FDA, OHRP draft guidance addresses informed consent complexity

Includes a potential framework to place key trial information at the beginning of the consent form.

The FDA and the Office for Human Research Protections recently published a draft guidance, “Key Information and Facilitating Understanding in Informed Consent,” which is open for public comment until April 30, 2024.

CDER Director Patrizia Cavazzoni, M.D., and Chief Medical Officer Hilary Marston, M.D., M.P.H., noted in a release that “too often…informed consent forms are lengthy and difficult for potential research participants to understand.” According to the agency, this draft guidance provides recommendations on implementing informed consent requirements that exist in both a proposed FDA rule, and a current revised Common Rule. Both are aimed at improving a potential participant’s understanding of a specific clinical trial, as well as the potential risk and benefits more concisely and in plain language.

This draft guidance includes a graphic framework that research sponsors, investigators, and institutional review boards (IRBs) could adapt to address the dual purposes. Specifically that informed consent “begins with key information about the research presented in a clear and concise manner,” and “…presented in a way that facilitates understanding of the reasons why someone might or might not want to participate in the research.”