The
IRB-01 Full Board is scheduled to meet on the first
and third Wednesday of each month. The meetings take
place at Shands hospital in conference room 10-214.
Meetings start at 8:30 AM and run until 2:00 PM. All
guests are required to sign in.
How
do you get your paperwork reviewed at a specific meeting?
You
must submit your paperwork to the IRB-01 administrative
office prior to a meeting's deadline in order to have
it prepared and reviewed at that meeting. Click
here for the list of meeting dates and their deadlines.
Simply submitting your paperwork at the deadline
does not guarantee that your submission will be scheduled
for the meeting! Once received by the office,
your submission will undergo an administrative review.
Only submissions which use current forms, include
all of the required paperwork, and fulfill all of
our administrative requirements (such as including
original, signed documents plus 4 photocopies) will
be scheduled for the meeting. If the office finds
any issues with your submission, you must correct
them quickly in order for your submission to be scheduled
for the meeting. Please read our Submitting
Paperwork page in order to learn more about how
we process submissions.
Your
paperwork is scheduled to be reviewed at a meeting.
At what point in the meeting will it be reviewed?
Each
meeting has its own Agenda. The Agenda lists which
projects are scheduled to be reviewed and the order
which they will be presented. A couple days before
the meeting you may visit the office in order to obtain
a hard copy of the agenda.
Each
Agenda is divided into sections. The Board reviews
the sections in the order they are listed in the Agenda.
Within each section the Board reviews projects
according to the following prioritization:
- Submissions
which are represented by a PI or associate will
be addressed first in their section. If more than
one representative is present, submissions within
that section will be presented in the order which
guests signed in.
- The
remainder of the submissions in each section which
are not represented will then be presented in the
order they are listed in the agenda.
Does
the PI or a representative have to attend the meeting?
No.
The PI or a representative is not required to attend
the meeting. HOWEVER, the Board recommends that the
PI or a knowledgeable representative should be available
to answer any questions which the Board may have concerning
the PI's project. If you sign-in at the beginning
of the meeting and leave accurate contact information
(phone number, pager), we can call you shortly before
we expect your project to be reviewed or, if you prefer,
only in the event that the Board has any questions.
What
steps does the Board follow when reviewing a submission?
The
Board uses the following procedure for reviewing projects:
- The
IRB members who were assigned to review the project
will briefly present the submission.
- The
Board may discuss the project further and, if necessary,
discuss any questions, comments, or concerns with
the project representative.
- If
present, the representative will be asked to leave
the room for final deliberations and voting. We
ask that the representative wait outside the room
in the event additional questions arise during deliberations.
- An
IRB staff member will step outside to inform the
representative of the Board's action.
The
Board has reviewed your project. What happens now?
(additional
information is available in our Policies
& Procedures Manual)
After
reviewing your project, the Board usually takes one
of the following four actions:
| Approved |
The
Board has approved what has been submitted and
reviewed. Prior to initiating any research activity
you must obtain the appropriate approval paperwork
from the IRB administrative office, especially
if there is a newly approved Informed Consent
form. |
| Approved
pending Explicit Changes |
The
Board has reviewed your project and deemed it
approvable IF specific explicit changes
are submitted. Note, your project is not approved
until you submit the changes and they are reviewed
and approved. The project may be approved administratively
within the IRB-01 Office if you submit all of
the changes exactly as they are requested by the
Board. However, additional review by a Chairperson
or possibly even the Full Board will be necessary
(1) if you fail to make all of the requested changes
or (2) if additional changes are made. NOTE: the
smallest deviation from the requested changes
will at least require review by a Chairperson.
NOTE: we recognize that PIs may want or need to
make changes which differ from what the Board
has requested. If the PI feels it is inappropriate
to fully comply with the requested changes, please
include a coverletter indicating (1) which requested
changes were not made and the reason for omitting
them, and/or (2) which changes are in addition
to the requested changes and why these changes
are included. |
| Tabled |
The
Board has requested substantive clarifications,
protocol modifications, or consent document revisions
which could not be easily resolved or provided
during the meeting. The submission is NOT approved.
You must respond to the Board's issues, and your
response will be reviewed at another Full Board
meeting. As a courtesy to our researchers, the
deadline for the next meeting is extended
for tabled projects - typically 9 AM on the Monday
following the meeting which the project was tabled.
NOTE: the extension only applies for the meeting
immediately after the project is tabled. Any responses
you submit after this one time extension will
be processed according to the normal Full Board
deadlines. |
| Disapproved |
The
submission is unapprovable as submitted. The PI
may resubmit the protocol after addressing the
Board's concerns. |
The
Administrative Office makes every effort to produce
meeting correspondence, approval paperwork, etc as
quickly as possible because we realize that researchers
are eager to initiate their research. Please recognize
that we have a large amount of correspondence to produce
and that it takes a significant amount of time to
respond to all of the items reviewed at the meeting.
While some letters are available as early as the day
after the meeting, it is not unusual for some paperwork
to be completed up to a week after the meeting. We
encourage researchers to send a representative to
the meeting in order to expedite the approval process.
Please contact the IRB-01
Administrative Office if you have any questions.
What
happens if the Board runs out of time and cannot review
all of the items scheduled on the agenda?
Sometimes
the Board is unable to review all of the projects
scheduled for a meeting. If the Board recognizes an
hour or so before the end of the meeting that they
will be unable to review everything that is scheduled,
they will give additional priority to projects which
have a representative present for the review. Thus,
if a representative attends the meeting we will make
every effort to review your project that day.
Unfortunately
it is sometimes impossible to review everything that
was submitted in time for the meeting. If the Board
is unable to address your submission it will be scheduled
to be reviewed at the beginning of the next Full Board
meeting. The Board does try to schedule extra meetings
when warranted.
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