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# FDA Informed Consent Final Guidance
- URL: https://www.fdaweb.com/fda-informed-consent-final-guidance/
- Published: 2023-09-05T12:00:00.000Z
- Updated: 2026-09-14T18:54:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155252

Six Epstein Becker Green attorneys say an 8/15 FDA final guidance on informed consent for clinical investigations updates the agency’s 7/2014 draft guidance and supersedes a 9/1998 guide to informed consent. The attorneys [say](https://www.natlawreview.com/article/fda-issues-final-guidance-informed-consent-irbs-clinical-investigators-and-sponsors?ref=fdaweb.com) the final guidance:

- summarizes the informed consent process;
- outlines and discusses FDA’s informed consent requirements;
- addresses the respective responsibilities of institutional review boards, clinical investigators, and sponsors for ensuring the informed consent form and processes are adequate and meet FDA’s regulatory requirements; and
- concludes with a series of frequently asked questions.

The attorneys note the guidance does not reflect any of the agency’s possible future changes to the informed consent regulations that may be implemented as part of its ongoing efforts to harmonize its human subject protection regulations in connection with the 2018 HHS Common Rule. “FDA expressly leaves open the possibility that FDA may revise this final guidance in the future to account for such changes,” they say.

The post highlights several noteworthy changes from the 2014 draft guidance and the 1998 guide. It recommends that clinical research sponsors, institutional review boards, research institutions, and clinical research service providers review current informed consent form templates and related policies and procedures to confirm they are consistent with the final guidance.