Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 1, Jan., 2022

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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.

January 2022 Issue Cover

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Excerpt from pg. 3 … IRBs and FDA’s Advice on How To Cope With Coronavirus (#7)

We continue here with more recent updates for IRBs and others on the effects of COVID-19 on different types of human subjects studies.

Our focus in this article is on the revised Q&A guidance from FDA titled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency — Guidance for Industry, Investigators, and Institutional Review Boards.

We resume where we left off in the December, 2021, HRR with the FDA’s advice for IRBs and others on whether to halt or to continue certain types of human subjects research during the COVID crisis.

Pausing enrollment in a trial to decrease potential exposure to COVID-19 would not generally be expected to significantly affect trial participant safety, the scope of the investigation, or the scientific quality of the study; therefore, submitting a protocol amendment would not be required under the regulation for such a pause