Fees Schedule

Fee Schedule 3: For studies submitted on or after July 1, 2016

Type of Application

Payment by Check

Payment by Campus Order*

New Studies

$2,315.00

$1,696.00

Continuing Review (Renewal)

$823.00

$603.00

Sponsor Initiated Amendment

$823.00

$603.00

Continuing Review + Amendment

$1,646.00

$1,206.00

*Accounting will charge the F&A according to your negotiated rate.

Fee Schedule 2: For studies submitted between November 1, 2012 and June 30, 2016**

Type of Application

Payment by Check

Payment by Campus Order*

New Studies

$2,250.00

$1,696.00

Continuing Review (Renewal)

$800.00

$603.00

Sponsor Initiated Amendment

$800.00

$603.00

Continuing Review + Amendment

$1,600.00

$1,206.00

*Accounting will charge the F&A according to your negotiated rate.
**Studies originally submitted to the IRB between November 1, 2012 and before July 1, 2016 will be charged according to Fee Schedule 2 for the duration of the study.

Fee Schedule 1: For studies submitted on or before October 31, 2012**

Type of Application

Payment by Check

Payment by Campus Order*

New Studies

$1,600.00

$1,206.00

Continuing Review (Renewal)

$575.00

$434.00

Sponsor Initiated Amendment

$575.00

$434.00

Continuing Review + Amendment

$1,150.00

$867.00

*Accounting will charge the F&A according to your negotiated rate.
**Studies originally submitted to the IRB on or before October 31, 2016 will be charged according to Fee Schedule 1 for the duration of the study.

 

Fee Procedure

Effective September 7, 2004, the University of Utah Institutional Review Board (IRB) began charging fees for all industry-sponsored study submissions. These fees are subject to the University indirect cost rate. Continuing review fees are assessed annually until a Final Project Report is submitted to close the study.

The IRB considers a study industry-sponsored when a commercial entity contributes to the design or conduct of the study (as evidenced by a sponsor’s protocol, investigator brochure, etc.), coordinates the study as a multicenter trial, reimburses the university or a university investigator to costs associated with conducting the trial, or will have access to, will publish, or will present the data gained from conducting the trial.

All initial study submissions to the IRB must identify the funding sources supporting the proposed research, including whether there is current or planned support from an industry sponsor. When an IRB submission is received and is not designated as industry-sponsored, but is later determined by the IRB to be industry-sponsored, appropriate IRB fees will be assessed.

Payment of IRB fees is regarded as a contractual responsibility of the sponsor. The fees are assessments of actual costs associated with protocol review by the IRB and are charged for services rendered. Because the IRB commits its full resources to each review, the fees are due in full from the sponsor, even if the IRB does not approve the study, subjects are never enrolled, expenditures exceed revenue, a contract is never finalized, or the study is terminated before objectives are reached. If there is uncertainty as to whether or not the contract will be finalized or the trial will actually go forward, sponsors may wish to delay incurring these charges until all plans are final.

Fees should only be submitted to the IRB after the study team receives an invoice via the ERICA system. If no ERICA invoice exists in relation to a check or campus order received by the IRB, it will be destroyed after 30 days.

New Studies

Fees for New Study Applications are due in full before the pre-review process begins. Pre-review will not begin until the fee has been received.

If a sponsor amendment is added to a new study during the pre-review process, the amendment fee will be charged in addition to the new study application fee, which is charged when the application is initially submitted. The amendment fee will be required prior to final processing.

Continuing Reviews

Fees for Continuing Reviews are due in full prior to final processing. Final approval will not be given until the fee has been received.

If a sponsor amendment is included with a continuing review application, the amendment fee will be charged in addition to the continuing review fee.

Amendments

Fees for sponsor-initiated amendments are due in full prior to final processing. Final approval will not be given until the fee has been received. Fees are charged for both expedited and full board amendments.

Fee Appeals

Fee appeals will be considered on a case-by-case basis for extenuating circumstances. Fee appeals must be submitted by the principal investigator via email to the IRB Director. The request should contain the following information:

  • A summary of the study objectives and procedures; and
  • The study budget summary; and
  • Justification for the waiver of the fee for IRB review.