Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 3, March, 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.

HRR March 2023

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Excerpt from pg. 3 … IRB Requirements for Expanded Access (#4)

As Since FDA has proposed so many changes recently for IRB regulations, we present more of their proposals in this article.

The proposals are contained in a draft guidance described in the agency’s late 2022 announcement in the FEDERAL REGISTER (see 87 Fed. Reg. 66191, November 2, 2022).

However, in contrast to the various IRB protocol review steps that we’ve also been covering (e.g., see the third article in this HRR), we focus in the present article on what IRBs should do when researchers seek IRB approval of “expanded access” uses of investigational drugs.

“Q2. Are there safeguards in place for expanded access use of an unapproved drug?

A licensed physician under whose immediate direction an investigational drug is administered or dispensed for an expanded use is considered an investigator (§312.305 (c)(1)