Friday, April 21, 2017

Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

Shweder and Nisbett hope for vast deregulation

On March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the Chronicle of Higher Education celebrating the new final rule:

in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.

In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”

[Richard A. Shweder and Richard E. Nisbett, “Long-Sought Research Deregulation Is Upon Us. Don’t Squander the MomentChronicle of Higher Education, March 12, 2017.

Meyer asks, what’s new?

On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has grudgingly acknowledged that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.

On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”

(GIF re-posted here with Meyer's permission.)

Comments posted to the Chronicle website made similar points. They noted, for instance, that the final rule abandons the ANPRM’s proposal that for minimal-risk projects, “researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential information about the study,” and that regulations could “discourage having each of these registration forms undergo a comprehensive administrative review prior to commencing the study or even afterward.”

Shweder and Nisbett remain hopeful

In an April 19 essay, marking three months since the Federal Register publication of the proposed final rule, Shweder and Nisbett acknowledge the criticism. But they also emphasize that the proposed rule eliminates “the box” that encouraged institutions to submit all research, not just projects funded by the federal government, to federal oversight. “The Office for Human Research Protections has made it clear that it has no interest in overseeing research not funded by agencies bound by the Common Rule, the federal government regulations for human-subject research, or in applying the new regulations to such projects,” they write, and they encourage universities to take advantage of the new climate.

[Richard A. Shweder and Richard E. Nisbett, “Don’t Let Your Misunderstanding of the Rules Hinder Your Research,” Chronicle of Higher Education, April 19, 2017]

Dingwall Despairs

Writing in Nature Human Behavior, Robert Dingwall despairs that the final rule did not adopt the bolder approaches of the National Research Council’s 2014 report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. He writes, “The results are incoherent and unlikely to reduce the mistrust between social scientists and ethics regulators.”

[Robert Dingwall, “Social Sciences Lose out Again in Common Rule Reform,” Nature Human Behaviour 1 (April 7, 2017): 83, doi:10.1038/s41562–017–0083.]

Anthropologists, sociologists mostly silent

The American Sociological Association announced the biggest change to human subjects regulation in a generation in a 240-word item on page 3 of its newsletter. No analysis of how this will affect sociological research, or the failure of the final rule to incorporate the ASA’s recommendations. I haven’t found even that much notice by the American Anthropological Association. Also nothing that I can find from the Law and Society Association, which in 2007 and 2008 was so vocal on IRB issues.

Historians are happy

Historians are just happy to be free.

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