IRB Review Fees

IRB Review Fees

The University of Minnesota IRB has established the following IRB review fees to cover the costs associated with the conduct of IRB review and regulatory oversight:

  • IRB Fees for the Review of Business and Industry sponsored research
  • IRB Fees for the University of Minnesota IRB serving as the single IRB (sIRB)
  • IRB Fees for non-federally funded human research seeking reliance on an external IRB
  • IRB Fees for Gillette and Fairview

Fee-eligible studies will not be granted initial approval or permission to rely on an external IRB until the billing information has been provided to the IRB office.

Can an IRB Fee be waived?
Under extenuating circumstances, and with appropriate documentation to support such circumstances, you may request a fee waiver from the HRPP Executive Director. Requests to waive an IRB fee must be submitted and approved by the Executive Director of the Human Research Protection Program.

What types of studies are excluded from IRB fees?

  • Unfunded/department funded investigator-initiated studies
  • Single-patient expanded access reviews
  • Non-federally funded research (e.g. foundation/non-profit/internal grants) where UMN IRB will not serve as the IRB of record of other institutions/organizations.
  • Unfunded research with a student Principal Investigator (PI)
  • State funded (not associated with federal dollars)

What are the submission requirements for fee-eligible studies?

  • Ensure all funding sources for your research are included in the funding section of your ETHOS submission at the time of submission.
  • A completed HRP-537 Form Business and Industry Funded Study Fee must be uploaded in the documents section of ETHOS when you submit your application. For studies conducted by UMN Investigators, this form must include the chartstring that will be used to pay the fee. A reference guide to chartstrings is available as well as additional information on the Controller’s Office website.
  • If your study appears to be fee eligible and a completed HRP-537 Form. If the HRP-537 Business and Industry Funded Study Fee document is not included in your application, the IRB will request it.

Why Must Fees Be Increased or Added at This Time?
The shifting regulatory landscape necessitates adaptation to maintain financial stability. The IRB’s current fee structure does not sufficiently cover the escalating operating expenses involved in carrying out IRB reviews. Additionally, there is an increased interest to have the University of Minnesota IRB serve as the IRB of record for multi-site/collaborative research. The IRB office has been managing select federally funded sIRB submissions at no cost to the study team. We are unable to expand services to meet this growing need without aligning staffing. New and increased fees allow us to appropriately resource the IRB to meet our community’s needs.
 

More Information About IRB Review Fees

Expand all

IRB Fees for the Review of Business and Industry

The University of Minnesota assesses a fee for review of business and industry sponsored clinical trials whether reviewed by the UMN IRB or by an external IRB. This is a one-time fee that covers initial and ongoing review. The IRB fee should be included in contract negotiations, including initial review, whether the study contract is finalized or not. It should be a line item in the budget of the formal contract as an upfront and non-refundable item.

Effective September 1, 2026: 
Fee for review by University of Minnesota’s IRB: $3,500

This B&I fee will be applied to all new studies that meet all three criteria below:

  • Business/industry sponsored
  • Biomedical research study
  • Requires full IRB committee review
     

IRB Fees for human research seeking reliance on an external IRB

Any study eligible for reliance on an external IRB that is not federally funded, will be assessed a one-time reliance fee of $2400. This includes:

  • Business and Industry sponsored human research, regardless of the level of review (Effective December 1, 2026)
  • Non-federally funded human research (e.g. department funded, internal grant) (Effective January 1, 2027)
     

IRB Fees for UMN serving as the Single IRB - Effective January 1, 2027

To cover the costs associated with serving as the single IRB (sIRB), starting on January 1, 2027, the University of Minnesota will assess an sIRB fee for the review of federally funded non-exempt human research studies where the University of Minnesota IRB has agreed to serve as the single IRB (sIRB):

Fee for sIRB service: $1500 per participating site*

This fee will be required for new or competing grants or contracts submitted on or after January 1, 2027. Ongoing, noncompeting awards will not be expected to comply with the policy until a competing renewal application is submitted. In addition, the fee will be prompted for any request for UMN IRB to serve as the sIRB, in order to prepare for this transition.

*This is a flat rate fee per site and the total cost is based on the number of participating sites where UMN IRB has agreed to serve as the sIRB.

sIRB Fee Exclusions:

  • Studies not subject to the sIRB mandate
  • sIRB studies submitted before January 1, 2027, will not be subject to the sIRB fee.
  • A fee waiver may be approved by the Executive Director during this period of transition.
     

NIH Grant Budgeting Resources

NIH-funded Research

The UMN sIRB fees must be budgeted as direct costs in the funding proposal. NIH is expecting this and has provided detailed information at the sIRB FAQ and a specific costs guidance document, including topics such as:

If you have questions, contact:

  • The NIH financial officer identified in your FOA or RFP and/or
  • Your department’s contact person at the Sponsored Projects Administration (SPA)

Will the University serve as the sIRB for non-federally funded research?
Not at this time. However, there is a plan in progress to allow for this service with an expectation of a process to be released in Summer 2027, that will include the same sIRB fee for service:

IRB Fees for Central IRB Studies - Effective July 1, 2027
If the University of Minnesota IRB has agreed to serve as a central IRB (single IRB of record) for non-federally funded multi-site or collaborative non-exempt human research:
Fee for sIRB service: $1500 per participating site*

Review Fee for Studies from Fairview or Gillette Investigators

The University IRB acts as the IRB for Fairview Health Systems and Gillette Children’s Specialty Healthcare. A negotiated fee for review of studies is paid by Fairview and Gillette.