Monday, December 17, 2012

Law Professor Decries, Ponders IRB Variability

Christopher Robertson, associate professor at the James E. Rogers College of Law, University of Arizona, laments the variation in IRB policies and practices from one institution to another and sees it as an opportunity for research.

[Christopher Robertson, "Variability in Local IRB Regulation: A Gold Mine for Future Research," Bill of Health, November 24, 2012.]

Robertson opens with an all-too-common tale of inconsistency between institutions:

When I moved to the University of Arizona, I quickly discovered something that I'll politely call "heterogeneity" in Institutional Review Board's (IRB) policies and practices. All of a sudden, some of the rather vanilla human subjects research practices I had been doing for years, with IRB approval, were now forbidden. Turns out that I had been exerting "undue influence" on human subjects all along by — wait for it — telling them how much I proposed to pay them. (Good thing there is no IRB jail for miscreants like me.)

As he explains,

There seems to be variation in local policies, such as implementation guidelines and boilerplate informed consent language. Indeed, on a particular policy question that I am now studying, I have found an entire gamut, with some schools forbidding precisely what others mandate (and everything in between), with practically nobody in the normative literature arguing for either of those polar extremes.

He also notes more systematic studies of such variability, such as Lee A Green, Julie C Lowery, Christine P Kowalski, and Leon Wyszewianski. "Impact of Institutional Review Board Practice Variation on Observational Health Services Research." Health Services Research 41, no. 1 (February 2006): 214–230. doi:10.1111/j.1475-6773.2005.00458.x.

Rather than cursing the darkness, Robertson proposes to study the phenomenon, the way other researchers have studied local prosecutors' offices. "Somebody needs to do the same for IRB regulation — getting into the black box to figure out what, if anything, really explains all this variation in outcomes for identical cases. Are there in fact internal constraints?"

I agree that there's work to be done along these lines. I'd be particularly interested in comparisons between those IRB administrators who have and have not had extensive certification and contact with PRIM&R, which I think seeks to promote best practices across institutions.

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