Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 39, No. 7, July, 2024
Back Issues
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 … IRB Waivers for Minimal Risk Investigations (#4)
We resume this month with more highlights of negative comments received by FDA when it published an earlier proposed version of its changes to existing IRB regulations at 21 CFR Parts 50, 312, and 812. The changes affect IRB reviews of “minimal risk” research and include a new waiver option.
FDA’s “Responses” to these “Comments” can help prepare IRBs who may face similar objections over alleged “weakened” human subject protections.
“(Comment 5) Several comments argue that waivers of informed consent weaken human subjects protections and would allow IRBs to retreat from their human subject protection responsibilities. These comments also express concern that the proposal might decrease public trust in both research and healthcare providers.
One comment states that no third parties, including IRBs, should be allowed to make decisions for study subjects as to what constitutes ‘minimal risk’ ” (88 Fed. Reg. 88228-88249 at page 88233, December 21, 2023).