Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 8, August, 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 and Signature Waivers For Clinical Researchers (#3)

We continue here with a topic we introduced in the June HRR; namely, the way for certain researchers to obtain a waiver from the usual assurance that FDA typically requires for conducting human subjects research. The waiver in question is permission from FDA to not submit and sign a “Form FDA 1572.”

The relevant FDA guidance covers IRB- and researcher-related requirements for both domestic U.S. studies and those conducted in other countries.

The new FDA guidance is titled “Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs — Frequently Asked Questions, Statement of Investigator (Form FDA 1572) (Revision 1).”

Note that the entry “(New 2021)” for any Q&A in this guidance means that the information is new for the year 2021 and the entry changes the existing guidance accordingly.