Thursday, July 19, 2012

IRB Chair Denies Being a Vampire

Patricia Price, a geographer and IRB chair at Florida International University, assures us that her board is not "a malevolent, vampirish entity."

[Patricia L. Price, "Geography, Me, and the IRB: From Roadblock to Resource," Professional Geographer 64, no. 1 (2012): 34-42, DOI:10.1080/00330124.2011.596789]

Price understands that IRB horror stories emerge from real mismatches between the structure of IRBs and the reality of research. As a geographer, she highlights two mismatches grounded in space. First, she notes that the collection of locational data can threaten subjects' privacy, but that "few IRB chairs are knowledgeable enough about GIScience to make useful suggestions to researchers about how to treat such data." Therefore, "geographers, as well as others using GIScience techniques, must take it on themselves to educate IRBs about the best (i.e., most appropriate as well as methodologically sound) ways to utilize linked sociospatial data without compromising confidentiality."

Second, she notes that the standard IRB model more or less assumes that researchers, subjects, and IRBs will stay put during the course of a project, but that "as researchers, human subjects, and IRB members move about locationally and institutionally, consistency and continuity of human subjects protection oversight is difficult to maintain."

Rather than propose any structural solution, Price calls on researchers to trust their IRB chairs.

Most IRBs (almost always the ones you do not hear about) are chaired by thoughtful scholar-administrators whose desire to facilitate research at the home institution is balanced by the nagging fear of that one-in-a-thousand protocols that has the potential to bring the university’s research to an embarrassingly public halt as federal regulators audit everything. The best among us are interpretivists, as opposed to literalists, who attempt to work with, rather than against, our local circumstances and cultures. We recognize that ours is largely a deliberative task, rather than the strict application of clearly defined parameters. We strive to stack our boards with a diversity of fellow faculty known primarily for their equanimity. And most of our time is not spent on regulatory issues but rather on education and outreach, particularly with graduate students and new faculty. Human subjects protection is as much, if not more, a cultural rather than a technical issue.

Price offers no evidence for these claims. I have no reason to doubt that Price herself is a fine IRB chair, though if she's done any research into FIU researchers' attitudes toward their IRB, she doesn't cite it. For instance, her article mentions but does not engage with the critiques articulated by Amy Ritterbusch in her essay, though Ritterbusch is Price's advisee and presumably is complaining of the "standardized or operationalized" procedures demanded by Price's IRB.

More significantly, though, Price gives us no reason to think that enlightened chairs are the exception rather than the rule. She concedes that IRB chairs exchange "chilling tales of university-wide research shutdowns during a federal for-cause audit wherein the buck ultimately stops with the IRB chair." If only 20 percent of chairs run their IRBs with the intention of avoiding federal audits rather than protecting subjects, that would still be a national disaster.

Nor does Price discuss the role of IRB staff and related entities. For example, her university requires all researchers, regardless of discipline, to complete either the NIH course in Protecting Human Research Participants or the mortifyingly stupid CITI Program. Regardless of what happens to their protocols, self-respecting researchers detest such mind-numbing, coercive, counterproductive McEthics.

Price ends by calling for researchers to serve on their IRBs, claiming that this will diminish "much miscommunication, misinformation, and ill will toward IRBs emanating from researchers conducting surveys, focus groups, oral and life histories, or utilizing other qualitative techniques that do not fall under the methodological umbrella of clinical trials and behavioral interventions."

Maybe she should tell that to researchers like Rena Lederman, Anthony Langlois, and Dominique Rivière, whose service on ethics committees did not extinguish their skepticism about the whole process. [Note: I hope to post comments on Rivière's piece before too long.]

Then Price tells researchers to "Familiarize yourself with the regulations." That's a good suggestion only so long as the IRB and IRB staff promise to follow the regulations themselves. Keep in mind that PRIM&R argues "that institutions should always be permitted to add additional protections to the minimal regulatory requirements as they see fit without special permission." So long as this is the case, a researcher who knows the regulations well may be all the more frustrated when the IRB imposes additional restrictions. What is a researcher familiar with regulations to do when IRB offices demand review of obviously exempt research?

In sum, Price acknowledges that IRBs--especially their chairs--enjoy somewhat dictatorial powers, but she tells us that dictators can be relied on to work fairly in obscurity. Whether dealing with IRBs or vampires, I put my trust in sunshine.

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