Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 4, April, 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 April 2023

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Excerpt from pg. 3 … IRBs and Major Changes To Federal Regulations (#5)

We continue this month with more recommendations for IRBs from FDA on “expedited reviews” of research protocols.

Importantly, these recommendations come in the form of proposals for changes to current federal regulations on the protection of human research subjects.

As we concluded last month’s article on this topic, we presented some of FDA’s main concerns about the applicability of expedited IRB reviews in relation to the existing Common Rule. We resume with:

Under the current wording of the ‘Applicability’ section, to be eligible for expedited review[,] research must present no more than minimal risk to subjects.

Therefore, application of the 1998 HHS Expedited Review List means that, in order for research to qualify for expedited review under the revised Common Rule, a determination must still be made that the specific circumstances of the proposed research involve no more than minimal risk to human subjects