Reliance refers to an arrangement where an IRB allows another IRB to perform review and approval of a study.
The UNMC IRB uses the term “single IRB” or “sIRB” to indicate that UNMC is serving as the reviewing IRB (i.e., the IRB of record) of a multisite study.
A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate IRB review to another IRB. This document generally outlines the responsibility of the single IRB and the participating site. Often the reliance agreement is accompanied by addenda or other forms that are designed to further clarify responsibilities or collect pSite local context information.
Reliance agreements come in many formats. They may also be called:
- IRB Authorization Agreement (IAA)
- “Cooperative,” “Network,” or “Master” Agreement
- Reliance Memorandum of Understanding (MoU)
- Institutional Investigator Agreement (IIA)
- Letter of Acknowledgement, “Cede” Letter
UNMC is a SMART IRB participating site and strongly prefers to document reliance using the SMART IRB Online Reliance System (SMART IRB ORS). In addition, we ask that sites complete the SMART IRB Implementation Checklist. This will be provided during the reliance negotiation.
Note: SMART IRB is not an IRB, but a tool that IRBs use to document reliance.
Note: The UNMC sIRB Team has elected to initiate and maintain requests in the SMART IRB ORS, rather than have the lead site investigator or study team create requests. Please contact email@example.com with questions.
If a site is not a SMART IRB participating institution, other reliance formats will be made available for use during the reliance negotiation.
The term reliance negotiation refers to the process of the reviewing and relying IRB representatives communicating and agreeing to the reliance agreement format and terms. The UNMC sIRB Team will initiate the negotiation during the pSite Onboarding stage of review.