FDA DRAFT GUIDANCE for recording "Minutes of Institutional Review Board (IRB) Meetings
06 Mar 2018
I. IRB must prepare and maintain adequate documentation of IRB activities, including minutes (MOM) in sufficient detail to show:
Attendance, actions by IRB, vote on these actions (voting for, against, and abstaining); basis for requiring changes in or disapproving research, summary of the discussion of controverted issues and their resolution.
A. Attendance at the IRB Meeting:
MOM must be in sufficient detail to show attendance during meeting of the IRB, and the research to be approved must receive approval of a majority of those members present at the meeting (45 CFR 46.108(b); 21 CFR 56.108(c)).
Additionally, for EXPEDITED REVIEW PROCEDURE, IRB must review the proposed research at a convened meeting where a majority of members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.
- Members, Alternates, Consultants and Guests:
The minutes should contain:
- Accurate record who (Full name) ATTENDED the meeting.
- If any IRB member participates the meeting via TELEPHONE or VIDEO CONFERENCING, the details should be captured in minutes.
- Details of ALTERNATE MEMBERS:
If IRB has appointed alternate members (for the whole meeting or for a part of the meeting), by replacing primary members, the minutes should document any circumstance in which an alternate member is replacing a primary member. In such a case, minutes must provide the alternate’s name and representative status, the name of the primary member for whom the alternate is substituting, and the reason for the substitution (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).
- Name of the CONSULTANT and a brief description of the consultant’s expertise (In case IRB has invited consultants to assist in the review of a particular study) and a declaration that the consultant did not vote (as per 45 CFR 46.107(f); 21 CFR 56.107(f)).
- The records of all non-members and guests to attend a convened meeting (in case, they are invited) including with clarity that the non-member or guest did not participate in the deliberation and voting.
A quorum is the minimum number and type of IRB member that must be present at a convened meeting. For review of the proposed research, below requirements should be fulfilled:
- Majority of the members of the IRB must be present, including at least one member whose primary concerns are in nonscientific areas (45 CFR 46.108(b); 21 CFR 56.108(c)).
- Calculate the majority by using the “HALF-PLUS-ONE” technique: For example, if the total IRB membership is 10 (EVEN), then majority is 6 (half of 10 is 5, plus 1 equals 6), On the other side, if the IRB membership is 15 (ODD), then majority is 8 (half of 15 is 7.5, and rounding up to the next whole number is 8).
- If quorum is lost during a meeting, then the IRB may not take any further action or vote on the proposed research
- Approve, Require Modifications to Secure Approval, Disapprove:
- IRB must have the authority to approve, require modifications in (to secure approval), or disapprove all proposed research activities.
- Additionally, the IRB or institution may develop a range of other allowable actions the IRB may take when reviewing proposed research activities (e.g., approve with conditions, table the proposed research until additional information can be obtained, or defer a decision).
- If a proposed research activity is approved with conditions, the minutes should state the process to be followed to ensure that the conditions are met.
- The minutes should identify the effective date of approval and the approval period (continuing review interval) for any study approved by the IRB.
- Suspension or Termination of IRB Approval
Both OHRP and FDA regulations authorize an IRB to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects (45 CFR 46.113; 21 CFR 56.113).
Any IRB action to suspend or terminate IRB approval must be summarized in minutes including the reason(s) for the IRB’s action(s) and any follow-up action items.
- Other IRB Regulatory Determinations and Review Responsibilities:
IRBs must make certain regulatory findings and determinations in order to approve research.
- Criteria for IRB Approval of Research: For any approval (initial/continuing), IRB must determine that all of the criteria for IRB approval of research are satisfied. The minutes, or other IRB record, should summarize all such criterias.
- Informed Consent: The IRB must also determine that informed consent will be appropriately documented in accordance with the regulations (45 CFR 46.111(a)(5); 21 CFR 56.111(a)(5)).
- Studies Involving Children: IRB to ensure the research meets the conditions of 45 CFR 46.404 or 21 CFR 50.51 (research/clinical investigations not involving greater than minimal risk); 45 CFR 46.405 or 21 CFR 50.52 (clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects); or 45 CFR 46.406 or 21 CFR 50.53 (research/clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition). Additionally, IRB to ensure that requirements for permission by parents or guardians and for assent by children are met (45 CFR 46.408; 21 CFR 50.55).
- Emergency Research: IRB must find and document that the proposed research satisfies the criteria found in OHRP’s Secretarial Waiver8 and/or FDA’s regulations at 21 CFR 50.24.
- FDA-Regulated Medical Device Studies: For these studies, sponsors are responsible for determining whether the device study is a significant risk (SR) or nonsignificant risk (NSR) and present the information to the IRB. IRB must then make its own SR or NSR determination about the study and either agree or disagree with the sponsor, by reviewing relevant information provided by the sponsor
- Studies Involving Pregnant Women, Human Fetuses and Neonates: All required findings should be documented in the minutes, including protocol-specific information justifying the IRB’s findings.
- Studies Involving Prisoners: All required findings should be documented in the minutes.
- Reporting of Expedited Review Activities: There are various methods IRBs can use to keep the IRB members appraised of expedited actions (45 CFR 46.110(c); 21 CFR 56.110(c)). If IRB reviews a report summarizing EXPEDITED REVIEW ACTIONS at a convened meeting, the minutes should describe what was presented to the IRB, indicate that the IRB members had an opportunity to raise concerns, and summarize questions or concerns, if any.
- Unanticipated Problems, Serious or Continuing Noncompliance, Suspension or Termination of IRB Approval: If IRB reviews an issue that requires prompt reporting to the IRB, the minutes should summarize the report and must document the IRB’s action, if any, resulting from that review.
- The following are examples of acceptable formats for documenting. Each example assumes that 15 members were present for the vote:Total Voting = 15; Vote: For = 14, Opposed = 0, Abstained = 1.
Total Voting = 14 [1 member was recused and did not vote]; Vote: For = 12, Against = 1, Abstained = 1.
- The minutes should have details of any member who has a conflicting interest in a research study. And the members who are recused from voting on a specific study because of conflicting interests may not be counted toward the quorum. Additionally, IRB members who participate in a meeting via telephone or video conferencing may vote and be counted towards the quorum.
- IRB members may not vote outside of the convened meeting (e.g., via email prior to the convened meeting).
- Resolution of the controverted issue if reached: The minutes must summarize IRB’s discussion and how they were resolved.
- Resolution of the controverted issue if NOT reached: The minutes must summarize IRB’s discussion and plans for seeking resolution.
- IRBs decide who is responsible for preparing and maintaining minutes.
- IRBs may choose to record IRB meetings (e.g., video, audio tape).
- Records required by the regulations, including meeting minutes, must be retained for at least 3 years after completion of the research subject of the review.
B. Actions Taken by the IRB:
The minutes must summarize all research activities being reviewed by the IRB at that meeting, and must document “actions taken by the IRB” (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).
C.The Vote on IRB Actions
D.Requiring Changes or Disapproving Research: If the IRB disapproves a research activity, the IRB must include a statement of the reasons for its decision.
E.Controverted Issues and Their Resolution: