Status Report
Office of Research and Sponsored Programs
1 UNF Drive
Jacksonville, FL 32224-2665
904-620-2455 FAX 904-620-2457
Equal Opportunity/Equal Access/Affirmative Action Institution
MEMORANDUM
DATE:
TO:
FROM:
RE:
Status Report for IRB#
Project Title “
”
Original IRB approval date
Most recent IRB extension approval date (if applicable)
1. The total number of subjects entered in the study to this point (active and/or completed), the
number of subjects enrolled since last IRB review, and the number anticipated in the future:

2. Details of any adverse or unexpected problems/side effects that have occurred or that are
expected (if none, then please state none):

3. The total number of participants who discontinued their participation and a summary of the
reasons for the withdrawals (if known):

4. A summary of any complaints about the research from subjects or others since the last IRB
review:

5. New information that could affect the risk/benefit ratio for this project (e.g., significant new
findings (published or unpublished) that developed during the course of the research which may
relate to the subjects’ willingness to continue participation). This includes any changes in the
investigator’s situation or qualifications (e.g., institutional affiliation, change in professional
license and/or certification status, significant increase in the number of research studies
conducted by the investigator):

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6. A summary of the research progress to date:

7. Information regarding any changes to the approved project (if none, then please state none):

8. Information regarding any changes to the originally approved informed consent/assent process:

9. Initial below confirms that a copy of the current consent/assent/parental permission documents
have been submitted with this status report (required for all projects):
10. Instances of incidental findings (e.g., suicidal intent, blood pressure readings of greater than or
equal to 140/90 mmHg or less than or equal to 90/60mmHg based on medical standards, resting
pulse rate of over 100 bpm or under 60 bpm based on medical standards) found in the study
population and a summary of those findings:
Not applicable, this study has no potential to generate incidental findings (skip items a & b
below)
This study has the potential to generate incidental findings but none have occurred (skip
items a & b below but indicate whether a new or updated response plan will be submitted)
This study has the potential to generate incidental findings and one or more have occurred
(complete items a & b below and indicate whether a new or updated response plan will be
submitted)
a) Summary of incidental findings and your response to those findings:

b) Do these findings elevate or alter risk for research participants? Why or why not?

Copy of new or updated response plan (i.e., plan in event of incidental finding) included
Additional comments/clarifications for reviewer (if applicable):
Investigator Acknowledgment:
This report has been personally reviewed and assessed by the principal investigator. By submitting this
form, the Principal Investigator assures that all information provided is accurate. He/she assures that
procedures performed under this project will be conducted in strict accordance with federal regulations
and University of North Florida policies and procedures that govern research involving human subjects.
He/she acknowledges that he/she has the resources required to conduct research in a way that will
protect the rights and welfare of participants and that he/she will employ sound study design which
minimizes risks to subjects. The Investigator’s signature on this submission affirms this statement.
Principal Investigator Signature (please type name):
Date:
Faculty Advisor Signature (please type name):
(Only required for student projects)
Date:
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