From the Director: National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

Elisa Hurley

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters” (xii). It made specific recommendations to reduce regulatory burden, and also recommended the creation of a “public-private Research Policy Board to streamline research policies.”

Part 2 concludes the analysis of regulations governing federally funded research and includes, in Chapter 9, a critical examination of the ethical, legal, and regulatory framework for human subjects research. The chapter begins by acknowledging that the research landscape has changed dramatically since the publication nearly 40 years ago of the Belmont Report, which established the three basic principles that provide the ethical foundation for the conduct of human subjects research in the United States. Changes in research methodologies and technologies, including comparative effectiveness research, research on de-identified biospecimens, observational studies of large datasets, cluster randomized trials, and research in emergency settings—as well as longstanding questions about the applicability to social and behavioral research of rules written for the biomedical research context—raise challenging questions about how to apply and balance the Belmont principles of respect for persons, beneficence, and justice across much of today’s research enterprise.

The report also points to an emerging view that, because we are all potential beneficiaries of research, and because research has the greatest potential to advance human health when there is broad participation, we all have a responsibility to participate in research. Belmont, however, does not articulate an ethical obligation to participate in research—if anything, the primary concern at the time Belmont was written, on the heels of the discovery of the US Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male, was adequate protection from being unjustly enrolled in research.

The committee suggests that these and other “formidable questions about the application and scope of the Belmont principles” (156) call for a broad reconsideration of the regulatory framework governing human subjects research. Addressing these challenges, the report goes on, will require careful thinking about “how to balance our societal obligations to protect human subjects in research with the goal of maximizing the benefits to human well-being of society’s investments in biomedical and socio-behavioral research.” (157)

And though the recent Notice of Proposed Rulemaking (NPRM) to revise the Common Rule is motivated by, and attempts to address, many of the same challenges the committee highlights, the report concludes the NPRM is not up to the task.

The report reviews some of the criticisms of the NPRM that PRIM&R and others have articulated, including the charge that the proposed rule is lengthy, complex, internally inconsistent, unsupported by evidence, and troublingly incomplete, given the lack of availability at the time of publication of several of the rule’s key tools (including the exemption determination tool and the broad consent templates, to name just two). The report also reviews and reinforces criticisms around some specific NPRM provisions, including the redefinition of all research with biospecimens as human subjects research requiring broad consent, and the provisions that would reduce IRB or administrative oversight of exclusion and exemption determinations. It concludes that the NPRM

would impose additional burdens that could be detrimental to areas of important research. The committee believes the NPRM does not adequately or effectively address the breadth, depth, and import of unanswered questions; rather, its inadequacies signal a pressing need for a comprehensive review of the nation’s ethical, legal, regulatory, and institutional frameworks for protecting human research subjects. (168)

The committee then makes two bold recommendations that could have profound and far-reaching impact on the human subjects research enterprise.

The first recommendation is that “Congress authorize, and the President appoint, an independent, free-standing national commission modeled on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,” the body that created the Belmont Report in 1978. The basic charge to the commission should be to “examin[e] and update[e] as necessary the ethical, legal, and regulatory frameworks governing human research.” The commission should be asked, more specifically, to make recommendations “regarding how the basic ethical principles of human subjects research should be applied to unresolved human research questions and novel human research contexts.” (168)

The second recommendation is that the executive branch withdraw the NPRM to revise the Common Rule and that the regulations governing human subjects research not be revised until the national commission has issued a report and various stakeholders, including the research community, patients, and the public, have had an opportunity to weigh in on its recommendations.

In other words, the committee is saying that the research landscape has changed dramatically enough in the last 40 years that we should stop all current efforts at mere regulatory reform and go back to the beginning, start fresh, and ask what ethical principles are appropriate for the contemporary research enterprise. What would a “Belmont 2.0” – which is essentially what the committee is calling for – look like? (Thanks to Steve Joffe for suggesting the “Belmont 2.0” label). Are respect, beneficence, and justice the right principles? Are there other principles that should come into play? In addition to the changes in research methodologies and technologies pointed out earlier, the public is engaged in research – as participants and partners – in ways that weren’t imaginable 40 years ago. We thus talk today about the importance of transparency and trust in research; neither of those concepts appears in Belmont (though it’s clear that Belmont’s articulation of principles is in part an attempt to regain trust in research that had been sorely tested after the US PHS Tuskegee study was revealed). Are they key ethical principles that should, going forward, be woven into our governing frameworks?

At this point, we might also be wondering what the release of this report means for the fate of the NPRM. By now we all know that there is momentum behind efforts to publish the final rule by the fall. Will this slow that momentum? It’s not clear. The National Academies do not lobby, and this document does not have regulatory force. But it seems unlikely these recommendations can be ignored.

We will keep you updated here on Ampersand of any future developments. In the meantime, what do you think about the NAS recommendations? Do you think a “Belmont 2.0” is a good idea? What kinds of ethical principles could you imagine being included in such a report? Do you agree with the idea of scrapping the NPRM? And what do you think the NAS report means for the fate of the NPRM?