Final Rule, three months later

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

Protecting He-Man Subjects

After frustrating encounters with IRBs concerning two research projects, sociologists Liberty Walther Barnes and Christin L. Munsch argue that “IRBs are gendered institutions in which members base their decisions on culturally dominant, normative images of women and men.”

[Liberty Walther Barnes and Christin L. Munsch, “The Paradoxical Privilege of Men and Masculinity in Institutional Review Boards,” Feminist Studies 41, no. 3 (2015): 594–622, doi:10.15767/feministstudies.41.3.594.]

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.

UNM, NYU: Miller's Fatshaming Tweet Wasn't Research

Two IRBs have concluded that Geoffrey Miller's June tweet about "obese PhD applicants" was not human subjects research.

A UNM statement explains,

Miller at first claimed his tweet was part of a research project, but investigations by the Institutional Review Board at New York University where he was a visiting professor, and the IRB at UNM where he is a tenured professor, concluded that was not correct.

The statement also lists the terms of a censure by the university.

For background, see Trolling Isn't Human Subjects Research and Michelle Meyer: Miller Interacted, Intervened

Michelle Meyer: Miller Interacted, Intervened

Michelle Meyer had more to say about my comments on Geoffrey Miller's fatshaming troll-tweet than would fit in Blogger's comment box. I post her comments here, along with some responses.

Trolling Isn't Human Subjects Research

The Chronicle of Higher Education reports that IRBs at both NYU and the University of New Mexico are investigating the conduct of Professor Geoffrey Miller, now notorious for a June 2 tweet warning "obese PhD applicants" that "if you didn't have the willpower to stop eating carbs, you won't have the willpower to do a dissertation."

According to the Chronicle, Miller "explained his action to university officials in New Mexico by saying he had sent the Twitter message as part of a research project." (In proper troll-speak, one says "social experiment.") But Miller also maintains that "IRB approval was not necessary under his own understanding of federal law."

[Basken, Paul. “In Reversal, NYU Investigates Professor Who Tweeted on Obese Ph.D. Students.” The Chronicle of Higher Education, June 11, 2013.]

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.

National Academies Run Workshops on Common Rule Revisions

The National Academies are running workshops on "Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences." I was unaware of the first two meetings in January, but I hope to attend the upcoming meetings on March 21 and 22.

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.]

Sociologist: IRBs Have Almost Killed Fieldwork

Laurie Essig, Assistant Professor of Sociology and Women's & Gender Studies at Middlebury College and a contributor to the Chronicle of Higher Education's Brainstorm blog, complains that "IRBs have effectively shut down our ability to actually find out about people’s lived experiences. IRBs have treated speaking with someone as equivalent to experimenting on them and have almost killed fieldwork in the process."

[Laurie Essig, "The IRB and the Future of Fieldwork," Brainstorm: Ideas and Culture, 12 August 2011.]

CITI Program as Mind-Numbing, Coercive, Counterproductive McEthics

Sanjay Srivastava of The Hardest Science kindly alerted me to a newly published critique of the mortifyingly stupid CITI Program.

[Jennifer J. Freyd, "Journal Vitality, Intellectual Integrity, and the Problems of McEthics," Journal of Trauma & Dissociation, available online: 15 July 2011, DOI:10.1080/15299732.2011.602290]

Research Psychologist Blogs ANPRM

Sanjay Srivastava, associate professor in the Department of Psychology at the University of Oregon, has been posting some helpful observations about the ANPRM on his blog, The Hardest Science:

Bersoff Reviews Ethical Imperialism

Donald N. Bersoff, a professor of psychology and law at Drexel University, has reviewed Ethical Imperialism for PsycCRITIQUES, the American Psychological Association's online database of book reviews.

[Donald N. Bersoff, "Common Rule or Common Ignorance? A Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 by Zachary M. Schrag," PsycCRITIQUES 56, Release 18 (4 May 2011), Article 3.]

APA Launches Committee on Human Research

John Mueller kindly alerted me to the formation of the American Psychological Association's Committee on Human Research, which met for the first time in March. The committee expects to work for the next 3-5 years on various issues, including, at the top of the list, "interpreting federal regulations for psychological research."

Among the committee members is Miriam F. Kelty, who, as an NIH psychologist, served on the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s.

Psychologist Blasts "Taxonomic Chaos"

John J. Furedy, Emeritus Professor of Psychology, University of Toronto, has posted, "Implications for Australian Research of the Taxonomic Chaos in the Canadian Bioethics Industry: Après Moi le Deluge," originally presented at a June 2009 ethics conference in Australia. Though Furedy's expertise is in experimental psychology--a field outside the scope of this blog--his paper is relevant to the social sciences and humanities as well.

Furedy, who himself served for decades on ethics committees, argues that Canadian research ethics boards worked pretty well until the early 1990s. But since then bioethicists "have created taxonomic chaos by conflating such distinctions as the distinction between ethical and epistemological issues, or the differences among medical drug evaluation studies, psychological experiments, and sociological surveys."

He offers three specific complaints:

1. "REBs have taken it upon themselves to judge not only whether the proposed research is ethical, but also whether it is scientifically valid. But research-design issues for a particular piece of research require a specific sort of epistemological expertise which most REB members do not possess."

2. "The Tri-Council committee has succeeded in persuading governments and universities to treat a sociological opinion survey and a drug evaluation study, as if they were all part of 'human subject research,' that can be evaluated by the same all-knowing REB, using criteria that may apply to medical treatment-evaluation studies, but that do not apply to most social science research."

3. Though the Tri-Council agreed to drop the term "code" (with its suggestion of mandatory rules), "it was made clear to REBs, that if a researcher did not follow the so-called "statement", the right to apply for funding would be denied, because the REB would refuse to accept the proposed research."

Furedy stresses that all of this is relatively new, but that new scholars may not understand that. He writes,

senior investigators are likely to be able get their research proposals through, even though they know, in their heart of hearts, the significance of distinctions such as the one between ethical and epistemological or research-design issues. But for younger researchers, and especially those who are currently students, the distinction between ethical and epistemological issues has been conflated, and so they lack a memory of how research used to be conducted. So researchers of the future are likely to succumb to the bioethics industry. They will, in the epistemological sense, be corrupted by these developments. Current senior researchers, then, who are in control to-day, are acting like France's Louis XV, who was said to have said "Après moi, le deluge."

As a historian, I applaud both the reference to the Bourbon monarchy and Furedy's emphasis on the need for historical consicousness. If younger researchers understand that scholars did not always operate under today's restrictive conditions, they are more likely to imagine alternatives.

The Psychologist Who Would Be Journalist

Back in August 2007, I mentioned the controversy surrounding the book The Man Who Would be Queen (Washington: Joseph Henry Press, 2003) by J. Michael Bailey, Professor of Psychology, Northwestern University. At the time, Professor Alice Domurat Dreger, also of Northwestern, had just posted a draft article on the controversy. Now that article, along with twenty-three commentaries and a reply from Dreger, has appeared in the June 2008 issue of the Archives of Sexual Behavior.

Dreger's article, the commentaries, and Dreger's response focus on big questions about the nature of transsexuality, the definitions of science, power relationships in research, and the ground rules of scholarly debates. Only a handful take up the smaller question of whether—as a matter of law and as a matter of ethics--Bailey should have sought IRB approval prior to writing his book. But that's the question that falls within the scope of this blog.

Northwestern IRB: Unsystematic Interviews Are Not Subject to Review

Today's New York Times features a story, "Criticism of a Gender Theory, and a Scientist Under Siege," about the case of J. Michael Bailey, Professor of Psychology, Northwestern University. Bailey's controversial book about identity. The book provoked several complaints, including the charge by "four of the transgender women who spoke to Dr. Bailey during his reporting for the book . . . that they had been used as research subjects without having given, or been asked to sign, written consent."

As reported by the Times, the case was investigated by Alice Domurat Dreger, Associate Professor of Clinical Medical Humanities & Bioethics at Northwestern, who has posted a draft article on the subject, "The Controversy Surrounding The Man Who Would Be Queen: A Case History of the Politics of Science, Identity, and Sex in the Internet Age," [PDF]

Dreger finds that Bailey did not commit serious ethical violations, nor did he violate the requirements for IRB review:

the kind of research that is subject to IRB oversight is significantly more limited than the regulatory definition of “human subject” implies. What is critical to understand here is that, in the federal regulations regarding human subjects research, research is defined very specifically as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (United States Department of Health and Human Services, 2005, sect. 46.102, def. “b”). In other words, only research that is truly scientific in nature—that which is systematic and generalizable—is meant to be overseen by IRBs. Thus, a person might fit the U.S. federal definition of “human subject” in being a person from whom a researcher gains knowledge through interpersonal interaction, but if the way that the the knowledge she or he intends to gain is unlikely to be generalizable in the scientific sense, the research does not fall under the purview of the researcher’s IRB.

It is worth noting here, for purposes of illustration of what does and doesn’t count as IRB-qualified work, that I consulted with the Northwestern IRB to confirm that the interviews I have conducted for this particular project do not fall under the purview of Northwestern’s IRB. Although I have intentionally obtained data through interpersonal interaction, the interview work I have conducted for this historical project has been neither scientifically systematic nor generalizable. That is, I have not asked each subject a list of standardized questions—indeed, I typically enjoyed highly interactive conversations during interviews; I have not interviewed all of my subjects in the same way; I have negotiated with some of them to what extent I would protect their identities. This is a scholarly study, but not a systematic one in the scientific sense. Nor will the knowledge produced from this scholarly history be generalizable in the scientific sense. No one will be able to use this work to reasonably make any broad claims about transsexual women, sex researchers, or any other group.

When I put my methodology to the Northwestern IRB, the IRB agreed with me that my work on this project is not IRB-qualified, i.e., that, although I have obtained data from living persons via interactions with them, what I am doing here is neither systematic nor generalizable in the scientific sense.

Clearly Bailey's work hurt the feelings of some people he wrote about, but, as Dreger notes, "scholarship (like journalism) would come to a screeching halt if scholars were only ever able to write about people exactly according to how they wish to be portrayed." Indeed, that's what social scientists have been arguing for three decades.