Fees

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

The following fee schedule is applicable 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

The following fee schedule is applicable 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

The following fee schedule is applicable 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
Continuing 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 studies supported by industry to conduct the study, such as pharmaceutical firms and other for-profit entities that are submitted to the UTHSC IRB. In the case of industry support that is limited to solely supplying the biologic/drug/device, but not the conduct of the study, there will not be an IRB fee.

The IRB does  not charge IRB review fee(s) for federal, foundation, investigator-initiated, or university/medical center-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,  subjects are never enrolled, or the study is terminated before objectives are reached. However, if the contract is not executed and the researcher never receives the funds, then the researcher is not expected to pay the IRB review fee.

IRB Review Fee Invoice and Collections Process

Invoices for the IRB review fee are generated by the IRB staff, addressed to the industry sponsor, 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 when UTHSC holds the contract, or to the outside organization/institution when appropriate. Each invoice issued by the IRB is tied to a specific research study submission form in iMedRIS, the IRB electronic system. The IRB cannot access the invoice template in iMedRIS until a UTHSC IRB Form 1: Study/Project Application, Form 2: Change Request and Amendment, Form 3: Continuing Review, or Documents from Reviewing IRB is submitted to the UTHSC IRB via iMedRIS.

Invoices are due and payable upon receipt. Should there be a delay in payment of the IRB review fee, the IRB staff may 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: 

• Industry sponsor or CRO may send a check directly to the UTHSC IRB office; or
• Industry sponsor may make their payment to UTHSC and the check may be received by the UTHSC Finance and Operations.  It is then the responsibility of the Principal Investigator and/or Business Manager to verify that the appropriate amount has been transferred to the UTHSC IRB account; or
• Industry sponsor may make their payment to UTHSC and the check may be received by the UTHSC Office of Sponsored Programs, who in turn will deposit the check directly to the Principal Investigator’s department account.  It is then the responsibility of the Principal Investigator and/or Business Manager to verify that the appropriate amount has been transferred to the UTHSC IRB; or
• Invoices may be paid via journal voucher within the UT financial system, IRIS/DASH. The transfer is approved by the Office for the Vice Chancellor 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, G/L Code: I071300010-813100. A copy of the approved transfer is forwarded to the IRB by the Office for the Vice Chancellor of Research, to be uploaded to the iMedRIS study record, and receipt of payment is noted in the invoice module of iMedRIS. The Office for the Vice Chancellor of Research reconciles the IRB expense and income ledgers.

For industry-sponsored research studies where an outside organization/institution holds (or will hold) the contract with the industry sponsor: 

• Industry sponsor or CRO may send a check directly to the UTHSC IRB office; or
• The outside organization/institution may 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, researchers may email the Associate Director or Director 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 or Director 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 or Director at 901.448.4824
• The facilitation of a clinical trial - contact the Office of Sponsored Programs at 901.448.5587
• External funding for research and other sponsored projects – contact the Office of Sponsored Programs at 901.448.5571