FDA & OHRP on How to Document IRB Activities

FDA Draft Guidance on How to Document IRB Meeting Minutes

FDA recently teamed up with the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) to develop and publish a draft guidance entitled, “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.”

Meeting minutes serve two purposes. They provide an overview of what happened at the meeting for the people who were not present and just as importantly, they memorialize findings, conclusions and decisions reached. The minutes also provide documentation of the IRB’s compliance with regulatory requirements.

45 CFR 46.115

Title 45, part 46, section 115 of the Code of Federal Regulations (45 CFR 46.115) states that institutions, or in some cases IRBs themselves, are required to “prepare and maintain adequate documentation of IRB activities”, including the minutes of IRB meetings. The minutes provide a summary of what happened and state any findings or determinations made by the IRB during the meeting.

According to the regulation, the minutes must be taken and recorded at every meeting and “shall be in 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.”

Draft Guidance

The FDA & OHRP’s draft guidance was announced on November 5, 2015, and conveys the details on the nature and quantity of the information that must be included in IRB meeting minutes.

According to the document, minutes should provide sufficient detail to show:

  1. Attendance at the meetings
  2. Actions taken by the IRB
  3. The vote on these actions, including number of members voting for, against, and abstaining
  4. The basis for requiring changes in or disapproving research
  5. A written summary of the discussion of controverted issues and their resolution.

The guidance goes into further detail about the recording of attendance at IRB meetings and actions taken by the IRB. With regards to attendance, the agencies stress the importance of keeping an accurate record of who attends each meeting and recommends that attendance is “listed at the beginning of the minutes so it is clear who was present at the meeting.”

In addition to providing the attendance information in the minutes, the document provides details regarding quorum (the minimum number and type of IRB member that must be present at a convened meeting for the IRB to conduct business). “In order to review proposed research at a convened meeting, a majority of the members of the IRB must be present, including at least one member whose primary concerns are in nonscientific areas.”

The document also provides additional information on the documentation of actions taken by the IRB. The guidance states that the minutes should provide details of all “actions taken by the IRB,” which the guidance refers to as any vote taken by the IRB related to a proposed research activity. The minutes should include the number of members voting for and against the research activity, as well as the number of people choosing to abstain. In conclusion, the document states that “the minutes should serve as a central repository for IRB decisions on proposed research activities.”

The guidance also states that, in the past, citations have been issued in the form of OHRP Determination Letters and FDA Warning Letters to IRBs who have failed to prepare and maintain “adequate minutes.” As such, the guidance provides examples of noncompliance related to minutes, including:

  • 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 has been published for comment purposes only, which will be accepted until January 4, 2016. For more details, view the full guidance here; or submit comments and suggestions on the draft document here.