Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 39, No. 1, January, 2024

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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.

Vol. 39, No. 1, January, 2024
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Excerpt from pg. 3 … IRBs and Expanded Access Submissions (#4)

With this article we conclude our highlight excerpts from the FDA guidance titled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products” (September, 2023; on the Web at

We resume coverage with more recommendations for IRBs from the FDA in the guidance section titled “Recommendations on IRB Procedures and Factors to Consider for Individual Patient Expanded Access

“FDA regulations under 21 CFR 56.111 outline the criteria for IRB approval of research. In the context of an individual patient expanded access submission, FDA does not expect that a protocol will be necessary to provide the IRB with sufficient information to determine whether those criteria are satisfied…”