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# FDA Guide on Informed Consent Key Info
- URL: https://www.fdaweb.com/fda-guide-on-informed-consent-key-info/
- Published: 2024-03-01T12:00:00.000Z
- Updated: 2026-09-14T14:24:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156467

FDA has released a [draft guidance](https://www.fda.gov/media/176663/download?ref=fdaweb.com) on “Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards.” The document provides recommendations on provisions in HHS’ regulations on protecting human subjects in clinical trials and it addresses the presentation of key information and includes recommendations for the content, organization, and presentation of informed consent information in FDA-regulated clinical investigations of drugs, devices, and biologics.

"The draft guidance provides recommendations on how to present key information at the beginning of the informed consent document," an [FDA post says](https://www.fda.gov/news-events/fda-voices/fda-works-make-informed-consent-easier-understand?utm%5Fmedium=email&utm%5Fsource=govdelivery). "Key information should include topics that are generally important for participants to understand, for example, the purpose of the research, the possible risks and benefits of the study, and the study’s length and procedures. The draft guidance also discusses how the inclusion of key information in consent documents could be a useful resource for current study participants."

The document also encourages investigators to use key information as a guide when discussing consent with potential participants. "It allows for flexibility in implementing the key information requirement to ensure that the informed consent process makes information accessible for patients," the agency says. It encourages sponsors, investigators, and IRBs to consider a variety of delivery methods for key information, such as written, oral, or media (illustrations or video) and electronic consent.