Federal Agencies Announce a Notice of Proposed Rule Making Proposing Additional Delay in Common Rule Revisions
On January 19, 2017, the Department of Health and Human Services (HHS) and other federal agencies had announced a final rule that outlined revisions to the Common Rule, the regulations adopted by 17 federal department and agencies that govern IRB review requirements. These revisions were 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.
HHS issued Notice of Proposed Rule Making (NPRM) on April 20, 2018, which proposes an additional delay of six months to the compliance date for the revisions to the Common Rule. This NPRM is intended to provide those regulated by the Common Rule additional time to prepare to comply with the requirements of the new revisions.
The NPRM is currently requesting comments on whether to permit institutions to implement three burden reducing provisions from the Common Rule revisions during this six month delay period. Those provisions are:
- A revised definition of research, which deems certain categories of activities to not be research;
- The allowance of 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.
Under the NPRM, the compliance date of the Common Rule revisions would be changed from July 19, 2018, to January 21, 2019.
The MedStar Research Compliance Program and Office of Research Integrity are working to prepare for implementation of the revisions to the Common Rule. As the compliance date approaches, additional information will be distributed and education sessions will be scheduled.