by Zachary M. Schrag. Baltimore: Johns Hopkins University Press, 2010. 264pp. Cloth $45.00. ISBN: 9780801894909.Reviewed by George R. La Noue, Professor of Political Science and Professor of Public Policy, University of Maryland Baltimore County. glanoue [at] umbc.edu.
pp.616-618
Institutional Review Boards (IRBs) are at once both ubiquitous and paradoxical in higher education. Since their creation in 1966 with a limited mandate over medical and behavioral research, IRBs now assert the right to review, amend, censor or reject any research, funded or unfunded, by any member of the academic community that involves “human subjects.” No one knows how many tens of thousands of projects are submitted and shaped by this process every year.
Universities might seem to be a most unlikely place to welcome and implement a process that is in effect a form of prior censorship. Reconciling the IRB process with legal or professorial concepts of academic freedom is extremely difficult. How this development occurred and what consequences have resulted are examined by Zachary M. Schrag, an associate professor of history at George Mason University. While there have been extensive grumbling and some spirited exchanges in the literature about IRBs, Schrag’s ETHICAL IMPERIALISM: INSTITUTIONAL REVIEW BOARDS AND THE SOCIAL SCIENCES 1965-2009 is the first comprehensive description of the IRB phenomena. The book is a powerful indictment of the IRB regime.
Schrag makes several key findings. First, he concludes that IRBs are not based on any empirical investigation of previous social science ethical abuses. Second, the author contends that there are better alternatives to prevent abuse, though that concept is not well developed in the book. Third, he finds that social science and humanities scholars need to be better represented in the rule making process. Fourth, he concludes that the extension of IRBs over most social science research has been largely unintentional and that no one has been willing to take responsibility for the unintended consequences. Fifth, he shows there never was a “golden age” of the IRB process and it is not improving with time. Sixth, he argues that the failure to understand the history of IRBs leads to an amnesia that frustrates reform of the federal rules.
Few new faculty members or graduate students have much knowledge of the origins or policy debates about IRBs. For most, the requirement to submit research proposals and submit to the committee’s ethical judgments is taken for granted like following traffic and parking rules. Schrag provides a carefully researched and well written historical perspective providing all members of the academy with essential information to reconsider the role of IRBs. [*617]
Schrag traces the origin of IRBs to a concern among a few Congresspersons about “sensitive” or “intrusive” questions being asked first of some applicants for federal employment and later by federal agencies interested in farm life or law enforcement. That led the Public Health Service to rule in 1966 that for any grant application for “clinical research” involving human beings there must be a “prior review” of the rights and welfare of the participants, informed consent, and a determination of the risks and potential medical benefits of the investigation. That rule did not apply to unfunded research or to almost all social science inquiry. For the next two decades, there were continued discussions between prominent social scientists, academic and professional associations, congresspersons and bureaucrats about the scope and flexibility of new IRBs jurisdiction. Even Antonin Scalia, then a Chicago law professor and IRB member puts in a cameo appearance in the book, declaring he was “disturbed by the authority I find myself and my colleagues wielding over the most innocuous sorts of intellectual inquiry.” While the full ebb and flow of the prolonged debate which Schrag meticulously recounts cannot be recorded here, suffice it to say that at critical junctures the bureaucratic argument for uniformity trumped all other policy goals. Even after many hearings, newspaper editorials, and association resolutions raising important objections, the coup de grace for the IRB opponents came in the form of the most innocuous appearing of bureaucratic tools – a model assurance statement for NIH-funded institutions. While in theory, universities could create their own assurance statement, the path of least resistance was to sign the twenty-one page federal model, even if it contained excruciating detail, such as that IRBs would always meet on the third Wednesday of the month. Because the model was not mandatory, it did not have to go through the public comment process required of federal regulations. Nevertheless, the assurances required university stipulations that their IRBs cover social science research as well as unfunded research, both of which had been the previous points of contention. By 1995, these concepts were added to new regulations without much comment by a quiescent university community. As Schrag points out one of the shifts in power during this period was that universities now had fulltime professional IRB administrators (Northwestern had twenty-six) who generally supported expansion of IRB authority and thus their personal roles.
Schrag does not discuss this issue in depth, but the standards applied by IRBs in evaluating research are exceedingly ambiguous. Borrowed from the domains of medical and psychological research, IRBs require that all human research subjects be treated with “autonomy,” “benevolence,” and “justice.” Those words may sound innocuous, but the interpretations must necessarily be subjective, perhaps even ideological. While a physician should treat all without making any moral judgments about patient behaviors, particularly for qualitative social science research moral and legal evaluations may be socially valuable. Think of the many recent books written about the debacles in the world financial markets which criticize institutions and individuals by name.
Schrag’s very useful historical perspective comes at a time when there [*618] is a second wave of criticisms of IRBs from various professional associations, including the American Political Science Association, the American Historical Association, and the American Association of University Professors. But is anything likely to change? No current politician has championed IRB reform. The 38 year old Tuskegee experiment using African-American males to determine the effects of treated and untreated syphilis still stifles rational discussion. Campus administrators have grown comfortable with IRB reviews because they insulate them from conflicts with their public funders and muffle more controversial lines of research that might annoy private funders. Schrag does not devote much attention to the constitutional issues IRBs raise, however it is inexplicable that there has been no judicial review of that process. Neither the ACLU nor the Foundation for Individual Rights in Education (FIRE), so sensitive to censorship in other venues, has taken up the issue. Given the right set of facts, it is easy to imagine that courts would apply prior censorship prohibitions to IRBs, as they have done in striking down campus speech codes, but there is another legal strand that is extremely deferential to the university decision making in admissions and employment areas.
What is missing is comparative empirical research about the standards and procedures of a variety of IRBs in different settings. While it seems intuitively unlikely that the process is always fair, objective and consistent, from IRB committee to committee, campus to campus, beyond anecdotes what proof exists? Without an appropriate factual basis, courts would struggle with both the compelling interest and narrow tailoring prongs that constitute the strict scrutiny test that should apply to censorship. Schrag’s book provides a necessary and very carefully researched historical context for the debate about IRBs, but the next step needs to be taken by professional associations and social scientists to study their actual practice to see if the current system can be improved.
© Copyright 2010 by the author, George R. La Noue.
