The AAMC submitted a letter (PDF) on April 30 to the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on the draft guidance, Key Information and Facilitating Understanding in Informed Consent (PDF). The draft guidance provides recommendations on two main aspects of the revised Federal Policy for the Protections of Human Subjects also known as the revised Common Rule, which was issued by the HHS in 2017 [refer to Washington Highlights, Jan. 18, 2017].
As stated by the FDA, “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 and identical provisions in FDA's proposed rule.” In response to the FDA, the AAMC provided four key recommendations:
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Informed consent process. Need for additional guidance on the process, not just the content or format of the consent form.
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Innovative approaches to informed consent. Ensuring the draft guidance emphasizes the importance of engaging with diverse organizations and populations to develop new approaches to key information, including considering existing research and example consent forms.
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Key information and elements of consent. Proposed recommendations for when the FDA and OHRP should discuss the necessity of the “key information” label in the draft guidance.
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Facilitating understanding. Ensure the draft guidance includes recommendations on the measurement of a prospective subject’s comprehension of the information provided, as well as considerations for language fluency.
In September 2022, the FDA issued two proposed rules to align key aspects of its regulations with the revised Common Rule. The AAMC commented on both proposals, commending the FDA's interest in prioritizing the harmonization of specific elements in the revised Common Rule such as those pertaining to informed consent [refer to Washington Highlights, Jan. 13, 2023].