Effective July 1, 2026, UNC-Chapel Hill IRB review fees will apply to certain studies as outlined below.

Studies Subject to IRB Fees

IRB review fees will be assessed for:

1. Studies administered by the Clinical Research Partners (CRP)

• The University’s comprehensive administrative activation fee model will no longer apply to these studies.
• As a result, IRB review costs will be charged separately.
• Reduced fees will apply for studies that rely on an external IRB.

2. Studies where UNC-CH IRB serves as the Single IRB (sIRB)

• Fees will apply when UNC-CH provides IRB oversight for external (non-UNC) sites.

Studies Not Subject to IRB Fees

IRB review fees will not be charged when ALL of the following conditions are met:

• UNC-CH is conducting only local site review, and
• The study does not receive funding from a for-profit entity, and
• The study falls into one of the following categories:
  • Federally funded research
  • Research funded by another academic institution
  • Investigator-initiated research

In addition:

Non-federally funded interventional studies administered directly by the University (not through CRP) will not incur separate IRB review fees, as they will continue to be covered under the University’s comprehensive administrative activation fee model, consistent with current practice.

1. UNC-CH IRB will not always agree to provide Single IRB services for multi-center studies.

Approval for UNC-CH IRB to be the sIRB of record are limited and granted on a case-by-case basis.

* The following scenarios are not generally considered to be a good fit for the UNC-CH IRB to serve as sIRB:

• Industry sponsored drug and device trials;
• Federally funded studies if UNC-CH is not the lead site, coordinating center, or primary contributor to the project;
• Studies with a large number of sites (greater than 6);
• Studies with complex designs and procedures;
• Studies on topics that have conflicting state laws within the United States, if the sites are in different states;
• Studies that have international sites.

Please contact [email protected] for questions or resources regarding Single IRB services.

2. IRB fees are non-negotiable and non-refundable.

Fees are due in full even if the IRB does not approve the study, subjects are never enrolled, a research contract or Clinical Trial Agreement (CTA) is never executed, or the study is terminated before objectives are achieved. Fees will be charged at prevailing rates; they are not locked for the duration of a study.  Fee includes review of all research associated documents (protocol, consent forms, recruitment materials, IB, etc.).

All budgets that are negotiated for industry funded studies must include the following four line items for IRB fees:

• Initial,
• Continuing Review(s) (with the number of reviews being based off the proposed duration of the protocol), and
• Modification(s) (which should be captured as invoiced per occurrence), and
• Closure

3. “External IRB” means a non UNC-CH IRB.

This generally refers to commercial IRBs, such as WCG, Advarra, Sterling, but could refer to another external IRB. Industry sponsors are expected to pay IRB review fees to such External IRBs directly.

4. Includes the HRPP review for compliance with institutional requirements for human subjects research and to provide any necessary applicable local considerations to the External IRB.

Charged at the time of initial local review only. IRB Fees charged by the External IRB are not included in the above and will be subject to the charges imposed by the respective External IRB. 

5. This fee schedule is based on comparable rates.

From Duke Health, Indiana University, Tulane, Georgetown, Johns Hopkins, Yale, and University of Pennsylvania.

6. To ensure overall efficiency, each department is required to specify a non-sponsored account for billing of IRB review fees.

All IRB review fees for principal investigators in that department will be billed against that account until it is determined that a study specific project number has been assigned to the reviewed study.