External IRB Review Overview

A Reliance Agreement, also referred to as an IRB Authorization Agreement, allows the IRB of one institution to rely on the IRB of another institution for review of human subjects research. The scope of the reliance agreement may be limited to a specific protocol or to any protocol agreed upon by both parties on a case-by-case basis.

UMMC requirements

Before the study may begin

• Obtain approval from the external IRB.
• Submit an abbreviated application to the Human Research Office through the electronic submission system. This will ensure that all institutional requirements are satisfied.*
• A UMMC reliance approval letter will be sent to you, permitting the research to begin.

* Studies that require Radiation Safety (RSC), Biosafety and Embryonic Stem Cell (ESCRO) review will continue to submit to UMMC's RSC, Biosafety, and ESCRO. The committee determination letters will be submitted with the abbreviated application.

After the study begins

All modifications (including personnel changes), renewals, incident reports, and study closures must be submitted first to the external IRB for approval. Once approved by the external IRB, an abbreviated application for the approved amendment, continuing review, and study closure submission can be submitted to the Human Research Office through the electronic submission system. UMMC’s IRB requires that a study closure be submitted in the electronic submission system for record-keeping purposes even if the reviewing, external IRB does not accept final reports.