Lexology September 6, 2023
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.
In Depth
The final guidance supersedes the FDA’s guidance entitled A Guide to Informed Consent, issued in September 1998, and finalizes the 2014 draft guidance. The final guidance reflects the FDA’s current thinking and recommendations regarding informed consent and describes FDA regulatory requirements to help protect human subjects’ rights and welfare in clinical investigations.
In the nearly 10 years since the draft guidance...
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