Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 36, No. 8, August, 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 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.