The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The 61-page document supersedes the Agency’s “A Guide to Informed Consent” (Sept. 1998) and finalizes the draft guidance, “Informed Consent Information Sheet” (July 2014).
The document provides general guidance as well as a series of frequently asked questions regarding the FDA’s informed consent requirements for Agency-regulated clinical investigations of drugs, including biologics, and medical devices. These informed consent requirements are found in the FDA’s regulations on the protection of human subjects (21 CFR Part 50), Investigational New Drug Applications (21 CFR Part 312), and Investigational Device Exemptions (21 CFR Part 812). Importantly, such FDA informed consent requirements do not preempt any federal, state, or local laws that require further information to be disclosed for informed consent to be legally effective.
If a drug or medical device clinical investigation is conducted… Read more
