Single IRB Review

Single IRB (SIRB) is a review model to allow multiple institutions that are conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research for each individual site. 

In order for the SIRB model to be utilized, the institution who will serve as the single, reviewing IRB and the institution who will rely on the single IRB for review and oversight must enter into a formal arrangement called a reliance agreement. 

The process to request a reliance agreement for single IRB review is detailed below. 

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

Investigators must submit a request to the HRPP Office for OUHSC to serve as the SIRB for outside sites. This request is submitted in REDCap and processed by the SIRB Administrator to obtain concurrence from University officials, HRPP Director, and IRB Chair.  

For IRB submissions, 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.

• Initial IRB approval of the study will only be applied to the OUHSC site.
• IRB approval for each non-OU site will issued after reliance agreements with each institution has been finalized and executed.
• The SIRB Administrator and the HRPP Office will help facilitate the process for obtaining this reliance agreement. 

Activation and approval of non-OU sites relying on OUHSC IRB is achieved by the OUHSC investigator and study team, who is responsible for submitting the Relying Site form in iRIS after the reliance agreement has been executed. Only one site may be submitted per form. Your IRB Administrator and SIRB Administrator will walk you step-by-step through this process. 

Relying on an external IRB to conduct IRB review and provide oversight of a study must be approved by University officials. Investigators who are approached by an outside investigator, sponsor, or central IRB to participate in a multi-site research study, and use their designated IRB for review, must submit a request to the HRPP Office.  

Various factors are considered when reviewing requests to rely on an external IRB such as: the risk level of a study, exempt/non-exempt status, the funding/sponsoring entity, and whether the outside institution is accredited. 

After a reliance agreement is finalized and executed, investigators must create a research file in iRIS by submitting a Relying on an External IRB application. 

IMPORTANT:

1. When relying on an external IRB, it is the local (OU) Principal Investigator's responsibility to learn and comply with the policies and procedures of the external, reviewing IRB. In cases where research is reviewing by an external IRB, their policies will prevail. For example, it is imperative that PI's are aware of the external IRB's reporting requirements and timelines for protocol deviations and unanticipated problems because the process and timeline may differ from OUHSC's IRB reporting requirements. 
2. Studies covered by a master agreement are excluded from submitting REDCap requests to rely on the external IRB so long as the research falls within the defined scope of the master agreement. Studies that fall outside the scope of a master agreement must submit a request in REDCap to the HRPP Office.
3. ALL studies using an outside IRB covered by a master agreement or individual reliance agreement must submit the Relying on an External IRB application in iRIS.