Can Macalester's Divisional Review Work Elsewhere?

In his contribution to the Professional Geographer special issue, Dan Trudeau of Macalester College writes that "IRBs can be a pedagogical asset, particularly if institutional review practices cultivate the habits of mind and strategies necessary for engaged and reflexive research." The key, his article suggests, may be the devolution of review to specialized committees rather than the general-purpose IRBs that are the norm. But Trudeau does not stress the degree to which Macalester's sucess depends on its departure from federal standards.

[Dan Trudeau, "IRBs as Asset for Ethics Education in Geography," Professional Geographer 64, no. 1 (2012): 25-33, DOI: 10.1080/00330124.2011.596786.]

Dreger Wants to Scrap IRBs

On the heels of Laura Stark's Los Angeles Times op-ed calling for the replacement of local IRBs with centralized boards of experts, historian Alice Dreger has published her own call for a national system of ethics review based on expertise and transparency.

[Alice Dreger, "Nationalizing IRBs for Biomedical Research – and for Justice," Bioethics Forum, 22 October 2010.]

Troubled by her IRB's approval of a project she considers unethical, and by Carl Elliott's White Coat, Black Hat: Adventures on the Dark Side of Medicine, Dreger concludes that the system of local review is ineffective:

We’ve reached the point where many people in medicine and medical ethics don’t even expect IRBs to act as something other than liability shields for their universities. But do patients who come to us only to be turned into subjects know that? Do they know that there is literally a price on their heads put there by research recruiters?

I’ve come to believe we need a radical solution. Maybe what we need is a nationalized system of IRBs for biomedical research, one that operates on the model of circuit courts, so that relationships cannot easily develop between the IRBs and the people seeking approval. This system could be run out of the Office for Human Research Protections and involve districts, similar to the federal courts system. Deliberations would be made transparent, so that all interested parties could understand (and question) decisions being made.

Think of the advantages: the possibility of actually focusing on the protection of human subjects first and foremost, free of conflicts of interest; the possibility of having nothing but trained professionals (not rotating unqualified faculty and staff) sitting on review panels; the possibility of marking biomedical research as clearly different from the social science and educational research unreasonably managed by many IRBs; the possibility of much greater transparency to those interested in seeing what’s going on; the possibility of having multi-center trials obtain a single approval from one centralized IRB, rather than trying to manage approvals from multiple local institutions. And the possibility of shutting down the deeply opaque, highly questionable private IRBs Elliott describes as being increasingly used by universities. (Go ahead, call me a Communist for caring about the Common Rule.)

Her Communist leanings aside, I don't know why Dreger presents her argument as a defense of the Common Rule, which fails to distinguish between biomedical and social research, puts ethics review in the hands of rotating unqualified faculty and staff, and keeps deliberations opaque. But her wish for the kind of coordination and transparency provided by the court system has a long lineage. I've quoted it before, and I'll quote it again:

The review committees work in isolation from one another, and no mechanisms have been established for disseminating whatever knowledge is gained from their individual experiences. Thus, each committee is condemned to repeat the process of finding its own answers. This is not only an overwhelming, unnecessary and unproductive assignment, but also one which most review committees are neither prepared nor willing to assume.

[Jay Katz, testimony, U.S. Senate, Quality of Health Care—Human Experimentation, 1973: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, Part 3 (93d Cong., 1st sess., 1973), 1050].

It is not lack of good intentions or hard work that leads IRBs to restrict ethically sound surveys while permitting unethical experimental surgery. It is the ignorance and isolation identified by Katz in 1973 and still in place today.

Princeton IRB Delays Student Research

The Daily Princetonian reports a sociology major's difficulties getting IRB approval for her senior thesis on Brazilian immigrants' changing perceptions of gender roles.

"It's such a long process that it thwarts your field work efforts," [Christine] Vidmar said, noting that the review board does not meet to approve proposals during the summer. "I've been waiting since I got back to school. The first deadline that I could apply for was in October. It's November now, and I still can't officially go do my interviews."

. . .

Vidmar noted that a well-researched thesis may require up to a year of field work, adding that review board hurdles make it more challenging to complete sufficient research. "If you're a senior and you don't have a thesis chosen by the spring of junior year then you can't start field research until November or December of senior year, which is really late," she said. "You need to be in the field in order to know what questions you're going to ask, but in order to be in the field you need to have given the IRB your questions ahead of time."

As horror stories go, this one is mild. But consider the following:

• While details are lacking, Vidmar's proposed research sounds to be exempt under federal regulations; she's just interviewing adults about their perceptions of gender.
  
• Princeton demands full board review for "almost all proposals," offering expedited review only on "an exception basis."
  
• The IRB does not meet for three and a half months in the summer and requires proposals to be submitted two weeks in advance of the meeting. Hence, a student who misses the late-May deadline must wait almost four months until late September for review.
  

Put these together, and it seems that Princeton has built a substantial impediment to students who would like to interact with people as a capstone to their undergraduate training but are unable to write detailed research protocols six months in advance.

This is not to say that undergraduates should be sent into the field without training or supervision. But review by at the department level, as suggested by Felice Levine and Paula Skedsvold; subcommittee review, as practiced at Macquarie University; or researcher certification as permitted at the University of Pennsylvania, might well achieve the same or better levels of oversight as full-board review without delaying the work and discouraging the curiosity of a student researcher.

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."