Lexology March 11, 2024
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) published new draft guidance on how to present key information at the beginning of an informed consent document. The recommendations in the guidance are intended to align with the requirements of the revised Common Rule and help implement FDA’s 2022 proposed rules on the matter. In particular, the guidance provides sponsors of drugs, biologics, and medical devices, as well as investigators and institutional review boards (IRBs), with recommendations on how to provide concise and easy-to-understand language to help prospective participants...
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