25
Oct2017

Last month, the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released final guidance on meeting minutes for IRBs who oversee human subjects research under FDA and/or HHS regulations. The final guidance includes a few small changes from the draft released in November 2015. This is the first time the two agencies have jointly issued guidance in this area; the guidance summarizes how the agencies believe IRBs and institutions should apply the federal regulations as they pertain to the creation of IRB meeting minutes.

In February 2016, PRIM&R submitted comments on the draft version of this guidance, supporting OHRP and FDA’s harmonization efforts on this topic and acknowledging that such harmonization will greatly simplify the process by which IRBs who are answerable to both the HHS and FDA can comply with both sets of regulations. However, we expressed concern about the draft guidance’s focus on detailed documentation, noting that documentation requirements can at times “represent a double-edged sword.” We noted that while broad requirements can drive substantive discussion of key human subject protection issues and actions, an excessive focus on "detailed" documentation might lead to unwanted consequences and wasted IRB effort.  We specifically cited our concerns with provisions such as the following:  "Minutes should be detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations."

The general tenor of the final guidance document remains unchanged from the draft version; the agencies made minor wording changes for clarification, and we are pleased to report that several provisions related to the level of detail required in minutes were modified. For instance, the agencies changed recommendations regarding the inclusion of information in minutes if the information can be addressed in other types of IRB recordsThe agencies previously said, “The minutes must summarize all research activities being reviewed by the IRB at that meeting,” while the final guidance asks that IRBs provide “sufficient information” to identify what research activities are being reviewed and voted upon, for example, by providing the protocol number.

Furthermore, language in the section “IRB Regulatory Determinations and Review Responsibilities,” which includes informed consent issues, no longer requires that the IRB include in its minutes, “protocol-specific information justifying the IRB’s” decision or findings.

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. However, the guidance does remind the public 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, so IRBs should take the time to review the final version of the guidance.

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