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October 22, 2012

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Glenn Cohen

Great post Michelle! Curious whether you think law school ELS types are better of being reviewed by a single university-wide IRB or whether you'd advise them to consider pushing their dean to start a law school specific IRB (or together with other "low risk" departments"? Do you think some of the creep is "bleed" from the medical to the behavioral? Also are there any studies on heterogeneity of expedited review procedures specifically among IRBs?
Cross-Posted at Bill of Health

Michelle Meyer

[Note to readers: There has been quite a bit of discussion on this post over at Bill of Health. Parts of my answer to Glenn, below, cross-reference responses I've made to other comments there. Interested readers can find the fuller discussion at blogs.law.harvard.edu/billofhealth/2012/10/22/exempt-human-subjects-research-expedited-irb-review-curb-your-enthusiasm.]

@Glenn: There is, of course, lots that ails the IRB system, and so I say let a thousand flowers bloom as we try various ways of redressing these flaws. That said, I don’t think that non-biomedical IRBs are a panacea for much of what ails the IRB system. And so, given limited human resources, I’d rather see ELS types (and their colleagues) train their legal expertise on questions about the problems we’re trying to solve with the IRB system and how to optimize that regulatory system to solve those problems.

The regs were clearly designed by people whose primary work was in the area of biomedicine, and the regs reflect that origin in various ways. But short of amending the regulations to scale back that creep, there’s not much that can be done about what the regs call for across disciplines and methodologies.

No doubt, non-biomedical research is sometimes unduly delayed or restricted because, for instance, biomedical ethicists and researchers fail to understand such a study’s somewhat foreign aims or methodologies and apply the regs accordingly. But I’m skeptical that when IRBs delay or restrict social science or humanities research, they do so primarily because they’re reviewing non-biomedical as opposed to biomedical research. Many institutions (e.g., major research universities) already have an IRB dedicated to non-biomedical research, and my sense (again: we lack good data; see responses to other comments) is that these haven’t been a panacea at those institutions. I’d be happy and interested to hear otherwise from researchers.

Certainly, plenty of anecdotes exist in which an IRB shuts down social science research, and it turns out to have been a fellow social scientist on the IRB who hammered the final nail into the study’s coffin. Intradiscipline disputes about “proper” methodologies and sufficiently “important” research questions (not to mention turf wars and the usual petty academic politics) exist, and perhaps continue to grow with greater innovation in research methodologies, and IRB decisions can and do reflect these disputes, biases and limited understandings.

Conversely, although I’m skeptical of the popular view that biomedical research is riskier than non-biomedical research (such that we should restrict IRB review to biomedical research), to the extent that this is true (or simply believed to be true by IRBs), one can imagine biomedically oriented IRBs viewing the social science research they review as comparatively innocuous. If so, then biomedically-oriented IRBs ought to work in favor of social scientists hoping to get their work through relatively quickly and with few or no required substantive alterations.

Rather, I think that some of the biggest and most fundamental problems with the IRB system run across pretty much all types of research and all types of reviewers. The regs are necessarily open to interpretation, and IRBs tend to interpret both them and the studies they review in ways that involve more rather than less review. IRBs do so for a variety of reasons, including some I alluded to in my response to Paul Reitemeier. In addition to risk aversion (and here again, there are in turn multiple reasons for IRB risk aversion), IRBs, being comprised of human beings who have a natural desire to feel needed and useful, tend to want to spot at least some issues in a protocol (when was the last time a colleague asked you to provide feedback on a paper and you reported that it was just perfect as-is?). That very human tendency will persist even if it is fellow social scientists who are reviewing social science studies (indeed, the tendency may be stronger, as they are now “uber-experts” reviewing studies in their home discipline or field).

(On empirical studies of how IRBs deal with expeditable research, see my responses to Chris and Norm.)

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I’d rather see ELS types (and their colleagues) train their legal expertise on questions about the problems we’re trying to solve with the IRB system and how to optimize that regulatory system to solve those problems.

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