Change in Federal Common Rule for Human Subject Research

Change in Federal Common Rule for Human Subject Research

NOTE: Effective January 21, 2019

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the “Revised Common Rule” or “Final Rule”) that went into effect January 21, 2019.

For the most part, this new “Final Rule” on the Protection of Human Subjects (the “Revised Common Rule”) has minor operational differences from the previous rule. Guidance from federal agencies and the North Texas Regional IRB will be forthcoming, and IRB submissions forms have been modified as needed.

Please note that protocols approved by the IRB prior to January 21, 2019 will continue to follow Pre-2018 Requirements (the “Common Rule”). Any protocol approved by the IRB on or after January 21, 2019 will follow the Revised Common Rule (or 2018 Requirements).

For those investigators seeking in-depth information on the various features of this new Common Rule, we have contracted a specific training course at CITI to assist in your understanding of the subtleties and nuances of these changes.

For access to this training course, go to the CITI home page at:

https://about.citiprogram.org/en/homepage/citi

Login as usual, then go to the “North Texas Regional IRB” affiliation (not UNTHSC), click on “View Courses”, then scroll down to “Revised Common Rule”.

As specific support guidance becomes available (from the federal agencies as well as NTR-IRB), we will make announcements to the research community.

Finally, note that this revised Common Rule does NOT impact FDA-regulated research. The FDA has not signed onto the revised rule and still follows pre-2018 regulations.