Draft Guidance on Key Information and Facilitating Understanding in Informed Consent

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) have announced draft guidance, “Key Information and Facilitating Understanding in Informed Consent.” Notice of this draft guidance is included in the March 1, 2024 issue of the Federal Register (89 FR 15094) and can be accessed here, links to an external website.

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.

The text of the draft guidance document appears on OHRP’s website (https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-key-information-facilitating-understanding-informed-consent/index.html) and is also available on the FDA website.

This draft guidance has a public comment period of 60 days, closing on April 30, 2024. See the Federal Register Notice for details regarding how to submit public comment. Thank you.