University of North Florida
Office of Research and Sponsored Programs
Institutional Review Board
Project Closing Report
Request to close a protocol previously approved by the UNF Institutional Review Board
To Be Completed by the Principal Investigator:
Principal Investigator (Faculty, Staff, Thesis Student, Dissertation Student):
Faculty Advisor (for Master’s Thesis or Dissertation project):
College/Dept.:
Project Title:
IRB Protocol #:
Date of IRB Approval or Exemption:
IRB Classification:
Funding Type:
Exempt/Category #
Non-funded
Expedited/Category #
Externally Funded Research
Full IRB
Internally Funded Research
SECTION I: CURRENT STUDY STATUS
Study was not initiated:
Explain and skip to Section III:
Study closed prior to completion
Date closed:
Explain:
Study completed, project can be closed
Date completed:
NOTE: This study can only be closed under the following circumstances and conditions:
1. There will be no further interaction/intervention with subjects, including follow-up, or access to
subjects’ personally identifiable information for the purpose of research data collection. (Please note
that after a study is closed interaction and intervention with human subjects is not permitted).
AND
2. Either of the following (mark the appropriate box)
All data analysis involving the research site(s), under the University of North Florida IRB
approval, is complete. (Please note that after a study is closed, using, studying, or analyzing
identifiable private information is not permitted).
AND/OR
Data have been de-identified, with no codes or keys that would allow for the potential of
identifying individuals in the future.
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If you have de-identified data, please describe how this was accomplished:
SECTION II: SUBJECT SUMMARY
Check here to confirm that research records (e.g., signed informed consent forms, copies of research
proposals, progress reports, injury reports, records of continuing review, information about
significant new findings) will be retained for at least 3 years after completion of the research (see 45
CFR 46.115). Please note that these records must be stored as outlined in your approved protocol. If
data or records are covered by HIPAA, those materials will need to be maintained for 6 years from
creation date or date of last effect, whichever is later.
Check here if the IRB has approved a complete waiver of consent for your study (note: this is not
the same as a waiver of signed informed consent).
If necessary, please provide further explanation regarding above information:
1. SUBJECT SUMMARY TABLE
Date first subject was enrolled:
Since last IRB
review
Total number of subjects CONSENTED
Total number of subjects who have WITHDRAWN from the study
Since
beginning of
study
Total number of subjects CONSENTED
Total number of subjects who have WITHDRAWN from the study
Number of subjects who have COMPLETED the study
If necessary, please provide further explanation regarding the subject summary:
2. WITHDRAWAL
Have any subjects withdrawn from the study since the last IRB review?
No
Yes, state the reasons for withdrawal (if known):
3. VULNERABLE POPULATIONS
Are any of the subjects who have consented or enrolled in the study members of a vulnerable population?
No.
Yes*
* Has the IRB previously approved enrollment of these subjects?
Not applicable
Yes.
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No. Subjects in the following vulnerable populations were enrolled without prior IRB approval:
Minors
Human Fetuses or Neonates
Prisoners
Economically/Educationally Disadvantaged
Cognitively Impaired
Students
Pregnant Women
Other
If you checked no above indicating that vulnerable populations were included in the study without prior
IRB approval, that is considered a protocol deviation and it will be necessary to complete and submit an
Event Report Form for review by the UNF IRB. (Please note that pregnant women may be enrolled in minimal
risk studies when the pregnancy is entirely coincidental and bears no relationships to the research).
SECTION III: SUMMARY OF EVENTS
1. Since the last IRB review, did any unanticipated problems, including adverse events, protocol deviations,
or subject complaints, or noncompliance occur that required prompt reporting to the IRB?
No.
Yes. Were these events reported previously to the IRB?
No. Please explain why these events were not previously reported:
Yes. Provide a summary of these events:
Check here if the summary is attached.
2. Based on the above information, do you feel the validity of the data is affected?
No.
Yes. Explain:
3. Based on the above information, do you feel there is an increase in risk to subjects or others or in the
frequency or severity of adverse events, protocol deviations, problems, complaints, etc. since the last IRB
review?
No.
Yes. Explain:
SECTION IV: INVESTIGATOR STATEMENT OF COMPLIANCE
By submitting this form, the Principal Investigator assures that all information provided is accurate and that the
following guidelines will be followed:
1. The principal investigator will maintain records according to federal, state, and institutional regulations
and guidelines. Please maintain these records for a minimum of three years.
2. The principal investigator will report and follow-up on any adverse events or unanticipated problems
involving risk.
3. The principal investigator assures that no further research is conducted, including analysis of identifiable
data without IRB approval.
Investigator Signature:
Date:
Faculty Advisor Signature:
(only required if applicable)
Date:
If you have questions about completing this form, please contact a research integrity administrator by calling
(904) 620-2455 or by emailing irb@unf.edu.
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