2014, FDA and Informed Consent - Health Care Compliance Brief

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.

Informed Consent

Informed Consent FDA

FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S.

Informed Consent

Informed Consent FDA Compliance Regulatory Compliance

Health Care Compliance Brief

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

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