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Informed Consent Guidance Issued for Comments

Document, Jointly Developed by OHRP and FDA, Is Open for Comments Until April 30

Darla M. Fera

March 5, 2024 at 08:15:35 ET

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have posted for stakeholder comments a draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent,” which addresses provisions of the revised Common Rule that prescribe informed consent in clinical research, includ... Read More

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Informed Consent Guidance Issued for Comments

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