Fee for Service: Single IRB (SIRB) Review Services for Multi-Site Studies

All funded studies who wish to use the UU IRB as the Single IRB.  This includes studies with federal funding, industry funding and for-profit, foundation funding, etc. Fees are also assessed for industry-sponsored studies wishing to use an external SIRB. 

The University of Utah SIRB fee for each study is calculated based on the following factors:

• Number of years the study will be open.  The longer a study is open, the more SIRB review effort is needed. This results in a higher fee for service.

• Number of participating research sites that need SIRB review.  The more sites involved, the more SIRB review effort is needed. This results in a higher fee for service. 

• Complexity of the study design.  Complex studies require more sIRB review effort. Complex studies generally have more amendment submissions, longer consent documents, and more procedures.  This contributes to the increase in sIRB review effort and higher fee for service. 
  
  The UU IRB does not charge an itemized, per-submission fee based on the number of documents a study uses, the number of amendments submitted, or the number of continuing reviews. We charge a flat rate each year based on whether your study is interventional or non-interventional and the median amount of SIRB effort needed for such a study.  If you use more than the median amount of effort, we will not charge you more.  Additionally, we review all reportable problems and events free of charge. We charge a fee to process study closures for industry sponsored studies.

• Whether the University of Utah or its Affiliate Institutions are participating sites in the study.  If the University of Utah or one of its Affiliate Institutions is a participating site in the study, we will waive a portion of the SIRB review fee for federally-funded research.  Because the University of Utah continues to cover a portion of the IRB review costs as part of the indirect rate, we will reduce the amount billed as a direct cost to an award. 

Reliance Consultation & Confirmation Services

• Basic reliance agreement negotiation with each site
• Communication and coordination with the Human Research Programs (HRPs) at each site
• Reliance documentation procurement

 Initial SIRB Review

• Overall protocol and supporting documents review
• Generic and site-specific informed consent review (unlimited number of documents)
• Recruitment material review (unlimited number of documents)
• Site-specific community and institutional considerations

 Ongoing SIRB Review

• Amendment reviews (unlimited number of amendments)
• Continuing/Annual reviews
• Reportable problem and event reviews
• Individual site and overall study closure

Here is what the SIRB Review Fee does not cover:

• Pre-IND/IDE Compliance Reviews for Sponsor-Investigators - $250
  The UU IRB can provide this compliance review before an investigational drug or device study begins, to ensure that the Sponsor-Investigator is prepared to meet all of the FDA requirements.  This can generally be completed remotely and does not require travel costs. 
  
  
• Regulatory Audits - $1,000 per day + travel
  The UU IRB can provide comprehensive regulatory audit services through our quality and compliance team. 
  
  
• Complex Reliance Agreement Negotiation - $1,000
  There are several, known reliance agreements that are used nationally that we cover in our standard SIRB review fee.  However, if a different reliance agreement needs to be negotiated, an additional fee is charged.   

Invoices are sent by the ERICA system via email directly to the Responsible Investigator for the project, including that investigator's contacts listed in the ERICA application. Individual invoices are not sent to each participating site investigator. It is expected that the Responsible Investigator will coordinate payment of the fees, whether the fee is paid as a direct cost on the primary award or from a subcontract.  

An initial payment is required to initiate the SIRB Review Services for the new study.  After a study is approved, an annual fee is assessed for the lifetime of the study to cover services provided in the previous year.  All payments can be initiated upon receipt of the initial or annual invoices. 

We charge Single IRB Review fees to cover the costs of IRB review for external study sites of funded studies that choose the University of Utah IRB to cover their IRB review needs.  The fee covers the extra work the University of Utah IRB performs to review and oversee research with human subjects at an external site.

Yes, but this decision must be made in the pre-award process, and we will need to discuss this request with investigators prior to submitting a proposal. You may request a fee waiver by submitting the Fee Waiver Request form on the IRB website.

Yes. We offer consultations during the pre-award period and the study team can request a Single IRB fee quote for use in building their budget. For more information about the University of Utah’s Single IRB Review process and the required costs, please visit our website at the links below.