The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines.
Yes, the NPRM has problems
The report identifies four main problems with the NPRM:
Several provisions of the proposed regulations have been identified as problematic. These include: (1) proposed changes relating to the definition and handling of biospecimens; (2) how determinations are made regarding whether certain types of research may be excluded from administrative or institutional review board consideration; (3) inconsistencies amongst the proposed changes; and (4) an absence of specifics for key deliverables… .
The omission of specifics on key tools and guidelines like the exemption determination tool, consent templates, and list of privacy safeguards is problematic; because the items are undefined at present, it is impossible to comment on their merit or utility prior to the issuance of the final rule. Furthermore, it is not possible to provide an accurate estimation of regulatory impact without a clear understanding of what compliance will involve.
But the NAS counterproposal is unrealistic
The report recommends
that Congress authorize, and the President appoint, an independent, free-standing national commission modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. This commission was authorized by Congress under Public Law 95–622 in 1978, appointed by the President in 1979, and existed outside the structure of federal departments and agencies. The commission had a direct line-item appropriation from Congress, appointed its own staff, and set its own agenda.
Congress should charge the proposed commission with examining and updating as necessary the ethical, legal, and institutional frameworks governing human subjects research. The commission should make recommendations to the President, Congress, and relevant federal agencies regarding how the basic ethical principles governing human subjects research should be applied to unresolved human research questions and novel human research contexts …
The report notes that Congress ignored a 2002 proposal from the Institute of Medicine “for a standing independent, multidisciplinary, nonpartisan expert Committee on Human Research Participant Protections.” The report does not mention the half dozen failed efforts by Glenn and DeGette to pass new human subjects legislation. There is little chance that Congress is going to do anything.
And even if Congress did act, that would take a couple of years, plus four or five years for the commission to run, then someone would have to translate its recommendation into a proposed rule, then the notice and comment, then the final rule. So really, the NAS is proposing a decade or more of the crappy status quo.
The NAS perpetuates ethical imperialism
The NAS chapter rests firmly in the half-century tradition of designing rules for biomedical research and imposing them on the social sciences and humanities.
It does acknowledge briefly that “the optimal application of regulations, developed primarily in the context of biomedical research, to the entire spectrum of sociobehavioral research has been contested for decades and remains unresolved,” citing the National Research Council’s 2014 Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences and C. K. Gunsalus et al., “Mission Creep in the IRB World.” (2006). But it does not engage with social scientists’ comments on the ANPRM or NPRM, instead relying on the biomedically oriented submissions from the Association of American Medical Colleges, the Council on Governmental Relations, the Association of American Universities and the Association of Public and Land-grant Universities, and PRIM&R.
Based on this narrow reading, the report proposes that its imagined commission would study:
- Research involving anonymous and de-identified human biospecimens;
- Research involving large datasets, for example, research with human genomic, transcriptomic, proteomic, or metabolomic data or associated
DNA, RNA, and protein analyses and relevant integrated approaches;
- Research in which the interests of discrete and insular communities are
- Clinical studies conducted in emergency settings;
- Research involving adults with diminished decision-making capacities;
- Clinical trials where the unit of intervention is a cluster or group;
- Clinical studies comparing the effectiveness of different accepted interventions for a given disorder to determine whether one approach may be
preferable to the other;
- Observational research involving large-scale databases;
- The appropriate boundaries of regulation of minimal-risk sociobehavioral research; and
- Research aimed at clinical innovation and quality assurance and improvement.
While history cannot predict future events, we know that such a commission would have few, if any, experts in the ethics of research in the social sciences and the humanities, and that little, if any, attention would be devoted to item 9 on that 10-point list.
the creation of a commission constituted specifically of social scientists (e.g., sociologists and the like), humanistic social researchers (e.g., cultural anthropologists and the like), and humanists (e.g., historians, legal scholars, and the like). Rather than adapting strategies developed to protect biomedical information–which are fundamentally incompatible with core intellectual and ethical commitments of humanistic social studies–this commission would be tasked with developing alternative guidance appropriate for their fields.
Had the NAS committee considered that proposal and rejected it, at least it would have shown that it had done its homework. Instead, it has displayed the same contempt for the social sciences that has infected human subjects regulations from the start.