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# Check Key Info in Informed Consent
- URL: https://www.fdaweb.com/check-key-info-in-informed-consent/
- Published: 2024-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:25:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156595

Attorneys **Dominick DiSabatino** and **Arushi Pandya** (SheppardMullin) say FDA’s publication of a draft guidance on key information and facilitating understanding in informed consent may mean the agency will soon finalize its 9/28/2022 proposed rule that will harmonize FDA regulations with the HHS common rule on the protection of human subjects in research. Writing in an *FDA Law Update* online [post](https://www.fdalawblog.com/2024/03/articles/fda/time-to-refresh-fda-issues-draft-guidance-on-key-information-and-informed-consent/?utm%5Fmedium=email&utm%5Fcampaign=FDA%20Law%20Update%20Blog&utm%5Fcontent=FDA%20Law%20Update%20Blog+CID%5F06ad443d673c8ec5a0ad2fddae9d8373&utm%5Fsource=Create%20Send%20campaigns&utm%5Fterm=here), they say the guidance “identifies and recommends a significant amount of information which may need to be newly incorporated into an informed consent or recognized in a manner which facilitates understanding for prospective subjects.”

In the guidance, FDA also suggests novel formatting and organizational methods, the post says.

The attorneys say clinical trial sponsors, investigators, and institutional review boards should revisit their informed consents sooner rather than later to not only ensure a key information section is appropriately included, but also to evaluate whether any formatting updates may be necessary to comply with FDA rulemaking and regulations.

“The guidance also emphasizes the importance of the key information section in assisting prospective subjects’ decision to participate in a clinical trial as well as guiding discussions between potential research subjects and investigators,” DiSabatino and Pandya conclude. “Clinical trial sponsors may need to evaluate their informed consent process, including its timing and suitability for its relevant subject population. Furthermore, to the extent a clinical trial sponsor relies on external companies or third-party vendors for patient recruitment, further conversations between the parties may be needed to ensure prospective subjects provide informed consent at the appropriate time in the recruitment process and in accordance with regulatory requirements and guidance.”