IRB Protocol Amendment Form
Revised June 2010
University of North Carolina Wilmington
Institutional Review Board
Protocol Amendment Form
For IRB Use Only
Protocol #: _________________
Orig. Rev. Type: ___________
Last Approval Date:_________
Amendment Date: ___________
Expiration Date: ____________
PART A: General Protocol Information
Title of Project:
Protocol Number:
PI Name:
Department:
Check if this research has been audited since the last IRB review.
Office Use ONLY:
Type of IRB Review:
Full Review
Expedited
Type of Protocol Changes:
Major Changes
Minor Changes
Results: Approved
Approved Pending Revisions
Tabled
________________________________________________
Signature of the IRB Chair or Designate
If necessary, revisions received:
Results: Approved
Approved Pending Revisions
________________________________________________
Signature of the IRB Chair or Designate
Exempt
Disapproved
__________________
Date
Tabled
Disapproved
__________________
Date
EXPIRATION DATE:
A copy of this page, signed by the IRB Chair, serves as formal notice of the approval
or disapproval of this amendment, or the need to revise. This amendment approval
does not change the existing expiration date of the protocol. The protocol is effective
during the dates in the upper right corner. If the study is expected to continue past
the expiration date, please submit an Annual Renewal form. UNCW IRB Policy
requires the submission of a Closure form at the completion of a study.
PART B: Changes to Funding Source
There is a different/additional funding source. Please explain:
PART C: Changes to the Protocol (such as changes in the number or type of
subjects, changes in procedures, changes to surveys or recruitment materials, etc.)
Changes to the protocol are needed. Please explain:
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PART D: Changes to Personnel
Changes to personnel are needed. Please explain: (Ensure ORSSP has
documentation of training completion on file.)
PART E: Changes to Location
Changes to the location are needed. Please explain: (Attach a copy of the site letter
of support if you are changing to a new location where the subjects have a
reasonable expectation of privacy, such as a public school, nursing home, or clinic.)
PART F: Changes to the Consent or Assent/Permission Form
Changes to the consent or assent/permission form are needed. Please explain:
(Attach a copy of the revised form to be stamped.)
PART G: New Conflicts of Interest
New conflicts of interest have been identified. Please explain how the conflict(s)
will be managed:
Do any of the proposed changes increase the potential risk to the subjects or others?
No
Yes, Explain:
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
__________________
Type Name
Submit one original signed, hard copy of this form and if applicable, 1) training
certificates for new personnel (if not already on file) 2) letters of support for new sites
and 3) proposed consent form or assent/permission form to the Regulatory
Compliance Officer, Angela Pennell Kelly, Hoggard Hall, Room 174 or Campus Mail
Box 5973.
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PART H: Attachments
None
Letters of Support for New Sites
Informed Consent Form to be Stamped
Assent/Permission Form to be Stamped
Other
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