NSF Officer Misstates Belmont and Common Rule Standards

In the final contribution to the PS symposium, Lee Demetrius Walker, currently serving as program officer for the Political Science Program at the National Science Foundation, acknowledges the problems of applying a biomedical review system to social science. But he misstates the Belmont and Common Rule standards for assessing research.

[Lee Demetrius Walker, “National Science Foundation, Institutional Review Boards, and Political and Social Science,” PS: Political Science & Politics 49, no. 02 (April 2016): 309–12, doi:10.1017/S1049096516000263.]

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.

AAHRPP and PRIM&R Plan Conferences

Both the Association for the Accreditation of Human Research Protection Programs, Inc ., (AAHRPP) and Public Responsibility in Medicine and Research (PRIM&R) plan conferences next month. AAHRPP's conference, "Breaking Down Barriers, will be held in Washington, April 6-8, then PRIM&R meets in Boston, April 28-29, for a "Social, Behavioral & Educational Research Conference."

Does the NSF Have an Oral History Policy?

An independent scholar has been told by a National Science Foundation program officer that if she plans to do oral history she should "speak in the application to the problem of IRB review."

If the NSF is requiring IRB review of oral history, it is out of step with the recent actions other federal agencies, including the Smithsonian, the Army, and the Office for Human Research Protections.

I am not aware of any NSF policy document on this issue, so it is not clear if the program officer's statement represented the NSF position or the officer's personal views.

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.