Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 36, No. 12, December, 2021
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.
Excerpt from pg. 3 … IRBs and FDA’s Advice on How To Cope With Coronavirus (#6)
We continue here with more recent updates for IRBs, researchers, and others on the effects of COVID-19 upon a variety of 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 October 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.
“FDA recognizes that in some circumstances it may be necessary (e.g., based on lack of product supply or inability to administer or ensure the safe use of the investigational product) to discontinue investigational product administration in a trial” (guidance, rev. December 4, 2020, pp. 9 of 35; on the Web at https://www.fda.gov/media/136238/download).