HHS and FDA Release Updated Guidance on Informed Consent

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On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing Understanding in Informed Consent (“Draft Guidance”). This release signifies a progressive stride in HHS’s ongoing endeavors to update and synchronize federal regulations concerning the safeguarding of human research subjects….
By: Benesch
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