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.

The New SMART IRB Reliance Agreement Version 3 – What to Know

SMART IRB* has updated their reliance agreement to version 3. It “goes live” on March 17, 2025. What does this mean for reliance studies using the SMART IRB reliance agreement?

When UNC is the IRB of Record for External Sites:

• If the SMART IRB reliance agreements were signed using versions 1 or 2 before March 17, 2025, and external sites are relying on UNC for single IRB review, there’s no need to switch to version 3 unless new sites join the study.
• For new studies starting after March 17, 2025, where external sites rely on UNC for single IRB review, UNC and all relying sites must use version 3 of the SMART IRB reliance agreement.

When UNC is Relying on an External IRB as the IRB of Record:

• If the SMART IRB reliance agreement was signed using version 1 or 2 before March 17, 2025, the external IRB of record will decide if they need to switch to version 3.
• For any new reliance on an external IRB after March 17, 2025, for which the IRB of Record requests that the agreement be executed via the SMART IRB agreement, all sites must use version 3.

This is for SMART IRB reliance agreements only. The UNC Reliance Team will contact you if your study requires action. Please reach out if you have any questions (IRBreliance@unc.edu).

*SMART IRB is a type of reliance agreement, not an IRB.

Median Turnaround Times for Rely On Study Reviews (Jan 2024-Dec 2024)

Rely On Review: 71 days
IRB Review: 20 days
PI Review: 51 days

Updated 3/20/2025

Review Criteria for Reliance 

As requests for reliance increase, we want to remind the research community of the criteria OHRE uses when considering if UNC will serve as the IRB of record for external sites or if UNC will rely on an external IRB. Decisions to enter into reliance agreements are based heavily on the criteria below. If a request does not meet the criteria below, UNC may request additional rationales and/or information related to the reliance request. This allows UNC to provide the best possible review, in the most efficient manner, for those studies that regulatorily require single IRB review. 

For UNC to serve as the single IRB (sIRB) for external sites, the Reliance Team will ask: 

• Is the study federally funded (requiring sIRB review)? 

• Is the study non-exempt human subjects research? 

• What is the risk of the study? 

• How many sites are requesting to rely on UNC IRB? 

• Where are the sites located (are any international)? 

• Does each site’s involvement meet the definition of engaged in human subjects research by meeting at least one of the following: 

• Prime on a federal award for a human subjects research study 

• Directly interacting with participants for research purposes 

• Accessing, receiving, using identifiable private information for research purposes 

• Do the sites hold Federalwide Assurances (FWAs)? 

• Are the sites AAHRPP accredited? 

• Do the sites have HRPP/Reliance policies? 

• What is each site’s involvement in the conduct of the study (i.e., are they enrolling participants, are they involved in data analyses, etc.)? 

Contact the Reliance Team as soon as possible to discuss requests for UNC to serve as the sIRB. This can be as early as the grant writing stage. Having these conversations will help make a more efficient review later in the process.  

When requesting UNC to serve as IRB of record for external sites, complete the Intake Form in IRBIS. (Video instructions for completing the form).

Please answer all questions thoroughly and accurately. Unanswered questions and incorrect/incomplete information will prolong the process. 

When there is a request to rely on an institutional external IRB, the Reliance Team will ask: 

• Is the study federally funded (requiring sIRB review)? 

• Does UNC’s involvement meet the definition of engaged in human subjects research by meeting at least one of the following: 

• Prime on a federal award for a human subjects research study 

• Directly interacting with participants for research purposes 

• Accessing, receiving, using identifiable private information for research purposes 

• Is the study non-exempt human subjects research? 

• Is UNC prime on a federal award? 

• Where is the IRB/institution located (is it outside of the U.S.)? 

• Does the institution hold an FWA? 

• Is the institution AAHRPP accredited? 

Please reach out to the team at IRBReliance@unc.edu any time you have a question! 

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.

New Reliance Intake Form in IRBIS

The new form helps Reliance staff decide whether UNC can and will agree to serve as the IRB of record for external sites. This video will show you where to find the intake form in IRBIS, how to complete it correctly, and submit it to OHRE. Published 7/5/2024.

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