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AAMC Responds to FDA’s Draft Guidance on Informed Consent

September 19, 2014— The AAMC Sept. 15 submitted a comment letter  to the U.S. Food and Drug Administration (FDA), regarding its draft guidance titled, “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.” The FDA announced the availability of the draft guidance document for comment through the July 15 Federal Register.

The AAMC urged the FDA to “consider this guidance document an opportunity to reinforce that a document capturing required elements of informed consent is only a component of the ethical obligation to ensure that research subjects have meaningful awareness of what their participation in a clinical trial means to them,” and expressed concern that the draft guidance could result in longer documents for potential research subjects.

In the letter, the AAMC encouraged the FDA to ensure that its approach to informed consent aligned with any future changes proposed by the Department of Health and Human Services following an advance notice of its intention to make significant changes to the regulations known as the “Common Rule” [see Washington Highlights, Oct. 28, 2011]

The AAMC also asked that the FDA provide guidance that allows investigators, institutions, and sponsors to “integrate appropriate communication formats that recognize the culture, language, and voice of all subjects, especially those in historically underserved groups.”


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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