FDA Draft Guidance on Informed Consent
Published: 03/06/2024
Sources:
- Food and Drug Administration
Relevant To:
- Critical Access Hospitals,
- Hospitals
The U.S. Food and Drug Administration is seeking input on new draft guidance “Key Information and Facilitating Understanding in Informed Consent,” and will accept comments through April 30, 2024.
The draft guidance provides research sponsors, investigators, and institutional review boards (IRBs) with recommendations on how to implement two proposed requirements in the FDA proposed rule, “Protection of Human Subjects and Institutional Review Boards” and the corresponding current requirements …
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