This new post by Holly F. Lynch appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.
On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?
First, it is important to understand where things stood. The Common Rule was initially adopted in 1991, with each relevant agency codifying the same set of regulations (the Department of Health and Human Service’s codification is found at 45 C.F.R. Part 46). The primary functions of the Common Rule are to require that research with human subjects be approved by an Institutional Review Board (IRB) and that subjects provide informed consent to research participation, with some important exceptions on each front. (FDA has similar, but not identical requirements, for clinical investigations, which are now likely to be harmonized with the new Common Rule.) […]
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