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Past Just the One

The new iteration of the US National Institutes of Health's Common Rule, which governs medical research involving people, only requires the approval of a single institutional review board for multi-site studies, as long as all the sites are in the US.

As Carrie Wolinetz, the associate director for science policy at NIH, and Francis Collins, the NIH director, write in the American Journal of Bioethics, getting approval from each site can be cumbersome for researchers. For instance, they note that it took investigators 27 months and 115 submissions to get a hypertension study past 17 IRBs and that longer delays have also been reported.

With the new Common Rule, they hope to address this issue. Only one IRB of record will be required for US-based multi-site studies, starting in 2020. Wolinetz and Collins note that a 2011 report from the Office of Human Research Protections concluded that there's "very little evidence that having multiple IRBs review the same study, results in enhanced protections for subjects."

"As stewards of the public trust, it is our obligation to honor that contract by seeking to eliminate unnecessary burdens that delay research and frustrate researchers and participants alike," Wolinetz and Collins write. "We believe that the shift toward requirement of single IRBs represents a common sense solution to a longstanding problem."