On July 15, 2014, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a draft guidance document, entitled “Informed Consent Information Sheet,” to assist Institutional Review Boards (“IRBs”), clinical investigators and sponsors involved in clinical investigations of FDA-regulated products in obtaining informed consent from subjects.
FDA’s informed consent requirements are codified in 21 C.F.R. Part 50, and include specified “elements” that must be included in a consent document, including information about the risks and benefits of participation and available alternatives and whether compensation for subject-related injuries will be provided.
The draft guidance addresses issues that have been a frequent source of questions to FDA’s Office of Good Clinical Practice (“OGCP”), and in some cases broadens the scope of sponsor disclosure obligations. For example, whereas the regulations require only “an explanation” regarding whether any compensation for subject injury “is available,” the draft guidance suggests that compliance with this element also requires sponsors to include a statement that subjects are “not precluded from seeking to collect compensation for injury related to malpractice, fault or blame on the part of those involved in the research.”
The draft guidance also directs clinical investigators to “consider whether information related to financial relationships or interests should be provided to subjects.” Although sponsors currently must disclose certain investigator conflicts to the FDA, such disclosure is not a required element of consent. Nevertheless, the draft guidance states that “information about financial relationships and interests may be important to the subject” as such conflict of interest may “affect the rights and welfare of subjects.”
The draft guidance also acknowledges increased interest by sponsors and investigators in obtaining informed consent using new technologies, such as through e-mail or facsimile, commenting that methods other than face-to-face interviews “may be acceptable” if they enable adequate information exchange, documentation and verification of subject identity. This approach is consistent with FDA’s broader effort to facilitate the use of new technologies in protecting the public health.
Finally, the draft guidance provides additional considerations when seeking consent from vulnerable populations, including children, those with impaired consent capacity, non-English speakers and those with low literacy or numeracy.
The draft guidance comes ahead of a long-expected overhaul of the federal human subjects protection regulations (the “Common Rule”) by the Department of Health and Human Services (“HHS”). Although HHS sought public comments in 2011 on a wide range of human subjects protection issues—including informed consent—the Department has not yet issued a proposed rule.
If finalized, the draft guidance will supersede FDA’s 1998 “Guide to Informed Consent.” The deadline for submitting comments is September 15, 2014. The draft guidance is availablehere.