Some
research that involves human subjects must be reviewed
other committees as well as the IRB before the research
is conducted. Review by other committees usually
depends on what the research includes (for example,
if it uses radiation, gene therapy, includes veterans
as subjects, etc) and/or where the research is going
to be conducted. Review by other committees is mandated
by university or hospital policy, in part due to
the risk to subjects that must be evaluated by these
other groups with specialized expertise.
Approval
by each committee occurs INDEPENDENTLY of IRB review.
If HURRC, IBC, and/or the VAMC Subcommittee for
Clinical Investigation must review your project,
you should submit your project to the applicable
committees prior to IRB review in order TO PREVENT
DELAYS IN STARTING YOUR PROJECT! The IRB does not
forward copies of your submission to the other committees
- it is the researcher's responsibility to submit
the research to all of the appropriate committees.
Please be sure to familiarize yourself with their
requirements.
Do
you want to conduct your research in the General
Clinical Research Center (GCRC)?
The
GCRC is an NIH funded center charged with advancing
medical knowledge in a clinical setting. UF's
GCRC has been in continuous operation since 1962,
is one of 70 GCRCs in the United States, and currently
occupies over 9,700 sq ft on the third floor of
Shands Hospital in Gainesville. The GCRC provides
a variety of resources to researchers who choose
to conduct their research in the center. Separate
GCRC submission and approval is required in order
to use the Center. For more information visit
the GCRC's web site at http://www.gcrc.ufl.edu/or
contact the Administrative Manager, Ann Coutu,
at 265-8909 or coutua@gcrc.ufl.edu
Does
your project involve the research use of radiation
and/or radioactive materials?
The
Human Use of Radioisotopes and Radiation Committee
(HURRC) must review all projects that involve
the RESEARCH USE of DIAGNOSTIC X-RAYS, RADIOACTIVE
MATERIALS, or THERAPEUTIC RADIATION, as well
as all research submitted to WIRB (regardless
of whether it involves radiation). Even a standard
diagnostic test used more frequently than clinically
indicated would constitute research with radiation.
If HURRC review is required, you cannot begin
the project until you have both IRB and HURRC
approvals. If you have questions about HURRC review,
please contact Mr. Don Munroe at 392-7359 or via
e-mail at don@ehs.ufl.edu.
Mail should be sent to Box 118340. Additional
information can be obtained at: http://www.ehs.ufl.edu/Rad/
or http://www.ehs.ufl.edu/Rad/RCGuide/HURRC.htm
Does your project involve human
gene therapy?
The
Institutional Biosafety Committee (IBC) must review
all projects that involve HUMAN GENE THERAPY.
A project that needs IBC review cannot begin until
it has the approval of both the IBC and the IRB.
Also, the IBC will review all revisions to human
gene therapy projects to ensure that National
Institutes of Health guidelines are being met.
Therefore, investigators will be required to SUBMIT
ALL REVISIONS TO BOTH the IBC and the IRB. If
you have questions about IBC review, please contact
Dr. Phillip S. Collis at 392-1591 or via e-mail
at pcollis@ehs.ufl.edu.
Mail should be sent to Box 112190. Additional
information can be obtained at: http://www.ehs.ufl.edu/Bio/default.asp
Will your project or part of
your project be conducted at the VAMC?
Visit
the IRB's website about conducting research at
the North Florida/South Georgia Veteran Health
System at:
http://irb.ufl.edu/irb01/va.htm
or
the VA's new research web site at:
http://www1.va.gov/visn8/nfsg/Research/
Will
your project be conducted at Shands facilities other
than
Shands @ UF?
If
you wish to conduct research at any of the Shands
facilities other than Shands at UF, you are required
to receive permission from each facility prior
to conducting the research there. In addition
this information must be listed in your approved
Introductory Questionnaire.
Shands
at AGH
R. Peter Iafrate, Pharm.D.
Director of Pharmacy
352-338-2193
Shands at Lake Shore
Bobbie Rodgers
Director of Pharmacy
386-754-8050
Shands
at Starke
Martha Epps, R. N.
Director of Patient Services
(904) 368 - 2348
Shands
at Vista \ Shands Rehab Hospital
Gail Stahl, RN
Director of Quality Management
352-265-5491 (x7-0022)
