Reliance Agreements

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

How to Request a Reliance Agreement

A reliance agreement may be required when you are collaborating with researchers external to UNC who are engaged in non-exempt human subjects research. This document, How to Request a Reliance Agreement, describes how to complete the IRBIS application to request one of the following:

• UNC provide IRB oversight for institutions, groups or organizations external to UNC
• UNC provide IRB oversight for individuals (whose collaboration is NOT on behalf of an external institution, group or organization) external to UNC
• UNC rely on an Institutional IRB
• UNC rely on an Independent/Commercial IRB
• UNC rely on the NCI CIRB

The UNC Institutional Profile

The UNC Institutional Profile contains basic information about the UNC IRB and institutional processes and requirements when reliance agreements are being considered or negotiated with collaborating sites.

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 may be requested of external sites relying on the UNC IRB in order to provide local context information. This worksheet will be required to be completed by any relying site that will be enrolling study participants locally at their site
• 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.

Reliance Presentations

Reliance Agreements – March 2020

IRB & WIRB – April 2020

• A recording of this presentation is also available: Play recording (43 mins), Recording password: uncWIRB1

UNC WCG IRB Connexus Training Slides 7/21/2021

• A recording of this presentation is available on the UNC NRP website.