A satisfied customer at American University

Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.

[Patricia Aufderheide, “Does This Have to Go Through the IRB?,” Chronicle of Higher Education, August 17, 2016.]

Alarmist Claims about Public Administration Research

Two scholars from the University of South Africa claim that more than one in four articles they sampled in two journals of public administration involved “research of a more than minimal risk level.” This claim appears to be based on a misunderstanding of U.S. regulations.

[Jacobus S. Wessels and Retha G. Visagie, “The Eligibility of Public Administration Research for Ethics Review: A Case Study of Two International Peer-Reviewed Journals,” International Review of Administrative Sciences, September 3, 2015, 0020852315585949, doi:10.1177/0020852315585949.]

A Bit of Historical Perspective on the Facebook Flap

IRBs and behavioral research are all over the news, as a result of a paper that manipulated the news feeds of 689,003 Facebook users.

[Kramer, Adam D. I., Jamie E. Guillory, and Jeffrey T. Hancock. “Experimental Evidence of Massive-Scale Emotional Contagion through Social Networks.” Proceedings of the National Academy of Sciences 111, no. 24 (June 17, 2014): 8788–90. doi:10.1073/pnas.1320040111.]

Michelle Meyer has posted a detailed analysis of the regulatory context, explaining multiple ways a project like this could have been approved. She concludes that "so long as we allow private entities freely to engage in these practices, we ought not unduly restrain academics trying to determine their effects."

[Meyer, Michelle N. “How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why That May Be a Good Thing.” The Faculty Lounge, June 29, 2014. http://www.thefacultylounge.org/2014/06/how-an-irb-could-have-legitimately-approved-the-facebook-experimentand-why-that-may-be-a-good-thing.html.]

I have little to add to Meyer's excellent post, except a bit of historical perspective. Psychological experiments—whether in the lab, in the field, or online—fall outside my main area of concern, but perhaps I can offer a few relevant points.

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.

Can Macalester's Divisional Review Work Elsewhere?

In his contribution to the Professional Geographer special issue, Dan Trudeau of Macalester College writes that "IRBs can be a pedagogical asset, particularly if institutional review practices cultivate the habits of mind and strategies necessary for engaged and reflexive research." The key, his article suggests, may be the devolution of review to specialized committees rather than the general-purpose IRBs that are the norm. But Trudeau does not stress the degree to which Macalester's sucess depends on its departure from federal standards.

[Dan Trudeau, "IRBs as Asset for Ethics Education in Geography," Professional Geographer 64, no. 1 (2012): 25-33, DOI: 10.1080/00330124.2011.596786.]

Sex and Trauma Surveys No Riskier Than Cognitive Tests

A team of psychologists has found that responding to survey questions about trauma and sex is no more stressful than completing "well-established cognitive tests."

[Elizabeth Yeater, Geoffrey Miller, Jenny Rinehart, and Erica Nason. "Trauma and Sex Surveys Meet Minimal Risk Standards Implications for Institutional Review Boards." Psychological Science (Published online before print May 22, 2012), doi: 10.1177/0956797611435131. h/t Michelle Meyer.]

Minimal Risk Approval: 27 months, $170,000

A team of health services researchers found that getting approval for a minimal risk study took 27 months and consumed $170,000 in staff time.

[Laura A. Petersen, Kate Simpson, Richard SoRelle, Tracy Urech, and Supicha Sookanan Chitwood, "How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services Research," Annals of Internal Medicine 156, no. 10 (May 15, 2012): 728–735. h/t Human Subject News.]

Philosopher and IRB Chair Call for Repeal of IRB Exemptions

Writing in IRB: Ethics & Human Research, Mahesh Ananth and Michael Scheessele, both of Indiana University South Bend, argue against exempting all minimal-risk research from IRB review. They do so in terms that would require the repeal of the 45 CFR 46.101 exemptions, though it is not clear they understand the implications of their own argument.

[Mahesh Ananth and Michael R. Scheessele, "Exempting All Minimal-Risk Research from IRB Review: Pruning or Poisoning the Regulatory Tree?" IRB: Ethics & Human Research 34, no. 2 (April 2012): 9–14.]

Could Retrospective Review End Nitpicking?

Robert Klitzman and Paul Appelbaum, both of Columbia University, suggest that shifting research oversight to the retrospective review of a subset of projects, rather than prospective review of proposals, could reduce the "variability and subjectivity across IRBs" that now characterizes ethics review.

[Robert Klitzman and Paul S. Appelbaum, "To Protect Human Subjects, Review What Was Done, Not Proposed," Science 335 no. 6076 (30 March 2012): 1576-1577,
DOI: 10.1126/science.1217225.]

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge surprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

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.

And the Bush Was Not Consumed

Robert Dingwall kindly alerted me to Scott Kim, Peter Ubel, and Raymond De Vries, "Pruning the Regulatory Tree," Nature 457 (29 January 2009), 534-535.

The authors have complex disciplinary backgrounds. Kim has an MD and a PhD in philosophy, and teaches psychiatry. De Vries has a PhD in sociology and the title of associate professor of bioethics/medical education. And Ubel has an MD and describes himself as a "physician and behavioral scientist." Together, they are unusually well prepared to think about the full range of disciplines affected by human subjects regulations.

The authors complain that IRB review of minimal risk research wastes time and money, infringes academic freedom, and threatens public health by impeding important research. They conclude that "it is unethical to support a system that creates a significant financial, scientific, clinical and ethical burden with virtually no counterbalancing good."

To fix this, they propose "a simple regulatory change that is far-reaching, equitable and yet low risk: exempt minimal-risk research from IRB review." In their scheme, researchers would still "complete a brief application describing research procedures, risks, burdens and the potential loss of otherwise expected benefits to the subjects. An institution-designated person reviews the application, and exempted protocols would not be subject to further IRB review. The application becomes the project's registration and serves as an accountability document."

This sounds fine on the surface, but the proposal raises some questions.