BRIGHT IDEAS: Zach Schrag’s Ethical Imperialism

Zachary Schrag, a professor of history at George Mason, has graciously agreed to join us today to talk about his fantastic book, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 [buy your hard copy, or get a Kindle version].  Professor Schrag’s work came onto my radar when he wrote a good comment to my post about IRBs and caselaw research, and I’ve since become a regular reader of his Institutional Review Blog.  In Ethical Imperialism, Schrag argues that the modern university IRB is the product of a series of historical accidents and reactive, bureaucratic, mission creep, coupled with a failure by academics and their professional organizations to push back against bad government policy. The book was persuasively argued, and provides a very nice and nuanced history of a modern bureaucracy & its attendant regulatory rules, quite apart from the importance of the subject for those of us who have to work with IRBs directly.  After the jump, you’ll find a Q&A about the book, which I think is a must read for folks who want to understand the IRB system.

DH:  What motivated you to write Ethical Imperialism?

ZS:  I stumbled into this topic while writing my first book, The Great Society Subway: A History of the Washington Metro. I had taken a graduate seminar in oral history without ever hearing of institutional review boards. But as I pursued my research, both Columbia University and George Mason University asked me to get official approval to conduct interviews. Neither institution did a good job explaining why that was necessary, so I began investigating the history of such requirements.

DH: The story of IRB regulation of the social sciences seems to be one of contingency and overreaction to crises. What were the key turning points that led us to where we’re at now?

ZS:  In the 1960s, 1970s, and again in the 1990s, the Public Health Service and, to a lesser extent, Congress became worried about ethical abuses by medical researchers. In an effort to restrain them, they enacted laws, regulations, and policies that swept in a great deal of non-medical research. Less haste and more deliberation could have produced very different rules.

DH:  The book contains a definite set of heroes and villains, many of whom you interviewed.  Tell us about those interviews — now that people have had time to reflect on how policy has developed, what would they do differently?

ZS:  The most interesting interviews were with Tom Beauchamp, Bradford Gray, and Albert Jonsen, all of whom shaped the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s. When I spoke with them, each recognized that the commission had failed to investigate adequately the problems involved in regulating the social sciences, yet none believed that it had been his responsibility to look out for the social sciences. The lesson is that it is vital for official bodies to include representatives of all groups that will be affected by their work.

DH:  Law professors, at least those not doing quantitative or experimental work, generally ignore IRBs.  Why do you think they’ve been able to when historians have gotten caught up in the web?

ZS:  I imagine this is due to institutional arrangements. Historians report to the same deans who oversee psychology and anthropology, while law schools have their own deans. And history graduate students produce dissertations, which receive scrutiny from central university administrations in a way that law review notes do not.
DH:  What are the worst examples of research prevented by IRB regulation? The best examples of ethical obscenities avoided?

ZS:  IRBs interfere with a wide range of research. At one extreme, they may block research that does raise significant ethical issues but is of such importance that it should proceed. Scott Atran’s work on failed suicide bombers comes to mind; by blocking his inquiries, IRBs may be retarding global efforts to combat terrorism. At the other extreme, IRBs block research that is of relatively little importance but which is also wholly innocuous, such as student interviews with relatives. I don’t know which extreme is worse.

While I have come across a few social scientists who say that IRBs helped them think through some ethical challenges, I have never heard of an IRB preventing an ethical obscenity by a researcher in the social sciences or humanities. Either it doesn’t happen, or the IRB community has done a poor job of communicating its worth.

DH: You are careful in the book not to take too strong a position on how to fix the IRB system.  Would you care to expand on your views now?

ZS:  Many scholars, myself included, are frustrated with their local IRBs. But while local reform is helpful, I found that this is a national problem, so I think the solution must take place at the federal level. The health agencies have a long history of broken promises of reform, so I would like to see Congress take a serious look at the issue. But there are other paths, including reform within the executive branch and litigation. I also think that reform in the United States would have beneficial effects abroad, since other countries often take their cue from American developments.

DH:  Did you have to get IRB approval to work on this project? What was the process like?

ZS:  George Mason University’s “Human Subjects Research Definition” requires IRB oversight of studies “designed to develop or contribute to generalizable knowledge.” By the time I began this book, I had learned that such a definition did not include the kinds of interviews I do, so I did not seek IRB approval.

DH:  There’s a strong sense in the book that IRBs are increasingly being used to squash politically uncomfortable research projects. Can you give some examples?

ZS:  One common problem comes with the study of sexuality. For example, I recently came across an article by two researchers at the Ohio State University who found that their IRB’s biomedical boilerplate interfered with their study of lesbian, gay, bisexual, transgender, and queer teens. They argue that “Homophobic interpretations of human subject exemptions to parental consent in U.S. academic institutions may (un)intentionally infantilize LGBTQ lives and render such subjects’ educational needs unresearchable unless authorized by parents or guardians.” [James H. Sanders III and Christine Ballengee-Morris, “Troubling the IRB: Institutional Review Boards’ Impact on Art Educators Conducting Social Science Research Involving Human Subjects,” Studies in Art Education: A Journal of Issues and Research in Art Education, 49 n4 (2008): 311-327.] The book provides other examples along these lines.

DH:  Are you aware of other historians writing about the history of various federal regulations? What special challenges arise when you are studying a modern bureaucracy?

ZS: I am not a political scientist, and one of the weaknesses of the book is its failure to contextualize adequately the actions taken by the health bureaucracy. As I noted in a commentary on an article by law professor Scott Burris,  the Code of Federal Regulations includes many requirements that manufacturers use “good engineering judgment.” Is it any easier to reach consensus on engineering judgment than on matters of research ethics? Have federal regulators been more sensitive to the disciplinary differences among engineers than those among scholarly researchers? I had trouble finding scholarship to asnwer such questions.

I must say that I had it pretty easy in terms of access to archival sources. While the overall records of the Department of Health and Human Services have not been processed by the National Archives, those of the National Institutes of Health are in good order. And while I wish the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research had preserved more complete archives–with internal memoranda among staffers–the records it did preserve at Georgetown University made the book possible. A historian can always wish for a better documentary record, but in this case, I found answers to most of my key questions.

DH: You seem to suggest that professional organizations, once a bulwark against IRB overreach, have generally retired from the field.  What is happening now?

ZS:  Historians’ organizations, particularly the American Historical Association, have maintained a firm stance against IRB encroachment. So has the American Association of University Professors. Anthropologists’ and sociologists’ organizations have been relatively quiet, despite widespread dissatisfaction among individual researchers. There are some efforts by those scholars to get their national organizations back into the debate.

DH: What, in your view, is the appropriate strategy for a researcher convinced that his or her project is exempt?  Accommodation or resistance?

ZS:  I would like to see frustrated researchers publicize their experiences. IRB defenders at times claim that IRB abuses are anomalous, but that argument breaks down as more researchers find each other and share their experiences. There is strength in numbers, both within a university and at the national level.

DH: What other books should readers interested in this topic have on their bookshelf?

ZS:  There is very little about IRBs in book form, apart from uncritical handbooks on how to run an IRB. Two exceptions are Will C. van den Hoonaard, ed., Walking the Tightrope: Ethical Issues for Qualitative Researchers (Toronto: University of Toronto Press, 2002) and Mark Israel and Iain Hay, Research Ethics for Social Scientists: Between Ethical Conduct and Regulatory Compliance (London: Sage, 2006).  I am looking forward to the publication of a second book by Professor van den Hoonaard:, The Seduction of Ethics: The Transformation of the Social Sciences.

For the most part, if you are interested in the ongoing debate about IRBs and the social sciences, you must look to journals. And even this is a challenge, since scholars tend to publish in their disciplines, rather than in any central periodicals about research ethics. That’s how you get an important critique of IRBs, which I cite above, published in Studies in Art Education, where scholars from other disciplines may not find it. I do my best to track these dispersed articles and essays on my blog, Institutional Review Blog, http://www.institutionalreviewblog.com.

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