Thursday, May 10, 2007

Boise State University's IRB Makes a Poor First Impression

I received an anonymous comment expressing alarm about the new website of Boise State University's Office of Research Administration.

The site presents the following information about the requirement of IRB review:

Federal, state and university regulations require all research (including surveys and questionnaires) involving human subjects or data collected, directly or through records (i.e. medical records, specimens, educational test results, or legal documents) to be reviewed by an Institutional Review Board (IRB) . . .

If you are a faculty or staff member, or student at Boise State University, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires human subjects review.

"Research" is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge." 45 CFR 46.102(d). Research includes surveys and interviews, behavioral investigations, retrospective reviews of medical information, experiments with blood and tissue, and demonstration and service programs and clinical trials. In addition, FDA includes under the definition of reviewable research, any use of a FDA regulated product except for use of a marketed product in the practice of medicine.

Note: Any administrative, departmental or course assignments involving surveys, questionnaires and interviews designed for internal use and operations of the University do not constitute "research" within the meaning of this policy if the information or conclusion of this data is not intended for scholarly publication or for dissemination to persons outside the administrative organization of the University.

That's it. No explanation of what federal and state regulations apply. No hint of the exceptions specified in 45 CFR 46.101, nor an easy way to learn more about the requirements.

The site does offer a link to the university's "Human Research Protection Policy - BSU 6325 B," but that link, as well as others on the site, is broken. (Yesterday I wrote to the e-mail address on the site, pointing out these broken links, but I have not received a reply). There's also a link to an "IRB Guideline Summary," which in turn offers a link to a Word document called "TYPES OF IRB REVIEW AND APPROVAL," which finally lists the exceptions. Since neither of these link titles mention exceptions, a visitor who knows enough to find this document probably knows about the exceptions already.

All told, my correspondent can be forgiven for fearing (I hope mistakenly) that Boise State "seems to require submission to IRB for analysis of any record of human behavior."

Boise State's Office of Research Administration shows how to antagonize researchers before even meeting them. I would like to remind all such offices that researchers are trained to read critically. Offer them complete and accurate information, and cite your sources.

Update: The links were fixed on May 15.

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