Reliance Agreements

What is a Reliance Agreement?

The Reliance Agreement, also known as an Institutional Authorization Agreement (IAA), refers to the formal written agreement between institutions that documents respective authorities, roles, responsibilities, and communication between the Institution providing the review as the IRB of record (reviewing IRB) and the participating institution relying on that IRB (relying IRB). The IRB other than the ORSIRB is also referred to as the external IRB.

Reliance agreements do not replace the need for IRB review and determination. However, one is only needed if the IRB determination category is expedited or full board review. Determinations of not human subjects or exempt do not require reliance agreements.

Obtaining reliance agreements often requires negotiation between the two institutions. This may prolong the time to the IRB determination.

Reliance Agreement Process

The Oak Ridge Sitewide Institutional Review Board (ORSIRB) is the Reviewing IRB

When an IRB other than the ORSIRB (external IRB) is the relying IRB, a reliance agreement is required, as well as a local review for compliance with local policies of the Institution and DOE-specific requirements (see HRP-801-SOP-Establishing Authorization Agreements and HRP-590-TEMPLATE-IRB Authorization Agreement). When the ORSIRB provides IRB review for other institutions, the ORSIRB will follow its established policies and procedures to ensure that the composition of the IRB is appropriate to review the research and will comply with applicable laws of the relying site and any relevant DOE-specific requirements.

The ORSIRB will notify the researcher (and institution) of its decisions, make relevant IRB policies and records available to the relying institution and specify an IRB contact for communication.

The ORSIRB is the Relying IRB

When human subjects research carried out at this Institution or by its agents is reviewed by an IRB at another Institution (reviewing IRB), the ORSIRB will follow established policies and procedures that specify which studies are eligible for reliance, how reliance is determined, and will provide information to researchers about reliance criteria and the process for seeking IRB reliance. The reviewing IRB must have a Federalwide Assurance of Compliance.

This institution will comply with the determinations of the reviewing IRB and follow reporting and conflict of interest disclosure requirements as specified in the reliance agreement which may include:

• conducting monitoring,
• identifying an appropriate contact person,
• ensuring researchers have appropriate qualifications which may include tracking training, and
• providing local context information (and any updates) to the reviewing IRB.