Key Terms

Single IRB (sIRB): One IRB designated to provide IRB review and approval of a study for multiple institutions.

External IRB: the sIRB / Reviewing IRB that is outside OUHSC. Also known as the non-OU or outside IRB. 

Reviewing IRB: the IRB designated to conduct the offiical review in an sIRB setting. Also known as the sIRB or IRB of record.

Relying Site: the site(s) participating in research that cede IRB oversight to the Reviewing IRB. Also known as the participating site. 

Reliance Agreement: an agreement between the institutions that defines the roles and responsibilities between the sIRB and the Relying Site. Also known as an IRB Authorization Agreement (IAA). 

Single IRB (sIRB) and External IRB Review: Reliance Agreements

Single IRB (sIRB) and external IRB are terms used to reference a formal arrangement allowing IRB review and oversight of a study by one IRB when multiple institutions have jurisdiction for the same research protocol. This arrangement is called a reliance agreement.

Most federally funded multi-site research requires the designation of a single IRB to serve as the reviewing IRB for all participating sites as of January 20, 2020. Prior to that, the National Institutes of Health (NIH) implemented a Single IRB-of-Record policy for NIH-funded multi-site research that went into effect on January 25, 2018. 

At OUHSC, researchers may be permitted to enter into a reliance agreement upon request. These requests are approved by University officials, the OUHSC HRPP, and IRB. Reliance agreements are signed and executed by an institutional signatory authority. 

The process for requesting to enter a reliance agreement varies depending on whether OUHSC IRB will serve as the reviewing IRB for a non-OU site or whether OUHSC will defer IRB review to an outside IRB. 

See below for more information about sIRB review processes and resources. 

sIRB Processes and Resources

Relying on an External IRB

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.

Submitting Requests to Rely on an External IRB

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.

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

Requesting OUHSC IRB to Serve as the Single IRB of Record for Multi-Site Research

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. 

IRB Oversight for Non-OU Collaborators

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.

Templates and Documents

Template and other resources are coming soon! Stay tuned for more information!

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