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O n Jan. 1, the University of Minnesota launched a major overhaul of its institutional review boards (IRBs) with the goal of increasing efficiency, quality, and — most importantly for many IRB critics — the speed with which it reviews new clinical trial protocols. The reforms represent one approach to fi xing the problems that have been plaguing IRBs everywhere for more than a decade. Charged with protecting human research subjects, IRBs have been facing increasing workloads, diffi culty attracting qualified members, and lack of expertise in specifi c areas of medicine. The University of Minnesota’s local reforms buck the growing trend toward use of external or “central” IRBs to solve these problems. Outsourcing review to central IRBs, including the independent, for-profi t boards that charge a fee, is increasingly common and has the explicit support of federal agencies including the Offi ce for Human Research Protections (OHRP), the U.S. Food and Drug Admi nistration, and the National Cancer Institute. Nevertheless, the debate over local versus central review continues, as does the search for alternative models that might include the advantages of both. What happens in Minnesota in the next few years, as well as with the growing number of alternatives, will be closely watched by the entire clinical trial community. At the University of Minnesota, the new IRB has started meeting once a week rather than once a month. Several boards have been consolidated into one, with its members rotating according to the expertise needed. Its members, all senior investigators, will be paid. These reforms and others — the use of electronic forms and assistance with applications, for example — should speed up the clinical research process, improve the expertise of the review, and lessen pressure to use central IRBs, said Richard Bianco , associate vice president for research. Over the next few years, he will be collecting data to help gauge the success of this approach, including the time it takes for each stage of the process; for example, how long it takes the IRB staff to present the application to the board members, the time it takes the IRB to approve the trial with stipulations, and the total time to fi nal approval. “I don’t believe our system of local reviews is seriously fl awed,” Bianco said, speaking at a national conference on IRBs convened by OHRP and other national groups last November. “Our patients and subjects can best be served by continuing to strengthen our local IRBs.”

Debate Over Institutional Review Boards Continues as Alternative Options Emerge