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Promoting Disclosure and Understanding in Informed Consent: Optimizing the Impact of the Common Rule “Key Information” Requirement

Millum and Bromwich (2021) provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclosure and understanding. They conclude by applauding the “key information” requirement in the 2018 revision of the federal Common Rule, which provides guidelines for protecting human research participants and now requires informed consent forms to begin with a presentation of key information about the research (Department of Health and Human Services (DHHS) 2018). The authors state that key information should be interpreted as the information that potential participants need to understand and would consider relevant to their decisions (Millum and Bromwich 2021). Here, we build on their analyses and examine the key information requirement’s potential to address the goals of both disclosure and understanding, identifying opportunities for investigators and IRBs to use this requirement to better support potential participants during the informed consent process. INFORMED CONSENT AND THE “KEY INFORMATION” REQUIREMENT