On June 29, the National Academies of Sciences, Engineering, and Medicine released part 2 of its report Optimizing the Nation’s Investment in Academic Research (the first part had been released in 2015). Of particular significance to the social and behavioral science research community is a chapter within the report on the “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” In it, the panel issues a stinging criticism of the Department of Health and Human Services’ (HHS) September 2015 Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects. The chapter argues that the NPRM should be abandoned and that it “would impose additional burdens that could be detrimental to important areas of research.”
COSSA’s comment on the NPRM, submitted jointly with the American Educational Research Association (AERA) and the Inter-university Consortium for Political and Social Research (ICPSR), was largely supportive of the proposal, particularly those provisions that made the regulations less burdensome for low-risk social and behavioral research. What is more, the recommendations made in this latest report are in many ways inconsistent with those of the National Research Council’s (NRC) 2014 report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.
The report released last week characterizes the overall responses to the NPRM as largely negative, citing an analysis of public comments conducted by the Council on Government Relations and the Association of Public and Land-grant Universities (APLU).
The authors’ objections to the NPRM focus on three broad areas: (1) the proposed changes to the classification and consent procedure for use of biospecimens; (2) the process for determining which categories of research are “excluded” from the Common Rule (include some types of social and behavioral research); and (3) lack of specifics on the products and tools HHS would produce to aid in research review, including the online tool for determining whether a study should qualify as exempt; the broad consent template for storage, maintenance, and future use of biospecimens; and the list of privacy safeguards researchers would need to follow. The report also suggests the NPRM contains internal inconsistencies.
The report concludes:
“The NPRM is marred by omissions, the absence of essential elements, and a lack of clarity. In addition, important questions about the long-term costs of the proposed regulatory changes are unresolved. In light of these deficiencies, it would be impractical to use the current NPRM as the basis for achieving a meaningful, consistent, and harmonious revisions of the regulations governing human subjects research…”
The chapter recommends (1) that Congress establish an “independent, free-standing national commission” that would be charged with “examining and updating as necessary the ethical, legal, and institutional frameworks governing human subjects research,” and (2) that HHS withdraw the NPRM and refrain from updating the Common Rule until the proposed commission has had the opportunity to issue a report.
The Common Rule has not been revised since 1991.