Fees

The below fees are subject to change in the future; 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 above fees apply only to studies supported by industry, such as pharmaceutical firms and other for-profit entities. No IRB fee is charged when industry support is limited to supplying the biologic, drug, or device only (not funding the study's conduct). IRB review fees also do not apply to federal, foundation, investigator-initiated, or university/medical center-supported research.

Budget and Sponsor Information

Investigators submitting industry-sponsored research should include IRB fees in their study budget, accounting for potential future fee changes.

IRB fees are the sponsor's contractual responsibility and reflect the actual costs of protocol review. Because the IRB commits full resources to every review, fees are due in full — even if the study is not approved, no subjects are enrolled, or the study ends early. The only exception is if the contract is never executed and the researcher does not receive funding, in which case the IRB review fee is waived.

IRB Review Fee Invoice and Collections Process

Once a research application is submitted, IRB staff will generate an invoice addressed to the industry sponsor and send it to the study contact/s. The Principal Investigator is responsible for forwarding the invoice to the sponsor (if UTHSC holds the contract) or to the appropriate outside organization/institution. Each invoice issued by the IRB is tied to a specific study submission form in DASH Research IRB, the IRB electronic system. 

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.

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 sponsors may submit payment to UTHSC Finance and Operations. The Principal Investigator and/or business manager is then responsible for verifying that the correct amount has been transferred to the UTHSC IRB account; or
• Industry sponsors may submit payment to the UTHSC Office of Sponsored Programs, which will deposit the funds directly into the Principal Investigator's department account. The Principal Investigator and/or business manager is then responsible for verifying that the correct amount has been transferred to the UTHSC IRB; or
• Invoices may be paid via journal voucher within the UT financial system, DASH. 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, G/L Code: 70-1100001-702603-430000-000-A001.  A copy of the transfer is forwarded to the IRB by the Office for the Vice Chancellor of Research, to be uploaded in IRB Invoice Records. The Office 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 will be listed as “Approved – Awaiting Payment.” Researchers will not be able to submit any additional documents for IRB review until payment of the IRB review fee is received. Upon payment receipt, the status of the study will be changed from “Approved – Awaiting Payment” to “Approved”. In extenuating circumstances, researchers may email the Associate Director or Director of the IRB to temporarily change the status of the study prior to receipt of payment. 

Waiver/Alteration of IRB Fees

The Associate Director or Director of the UTHSC IRB has the flexibility to alter or waive fees for particular projects based on extenuating circumstances. Documentation of any waiver/alteration of IRB fee/s will be noted in the study record.

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