FDA Won’t Regulate ‘IRB Shopping’

The Food and Drug Administration announced last week that it would not regulate “IRB shopping,” a practice in which sponsors of clinical trials choose to submit proposed research to institutional review boards that they believe will approve it. The FDA said it had concluded that such choosiness either does not occur or is not a significant problem.

Many large universities and higher-education groups had criticized the idea of new rules, saying they would bog down institutional review boards in paperwork without providing additional protection for research subjects. But advocates for those research volunteers say the practice, even if it cannot be quantitatively documented, is real and worrisome because it could allow ethically suspect studies to avoid adequate oversight.

Federal rules make the review boards, known as IRB’s, responsible for protecting the safety and welfare of volunteers in biomedical and behavioral research regulated by the FDA or financed by the U.S. Department of Health and Human Services.

In 1998 the inspector general of the department, which is the FDA’s parent agency, recommended a rule against “IRB shopping.” In a report, that office said it had “heard of a few situations where sponsors and/or research investigators who were unhappy with one IRB’s reviews switched to another without the new IRB being aware of the other’s prior involvement.”

The FDA had requested comment in 2002 on whether new rules were needed to control the practice. In particular, the agency was mulling the idea of requiring sponsors of studies regulated by the agency, and academic scientists who performed them, to inform institutional review boards of prior decisions by other review panels.

In an announcement in the January 17 Federal Register, the FDA said most of the 55 comments it had received — from pharmaceutical companies, colleges, and other organizations — contended that IRB shopping was not a big problem.

http://chronicle.com Section: Government & Politics Volume 52, Issue 21, Page A25