IRB-02: Behavioral/NonMedical Institutional Review Board |
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IRB-02:
Behavioral/NonMedical Institutional Review Board
Continuing Review / Study Closure Form
Please type or wordprocess the following information.
For a copy of this report in Microsoft Word format, click here.
UFIRB #_________ PRINCIPAL INVESTIGATOR____________________________________________
PROTOCOL TITLE___________________________________________________________________________
Continuing Review/Study Closure Report
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. If you have any questions, please call 392-0433. (This form is also available at http://irb.ufl.edu/irb02)
Check all items that apply to your protocol and provide requested information. (You may attach additional sheets if necessary.)
1. On what date did data collection begin?__________ Principal Investigator:_______________________ Date __________________2. Please indicate the statement that best describes the status of this protocol:
___ a) I have completed work on this protocol. I will answer the remaining questions on this form to enable the IRB office to officially close the protocol. 3. If there have been any additions or deletions to the list of researchers involved with this protocol, I have described the reason for each change below and have updated the informed consent form to include only the current researcher(s):___ b) I have not begun data collection. I plan to start on __________.
___ c) Human participants are currently being recruited.___ d) No further recruiting will occur after the expiration date. However, the data collected during the research shall be analyzed. I have attached 3 clean copies of the current informed consent. Upon approval, the IRB will stamp an expiration date on them, and return one copy for me to duplicate.
___ 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. These follow-up activities are described as follows:
4. If the protocol is externally funded, and the information about sponsorship is not correct in the protocol, the revised IRB form identifies the following sponsor(s):
5. Please indicate the following:
___ a) The total number of participants recruited during the past year:__________ 10. The research participants in this protocol include the following that are checked:___ b) The total number of participants to be recruited during the next year:__________
___ c) I have recruited, or plan to recruit, more participants than originally estimated because:
___d) I have recruited no participants because:
6. Was written informed consent required by the IRB and obtained from each participant?__Yes__No
If the answer is YES, attach to this form a photocopy of the last signed consent that you obtained.
If the answer is NO, please explain the circumstances under which written informed consent was not obtained (most commonly, signatures were not required):7. Were any changes, however minor, made to your protocol last year?___Yes___No
If YES, were those changes reviewed and approved by the IRB prior to their implementation?___Yes___No
If changes were made to the protocol that were not submitted to and approved by the IRB, please describe the revision and explain why it was not sent to the IRB for review:
8. Did any unanticipated outcomes or adverse events occur the past year?__Yes__No
If YES, please indicate which ones were previously reported to the IRB:
9. Did any participant withdraw from this research project during the past year?__Yes__No
If YES, please indicate the reason for EACH participant's withdrawal:
:___Infants ___Children ___Adolescents
___Adults ___Prisoners ___Pregnant women
___Mentally or emotionally challenged individuals
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.
• 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 in the 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, attached one copy of each published report.
Supervisor (of student PI)____________________ Date __________________
Department Chair__________________________ 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 8, 2007
