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 [email protected].
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 Documents Checklist can be used by study teams to assist in drafting and submitting a request to rely on a commercial IRB.
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 siteโs 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 siteโs 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 UNCโs 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 [email protected] 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-Chapel Hill Single IRB (sIRB) Reliance Request Intake Form
- UNCโs 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.
- Single IRB review Letter of Support โ 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 [email protected]
- Single IRB review Letter of Support โ 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 [email protected]
- 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 pdfโs 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.
Median Turnaround Times for Rely On Study Reviews (Jan 2025-Dec 2025)
Rely On Review: 72 days
IRB Court: 6 days
PI Court: 66 days
Updated 06/02/2025
The New โCompoundโ Informed Consent Document Incorporating HIPAA Authorization: When Can it be Used for Reliance Studies, and When Canโt it be Used?
Studies Relying on an External IRB
WCG, Advarra, and Sterling IRBs: Use of a compound consent form that includes HIPAA Authorization is not permitted at this time.
Other Commercial IRBs: Use of a compound consent form will be evaluated on a case-by-case basis, taking into consideration:
- Requirements of the IRB of Record
- Terms of the executed reliance agreement for the study
Institutional IRBs
Use of a compound consent form will be evaluated on a case-by-case basis, taking into consideration:
- Requirements of the IRB of Record
- Terms of the executed reliance agreement for the study
Studies for Which External Sites Are Relying on the UNC-CH IRB
UNC may use a compound informed consent document that includes HIPAA Authorization for UNC only. All external relying sites must use a standalone HIPAA Authorization document, as the relying institution typically retains Privacy Board/HIPAA responsibilities.
Use of UNC Consent Forms as Templates for Relying Sites
If UNC uses a compound consent form and shares the approved consent document with relying sites as a template, all UNC-specific information must be removed from the relying site’s consent form, including the entire HIPAA Authorization section. 
Additional Requirements for Relying Sites
External sites should consider including the following statement in their consent forms: You will be asked to sign a separate form (“HIPAA Authorization”) to allow researchers to review your medical records.
All UNC-specific language must be replaced with relying site-specific information, including but not limited to:
- Contact information
- Subject injury language
- Confidentiality language
- Institutional references
Important Note for Currently Approved Studies
If a currently approved study with sites relying on the UNC-CH IRB, has a standalone HIPAA Authorization for UNC, the UNC study team may submit a modification to implement a compound consent/HIPAA Authorization document for UNC only.
Relying sites:
- May not transition to a compound consent/HIPAA Authorization document
- Must continue using a standalone HIPAA Authorization
Important: HIPAA responsibilities generally remain with the relying institution. Therefore, although UNC may use a compound consent form, relying sites must continue to use a separate HIPAA Authorization document.
If you have any additional questions, please see the guidance document, or contact the UNC-CH Reliance Team at [email protected].