Industry-Sponsored Protocols

Industry-Sponsored Protocols

Investigators submit all applications for initial review to the OIRB. Depending upon the type of sponsor and type of review, the OIRB may coordinate review by one of the other IRBs that UAB is authorized to use. For example, UAB has a contract with Western IRB (WIRB). Under the contract, WIRB provides initial and ongoing review for most industry-sponsored research that requires convened review.

WIRB reviews industry-sponsored protocols unless the protocol:

  1. Is eligible for NHSR, Exempt, or Expedited review
  2. Is sponsor-investigator (i.e., investigator-initiated) research or
  3. Involves gene transfer.

Note: Investigators whose protocols are sent to WIRB will have conflict of interest review by both the UAB CIRB and WIRB.

The UAB WIRB Liaison works with investigators to ensure that all UAB requirements are met. WIRB will only review UAB protocols sent to them by the UAB WIRB Liaison. The UAB web site has a WIRB section (www.uab.edu/irb/wirb) with links to forms and information for investigators. The New Review Cover Letter/Checklist lists all materials required for submissions.

The UAB IRB reviews industry-sponsored protocols that are not reviewed by WIRB.

WIRB Fees

The WIRB fee schedule should be treated as confidential. It is available from the UAB WIRB Liaison, Ms. Margie Lawson, by calling the OIRB at (205) 934-3789.

UAB Fees

  • When WIRB reviews a protocol, UAB charges a one-time fee of $1,000 for coordinating the initial review process. The fee covers initial administrative review and conflict of interest review.
  • For full convened UAB IRB review of industry-sponsored protocols (e.g. gene therapy), the UAB IRB charges a one-time fee of $2,000.
  • For expedited review of industry-sponsored protocols, the UAB IRB charges a one-time fee of $1,000.

The UAB IRB does not charge a fee for providing convened review of protocols that are investigator initiated, are unfunded, or are funded by federal agencies or nonprofit agencies.

Investigators complete the Industry-Sponsored Protocol Billing Information form as part of the application materials. This form provides the OIRB with information necessary to coordinate payment of the fee through the sponsor.

Investigators should inform potential sponsors of this fee during contract negotiations. The UAB fee should not be included in the protocol budget. Upon request, the OIRB will provide a “Dear Sponsor’ letter for the investigator to give to the sponsor, describing the billing procedures, and will process billing.

Additional Information

The WIRB section of the UAB IRB web site is available at www.uab.edu/irb/wirb.

Please direct questions about WIRB review and industry sponsors to the UAB WIRB Liaison: Ms. Margie Lawson (mlawson@uab.edu; 934-3789).

Page updated: May 8, 2013