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The Western Institutional Review Board (WIRB®) is available for USF investigators conducting clinical trials for multi-centered studies that are sponsored by private companies. WIRB® is the oldest and most experienced independent IRB in America. The Board has provided review services for the research of more than 10,000 investigators in over 30 countries, and in all 50 United States. WIRB has reviewed the research of independent investigators since 1968, and has provided institutional and international services since 1986.
Designation of an external IRB does not alleviate USF from its responsibilities to ensure that the safety and rights of subjects participating in research conducted by USF are adequately protected. The USF IRB does not delegate to the Western IRB certain functions that are related to human research subjects protections including departmental/college scientific review, Human Research Protections (HRP) training for all investigators and research staff, a comprehensive Quality Assurance Program to provide hands-on guidance to investigators in meeting federal and institutional regulations and policies, and standard operating procedures for the management and investigation of subjects concerns or complaints and allegations of non-compliance. These functions are set forth in the USF IRB’s policies and procedures.
The following questions and answers are provided to assist investigators with WIRB® submissions:
1. What USF studies are eligible for WIRB® submission?
Studies may be submitted to WIRB® only if they meet all five of the following conditions:
- The trial is a multi-centered, industry-sponsored and FDA regulated drug or IDE study (investigator-initiated studies are not currently eligible). Non-therapeutic trials cannot be submitted to or reviewed by WIRB®.
- The research is not related to behavioral science.
- The investigator has not previously submitted the clinical trial to another IRB.
- The study does not involve the Veteran's Administration (i.e. use of VA facilities, equipment, or patients), is not in collaboration with an employee of the VA during his/her VA tour of duty; and is not used by an employee to fulfill VA responsibilities.
- The study is not a Phase I trial. Phase I trials may not be submitted to or reviewed by WIRB®.
2. Who must submit protocols to WIRB®?
USF established a relationship with WIRBŪ to help relieve some of the workload of the USF IRB. USF investigators are encouraged to submit all eligible studies to WIRBŪ if the sponsor is willing to provide support.
3. How much money should be budgeted for WIRB® studies?
The services will be directly billed by most sponsors. Contact your Research Proposal Services Grants Specialist for exceptions.
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WIRB® Service
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Cost
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Initial Review (Protocol, PI, Consent Forms, Recruitment materials)
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$1,700
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Multicenter Studies, Additional Investigators (each); Site-Specific Consent forms, Site Specific Recruitment Materials
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$800
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Renewal Review of Protocol (each site, at least annually)
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$800
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Changes to Research (each site); Protocol Amendments/Revisions, Consent form modifications, change of PI, new/updated recruitment/retention materials, site prepared translations, other changes
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$275
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Co-Investigator or Change of Investigator
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$800
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Videoconference
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$350
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Teleconference
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$150
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Generic Non-Protocol Related Material
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$550
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Translations
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variable
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WIRB Written Consent Form
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variable
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NOTE: There is a fee to have WIRB® develop the Informed Consent form. This is negotiated between the Sponsor and WIRB®. WIRB® develops the Informed Consent form based on the Sponsor's template. WIRB® will ensure that the appropriate Institution-specific Injury Clause(s) are incorporated into the informed consent form. It is therefore important that all research sites be identified at time of submission.
4. How does the process work?
- Prepare WIRB’s Application packet.
- Prepare forms (e.g., Financial Disclosure Form and Scientific Reviewer Signature)
- Submit Internal Review Packets for USF IRB, USF Health Clinical Research (Dr. Patricia Emmanuel c/o Charmaine Disimile at MDC02 or location CMS 3055), and Division of Sponsored Research (DSR).
- Obtain WIRB Approval Letter from USF IRB to be included with WIRB’s Application Packet.
5. Do you need assistance with your WIRB® submission?
You can visit the WIRB® web site at http://www.wirb.com in order to learn more about WIRB®, download their forms, contact WIRB®, etc.
Contact WIRB® at:
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Telephone
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800-562-4789
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Fax
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360-252-2498
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E-mail
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wirb@wirb.com
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Mail
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P.O. Box 12029
Olympia, Washington, USA 98508-2029
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Contact the University of South Florida's WIRB® liaison, Henry Zych, at:
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Telephone
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813-974-7454
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Fax
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813-974-5618
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E-mail
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hzych@research.usf.edu
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Mail
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USF Division of Research Integrity & Compliance
12901 Bruce B. Downs Blvd., MDC35
Tampa, FL 33613
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