Common Rule Implementation Delayed Six Months; Further Delays Likely

The 16 U.S. federal agencies subject to the Common Rule, the set of regulations governing research involving human subjects, announced a six-month delay on the implementation of revisions originally announced in January 2017 (see COSSA’s analysis of the changes). The delay was announced as an Interim Final Rule in a Federal Register notice published on January 17, 2018, two days before the changes were scheduled to go into effect. According to the notice, federal agencies subject to the Common Rule are “in the process of developing a proposed rule to further delay implementation of the 2018 requirements,” and the six-month delay will allow for a full notice and comment period on this proposal. Details on what this second delay would entail—including whether the agencies are considering more substantive changes to the revisions—are not provided. A statement issued by the Department of Health and Human Services suggests a possible proposed implementation date of January 21, 2019, but this could change. As the regulations currently stand, the new implementation date is July 19, 2018.

The fate of the changes had been left in limbo since the presidential transition, as one of the Trump Administrations’ first acts was to freeze the implementation of new regulations pending review by the Office of Management and Budget, leading to uncertainty over when—and whether—the changes would go into effect.

A number of the changes to the Common Rule were designed to make the regulations less burdensome for research that posed no or minimal risk to participants, like a lot of social and behavioral research. Until the changes are implemented, research involving human subjects will continue to be guided by the existing regulations, which have not been updated since 1991. You can follow COSSA’s ongoing coverage of this issue here.

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