Lexology November 2, 2023
Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final guidance supersedes FDA’s 1998 final guidance, “A Guide to Informed Consent,” and finalizes the 2014 draft guidance, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,” with additional examples and illustrations.
Since FDA’s issuance of the 2014 draft guidance, FDA has made significant investments in the clinical operations space to increase efficiency, improve diversity and inclusion, and embrace technological advances. These changes include innovations like platforms supporting decentralized research and the ability to target therapies based on genetic variations using machine learning and artificial intelligence. Drawing from...
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