Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 9, September, 2023

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Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.

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Excerpt from pg. 3 … Multi-Agency Review of Pediatric Research (#4)

We continue here with more coverage of the FDA guidance titled “Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP.”

We resume our coverage here by picking up where we left off in the August HRR (p. 5) with FDA’s advice to IRBs about the specific documentation that IRBs must provide to FDA (in contrast to information provided to OHRP) before FDA will approve such research.

As noted … [last month in HRR], FDA will identify for the referring IRB and/or sponsor, as appropriate, the relevant documents that the agency intends to post for the PAC/PES meeting to meet the requirement for public review and comment and that may be discussed during the PAC/PES meeting