Clinical Trials: Consent Process Clarified in New FDA Final Guidance

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August 15, 2023. This guidance supersedes the FDA’s 1998 guidance titled “A Guide to Informed Consent” and finalizes the FDA’s draft guidance issued in July 2014. The non-binding final guidance represents the FDA’s current thinking on the process and necessary elements of informed…
By: Foley & Lardner LLP