Saturday, March 30, 2013

Rivera: Faculty Researchers Are Notoriously Poor Judges of Risks

Suzanne Rivera, Associate Vice President for Research at Case Western Reserve University and member of the Secretary's Advisory Committee on Human Research Protections, responds to the AAUP's IRB report by asserting that faculty are inept at making determinations of exemption. I question this claim.

[Rivera, Suzanne A. “Academic Freedom and Responsibility |.” Bill of Health. Accessed March 28, 2013. h/t Michelle Meyer]

I have posted the following comments on the blog where Rivera's statement appeared.

Dear Dr. Rivera,

Thank you for taking the time to comment on the AAUP's recent report, "Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board," which I helped prepare. As you note, the report recommends that researchers conducting some types of minimal-risk studies should be allowed to proceed without first getting approval from an IRB office or an IRB itself. This was the intention of at least some of the drafters of the current regulations, and in 2009 OHRP affirmed that "the regulations do not require that someone other than the investigator be involved in making a determination that a research study is exempt."

This is not good enough for you, however. "Placing responsibility for exemption determinations entirely in the hands of researchers is a bad fix," you write. "Faculty researchers are notoriously poor judges of the risks posed by their studies. Ask anyone experienced in the IRB 'intake' process about how often studies posing more than minimal risk are submitted for verification of 'exempt' status and I can bet the number will not be insubstantial."

I imagine that you intended this last sentence as a rhetorical device. But why should it be? Your biography explains that you have "responsibility for oversight of the research enterprise" at Case Western Reserve University, so presumably you have ample opportunity to ask your staff how often faculty researchers underestimate the risk of their studies. Have you done so?

Specifically, I would like to know the following:

* How many proposals in the social sciences and humanities (the major concern of the AAUP report) sought exempt status at Case Western in 2012?

* Of these, how many did the IRB intake staff find to be non-exempt under the terms of the Common Rule?

* How were these disagreements between researcher and staff distributed among the six categories and various subcategories of exemption in 45 CFR 46.101(b)? For example, did any faculty researcher mistakenly claim to be interviewing elected or appointed public officials or candidates for public office? Did any misunderstand the federal department-approval requirements of category 5?

* When IRB staff and researchers disagree over a project's eligibility for exemption, how is this resolved? Do you assume that the IRB staff is always right? Or do you audit their work to guard against unnecessary escalation of review? Can researchers appeal the determination?

* As a member of SACHRP, have you collected or sponsored any research to determine the frequency of inappropriate requests for exemption, and their breakdown by category, nationwide? Have you collected or sponsored any such research about unnecessary escalation?

I know of only scant data on such questions. In 1998, James Bell Associates reported that "According to chairs, about one-half or fewer protocols eligible for exemption were actually exempted from review, depending on research category." And while that study is rather old now, a 2010 report on the IRB process at my university found a similar figure: "of the nine protocols that were given an expedited review, five or 55% could have been exempted from review." (I am glad to report that matters have improved since then.) Rather than finding that "faculty researchers are notoriously poor judges," these reports suggest that IRBs and their staffs can be the poor judges of exemption eligibility.

If you have "not insubstantial" numbers suggesting otherwise, I would be glad to consider them and discuss ways they could be used to reform the regulations. For example, if most of the disputes over exemption concentrate in one or two categories, then perhaps researchers could be allowed to determine their eligibility for other exemptions while regulators rewrote the confusing exemptions in clearer terms.

But if you lack numbers, perhaps we should discuss the terms of a bet.

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