Rule Would Extend Deadline for 2018 Common Rule Requirements

The Department of Health and Human Services and other federal agencies today proposed delaying the general compliance date for 2018 requirements under the Common Rule to Jan. 21, 2019, which would give covered entities six additional months to implement the requirements. The agencies will accept comment on the proposed rule for 30 days, including whether to continue to permit institutions to implement on July 19 three provisions of the 2018 requirements intended to reduce burdens on regulated entities. The Common Rule establishes specific requirements to protect the safety and privacy of individuals participating in human subjects research, including requirements for institutional review boards, informed consent and assurance of compliance for institutions conducting research.