PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations.

The draft guidance explains how the agencies think institutions and IRBs should apply the regulations with respect to preparing and maintaining IRB meeting minutes. The guidance reminds readers that institutions and IRBs who have not maintained sufficient documentation of IRB meeting activities may be cited in FDA warning letters and OHRP determination letters.

PRIM&R agrees with OHRP and FDA that additional guidance about the required content and emphasis of IRB meeting minutes could benefit the research community, and we support their effort to engage in public consultation on this issue. We also recognize that OHRP and FDA are harmonizing their guidance in this area, and we approve of such efforts to simplify the process by which IRBs who are answerable to both the DHHS and FDA can comply with both sets of regulations.

PRIM&R also agrees that documentation requirements can support human subjects protections by fostering appropriate deliberations around matters most critical to protocol review and approval. However, documentation requirements represent a double-edged sword. While broad requirements can constructively drive substantive discussion of key subject protection issues and actions, an excessive focus on “detailed” documentation will have unwanted consequences and lead to wasted effort and less meaningful written records of IRB activity.

To that end, PRIM&R suggests that the final guidance provide additional clarification of expectations with regard to the statements “minutes should be detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations” and specifically, “the minutes should summarize the IRB’s consideration of the approval criteria and include a determination as to whether the criteria were met.”

PRIM&R’s blog post summarizing the guidance document can be found here. We encourage and welcome you to share your thoughts on our comments and the guidance document by leaving a comment below.