|UTGSM IRB Review:||Fee|
|Full Board Initial Review||$3,000|
|Expedited Initial Review||$2,000|
|Exempt Initial Review||$1,000|
|Revisions Initiated by the Sponsor||$1,000|
|UTGSM IRB Administrative Review of External IRB Submissions||Fee|
|Revisions Initiated by the Sponsor||$500|
Refer to the below table for IRB fees for industry-sponsored studies submitted before January 1, 2018.
|IRB Review Category||Fee|
|Full Board Review*||$2,400|
Revisions - Major Changes*
|Revisions - Minor changes*
|Recruitment Materials||No charge|
|Adverse Events||No charge|
*Appropriateness of review category determined by the IRB office
The fees above apply only to trials supported by pharmaceutical firms and other for-profit entities that are submitted to the UTGSM IRB. There will continue to be no charge for investigator-initiated, or university-supported research. There will continue to be no charge for federal or foundation supported research unless an IRB fee is included in the budget by a granting agency.
Budget and Sponsor Information
All investigators submitting industry-sponsored research protocols to the IRB should incorporate the appropriate IRB fees into their study budget. Further, because fees are subject to change in the future, this should be accounted for in budget planning. Fees are reviewed annually and are subject to change.
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/CRO, even if the IRB does not approve the study, the contract is not executed, subjects are never enrolled, or the study is terminated before objectives are reached.
IRB Review Fee Invoice and Collections Process
Invoices for the IRB review fee are generated by the IRB staff and submitted to the Study Contact(s) once the research application has been submitted to the IRB for review. It is the responsibility of the Principal Investigator to forward the invoice to the sponsor. Each invoice issued by the IRB is tied to a specific research application submitted by the PI in iMedRIS (IRB electronic system). The IRB cannot access the invoice template in iMedRIS until the PI submits a research application for review.
Invoices are due and payable upon receipt. Should there be a delay in payment of the IRB review fee, the IRB staff will issue regular reminder notices via the correspondence option in iMedRIS.
For industry-sponsored research studies where UTGSM holds (or will hold) the contract with the industry sponsor: Invoices will be paid via transfer voucher within the UT financial system, SAP/IRIS. The transfer is approved by the Business Office and by the PI's department business manager. The transfer is debited to the department expense account, and credited to the IRB recovery account. A copy of the approved transfer is forwarded to the IRB by the Business Office, to the uploaded to the iMedRIS study record, and receipt of payment is noted in the invoice module of iMedRIS. The Business Office reconciles the IRB expense and income ledgers.
The study sponsor will make their payment to UTGSM. The check will be received by the UTGSM Business Office and will be deposited directly to the PI's department account.
If an application is approved prior to payment of the IRB review fee, the status of the study in iMedRIS will be listed as Approved - Awaiting Payment. Such a status will not allow researchers to submit any additional documents for IRB review until payment of the IRB review fee is received. Upon receipt of payment, the IRB staff will change the status of the study from Approved-Awaiting Payment to Approved. Under extenuating circumstances, it may be necessary for the Director or Chair of the IRB to temporarily change the status of the study prior to receipt of payment. Documentation of such a change in study status will be noted in the study record in iMedRIS so that the IRB staff may appropriately follow up with the investigator.
Waiver/Alteration of IRB Fees
The Director and/or Chair of the UTGSM IRB shall have the flexibility to alter or waive the fees for particular projects based on extenuating circumstances. Documentation of any waiver or alteration of the IRB fees(s) will be noted in the study record in iMedRIS.