IRB Protocol Amendment Form Revised March 2015 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. Attach a copy of the grant proposal. 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: 1 PART D: Changes to Personnel Changes to personnel are needed. Please explain: Ensure ORS 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 IRB Coordinator, Leanne Prete, Hoggard Hall, Room 176 or Campus Mail Box 5973. 2 PART H: Attachments None Grant Proposal for New Funding Source New/revised surveys, questionnaires, recruitment letters, etc. Training Certificates for New Personnel Letters of Support for New Sites Informed Consent Form to be Stamped Assent/Permission Form to be Stamped Other 3