Regulated Research

Reviewed by Ellen Marakowitz

Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009. Zachary M. Schrag. Baltimore: Johns Hopkins University Press, 2010.

I hear frequently from my graduate students, and sometimes even my colleagues, “I have to get institutional review board approval for my research. Can you help?” As an anthropologist and a member of my university’s institutional review board (IRB), I am sought out for guidance on how to get through a process that is dreaded and often derided. And mandatory. The central goal of IRB review of research projects is to protect human research subjects from harm and to minimize potential risks from participating in the research. But how do issues of harm and risk to subjects intersect with the methodologies employed in social science research, such as interviews, surveys, and ethnographic work? My hope was that Zachary M. Schrag’s book Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 would shed some light on the juncture of social science research and federal regulation. Has the academic freedom of social scientists to engage in research been compromised by IRB regulations?

I am happy to report that Ethical Imperialism provides a well-documented history of the impact of institutional review boards on social science research in the United States. In his introduction, Schrag makes his position clear: IRBs have had a chilling effect on the academic freedom of researchers in the social sciences. “While we cannot measure the research lost to ethics review,” he states, “it is clear that as a result of IRB oversight, society as [a] whole has fewer books and articles, and has fewer scholars willing to interact with other human beings.” Schrag argues that social science research has been at best misunderstood by IRB reviewers, and at worst shut down or preempted by IRB oversight.

Ethical Imperialism details the story of the various governmental actors who shaped IRB regulations, the concurrent story of social scientists who must fulfill the terms of these regulations, and the continuing contest over the implementation of ethics review in social science research. As Schrag illustrates, IRB review of social science research has been caught in definitions of research, harm, risk, and protection that are not suited to the field. While legislative and governmental agencies were charged with defining these terms, social scientists, though very vocal at certain moments, were often effectively kept on the sidelines.

As a result, the definitional framework of protections that guided what came to be known as “human subjects research” grew out of biomedical research models. Unlike biomedical or psychological research, which relies on laboratory or controlled experiments, however, sociological and anthropological research typically involves qualitative research not designed to test a hypothesis. The unwillingness to recognize a distinction in research methodologies and aims meant that social scientists found themselves having to define their research through IRB parameters such as “number of research subjects,” “informed consent,” and “hypothesis to be tested.” But ethnographic research, for example, is open-ended in nature, and it quickly becomes apparent to an anthropologist that it is both unwieldy and impractical to define one’s work in these terms. As Schrag shows, some researchers may simply avoid the IRB process, or do what is necessary to get IRB approval and then do what they want in the field anyway. Thus the protections prescribed are often ineffectual in practice, and might even create harm. Written documentation of informed consent, for example, is required by the IRB unless a waiver is granted, but a record of participation could be dangerous in certain sensitive research projects (as when a husband learns of his wife’s participation in research on domestic abuse).

By presenting and pulling together copious archival material on legislative hearings, federal commissions, and disciplinary debates (in sociology and anthropology, in particular), as well as interviews with key actors, Schrag provides a clear story of the legislative responses to ethical concerns often stemming from research debacles with human subjects in biomedical research. He skillfully deals as well with the many tentacles of a complicated legislative and bureaucratic history.

Schrag also provides strong evidence that social science research was included in the discourse on human-subject protections in a haphazard way, with much uncertainty on the part of legislators and commission experts as to whether the guidelines were really intended to cover social science research. He points to the publication of Laud Humphreys’s 1970 study of gay male sex in public places, Tearoom Trade: Impersonal Sex in Public Places, as a pivotal moment in drawing attention to the ethics of social science research. The reception of this research was mixed. Some condemned Humphreys for using “deception, misrepresentation, and manipulation”—his deceit included everything from acting as a “participant” while observing gay sex in bathrooms to gaining the identities of the men he observed through a scheme that included noting license plate numbers. Others defended him by rejecting an “ethic of full disclosure.” Schrag explains that “IRB advocates have used Tearoom Trade as evidence for the need for IRB review of social research,” but he argues, on the contrary, that the kind of research Humphreys engaged in (covert observation) is quite rare and, moreover, that “the IRB system is premised on the [faulty] idea that a committee of researchers will have better moral judgment.” Protections based on medical research models cannot provide useful moral guidance for the ethics of social science research.

Schrag takes us through the various phases of human-subjects review legislation. Key actors include the Public Health Service, the National Institutes of Health, and ultimately Congress, with the passage of the National Research Act. The years 1974–81 were critical: among other things, they saw the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which, despite its title, did not include representatives from the social sciences. The work of this commission led to the expansion of the definition of human-subjects research to “include all surveys, all fieldwork, even conversations.” During this period too The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research was published by the commission. This report, issued in 1978, came to exert enormous influence. To this day, almost every US university follows the ethical guidelines set out in the Belmont Report, which now have quasi-legal force.

Social scientists reacted sharply to the National Research Act and elements of the Belmont Report. Schrag documents the many hundreds who protested IRB review between 1977 and 1980, with particular attention to Ithiel de Sola Pool, a political science professor from the Massachusetts Institute of Technology who fought for “broad exemptions of categories of research which normally present little or no risk of harm to subjects.” Schrag tells the story of how tantalizingly close social science research came to being considered not part of the IRB regulations at all. In 1981 regulations exempted some survey research, and also added the freedom to interview public officials. Later, however, IRB review was expanded to include even nonfunded projects. This was one of the most invasive and protested changes.

Schrag covers the responses of both universities and professional associations, including the AAUP, to the current IRB regulations. (Schrag served on the subcommittee that drafted the AAUP’s recent report on IRBs, Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board.) Oral historians have argued, with some success, that oral history should be exempt from IRB oversight because it “does not represent research as defined by legislation.” Anthropology, as a discipline, has tried to self-regulate the ethical stance of its researchers through its own set of guidelines but still struggles with the imposition of IRB review on ethnographic research. Within all fields, Schrag describes both those who attempt to comply and those he terms “resisters.”

While there are examples of social scientists who have committed ethical breaches, Schrag notes that the current system of IRB oversight can do little to prevent those abuses. If the goal is to protect subjects, he argues, a very different kind of review of social science research is needed.

Schrag’s stance on the dangers of IRBs to the academic freedom of social scientists is unwavering, and he does not give much credence to the possibility of real risks in social science research. He contends, for example, that while a breach of confidentiality might cause some harm, it happens very infrequently. He also asserts that “the most serious threat to . . . confidentiality is not an unethical researcher, but a government subpoena.” He does not, however, mention the “certificate of confidentiality” that IRBs can require of a researcher to keep potentially harmful data, such as information on illegal activities, from subpoena.

Perhaps a way to use current IRB oversight more effectively would be to think about it as a prompt to at least consider the impact of research on those being studied. I have worked with some students who were initially strongly opposed to having to seek IRB approval. In the end, however, several told me that the process not only did not impede their research but actually made them think critically about their practices, including potential risks to subjects. Schrag is correct in noting that in most social science research the risk is minimal, but even so, it must be taken into consideration. The best IRB reviews would be flexible and open to the complicated nature of social science research.

This approach is not one Schrag would endorse, because, as he puts it, “IRB review of the social sciences . . . was founded on ignorance, haste, and disrespect.” He advocates instead taking the regulation of social science research out of the hands of the federal government altogether, and he makes a strong case for this approach in Ethical Imperialism.

Schrag contributes much to our understanding of how social scientists’ lack of input, or the lack of response to that input, in the development of federal guidelines for ethical research resulted in a loss of academic freedom for social scientists. I highly recommend his book for its contribution to the discussion of academic freedom, social science research, and the regulation of research ethics.

Ellen Marakowitz is on the faculty of the Department of Anthropology at Columbia University. She is also a member of the institutional review board at Columbia. Her e-mail address is em8@columbia.edu.

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