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Focus on Regulation

FDA Issues Draft Guidance on Informed Consent Regulations

On July 15, 2014, the Food and Drug Administration (FDA or the Agency) announced a new Draft Guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors. FDA’s previous Information Sheet on this topic, “A Guide to Informed Consent,” was issued over 15 years ago, in 1998. The Agency states that when the new Draft Guidance is finalized, it will supersede the previous Information Sheet.

Coming in at 42 pages, the new Draft Guidance provides a comprehensive update to FDA’s informed consent policies, covering the various elements of informed consent and the particular responsibilities of IRBs, clinical investigators, and sponsors. The Draft Guidance steps through individual provisions of the informed consent regulations at 21 CFR Part 50, and provides several examples of recommended language to assist parties in fulfilling the informed consent requirements.

More broadly, the new Draft Guidance is part of a larger coordinated effort with the Department of Health and Human Services (HHS) to harmonize informed consent requirements across the agencies. As background, parties are subject to a separate set of informed consent regulations at 45 CFR Part 46 – the so-called “Common Rule” – when an investigation receives funding from HHS. Similar to FDA, HHS is in the process of updating its informed consent policies, and published a notice in the Federal Register in 2011 containing proposed revisions to the Common Rule. FDA states that it will attempt to make its informed consent standards consistent with the Common Rule where there is overlap. In situation where both FDA’s regulations and the Common Rule apply, the Draft Guidance recommends that parties should follow the regulations that offer the greater protection to human subjects.

The Draft Guidance addresses a number of key topics. First, it contains recommendations on obtaining informed consent from non-English speaking subjects, children, and subjects with low literacy. In addition, the Draft Guidance includes recommendations regarding the review and confidentiality of subject records, as well as obligations to subjects when a study is suspended or terminated.

Perhaps of greater significance to industry, the Draft Guidance includes a section titled “Alternative Methods of Obtaining Informed Consent,” which recognizes that new technologies may be used as part of the consent process. In particular, the Draft Guidance states:

New technologies are becoming available that may serve as an alternative to the paper consent form in the informed consent process. Parties interested in pursuing alternative methods of obtaining informed consent are encouraged to contact FDA. Currently, FDA is considering alternative methods using these new technologies and would be interested in comments on these alternative methods.

Also of interest to pharmaceutical and biotechnology companies, the Draft Guidance addresses the question of subjects who participate simultaneously in more than one clinical trial or enroll in a single clinical investigation multiple times. On this topic, the Draft Guidance states:

FDA strongly discourages these practices as enrollment in more than one clinical investigation could increase risks to subjects, particularly because they may be exposed to more than one investigational product for which the safety profile may not be well understood. In addition, the subjects may find it difficult to understand all the risks and proposed benefits, much less meet the demands, of multiple protocols.

In sum, the Draft Guidance provides a very substantial amount of new and updated information regarding FDA’s views on the informed consent process. For more information about the Draft Guidance, FDA’s informed consent regulations, or the Agency’s Good Clinical Practice standards, please contact the authors or the Hogan Lovells lawyer with whom you work.