Implementation and Transition to the New Rule

 

Implementation for New Studies

Exempt Studies: Exempt submissions should be submitted on the current forms under the Pre-2018 Rule.   Effective July 19, 2018, exemptions will be accepted on the new forms and will be processed under the New Rule.

New Expedited and Full Board studies processed after July 19, 2018 will need to be in compliance with the New Rule.  This includes protocols that are submitted to HRPO prior to July 19, 2018 but processed on or after that date.  

 

Transition for Existing Studies

Transition Steps:

  1. Determine the need for transition: either IRB requested or investigator anticipates transition based on the Decision Tree
  2. Utilize the Transition Action Form to determine changes to be made
  3. Open modification in OSIRIS
  4. Specify the reason in the modification cover sheet: transition to New Rule
  5. Make necessary change and submit

Existing studies that require full board review will be assessed at the time of continuing review or modification to determine if compliance with the New Rule will be required.  The IRB will make this determination based on the nature and content of the study.  Investigators conducting studies that include banking procedures and whole genome sequencing should be prepared to be in line with the New Rule. Please refer to the Decision Tree to get an idea of what studies will be required to comply with the New Rule. 

Expedited studies and continuing review: When the New Rule goes into effect, certain expedited studies will no longer be required to renew annually.  All studies should be submitted to HRPO at the upcoming renewal date.  HRPO will determine if the study will need to be submitted for Continuing Review in the future.  Please refer to the Continuing Review Table for guidance on what may or may not be required to comply.