",
 "description": "",
 "keywords": "dhhs--independent-irb-reviews-research-with-pregnant-individuals-fetuses-or-neonates,dhhs-internal-irb-reviews-research-with-pregnant-individuals-fetuses-or-neonates",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "dhhs---consent-process--research-involving-pregnant-women--fetuses--or-neonates",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements:<ul><li>When research involves pregnant women, the IRB/EC determines that the consent of the pregnant women is required if the research holds out:<ul><li>The prospect of direct benefit to the pregnant woman.</li><li>The prospect of direct benefit both to the pregnant woman and the fetus.</li><li>No prospect of benefit for the woman or the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means.</li></ul></li><li>When research involves pregnant women, the IRB/EC determines that the consent of the pregnant woman and the father is required, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest if the research holds out the prospect of direct benefit solely to the fetus.</li><li>When the research involves neonates of uncertain viability, the IRB/EC determines that the consent of either parent of the neonate is required or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective consent of either parent’s legally authorized representative is required, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.</li><li>When the research involves non-viable neonates, the IRB/EC determines that the consent of both parents is required, except:<ul><li>If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the consent of one parent is required.</li><li>If the pregnancy resulted from rape or incest the consent of the father need not be obtained.</li></ul></li><li>When the research involves non-viable neonates, the IRB/EC is not allowed to approve the consent of a legally authorized representative.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs-fda---consent-process--research-involving-children",
 "title": "When following DHHS and/or US FDA requirements, written materials describe:<ul><li>When research involves children, the IRB/EC follows the requirements in Subpart D pertaining to obtaining assent of children and permission of the parents or guardian. </li><li>For research that involves no more than minimal risk or more than minimal risk with the prospect of direct benefit to the individual children, the IRB/EC determines whether:<ul><li>The permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, or the permission of one parent is sufficient.</li></ul></li><li>For research that involves more than minimal risk without the prospect of direct benefit to the individual children, the IRB/EC determines that the permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.</li><li>The IRB/EC determines and documents that assent is a requirement of:<ul><li>All children.</li><li>Some children.</li><li>None of the children.</li></ul></li><li>When the IRB/EC determines that assent is not a requirement of some children, the IRB/EC determines and documents which children are not required to assent.</li><li>When the IRB/EC determines that assent is not a requirement for some or all children, the IRB/EC determines and documents one or more of the following:<ul><li>The children are not capable of providing assent based on the age, maturity, or psychological state.</li><li>The capability of the children is so limited that they cannot reasonably be consulted.</li><li>The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research.</li><li>Assent can be waived using the criteria for waiver of the consent process.</li></ul></li><li>When the IRB/EC determines that assent is a requirement, the IRB/EC determines whether:<ul><li>Assent will be documented.</li><li>If so, the process to document assent.</li></ul></li></ul>",
 "description": "",
 "keywords": "dhhs-independent-irb---reviews-research-with-children,dhhs-internal-irb---reviews-research-with-children,fda-independent-irb---reviews-research-with-children,fda-internal-irb---reviews-research-with-children",
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 "type": "text/review-assessment-snippet",
 "key": "dhhs-fda---consent-process--research-involving-children",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS and/or US FDA requirements:<ul><li>When research involves children, the IRB/EC follows the requirements in Subpart D pertaining to obtaining assent of children and permission of the parents or guardian.</li><li>For research that involves no more than minimal risk or more than minimal risk with the prospect of direct benefit to the individual children, the IRB/EC determines whether:<ul><li>The permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, or the permission of one parent is sufficient.</li></ul></li><li>For research that involves more than minimal risk without the prospect of direct benefit to the individual children, the IRB/EC determines that the permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.</li><li>The IRB/EC determines and documents that assent is a requirement of:<ul><li>All children.</li><li>Some children.</li><li>None of the children.</li></ul></li><li>When the IRB/EC determines that assent is not a requirement of some children, the IRB/EC determines and documents which children are not required to assent.</li><li>When the IRB/EC determines that assent is not a requirement for some or all children, the IRB/EC determines and documents one or more of the following:<ul><li>The children are not capable of providing assent based on the age, maturity, or psychological state.</li><li>The capability of the children is so limited that they cannot reasonably be consulted.</li><li>The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research.</li><li>Assent can be waived using the criteria for waiver of the consent process.</li></ul></li><li>When the IRB/EC determines that assent is a requirement, the IRB/EC determines whether:<ul><li>Assent will be documented.</li><li>If so, the process to document assent.</li></ul></li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "dod--legally-authorized-representative",
 "title": "When following DoD requirements, <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">written materials describe that if consent is to be\nobtained from the legal representative of the experimental subjects as defined\nin DODI 3216.02, the research must intend to benefit each participant enrolled\nin the study.",
 "description": "",
 "keywords": "dod-facility-with-internal-irb,serves-as-an-irb-for-dod-organizations",
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 "key": "dod--legally-authorized-representative",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements, if consent is to be obtained from the legal representative of the experimental subjects as defined in DODI 3216.02, the research must intend to benefit each participant enrolled in the study.",
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 },
 {
 "type": "question/review-assessment",
 "key": "ed--protection-of-pupil-rights-amendment",
 "title": "When following ED requirements, written materials describe:<ul><li>The process to comply with the Protection of Pupil Rights Amendment:<ul><li>For research funded by the US Department of Education, no student shall be required, as part of any research project, to submit without prior consent to surveys, psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:</li><li>Political affiliations.</li><li>Mental and psychological problems potentially embarrassing to the student or his or her family.</li><li>Sex behavior and attitudes.</li><li>Illegal, anti-social, self-incriminating, and demeaning behavior.</li><li>Critical appraisals of other individuals with whom the student has close family relationships.</li><li>Legally recognized privileged and analogous relationships, such as those of lawyers, physicians, and ministers. </li><li>Religious practices, affiliations, or beliefs of the student or student’s parent.</li><li>Income, other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under a program.</li></ul></li><li>Prior consent means:<ul><li>Prior consent of the student, if the student is an adult or emancipated minor; or</li><li>Prior written consent of the parent or guardian, if the student is an un-emancipated minor. Schools and contractors obtain prior written parental consent before minor students are required to participate in any ED-funded survey, analysis, or evaluation.</li></ul></li><li>For certain research not directly funded by the ED and conducted in a school that receives funding from the ED: The IRB/EC must verify compliance with the ED regulations that schools are required to develop and adopt policies in conjunction with parents regarding the following:<ul><li>The right of a parent of a student to inspect, upon the request of the parent, a survey created by a third party before the survey is administered or distributed by a school to a student.<ul><li>Any applicable procedures for granting a request by a parent for reasonable access to such survey within a reasonable period of time after the request is received.</li></ul></li><li>Arrangements to protect student privacy that are provided by the agency in the event of the administration or distribution of a survey to a student containing one or more of the following items (including the right of a parent of a student to inspect, upon the request of the parent, any survey containing one or more of such items):<ul><li>Political affiliations or beliefs of the student or the student’s parent.</li><li>Mental or psychological problems of the student or the student’s family.</li><li>Sex behavior or attitudes.</li><li>Illegal, anti-social, self-incriminating, or demeaning behavior.</li><li>Critical appraisals of other individuals with whom respondents have close family relationships.</li><li>Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers.</li><li>Religious practices, affiliations, or beliefs of the student or the student’s parent.</li><li>Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).</li></ul></li><li>The right of a parent of a student to inspect, upon the request of the parent, any instructional material used as part of the educational curriculum for the student.</li><li> Any applicable procedures for granting a request by a parent for reasonable access to instructional material received.</li><li>The administration of physical examinations or screenings that the school or agency may administer to a student.</li><li>The collection, disclosure, or use of personal information collected from students for the purpose of marketing or for selling that information (or otherwise providing that information to others for that purpose), including arrangements to protect student privacy that are provided by the agency in the event of such collection, disclosure, or use.</li><li>The right of a parent of a student to inspect, upon the request of the parent, any instrument used in the collection of personal information before the instrument is administered or distributed to a student.</li><li>Any applicable procedures for granting a request by a parent for reasonable access to such instrument within a reasonable period of time after the request is received.</li></ul></li></ul>",
 "description": "",
 "keywords": "ed-independent-irb,ed-internal-irb",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "ed--protection-of-pupil-rights-amendment",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following ED requirements:<ul><li>The process to comply with the Protection of Pupil Rights Amendment:<ul><li>For research funded by the US Department of Education, no student shall be required, as part of any research project, to submit without prior consent to surveys, psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:</li><li>Political affiliations.</li><li>Mental and psychological problems potentially embarrassing to the student or his or her family.</li><li>Sex behavior and attitudes.</li><li>Illegal, anti-social, self-incriminating, and demeaning behavior.</li><li>Critical appraisals of other individuals with whom the student has close family relationships.</li><li>Legally recognized privileged and analogous relationships, such as those of lawyers, physicians, and ministers.</li><li>Religious practices, affiliations, or beliefs of the student or student’s parent.</li><li>Income, other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under a program.</li></ul></li><li>Prior consent means:<ul><li>Prior consent of the student, if the student is an adult or emancipated minor; or</li><li>Prior written consent of the parent or guardian, if the student is an un-emancipated minor. Schools and contractors obtain prior written parental consent before minor students are required to participate in any ED-funded survey, analysis, or evaluation.</li></ul></li><li>For certain research not directly funded by the ED and conducted in a school that receives funding from the ED: The IRB/EC must verify compliance with the ED regulations that schools are required to develop and adopt policies in conjunction with parents regarding the following:<ul><li>The right of a parent of a student to inspect, upon the request of the parent, a survey created by a third party before the survey is administered or distributed by a school to a student.<ul><li>Any applicable procedures for granting a request by a parent for reasonable access to such survey within a reasonable period of time after the request is received.</li></ul></li><li>Arrangements to protect student privacy that are provided by the agency in the event of the administration or distribution of a survey to a student containing one or more of the following items (including the right of a parent of a student to inspect, upon the request of the parent, any survey containing one or more of such items):<ul><li>Political affiliations or beliefs of the student or the student’s parent.</li><li>Mental or psychological problems of the student or the student’s family.</li><li>Sex behavior or attitudes.</li><li>Illegal, anti-social, self-incriminating, or demeaning behavior.</li><li>Critical appraisals of other individuals with whom respondents have close family relationships.</li><li>Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers.</li><li>Religious practices, affiliations, or beliefs of the student or the student’s parent.</li><li>Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).</li></ul></li><li>The right of a parent of a student to inspect, upon the request of the parent, any instructional material used as part of the educational curriculum for the student.</li><li> Any applicable procedures for granting a request by a parent for reasonable access to instructional material received.</li><li>The administration of physical examinations or screenings that the school or agency may administer to a student.</li><li>The collection, disclosure, or use of personal information collected from students for the purpose of marketing or for selling that information (or otherwise providing that information to others for that purpose), including arrangements to protect student privacy that are provided by the agency in the event of such collection, disclosure, or use.</li><li>The right of a parent of a student to inspect, upon the request of the parent, any instrument used in the collection of personal information before the instrument is administered or distributed to a student.</li><li>Any applicable procedures for granting a request by a parent for reasonable access to such instrument within a reasonable period of time after the request is received.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
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 ]
 }
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 }
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 },
 {
 "type": "section/element",
 "key": "element-ii-4-c",
 "title": "ELEMENT II.4.C.",
 "description": "The IRB or EC has and follows written policies and procedures for making exceptions to consent requirements for planned emergency research and reviews such exceptions according to applicable laws, regulations, codes, and guidance. ",
 "keywords": "non-us---emergency-research---independent-irb,non-us---emergency-research---internal-irb,us---emergency-research---independent-irb,us---emergency-research---internal-irb",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "non-us-based-emergency-research,us-based-emergency-research",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--exception-from-informed-consent-for-emergency-research",
 "title": "When following DHHS requirements and research is not subject to FDA regulations, but follows DHHS regulations, written materials describe that the IRB/EC finds, documents, and reports to DHHS that the following conditions have been met relative to the planned emergency research:<ul><li>The IRB/EC found and documented that the research is not subject to regulations codified by the FDA at 21 CFR 50.</li><li>The research participants are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.</li><li>Obtaining consent is not feasible because:<ul><li>The participants are not able to give their consent as a result of their medical condition.</li><li>The intervention involved in the research is administered before consent from the participants’ legally authorized representatives is feasible.</li><li>There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the research.</li></ul></li><li>Participation in the research held out the prospect of direct benefit to the participants because:<ul><li>Participants are facing a life-threatening situation that necessitated intervention.</li><li>Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence supported the potential for the intervention to provide a direct benefit to the individual participants.</li><li>The risks associated with the research are reasonable in relation to what is known about the medical condition of the potential class of participants, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.</li></ul></li><li>The research could not practicably be carried out without the waiver.</li><li>The proposed research protocol defines the length of the potential therapeutic window based on scientific evidence, and the researcher has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The researcher will summarize efforts made to contact representatives and make this information available to the IRB/EC at the time of continuing review.</li><li>The IRB/EC has reviewed and approved consent procedures and a consent document in accord with 45 CFR 46.116 and 46.117.<ul><li>These procedures and the consent document are to be used with participants or their legally authorized representatives in situations where use of such procedures and documentation is feasible.</li><li>The IRB/EC has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a participant’s participation in the research consistent with the paragraph of this waiver.</li></ul></li><li>Additional protections of the rights and welfare of the participants are provided, including, at least:<ul><li>Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the research is conducted and from which the participants are drawn.</li><li>Public disclosure to the communities in which the research is conducted and from which the participants are drawn, prior to initiation of the research, of plans for the research and its risks and expected benefits.</li><li>Public disclosure of sufficient information following completion of the research to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results.</li><li>Establishment of an independent data monitoring committee to exercise oversight of the research.</li><li>If obtaining consent is not feasible and a legally authorized representative is not reasonably available, the researcher has committed, if feasible, to attempting to contact within the therapeutic window the participant’s family member who is not a legally authorized representative, and asking whether he or she objects to the participant’s participation in the research.<ul><li>The researcher will summarize efforts made to contact family members and make this information available to the IRB/EC at the time of continuing review.</li><li>Procedures are in place to inform, at the earliest feasible opportunity, each participant, or if the participant remained incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, of the participant’s inclusion in the research, the details of the research, and other information contained in the consent document.</li><li>There is a procedure to inform the participant, or if the participant remained incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, that he or she may discontinue the participant’s participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>If a legally authorized representative or family member is told about the research and the participant’s condition improves, the participant is also informed as soon as feasible.</li><li>If a participant is entered into research with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the research is provided to the participant’s legally authorized representative or family member, if feasible.</li><li>For the purposes of this waiver “family member” means any one of the following legally competent persons: spouses; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the participant is the equivalent of a family relationship.</li></ul></li></ul></li></ul>GUIDANCEThis Element generally is not applicable if the organization has an internal IRB/EC or is an independent IRB/EC that does not review planned emergency research that requests a waiver of consent. If you have\nquestions, contact AAHRPP Staff.This Element is most likely not applicable for\norganizations outside the US. Organizations outside the US are not required to\nfollow FDA regulations, and in many cases, are not required to follow DHHS\nregulations. Some countries have laws governing planned emergency consent\nwithout consent (e.g., Australia). Please check the Addendum to see whether\nthis is applicable. If the organization’s policies include planned emergency\nresearch, use FDA’s regulations to evaluate equivalent protections. If you have\nquestions, contact AAHRPP Staff. ",
 "description": "",
 "keywords": "us-based-emergency-research",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--exception-from-informed-consent-for-emergency-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements and research is not subject to FDA regulations, but follows DHHS regulations, the IRB/EC finds, documents, and reports to DHHS that the following conditions have been met relative to the planned emergency research:<ul><li>The IRB/EC found and documented that the research is not subject to regulations codified by the FDA at 21 CFR 50.</li><li>The research participants are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.</li><li>Obtaining consent is not feasible because:<ul><li>The participants are not able to give their consent as a result of their medical condition.</li><li>The intervention involved in the research is administered before consent from the participants’ legally authorized representatives is feasible.</li><li>There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the research.</li></ul></li><li>Participation in the research held out the prospect of direct benefit to the participants because:<ul><li>Participants are facing a life-threatening situation that necessitated intervention.</li><li>Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence supported the potential for the intervention to provide a direct benefit to the individual participants.</li><li>The risks associated with the research are reasonable in relation to what is known about the medical condition of the potential class of participants, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.</li></ul></li><li>The research could not practicably be carried out without the waiver.</li><li>The proposed research protocol defines the length of the potential therapeutic window based on scientific evidence, and the researcher has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The researcher will summarize efforts made to contact representatives and make this information available to the IRB/EC at the time of continuing review.</li><li>The IRB/EC has reviewed and approved consent procedures and a consent document in accord with 45 CFR 46.116 and 46.117.<ul><li>These procedures and the consent document are to be used with participants or their legally authorized representatives in situations where use of such procedures and documentation is feasible.</li><li>The IRB/EC has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a participant’s participation in the research consistent with the paragraph of this waiver.</li></ul></li><li>Additional protections of the rights and welfare of the participants are provided, including, at least:<ul><li>Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the research is conducted and from which the participants are drawn.</li><li>Public disclosure to the communities in which the research is conducted and from which the participants are drawn, prior to initiation of the research, of plans for the research and its risks and expected benefits.</li><li>Public disclosure of sufficient information following completion of the research to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results.</li><li>Establishment of an independent data monitoring committee to exercise oversight of the research.</li><li>If obtaining consent is not feasible and a legally authorized representative is not reasonably available, the researcher has committed, if feasible, to attempting to contact within the therapeutic window the participant’s family member who is not a legally authorized representative, and asking whether he or she objects to the participant’s participation in the research.<ul><li>The researcher will summarize efforts made to contact family members and make this information available to the IRB/EC at the time of continuing review.</li><li>Procedures are in place to inform, at the earliest feasible opportunity, each participant, or if the participant remained incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, of the participant’s inclusion in the research, the details of the research, and other information contained in the consent document.</li><li>There is a procedure to inform the participant, or if the participant remained incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, that he or she may discontinue the participant’s participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>If a legally authorized representative or family member is told about the research and the participant’s condition improves, the participant is also informed as soon as feasible.</li><li>If a participant is entered into research with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the research is provided to the participant’s legally authorized representative or family member, if feasible.</li><li>For the purposes of this waiver “family member” means any one of the following legally competent persons: spouses; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the participant is the equivalent of a family relationship.</li></ul></li></ul></li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "us-fda--exception-from-informed-consent-for-emergency-research",
 "title": "When following FDA requirements, written materials describe that the IRB/EC with the concurrence of a licensed physician who is a member of or consultant to the IRB/EC and who is not otherwise participating in the clinical investigation finds and documents each of the following:<ul><li>The research activity is subject to regulations codified by the Food and Drug Administration (FDA) 21 CFR 50 and will be carried out under an FDA investigational new drug application (IND) or an FDA investigational device exemption (IDE).</li><li>The application clearly identifies the protocols that will include participants who are unable to consent.</li><li>The research participants are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which might include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.</li><li>Obtaining consent is not feasible because:<ul><li>The participants will not be able to give their consent as a result of their medical condition.</li><li>The intervention under investigation must be administered before consent from the participants’ legally authorized representatives is feasible.</li><li>There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.</li></ul></li><li>Participation in the research holds out the prospect of direct benefit to the participants because:<ul><li>Participants are facing a life-threatening situation that necessitates intervention.</li><li>Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence supported the potential for the intervention to provide a direct benefit to the individual participants.</li><li>Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of participants, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.</li></ul></li><li>The clinical investigation could not practicably be carried out without the waiver.</li><li>The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the researcher has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.<ul><li>The researcher will summarize efforts made to contact legally authorized representatives and make this information available to the IRB/EC at the time of continuing review.</li></ul></li><li>The IRB/EC has reviewed and approved consent procedures and a consent document consistent with 50.25. These procedures and the consent document are to be used with participants or their legally authorized representatives in situations where use of such procedures and documentation is feasible.<ul><li>The IRB/EC has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a participant’s participation in the clinical investigation consistent with the paragraph below.</li></ul></li><li>Additional protections of the rights and welfare of the participants will be provided, including, at least:<ul><li>Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the participants will be drawn.</li><li>Public disclosure to the communities in which the clinical investigation will be conducted and from which the participants will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits.</li><li>Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results.</li><li>Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation.</li><li>If obtaining consent is not feasible and a legally authorized representative is not reasonably available, the researcher has committed, if feasible, to attempting to contact within the therapeutic window the participant’s family member who is not a legally authorized representative, and asking whether he or she objects to the participant’s participation in the clinical investigation.<ul><li>The researcher will summarize efforts made to contact family members and make this information available to the IRB/EC at the time of continuing review.</li></ul></li></ul></li><li>Procedures are in place to inform, at the earliest feasible opportunity, each participant, or if the participant remains incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, of the participant’s inclusion in the clinical investigation, the details of the investigation and other information contained in the consent document.</li><li>There is a procedure to inform the participant, or if the participant remains incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, that he or she might discontinue the participant’s participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>If a legally authorized representative or family member is told about the clinical investigation and the participant’s condition improves, the participant is also to be informed as soon as feasible.</li><li>If a participant is entered into a clinical investigation with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the participant’s legally authorized representative or family member, if feasible.</li><li>The protocol is performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identified such protocols as protocols that might include participants who are unable to consent.</li><li>The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists.</li><li>If an IRB/EC determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception or because of other relevant ethical concerns, the IRB/EC must document its findings and provide these findings promptly (no longer than within 30 days) in writing to the clinical investigator and to the sponsor of the clinical investigation.</li></ul>GUIDANCEThis Element generally is not applicable if the organization has an internal IRB/EC or is an independent IRB/EC that does not review planned emergency research that requests a waiver of consent. If you have questions, contact AAHRPP Staff.This Element is most likely not applicable for organizations outside the US. Organizations outside the US are not required to follow FDA regulations, and in many cases, are not required to follow DHHS regulations. Some countries have laws governing planned emergency consent without consent (e.g., Australia). Please check the Addendum to see whether this is applicable. If the organization’s policies include planned emergency research, use FDA’s regulations to evaluate equivalent protections. If you have questions, contact AAHRPP Staff. ",
 "description": "",
 "keywords": "us-based-emergency-research",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "us-fda--exception-from-informed-consent-for-emergency-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following FDA requirements, the IRB/EC with the concurrence of a licensed physician who is a member of or consultant to the IRB/EC and who is not otherwise participating in the clinical investigation finds and documents each of the following:<ul><li>The research activity is subject to regulations codified by the Food and Drug Administration (FDA) 21 CFR 50 and will be carried out under an FDA investigational new drug application (IND) or an FDA investigational device exemption (IDE).</li><li>The application clearly identifies the protocols that will include participants who are unable to consent.</li><li>The research participants are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which might include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.</li><li>Obtaining consent is not feasible because:<ul><li>The participants will not be able to give their consent as a result of their medical condition.</li><li>The intervention under investigation must be administered before consent from the participants’ legally authorized representatives is feasible.</li><li>There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.</li></ul></li><li>Participation in the research holds out the prospect of direct benefit to the participants because:<ul><li>Participants are facing a life-threatening situation that necessitates intervention.</li><li>Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence supported the potential for the intervention to provide a direct benefit to the individual participants.</li><li>Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of participants, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.</li></ul></li><li>The clinical investigation could not practicably be carried out without the waiver.</li><li>The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the researcher has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.<ul><li>The researcher will summarize efforts made to contact legally authorized representatives and make this information available to the IRB/EC at the time of continuing review.</li></ul></li><li>The IRB/EC has reviewed and approved consent procedures and a consent document consistent with 50.25. These procedures and the consent document are to be used with participants or their legally authorized representatives in situations where use of such procedures and documentation is feasible.<ul><li>The IRB/EC has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a participant’s participation in the clinical investigation consistent with the paragraph below.</li></ul></li><li>Additional protections of the rights and welfare of the participants will be provided, including, at least:<ul><li>Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the participants will be drawn.</li><li>Public disclosure to the communities in which the clinical investigation will be conducted and from which the participants will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits.</li><li>Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results.</li><li>Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation.</li><li>If obtaining consent is not feasible and a legally authorized representative is not reasonably available, the researcher has committed, if feasible, to attempting to contact within the therapeutic window the participant’s family member who is not a legally authorized representative, and asking whether he or she objects to the participant’s participation in the clinical investigation.<ul><li>The researcher will summarize efforts made to contact family members and make this information available to the IRB/EC at the time of continuing review.</li></ul></li></ul></li><li>Procedures are in place to inform, at the earliest feasible opportunity, each participant, or if the participant remains incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, of the participant’s inclusion in the clinical investigation, the details of the investigation and other information contained in the consent document.</li><li>There is a procedure to inform the participant, or if the participant remains incapacitated, a legally authorized representative of the participant, or if such a representative is not reasonably available, a family member, that he or she might discontinue the participant’s participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</li><li>If a legally authorized representative or family member is told about the clinical investigation and the participant’s condition improves, the participant is also to be informed as soon as feasible.</li><li>If a participant is entered into a clinical investigation with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the participant’s legally authorized representative or family member, if feasible.</li><li>The protocol is performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identified such protocols as protocols that might include participants who are unable to consent.</li><li>The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists.</li><li>If an IRB/EC determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception or because of other relevant ethical concerns, the IRB/EC must document its findings and provide these findings promptly (no longer than within 30 days) in writing to the clinical investigator and to the sponsor of the clinical investigation.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dod--exception-from-informed-consent-for-emergency-research",
 "title": "When following DoD requirements and reviewing emergency medicine research, written materials describe t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">he process to obtain approval from the DOHRP on behalf of the Secretary of Defense for a waiver of the advance informed consent provision of 10 USC 980 and w<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">ho is responsible and the process they go through to obtain approval.",
 "description": "",
 "keywords": "dod-facility-with-internal-irb,irb-ec---reviews-dod-research,serves-as-an-irb-for-dod-organizations",
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 "key": "dod--exception-from-informed-consent-for-emergency-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements and reviewing emergency medicine research, the process to obtain approval from the DOHRP on behalf of the Secretary of Defense for a waiver of the advance informed consent provision of 10 USC 980 and who is responsible and the process they go through to obtain approval.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--exception-from-informed-consent-for-emergency-research",
 "title": "When following the ICH-GCP (E6) guideline, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as possible in accordance with applicable regulatory requirements and the processes approved by the IRB/EC.</li><li>Where the protocol indicates that prior consent of the trial participant or the participant’s legally acceptable representative is not possible, the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meet applicable regulatory requirements for such trials (e.g., in emergency situations).</li></ul>GUIDANCEFor organizations in other\ncountries, evaluate using country-specific law, not DHHS or FDA requirements.",
 "description": "",
 "keywords": "non-us-based-emergency-research",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "ich-gcp--exception-from-informed-consent-for-emergency-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following the ICH-GCP (E6) guideline, written materials describe:<ul><li>In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as possible in accordance with applicable regulatory requirements and the processes approved by the IRB/EC.</li><li>Where the protocol indicates that prior consent of the trial participant or the participant’s legally acceptable representative is not possible, the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meet applicable regulatory requirements for such trials (e.g., in emergency situations).</li></ul>",
 "description": "",
 "keywords": "",
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 }
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 },
 {
 "type": "question/review-assessment",
 "key": "va--exception-from-informed-consent-for-emergency-research",
 "title": "When following VA requirements, written materials describe lanned emergency\nresearch involving human participants cannot be approved by a VA facility IRB/EC\nor affiliated IRB/EC or Research and Development Committee or performed at VA\nfacilities. ",
 "description": "",
 "keywords": "org-is-va-with-internal-irb,serves-as-an-irb-for-va-facilities",
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 "key": "va--exception-from-informed-consent-for-emergency-research",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements, lanned emergency research involving human participants cannot be approved by a VA facility IRB/EC or affiliated IRB/EC or Research and Development Committee or performed at VA facilities. ",
 "description": "",
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 },
 {
 "type": "section/standard",
 "key": "standard-ii-5",
 "title": "STANDARD II-5",
 "description": "The IRB or EC maintains documentation of its activities.",
 "keywords": "",
 "components": [
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 "type": "section/element",
 "key": "element-ii-5-a",
 "title": "ELEMENT II.5.A.",
 "description": "The IRB or EC maintains a complete set of materials relevant to the review of the research protocol or plan for a period of time sufficient to comply with legal and regulatory requirements, sponsor requirements, and organizational policies and procedures. ",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,org-is-va,us-based-internal-irb",
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 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,org-is-va,us-based-internal-irb",
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 {
 "type": "question/review-assessment",
 "key": "irb-ec-records--records-obtained",
 "title": "Essential RequirementsWritten materials describe that in order to allow a reconstruction of a complete history of IRB/EC actions related to the review and approval of the research, the IRB/EC records include copies of:<ul><li>Protocols or research plans.</li><li>Investigator’s brochure, if any.</li><li>Scientific evaluations, when provided by an entity other than the IRB/EC.</li><li>Recruitment materials.</li><li>Consent documents.</li><li>Progress reports submitted by researchers. </li><li>Reports of injuries to participants.</li><li>Records of continuing review activities.</li><li>Data and safety monitoring reports, if any.</li><li>Modifications to previously approved research.</li><li>Unanticipated problems involving risks to participants or others.</li><li>Documentation of noncompliance.</li><li>Significant new findings.</li><li>All correspondence between the IRB/EC and researchers.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "title": "Add to or describe in written materials [page xx or elsewhere]:In order to allow a reconstruction of a complete history of IRB/EC actions related to the review and approval of the research, the IRB/EC records include copies of:<ul><li>Protocols or research plans.</li><li>Investigator’s brochure, if any.</li><li>Scientific evaluations, when provided by an entity other than the IRB/EC.</li><li>Recruitment materials.</li><li>Consent documents.</li><li>Progress reports submitted by researchers.</li><li>Reports of injuries to participants.</li><li>Records of continuing review activities.</li><li>Data and safety monitoring reports, if any.</li><li>Modifications to previously approved research.</li><li>Unanticipated problems involving risks to participants or others.</li><li>Documentation of noncompliance.</li><li>Significant new findings.</li><li>All correspondence between the IRB/EC and researchers.</li></ul>",
 "description": "",
 "keywords": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-records--expedited-review",
 "title": "Essential RequirementsWritten materials describe that IRB/EC records for initial and continuing review of research by the expedited procedure include:<ul><li>The justification for using the expedited procedure.</li><li>Justification that the criteria for approval are met.</li><li>Actions taken by the reviewer.</li><li>Any findings required by laws, regulations, codes, and guidance to be documented. </li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "irb-ec-records--expedited-review",
 "title": "Add to or describe in written materials [page xx or elsewhere]:IRB/EC records for initial and continuing review of research by the expedited procedure include:<ul><li>The justification for using the expedited procedure.</li><li>Justification that the criteria for approval are met.</li><li>Actions taken by the reviewer.</li><li>Any findings required by laws, regulations, codes, and guidance to be documented. </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
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 ]
 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-records--exempt-review",
 "title": "Essential RequirementsWritten materials describe that IRB/EC records document the justification for exempt determinations.GUIDANCEIf an entity other than or in addition to the IRB/EC makes exemption determinations, ensure that the written materials describe that their records document the justification for exempt determinations.  ",
 "description": "",
 "keywords": "conduct-exempt-review---non-us,conduct-exempt-review---us",
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 "type": "text/review-assessment-snippet",
 "key": "irb-ec-records--exempt-review",
 "title": "Add to or describe in written materials [page xx or elsewhere]:IRB/EC records document the justification for exempt determinations.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-records--regulatory-determinations",
 "title": "Essential RequirementsWritten materials describe that IRB/EC records\ndocument determinations required by laws, regulations, codes, and guidance,\nincluding documenting the criteria for approval are met, and other required\ndeterminations, including whether noncompliance is serious or continuing, and\nwhether a reported event is an unanticipated problem involving risks to\nparticipants or others. ",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "irb-ec-records--regulatory-determinations",
 "title": "Add to or describe in written materials [page xx or elsewhere]:IRB/EC records document determinations required by laws, regulations, codes, and guidance, including documenting the criteria for approval are met, and other required determinations, including whether noncompliance is serious or continuing, and whether a reported event is an unanticipated problem involving risks to participants or others. <div> </div>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-records--retention",
 "title": "Essential RequirementsWritten materials describe:<ul><li>IRB/EC records relating to research are retained for at least three years after completion of the research. </li><li>All other records are retained for at least three years. </li><li>Records are accessible for inspection and copying by authorized representatives of regulatory agencies or departments at reasonable times and in a reasonable manner.</li><li>If a study is cancelled without participant enrollment, IRB/EC records are maintained for at least three years after cancellation.</li></ul>GUIDANCEIf otherwise required by law, evaluate for a longer\nretention period.",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:<ul><li>IRB/EC records relating to research are retained for at least three years after completion of the research.</li><li>All other records are retained for at least three years.</li><li>Records are accessible for inspection and copying by authorized representatives of regulatory agencies or departments at reasonable times and in a reasonable manner.</li><li>If a study is cancelled without participant enrollment, IRB/EC records are maintained for at least three years after cancellation.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "dod--records-maintained-by-non-dod-organizations",
 "title": "When following DoD requirements, written materials describe that records maintained by non-DoD organizations that document compliance or noncompliance with DoD requirements shall be made accessible for inspection and copying by representatives of the DoD.",
 "description": "",
 "keywords": "irb-ec---reviews-dod-research,serves-as-an-irb-for-dod-organizations",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DoD requirements, records maintained by non-DoD organizations that document compliance or noncompliance with DoD requirements shall be made accessible for inspection and copying by representatives of the DoD.",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va--records-responsibilities",
 "title": "When following VA requirements, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">IRB/EC records are the responsibility of the local research office. </li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The local VA facility must designate how the records can be accessed and where the records will be maintained or stored. </li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Records of an IRB/EC must be addressed in the MOU for the VA Facility’s use of another entity’s IRB/EC.<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The MOU must ensure that all applicable Federal and VA regulations are met.</li></ul></li></ul><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">GUIDANCEThis language must be included when the VA facility relies upon the IRB/EC of an academic affiliate. It does not need to be in IRB/EC policies and procedures for VAs that use their own IRB.",
 "description": "",
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 "key": "va--records-responsibilities",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements:<ul><li>IRB/EC records are the responsibility of the local research office.</li><li>The local VA facility must designate how the records can be accessed and where the records will be maintained or stored.</li><li>Records of an IRB/EC must be addressed in the MOU for the VA Facility’s use of another entity’s IRB/EC.<ul><li>The MOU must ensure that all applicable Federal and VA regulations are met.</li><li></li></ul></li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va--providing-irb-minutes-to-the-r-d",
 "title": "When following VA requirements, written materials describe:<ul type=\"disc\"><li>A copy of the final IRB/EC minutes must be submitted to the R&D Committee in accordance with local SOPs.</li></ul>",
 "description": "",
 "keywords": "org-is-va-with-internal-irb,serves-as-an-irb-for-va-facilities",
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 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va--providing-irb-minutes",
 "title": "When following VA requirements, written materials describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">When the IRB/EC of Record for a VA facility is the IRB/EC of a non-VA entity (e.g., IRB/EC of another Federal entity, IRB/EC of an academic affiliate), the non-VA entity must either:<ul><li>Provide VA with, or access to, unredacted copies of meeting minutes in a timely manner that allows the R&D Committee to review the IRB’s/EC’s deliberations on VA protocols; or</li><li>Provide VA with, or access to, redacted copies of meeting minutes in a timely manner that allows the R&D Committee to review the IRB’s/EC’s deliberations on VA protocols. The non-VA entity must permit relevant VA personnel (including, but not limited to, ORO staff, local VA research office staff, local RCOs, and R&D Committee members) to review the unredacted meeting minutes within two business days of a written request from VA. Such review may occur at either site during normal business hours, or as otherwise mutually acceptable to VA and the IRB. Redacted copies of meeting minutes should include the parts of the minutes related to the IRB’s/EC’s review of VA protocols in a timely manner.</li></ul></li></ul>",
 "description": "",
 "keywords": "serves-as-an-irb-for-va-facilities",
 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "va--providing-irb-minutes",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">When the IRB/EC of Record for a VA facility is the IRB/EC of a non-VA entity (e.g., IRB/EC of another Federal entity, IRB/EC of an academic affiliate), the non-VA entity must either:<ul><li>Provide VA with, or access to, unredacted copies of meeting minutes in a timely manner that allows the R&D Committee to review the IRB’s/EC’s deliberations on VA protocols; or</li><li>Provide VA with, or access to, redacted copies of meeting minutes in a timely manner that allows the R&D Committee to review the IRB’s/EC’s deliberations on VA protocols. The non-VA entity must permit relevant VA personnel (including, but not limited to, ORO staff, local VA research office staff, local RCOs, and R&D Committee members) to review the unredacted meeting minutes within two business days of a written request from VA. Such review may occur at either site during normal business hours, or as otherwise mutually acceptable to VA and the IRB. Redacted copies of meeting minutes should include the parts of the minutes related to the IRB’s/EC’s review of VA protocols in a timely manner.</li></ul></li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "va-facility--record-accessibility",
 "title": "For VA facilitiesWritten materials describe that all records must be accessible for inspection and copying (by authorized representatives of VA, ORO, OHRP, FDA, and other authorized entities or Federal department or agencies) at reasonable times and in a reasonable manner. Records constituting a Federal record in VA research must be retained in accordance with VHA RCS 10-1.",
 "description": "",
 "keywords": "org-is-va",
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 "key": "va-facility--record-accessibility",
 "title": "Add to or describe in written materials [page xx or elsewhere]:All records must be accessible for inspection and copying (by authorized representatives of VA, ORO, OHRP, FDA, and other authorized entities or Federal department or agencies) at reasonable times and in a reasonable manner. Records constituting a Federal record in VA research must be retained in accordance with VHA RCS 10-1.",
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 },
 {
 "type": "section/element",
 "key": "element-ii-5-b",
 "title": "ELEMENT II.5.B.",
 "description": "The IRB or EC documents discussions and decisions on research studies and activities in accordance with legal and regulatory requirements, sponsor requirements (if any), and organizational policies and procedures.  ",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "type": "question/applicant-documents",
 "key": "q1",
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 "description": "",
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 "components": [
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "irb-ec-minutes--general-content",
 "title": "Written materials describe that IRB/EC minutes document:<ul><li>Actions taken by the IRB, including documenting the criteria for approval are met.</li><li>Separate deliberations for each action.</li><li>Votes for each protocol as numbers for, against, or abstaining.</li><li>Attendance at the meeting.</li><li>When an alternate member replaces a primary member.</li><li>The basis for requiring changes in research.</li><li>The basis for disapproving research.</li><li>A written summary of the discussion of controverted issues and their resolution.</li><li>For initial and continuing review, the approval period.</li><li>The names of IRB/EC members who leave the meeting because of a conflict of interest along with the fact that a conflict of interest is the reason for the absence.</li></ul>",
 "description": "",
 "keywords": "outside-us-internal-irb,org-is-independent-irb-ec,us-based-internal-irb",
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 "key": "irb-ec-minutes--general-content",
 "title": "Add to or describe in written materials [page xx or elsewhere]:IRB/EC minutes document:<ul><li>Actions taken by the IRB, including documenting the criteria for approval are met.</li><li>Separate deliberations for each action.</li><li>Votes for each protocol as numbers for, against, or abstaining.</li><li>Attendance at the meeting.</li><li>When an alternate member replaces a primary member.</li><li>The basis for requiring changes in research.</li><li>The basis for disapproving research.</li><li>A written summary of the discussion of controverted issues and their resolution.</li><li>For initial and continuing review, the approval period.</li><li>The names of IRB/EC members who leave the meeting because of a conflict of interest along with the fact that a conflict of interest is the reason for the absence.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "irb-ec-minutes--study-specific-findings",
 "title": "Written materials describe that minutes document required determinations and protocol-specific findings justifying those determinations for:<ul><li>Waiver or alteration of the consent process.</li><li>Research involving pregnant women, fetuses, and neonates.</li><li>Research involving prisoners.</li><li>Research involving children.</li><li>Research involving participants with diminished capacity.</li></ul>AND (WHEN APPLICABLE)When documentation of the IRB’s/EC’s determinations involves minutes and supplemental materials such as worksheets completed by IRB/EC members, written materials describe: <ul><li>The process for retaining worksheets.</li><li>The process to document reconciliation of controverted issues when worksheets contain different opinions from reviewers.</li></ul>GUIDANCEIf an organization uses checklists to record documentation of the IRB’s/EC’s actions, written materials must describe the process to maintain records, and when using reviewer sheets where different reviewers may make different comments, a process to document controverted issues. ",
 "description": "",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:Minutes document required determinations and protocol-specific findings justifying those determinations for:<ul><li>Waiver or alteration of the consent process.</li><li>Research involving pregnant women, fetuses, and neonates.</li><li>Research involving prisoners.</li><li>Research involving children.</li><li>Research involving participants with diminished capacity.</li></ul>AND (IF APPLICABLE)Add to or describe in written materials [page xx or elsewhere]:When documentation of the IRB’s/EC’s determinations involves minutes and supplemental materials such as worksheets completed by IRB/EC members:<ul><li>The process for retaining worksheets.</li><li>The process to document reconciliation of controverted issues when worksheets contain different opinions from reviewers.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--determination-documentation-requirements",
 "title": "When following DHHS requirements, written materials describe:<ul><li>Records must include the rationale for conducting continuing review on research that otherwise would not require continuing review.</li><li>Records must include the rationale for an expedited reviewer's determination that research appearing on the expedited review list is more than minimal risk.</li></ul>",
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 "title": "Add to or describe in written materials [page xx or elsewhere]:When following DHHS requirements:<ul><li>Records must include the rationale for conducting continuing review on research that otherwise would not require continuing review.</li><li>Records must include the rationale for an expedited reviewer's determination that research appearing on the expedited review list is more than minimal risk.</li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "us-fda--regulatory-determinations-documentation",
 "title": "When following FDA requirements, written materials describe that IRB/EC minutes\ndocument the rationale for significant risk/non-significant risk device\ndeterminations.",
 "description": "",
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 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "va--regulatory-determinations-documentation",
 "title": "When following VA requirements, written materials describe that the IRB/EC must determine and document in the minutes or IRB/EC records specific findings in accordance with VA requirements.",
 "description": "",
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 "components": [
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 "type": "text/review-assessment-snippet",
 "key": "va--regulatory-determinations-documentation",
 "title": "Add to or describe in written materials [page xx or elsewhere]:When following VA requirements, the IRB/EC must determine and document in the minutes or IRB/EC records specific findings in accordance with VA requirements.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/domain",
 "key": "domain-iii-researchers-and-research-staff",
 "title": "DOMAIN III: RESEARCHER AND RESEARCH STAFF",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "section/standard",
 "key": "standard-iii-1",
 "title": "STANDARD III-1",
 "description": "In addition to following applicable laws and regulations, researchers and research staff adhere to ethical principles and standards appropriate for their discipline. In designing and conducting research studies, researchers and research staff have the protection of the rights and welfare of research participants as a primary concern.",
 "keywords": "",
 "components": [
 {
 "type": "section/element",
 "key": "element-iii-1-a",
 "title": "ELEMENT III.1.A.",
 "description": "Researchers and research staff know which of the activities they conduct are overseen by the Human Research Protection Program, and they seek guidance when appropriate.",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "educational-materials-for-researchers",
 "title": "Essential requirementsIf the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for\nresearchers, or the researcher handbook, information for researchers and research staff explaining which of the activities they conduct are overseen by the HRPP and how to seek guidance when appropriate, including:<ul><li>A definition of “research involving human participants”.</li><li>The process for researchers and research staff to obtain guidance about whether an activity is research involving human participants, and how to obtain determinations from the organization.</li><li>A description of the scope of human participants research that requires review by an IRB or EC, whether it is the organization’s IRB/EC (e.g., all research by employees or all research in facilities) or an external IRB/EC, the process to obtain IRB/EC review, and any policies and procedures that must be followed if an IRB/EC external to the organization will review the research.</li><li>A description of the criteria by which persons are considered engaged (agents) in the research and come under the requirements of the IRB or EC.</li><li>Guidance concerning activities that sometimes are or are not overseen by the HRPP at the organization, such as classroom research, quality improvement, case reports, program evaluation, and public health surveillance activities, scholarly and journalistic activities.</li><li>A definition of any other activities the organization considers research, when these are outside the scope of activities covered by regulations or laws (e.g., research on non-living individuals).</li><li>When activities are covered under other laws, the definition encompasses activities that are “research involving human participants” as defined by those laws. </li></ul>GUIDANCEIf there is a researcher manual, recommend places\nwithin the manual to add materials but do not recommend adding to other\nmaterials. If there is no researcher manual and the\norganization’s policies are how researchers are informed of their requirements,\nand missing information has been requested above, do not duplicate the request\nunder Domain III.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">A definition of “research involving human participants”.</li><li>The process for researchers and research staff to obtain guidance about whether an activity is research involving human participants, and how to obtain determinations from the organization.</li><li>A description of the scope of human participants research that requires review by an IRB or EC, whether it is the organization’s IRB/EC (e.g., all research by employees or all research in facilities) or an external IRB/EC, the process to obtain IRB/EC review, and any policies and procedures that must be followed if an IRB/EC external to the organization will review the research.</li><li>A description of the criteria by which persons are considered engaged (agents) in the research and come under the requirements of the IRB or EC.</li><li>Guidance concerning activities that sometimes are or are not overseen by the HRPP at the organization, such as classroom research, quality improvement, case reports, program evaluation, and public health surveillance activities, scholarly and journalistic activities.</li><li>A definition of any other activities the organization considers research, when these are outside the scope of activities covered by regulations or laws (e.g., research on non-living individuals).</li><li>When activities are covered under other laws, the definition encompasses activities that are “research involving human participants” as defined by those laws.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--educational-materials-for-researchers",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to DHHS requirements in Element I.1.A, including:<ul><li>The definition of \"research involving human participants\" encompasses activities that are “research” and involve “human subjects” as those terms are defined by DHHS regulations:<ul><li>Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.</li><li>Human participant means a living individual about whom a researcher conducting research:<ul><li>Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.</li><li>Obtains uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.</li></ul></li></ul></li></ul><ul><li>Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.</li><li>The following activities are not considered research:<ul><li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.</li><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.<ul><li>Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.</li><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul></li><li>Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.</li><li>Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.</li></ul></li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "dhhs",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, who must comply with DHHS requirements [page xx or elsewhere]:<ul><li>The definition of \"research involving human participants\" encompasses activities that are “research” and involve “human subjects” as those terms are defined by DHHS regulations:<ul><li>Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.</li><li>Human participant means a living individual about whom a researcher conducting research:<ul><li>Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.</li><li>Obtains uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.</li></ul></li></ul></li></ul><ul><li>Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.</li><li>The following activities are not considered research:<ul><li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.</li><li>Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.<ul><li>Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.</li><li>Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.</li><li>Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).</li></ul></li><li>Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.</li><li>Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "fda--educational-materials-for-researchers",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures for FDA-regulated research pertaining to Element I.1.A, including:<ul><li>Research is any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505 (i) or 520 (g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations.</li><li>Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.</li><li>When medical device research involves in vitro  diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III. ",
 "description": "",
 "keywords": "us-fda",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "fda--educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, who must comply with FDA policies and procedures [page xx or elsewhere]:<ul><li>Research is any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505 (i) or 520 (g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations.</li><li>Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.</li><li>When medical device research involves in vitro  diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dod--educational-materials-for-researchers",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with DoD policies and procedures pertaining to Element I.1.A, including:<ul><li>Human participant research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving human participant research can begin, the DoD component seeking to conduct such research must obtain explicit written approval from the DoD Office for Human Research Protections (DOHRP).<ul><li>Policies and procedures must specifically indicate whether the organization permits research involving chemical or biological agents under an exception, and if such research is allowed, describe who in the organization is responsible for obtaining approval and the process they go through.</li></ul></li><li>Written materials ensure “research involving a human being as an experimental subject” is conducted in accordance with 10 USC 980, as implemented by DoDI 3216.02, section 3.11.<ul><li>Research involving an “experimental subject” is an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving “experimental subjects” is a subset of research involving human participants. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of 32 CFR 219.</li><li>Written materials must specifically indicate whether the organization conducts research involving experimental subjects.</li></ul></li><li>Classified research is defined in DoDI 3216.02 section 3.13.<ul><li>Policies and procedures must specifically indicate whether the organization allows the conduct of classified research, and must describe who in the organization is responsible for obtaining approval for such research and the process they go through.</li></ul></li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III. ",
 "description": "",
 "keywords": "dod",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dod--educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, pertaining research that must comply with DoD policies and procedures [page xx or elsewhere]:<ul><li>Human participant research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving human participant research can begin, the DoD component seeking to conduct such research must obtain explicit written approval from the DoD Office for Human Research Protections (DOHRP).<ul><li>Policies and procedures must specifically indicate whether the organization permits research involving chemical or biological agents under an exception, and if such research is allowed, describe who in the organization is responsible for obtaining approval and the process they go through.</li></ul></li><li>Written materials ensure “research involving a human being as an experimental subject” is conducted in accordance with 10 USC 980, as implemented by DoDI 3216.02, section 3.11.<ul><li>Research involving an “experimental subject” is an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving “experimental subjects” is a subset of research involving human participants. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of 32 CFR 219.</li><li>Written materials must specifically indicate whether the organization conducts research involving experimental subjects.</li></ul></li><li>Classified research is defined in DoDI 3216.02 section 3.13.<ul><li>Policies and procedures must specifically indicate whether the organization allows the conduct of classified research, and must describe who in the organization is responsible for obtaining approval for such research and the process they go through.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "doe--educational-materials-for-researchers",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with DOE policies and procedures pertaining to Element I.1.A, including:<ul><li>DOE requirements apply to all research conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research. <ul><li>When research involves contractors, DOE “Contractor Requirements Document” describing contractor responsibilities for protecting human research participants must be included in contracts.</li><li>Policies and procedures must specify whether the organization conducts classified research.</li></ul></li><li>Research that uses social media data must be submitted to the appropriate IRB for human participant research review and determination.</li><li>Research that involves the study of humans in a systematically modified environment must be submitted to the appropriate IRB for HSR review and determination.</li><li>Classified and unclassified human participant research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB-Classified.</li><li>Human Terrain Mapping (HTM) is managed as research involving human participants.<ul><li>Policies and procedures must specify whether the organization engages in DOE human terrain mapping research.</li></ul></li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "doe",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "doe--educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, that must comply with DOE policies and procedures [page xx or elsewhere]:<ul><li>DOE requirements apply to all research conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research. <ul><li>When research involves contractors, DOE “Contractor Requirements Document” describing contractor responsibilities for protecting human research participants must be included in contracts.</li><li>Policies and procedures must specify whether the organization conducts classified research.</li></ul></li><li>Research that uses social media data must be submitted to the appropriate IRB for human participant research review and determination.</li><li>Research that involves the study of humans in a systematically modified environment must be submitted to the appropriate IRB for HSR review and determination.</li><li>Classified and unclassified human participant research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB-Classified.</li><li>Human Terrain Mapping (HTM) is managed as research involving human participants.<ul><li>Policies and procedures must specify whether the organization engages in DOE human terrain mapping research.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "doj--educational-materials-for-researchers",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with DoJ policies and procedures pertaining to Element I.1.A, including:For research conducted within the Bureau of Prisons:  Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research. GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "doj",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "doj--educational-materials-for-researchers",
 "title": "Add to written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, for researchers who must comply with DoJ policies and procedures [page xx or elsewhere]:For research conducted within the Bureau of Prisons:  Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research. ",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--educational-materials-for-researchers",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to Element I.1.A related to ICH GCP (E6)(R3), including:<ul><li>The guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities.</li><li>This guideline may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorization applications in accordance with local requirements.</li><li>If applicable, policies and procedures should describe whether there are additional local requirements.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "ich-gcp-all,ich-gcp-sponsor-request",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "ich-gcp--educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, for research that must comply with ICH GCP (E6)(R3) guidelines [page xx or elsewhere]:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities.</li><li>This guideline may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorization applications in accordance with local requirements.</li><li>If applicable, policies and procedures should describe whether there are additional local requirements.</li></ul> ",
 "description": "",
 "keywords": "",
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 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va--educational-materials-for-researchers",
 "title": "Written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, address and are consistent with policies and procedures pertaining to Element I.1.A when researchers must comply with VA regulations, including:<ul><li>VA research is research that is conducted by researchers serving on VA compensated, without compensation (WOC), or interagency personnel agreement (IPA) appointments while on VA time or on VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have Research and Development (R&D) Committee approval before it is considered VA Research and before it can be initiated. All research activities approved by the R&D Committee are considered VA Research.</li><li>VA-affiliated nonprofit research and education corporations (NPC) are authorized by Congress under 38 U.S.C. 7361-7366 to provide flexible funding mechanisms for the conduct of research and education at one or more VA facilities. Research approved by a facility R&D Committee and education approved by the facility Education Committee are considered to be a VA research project or a VA education activity respectively, regardless of the source of funding, the entity administering the funds, or the research or education site.</li><li>VA research includes VA-approved research conducted at international sites not within the United States, its territories, or Commonwealths; and includes any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data outside the United States.</li><li>The VA does not conduct classified research involving human participants. Classified research is research that is considered restricted or secret by the Federal government, sponsor, or any third party. For example, research for the Federal government that is considered sensitive or would affect national security. </li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va--educational-materials-for-researchers",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, for research that must comply with VA regulations [page xx or elsewhere]:<ul><li>VA research is research that is conducted by researchers serving on VA compensated, without compensation (WOC), or interagency personnel agreement (IPA) appointments while on VA time or on VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have Research and Development (R&D) Committee approval before it is considered VA Research and before it can be initiated. All research activities approved by the R&D Committee are considered VA Research.</li><li>VA-affiliated nonprofit research and education corporations (NPC) are authorized by Congress under 38 U.S.C. 7361-7366 to provide flexible funding mechanisms for the conduct of research and education at one or more VA facilities. Research approved by a facility R&D Committee and education approved by the facility Education Committee are considered to be a VA research project or a VA education activity respectively, regardless of the source of funding, the entity administering the funds, or the research or education site.</li><li>VA research includes VA-approved research conducted at international sites not within the United States, its territories, or Commonwealths; and includes any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data outside the United States.</li><li>The VA does not conduct classified research involving human participants. Classified research is research that is considered restricted or secret by the Federal government, sponsor, or any third party. For example, research for the Federal government that is considered sensitive or would affect national security. </li></ul>",
 "description": "",
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 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-iii-1-b",
 "title": "ELEMENT III.1.B.",
 "description": "Researchers and research staff identify and disclose financial interests according to organizational policies and regulatory requirements and, with the organization, manage, minimize, or eliminate financial conflicts of interest. ",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "researcher-cois--identification-and-disclosure",
 "title": "Essential requirementsIf the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to Element I.6.B., including:<ul><li>Definition of the financial interests of researchers and research staff for which the organization requires disclosure.</li><li>Who must disclose financial interests.</li><li>Responsibilities researchers and research staff have related to disclosures of financial conflicts of interest.</li><li>How and when financial interests are disclosed. </li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials. If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain IIIFor reference: ELEMENT I.6.B.: The organization has and follows written policies and procedures to identify, manage, and minimize or eliminate individual financial conflicts of interest of Researchers and research staff that could influence the conduct of the research or the integrity of the Human Research Protection Program. The organization works with the Institutional Review Board or Ethics Committee in ensuring that financial conflicts of interest are managed and minimized or eliminated, when appropriate. ",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "researcher-cois--identification-and-disclosure",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: <ul><li>Definition of the financial interests of researchers and research staff for which the organization requires disclosure.</li><li>Who must disclose financial interests.</li><li>Responsibilities researchers and research staff have related to disclosures of financial conflicts of interest.</li><li>How and when financial interests are disclosed. </li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "phs-(dhhs---fda)--researcher-cois",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to Element I.6.B when researchers must comply with DHHS and/or FDA requirements, including:<ul><li>The process the organization uses to obtain disclosures from researchers and research staff of institutional responsibilities related to significant financial interests.</li><li>The process for researchers and research staff to disclose reimbursed or sponsored travel related to institutional responsibilities.</li><li>What reimbursed or sponsored travel is required to be reported.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials. If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "dhhs,us-fda",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "phs-(dhhs---fda)--researcher-cois",
 "title": "For researchers who must comply with DHHS and/or US FDA requirements Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook for researchers who must comply with DHHS or US FDA requirements [page xx or elsewhere]: <ul><li>The process the organization uses to obtain disclosures from researchers and research staff of institutional responsibilities related to significant financial interests.</li><li>The process for researchers and research staff to disclose reimbursed or sponsored travel related to institutional responsibilities.</li><li>What reimbursed or sponsored travel is required to be reported.</li></ul>For researchers who must comply with DHHS requirements onlyAdd to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook for researchers who must comply with DHHS requirements [page xx or elsewhere]: <ul><li>The process the organization uses to obtain disclosures from researchers and research staff of institutional responsibilities related to significant financial interests.</li><li>The process for researchers and research staff to disclose reimbursed or sponsored travel related to institutional responsibilities.</li><li>What reimbursed or sponsored travel is required to be reported.</li></ul>For researchers who must comply with US FDA requirements onlyAdd to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook for researchers who must comply with FDA requirements [page xx or elsewhere]: <ul><li>The process the organization uses to obtain disclosures from researchers and research staff of institutional responsibilities related to significant financial interests.</li><li>The process for researchers and research staff to disclose reimbursed or sponsored travel related to institutional responsibilities.</li><li>What reimbursed or sponsored travel is required to be reported.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "va--researcher-cois",
 "title": "When following VA requirements, <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">written materials describe that researchers must\ndisclose conflicts of interest. This means disclosing to the IRB/EC any\npotential, actual, or perceived conflict of interest of a financial,\nprofessional, or personal nature that may affect any aspect of the research,\nand complying with all applicable VA and other federal requirements regarding\nconflict of interest.",
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 "keywords": "org-is-va,serves-as-an-irb-for-va-facilities",
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 "key": "va--researcher-cois",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook for researchers who must comply with VA requirements [page xx or elsewhere]: Researchers must disclose conflicts of interest when following VA regulations. This means disclosing to the IRB/EC any potential, actual, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and complying with all applicable VA and other federal requirements regarding conflict of interest.",
 "description": "",
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 {
 "type": "section/element",
 "key": "element-iii-1-c",
 "title": "ELEMENT III.1.C.",
 "description": "Researchers employ sound study design in accordance with the standards of the discipline. Researchers design studies in a manner that minimizes risks to participants.",
 "keywords": "all",
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 "key": "q1",
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 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 {
 "type": "question/review-assessment",
 "key": "researchers-employ-sound-study-design",
 "title": "Essential requirementsIf the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.A., II.3.B., and II.4.A., including:<ul><li>The following information is included in an IRB/EC application or research protocol to allow the IRB or EC to conduct an analysis of the risks and potential benefits of the research, such as:<ul><li>The purposes of the research.</li><li>The scientific or scholarly rationale.</li><li>The procedures to be performed.</li><li>A description of the procedures being performed already for diagnostic or treatment purposes.</li><li>The risks and potential benefits of the research to participants.</li></ul></li></ul><ul><li>The following are considered when designing a study:<ul><li>Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.</li><li>Risks to participants are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.</li><li>Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that may be expected to result.</li><li>Research studies have the resources necessary to protect participants:</li><li>Adequate time for the researchers to conduct and complete the research.</li><li>Adequate number of qualified staff.</li><li>Adequate facilities.</li><li>Access to a population that will allow recruitment of the necessary number of participants.</li><li>Availability of medical or psychosocial resources that participants may need as a consequence of the research.</li><li>Data monitoring, such as:<ul><li>What safety information will be collected, including serious adverse events.</li><li>How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants). </li><li>The frequency of data collection, including when safety data collection starts.</li><li>The frequency or periodicity of review of cumulative safety data.</li><li>The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor.</li><li>For studies that do not have or are not required to have a data monitoring committee and are blinded, have multiple sites, enter vulnerable populations, or employ high-risk interventions, the IRB or EC needs to carefully review the data and safety monitoring plan and determine whether a data monitoring committee is needed. </li><li>If not using a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring.</li><li>Provisions for the oversight of safety data (e.g., by a data monitoring committee).</li><li>Conditions that trigger an immediate suspension of the research, if applicable.</li></ul></li></ul></li><li>The following information is included in an IRB/EC application or research protocol to allow the IRB or EC to conduct an analysis of the risks to vulnerable participants included in the research and ensure additional protections are provided such as:<ul><li>Whether some or all of the participants are likely to be vulnerable to coercion or undue influence, including pregnant women, fetuses, or neonates; prisoners; children; or adults unable to provide consent.</li><li>When some or all of the participants are likely to be vulnerable, applications include a description of additional safeguards included in the protocol to protect their rights and welfare.</li></ul></li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials. If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.For referenceELEMENT II.3.A.: The IRB or EC has and follows written policies and procedures for identifying and analyzing risks and identifying measures to minimize such risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to the potential benefits to participants and to society.ELEMENT II.3.B.: The IRB or EC has and follows written policies and procedures for reviewing the plans for data and safety monitoring, when applicable, and determines that the data and safety monitoring plan provides adequate protection for participants. ELEMENT II.4.A.: The IRB or EC has and follows written policies and procedures for determining the risks to prospective participants who are vulnerable to coercion or undue influence and ensuring that additional protections are provided as required by applicable laws, regulations, codes, and guidance.",
 "description": "",
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 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: <ul type=\"disc\"><li>The following information is included in an IRB/EC application or research protocol to allow the IRB or EC to conduct an analysis of the risks and potential benefits of the research, such as:</li><ul type=\"disc\"><li>The purposes of the research.</li><li>The scientific or scholarly rationale.</li><li>The procedures to be performed.</li><li>A description of the procedures being performed already for diagnostic or treatment purposes.</li><li>The risks and potential benefits of the research to participants.</li></ul></ul><ul type=\"disc\"><li>The following are considered when designing a study:</li><ul type=\"disc\"><li>Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.</li><li>Risks to participants are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.</li><li>Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that may be expected to result.</li><li>Research studies have the resources necessary to protect participants:</li><li>Adequate time for the researchers to conduct and complete the research.</li><li>Adequate number of qualified staff.</li><li>Adequate facilities.</li><li>Access to a population that will allow recruitment of the necessary number of participants.</li><li>Availability of medical or psychosocial resources that participants may need as a consequence of the research.</li><li>Data monitoring, such as:</li><ul type=\"disc\"><li>What safety information will be collected, including serious adverse events.</li><li>How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants).</li><li>The frequency of data collection, including when safety data collection starts.</li><li>The frequency or periodicity of review of cumulative safety data.</li><li>The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor. </li><li>For studies that do not have or are not required to have a data monitoring committee and are blinded, have multiple sites, enter vulnerable populations, or employ high-risk interventions, the IRB or EC needs to carefully review the data and safety monitoring plan and determine whether a data monitoring committee is needed.</li><li>If not using a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring.</li><li>Provisions for the oversight of safety data (e.g., by a data monitoring committee).</li><li>Conditions that trigger an immediate suspension of the research, if applicable.</li></ul></ul><li>The following information is included in an IRB/EC application or research protocol to allow the IRB or EC to conduct an analysis of the risks to vulnerable participants included in the research and ensure additional protections are provided such as:</li><ul type=\"disc\"><li>Whether some or all of the participants are likely to be vulnerable to coercion or undue influence, including pregnant women, fetuses, or neonates; prisoners; children; or adults unable to provide consent.</li><li>When some or all of the participants are likely to be vulnerable, applications include a description of additional safeguards included in the protocol to protect their rights and welfare.</li></ul></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "doj--sound-research-design",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.A., II.3.B., and II.4.A. when research must comply with DoJ requirements, including:<ul><li>For research conducted within the Bureau of Prisons, the researcher must have academic preparation or experience in the area of study of the proposed research.</li><li>For research conducted within the Bureau of Prisons, when submitting a research proposal, the applicant shall provide the following information:<ul><li>A summary statement, which includes: <ul><li>Names and current affiliations of the researchers.</li><li>Title of the study.</li><li>Purpose of the study.</li><li>Location of the study.</li><li>Methods to be employed.</li><li>Anticipated results.</li><li>Duration of the study.</li><li>Number of participants (staff or inmates) required, and amount of time required from each.</li><li>Indication of risk or discomfort involved as a result of participation.</li></ul></li><li>A comprehensive statement, which includes:<ul><li>Review of related literature.</li><li>Detailed description of the research method.</li><li>Significance of anticipated results and their contribution to the advancement of knowledge.</li><li>Specific resources required from the Bureau of Prisons.</li><li>Description of all possible risks, discomforts, and benefits to individual participants or a class of participants, and a discussion of the likelihood that the risks and discomforts will actually occur.</li><li>Description of steps taken to minimize any risks.</li></ul></li><li>Description of physical or administrative procedures to be followed to:<ul><li>Ensure the security of any individually identifiable data that are being collected for the study.</li><li>Destroy research records or remove individual identifiers from those records when the research has been completed.</li></ul></li><li>Description of any anticipated effects of the research study on organizational programs and operations.</li><li>Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules. </li><li>A statement regarding assurances and certification required by 28 CFR 46, if applicable.</li></ul></li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: <ul><li>When following DoJ requlations:<ul><li>For research conducted within the Bureau of Prisons, the researcher must have academic preparation or experience in the area of study of the proposed research.</li><li>For research conducted within the Bureau of Prisons, when submitting a research proposal, the applicant shall provide the following information: <ul><li>A summary statement, which includes:<ul><li>Names and current affiliations of the researchers.</li><li>Title of the study.</li><li>Purpose of the study.</li><li>Location of the study.</li><li>Methods to be employed.</li><li>Anticipated results.</li><li>Duration of the study.</li><li>Number of participants (staff or inmates) required, and amount of time required from each.</li><li>Indication of risk or discomfort involved as a result of participation.</li></ul></li><li>A comprehensive statement, which includes:<ul><li>Review of related literature.</li><li>Detailed description of the research method.</li><li>Significance of anticipated results and their contribution to the advancement of knowledge.</li><li>Specific resources required from the Bureau of Prisons.</li><li>Description of all possible risks, discomforts, and benefits to individual participants or a class of participants, and a discussion of the likelihood that the risks and discomforts will actually occur.</li><li>Description of steps taken to minimize any risks.</li></ul></li><li>Description of physical or administrative procedures to be followed to:<ul><li>Ensure the security of any individually identifiable data that are being collected for the study.</li><li>Destroy research records or remove individual identifiers from those records when the research has been completed.</li></ul></li><li>Description of any anticipated effects of the research study on organizational programs and operations.</li><li>Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules.</li><li>A statement regarding assurances and certification required by 28 CFR 46, if applicable.</li></ul></li></ul></li></ul>",
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 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--sound-research-design",
 "title": "When following the ICH-GCP (E6) guideline, written materials describe researcher responsibilities in a form accessible or provided to researchers:<ul><li>A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) who is an investigator or a sub-investigator for the trial should have the responsibility for trial-related medical care and decisions.  </li><li>Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements. </li><li>During and following participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a participant when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.  </li><li>The investigator should inform the participant’s primary physician about the participant’s involvement in the trial if the participant has a primary physician and agrees to the primary physician being informed.  </li><li>The investigator should follow the trial’s randomization procedures, if any, and, in the case of an investigator-blinded trial, should ensure that the treatment randomization code is broken only in accordance with the protocol. In the case of an emergency, to protect participant safety, the investigator should be prepared and capable from the start of the trial to perform unblinding without undue delay and hindrance. The investigator should promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, emergency unblinding to protect trial participant, unblinding due to an SAE) of the investigational product(s). </li><li>When a participant decides to stop treatment with the investigational product or withdraw from a trial; is discontinued from the trial; or reaches the routine end of the trial, the investigator should follow the protocol and/or other protocol-related documents. For participants who did not reach the routine end of the trial, this may include instructions to avoid loss of already collected data, in accordance with applicable regulatory requirements, to ensure that trial results are reliable. In general, loss of already collected data may bias results and may lead to, for example, inaccurate conclusions regarding the safety profile of the investigational product.</li></ul>",
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 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]:When following ICH-GCP guidelines: <ul><li>A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) who is an investigator or a sub-investigator for the trial should have the responsibility for trial-related medical care and decisions. </li><li>Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.</li><li>During and following participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a participant when medical care is needed for intercurrent illness(es) of which the investigator becomes aware. </li><li>The investigator should inform the participant’s primary physician about the participant’s involvement in the trial if the participant has a primary physician and agrees to the primary physician being informed. </li><li>The investigator should follow the trial’s randomization procedures, if any, and, in the case of an investigator-blinded trial, should ensure that the treatment randomization code is broken only in accordance with the protocol. In the case of an emergency, to protect participant safety, the investigator should be prepared and capable from the start of the trial to perform unblinding without undue delay and hindrance. The investigator should promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, emergency unblinding to protect trial participant, unblinding due to an SAE) of the investigational product(s).</li><li>When a participant decides to stop treatment with the investigational product or withdraw from a trial; is discontinued from the trial; or reaches the routine end of the trial, the investigator should follow the protocol and/or other protocol-related documents. For participants who did not reach the routine end of the trial, this may include instructions to avoid loss of already collected data, in accordance with applicable regulatory requirements, to ensure that trial results are reliable. In general, loss of already collected data may bias results and may lead to, for example, inaccurate conclusions regarding the safety profile of the investigational product.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va--sound-research-design",
 "title": "When following VA requirements, written materials describe that t<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">he VA researcher is responsible for developing and submitting a research protocol that is scientifically valid and ethical, describes the research objectives, background and methodology, and is relevant to the health or welfare of the Veteran population.",
 "description": "",
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 "key": "va--sound-research-design",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: When following VA requirements, a VA researcher is responsible for developing and submitting a research protocol that is scientifically valid and ethical, describes the research objectives, background and methodology, and is relevant to the health or welfare of the Veteran population.",
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 {
 "type": "section/element",
 "key": "element-iii-1-d",
 "title": "ELEMENT III.1.D.",
 "description": "Researchers determine that the resources necessary to protect participants are present before conducting each research study. ",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "researchers-ensure-resources-necessary-to-protect-participants-are-present",
 "title": "Essential requirementsIf the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.A., including:Researchers are responsible to:<ul><li>Use procedures that are consistent with sound research design and do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.</li><li>Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient researcher time; sufficient number of personnel; psychological, social, or medical services (including counseling or social support services that may be required because of research participation); psychological, social, or medical monitoring; ancillary care, equipment needed to protect participants, and resources for participant communication (e.g., language translation services. equipment).</li><li>Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, and, when relevant, privileges) to perform procedures assigned to them during the study.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.For referenceELEMENT II.3.A.: The IRB or EC has and follows written policies and procedures for identifying and analyzing risks and identifying measures to minimize such risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to the potential benefits to participants and to society.",
 "description": "",
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 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: Researchers are responsible to:<ul><li>Use procedures that are consistent with sound research design and do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.</li><li>Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient researcher time; sufficient number of personnel; psychological, social, or medical services (including counseling or social support services that may be required because of research participation); psychological, social, or medical monitoring; ancillary care, equipment needed to protect participants, and resources for participant communication (e.g., language translation services. equipment).</li><li>Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, and, when relevant, privileges) to perform procedures assigned to them during the study.</li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "va--research-qualifications",
 "title": "When following VA requirements, written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook, describe: <ul><li>R<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">esearchers and their staff conducting human participants research must be credentialed and privileged as required by current local and VA requirements. </li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Researchers and their research staff may only perform those activities in a research study for which they have the relevant credentials and privileges.</li></ul>",
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 "title": "Add to educational materials or website information for researchers, or the researcher handbook [page xx or elsewhere]:When following VA requirements:<ul><li>Researchers and their staff conducting human participants research must be credentialed and privileged as required by current local and VA requirements.</li><li>Researchers and their research staff may only perform those activities in a research study for which they have the relevant credentials and privileges.</li></ul>",
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 },
 {
 "type": "section/element",
 "key": "element-iii-1-e",
 "title": "ELEMENT III.1.E.",
 "description": "Researchers and research staff recruit participants in a fair and equitable manner. ",
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 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "Essential requirementsIf the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.C., including:<ul><li>Researchers design studies and recruitment strategies that promote equitable selection of subjects.</li><li>Researchers include information in their protocols or applications to allow the IRB or EC to determine whether selection of participants will be equitable, such as:<ul><li>The purposes of the research.</li><li>The setting in which the research will be conducted.</li><li>Whether prospective participants will be vulnerable to coercion or undue influence.</li><li>The selection (inclusion/exclusion) criteria.</li><li>Participant recruitment and enrollment procedures.</li><li>The amount and timing of payments to participants.</li></ul></li><li>Researchers provide recruitment materials to the IRB or EC review, including:<ul><li>The information contained in the advertisement.</li><li>The mode of its communication.</li><li>The final copy of printed advertisements.</li><li>The final audio or video taped advertisements.</li></ul></li><li>Researchers create recruitment materials that do not:<ul><li>State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.</li><li>Include exculpatory language.</li><li>Emphasize the payment or the amount to be paid, by such means as larger or bold type.</li><li>Promise “free treatment” when the intent is only to say participants will not be charged for taking part in the investigation.</li></ul></li><li>Researchers create advertisements that are limited to the information prospective participants need to determine their eligibility and interest, such as:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The name and address of the researcher or research facility.</li><li>The purpose of the research or the condition under study.</li><li>In summary form, the criteria that will be used to determine eligibility for the study.</li><li>A brief list of benefits to participants, if any.</li><li>The time or other commitment required of the participants.</li><li>The location of the research and the person or office to contact for further information.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li></ul></li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Researchers:<ul><li>Do not enter into unacceptable payment arrangements for the sponsor, organization, researcher, and those referring research participants.</li><li>Do not receive payment from sponsors in exchange for referrals of prospective participants (“finder’s fees” or “referral fees”).</li><li>Do not receive payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”).</li><li>Do not provide compensate participants using an amount, method, or timing of disbursement that is coercive or presents undue influence.</li><li>Ensure credit for payment accrues as the study progresses and not be contingent upon the participant completing the entire study.</li><li>Ensure any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.</li><li>Ensure all information concerning payment, including the amount and schedule of payments, is set forth in the consent document.</li></ul></li></ul><ol></ol>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.For referenceELEMENT II.3.C.: The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants. ",
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 "type": "text/review-assessment-snippet",
 "key": "researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: <ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Researchers design studies and recruitment strategies that promote equitable selection of subjects.</li><li>Researchers include information in their protocols or applications to allow the IRB or EC to determine whether selection of participants will be equitable, such as:<ul><li>The purposes of the research.</li><li>The setting in which the research will be conducted.</li><li>Whether prospective participants will be vulnerable to coercion or undue influence.</li><li>The selection (inclusion/exclusion) criteria.</li><li>Participant recruitment and enrollment procedures.</li><li>The amount and timing of payments to participants.</li></ul></li><li>Researchers provide recruitment materials to the IRB or EC review, including:<ul><li>The information contained in the advertisement.</li><li>The mode of its communication.</li><li>The final copy of printed advertisements.</li><li>The final audio or video taped advertisements.</li></ul></li><li>Researchers create recruitment materials that do not:<ul><li>State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.</li><li>Include exculpatory language.</li><li>Emphasize the payment or the amount to be paid, by such means as larger or bold type.</li><li>Promise “free treatment” when the intent is only to say participants will not be charged for taking part in the investigation.</li></ul></li><li>Researchers create advertisements that are limited to the information prospective participants need to determine their eligibility and interest, such as:<ul><li>The name and address of the researcher or research facility.</li><li>The purpose of the research or the condition under study.</li><li>In summary form, the criteria that will be used to determine eligibility for the study.</li><li>A brief list of benefits to participants, if any.</li><li>The time or other commitment required of the participants.</li><li>The location of the research and the person or office to contact for further information.</li></ul></li><li>Researchers:<ul><li>Do not enter into unacceptable payment arrangements for the sponsor, organization, researcher, and those referring research participants.</li><li>Do not receive payment from sponsors in exchange for referrals of prospective participants (“finder’s fees” or “referral fees”).</li><li>Do not receive payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”).</li><li>Do not provide compensate participants using an amount, method, or timing of disbursement that is coercive or presents undue influence.</li><li>Ensure credit for payment accrues as the study progresses and not be contingent upon the participant completing the entire study.</li><li>Ensure any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.</li><li>Ensure all information concerning payment, including the amount and schedule of payments, is set forth in the consent document. </li></ul></li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "us-fda--researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "When following US FDA regulations, if the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.C., including:<ul><li>Researchers ensure that advertisements do not:<ul><li>Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.</li><li>Use terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that the test article is investigational.</li><li>Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.</li></ul></li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.For referenceELEMENT II.3.C.: The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants. ",
 "description": "",
 "keywords": "us-fda",
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 "key": "us-fda--researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "Add to educational materials or website information for researchers, or the researcher handbook [page xx or elsewhere]:When following US FDA regulations:<ul><li>Researchers ensure that advertisements do not:<ul><li>Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.</li><li>Use terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that the test article is investigational.</li><li>Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.</li></ul></li></ul>",
 "description": "",
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 {
 "type": "question/review-assessment",
 "key": "dod--researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "When following DoD requirements, if the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.C., including:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">DoD-affiliated personnel, military and civilian supervisors, officers, and others in the chain of command:<ul><li>Are prohibited from influencing their subordinates to participate in research involving human participants. </li><li>Must not be present at any human participant recruitment sessions or during the consent process for DoD-affiliated personnel.</li><li>May participate in separate human participant research recruitment sessions. </li></ul></li></ul><ul><li>When research involves U.S. military personnel, researchers follow the required limitations on dual compensation:<ul><li>Prohibit an individual from receiving pay of compensation for research during duty hours.</li><li>An individual may be compensated for research if the participant is involved in the research when not on duty.</li><li>Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.</li><li>Non-Federal persons may be compensated for research participating other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.</li></ul></li><li>Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.For referenceELEMENT II.3.C.: The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants. ",
 "description": "",
 "keywords": "dod",
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 "key": "dod--researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "Add to educational materials or website information for researchers, or the researcher handbook [page xx or elsewhere]:When following DoD requirements:<ul><li>DoD-affiliated personnel, military and civilian supervisors, officers, and others in the chain of command:<ul><li>Are prohibited from influencing their subordinates to participate in research involving human participants. </li><li>Must not be present at any human participant recruitment sessions or during the consent process for DoD-affiliated personnel.</li><li>May participate in separate human participant research recruitment sessions. </li></ul></li></ul><ul><li>When research involves U.S. military personnel, researchers follow the required limitations on dual compensation:<ul><li>Prohibit an individual from receiving pay of compensation for research during duty hours.</li><li>An individual may be compensated for research if the participant is involved in the research when not on duty.</li><li>Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.</li><li>Non-Federal persons may be compensated for research participating other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.</li></ul></li><li>Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "ich-gcp--provision-of-medical-care",
 "title": "The following information is provided in a form accessible or given to researchers:<ul><li>During and following participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial. </li><li>The investigator/institution should inform a participant when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.</li></ul>",
 "description": "",
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 "key": "ich-gcp--provision-of-care",
 "title": "Add to or describe in written materials accessible or given to researchers [page xx or elsewhere]:When following ICH GCP guidelines: <ul><li>During and following participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial.</li><li>The investigator/institution should inform a participant when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--participant-withdrawals",
 "title": "Written materials for accessible or provided to research describe that although a participant is not obliged to give his or her reasons for withdrawing prematurely from a clinical trial, the researcher makes a reasonable effort to ascertain the reason, while fully respecting the participant’s rights.",
 "description": "",
 "keywords": "ich-gcp-all,ich-gcp-sponsor-request",
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 "key": "ich-gcp--participant-withdrawals",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following ICH GCP guidelines, although a participant is not obliged to give his or her reasons for withdrawing prematurely from a clinical trial, the researcher makes a reasonable effort to ascertain the reason, while fully respecting the participant’s rights.",
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 {
 "type": "question/review-assessment",
 "key": "va--researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "When following VA requirements, written materials accessible or provided to researchers describe:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">During recruitment process, VA researchers are responsible for:<ul><li>Making initial contact with potential participants in person or by letter prior to initiating any telephone contact, unless there is written documentation that the participant is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study.</li><li>If a contractor makes the initial contact by letter, the VA researcher must sign the letter.</li></ul></li></ul><ul><li>For studies in which information about the participant’s participation will be included in the participant’s VHA medical record, information must be given to the prospective participants as part of the informed consent process that information regarding study participation will be included in the medical record.</li></ul>",
 "description": "",
 "keywords": "va",
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 "key": "va--researchers-recruit-in-a-fair-and-equitable-manner",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]:When following VA requirements:<ul><li>During recruitment process, VA researchers are responsible for:<ul><li>Making initial contact with potential participants in person or by letter prior to initiating any telephone contact, unless there is written documentation that the participant is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study.</li></ul></li><li>If a contractor makes the initial contact by letter, the VA researcher must sign the letter.</li><li>For studies in which information about the participant’s participation will be included in the participant’s VHA medical record, information must be given to the prospective participants as part of the informed consent process that information regarding study participation will be included in the medical record.</li></ul>",
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 {
 "type": "section/element",
 "key": "element-iii-1-f",
 "title": "ELEMENT III.1.F.",
 "description": "Researchers employ consent processes and methods of documentation appropriate to the type of research and the study population, emphasizing the importance of comprehension and voluntary participation to foster informed decision-making by participants.",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
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 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 {
 "type": "question/review-assessment",
 "key": "informed-consent-process-and-documentation",
 "title": "Essential requirementsIf the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.F., II.3.G., and II.4.B., including:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The researcher obtains the legally effective consent of the participant or the participant’s legally authorized representative.</li><li>The consent process provides sufficient opportunity for the participant or the participant’s legally authorized representative to consider whether to participate.</li><li>The consent process minimizes the possibility of coercion or undue influence.</li><li>The consent discussion is in language understandable to the participant or the representative.</li><li>The consent discussion is free of exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights.</li><li>Documentation of consent contains all applicable basic and additional elements of disclosure, and meets requirements in law and regulation, either with a long-form consent document, or a short-form consent document, or a broad consent document.</li><li>When informed consent is waived, a written statement describing the research is provided to participants, when required by the IRB or EC.</li><li>The researcher considers whether the research involves participants whose decision-making capacity is in question and, when some or all of the participants are likely to have diminished decision-making capacity, considers whether additional safeguards are needed as part of the consent process.</li><li>When research involves children as participants, the researcher follow the assent process for children and consent process for parents or guardians approved by the IRB or EC.</li><li>When researchers are likely to approach adults who lack the ability to consent, researchers assess of the capacity to consent is adequate and obtain assent of the participants as required by the IRB or EC. <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li></ul><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">For referenceELEMENT II.3.F.: The IRB or EC has and follows written policies and procedures to evaluate the consent process and to require that the researcher appropriately document the consent process.ELEMENT II.3.G.: The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation. ELEMENT II.4.B.: The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question. ELEMENT II.4.B.: The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question. ",
 "description": "",
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 "key": "informed-consent-process-and-documentation",
 "title": "Add to or describe in written materials for researchers, such as educational materials, website information for researchers, or the researcher handbook [page xx or elsewhere]: <ul><li>The researcher obtains the legally effective consent of the participant or the participant’s legally authorized representative.</li><li>The consent process provides sufficient opportunity for the participant or the participant’s legally authorized representative to consider whether to participate.</li><li>The consent process minimizes the possibility of coercion or undue influence.</li><li>The consent discussion is in language understandable to the participant or the representative.</li><li>The consent discussion is free of exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights.</li><li>Documentation of consent contains all applicable basic and additional elements of disclosure, and meets requirements in law and regulation, either with a long-form consent document, or a short-form consent document, or a broad consent document.</li><li>When informed consent is waived, a written statement describing the research is provided to participants, when required by the IRB or EC.</li><li>The researcher considers whether the research involves participants whose decision-making capacity is in question and, when some or all of the participants are likely to have diminished decision-making capacity, considers whether additional safeguards are needed as part of the consent process.</li><li>When research involves children as participants, the researcher follow the assent process for children and consent process for parents or guardians approved by the IRB or EC.</li><li>When researchers are likely to approach adults who lack the ability to consent, researchers assess of the capacity to consent is adequate and obtain assent of the participants as required by the IRB or EC. </li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs-or-us-fda--documentation-of-informed-consent",
 "title": "When following DHHS or FDA requirements, educational materials or website information for researchers, or the researcher handbook describe: <ul><li>When the long form of consent documentation is used, researchers or research staff follow regulatory and IRB/EC requirements.</li><li>When the short form of consent documentation is used, researchers or research staff follow regulatory and IRB/EC requirements.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
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 "key": "dhhs-or-us-fda--documentation-of-informed-consent",
 "title": "Add to educational materials or website information for researchers, or the researcher handbook [page xx or elsewhere]:When following DHHS or FDA requirements:<ul><li>When the long form of consent documentation is used, researchers or research staff follow regulatory and IRB/EC requirements.</li><li>When the short form of consent documentation is used, researchers or research staff follow regulatory and IRB/EC requirements.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "dhhs--consent-process",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to II.3.F., II.3.G., and II.4.B., for researchers who must follow DHHS requirements, including:<ul><li>The consent process and document begin with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.For referenceELEMENT II.3.F.: The IRB or EC has and follows written policies and procedures to evaluate the consent process and to require that the researcher appropriately document the consent process.ELEMENT II.3.G.: The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation. ELEMENT II.4.B.: The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question. ELEMENT II.4.B.: The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question.  ",
 "description": "",
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 "key": "dhhs--consent-process",
 "title": "Add to educational materials or website information for researchers, or the researcher handbook [page xx or elsewhere]:When following DHHS requirements:<ul><li>The consent process and document begin with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.</li></ul>",
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 {
 "type": "question/review-assessment",
 "key": "us-fda--consent-process",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent when following FDA regulations with policies and procedures pertaining to II.3.F., II.3.G., and II.4.B., including: <ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The participant or the participant’s legally authorized representative will sign and date the consent document.</li><li>The researcher will give either the participant or the legally authorized representative adequate opportunity to read the consent document before it is signed. </li><li>With regard to data retention when participants withdraw from a clinical trial: <ul><li>When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed.  The consent document cannot give the participant the option of having data removed.</li><li>A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information. </li><li>The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document).  The IRB or EC must approve the consent document.</li><li>If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status. </li></ul></li></ul>GUIDANCE<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
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 "title": "Add to educational materials or website information for researchers, or the researcher handbook [page xx or elsewhere]:When following FDA requirements:<ul type=\"disc\"><li>The participant or the participant’s legally authorized representative will sign and date the consent document.</li><li>The researcher will give either the participant or the legally authorized representative adequate opportunity to read the consent document before it is signed. </li><li>With regard to data retention when participants withdraw from a clinical trial: </li><ul type=\"disc\"><li>When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed.  The consent document cannot give the participant the option of having data removed.</li><li>A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information.</li><li>The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document).  The IRB or EC must approve the consent document.</li><li>If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status. </li></ul></ul>",
 "description": "",
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 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dod--informed-consent-process",
 "title": "Written materials accessible or provided to researchers describe: <ul><li>If the research involves a human being as an experimental subject and is supported by DoD-appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980.<ul><li>If the participant is unable to provide informed consent and consent will be obtained in advance from the participant’s legal representative, the research must be intended to benefit the individual participants.</li></ul></li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
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 "key": "dod--informed-consent-process",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DoD requirements:<ul><li>If the research involves a human being as an experimental subject and is supported by DoD-appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980.<ul><li>If the participant is unable to provide informed consent and consent will be obtained in advance from the participant’s legal representative, the research must be intended to benefit the individual participants.</li></ul></li></ul>",
 "description": "",
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 }
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 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--informed-consent-process",
 "title": "When following the ICH-GCP (E6) guideline, written materials accessible or provided to researchers describe that researchers and research staff provide all the disclosures and follow the requirements pertaining to consent covered by ICH-GCP (E6).",
 "description": "",
 "keywords": "ich-gcp-all,ich-gcp-sponsor-request",
 "components": [
 {
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 "key": "ich-gcp--informed-consent-process",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following the ICH-GCP (E6) guideline, researchers and research staff provide all the disclosures and follow the requirements pertaining to consent covered by ICH-GCP (E6).",
 "description": "",
 "keywords": "",
 "components": []
 }
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 },
 {
 "type": "question/review-assessment",
 "key": "va--informed-consent-process",
 "title": "When following VA requirements, written materials accessible or provided to researchers describe: <ul><li>The consent document must be signed and dated by the participant or legally authorized representative, unless the IRB has waived the requirement for the signature of the person obtaining consent (e.g., where the only contact with the participant is through telephone or mail). </li><li>A physical or electronic copy must be given or made available to the person signing the form. </li><li>The informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes; how the photographs, video, and/or audio recordings will be used for the research; and whether the photographs, video, and/or audio recordings will be disclosed outside VA.<ul><li>An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.</li><li>The consent for research does not give legal authority to disclose the photographs, video, and/or audio recordings outside VA.</li></ul></li></ul>",
 "description": "",
 "keywords": "va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va--informed-consent-process",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following VA requirements: <ul><li>The consent document must be signed and dated by the participant or legally authorized representative, unless the IRB has waived the requirement for the signature of the person obtaining consent (e.g., where the only contact with the participant is through telephone or mail).</li><li>A physical or electronic copy must be given or made available to the person signing the form. </li><li>The informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes; how the photographs, video, and/or audio recordings will be used for the research; and whether the photographs, video, and/or audio recordings will be disclosed outside VA.<ul><li>An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.</li><li>The consent for research does not give legal authority to disclose the photographs, video, and/or audio recordings outside VA.</li></ul></li></ul>",
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 }
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 }
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 },
 {
 "type": "section/element",
 "key": "element-iii-1-g",
 "title": "ELEMENT III.1.G.",
 "description": "Researchers and research staff have a process to address participants’ concerns, complaints, or requests for information.",
 "keywords": "all",
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 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
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 {
 "type": "question/review-assessment",
 "key": "concerns--complaints--or-questions-about-the-research-study",
 "title": "Essential RequirementsWritten materials accessible or provided to researchers describe: <ul><li>The way in which the organization provides research participants with information on how to contact the researchers or research staff in regard to:<ul><li>Concerns, complaints, or questions about the research study.</li><li>Request for information.</li></ul></li><li>Questions about the study should be answered to the satisfaction of the participant or the participant’s legally acceptable representative.</li></ul>",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "concerns--complaints--or-questions-about-the-research-study",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: <ul><li>The way in which the organization provides research participants with information on how to contact the researchers or research staff in regard to:<ul><li>Concerns, complaints, or questions about the research study.</li><li>Request for information.</li></ul></li><li>Questions about the study should be answered to the satisfaction of the participant or the participant’s legally acceptable representative.</li></ul>",
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 }
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 }
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 }
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 }
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 },
 {
 "type": "section/standard",
 "key": "standard-iii-2",
 "title": "STANDARD III-2",
 "description": "Researchers meet requirements for conducting research with participants and comply with all applicable laws, regulations, codes, and guidance; the organization’s policies and procedures for protecting research participants; and the IRB’s or EC’s determinations.",
 "keywords": "",
 "components": [
 {
 "type": "section/element",
 "key": "element-iii-2-a",
 "title": "ELEMENT III.2.A.",
 "description": "Researchers and research staff are qualified by training and experience for their research roles, including knowledge of applicable laws, regulations, codes, and guidance; relevant professional standards; and the organization’s policies and procedures regarding the protection of research participants.  ",
 "keywords": "all",
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 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
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 "components": []
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 },
 {
 "type": "question/review-assessment",
 "key": "researcher-qualification-for-roles-and-responsibilities",
 "title": "If the organization has developed written materials specifically directed toward for researchers and research staff, such as educational materials, website information for researchers, or the researcher handbook, ensure they are consistent with policies and procedures pertaining to I.1.D., including:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The ethical obligations and expectations of researchers and research staff, including students involved in the conduct of research.</li><li>The roles and responsibilities of researchers and research staff.</li><li>Training and education requirements to meet their obligations and responsibilities.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "all",
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 "type": "text/review-assessment-snippet",
 "key": "researcher-qualification-for-roles-and-responsibilities",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: <ul type=\"disc\"><li>The ethical obligations and expectations of researchers and research staff, including students involved in the conduct of research.</li><li>The roles and responsibilities of researchers and research staff.</li><li>Training and education requirements to meet their obligations and responsibilities.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--researcher-responsibilities-(not-independent-irbs-ecs)",
 "title": "When following the ICH-GCP (E6) guideline. written materials accessible or provided to researchers describe:<ul><li>The researcher provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB, or the regulatory authority.</li><li>The researcher is familiar with the appropriate use of the investigational product, as described in the protocol, in the current investigator’s brochure, in the product information, and in other information sources provided by the sponsor.</li><li>A qualified physician (or dentist, when appropriate), who is a researcher or a co-researcher for the clinical trial, is responsible for all clinical trial-related medical (or dental) decisions (not applicable to independent IRBs).</li><li>During and following a participant’s participation in a clinical trial, the researcher ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial (not applicable to independent IRBs). </li><li>The researcher ensures the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor. </li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The researcher permits monitoring and auditing by the sponsor and inspection by the appropriate regulatory authority.<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The researcher maintains the clinical trial documents as specified in Essential Documents for the Conduct of a Clinical Trial and as required by the applicable regulatory requirements.</li><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">Essential documents are retained until at least two years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational product.</li></ul>",
 "description": "",
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 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following the ICH-GCP (E6) guideline:<ul><li>The researcher provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB, or the regulatory authority.</li><li>The researcher is familiar with the appropriate use of the investigational product, as described in the protocol, in the current investigator’s brochure, in the product information, and in other information sources provided by the sponsor.</li><li>A qualified physician (or dentist, when appropriate), who is a researcher or a co-researcher for the clinical trial, is responsible for all clinical trial-related medical (or dental) decisions (not applicable to independent IRBs).</li><li>During and following a participant’s participation in a clinical trial, the researcher ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial (not applicable to independent IRBs).</li><li>The researcher ensures the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor.</li><li>The researcher permits monitoring and auditing by the sponsor and inspection by the appropriate regulatory authority.</li><li>The researcher maintains the clinical trial documents as specified in Essential Documents for the Conduct of a Clinical Trial and as required by the applicable regulatory requirements.</li><li>Essential documents are retained until at least two years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational product.</li></ul>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--researcher-responsibilities-(independent-irbs-ecs)",
 "title": "<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">When following the ICH-GCP (E6) guideline, written materials accessible or provided to researchers describe<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">:<ul><li>The researcher provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB, or the regulatory authority.</li><li>The researcher is familiar with the appropriate use of the investigational product, as described in the protocol, in the current investigator’s brochure, in the product information, and in other information sources provided by the sponsor.</li><li>A qualified physician (or dentist, when appropriate), who is a researcher or a co-researcher for the clinical trial, is responsible for all clinical trial-related medical (or dental) decisions (not applicable to independent IRBs).</li><li>During and following a participant’s participation in a clinical trial, the researcher ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial (not applicable to independent IRBs).<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\"></li></ul>",
 "description": "",
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 "type": "text/review-assessment-snippet",
 "key": "ich-gcp--researcher-responsibilities-(independent-irbs-ecs)",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following the ICH-GCP (E6) guideline:<ul><li>The researcher provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB, or the regulatory authority.</li><li>The researcher is familiar with the appropriate use of the investigational product, as described in the protocol, in the current investigator’s brochure, in the product information, and in other information sources provided by the sponsor.</li><li>A qualified physician (or dentist, when appropriate), who is a researcher or a co-researcher for the clinical trial, is responsible for all clinical trial-related medical (or dental) decisions (not applicable to independent IRBs).</li><li>During and following a participant’s participation in a clinical trial, the researcher ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial (not applicable to independent IRBs).</li></ul>",
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 },
 {
 "type": "section/element",
 "key": "element-iii-2-b",
 "title": "ELEMENT III.2.B.",
 "description": "Researchers maintain appropriate oversight of each research study, as well as research staff and trainees, and appropriately delegate research responsibilities and functions. ",
 "keywords": "all",
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 "type": "question/applicant-documents",
 "key": "q1",
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 "description": "",
 "keywords": "",
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 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
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 "description": "",
 "keywords": "all",
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 }
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 },
 {
 "type": "question/review-assessment",
 "key": "doj--researcher-oversight",
 "title": "When following DoJ requirements, <span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">written materials accessible or provided to\nresearchers describe that for research conducted within the Bureau of Prisons, the\nresearcher must assume responsibility for actions of any person engaged to\nparticipate in the research project as an associate, assistant, or\nsubcontractor to the researcher.",
 "description": "",
 "keywords": "doj",
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 {
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 "key": "doj--researcher-oversight",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DoJ requirements, researchers describe that for research conducted within the Bureau of Prisons, the researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.<div><span style=\"color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; white-space: inherit; background-color: rgba(0, 0, 0, 0); caret-color: auto\"> </div>",
 "description": "",
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 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--researcher-oversight",
 "title": "When following the ICH-GCP (E6) guideline, written materials accessible or provided to researchers describe responsibilities of researchers for supervising others, when relying on others to conduct the research:<ul><li>A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) should have the overall responsibility for the trial-related medical care given to and medical decisions made on behalf of participants. Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.</li><li>The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor.</li><li>The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data. The level of investigator oversight of the delegated activities should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.</li><li>The investigator should ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties in accordance with local regulatory requirements). Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience.</li><li>The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities. Documentation of delegation should be proportionate to the significance of the trial-related activities. In situations where the activities are performed as part of clinical practice, delegation documentation may not be required.</li></ul>",
 "description": "",
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 {
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 "key": "ich-gcp--researcher-oversight",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]:When following the ICH-GCP (E6) guideline, r<span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit\">esponsibilities of researchers for supervising others, when relying on others to conduct the research, include:<ul><li>A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) should have the overall responsibility for the trial-related medical care given to and medical decisions made on behalf of participants. Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.</li><li>The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor.</li><li>The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data. The level of investigator oversight of the delegated activities should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.</li><li>The investigator should ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties in accordance with local regulatory requirements). Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience.</li><li>The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities. Documentation of delegation should be proportionate to the significance of the trial-related activities. In situations where the activities are performed as part of clinical practice, delegation documentation may not be required.</li></ul>",
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 }
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 },
 {
 "type": "question/review-assessment",
 "key": "va--researcher-oversight",
 "title": "When following VA requirements, written materials accessible or provided to researchers describe: <ul><li>If the principal researcher or local site researcher does not personally obtain informed consent, the researcher must delegate this responsibility in writing (e.g., by use of a delegation letter) to research staff sufficiently knowledgeable about the protocol and related concerns to answer questions from prospective participants, and about the ethical basis of the informed consent process and protocol.</li><li>If the researcher contracts with a firm (e.g., a survey research firm) to obtain consent from participants, collect private individually identifiable information from human participants, or be involved in activities that would institutionally engage the firm in human participants research, the firm must have its own IRB/EC oversight of the activity.<ul><li>In addition, the Privacy Officer (PO) must determine that there is appropriate authority to allow the disclosure of individual names and other information to the contracted firm.</li></ul></li></ul>",
 "description": "",
 "keywords": "va",
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 "key": "va--researcher-oversight",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following VA requirements:<ul><li>If the principal researcher or local site researcher does not personally obtain informed consent, the researcher must delegate this responsibility in writing (e.g., by use of a delegation letter) to research staff sufficiently knowledgeable about the protocol and related concerns to answer questions from prospective participants, and about the ethical basis of the informed consent process and protocol.</li><li>If the researcher contracts with a firm (e.g., a survey research firm) to obtain consent from participants, collect private individually identifiable information from human participants, or be involved in activities that would institutionally engage the firm in human participants research, the firm must have its own IRB/EC oversight of the activity.<ul><li>In addition, the Privacy Officer (PO) must determine that there is appropriate authority to allow the disclosure of individual names and other information to the contracted firm.</li></ul></li></ul>",
 "description": "",
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 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-iii-2-c",
 "title": "ELEMENT III.2.C.",
 "description": "Researchers and research staff follow the requirements of the research protocol or plan and adhere to the policies and procedures of the organization and to the requirements or determinations of the IRB or EC.",
 "keywords": "all",
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 },
 {
 "type": "question/review-assessment",
 "key": "doe--researcher-compliance",
 "title": "When following DOE requirements, written materials accessible or provided to researchers describe that researchers conducted research in compliance with the DOE requirements for protecting personally identifiable information (PII). ",
 "description": "",
 "keywords": "doe",
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 "type": "text/review-assessment-snippet",
 "key": "doe--researcher-compliance",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DOE requirements, researchers conduct research in compliance with the DOE requirements for protecting personally identifiable information (PII). ",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ed--researcher-compliance",
 "title": "When following ED requirements, written materials accessible or provided to researchers describe access to instructional material used in a research or experimentation program as follows:<ul><li>All instructional material--including teachers' manuals, films, tapes, or other supplementary instructional material--which will be used in connection with any research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in such research.</li><li>Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.</li><li>Children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age or majority as determined under state law.</li></ul>",
 "description": "",
 "keywords": "ed",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "ed--researcher-compliance",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following ED requirements:<ul><li>All instructional material--including teachers' manuals, films, tapes, or other supplementary instructional material--which will be used in connection with any research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in such research.</li><li>Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.</li><li>Children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age or majority as determined under state law.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va--researcher-compliance",
 "title": "When following VA requirements, written materials accessible or provided to researchers describe that the principal researcher, local site researcher, and researcher must uphold professional and ethical standards and practices and adhere to all applicable VA and other federal requirements, including the local VA facility’s standard operating procedures, regarding the conduct of research and the protection of human participants. GUIDANCEThe responsibilities of the researcher may be defined in the protocol or IRB application.",
 "description": "",
 "keywords": "va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va--researcher-compliance",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following VA requirements:Tthe principal researcher, local site researcher, and researcher must uphold professional and ethical standards and practices and adhere to all applicable VA and other federal requirements, including the local VA facility’s standard operating procedures, regarding the conduct of research and the protection of human participants.",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 },
 {
 "type": "section/element",
 "key": "element-iii-2-d",
 "title": "ELEMENT III.2.D.",
 "description": "Researchers and research staff follow reporting requirements during a research study in accordance with applicable laws, regulations, codes, and guidance; the organization’s policies and procedures; and the IRB’s or EC’s requirements.  ",
 "keywords": "all",
 "components": [
 {
 "type": "question/applicant-documents",
 "key": "q1",
 "title": "",
 "description": "",
 "keywords": "",
 "components": [
 {
 "type": "question/review-assessment",
 "key": "provide-written-materials",
 "title": "The organization provided all documents relevant for the evaluation of this Element.",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "provide-written-materials",
 "title": "Please provide the following document(s) with your response to the Application Review:[document name]",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "researcher-reporting-requirements",
 "title": "Add to educational materials or website information for\nresearchers, or the researcher handbook materials that are consistent with the\nessential requirements of Elements I.5.D., II.2.G., II.2.H., and II.2.I.<ul><li><ul><li></li><li></li><li></li><li></li><li></li><li></li></ul></li><li><ul><li></li><li>Continuing noncompliance</li><li>Unanticipated problems involving risk to participants or others</li><li>Participant complaints</li><li>Changes implemented to prevent an apparent immediate hazard to participants</li><li>Suspension or termination of research</li><li>When the study has been closed.</li></ul></li></ul><ul><li></li></ul> ",
 "description": "",
 "keywords": "all",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "researcher-reporting-requirements",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: <ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">The types of events that are required to be reported to an IRB/EC reviewing the research, such as:<ul><li></li><li></li><li></li><li></li><li></li><li></li></ul></li><li><ul><li></li><li>Continuing noncompliance</li><li>Unanticipated problems involving risk to participants or others</li><li>Participant complaints</li><li>Changes implemented to prevent an apparent immediate hazard to participants</li><li>Suspension or termination of research</li><li>When the study has been closed.</li></ul></li></ul><ul><li></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dhhs--researcher-reporting",
 "title": "When following DHHS requirements, educational materials or website information for researchers, or the researcher handbook materials are consistent with the essential requirements of Elements I.5.D., II.2.G., II.2.H., and II.2.I., including:<ul><li><ul><li></li><li></li><li></li><li>Changes implemented to prevent an apparent immediate hazard to participants</li></ul></li></ul>",
 "description": "",
 "keywords": "dhhs",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dhhs--researcher-reporting",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DHHS requirements:<ul><li><ul><li></li><li></li><li></li><li>Changes implemented to prevent an apparent immediate hazard to participants</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "dod--researcher-reporting",
 "title": "When following DoD requirements, educational materials or website information for researchers, or the researcher handbook materials are consistent with the essential requirements of Elements I.5.D., II.2.G., II.2.H., and II.2.I., including:<ul><li>Researchers must report promptly to the IRB/EC reviewing the research:<ul><li>Audits of DoD-conducted or DoD-supported human participant research.</li><li>Allegations of serious or continuing noncompliance related to research involving human participants that are substantiated by investigation, and subsequent actions taken based on the findings.<ul><li>Substantiated allegations related to classified HSR must be reported immediately.</li></ul></li></ul></li><li>When conducting multi-site research, policies and procedures indicate that a formal agreement between organizations is required to specify the roles and responsibilities of each party.</li></ul>GUIDANCEIf there is a researcher manual, recommend places within the manual to add materials but do not recommend adding to other materials.If there is no researcher manual and the organization’s policies are how researchers are informed of their requirements, and missing information has been requested above, do not duplicate the request under Domain III.",
 "description": "",
 "keywords": "dod",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "dod--researcher-reporting",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DoD requirements:<ul><li>Researchers must report promptly to the IRB/EC reviewing the research:<ul><li>Audits of DoD-conducted or DoD-supported human participant research.</li><li>Allegations of serious or continuing noncompliance related to research involving human participants that are substantiated by investigation, and subsequent actions taken based on the findings.<ul><li>Substantiated allegations related to classified HSR must be reported immediately.</li></ul></li></ul></li><li>When conducting multi-site research, policies and procedures indicate that a formal agreement between organizations is required to specify the roles and responsibilities of each party.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "doe--researcher-reporting",
 "title": "When following DOE requirements, educational materials, or website information for researchers, or the researcher handbook describe:<ul><li>Researchers must report the following within 48 hours to the HSP Program Manager:<ul><li>Any significant adverse events, unanticipated problems, and complaints about the research, with a description of any corrective actions taken or to be taken.</li><li>Any suspension or termination of IRB/EC approval of research.</li><li>Any significant noncompliance with HRPP procedures or other requirements.</li></ul></li><li>Researchers must report the following immediately to the Human Subject Protection Program Manager:<ul><li>Any suspected or confirmed compromise of personally identifiable information, with a description of any corrective actions taken or to be taken. The incident must also be immediately reported to the DOE-Cyber Incident Response Capability.</li><li>Any serious adverse event, with a description of any corrective actions taken or to be taken.</li></ul></li></ul>",
 "description": "",
 "keywords": "doe",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "doe--researcher-reporting",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DOE requirements:<ul><li>Researchers must report the following within 48 hours to the HSP Program Manager:<ul><li>Any significant adverse events, unanticipated problems, and complaints about the research, with a description of any corrective actions taken or to be taken.</li><li>Any suspension or termination of IRB/EC approval of research.</li><li>Any significant noncompliance with HRPP procedures or other requirements.</li></ul></li><li>Researchers must report the following immediately to the Human Subject Protection Program Manager:<ul><li>Any suspected or confirmed compromise of personally identifiable information, with a description of any corrective actions taken or to be taken. The incident must also be immediately reported to the DOE-Cyber Incident Response Capability.</li><li>Any serious adverse event, with a description of any corrective actions taken or to be taken.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "doj--researcher-reporting",
 "title": "When following DoJ requirements, educational materials or website information for researchers, or the researcher handbook describe:<ul><li>For National Institute of Justice-funded research, a copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.<ul><li>At least once a year, the researcher shall provide the chief, Office of Research and Evaluation, with a report on the progress of the research.</li><li>At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance. The researcher shall include an abstract in the report of findings.</li><li>In any publication of results, the researcher shall acknowledge the Bureau's participation in the research project. </li><li>The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.</li><li>Prior to submitting for publication, the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.</li></ul></li></ul>",
 "description": "",
 "keywords": "doj",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "doj--researcher-reporting",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]: When following DoJ requirements:<ul><li>For National Institute of Justice-funded research, a copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.<ul><li>At least once a year, the researcher shall provide the chief, Office of Research and Evaluation, with a report on the progress of the research.</li><li>At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance. The researcher shall include an abstract in the report of findings.</li><li>In any publication of results, the researcher shall acknowledge the Bureau's participation in the research project.</li><li>The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.</li><li>Prior to submitting for publication, the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.</li></ul></li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "ich-gcp--researcher-reporting",
 "title": "When following the ICH-GCP (E6) guideline, the following researcher responsibilities are described in a form accessible or provided to researchers:<ul><li>Adverse events and/or abnormal test results required for safety evaluations (as outlined in the protocol) should be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol. Unfavorable medical events occurring in participants before investigational product administration (e.g., during screening) should be considered and reported to the sponsor if required by the protocol. </li><li>All serious adverse events (SAEs) should be reported immediately (after the investigator reasonably becomes aware of the event) to the sponsor. The investigator should also include an assessment of causality. In accordance with applicable regulatory requirements, the protocol may identify SAEs not requiring immediate reporting; for example, deaths or other events that are endpoints. Subsequent information should be submitted as a follow-up report, as necessary. </li><li>For reported deaths, the investigator should supply the sponsor, the IRB/IEC and, where applicable, the regulatory authority with any additional requested information (e.g., autopsy reports and terminal medical reports) when they become available.</li><li>The investigator may delegate activities for safety reporting to qualified investigator site staff but retains the overall responsibility for safety of participants under their responsibility and compliance with the reporting requirements. </li><li>If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial participants and should ensure appropriate therapy and follow-up for the participants.</li><li>If the sponsor terminates or suspends a trial, the investigator/institution or the sponsor, in accordance with applicable regulatory requirement(s), should promptly inform the IRB/IEC and the regulatory authorities and should provide an appropriate explanation.  </li><li>Where the investigator terminates or suspends their involvement in a trial without prior agreement by the sponsor, the investigator should promptly inform the institution, where applicable, the sponsor, the IRB/IEC and the regulatory authorities in accordance with applicable regulatory requirements and should provide a detailed explanation of the reasons.</li><li>If the IRB/IEC terminates or suspends its approval/favorable opinion of a trial the researcher should inform the institution, where applicable, and the researcher/institution should promptly notify the sponsor.</li><li>Upon completion of the trial, the investigator, where applicable, should inform the institution.</li><li>The investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome and, if applicable, the regulatory authority(ies) with any required reports.</li></ul>",
 "description": "",
 "keywords": "ich-gcp---independent-irb-ec,ich-gcp-all,ich-gcp-sponsor-request",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "ich-gcp--researcher-reporting",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]:When following the ICH-GCP (E6) guideline:<ul><li>Adverse events and/or abnormal test results required for safety evaluations (as outlined in the protocol) should be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol. Unfavorable medical events occurring in participants before investigational product administration (e.g., during screening) should be considered and reported to the sponsor if required by the protocol.</li><li>All serious adverse events (SAEs) should be reported immediately (after the investigator reasonably becomes aware of the event) to the sponsor. The investigator should also include an assessment of causality. In accordance with applicable regulatory requirements, the protocol may identify SAEs not requiring immediate reporting; for example, deaths or other events that are endpoints. Subsequent information should be submitted as a follow-up report, as necessary.</li><li>For reported deaths, the investigator should supply the sponsor, the IRB/IEC and, where applicable, the regulatory authority with any additional requested information (e.g., autopsy reports and terminal medical reports) when they become available.</li><li>The investigator may delegate activities for safety reporting to qualified investigator site staff but retains the overall responsibility for safety of participants under their responsibility and compliance with the reporting requirements.</li><li>If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial participants and should ensure appropriate therapy and follow-up for the participants.</li><li>If the sponsor terminates or suspends a trial, the investigator/institution or the sponsor, in accordance with applicable regulatory requirement(s), should promptly inform the IRB/IEC and the regulatory authorities and should provide an appropriate explanation. </li><li>Where the investigator terminates or suspends their involvement in a trial without prior agreement by the sponsor, the investigator should promptly inform the institution, where applicable, the sponsor, the IRB/IEC and the regulatory authorities in accordance with applicable regulatory requirements and should provide a detailed explanation of the reasons.</li><li>If the IRB/IEC terminates or suspends its approval/favorable opinion of a trial the researcher should inform the institution, where applicable, and the researcher/institution should promptly notify the sponsor.</li><li>Upon completion of the trial, the investigator, where applicable, should inform the institution.</li><li>The investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome and, if applicable, the regulatory authority(ies) with any required reports.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 },
 {
 "type": "question/review-assessment",
 "key": "va--researcher-reporting",
 "title": "When following VA requirements, educational materials or website information for researchers, or the researcher handbook, materials that are consistent with VA requirements pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I, including.:<ul><li><span style=\"background-color: rgba(0, 0, 0, 0); color: inherit; font-family: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit; font-size: inherit\">VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent serious and/or continuing noncompliance with applicable laws, regulations, policies, and agreements pertaining to non-exempt human participants research. This includes, but is not limited to, serious or continuing noncompliance with the Common Rule, local VA medical facility policies and SOPs related to human participants research, if developed, IRB-approved protocols, and the requirements or determinations of the IRB/EC.</li><li>In the event of a local research participant death, VA personnel must ensure that the appropriate IRB/EC of Record and VA ACOS/R&D are notified:<ul><li>With oral notification immediately (i.e., within one hour) upon becoming aware of any local research death of a human participant that is believed to be both unexpected and related or possibly related to participating in a VA non-exempt human participant study. VA personnel must also provide follow-up written notification to the appropriate IRB/EC of Record within one business day of becoming aware of such a death.<ul><li>The ACOS/R&D, or designee, must alert the VA medical facility Director and appropriate ORO workgroup by email or telephone within one (1) business day after receiving the initial oral notification and provide relevant information as requested.</li></ul></li></ul></li><li>In the event of any apparent UPIRTSO, VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent UPIRTSO involving a VA non-exempt human participants research study. <ul><li>An apparent UPIRTSO is an apparent incident, experience or outcome that is: unexpected and related or possibly related to participation in the research and indicative of the research placing participants or others at substantively greater risk of harm than was previously known or recognized. </li></ul></li><li>The VA medical facility Director, or designee, must report the IRB’s/EC’s determinations to the appropriate ORO workgroup within five business days after receiving the IRB’s/EC’s written notification.</li></ul>",
 "description": "",
 "keywords": "va",
 "components": [
 {
 "type": "text/review-assessment-snippet",
 "key": "va--researcher-reporting",
 "title": "Add to or describe in written materials accessible or provided to researchers [page xx or elsewhere]:When following VA requirements:<ul><li>VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent serious and/or continuing noncompliance with applicable laws, regulations, policies, and agreements pertaining to non-exempt human participants research. This includes, but is not limited to, serious or continuing noncompliance with the Common Rule, local VA medical facility policies and SOPs related to human participants research, if developed, IRB-approved protocols, and the requirements or determinations of the IRB/EC.</li><li>In the event of a local research participant death, VA personnel must ensure that the appropriate IRB/EC of Record and VA ACOS/R&D are notified:<ul><li>With oral notification immediately (i.e., within one hour) upon becoming aware of any local research death of a human participant that is believed to be both unexpected and related or possibly related to participating in a VA non-exempt human participant study. VA personnel must also provide follow-up written notification to the appropriate IRB/EC of Record within one business day of becoming aware of such a death.<ul><li>The ACOS/R&D, or designee, must alert the VA medical facility Director and appropriate ORO workgroup by email or telephone within one (1) business day after receiving the initial oral notification and provide relevant information as requested.</li></ul></li></ul></li><li>In the event of any apparent UPIRTSO, VA personnel must ensure that the appropriate IRB/EC of Record is notified, in writing, within five (5) business days after becoming aware of any apparent UPIRTSO involving a VA non-exempt human participants research study.<ul><li>An apparent UPIRTSO is an apparent incident, experience or outcome that is: unexpected and related or possibly related to participation in the research and indicative of the research placing participants or others at substantively greater risk of harm than was previously known or recognized.</li></ul></li><li>The VA medical facility Director, or designee, must report the IRB’s/EC’s determinations to the appropriate ORO workgroup within five business days after receiving the IRB’s/EC’s written notification.</li></ul>",
 "description": "",
 "keywords": "",
 "components": []
 }
 ]
 }
 ]
 }
 ]
 }
 ]
 }
 ]
 }
 ]
}

Testimonial

People are getting AAHRPP accredited because they want to…that’s significant because it requires a commitment to the goals of the accreditation…

Barbara Entwisle, PhD
Kenan Distinguished Professor
The University of North Carolina at Chapel Hill

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Table of Contents

DOMAIN III: RESEARCHER AND RESEARCH STAFF

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