Wednesday, November 26, 2008

IRBs vs Law and Society

The Law and Society Association (LSA) has posted “The Impact of Institutional Review Boards (IRBs) on Law & Society Researchers," a 2007 report by the association's Membership and Professional Issues Committee.

In the spring of 2007, the committee put out a general call for comments from association members, receiving 24 replies. Committee members also interviewed association members, taking special interest in those who had served on IRBs. This produced some accounts of frustrating encounters that led to the destruction of research, especially cases involving research on crime and punishment, a special concern of the association.

One particularly sad story came from "Respondent 019":

I knew when completing my [questionnaire] that I would have some difficulty getting my topic approved because it related to a protected population. I completed the [questionnaire] honestly and accurately and finally heard back that I had to make substantial revisions to my proposal. Not only did I take all of the IRB’s recommendations for review into account when completing a second questionnaire, but I even had frequent contact with the compliance coordinator and the secretary to make sure I was doing everything correctly. I submitted a second [questionnaire] that covered all the areas that caused problems with my first proposal. Finally, I heard back, and I was rejected on a whole other set of criteria that IRB never mentioned when they rejected me the first time. Finally I ended up changing my topic enough so that I no longer had to deal with IRB because they had pushed back the start date of my research so far that I couldn’t risk not getting approved again.

Other accounts describe IRB blocakge of research concerning mental health facilities that house sex offenders and prisons in the United States and Turkey.

The report concludes with three sets of recommendations:

First, it wants to restrict IRB jurisdiction: "the LSA should strive to minimize the scope of the IRBs regulations over non-behavioral studies and make the procedures of approving behavioral studies as smooth and expedient as possible."

Second, the report calls for a program of research and education, ranging from conference panels and publication to a statement of best practices for research. The goal is "a nuanced and contextual view of the IRB process, one that moves away from hard and fast 'rules' for most social science research, allowing for optimal protection of human subjects without inhibiting research goals."

Finally, the report claims that "the most successful IRBs (in terms of 'customer satisfaction') are those with a decentralized 'sub-board' system," citing UCLA and Macalester as examples. I find this unpersuasive, given that the report is based on part of the work of Jack Katz of UCLA, who seems pretty unsatisfied with his IRB.

While not directly inconsistent, these three recommendations are in some tension with each other, as well as with the evidence presented in the report and positions taken by the LSA. The report's collection of horror stories--unrelieved by any reports of IRB contributions to ethical research--calls into question the propriety of any IRB review of social research, and the report's analysis suggests that there is no legal requirement for such review. Put together, these sections of the report support Katz's conclusion that "the optional decision to push all ethical review of social science and humanistic research through a prior review sieve is not only massively inefficient, it is also counterproductive where risks are most serious." ["Toward a Natural History of Ethical Censorship," Law & Society Review 41 (December 2007), 807.]

By contrast, the calls for additional research, a more flexible IRB process, and decentralization all resemble the stance of Felice Levine and others, who advocate working within the current system.

In particular, the report raises the question of LSA's position on the scope of the "behavioral research"mentioned in the National Research Act and other forms of interactions with human beings. "There has been no mention, or expressed intention regarding human subject research in law and the social sciences," the report notes, "and clearly not all research in law and society is 'behavioral.'" If this is the case, then many of OHRP's policies and interpretations of the Common Rule lack a statutory basis. Yet in December 2007, five months after the report was presented to the association, the Association signed onto Levine's comment to OHRP, in which she wrote of "social and behavioral sciences (SBS)," conflating the very categories the report wishes to keep distinct.

The July 2008 newsletter of the association mentions the report, but it does not state whether the association has accepted its committee's position or taken any action in response. I hope the LSA will continue work in this field, and that it will consider further the question of whether all survey, interview, and observational research should be made subject to a law governing "behavioral research."

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