Deferring IRB Oversight to an External IRB

 

For OUHSC to defer IRB oversight to an external IRB, both institutions must be engaged in human subjects research. For more information about engagement, see the Reliance Agreement FAQ page or OHRP's Guidance on Engagement of Institutions in Human Subjects Research (2008).

 

University Concurrence

The University must concur to defer oversight to an external IRB before the reliance agreement is drafted.

For the HRPP Office to achieve University concurrence, the OUHSC PI submits the Request to Use an External IRB Form to the HRPP Office. 

 

Post-Concurrence

Once the University concurs, the HRPP Office will alert the OUHSC PI  and provide instructions for moving forward.

At this time, the OUHSC PI begins working with the outside IRB to draft the reliance agreement.

Once the agreement is drafted, it is routed through the Office of Research Administration (ORA) via their online submission system, SoonerTrack. At the same time, the OUHSC PI submits an External Application in iRIS.

 

Finalized Reliance Agreement

The reliance agreement is finalized when it has been routed through ORA and all University officials have signed the agreement.

Once the HRPP Office receives a copy of the finalized reliance agreement from the OUHSC PI, the HRPP-Accepted letter will be generated in iRIS, indicating that the HRPP Office has received all information required to accept the external IRB as IRB of record the the study.

Once the OUHSC PI receives the HRPP-Acceptance letter, research activities may begin so long as the external IRB has achieved final approval and there are not other contracts awaiting signature.

 

Please see the below infographic for additional information and click on each step to visit the webpage associated with that information.
 

 

Ext IRB Process 8.5 Click here to complete the Request to Use an External IRB Form