By Meredith Wadman

Over the last two decades, scientists have increasingly followed the mantra that “bigger is better” when planning drug trials. Large, multisite trials have become staples of clinical investigation, enabling wider enrollment and more statistically meaningful research results.

But, as the number of participating sites per study has grown, so has the administrative red tape. And, nowadays, dozens of local ethics committees—known as institutional review boards (IRBs)—are commonly involved in approving multisite studies, routinely suggesting changes to protocols and consent forms that then need to be reapproved by all the other parties involved. As a result, trials can take months to launch, delaying progress, and meaning that study participants don’t benefit from the oversight of one central committee with ultimate responsibility for the research.

The current system “is time consuming and slows research,” says Kathy Hudson, deputy director for science, outreach and policy at the US National Institutes of Health (NIH) in Bethesda, Maryland. “It also may introduce vulnerability for subjects, because if there are many, many IRBs involved, does any single IRB feel like they have the real responsibility to examine the risks and benefits to research participants in exquisite detail?”

To remedy the situation, on 22 July the NIH’s parent agency, the Department of Health and Human Services (HHS), proposed that multisite studies conducted in the US should each be overseen by a single IRB for that study. Under the proposal—made as part of a sweeping overhaul to the Common Rule, the 1991 regulation that governs human research funded by 17 federal agencies, including HHS—this centralized IRB would approve protocols on behalf of all institutions involved and oversee midcourse corrections in the study in response to any unexpected adverse events.

The proposed change, which is currently open for public comment, “would make a lot less work for all the individual IRBs and allow them to focus on the studies they should be focusing on: the homegrown studies that haven’t been reviewed by anybody else,” says Richard Galbraith, director of the University of Vermont Center for Clinical and Translational Science in Burlington, who has studied the issue for the Federation of American Societies for Experimental Biology (FASEB).

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