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 79 GCRCs in the United States, and currently
occupies over 9,700 sq ft on the third floor of
Shands Hospital at the University of Florida. The
GCRC
provides a variety of resources to researchers who
choose to conduct their research in the center.
In addition to obtaining IRB approval you must also
obtain approval from the GCRC Advisory Committe
in order to conduct your research in their Center.
Researchers
who wish to conduct their studies at the GCRC
must submit their project separately to both (1)
the IRB and (2) the GCRC
Advisory Committee. When doing so you must submit
the same exact paperwork to both committees.
If one committee requests any changes you must make
the same exact changes to the paperwork submitted
to the other committee.
After the initial protocol approval the investigator is responsible for sending a copy of all future IRB approved submissions (revisions, adverse events, continuing review, etc) to the GCRC. Please contact Ann Coutu for more information:(352) 265-8909
or coutua@gcrc.ufl.edu.
In
order to facilitate a faster review of new protocols
through both committees the IRB and GCRC
have collaborated to develop a harmonization process.
Click here to
download the GCRC-IRB Harmonization Checklist which
will help guide you through this process.
Please
note:
-
BEST PRACTICE: Obtain the fastest possible approval
by following the directions described in the GCRC-IRB
Harmonization Checklist.
- A
knowledgeable representative from your study must
attend the IRB meeting to assist the Board with
their review of the project.
- You
may choose to submit via the harmonization process
and wait until after the IRB meeting and reply
to all requests at one time. This is simpler for
the investigator, but will definitely mean it
will take a little longer for your project to
be reviewed.
- If
you are unable to make all of the changes requested
at the intermediate steps in the process you may
choose to wait until after the IRB conducts it's
review. Pro = only correct and copy paperwork
one time. Con = will result in longer amount of
time to have project approved.
-
You are not required to submit to one committee
before another - you may submit your project to
either committee at any time. However you must
remember that (1) you cannot start your project
anywhere until you have IRB approval, and (2)
you may not start your project on the GCRC
until you have approval from both committees.
|
IMPORTANT
NOTE:
|
| If
you choose to conduct your project at
the GCRC your protocol must be
submitted to both committees (IRB and
GCRC) in the GCRC's format. The different
format is required by the GCRC's funding
source, the NIH. |
|
Prior
to submitting any paperwork to the GCRC
or IRB you should visit their web site at http://www.gcrc.ufl.edu/
and contact the GCRC
Administrative Manager, Ann Coutu, at (352) 265-8909
or coutua@gcrc.ufl.edu
In particular, the "Guidelines for Protocol
Submission" (http://www.gcrc.ufl.edu/guidelines.php)
page on the GCRC
web site specifically addresses submitting paperwork
to the GCRC.
