Lexology March 19, 2024
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors, investigators, and Institutional Review Boards.[i] The guidance provides suggestions on which topics of information should be included in the key information section of an informed consent as well as how information can be presented and formatted in an informed consent to aid prospective subjects’ understanding of a clinical trial.
Background
The U.S. Department of Health and Human Services (“HHS”) sets forth regulations for the protection of human subjects in research in 45 CFR part 46, of which Subpart A is referred to as the “Common Rule.” The Common Rule generally requires...
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