Element II.2.F.

Element II.2.F.1. – Initial review
Element II.2.F.2. – Continuing review
Element II.2.F.3. – Review of proposed modifications to previously approved research

If the laws, regulations, codes, and guidance under which an organization conducts research involving human participants permit one or more IRB or EC members to conduct review of research outside of a convened IRB or EC meeting, written materials should describe a procedure for “expedited review.” In general, requirements and criteria to conduct review using the expedited procedure are identical to those for review by the convened IRB or EC.

Written materials should specify what research is eligible for expedited review, and whether any additional IRB or EC review is required after initial review and approval.

If laws, codes, and regulations do not require continuing review of the research by the IRB or EC, nevertheless, 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. When the IRB or 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.

When research is not covered by DHHS regulations or other laws or regulations that specify that only certain categories of research are eligible for expedited review, organizations may define additional categories of research beyond those specified in regulation to conduct expedited review. Written materials should define equivalent protections

when creating additional categories of research that may be reviewed using an expedited procedure.

Regulatory and guidance references

DHHS: 45 CFR 46.110, 21 CFR 56.110, Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure – FDA & DHHS, OHRP Guidance on Written Institutional Review Board (IRB) Procedures, OHRP Guidance on the Use of Expedited Review Procedures, OHRP Guidance on Continuing Review
DoD: Instruction 3216.02 4.b.4., SECNAVINST 3900.39D, para. 6e; OPNAVINST 5300.8C, DODI 8910.01
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
FDA: FDA Information Sheets: Continuing Review after Study Approval
ICH-GCP: 3.3.5
VA: VHA Directive 1200.05(3) section 5 and 1200.05(3) section 9
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Review of Research by the Expedited Procedure
AAHRPP Tip Sheet: Review of Research involving Prisoners and the Role of the Prisoner Representative

Required written materials

Essential requirements:
1. Policies and procedures describe:
  1. That only experienced IRB or EC members may conduct reviews using the expedited procedure.
    1. “Experienced” is defined in terms of professional competence.
  2. Policies and procedures describe the conduct of:
    1. Initial review.
    2. Continuing review, when required by law or regulation.
    3. Review of modifications using the expedited procedure, when required by law or regulation.
      1. Modifications that are “minor” are defined.
  3. Policies and procedures describe the information that researchers have to submit for review using the expedited procedure.
  4. Policies and procedures indicate that at least one reviewer receives and reviews the same materials that the convened IRB or EC receives for protocols reviewed by the convened IRB or EC. (See Element II.2.E.)
  5. Policies and procedures describe the evaluation by the reviewer of research undergoing initial review, modifications, and continuing review, when continuing review is required by law or regulation, using the expedited procedure:
    1. Policies and procedures describe the criteria for approval using the expedited procedure are the same as those for review by a convened IRB or EC, unless otherwise specified in law or regulation.
    2. When using the expedited procedure, reviewers are prohibited from disapproving research.
  6. Policies and procedures describe the process for informing IRB or EC members about approvals by review using the expedited procedure, including:
    1. Initial review.
    2. Continuing review, when required by law or regulation.
    3. Review of modifications to previously approved research.
  7. When continuing review of research is required by law or regulation, policies and procedures indicate that at least one IRB or EC member is provided and reviews the complete protocol, including a status report and any protocol modifications previously approved by the IRB or EC.
  8. The status report on the progress of the research includes:
    1. Number of participants accrued.
    2. A summary since the last IRB review of:
      1. Adverse events, untoward events, and adverse outcomes experienced by participants.
      2. Unanticipated problems involving risks to participants or others.
      3. Participant withdrawals.
      4. The reasons for withdrawals.
      5. Complaints about the research.
      6. Amendments or modifications.
      7. Any relevant recent literature.
    3. Any interim findings.
    4. Any relevant multi-center trial reports.
    5. The researcher’s current risk-potential benefit assessment based on study results.
  9. When continuing review of research is required by law or regulation, policies and procedures have the IRB or EC members determine:
    1. That the protocol needs verification from sources other than the researchers that no material changes had occurred since previous IRB or EC review.
    2. That the current consent document is still accurate and complete.
    3. That 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.
  10. When continuing review is required by law or regulation, if a researcher does not provide continuing review information to the IRB or EC or the IRB or EC has not approved a protocol by the expiration date, policies and procedures:
    1. Have all research activities stop.
    2. Have interventions and interactions on current participants stop, unless the IRB or 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.
    3. Do not allow new enrollment of participants to occur.
When following DHHS regulations:
1. Policies and procedures describe the process for review using the expedited procedure:
  1. The designation by the IRB or EC chair of IRB or EC members who may conduct review using the expedited procedure.
  2. The evaluation by the reviewer of whether research undergoing initial review using the expedited procedure:
    1. Does not involve more than minimal risk.
      1. Research appearing on the list of expedited review categories is deemed to be no more than minimal risk.
      2. 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 or EC.
    2. Represents one or more approvable categories of research.
    3. 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.
    4. Does not involve classified research.
    5. When research involves vulnerable populations, ,additional safeguards have been included in the study to protect the rights and welfare of these participants. (See Element II.4.A.)
2. 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 or EC or an expedited reviewer is not required when:
  1. Research meets one or more categories of research that qualify for expedited review.
  2. Research has progressed to the point that it involves only one or both of the following:
    1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
    2. Accessing follow-up clinical data from procedures that participants would undergo as part of clinical care.
3. The IRB or EC must justify the decision to conduct continuing review of research originally reviewed using the expedited procedure.
4. For organizations that eliminate the requirement for the IRB or 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.
When following DoD requirements:
1. 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.
2. For DoD-supported research reviewed using the expedited procedure, organizations must follow the same reporting requirements described in Element II.2.E.
When following DOE requirements:
1. When conducting or reviewing classified research, the use of the expedited review procedure is prohibited. The fact that research meets a particular expedited category may be noted, but review by a convened IRB is required.
When following FDA regulations:
1. Written materials describe the process for review using the expedited procedure:
  1. The designation by the IRB or EC chair of IRB or EC members who may conduct review using the expedited procedure.
  2. The evaluation by the reviewer of whether research undergoing initial review and continuing review using the expedited procedure:
    1. Represents one or more approvable categories of research.
    2. Does not include activities where identification of the participants or their responses would reasonably place them at risk of criminal of 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.
    3. Does not involve classified research.
    4. When research involves vulnerable populations, additional safeguards have been included in the participants.
2. Continuing review of research must occur at intervals appropriate to the degree of risk, but not less than once a year.
3. The IRB or EC must determine which clinical investigations require review more than annually.
4. The IRB or 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 or EC review. The IRB or EC should consider:
  1. The nature of and any risks posed by the clinical investigation.
  2. The degree of uncertainty regarding the risks involved.
  3. The vulnerability of the participants.
  4. The experience of the clinical investigator in conducting clinical research.
  5. The IRB’s or EC’s previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed
  6. consent, prior complaints from participants about the researcher).
  7. The projected rate of enrollment.
  8. Whether the study involves novel therapies.
When following VA requirements:
1. Policies and procedures indicate that if a researcher does not provide continuing review information to the IRB or the IRB has not approved a protocol by the expiration date:
  1. 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.
  2. The researcher must immediately submit to the IRB chair a list of research participants who could be harmed by stopping study procedures.
  3. The IRB chair, with appropriate consultation with the VA facility chief of staff, determines within two business days whether participants on the list may continue participating in the research interventions or interactions.

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

Application form
Reviewer checklist

Outcomes

Reviewers using the expedited procedures are experienced IRB or EC members.
Research protocols or plans reviewed by the expedited procedure were eligible for such review and did not require review by a convened IRB or EC.
Research approved by the expedited procedure meets the required criteria for approval.

Proceed To: Element II.2.G.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

Element II.2.F.