Western IRB (WIRB®) has been established as a fourth UF IRB for studies utilizing FDA regulated articles that are sponsored by private companies. The information on these pages are provided to assist investigators with WIRB® submissions.

Prior to submitting any research to WIRB® you must first determine if your project must be sent to a local UF IRB (IRB-01, IRB-02, or IRB-03) for review and approval. Please be sure to review all of the information below to insure it is appropriate to submit to WIRB®. Note: If you submit your project to WIRB but the project is not considered eligible for WIRB review, the University will have WIRB® rescind their approval and you will be required to resubmit your project to your local IRB. If you have any questions contact Michael Mahoney at 352-273-9601 for assistance.

Please use the links on the left to help you with submitting your paperwork to WIRB®.

1. What studies are eligible for WIRB® submission?

Studies may be submitted to WIRB® only if they meet all 5 of the following conditions:

a. The trial is industry-sponsored and FDA regulated (drugs and devices). Non-therapeutic trials cannot be submitted to or reviewed by WIRB®. Effective 4/25/2005 - for Principal Investigators in the College of Medicine, industry authored and supported non-therapeutic trials MUST be submitted to WIRB®. Non-therapeutic trials that are authored by a UF investigator and only being conducted at UF but are industry sponsored may request an exemption in order to submit to WIRB.

b. The research is not related to behavioral science.

c. The investigator has not previously submitted the clinical trial to another UF IRB.

d. Veteran's Administration Policies:

i. The trial does not involve the use of Veterans Administration facilities, equipment or patients. (VA central office policy)

ii. Part-time VA employees may be involved in these projects only if the research does not take place in a VA facility (including an approved off-site facility), is not part of the employee's VA duties and does not occur during his/her VA tour of duty.

iii. NOTE 07/13/2004: Full-time VA employees may not be involved as PI, Co-I, or Sub-I in any project submitted to WIRB.

e. The study is not supported in whole or part by the GCRC. NOTE: There are times when the study is fully supported by industry and the GCRC space and services are paid for. In those cases, WIRB may be used.

2. Who must submit protocols to WIRB®?

UF established a relationship with WIRB® to help relieve some of the workload of the UF IRBs. UF investigators are encouraged to submit all eligible studies to WIRB® if the sponsor is willing to provide support.

The College of Medicine Office of Research Affairs has issued the following policy statement:

Effective October 1, 2000, the College of Medicine Faculty (Gainesville and Jacksonville) will be expected to utilize the Western Institutional Review Board (WIRB®) for all industry-supported clinical research trials involving human subjects. Federally (PHS, DoD, etc.) supported clinical trials will continue to use the UF IRB 1 and UF IRB 3 panels. NOTE July 13, 2004: College of Medicine Faculty who wish to enroll VA subjects must submit their projects to IRB-01, indicating their intention to recruit VA subjects in the Introductory Questionnaire and attaching a cover letter highlighting VA subject recruitment to justify their submission to IRB-01 instead of WIRB.

This policy applies only to College of Medicine submissions assuming all of the conditions of question #1 are met. Please refer questions regarding this policy to M. Peter Pevonka.

September 2003: faculty and staff in other UF colleges (e.g. Denistry, Pharmacy, Nursing, etc.) may choose to use WIRB® if their study meets the criteria in question #1. Unlike the College of Medicine however, it is not mandatory.

3. Do you need assistance with your WIRB® submission?

Contact WIRB® at:

Telephone	800-562-4789
Fax	360-252-2498
E-mail	wirb@wirb.com
Mail	P.O. Box 12029 Olympia, Washington, USA 98508-2029

Contact the University of Florida's WIRB® liaison, Michael Mahoney, at:

Telephone	352-273-9601
Fax	352-273-9614
E-mail	mmahoney@ufl.edu
Mail	P.O. Box 100173 Gainesville, FL 32610-0173