FDA Finally Decides To Fix Informed Consent Guidance? FDA and OHRP Issue Draft Guidance On Key Information And Informed Consent; Comments Are Due By April 30, 2024

Comments to FDA do matter. If you care about informed consent, now may be the time to review their new document and write in with your opinion.

FDA and OHRP issue draft guidance on key information and informed consent; comments are due by April 30, 2024

To improve this informed consent process, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Office of the Assistant Secretary for Health, are announcing the availability of a draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent.” 

This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.” 

FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act.

The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule. 

To ensure that FDA and OHRP consider your comment on this draft guidance before the agencies begin work on the final version of the guidance, please submit comments to the docket at FDA-2022-D-2997 by April 30, 2024.

Also see the related article in FDA’s Voices at

https://www.fda.gov/news-events/fda-voices/fda-works-make-informed-consent-easier-understand

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