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.
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
Please use the links on the left to help you with submitting your paperwork to WIRB®.
What studies are eligible for WIRB® submission?
may be submitted to WIRB® only if they meet all 5 of the
The trial is industry-sponsored and FDA regulated (drugs and
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.
The research is not related to behavioral science.
The investigator has not previously submitted the clinical trial
to another UF IRB.
Veteran's Administration Policies:
The trial does not involve the use of Veterans Administration
facilities, equipment or patients. (VA central office policy)
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.
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.
The study is not supported in whole or part by the CTSI. NOTE:
There are times when the study is fully supported by industry
and the CTSI space and services are paid for. In those cases,
WIRB may be used.
Who must submit protocols to WIRB®?
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.
College of Medicine Office of Research Affairs has issued the
following policy statement:
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.
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 Michael Mahoney at (352) 273-9601 or email@example.com.
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.
Do you need assistance with your WIRB® submission?
Olympia, Washington, USA 98508-2029
the University of Florida's WIRB® liaison, Michael Mahoney,
Gainesville, FL 32610-0173