FDA issues Draft Guidance on Key Information in Informed Consent

Recommendation

19/20 November 2024

Complaint Handling and Recall Management - Live Online Training
How to implement EU-GMP Chapter 8

The FDA published a draft guidance on key information in informed consent. Comments are due by 30 April 2024.

Background

To improve the 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Research Protections (OHRP) in the Office of the Assistant Secretary for Health, are announcing the availability of a draft guidance entitled "Key Information and Facilitating Understanding in Informed Consent". The document provides recommendations related to 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.

Key Information and Flexible Approaches

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. The document encourages interested parties to consider developing flexible approaches to providing key information (e.g. key information could also be presented using alternative media, such as illustrations, video, and electronic tablets). One approach to developing the content of the key information section is for prospective subjects and other interested parties to advise on which basic and additional elements of informed consent may be considered “key” from the perspective of prospective subjects for a particular study. The agency recommends that the most important elements for a particular study be included at the beginning of the key information section.

In addition, the draft document contains an appendix with an example for a hypothetical clinical trial.

More information is available in FDA´s draft guidance Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards.