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Regulatory Focus™ > News Articles > FDA, HHS Finalize Guidance on Documenting IRB Activities

FDA, HHS Finalize Guidance on Documenting IRB Activities

Posted 25 September 2017 | By Michael Mezher 

FDA, HHS Finalize Guidance on Documenting IRB Activities

The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities.

The guidance, developed jointly by the two agencies, details how and what IRBs should document in the meeting minutes they are required to keep under 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2), which include:

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

According to the agencies, the final guidance includes editorial changes for clarity as well as some changes to the recommendations on documenting findings that are covered in other IRB records in accordance with goals laid out in the 21st Century Cures Act for reducing duplication.

Notably, the final guidance is clearer than the draft version when it comes to documenting findings and determinations made to fulfill other regulatory requirements, such as reviewing research involving children.

In the draft version, the guidance recommended that such determinations be recorded in the minutes "or elsewhere in the IRB records."

In contrast, the final version recommends that such findings and determinations be recorded in the minutes, but notes that they can be documented elsewhere "to avoid redundancy" and explains that the documentation "should include relevant summary information when such information contributes to an understanding of the IRB's findings and determinations."

The final guidance also clarifies that the references made to HHS regulations refer to the current regulations, and not to the regulations as amended by the final rule published on 19 January to modernize protections for human research subjects under the Common Rule, as the final rule is not yet in effect.



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