This is the second of a two blog series on the Draft Guidance for Institutions and IRBs. The first blog was published on January 7, 2016.
In November 2015, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) jointly issued a draft guidance to assist both institutions and institutional review boards (IRBs) in preparing and maintaining minutes of IRB meetings. The requirement for an institution or IRB to prepare and maintain adequate documentation of IRB activities can be found in the regulations (45 CFR 46.115; 21 CFR 56.115) and inadequate meeting minutes has shown up as a common deficiency in 2014 IRB inspections and Warning Letters. As a result, the draft guidance was prepared to provide recommendations on the type and amount of information to include in the minutes.
Meeting minutes serve a number of different purposes. They can provide a summary of what occurred during a meeting, provide a list of who was present or could not attend, document any findings or determinations and demonstrate compliance with regulatory requirements. Within previous Warning Letters issued to IRBs, the FDA has identified common issues involving meeting minutes. The draft guidance lists the following examples of noncompliance’s noted:
- Minutes are missing.
- Minutes lack sufficient detail to show the vote on actions taken by the IRB, including the number of members voting for, against, and abstaining.
- Minutes are incomplete and only describe voting actions as “passed unanimously.”
- Minutes do not clearly indicate, or contain discrepancies about what the IRB approved.
• The IRB maintains multiple sets of minutes with different information for the same meeting.
- Minutes fail to include a summary of the discussion of controverted issues.
The draft guidance put forth provides recommendations to ensure that the IRB or institution provides minutes that are “detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations.” Furthermore, as IRB meetings may result in determinations that proposed research fulfills a specific regulatory requirement, the guidance recommends that “IRBs document their findings and determinations in the minutes, or elsewhere in the IRB records.”
Let us now review certain aspects of the minutes where the guidance has provided additional recommendations to the regulations already in place.
Attendance at the IRB Meeting – Members, Alternates, Consultants and Guests
- Attendance information should be listed at the beginning of the minutes so it is clear who was present at the meeting.
- The minutes should make clear which members, if any, participated in the convened meeting via an alternative mechanism, such as telephone or video conferencing.
- The minutes should document any circumstance in which an alternate member is replacing a primary member.
- IRBs should document in the minutes if a consultant was present during the meeting and document that the consultant did not vote on the study.
- The IRB should consider having a written policy regarding attendance of non-members and guests.
Attendance at the IRB Meeting – Quorum
- If the IRB has an odd number of members, then majority should be calculated by taking half of the total number of IRB members, and rounding up to the next whole number.
- Minutes should provide sufficient information to indicate that a quorum is present throughout the meeting.
Actions Taken by the IRB
- The OHRP and FDA interpret “actions taken by the IRB” to refer to any vote taken by the IRB related to a proposed research activity.
- The minutes should show that the IRB made all of the findings and determinations required for approval under the regulations.
- Research activity approved with conditions should include the process to be followed to ensure the conditions are met.
- The minutes should identify the effective date of approval and the approval period for any study approved by the IRB.
- Any decision to suspend or terminate IRB approval that occurs outside of a convened meeting should be reported to the convened IRB and the discussion summarized in the minutes.
- Recommend that IRBs document all required findings and determinations in the minutes or elsewhere in the IRB records, and include protocol specific information justifying the findings and determinations.
- The minutes, or other IRB Record, should summarize the IRB’s consideration of the approval criteria and should include a determination as to whether the criteria were met, as applicable.
- Recommend that any such waiver of documentation of informed consent be documented in the minutes with protocol-specific information justifying the IRB’s decision(s).
- IRBs should be aware that the FDA does not have similar regulatory provisions permitting an IRB to waive elements of consent, or to waive informed consent altogether.
- OHRP and FDA recommend that the IRB’s findings and determinations for studies involving children be documented in the minutes.
- FDA recommends that the IRB document each significant risk (SR)/non-significant risk (NSR) determination in the minutes.
- There are various methods IRBs can use to keep the IRB members appraised of expedited actions. One method that may be used is to present a report of expedited actions during a convened meeting. If this method is used and the 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 ask questions or raise concerns, and summarize questions or concerns, if any, raised by the IRB members.
The Vote on IRB Actions
- The guidance recommends that minutes identify any member who has a conflicting interest in a research study, and as such, is excluded (recused) from participation in the IRB’s review of that particular research including the reason for the recusal.
- Members who are recused from voting on a specific study because of conflicting interest may not be counted toward the quorum.
Requiring Changes or Disapproving Research
- The minutes should summarize the IRB’s discussion and deliberations for its decision to disapprove proposed research, and clearly indicate the IRB’s reasons for its decisions.
- Recommend that institutions and IRBs decide who is responsible for preparing and maintaining minutes at their institutions and outline the process in the IRB’s written procedures.
- They may consider creating a standard template to assist in the preparation of their minutes.
- It is considered an acceptable practice to document other activities that occur during the meeting.
- The process of using a recording to prepare written minutes should be described in the IRB’s written procedures.
- It is not expected that the minutes include a verbatim transcription of what each member said during the course of the meeting.
Of note, is the absence of recommendations regarding controverted issues and their resolution. The guidance notes that “many IRBs struggle with the amount of detail that is necessary to satisfy this regulatory requirement” but does not provide a guideline on what would be considered a sufficient amount of detail. It does suggest that the minutes reflect if no controverted issues were noted. With this long list of recommendations it will be interesting to see what, if any, changes are found in the final guidance on this topic. These recommendations should provide a handy checklist for IRBs and institutions to use in order to demonstrate regulatory compliance prior to and during an inspection.