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On June 18, 2018, the Department of Health and Human Services (HHS) and other federal agencies announced a final rule to delay for an additional 6 months the general compliance date for changes made recently to revisions to the Common Rule, the regulations adopted by 16 federal department and agencies that govern IRB review requirements. The revisions were originally scheduled to become effective on January 19, 2018. In January 2018, the agencies published an interim final rule that delayed the effective and compliance date for these revisions until July 19, 2018. A Notice of Proposed Rule Making (NPRM) was then released which proposed an additional delay of six months to the compliance date for the revisions to the Common Rule. The NPRM also requested comments on whether to permit institutions to implement three burden reducing provisions from the Common Rule revisions during the proposed six month delay period.
The Final Rule adopts the proposals described in the April NPRM. The Final Rule delays the compliance date for an additional six month period until January 21, 2019. Institutions will be required to continue to implement the provisions of the pre-2018 version of the Common Rule until January 2019. The exception to that rule is that institutions will be permitted (but not required) to implement three burden-reducing provisions of the new rule. Those provisions are:
- A revised definition of research, which deems certain categories of activities to not be research;
- The allowance for no annual continuing review for certain categories of research, and
- The elimination of the requirement that IRBs review grant applications or other funding proposals related to research.
The MedStar Research Compliance Program and Office of Research Integrity are working to prepare for implementation of the revisions to the Common Rule and this new Final Rule. As the compliance date approaches, additional information will be distributed and education sessions will be scheduled.