Federal changes to human subjects regulations delayed until July 19
January 18, 2018
The U.S. Department of Health and Human Services and 15 other federal departments and agencies announced an interim final rule Jan. 17 that delays the effective date and general compliance date of the proposed Common Rule revisions by six months.
The changes were originally published in the Federal Register on Jan. 19, 2017. While most provisions in the revised Common Rule were scheduled to become effective on Jan. 19, 2018, changes have been delayed until July 19, 2018, in order to provide regulated entities additional time to prepare for implementation. Until July 19, 2018, regulated entities, including the University of Nebraska-Lincoln, will be required to comply with the pre-2018 Common Rule.
While the university’s Institutional Review Board was prepared to implement the changes, it also prepared a backup plan in case this delay occurred. The IRB is taking these steps to update the campus as quickly as possible:
- IRB is revising the Changes to the Common Rule webpage and other guidance information.
- As planned, IRB will proceed with implementing the removal of change requests for exempt protocols on Jan. 19, 2018. IRB made this decision outside the Common Rule changes in order to reduce burden on UNL investigators. Researchers should review the areas of exempt protocols that would still require them to submit a change request on the Common Rule webpage.
- Minor updates will be made to the 2018 new project application form in NUgrant. However, the majority of the changes already implemented can still be utilized. Investigators who have already started a project under this new application may continue to move forward. IRB will follow up with individuals as soon as possible. This delay should not greatly impact review.
- Review and approval will continue on projects under review on an older application (pre-2018). IRB will communicate with individual investigators as needed.
- Investigators should continue to use IRB’s updated informed consent templates. The changes made to these templates can still be implemented.
For more information, contact IRB at 402-472-6965.