The Ethical Imperialism of the NAS

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.

National Science Foundation Charged with "Non-Biomedical Science Perspective"

Rereading the e-mails mysteriously "obtained" by Public Citizen, I noticed that the White House has asked the National Science Foundation “to ensure that the ‘non-biomedical perspective is covered" in the forthcoming Notice of Proposed Rulemaking (NPRM), revising the Common Rule. Moreover, NSF "will identify places in the current regulatory text and preamble where edits are necessary to make the NPRM consistent with the January 2014 National Academy of Sciences' report that evaluated the applicability of the ideas presented in the 2011 ANPRM to the social and behavioral sciences."

[Margo Schwab to Andrea Palm, “Annotated draft reg text for Common Rule,” 29 October 2014, reproduced in Michael Carome, “Letter to Secretary Burwell Re: Common Rule NPRM,” November 20, 2014.]

This strikes me as hopeful news. The January 2014 report, though lacking in some respects, makes some sound recommendations for reform. And the NSF, which played only a minor part in writing the 1981 and 1991 regulations, is given a greater role in this round. As the sponsor of a great deal of social science research, NSF is indeed better positioned to take on this role than HHS or any other Common Rule agency.

NRC Report: Where's the Freedom?

My biggest disappointment with the new NRC report is its silence on the question of academic and personal freedom.

NRC Report: Assess Risk Empirically

One theme running throughout the NRC report is the need to replace the worthless gut reactions decried by Ezekiel Emanuel with a system that would base its judgments on the latest empirical evidence. But the report does not present a clear set of reforms that would effect this change without scrapping the current system of local IRB review.

NRC Report: Liberate Oral History

For historians, the most exciting passage in the new National Research Council report—the passage that had me cheering out loud—is the recommendation that the Common Rule be amended to explicitly exclude historical interviews, as well as other forms of information gathering that do not constitute “human-subjects research specifically in the biomedical, behavioral, and social sciences.”

National Research Council Issues IRB Report

The National Research Council has issued its long awaited report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.

[National Research Council. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, D.C.: The National Academies Press, 2014.]

Happy New Year, National Academy of Sciences!

As longtime readers of this blog will know, I used to begin each year by mocking OHRP for failing to issue "a lot of examples and will give more guidance on how to make the decision on what is research and what is not" by the end of 2007, as promised by a former director. That trope got a bit old after a few years, and I didn't recycle it in 2013.

I will note that the National Academy of Sciences pledged to issue a summary of its March 2013 workshop "in summer 2013" and that "the study report will be issued in early winter 2013."

Anyone seen either of those?

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

Deregulation "Is Not Going to Happen"

Linda Shopes kindly alerts me to the April 20 issue of COSSA Washington Update, the newsletter of the Consortium of Social Science Organizations, which reports on an April 1 meeting of the National Academies’ Board on Behavioral, Cognitive, and Sensory Sciences, at which IRBs were discussed.

Here's the key passage:

Philip Rubin, CEO of Haskins Laboratories in New Haven, CT, and former director of the National Science Foundation’s (NSF) Division of Behavioral and Cognitive Sciences, chairs the Board. He began the session with a review highlighting the difficulties social/behavioral researchers have had with the current system under the Common Rule regulation and its interpretation by campus Institutional Review Boards (IRBs). Complaints have been loud, but mostly anecdotal . . . Once again the bottom line is that despite efforts by Joan Sieber and the Journal of Empirical Research on Human Ethics, which she edits, there are still large gaps in our empirical knowledge of how the system works for social and behavioral scientists.

Rubin was followed by Jerry Menikoff, new head of the U.S. government’s Office of Human Research Protections (OHRP). Menikoff announced that he was all for “flexibility” in the system and that “changes can be made.” He also endorsed conducting more research. He rejected the arguments of the American Association of University Professors and Philip Hamburger of Northwestern University Law School that IRBs violate researchers’ first amendment rights. He acknowledged the importance of expedited review, but stated quite clearly that “removing minimal risk research from the system is not going to happen.”

I don't want to make too much of these comments; an OHRP spokesperson tells me that they were an extemporaneous response to Rubin, and not prepared remarks. Still, I am disappointed. Menikoff's comments suggest a retreat from his earlier concession that "flexibility" often can be code for arbitrary power. And it's a pity for a public official to insist that a given policy "is not going to happen" even as he endorses more research. Wise governance depends on making policies after finding facts, not before.