Revised Common Rule Implementation Delayed Until July 19
 
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January 2018

The federal agencies that are subject to the requirements of the Common Rule announced in the Federal Register on January 22 that the implementation of the updated regulations would be delayed until July 19. The revised regulations on human subject protections in research were finalized shortly before President Obama left office in January 2017 and were expected to go into effect on January 19, 2018.

“While we are pleased to see that no substantive changes were made to the Common Rule, AERA and the broader social and behavioral science community are concerned about further delays to the implementation of the revised Common Rule,” said AERA Executive Director Felice J. Levine. “AERA stands ready to be a resource as guidelines are developed to allow these revisions to move forward.”

According to the Federal Register announcement, “Representatives of the regulated community, and HHS's own advisory committee, have requested a delay in implementation of the 2018 Requirements, citing the final rule's complexity, the absence of needed guidance, and the need to revamp institutional procedures and electronic systems in order to come into compliance with the requirements of the rule.”

The Office of Human Research Protections at the Department of Health and Human Services is also seeking to request comments on a potential additional extension of implementing the revised regulations to January 2019. The agencies subject to the Common Rule are developing a notice of proposed rulemaking to receive feedback on the possible delay.

 
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