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Still a Muddle, OHRP Promises to Clarify sIRB Issues—But Not When

Among the many challenges facing universities and others that conduct research that falls under the Common Rule[1] is how to handle two related sets of requirements and deadlines—one imposed by the rule itself and the other by NIH. But information that might help clear up some questions will be forthcoming, Jerry Menikoff, director of the HHS Office for Human Research Protections (OHRP), recently promised. However, he couldn’t say when that would be.

Menikoff made his pledge at a meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) on Oct. 16.[2] Also at the meeting, SACHRP approved recommendations that address pay-for-play studies.[3]

Specifically, both NIH and the revised Common Rule mandated that “cooperative” research involving two or more U.S. sites utilize a single institutional review board (sIRB). NIH went first, issuing its final policy in June 2016 with a compliance date of May of the following year.[4]

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