In November 2015, the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) submitted joint draft guidance for preparing and maintaining minutes of IRB meetings. Quorum Review IRB has evaluated the draft guidance and notes that some recommendations exceed the current regulatory requirements for minutes; e.g., the documentation of a non-vote for consultants. Minutes provide information to persons not present at the meeting (e.g., institutional officials, regulators, IRB members who could not attend) about the IRB’s decisions and provide documentation of the IRB’s compliance with regulatory requirements. Minutes should be detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations. Examples of recent OHRP and FDA noncompliance findings relating to minutes include:
- 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; and
- Minutes fail to include a summary of the discussion of controverted issues.
For more details about this draft guidance and how it may impact your IRB record-keeping practices, read Jim Gearhart’s article OHRP and the FDA Share Expectations for IRB Minutes. With regards to Quorum’s IRB record-keeping practices, Quorum maintains a robust regulatory compliance program that ensures continued compliance with all regulatory requirements and agency guidance.
Comments may be submitted electronically, before February 3rd, 2016 at http://www.regulations.gov.