Tuesday, April 26, 2011

University of Iowa: Ask IRB Before Researching Neanderthals

Someone at the University of Iowa apparently thinks that the IRB has jurisdiction over research with dead Neanderthals.

The university administers the Stanley Graduate Awards for International Research, which are "given annually to UI graduate students for the pursuit of international research / fieldwork and career interests."

The program's web page states that "Since IRB approval is important for ALL student research projects and must be obtained PRIOR to receiving funding, **PLEASE SEE THE IRB INFORMATION PAGE**." (Emphases in the original.)

The IRB information page in turns tells applicants that they must

Submit an online "Human Subjects Research Determination" form through HawkIRB. The IRB chair and/or their designees will determine if your study meets the definition of human subjects research. Federal regulations do not allow investigators to make this determination themselves. If a study does not qualify as human subjects research, Hawk IRB will issue a memo stating that the project does not require IRB review or approval.

To be sure, the list of 2009-10 grants suggests that a majority of sponsored projects involve research with human subjects as defined by the Common Rule. But the program has also sponsored students to read twelfth‐century church records, tour ancient Greek and Roman houses, and examine "similarities and differences in the organization of worked bone technology by Neanderthals and modern humans in the Early Upper Palaeolithic."

Thus, because of the blanket policy, students who have no intention of conducting human subjects research face considerable bureaucratic requirements. According to my correspondents, applicants must complete the multi-hour CITI program just to submit the form stating that they are not conducting research with human subjects.

Two Misconceptions

The University of Iowa's policies appear to be based on two misconceptions.

First, if the web page is to be believed, this requirement is based on someone's belief that "Federal regulations do not allow investigators to make this determination [of whether they are conducting human subjects research] themselves." This is, of course, simply false.

OHRP has made clear that "the regulations do not require that someone other than the investigator be involved in making a determination that a research study is exempt." And that's for exemption, for which OHRP does recommend that "investigators not be given the authority to make an independent determination that human subjects research is exempt."

OHRP has, to my knowledge, never even recommended that researchers be forbidden to make an independent determination that they are not conducting human subjects research.

The University of Iowa appears to have borrowed the falsehood from the University of Southern California. USC's booklet, "Is Your Project Human Subjects Research? A Guide for Investigators, makes the false claim in identical language, and it is repeated in the University of Iowa's derivative work, "Do I need IRB Review? Is This Human Subjects Research? A Guide for Investigators."

The second misconception driving the policy is the apparent assumption that researchers' time has no value. As Scott Burris has noted, "No mechanism informs IRBs of the real cost of the 'small' changes they demand." Iowa offers a perfect example; I can't imagine that the people who set up the determination system reckoned the inconvenience it would impose on researchers who had no business with the IRB.

According to the IRB's website, Human Subjects Research Determination form was only added to the application system in October 2010. Rather than being an entrenched policy, the requirement may be just an unfortunate episode that will soon be remedied. But that remedy will come too late for those already inconvenienced.

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