IRB Annual Protocol Renewal Form
Revised July 2015
For IRB Use Only
Protocol #: H________________
Orig. Rev. Type: ____________
Last Approval Date: _________
Renewal Date: ______________
Expiration Date: ____________
University of North Carolina Wilmington
Institutional Review Board
Annual Protocol Renewal Form
PART A: General Protocol Information
Protocol Number: H
Principal Investigator:
Department:
Title of Project:
This study will be completed by:
Please Note: To qualify to use this form, the study must be completed within one year of
the renewal date. If the study might continue beyond that date, you must resubmit the
study in the new, online IRB system (“IRBIS”).
IRB Office Use ONLY:
Results:
Approved
Approved Pending Revisions
__________________________________________
Signature of the IRB Chair or Designate
Disapproved
_________________
Date
If necessary, revisions/clarification received: ____________________
Results: Approved
Approved Pending Revisions
Disapproved
__________________________________________
Signature of the IRB Chair or Designate
_________________
EXPIRATION DATE:
Date
A copy of this page, signed by the IRB Chair, serves as formal notice of the approval to
continue the protocol. The protocol, consent form and assent/permission form are
effective for ONE year from the date of approval. Any changes to this study, no matter
how small, are subject to approval by the IRB. UNCW policy requires the submission
of a Closure Report upon completion of a study.
PART B: Protocol Summary
Protocol Summary (in a few brief sentences, please describe the project):
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PART C: Protocol Status
Indicate all that apply to this protocol:
Active – project is ongoing.
The remaining research activities are limited to data analysis.
No additional risks have been identified.
Inactive – project was never initiated but the anticipated start date is
.
Check if this research has been audited since the last IRB review.
PART D: Number of Subjects
1.
Number of subjects approved by the IRB:
Include number approved on original protocol and approved on subsequent amendments, if
any.
2.
Total number of subjects accrued to date:
May not exceed the total number approved by the IRB. If you are nearing the total
number approved or if you expect to exceed it in the future, pleases submit an IRB
Protocol Amendment Form to request an increase in the number of subjects.
3.
Number of subjects who refused to participate, if any:
a. No refusals.
b. Refusals – Include number of subjects who refused to participate and the reason, if
given.
4.
Number of subjects who withdrew from participation:
a. No withdrawals.
b. Withdrawals – Include number of subjects who withdrew, whose decision it was to
withdraw, and the reason they withdrew.
PART E: Complaints, Adverse Events or Unanticipated Problems
1.
Complaints received about the research since the last IRB review:
a. No complaints.
b. Complaints – Include the number of complaints and the nature of each
complaint.
2.
Adverse events or unanticipated problems involving risks to subjects or others.
a. No adverse events/unanticipated problems.
b. Adverse events or Unanticipated problems – Include the number of
adverse events or unanticipated problems and the nature of each incident.
Please note: If any serious events occurred, provide the date reported to
the IRB.
PART F: Relevant Literature/Findings
Describe any relevant literature or interim findings since the last IRB review that
may affect the research project or subjects’ willingness to continue participating.
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PART G: Informed Consent
1.
Research Team Members Involved in Consent Process
Name the individuals, and indicate the date of their IRB training, who have
obtained informed consent from participants throughout the life of the protocol:
2.
Problems Obtaining Consent
Since the last IRB review, have any problems emerged in obtaining informed
consent?
a. No problems
b. The following problems obtaining consent occurred: Explain
3.
Future Recruitment
a. We are no longer recruiting subjects.
b. We will continue to recruit subjects.
If you are still recruiting subjects, attach a copy of the consent form to be
stamped on approval – even if you have made no changes to it.
Changes to Consent Form
a. No changes needed.
b. Changes to our approved consent form are needed: Attach an IRB Protocol
Amendment Form with revised consent form.
4.
PART H: Other Information
Describe any other information relevant to IRB review, especially information
about risks associated with the research. Describe any significant new findings that
may relate to the subjects’ willingness to continue participation (these findings must
be provided to the subject in the informed consent form).
PART I: Changes to Approved Methods and Procedures
No changes in approved methods and procedures are needed.
Changes are needed. Attach an IRB Protocol Amendment Form and describe
changes planned.
The information provided in this report is accurate to the best of my knowledge. I
assure the IRB that my work involving human participants has been conducted in
accordance with the policies and procedures of the University of North Carolina
Wilmington, and within the previously approved protocol and conditions, if any,
imposed by the IRB.
____________________________________________
Principal Investigator’s Signature
__________________
Date
Submit one original signed, hard copy of this form and one electronic copy, and if
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applicable, 1) Informed consent form to be stamped, and/or 2) assent/permission form to
be stamped, 3) amendment form noting any changes to the IRB Coordinator, Leanne
Prete, Hoggard Hall, Room 176 or Campus Mail Box 5973, electronic copy to
pretel@uncw.edu.
PART J: Attachments
None
Amendment form detailing any changes
Informed Consent Form to be stamped
Assent/Permission Form to be stamped
Other
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