What To Know About New FDA Informed Consent Guidance

This article by partners Mark Barnes and Gregory Levine and associates Abram Barth and David Peloquin was published by Law360 on August 11, 2017.

On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document1 announcing its intention not to object to an institutional review board's (IRB) waiving or altering of the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections. The guidance, which takes effect immediately, will align the FDA's policy on waiving informed consent with the "Federal Policy for the Protection of Human Subjects" (the Common Rule) (45 C.F.R. part 46, subpart A), which since 1991 has permitted an IRB to waive informed consent requirements for minimal-risk research in certain circumstances

Background

Members of the research community have expressed frustration that the FDA's regulations on human subjects protection have not contained a provision permitting the waiver of informed consent for minimal-risk research, in contrast to the waiver provision contained in the Common Rule.2 FDA regulations govern clinical investigations: (1) subject to FDA's investigational product application requirements (either an investigational device exemption under 21 U.S.C. § 360j(g) or an investigational new drug application under 21 U.S.C. § 355(i)); or (2) the results of which will be submitted to the FDA in support of a product application or held for inspection by the FDA.3 In contrast, the Common Rule applies to research conducted by or supported by most federal government departments or agencies.4

For research subject to FDA regulations and for research subject to both FDA regulations and the Common Rule,5 sponsors and their funded sites and investigators have been able to conduct clinical investigations only if express informed consent from the human participants has been obtained, regardless of the importance of the research, the risks posed by the research, and the feasibility of obtaining consent. That has marked a sharp distinction from research subject only to the Common Rule, for which IRBs can grant a waiver of consent for certain minimal-risk research, such as registry studies and observational research. One aspect of commonality in recent years has been an FDA enforcement discretion policy announced in 2006 that allowed for FDA-regulated clinical research on "leftover" de-identified specimens to be conducted without informed consent.6 But for other...