Research Compliance - Human Subjects
Human Subjects
In all research, development and related activities involving the use of human subjects, the University seeks assurance that those persons who participate as subjects or volunteers does not get expose to unreasonable risks to their health, general well-being or privacy. All projects involving human subjects must be reviewed and approved by the University's Institutional Review Board (described below) before the planned research may begin.
The Institutional Review Board (IRB) is a committee of appointed volunteers (both University and non-University representatives) who review and approve the use of human subjects, volunteers, or participants in research projects. The University of Florida has four IRBs:
1) Health Science Center/IRB-01: 352-846-1494, irb1@grove.ufl.edu
2) UF Non-Medical/IRB-02: 352-392-0433, irb2@ufl.edu
3) Jacksonville HSC/IRB-03: 904-244-3155, sheila.heim@jax.ufl.edu
4) Western IRB (WIRB)/IRB-04: 800-562-4789, wirb@wirb.com
Effective October 1, 2000, the College of Medicine Faculty (Gainesville and Jacksonville) will utilize the Western Institutional Review Board (WIRB) for all industry supported clinical research trials.
Federally (PHS, DoD, etc.) supported clinical trials will continue to use UF IRB-01 and UF IRB-03.
Investigators should budget the cost for WIRB in their proposals to industry sponsors. These costs are normally budgeted over and above the changes to conduct a complete clinical trial study.
The rationale for this policy is related to workload of UF IRB-01 and maintaining responsiveness to sponsors. The WIRB has proven to be an effective mechanism for handling industry sponsored trials. In most cases industry sponsors prefer to work with WIRB because most sponsors have a working relationship with WIRB and are aware of their requirements and procedures. The Dean?s Office will consider exemptions from this policy on a case by case basis and approve an alternative course only when compelling and strong evidence supports an exemption. Funding per se, will not be in and of itself considered satisfactory need for an exemption.
IRB-01 General Information
- COM Policy regarding IRB Selection & Utilization
- Western Institutional Review Board Fee Schedule
- Health Science Ctr. Institutional Review Board-01
- IRB Educational Events
- Training and Education Series
- HIPAA Training Sessions
Address
CB-172 (Through the stairwell on the east side of the Sun Terrace Food Court. Take these stairs down to the basement floor, take a left, then a right; the office will be on the left)
PO Box 100173
Gainesville, FL 32610
Phone: (352) 846-1494 / Fax: (352) 846-1497
IRB -01 Office Staff:
IRB-01 Membership Roster:
IRB Deadlines & Meeting Dates:
