F03 - Key Information in Informed Consent: Ethical Principles, Policy, and Practice

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In response to the growing length and complexity of consent documents, the revised Common Rule added two provisions: that require informed consent to begin with key information about the research which is to be presented in a clear and concise manner, and that informed consent as a whole be presented in a way that facilitates understanding of the reasons why someone might or might not want to participate in research. FDA issued a proposed rule to adopt identical language to harmonize with these provisions. In March 2024, FDA and OHRP published joint draft guidance discussing suggested approaches to presenting key information and facilitating understanding in the informed consent, including oral, written, and electronic consent. This session will address proposed approaches to key information and consent changes as described in draft guidance and discuss opportunities and challenges to reviewing key information and enhanced consent materials.