Requesting OUHSC to be IRB of Record for an Outside IRB

For OUHSC to serve as IRB of record for an outside IRB, the University will enter a reliance agreement.

For OUHSC to serve as IRB of record for an outside site, both OUHSC and the outside site 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 serve as IRB of record for an outside site before the reliance agreement is drafted.

For the HRPP Office to achieve University concurrence, the OUHSC PI submits the full study application in iRIS.

The non-OU collaborator, non-OU site, and reliance agreement sections must be completed in the application.

The protocol that is attached to the study application must describe all activities performed by non-OU collaborators at the non-OU sites so the University can make a concurrence decision.

 
 

Post-Concurrence

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

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

Once the reliance agreement is drafted, it is routed through the Office of Research Administration (ORA) via their online submission system, SoonerTrack.

 

Post-Concurrence

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

When the HRPP Office receives a copy of the finalized reliance agreement from the OUHSC PI -- and when all outstanding stipulations associated with the initial review of the study are addressed -- the HRPP Office will generate the outcome approval letter in iRIS.

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

 

 

 

 

iRIS.ouhsc.edu