Delay on Changes to the Common Rule

January 18th, 2018

The Department of Health and Human Services (DHHS) has announced a delay on implementation of the proposed changes to the Common Rule.  It had originally been proposed that new requirements and protections be implemented on January 19, 2018. However, a 6-month delay has been put in place and an additional 6-month delay is being considered.  See below for the announcement from DHHS.

The University of Utah IRB is prepared to assist researchers with implementation of the new requirements and protections. The IRB will provide the following resources nearer to the final implementation date as ultimately determined by DHHS:

• Updated ERICA information, including changes to the ERICA application to align with the new requirements and protections
• Updated consent templates and instructions
• Updated guidance and policies on the IRB website
• In-person and online classes to provide instruction on changes specific to implementation at the University of Utah

Subsequent announcements from the IRB will be made when these resources are available.

If you have any questions about the delay or how the changes to the Common Rule affect University of Utah researchers, please feel free to contact the IRB.

The Interim Final Rule (IFR) that delays the effective date of the revisions by six month has been put on public display by the Office of the Federal Register and can be accessed at Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.