FDA Invites Comments on Guidelines for Informed Consent

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The United States Food and Drug Administration is inviting comments on its new draft guidelines for informed consent. “This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations,” states their introduction. “Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation.” The goal of the new guidelines, the FDA states, is “to enhance human subject protection and reduce regulatory burden.” Comments can be submitted to the FDA until September 15, 2014.

Instructions for providing comments are available at the FDA website.

Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors – Draft Guidance (US Food and Drug Administration, July 2014)

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