Reliance Agreements

A reliance agreement may be required when you are collaborating with researchers external to UNC who are engaged in non-exempt human subjects research.

Due to recent changes in the request process, the Reliance Team is revising the guidance on reliance agreement requests. New guidance will be published soon.

Questions regarding reliance agreements, please email IRBreliance@unc.edu.

Reliance Documents for Collaborations with Organizations or Institutions

These are samples of the forms the IRB uses to document reliance arrangements. The UNC Reliance Team will be responsible for preparing these forms when specific reliance requests are made. They are provided here for informational purposes, and should not be completed by the study team unless during consultation with the Reliance Team.

• UNC’s IRB Authorization Agreement (IAA) template may be used when both parties have a Federal Wide Assurance (FWA).
• Smart IRB Authorization Agreement may be used when both parties have an FWA and are Smart IRB Participating Institutions.
• Smart IRB Letter of Acknowledgement (LOA) may be used to document a Smart IRB reliance arrangement (alternative to the online reliance system)
• Dear Investigator Letter is an example of a letter that UNC study teams may modify and used to initiate a conversation with a site intending to rely on the UNC IRB
• Local Context Worksheet will be requested of external sites relying on the UNC IRB in order to provide local context information.
• UNC Individual Investigator Agreement (IIA Institutional) is used when the external group or organization does NOT have a Federal Wide Assurance (FWA)
• Single IRB review Letter of Support – UNC Reviewing IRB (LOS) may be included in an application for research funding when single IRB review is anticipated and UNC is the Reviewing IRB. Requests for a Letter of Support should be emailed to IRBReliance@unc.edu
• Single IRB review Letter of Support – UNC ceding review to external IRB (LOS) may be included in an application for research funding when single IRB review is anticipated and UNC is ceding the review to an external IRB. Requests for a Letter of Support should be emailed to IRBReliance@unc.edu
• Amendment to IRB Authorization Agreement form may be used to document revisions to previously executed reliance agreements, such as a title change or change in PI at a participating site, or revisions to the terms of the agreement previously executed.

Reliance Documents for Collaborating Individuals

These forms are fillable pdf’s and may be used by the research team.

• UNC Individual Investigator Agreement (IIA Individual) is used when an Independent Investigator will be covered by the UNC IRB.
• Independent Investigator Confirmation Form is required of all Independent Investigators.

Requesting Reliance on a Commercial IRB

UNC allows investigators to utilize a commercial IRB for industry-sponsored, multi-center, clinical research studies for which one of the following approved commercial IRBs have been appointed as the commercial IRB by the Sponsor or CRO and the commercial IRB has already approved the study.

• WIRB-Copernicus
• Advarra (created by merger of Chesapeake IRB and Schulman IRB in 2017; Advarra acquired Quorum IRB in 2019)
• Sterling

This Commercial IRB Cover Page will be completed by the IRB staff and uploaded to the initial submission in IRBIS. The commercial IRB will not review UNCs involvement without this cover page.

The Commercial IRB Checklist can be used by study teams to assist in drafting and submitting a request to rely on a commercial IRB.