Institutional Review Board (IRB) Review Fee Policy
The University of Texas Southwestern Medical Center charges an IRB review fee of $3,000 for full-board initial review of all industry-initiated clinical studies and $1,500 for the full-board continuing review of those studies. Expedited reviews are charged $1,000 for the initial review and $500 for continuing reviews.
These fees are applied only to those studies that have been developed and prepared by an industry or corporate sponsor.
There is no charge for IRB review of studies developed by University investigators, government-funded studies, or studies sponsored by not-for-profit organizations. In addition, these fees will not be charged for applications involving non-research use of a Humanitarian Use Device or for single cases involving emergency use or expanded access of an investigational drug or device.
The IRB uses these fees to:
- Offset some of the costs associated with increasing regulatory requirements;
- Appropriately allocate and recognize the total costs of clinical trials; and
- Provide continuing education and training to IRB members and investigators with respect to federal regulations and ethical guidelines for conducting human research.
These costs are an essential part of the budget, but are not included as part of the “per-patient” costs. Rather, these fees should be included as a separate non-refundable, line item when calculating the study initiation fees for the study budget. It should appear as a flat fee and should be excluded from the calculation of indirect costs (i.e. when calculating indirect costs, do not include the IRB fee in the Total Direct Costs).
Billing and Payment Procedure
The Office of Clinical Research Facilitation (OCRF) will invoice the sponsor upon contract execution for initial review fees and at the time of IRB continuing review for renewal fees. Study accounts will be assessed these fees at the initial award set-up and after the continuing review has been submitted. All payments received by the sponsor will be deposited to the University clearing account and credited to the study account.
Lockbox Addresses for Receipt of Checks
UT Southwestern Clinical Trials
P.O. Box 842265
Dallas, TX 75284-2265
FedEx or Other Courier
Bank of America
Attn: Lockbox #842265
1950 N. Stemmons Fwy
Dallas, TX 75207
1-800-376-2703 (For courier airbill)
Tax ID Number
Note: Checks should be made payable to "The University of Texas Southwestern Medical Center" and should reference the Principal Investigator's name, protocol number and invoice number.