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Final Common Rule

January 18th, 2019

IRB Update: January 21st is the Go-Live Date for the New Version of the Common Rule*

* Also known as the Final Rule or the 2018 Common Rule. 

Which studies does this apply to?

  1. Studies that are subject to the rules and regulations of one of the Common Rule Agencies**; AND
  2. Studies approved by the IRB on or after January 21, 2019.
    ** Note that the FDA is not a Common Rule Agency.

 The New Common Rule doesn’t apply to every study.  The IRB will help you to know if you need to follow the New Common Rule as part of our pre-review. 

If your study was approved before January 21, 2019, your study will be grandfathered under the older version of the Common Rule; you will not be required to make any changes. For certain grandfathered studies, it may be beneficial to transition to the New Common Rule.  The IRB will provide you with this advice at continuing review. 

Click here for your centralized resource for navigating the New Common Rule at the University of Utah.  

Learn About the Changes to the Common Rule

  1. University of Utah FAQ
  2. University of Utah Training Video
  3. External Guidance & Resources

 

Learn How to Implement the Changes to the Common Rule

  1. How to transition a grandfathered study
  2. Consent Guidance, including Concise Summary Guidance
  3. IRB SOPs that address the changes

 

Last Updated: 2/19/19