Researcher Resources on the Revised Common Rule

U.S. Department of Health and Human Services Logo

Office for Research Protections     |     Institutional Review Board (IRB)


1/17/18 UPDATE: It was previously communicated that on January 19, 2018, changes to the federal requirements for studies submitted to the IRB would go into effect and CATS IRB was to have an outage to accommodate these changes. Official notification has been received that these requirements have been delayed (see the federal announcement). The new implementation date will be July 19, 2018. CATS IRB will still undergo major changes soon to comply with the NIH Single IRB policy; information on the new release date will be forthcoming. 

The Office for Research Protections has multiple resouces available to researchers to help them learn more about the revised Common Rule and how the changes will affect their research. The “Common Rule” is the set of federal policies mandating the protection of human subjects, and on January 19, 2018, a substantial revision to the Common Rule will take effect. These changes are meant to ease some researcher burden while enhancing the protection of human subjects. Studies submitted to the IRB on or after January 19, 2018 will be reviewed under the revised Common Rule.  The revised Common Rule does NOT apply to FDA-regulated and Department of Justice studies.

No action is required by researchers at this time, but if you have flexibility in the timing of when you submit a study to the IRB, we recommend submitting on or after January 19 to have your study reviewed under the revised Common Rule.  New templates to use for review under the revised Common Rule will be available early 2018.  Alternately, you will want to submit well in advance of January 19 to be reviewed under the current regulations; submissions to the IRB often require revisions that take time, and we want to help researchers avoid being caught in Common Rule "limbo." 

The primary resource for learning more about the Common Rule is our Common Rule and Other Changes page.  In addition, we will be hosting several workshops in the spring, which can be attended in-person or via Zoom

January 16 Recording: NIH Clinical Trials: 15 Minute Overview

January 18 Recording: New IRB Requirements for 2018 (Focus on the Revised Common Rule)

February 27: NIH Single IRB Policy and Using the SMART IRB Agreement

March 21: New IRB Requirements for 2018 (Focus on the Revised Common Rule)

Can't make it in person?  Sara Horn, IRB Director in the Office for Research Protections, presented on the Common Rule changes for the Prevention Research Center on December 6, 2017; view a recording of the presentation.