19
Jan2016

In November 2015, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes.

The draft guidance explains how the agencies think institutions and IRBs should apply the regulations with respect to preparing and maintaining IRB meeting minutes.

As this is a guidance document, FDA's and OHRP's commentary on the relevant IRB regulations should be seen as "recommendations" but not requirements. 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 pursuant to 21 CFR 56.115(a)(2); 45 CFR 46.115(a)(2).

Much of the guidance document focuses on the level of detail IRB minutes should provide. The guidance states that "Minutes should be detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations." The DHHS and FDA regulations both require that minutes show: meeting attendance, the actions the IRB took, votes on these actions (including the against and abstaining votes), the basis for requiring changes in or disapproving research; and a summary detailing any controverted issues that were discussed and the resolution.

FDA and OHRP are recommending that the following items also be detailed in the minutes: the reasoning behind an IRB's decision to suspend or terminate approval; and any substitution of an alternate IRB member for a primary IRB member, even if it is only for a portion of the meeting, along with the reasoning behind this substitution.

They also recommend that minutes "include protocol-specific information justifying the findings and determinations" in certain situations such as when an IRB finds that a pediatric study meets the additional regulatory protections provided for children or when a waiver of documentation of informed consent is granted.

Finally, the guidance document recommends that the IRB's written procedures include who will be responsible for preparing the minutes and a description of the process for preparing and maintaining minutes.

OHRP and FDA are accepting comments until February 3, 2016.

In the coming weeks, PRIM&R's Public Policy Committee will consider these issues as we prepare comments in response to the draft for submission to OHRP and FDA. As we begin this process, we encourage and welcome you to share your thoughts on the draft guidance in the comments. We look forward to sharing our comments here once they are finalized.

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