IRB-02:
Behavioral/NonMedical  Institutional Review Board

Research & Graduate Programs

University of Florida


Continuing Review / Study Closure Form

Please type or wordprocess the following information.
For a copy of this report in Microsoft Word format, click here.



To help us keep our records current, please complete the following and return it to the UFIRB Office, PO Box 112250, Gainesville, FL 32611-2250.  Should you have questions, please call 352-392-0433.  

 

UFIRB #

 

TITLE:

 

PI Name:

 

Co-PI(s)

 

1.       On what date did data collection begin?

 

2.       Please indicate the statement that best describes the status of the protocol:

□

a.         I have completed work on this protocol and would like to close this protocol.

□

b.        I have not begun data collection.  I plan to start on:

□

c.        Data collection has begun and I have attached three clean copies of the consent.

□

d.        No further recruiting will occur after the expiration date.  However, data collected will be analyzed.

□

e.       No further recruiting of participants will occur, but data collection will continue on at least one participant.

□

f.         No further recruiting will occur.  All interventions are completed on all participants, but follow-up is being conducted as described in the informed consent.   (Attach description of the follow-up activities.)

3.       Have there been additions or deletions to the list of researchers involved with this protocol?  If yes, describe the change(s).  □YES    □NO

 

 

4.        Please indicate:

a.       The total number of participants recruited during the past year

 

b.       The total number of participants recruited to date (include prior years)

 

c.        The total number of participants to be recruited in the upcoming year

 

d.      If you recruited or plan to recruit more participants than originally estimated, provide a justification for the increase.

e.      If you have not recruited participants please state why.

 

5.       Was written informed consent required by the IRB and obtained from each participant? (Attach copy of the last signed consent) □YES    □NO   If consent was required by IRB but not obtained, please attach an explanation of the circumstances. 

6.       Were changes, however minor, made to the protocol last year?

YES

NO

a.       If yes, were those changes approved by the IRB prior to being implemented?

YES

NO

b.       If changes were made to the protocol that were not submitted to and approved by the IRB, please describe the changes and give an explanation why it was not submitted.

 

7.       Did any unanticipated outcomes or adverse events occur the past year?   □YES    □NO

 If yes was the IRB informed of it?  Describe the events

 

8.       Did any participant(s) withdraw from this research project during the past year?  If YES, provide the reason for EACH participant’s withdrawal.

YES

NO

9.       The research participants in this protocol include the following:

         Infants

□YES

Children

□YES

Adolescents

□YES

Adults

□YES

     Prisoners

□YES

Mentally or emotionally challenged individuals

□YES

Pregnant Women

□YES

10.    If the protocol is externally funded, and the information about the funding was not disclosed in the protocol, please indicate the correct sponsor.

11.    The IRB, the University of Florida, and the Federal Regulatory agencies consider continuing reviews to be extremely important.  Research studies are approved based on an estimated ratio of potential benefits to possible risks.  Based on this, please complete the following:

·         Comment on how your participants responded to the study and your procedures.  (This item may be omitted only if no data were collected on research participants last year.)

 

 

 

·         Give your opinion about any changes in the risk-benefit ratio.  Is there any new information (e.g. alternative procedures, new information published in the literature) that might affect the risk-benefit ratio?

 

 

·         If data from your study have been reported, attach one copy of each published report.

 

SIGNATURE SECTION

Principal Inv.

 

Date

 

Spvr. (if PI student)

 

Date

 

Dept. Chair

 

Date

 

*****THIS SECTION FOR IRBO2 USE ONLY*****

Comments:

 

 

 

 

 

 

 

Approved By:

 

 

Date:

 

 

Thank you for completing this information. Please return this form to the UFIRB Office, PO Box 112250, Gainesville, FL 32611-2250. If you have any questions, please call 392-0433.

Updated June 12, 2009

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