Proposal would further delay Common Rule changes

News for Researchers

Posted May 2, 2018 by Ashley Washburn

The U.S. Department of Health and Human Services and 16 other federal departments and agencies announced a proposal in April to delay the general compliance date for revisions to the Federal Policy for the Protection of Human Subjects, known as the Common Rule, until 2019.

The Notice of Proposed Rulemaking would extend the Common Rule compliance date from July 19, 2018, to Jan. 21, 2019. The notice, still under consideration, is intended to provide regulated entities additional time to implement the 2018 requirements and would extend the interim final rule, announced in January that delayed the effective and compliance date for the 2018 requirements.

If finalized, the notice would require regulated entities, including the University of Nebraska-Lincoln IRB, to comply with the pre-2018 Common Rule requirements until Jan. 21, 2019. This newest proposal would allow IRBs to move forward with three burden-reducing provisions as detailed in the Federal Register notice. However, the IRB has determined that if the proposal moves forward, these provisions will not be implemented due to the minimal time and administrative savings to the campus over the six-month additional delay.

UNL researchers are encouraged to visit the university’s IRB website for information on Common Rule implementation.

For more information, contact IRB at 402-472-6965.

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