Relying on an IRB outside of OUHSC to conduct review and provide oversight of a study must be approved by University officials. Various factors are considered such as the risk level of a study and whether the outside institution is accredited. 

When relying on an external IRB, it is the local (OU) Principal Investigator's responsibility to know and comply with the policies and procedures of the external, reviewing IRB. In cases where research falls under the oversight of an external IRB, their policies will prevail. For example, it is imperative that PI's are aware of the external IRB's reporting requirements for protocol deviations and unanticipated problems because the process and timeline may differ from the OUHSC's IRB reporting requirements.

University administrative approval to rely on an external IRB is required prior to initiating a reliance agreement or submitting an application in iRIS. The Principal Investigator submits the request for administrative review in REDCap using the form linked below. A copy of the research protocol must be submitted with the form. The HRPP Office will inform investigators by email of the review outcome and how to proceed.

• Request to use an External IRB - REDCap form for administrative review. 
• Relying on an External IRB - iRIS application (submit after the REDCap form has been submitted)

Refer to the Templates and Documents section for local context, consent boilerplate language, and more. 

OUHSC IRB may serve as the single reviewing IRB for multi-site research. 

Investigators should add non-OU sites to the IRB application and select that the non-OU site is requesting OUHSC to serve as the IRB of record. The OUHSC HRPP will facilitate the process for obtaining IRB approval to serve as the IRB of record, as well as the process for obtaining a reliance agreement with the relying site. 

This may be completed either at the time of initial IRB review or by submitting a modification request to an ongoing study that has been approved by the IRB. 

NOTE: The investigator should keep in mind that the outside site may require an IRB-approved protocol before they rely on the OU IRB. In this case, investigators might choose to wait until after the study has been approved before adding non-OU sites to the application. 

When a non-OU collaborator is engaged in human research reviewed by an OUHSC IRB, and they are from an institution that does not have an IRB, an Individual Investigator Agreement (IIA) must be executed between the University and the non-OU collaborator. 

Investigators may contact the HRPP Office when submitting a new application to initiate this process; or HRPP staff will facilitate this process when non-OU collaborators are identified during the pre-review process. 

Refer also to HRPP SOP 602J to learn more about what is required under When OU Extends its FWA to Collaborating, Non-OU Investigators.