you want your submission reviewed FASTER?
read and follow the important directions below.
Failure to comply with these directions will
likely increase the amount of time it takes
to process, review, and approve your research.
Please contact us (call (352) 273-9600 or e-mail
if you ever have any questions, concerns, or
suggestions. Once you are familiar with our
requirements use the links above to obtain the
forms you need to submit to IRB-01.
must download and use the most current
IRB-01 continuously assesses
our compliance with the current interpretation
and implementation of existing and
new regulations, laws, guidance, as
well as federal citations of other
institutions in order to insure optimal
protection of those involved in research.
paperwork must be typed.
Our Board reviews approximately
10,000 submissions a year. Handwriting
is usually difficult to read, thereby
making the reviewer's job more difficult
and time consuming. At their behest,
the IRB-01 office will not accept
forms that are not typed.
submissions must be signed by the
The PI is responsible for
the conduct of the study and this
helps insure the PI is aware of the
status of the study. Co-PI or Sub-I
signatures are not sufficient unless
a temporary transfer of responsibility
is obtained previously. Click
here for more info.
must include copies of all pertinent,
Such as the protocol, grant, investigator
brochure, advertisements, patient/subject
questionnaires/surveys, data collection
you have a completed submission with
original signatures, you must also make
and submit an additional 1 to 3 photocopies of the entire submission
Why extra copies? The original stays
in the IRB office and the remaining
copies are distributed to the
different parties involved in the
review process. Requiring the PI to
provide copies expedites our ability
to distribute these materials to the
Keeping this in mind, please sort
your paperwork into separate
copies of the submission so we can
distribute one copy to each of
the separate reviewers. Paperwork
will be returned to you if it does
not include the appropriate number of copies. How many copies do you need? Each form indicates how many are needed, or you can print a list by clicking here.
to previously reviewed paperwork must
include (a) the changes tracked by
underlining any information to be
added to the paperwork (insertions)
and striking-out any information to
be removed (deletions), along with
(b) a clean final copy with the changes
changes greatly assist reviewers with
identifying and understanding what
you wish to change in your paperwork.
The clean copies then serve as the
final document once approved. Microsoft
Word automatically tracks insertions
and deletions. We offer instructions
on how to first unlock
our forms and then how to use
Word track changes feature. Lastly,
be sure to also include the appropriate
IRB form to identify why your changing
your paperwork: (a) the Revision Form
should be used when you are initiating
a change to your paperwork, (b) Explicit
Change Form should be used when responding
to the IRB's request for Explicit
Changes, or (c) Tabled Response Form
should be used when responding to
a Full Board Tabled letter. The later
two forms help us appropriately route
your response and insure proper processing
of the submission, thereby helping
us process your submission faster.
Please be sure to read the instructions
on each of these forms.
||Before submitting any forms to IRB-01
you should be intimately familiar
with all of our requirements.
Please visit our Instructions
for IRB-01 Forms page and our
Paperwork to IRB-01 page before
submitting any paperwork. Some forms
(e.g. the Informed Consent form) have
their own specific instructions. Important
information is also discussed in our
Policies & Procedures, Position
Papers,and other topics as listed
in the gray navigation bar on the
left of this page. You are required
to be familiar with any pertinent
information prior to submitting these
a separate coverletter if you need
to provide additional information.
The purpose of our forms is to give
the IRB the information it needs to
protect subjects and thereupon approve
your research. Unfortunately it is
difficult to design forms that accurately
address the many different kinds of
studies performed at our institution.
If a form doesn't fit your research
fill it out to the best of your ability
and attach a coverletter that provides
additional information and/or clarification.
The more information you can give
the IRB, the easier it is to evaluate
||Upon submission your paperwork must
be complete, correct, and meet our
Board does not wish to review submissions
that are incomplete, poorly prepared,
or fail to comply with pertinent requirements.
You can help us process, review, and
approve your submission faster by
insuring your paperwork is complete,
properly prepared, and complies with
all requirements. Click
here for more information.
Please note that your paperwork will
not be forwarded for review if it
is not complete and correct. This
is particularly important for paperwork
that must be reviewed at a Full Board
meeting because it may result in your
paperwork being reviewed at a meeting
later than you originally expected.
Please coordinate with the IRB Office
BEFORE our Full
Board Meeting Deadline in order
to insure that your paperwork is appropriate