Please provide contact information for a representative who can answer any questions that the IRB might have concerning this submission:
Name:
Position:
E-mail:
Phone #:
Pager #:
2nd Contact: / name + e-mail or phone #
Group:
- The Tabled Deadline is actually an extension/exception of the regular Full Board Deadline.
- The Tabled Deadline “extension/exception” is only available for the meeting immediately following the meeting that your submission was tabled. Should you miss this initial Tabled Deadline, normal meeting deadlines apply. You cannot utilize future Tabled Deadlines.
- We realize this is a short time frame to submit your reply. Please realize this is a courtesy to help motivated researchers to get their projects reviewed faster.
Form Instructions:
- Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful information, examples, and instructions that are only visible (and will never print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”. (Word 2007 users can download how to display Hidden Text at:
- Please attach a copy of the Tabled Submission letter that you are responding to.
- Submit the signed original copy plus one electronic copyof your submission to the IRB-03 office. This must include copies of all paperwork including grants, surveys, data collection tools, articles, etc
- You should also retain one copy of the submission for your files.
- You may need to submit copies to other committees/offices.
- Include (1) a copy of any altered pages with insertions underlined and deletions struck out, (2) a clean copy of these pages (with changes performed) for all forms except the Informed Consent, in which case you should submit a clean copy of the entire form. See final page of this form for additional instructions. Please read all instructions before completing and submitting your paperwork.
- Submissions that do not meet our Submission Acceptability Standards will be returned to the PI. Visit for more information.
- All submissions must be typed.
1. / Date:
2. / Principal Investigator:
UF ID#:
3. / IRB Project #:
4. / Project Title:
5. / Have you addressed all of the issues noted in the Tabled Submission letter? Answer any questions, provide additional information, and/or detail any revisions made to your submission. Note: You may choose to answer this question on separate pages (please indicate information is attached)
Yes
No - which revisions weren’t made and explain why you choose to omit them:
7. / Additional comments:
Signature of Principal Investigator / Date
The IRB requires the PI to sign all paperwork. The only exceptions are: (a) if a Temporary Transfer of Study Responsibility has been signed by the PI and a sub-Investigator on the study, or (b) if the PI has left the institution, in which case their supervisor is required to sign as the individual responsible for the study.
TABLED SUBMISSIONS--GENERAL INFORMATION
What does it really mean when your project has been tabled? First, your project is not approved. The Board has requested substantive clarifications, protocol modifications, and/or Informed Consent revisions that could not be easily resolved or obtained during the meeting. In order to proceed in the approval process, the Principal Investigator must respond in writing to the issues listed in the “Tabled Memo” from the IRB. Once received, the principal investigator’s response will be scheduled for review at the next appropriate Full Board meeting. Upon review, the Board will make one of the following actions: approve the submission, request explicit changes, table the submission again, or possibly even disapprove the submission.
VERY IMPORTANT: To Adjust or Revise IRB Documents, Follow the Procedures Below Exactly So Reviewers Can Quickly Locate and Review What Has Been Changed:
- ALL IRB FORMS (Introductory Questionnaire including the Project Cover Sheet, Protocol, Informed Consent Form, Continuing Review Report, or Adverse Event Report Form) and any related material: If the information in any of the forms is being changed, send the affected pages showing deletions in strikeout and additions in underline. Also include a copy of just the affected pages with the changes executed. Microsoft Word can automatically perform these actions for you by using the “Track Changes” function in the Tools menu. For instructions on how to use “Track Changes” or how to unlock our forms, visit our web site at:
- INFORMED CONSENT FORM: If revised you must submit not only the affected pages with insertions underlined and deletions struck out, but also a complete clean copy of the new consent form. We need a complete clean copy in order to stamp the new consent form with the new IRB approval period. Investigators are required to use a currently approved, stamped Consent Form for enrolling subjects during the approval period.
REMEMBER: All changes, no matter how minor, must be submitted for review and approval by the IRB before they are implemented.
You Do Not Need to Submit A Cover Letter With This Tabled Submission Response Memo!
Completing this memo is sufficient when responding to our request for additional information. However, you may choose to include a Cover Letter or attach separate pages if you wish to provide additional information.
If you have any questions concerning a Tabled Submission, please contact the IRB office at 244-9729
Tabled Submission ResponsePage 1 of 2
IRB Version date: 11/24/2009
PI Version date: