IRB Annual Protocol Renewal Form
Revised October 2011
For IRB Use Only
Protocol #: _________________
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:
Principal Investigator:
Department:
Title of Project:
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
_________________
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
EXPIRATION DATE:
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):
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.
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.
PART D: Number of Subjects
Number of subjects approved by the IRB:*
*Include number approved on original protocol and approved on subsequent amendments, if any.
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 a protocol
amendment form to request an increase in the number of subjects.
PART E: Withdrawal of Subjects or Adverse Events
 Describe any withdrawal of subjects from the research. Include whose decision
it was to withdraw and the reason.
 Describe any complaints received about the research since the last IRB review.
 Describe any adverse events or unanticipated problems involving risks to
subjects or others.
 If NONE for any of the above, this should be indicated. 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.
PART G: Informed Consent
If you are still recruiting subject, attach a copy of the consent form to be stamped on
approval – even if you have made no changes to it.
Describe any proposed changes made to the consent form.
Name the individuals, and indicate the date of their IRB training, who have
obtained informed consent from participants throughout the life of the protocol:
Since the last IRB review, have any problems emerged in obtaining informed
consent?
No
Yes (explain)
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: Future Plans
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No changes are planned.
Changes are planned. (Attach an IRB Protocol Amendment Form.)
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
applicable, 1) Informed consent form to be stamped, and/or 2) assent/permission form to
be stamped, 3) amendment form noting any changes to Angela Pennell Kelly, Regulatory
Compliance Officer, Hoggard Hall, Room 174 or Campus Mail Box 5973, electronic
copy to kellya@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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