An important initiative has been under way to increase the volume of clinical research studies at the University of Tennessee Health Science Center (UTHSC). In order to facilitate the process of administrative review, the Institutional Review Board (IRB) has expanded its facilities, staff and services. A critical component of the new services have involved the development of iMedRIS, the IRB electronic system. The implementation of iMedRIS has helped to reduce the review cycle and is eliminating the use of paper in the review process. To offset the additional administrative costs associated with the expansion and maintenance of this sophisticated electronic system, the UTHSC IRB revised the fee schedule for all industry sponsored study submissions requiring full board, expedited and exempt review effective July 1, 2009.
Refer to the following table for comparing previous and updated IRB fees.
IRB Review Category
Fee for Studies submitted on or after July 1, 2009
|Full Board Review*||
(full board review)
|*Appropriateness of review category determined by the IRB office|
The updated fees apply only to trials supported by pharmaceutical firms and other for-profit entities that are submitted to the UTHSC IRB on or after July 1, 2009. Research applications submitted between July 1, 2008 and June 30, 2009 will follow the appropriate fee schedule, and all research projects that were submitted on or prior to June 30, 2008 will continue to follow the fee schedule of a one-time global IRB fee. 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.
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, even if the IRB does not approve the study, 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 Principal Investigator (PI) and study coordinator (if applicable) 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.
IRB staff will issue an invoice via iMedRIS. 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.
There are two methods for processing payment of invoice to the IRB, depending on the budget terms negotiated or other circumstances: 1) Invoices can be paid by the study sponsor by check, or 2) invoices can be paid by the UT department via transfer voucher within the UT financial system, SAP/IRIS. If payment is submitted via check by the study sponsor, the check is received by the IRB Administrator; a copy of the check is uploaded to the iMedRIS study record; and receipt of payment is noted in the invoice module of iMedRIS. The check is forwarded to the Business Manager, Office of Research, for deposit processing. The deposit is processed in IRIS to the IRB Income account by the Administrative Assistant, Office of Research, and submitted to the Bursar’s Office.
If a Department processes invoice payment via transfer voucher in IRIS, the transfer is approved by the Business Manger, Office of Research. The transfer is coded to recovery in the IRB account. A copy of the approved transfer is forwarded to the IRB to be uploaded to the iMedRIS study record and receipt of payment is noted in the invoice module of iMedRIS. The Business Manager reconciles the IRB expense and income ledgers.
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 the investigator 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.
For questions regarding:
- IRB review, fee invoicing, and assessment - contact the IRB Associate Director, Director, or Chair at 901.448.4824 or at firstname.lastname@example.org.
- The facilitation of a clinical trial contact Elaine Todd, JD at 901.448.3303.
- External funding for research and other sponsored projects – contact Deborah Smith, Ed.D. at 901.448.4823.
UTHSC IRB office
Memphis, TN 38163
Phone: (901) 448-4824
Fax: (901) 448-5103