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For the first time since it was issued in 1991, the Common Rule — the set of federal regulations for ethical conduct of human-subjects research — has been updated. Most of the new requirements, many of which increase flexibility, will go into effect in 2018, which gives institutions a year to work toward implementation.
The public saw the beginnings of this effort in 2011, when the Department of Health and Human Services issued an Advance Notice of Proposed Rulemaking, signaling an interest in modernizing the regulations by enhancing protections for human research participants and reducing unnecessary burden and ambiguity for researchers.1 In September 2015, a Notice of Proposed Rulemaking (NPRM) identifying numerous proposed changes was released for public comment, generating a robust and energetic discussion of the proposals’ merits.2 More than 2100 comments were submitted, from a fairly wide swath of the public, including individuals, institutions, organizations, and societies. These comments, and influential reports including one from the National Academies of Sciences, Engineering, and Medicine,3 led to a long process of deliberation and discussion. The result is a final rule that differs significantly from what was initially proposed.
Most notably, the new rule does not adopt the proposal to cover researchers’ use of unidentified biospecimens (such as leftover portions of blood samples) and to require informed consent for such research. This proposal generated far more comments than any other, and by a substantial margin those comments opposed the proposal. Commenters in every category — institutions, researchers, people working in programs that protect research participants, and people with no employment connection to the research world — expressed concern that implementing this proposal could significantly harm the ability to do important research, without producing any substantial off-setting benefits. The public response was particularly noteworthy, given that the premise behind the proposal was specifically tied to public sentiment: the NPRM had stated that continuing to allow research on unidentified biospecimens without consent would place “the publicly-funded research establishment in an increasingly untenable position because it is not consistent with the majority of the public’s wishes.” That premise now seems questionable. Accordingly,...