ELEMENT III.2.D.

ELEMENT III.2.D.: 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.

Researchers and research staff should understand the organization’s reporting requirements for events related to their research. This includes information related to unanticipated problems involving risks to participants or others or non-compliance. While Researchers or research staff do not make determinations of whether an event is an unanticipated problem involving risks to participants or others, they should know the type of events to report to allow the IRB or EC to make determinations. Likewise, researchers and research staff should submit information related to possible non-compliance in order for the IRB or EC to make final determinations. In addition to reporting to the IRB or EC, regulations and organizational policies and procedures may require reporting to other people or entities within the organization as well as to regulatory agencies. Researchers and research staff should also report suspensions or termination of the research, complaints, and data safety and monitoring reports when they occur or become available.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(5)(i), OHRP Guidance on Reporting Incidents to OHRP, OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
DOJ: 28 CFR 512.19,20
FDA: 21 CFR 56.108(b)(1), 21 CFR 312.66, 21 CFR 812.150(a)(1), Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs – Improving Human Subject Protection
ICH-GCP: 4.10.1, 4.11.1-4.11.3, 4.12.1-4.12.3, 4.13
VA: 38 CFR 16.103(b)(5)(i), VHA Directive 1200.05, 9, VHA Directive 1058.01
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I. that address essential requirements.
When following DHHS regulations:
1. Policies and procedures pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I. that address specific DHHS regulations.
When following DoD requirements:
1. Policies and procedures pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I. that address specific DoD requirements.
When following DOE requirements:
1. Researchers must report the following within 48 hours to the HSP Program Manager:
  1. Any significant adverse events, unanticipated risks; and complaints about the research, with a description of any corrective actions taken or to be taken.
  2. Any suspension or termination of IRB approval of research.
  3. Any significant non-compliance with HRPP procedures or other requirements.
2. Researchers must report the following immediately to the Human Subject Protection Program Manager.
  1. 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.
  2. Any serious adverse event, with a description of any corrective actions taken or to be taken.
When following DOJ requirements:
1. Policies and procedures require that 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.
2. Policies and procedures require that for research conducted with the Bureau of Prisons:
  1. At least once a year, the researcher must provide the Chief, Office of Research and Evaluation, with a report on the progress of the research.
  2. At least 12 working days before any report of findings is to be released, the researcher must 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 must include an abstract in the report of findings.
  3. In any publication of results, the researcher must acknowledge the Bureau's participation in the research project.
  4. The researcher must expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
  5. Prior to submitting for publication the results of a research project conducted under this subpart, the researcher must provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.
When following FDA regulations:
1. Policies and procedures pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I. that address specific FDA regulations.
When following the ICH-GCP (E6) guideline:
1. Policies and procedures describe that researcher and research staff are knowledgeable about the following responsibilities:
  1. The researcher reports all serious adverse events (SAEs) to the sponsor except for those SAEs that the protocol or other document (e.g., investigator’s brochure) identifies as not needing immediate reporting. The researcher follows regulatory requirements related to the reporting of unexpected serious adverse drug reactions to the regulatory authority and the IRB or EC.
  2. The researcher reports adverse events or laboratory abnormalities identified in the protocol as critical to safety evaluations to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.
  3. For reported deaths, the researcher supplies the sponsor and the IRB or EC with any additional requested information (e.g., autopsy reports and terminal medical reports).
  4. The researcher provides written reports to the sponsor, the IRB or EC, and, where applicable, the organization on any changes significantly affecting the conduct of the clinical trial or increasing the risk to participants.
  5. If the researcher terminates or suspends a clinical trial without prior agreement of the sponsor, the researcher informs the organization, sponsor, and the IRB or EC.
  6. If the IRB or EC terminates or suspends approval of the clinical trial, the researcher promptly notifies the sponsor.
  7. Upon completion of the clinical trial, the researcher informs the organization; the IRB or EC with a summary of the trial’s outcome; and the regulatory authority with any reports required.
2. In the cases above, the policies and procedures pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I. also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Elements I.5.D., II.2.G., II.2.H., and II.2.I., but are in support of Element III.2.D., include them here.
When following VA requirements:
1. Policies and procedures pertaining to Elements I.5.D., II.2.G., II.2.H., and II.2.I. must address specific VA requirements.
2. VA personnel must ensure that the appropriate IRB 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.
3. In the event of a local research participant death, VA personnel must ensure that the appropriate IRB of Record and VA ACOS/R&D are notified:
  1. 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 of Record within one (1) business day of becoming aware of such a death.
  2. The ACOS/R&D, or designee, must alert the VA medical facility Director and appropriate ORO workgroup by email or telephone within one business day after receiving the initial oral notification and provide relevant information as requested.
4. In the event of any apparent UPIRTSO, VA personnel must ensure that the appropriate IRB of Record is notified, in writing, within five business days after becoming aware of any apparent UPIRTSO involving a VA non-exempt human participants research study.
  1. 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.
5. The VA medical facility Director, or designee, must report the IRB’s determinations to the appropriate ORO workgroup within five business days after receiving the IRB’s written notification.

Common types of materials that may be used to meet the element

Researcher manual

Outcomes

Researchers and research staff follow reporting requirements for research studies, including reporting:
- Events, incidents, and problems according to the organization’s policy on unanticipated problems involving risks to participants or others.
- Non-compliance.
- Suspensions or terminations of research.
- Complaints.
- Protocol deviations and violations.
- Data and safety monitoring reports.
- Other required information.

Proceed To: TABLES

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.2.D.