Lexology October 5, 2023
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. The Final Guidance reflects the FDA’s recommendations on informed consent and the regulatory requirements in place to protect human subjects’ rights and welfare in clinical investigations.
Elements of Informed Consent
Informed consent is a process by which a prospective participant in a clinical investigation (often referred to as a subject), or their legally authorized representative, is provided with information to allow the subject or their representative to make an informed decision about participation in the clinical investigation prior to enrollment. The Final Guidance...
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