Fees Charged by UAB for Industry-Sponsored Protocols

Fees Charged by UAB for Industry-Sponsored Protocols

Institutional Review Board (IRB) Industry Protocols Fees Charged by UAB for Industry-Sponsored Protocols

Fees Charged by UAB for Industry-Sponsored Protocols

UAB Human Subjects Review Fee

  • $2,000 for “convened” reviews of industry-initiated and sponsored protocols by any independent IRB (currently WIRB) or “expedited review” by UAB IRB.
    • When WIRB or another independent IRB reviews a protocol, UAB charges a one-time fee of $2,000 for coordinating the initial review process and record keeping.
    • For expedited review of industry-sponsored protocols, the UAB Human Subjects Review Fee is $2,000.
  •  $3,000 for “convened” review by UAB IRB of industry-initiated and sponsored protocols.
    • There is no UAB Human Subjects Review Fee for review of protocols that are investigator initiated, are unfunded, or are funded by federal agencies or nonprofit agencies. UAB charges a fee of $3,000 for providing convened review of protocols that are sponsored by industry but will not be reviewed by an independent IRB.

This amount is used to offset costs associated with reviews of industry-initiated and sponsored protocols by several areas involved in the activation process, including:

  • The Office of the IRB (OIRB) conducts a pre-review of the protocol for institutional and WIRB requirements and stores, maintains, and updates the file through the life of the protocol at UAB. If applicable, the UAB IRB will conduct an expedited or full review.
  • The Office of the Conflict of Interest Review Board (OCIRB) conducts a review of the responsible personnel on the project and their associated financial interests to ensure any conflicts that may exist are managed appropriately. These reviews occur as needed throughout the life of the protocol at UAB.
  • The Clinical Billing Review (CBR) unit of the Clinical Trials Office is responsible for conducting a coverage analysis for all clinical trials per UAB policy. This analysis provides an approved billing plan based on an objective determination of items/services that can and cannot be billed to third party payers using Medicare and local payer coverage rules along with clinical care billing guidelines. The CBR is also responsible for conducting reviews of any subsequent protocol amendments that modify the items/services required by the protocol and modifying the approved billing plan as needed. The approved billing plan is used to facilitate an accurate and compliant clinical trial billing process.

Please note: this fee is only applicable to industry-initiated and sponsored clinical trials and research studies and is not applicable to (1) investigator-initiated clinical trials or (2) those supported by non-profit foundations or government sponsors.

The Clinical Trials Office will invoice the PI for this amount and payment to the CTO should be made from the study account. The PI/study team is responsible for invoicing the study sponsor for funds to cover this fee. Remember to include the applicable F&A amount when invoicing the sponsor.

Fee Payment

Investigators complete the Billing Information Form as part of the application materials. This form provides the Clinical Trials Office with information necessary to bill the appropriate UAB billing contact.

Investigators should inform potential sponsors of this fee during contract negotiations. UAB has provided the attached memorandum to explain the UAB Human Subjects Review Fee for industry-initiated and sponsored protocols.

For questions about the UAB Human Subjects Review Fee, please contact Carolyn Whitmire in the UAB Clinical Trials Office at cwhitmire@uab.edu, or 975-0699.

For information about WIRB fees, which are charged by WIRB separately from the fees charged by UAB, please contact Ms. Margie Lawson, Assistant Director and WIRB Liaison, Office of the IRB at mlawson@uab.edu, or 975-3923.