Federal regulations require institutions and institutional review boards (IRB) that are responsible for review and oversight of human subject research to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings. On November 5, 2015, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) announced the availability of draft guidance regarding IRB minutes (Draft Guidance). (See 80 Fed. Reg. 68545.) The Draft Guidance is intended to assist institutions and IRBs in preparing IRB meeting minutes that comply with regulatory requirements, and is available on the OHRP and FDA websites or by clicking here.
The Draft Guidance was distributed for comment purposes only. Guidance documents do not establish legally enforceable standards separate from federal regulations, but rather explain an agency’s current thinking on a particular topic. In addition, guidance documents can provide insight into those areas where an agency may focus future compliance efforts. Therefore, commenting on proposed guidance documents can be valuable in helping assure that the agencies are taking industry perspectives into consideration. Comments to the Draft Guidance should be submitted by January 4, 2016, to ensure they are considered before the agencies begin work on the final guidance document.
Regulations Detail Minute Requirements
HHS and FDA regulations specifically require that minutes of IRB meetings have sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (See 45 C.F.R. § 46.115(a)(2) and 21 C.F.R. § 56.115(a)(2).) OHRP and FDA state in the Draft Guidance that minutes should be detailed enough for the agencies to be able to determine compliance with regulations.
Draft Guidance Highlights Noncompliance
The Draft Guidance notes several examples of noncompliance relating to minutes, including missing minutes; lack of sufficient detail to show the vote on actions, including number of members voting for and against an action, and number of members abstaining; minutes that are incomplete and only describe voting actions as “passed unanimously”; minutes that do not clearly indicate, or contain discrepancies about, what the IRB approved; multiple sets of minutes with different information for the same meeting; and the failure of minutes to include a summary of the discussion of controverted issues.
Even though the Draft Guidance is still a work-in-process, OHRP and FDA make clear that their representatives will review minutes and other appropriate IRB records to assess compliance with regulations. Accordingly, this may be a good time for institutions and IRBs to take a fresh look at their minutes and other IRB records, and consider whether their documentation includes the required elements and a sufficient level of detail.
The Draft Guidance Provides Direction and Recommendations for Compliance
Attendance at the IRB Meeting: The Draft Guidance highlights the importance of accurate and complete recordkeeping with respect to meeting attendance, especially when alternate members are substituted for primary members, and when consultants, non-members, or guests attend IRB meetings (for example, when IRB support staff or an investigator whose study is being reviewed is present for all or part of a meeting). The Draft Guidance provides recommendations regarding how such information should be reflected in the minutes.
The Draft Guidance also discusses quorum requirements, including accurate calculation of quorum and documenting a change in quorum during the course of the meeting. The Draft Guidance also recommends that minutes provide sufficient information to show that a quorum was present throughout the meeting.
Actions Taken by the IRB: The Draft Guidance notes that minutes must be in sufficient detail to show the actions taken by the IRB at the meeting, and the minutes should serve as a “central repository” for IRB decisions on proposed research activities. The minutes (or other IRB record) should show that the IRB made the findings and determinations required for approval under applicable regulations. If a research activity is approved with conditions, the IRB minutes should indicate the process to be followed to make sure the conditions are met. The minutes should also reflect dates of approval and approval periods for any study approved by the IRB.
The Draft Guidance also addresses documenting suspension or termination of IRB approval, and documentation of required findings and determinations with respect to criteria for IRB approval; informed consent; studies involving children; emergency research; FDA-regulated medical device studies; studies involving pregnant women, human fetuses and neonates; studies involving prisoners; and reporting of expedited review activities. OHRP and FDA recommend that documentation of required findings and determinations include protocol-specific information justifying such findings and determinations.
The Vote on IRB Actions: For purposes of documenting the votes taken on IRB actions, the Draft Guidance provides examples of acceptable formats for use in minutes to memorialize the outcome of voting. The Draft Guidance also suggests ways to document recusal of members due to conflict of interest, and states the importance of recording the votes of members who participate in a convened meeting via telephone or videoconferencing.
Requiring Changes or Disapproving Research: To the extent an IRB requires changes in or disapproves research, the minutes must contain sufficient detail to show the basis for the decision. For example, if the IRB requires the investigator to make changes to the protocol or the informed consent, the minutes must reflect the decision. Similarly, the minutes should summarize the IRB’s discussion and deliberations for any decision to disapprove a research proposal, with a clear indication of the IRB’s reasons for its decision.
Controverted Issues and Their Resolution: The Draft Guidance states that many IRB’s struggle with the amount of detail necessary to show discussion of controverted issues and their resolution. IRB members may resolve controverted issues with continued deliberation, by seeking clarification from the investigator or sponsor, or by voting. If resolution is not reached during an IRB meeting regarding a controverted issue and the IRB seeks additional information, the minutes must summarize the IRB’s discussion and plans for seeking resolution. When resolution is reached, the minutes must summarize the relevant discussion and how the controverted issues were resolved. If there were no controverted issues, the Draft Guidance states that this fact should also be noted in the minutes.
Additional Considerations: The Draft Guidance recommends that institutions and IRBs outline the process for preparing minutes in their written procedures and consider creating a standard template for IRB minutes. OHRP and FDA also comment on IRBs documenting in minutes other activities that occur during meetings (such as continuing education or communication of announcements), and discuss audio and videotape recordings of IRB meetings.
Finally, the Draft Guidance addresses record retention, noting that records required by federal regulations, including minutes, must be retained for at least three years after completion of the research that was the subject of the review. Those records must be accessible for inspection and copying by OHRP and FDA, as applicable. Minutes that include review of multiple studies must be retained until all of the studies that were reviewed at that meeting have been completed for at least three years.
Impact of Guidance
As noted above, guidance documents do not establish legally enforceable standards separate from federal regulations. However, courts usually give deference to guidance documents that purport to be the agency’s interpretation of its own regulations. Therefore, stakeholders should closely review the Draft Guidance and determine whether it would be beneficial to submit comments before it becomes final.