America’s Blood Centers (ABC) submitted comments to the U.S. Food and Drug Administration (FDA) on April 25th in response to the recently published draft guidance titled, “Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards.” The FDA informed consent comments expressed concern that the agency, “does not address health literacy and the need for this key information to be at an appropriate reading level.”
Specifically, ABC recommended in the FDA informed consent that the agency, “should ensure that key information is written at no higher than an eighth grade reading level, and preferably at a sixth or seventh grade reading level.” In addition to citing and providing multiple examples of other organizations and federal entities that urge health literacy in the form of key information being written at a middle school-reading level, ABC noted in the FDA informed consent comments that, “[w]hile FDA states in the draft guidance that ‘information should be presented in plain language at a level prospective subjects would likely comprehend,’ critical parts of the key information [in the] sample included in the appendix of the draft guidance, which is likely to be used as a template if the guidance is finalized as is, are close to a college reading comprehension level using Dale-Chall, the most accurate and reproducible analyzer available through Datayze…FDA should further recommend instruments that can be [used] to ensure these recommendations pertaining to reading levels are met.”
The FDA informed consent comments also explained that FDA should clarify the recommended length of key information, “[t]he draft guidance recommends [that] the ‘key information section of a consent document be relatively short (e.g., generally no more than a few pages).’ ABC recommends that FDA provide further clarity around the recommended length of the key information, to ensure this information is understandable and consistent.”
The FDA explained in the draft guidance that it contains, “recommendations on provisions of the U.S. Department of Health and Human Services (HHS) regulations on the protection of human subjects as well as certain proposed revisions to FDA’s current regulations for the protection of human subjects. Specifically, this guidance addresses the presentation of key information and includes recommendations for the content, organization, and presentation of informed consent information in FDA-regulated clinical investigations of drugs, devices, and biologics…and in HHS-supported or -conducted nonexempt human subjects research.”
An archive of all letters and comments written by ABC is available.