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Fees

Please note that the fees stated below are subject to change in the future; therefore, this should be accounted for in budget planning.

Refer to the table below for IRB fees for new industry-sponsored studies and their associated submissions, effective January 1, 2018, when the UTHSC IRB is the REVIEWING IRB:

UTHSC IRB Review: Fee
Full Board Initial Review $3,000
Expedited Initial Review $2,000
Exempt Initial Review $1,000
Continuing Reviews $1,000
Revisions Initiated by the Sponsor $1,000

Refer to the table below for IRB fees for new industry-sponsored studies and their associated submissions, effective January 1, 2018, when there is an IRB Authorization (or reliance) Agreement and UTHSC IRB is the RELYING IRB:

UTHSC IRB Administrative Review of External IRB Submissions Fee
Initial Review $1,500
Continuing Reviews $500
Revisions Initiated by the Sponsor

$500

Refer to the table below for IRB fees for industry-sponsored studies that were submitted to the UTHSC IRB BEFORE January 1, 2018:

IRB Review Category Fee
Full Board Review* $2,400
Expedited Review* $1,200
Exempt Status* $500
Annual Reviews $500
Revisions - Major Changes*
(full board review)
$500
Revisions - Minor changes*
(expedited review)
No charge
Recruitment Materials No charge
Adverse Events

No charge

*Appropriateness of review category determined by the IRB office

Applicability

The fees above apply only to trials supported by pharmaceutical firms and other for-profit entities that are submitted to the UTHSC IRB. There will continue to be no charge for federal, foundation, investigator-initiated, or university-supported research.

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.

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 UTHSC 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 Office of Research 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 Office of Research, to be uploaded to the iMedRIS study record, and receipt of payment is noted in the invoice module of iMedRIS. The Office of Research reconciles the IRB expense and income ledgers.

The study sponsor will make their payment to UTHSC. The check will be received by the UTHSC Office of Sponsored Programs and will be deposited directly to the PI’s department account.  

For industry-sponsored research studies where Methodist Healthcare or Le Bonheur Children’s Hospital holds (or will hold) the contract with the industry sponsor: Methodist Healthcare or Le Bonheur Children’s Hospital will issue the UTHSC IRB a check for IRB fees at the IRB’s address (Institutional Review Board, 910 Madison Ave., Ste. 600, Memphis, TN 38163). Each institution is responsible for recovering those IRB fees from the industry sponsor.

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 circumstance, it may be necessary for the Associate Director, Director, or the 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 Associate Director, Director, and/or Chair of the UTHSC 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 fee(s) will be noted in the study record in iMedRIS.

Contacts

For questions regarding:

  • IRB review, fee invoicing, and assessment - contact the IRB Associate Director, Director, or Chair at (901) 448-4824
  • For the facilitation of a clinical trial - contact Elaine Todd, JD at (901) 448-3303
  • External funding for research and other sponsored projects – contact the Office of Sponsored Programs at (901) 448-5571

Last Published: May 21, 2018