Over the past 15 years, a growing number of historians have wrestled with institutional review boards (IRBs). Initially developed to address abuses in the medical sciences, review boards slowly extended their reach to encompass remote areas of research including some forms of history. The policies applied by IRBs often remain fixed in their past among the harder sciences, and can vary widely in their implementation from campus to campus. In Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009, historian Zachary M. Schrag (George Mason Univ.) traces the development of these oversight regimes, and explains how they came to encroach in such odd ways on our discipline. The following article presents the text of an e-mail discussion between Robert Townsend, AHA’s assistant director for publications and research, and Zachary Schrag about the issues raised in and by his book.

Robert B. Townsend: Historians are often surprised to discover that some forms of history research come under scrutiny from institutional review boards (IRBs). When did you first discover that your work was subject to review?

Zachary Schrag: In 1998 I took Ron Grele’s graduate oral history seminar at Columbia University, which prides itself as the birthplace of oral history. We spent quite a lot of time on methods and ethics, but never once did we discuss IRBs. It was only when I got a dissertation grant from the National Science Foundation that I encountered the term “human subjects research” and first sought approval from a university ethics committee. And even then, the Columbia IRB was pretty flexible; for example, I asserted that having taken the seminar, I had sufficient training to interview people. But when I requested renewal of the approval, I was required to go through the medical-ethics training and begin filling out irrelevant forms.

RBT: How did your frustration with these IRB policies lead you to historical research into the origins of the policies governing human subject research?

ZS: When I joined the faculty at George Mason University and said I was planning to do interviews, I was told to complete the Collaborative IRB Training Initiative Course in the Protection of Human Research Subjects, which has become the dominant training required of university researchers. The course emphasizes a 1978 document known as the Belmont Report, stating, “The Belmont Report identifies three basic ethical principles that underlie all human subject research.” But when I read the Belmont Report itself, I found the following footnote: “Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the [National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research] specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies.”

In other words, a secondary source was claiming that the Belmont Report applied to “all human subject research,” while the primary source itself suggested that it did not apply to some categories of research, such as social experimentation. That gap was enough to make me wonder just what the creators of the IRB system thought—or did not think—about nonmedical research.

RBT: And as you note in your book, you also discovered that other historians using oral history methods were running afoul of these policies. How did that factor into your research on those questions?

ZS: I started trying to improve relations between IRBs and oral historians in late 2004, an effort that put me in touch with some eminent oral historians—Don Ritchie, Linda Shopes, and Mary Marshall Clark—who had been working along those lines for years. Only after two years of this effort, in late 2006, did I begin to think that archival research could help me understand the nature of this problem.

Though my activism preceded my scholarly research, I don’t think it interfered with my ability to write a story based on the evidence I found, rather than my preconceptions. In particular, I began the project expecting to find that IRBs began interfering with social science and historical research only in the 1990s as the result of some new interpretation of old rules. That is partially true, but I also found discussion of IRB review of social science dating back to the beginning of the IRB system in the mid-1960s, and, by the late 1970s, deliberate decisions to include social science in the jurisdiction of IRBs. The book presents these findings, not my expectations. And I did my best to explain the arguments of those who advocated IRB review, even when I concluded that those arguments had logical or evidentiary flaws.

RBT: Your book shows that the current patchwork of review board policies arose from a complex array of actors—legislators, scientists, philosophers, and bureaucrats. How did you set about reconstructing their often contradictory goals and efforts?

ZS: The book is grounded in three manuscript collections: the Central Files of the Office of the Director, National Institutes of Health, 1960–1982; the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Collection; and the Ithiel de Sola Pool Papers. The NIH papers gave me the perspective of the regulators, including some who believed that Congress had not empowered the Department of Health, Education, and Welfare to impose IRB review on the social sciences. The Pool papers include records of an impressive effort by social scientists from around the country to limit the reach of IRB regulations. And the National Commission papers document the thoughts of the architects of today’s IRB system, a group of physicians, psychologists, and ethicists who imposed rules on social scientists despite their ignorance of social science.

Though I rounded out and extended the story with other archives, publications, and interviews, it was the richness of these three main archives that allowed me to reconstruct the main events in my story from these multiple perspectives.

RBT: I note that you conducted a number of interviews as part of your research. Did you submit them to the review board at George Mason University, and did they express any concerns about your topic or approach?

ZS: In January 2007, I learned that the federal Office for Human Research Protections had conducted a series of oral history interviews and posted them on its web site without seeking IRB approval. A representative explained that such interviews did not fall under the federal definition of human subjects research. (www.institutionalreviewblog.com/2007/01/generalizable-revisited.html).

Since I would be conducting a similar set of interviews—indeed, I interviewed three of the same people—I concluded that IRB approval was not necessary for my interviews either, and I did not submit the project for IRB review.

RBT: As you trace the history of these policies, particularly from the 1970s to the present, much of this unevenness seems to arise from the many different ways these policies could be interpreted and implemented from the university to the federal level. How did so much ambiguity get into the system?

ZS: In 1973, the Tuskegee Syphilis Study Ad Hoc Advisory Panel proposed that “Publication of [important IRB] decisions would permit their intensive study both inside and outside the medical profession and would be a first step toward the case-by-case development of policies governing human experimentation. We regard such a development, analogous to the experience of the common law, as the best hope for ultimately providing workable standards for the regulation of the human experimentation process.”

Instead of following this advice, federal regulators let IRBs keep their reasoning mostly to themselves, giving researchers little guidance about what is acceptable. Researchers who submit identical proposals to multiple IRBs—such as those who want to survey students or faculty at multiple universities—find that what is unobjectionable at one campus is considered dangerous at another. One communication scholar tells students that IRB review is “a game, obviously using an Ouija board.”

This arbitrariness and inconsistency is less the fault of any one IRB than a design flaw in the system as a whole. And it affects medical research as well as social science research, which is pretty scary.

RBT: And as your study shows, the regulators and agencies creating these rules rarely study the effects of their regulations on the humanities and social sciences. Rather ironic for policymaking about research practices, isn’t it?

ZS: Historians of science have shown us that scientists, like everyone else, can have trouble abandoning their preconceptions when confronted by new evidence. But I was surprised to see just how often regulators and other officials deliberately solicited social scientists’ views, only to ignore any responses that challenged their plans. Unfortunately, that pattern continues, with the Office for Human Research Protections requesting comments that it then disregards.

RBT: As one of the regulators in your story observes, the first priority in rulemaking for IRBs is protecting the subject, the second is “self preservation of the bureaucrat,” and the third is the researcher (p. 134). What is lost in a system structured on those principles?

ZS: At every level, from federal rule-making to decisions by individual IRBs, the system imposes great penalties on those who err on the side of permitting research to proceed, but it rarely questions decisions to restrict research. This is a problem with medical research as well, but with lives and billions of dollars at stake, medical researchers have more ability (too much, perhaps) to contest the system or work around it.

Because regulators, university administrators, and local IRBs may not value their work, scholars in the social sciences and humanities lack that clout. As one law professor recently asserted, “many social science interviews and surveys will not contribute to democratic self-governance,” so “regulations that burden these communications should trigger something less than the exacting scrutiny that would be applied if IRB regulations were applied to journalists’ communication with their sources.” Indeed, the regulations make the most sense only if you think that neither social science nor the humanities contribute much to our society.

The American Academy of Arts and Sciences recently created a Commission on the Humanities and Social Sciences partly in response to the derogation of those fields in comparison to the hard sciences. IRBs’ treatment of the humanities and the social sciences is one manifestation of this broader problem, so perhaps the commission will address the issue.

RBT: Sadly, you report that historians (including the AHA) recognized the problems rather late, and then struggled to find a proper response. Is there a point where the discipline could have changed the terms of the debate?

ZS: Historians have been concerned about IRB overreach since at least 1978, but it was only in the mid-1990s, as more universities began restricting oral history, that the Oral History Association and the American Historical Association took leading roles in the debate.

Despite years of effort, the two associations failed to reach a firm agreement with federal regulators. Even in hindsight, it is not clear what they could have done differently. They approached the negotiations in good faith, but the regulators did not. And the longer history of IRBs shows that regulators respond to pressure from Congress or the Secretary of Health and Human Services but not to arguments from scholars.

RBT: You seem to end on an uncertain note, with scholars divided between those willing to work within the system and those trying to resist IRB authority at an individual level. Are there any promising alternatives out there?

ZS: Many people who care about research ethics and welcome some oversight still reject the system as it exists at most U.S. institutions. A few universities have worked out innovative policies. The University of Pennsylvania, for example, has a policy on ethnography that “eliminates the need for investigators doing evolving research to spell out the details of a dynamic research protocol.” And several universities have crafted policies that free oral history from IRB oversight. But scholars across the United States remain frustrated by rules that were crafted for medical experimentation.

Canada’s experience shows what could have happened had social scientists been given more of a voice. Since the 1990s, the Social Sciences and Humanities Research Council of Canada has been one of three authors of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. While the first edition of that statement, released in 1998, provoked severe criticism from social scientists, the second edition, released in late 2010, addresses many of those concerns.

In particular, a new chapter on qualitative research outlines the profound ethical and methodological differences between much social science work and the biomedical research that sparked regulation. I don’t think the Canadian system is perfect, but it is easily more promising than the American one.

Finland’s National Advisory Board on Research Ethics also recently studied the problem. Like the Canadian councils it concluded that the goal of avoiding harm—a cornerstone of medical research ethics—does not always apply, and “a researcher’s task is to produce new information without having to fear the reaction of authorities or other research subjects.” Moreover, it concluded that a social science project requires ethics review only if it involves one of six specific features, such as “an intervention in the physical integrity of subjects” or exposure “to exceptionally strong stimuli.” Of course some of the criteria require some judgment, but here the researcher is given the benefit of the doubt.

I do not have a simple solution to a longstanding problem. But I do think a solution must begin with the realization that these regulations were written in a specific time and place, by people who cared very little about the rights and responsibilities of scholars in the social sciences and humanities. In other words, I believe that good policy depends on sound history.

Robert B. Townsend is the AHA’s assistant director for research and publications.

Zachary Schrag

Zachary Schrag, associate professor of history at George Mason University, is the author of two books, He is the author of two books: The Great Society Subway: A History of the Washington Metro, and the book discussed in the conversation, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009, both published by the Johns Hopkins University Press. Schrag’s articles have been published in the Journal of Policy History, the Journal of Urban History, Technology and Culture, and Washington History, and his essays have appeared in Perspectives on History, TR News, and the Washington Post. Schrag is a member of the editorial board of the Journal of Urban History.

He has received grants and fellowships from the National Science Foundation, the Gerald Ford Foundation, and the Library of Congress, and has been awarded the Society for American City and Regional Planning History’s John Reps Prize and the Journal of Policy History’s Ellis Hawley Prize.

Schrag is currently working on a project entitled “The Militia and the Mob: Citizen Soldiers and Urban Riots, 1812–1992.”

—Adapted from profile on the web site of George Mason University