Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 10, October, 2021

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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.

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Excerpt from pg. 3 … IRBs, COVID, and Experiments With Drugs/Biologics (#3)

“We continue this month with more tips for IRBs and researchers from the FDA’s guidance titled “COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.” These tips can affect various aspects of IRB reviews.

We resume with more advice from the guidance subsection titled “B. Trial Design and Conduct Considerations,” as follows:

• Master protocol sponsors should seek concurrence from the Agency before implementing a change where a drug evaluated under the master protocol is incorporated into the trial as either background therapy or as part of the control arm.

It is possible that a drug may be incorporated into the control arm but not as background therapy for all arms in situations where it would be inappropriate to add therapies together (e.g., similar mechanism of action). …