Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 10, October, 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. 4 … Multi-Agency Review of Pediatric Research (#5)

We present here more IRB-focused elements from the FDA’s recent 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 by picking up where we left off in the September HRR (p. 3) with FDA’s advice to
about the kind of confidential information that IRBs must provide to OHRP (rather than to FDA) when seeking approval of applicable research with children.

If the IRB or referring institution or HHS division supporting or conducting the research objects to the disclosure of any nonpublic documents or information in the documents identified by OHRP for public posting and discussion, OHRP will work with the IRB or referring institution and/or sponsor to ensure that any redaction will not negatively impact either the opportunity for public review and comment that is required under the regulation or the discussion of the research at the expert panel meeting“…