Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 36, No. 7, July, 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 (#2)
“We continue here with a topic we introduced last month; namely, the possibility that certain researchers may obtain a waiver from the usual assurance required of them by federal agencies for clinical studies.
The waiver in question is permission from FDA to not submit and sign a Form FDA 1572.
For details on the overall content and usage of Form FDA 1572 for human subjects studies, please see the May 2021 issue of the HUMAN RESEARCH REPORT.
This new FDA guidance for IRBs and others is structured in a “Frequently Asked Questions” (FAQ) format.
We now resume, excerpted from the revised version of the previous guidance, with the FAQ numbered:
“13. If a sponsor chooses to conduct a foreign clinical study (or operate non-U.S. sites in a multinational study) under an IND and the investigators at these non-U.S. sites follow the recommendations in the ICH (International Conference on Harmonisation) E6 Good Clinical Practice Consolidated Guidance (February 2018), would the non-U.S. investigators also be in compliance with FDA’s IND requirements under 21 CFR part 312? (Revised 2021)”…”