Application for Approval for Research Involving Human Subjects REQUEST FOR MODIFICATION OF APPROVED PROTOCOL
SUBMISSION PROCEDURES
Investigator must submit most recent application, signature page, and any accompanying documents via email to irb@chapman.edu Application and informed consent forms must be submitted in a Word document. For any questions, please refer to the IRB website or contact the IRB staff at irb@chapman.edu or (714)628-7392.
IRB#	Current IRB#
Protocol Title:	Protocol Title
Today’s Date:	Today’s Date	Protocol Expiration Date:	Expiration Date

Chapman Principal Investigator (Faculty/Academic Professional Staff/Faculty Advisor):
☐	This is a Student-Directed Project and I am serving as Faculty Advisor
Name:	PI Name or Faculty Advisor	Email:	Email
Institute/Center/Department:	Institute/Center/Department
School/College:	Choose or type a School/College...	Phone:	Phone Number

Student Investigator (Complete only if Student-Directed Project – MUST have Faculty Advisor listed above):
☐	Graduate	☐	Undergraduate	Program/Major:	Program/Major
Name:	Undergraduate Co-Investigator	Email:	Email
Institute/Center/Department:	Institute/Center/Department
School/College:	Choose or type a School/College...	Phone:	Phone Number

CHECKLIST: Submit the following items with this Request for Modification:
☐	Updated consent forms, if applicable (One copy with changes marked + one clean copy for approval stamp)
☐	Any other supplementary documentation. Please describe:
Click here to enter text.

1) BRIEF DESCRIPTION OF ORIGINAL PROTOCOL:
Brief description of original protocol

2) DESCRIBE THE MODIFICATION(S) REQUESTED: Be sure to include reasons for the change(s). Make sure to identify, by name, any researchers or student researchers that have been removed and/or added to the protocol. Each new researcher must also complete the NIH (undergraduates) or CITI (graduates/faculty) training or provide proof of completion within the last 2 years.
Describe the modification(s) requested and give reason(s) for the change(s)

3) RISK TO HUMAN SUBJECT(S):
Will the modification(s), in your opinion, INCREASE or DECREASE the risk of harm to the subjects?	☐ Increase	☐ Decrease	☐ No Change
Please explain:	Explain change/no change in risk of harm

4) CONSENT FORM:
Will the modification(s) alter the approved consent form?	☐Yes	☐No
If yes, attach one highlighted copy of the revised consent form with additions and deletions clearly marked for review and approval, and a clean copy for approval in Word format.

5) UNANTICIPATED PROTOCOL DEVIATIONS:
Did any unanticipated protocol deviations (including errors and accidents) occur since the last review?	☐Yes	☐No
If yes, summarize all protocol deviations:
Summarize protocol deviations, if applicable

6) UNANTICIPATED RISKS OR FINDINGS
Have unanticipated risks or significant new findings been discovered since the previous IRB review that might affect the subject’s willingness to continue participation?	☐Yes	☐No
If yes, please complete the following:
6a)	Explain the risks or findings in detail:
Explain the risks or findings.
6b)	Do these risks or findings require modification to the informed consent form?	☐Yes	☐No
6c)	Were subjects notified of these risks or findings?	☐Yes	☐No
6d)	Were subjects reconsented?	☐Yes	☐No

PRINCIPAL INVESTIGATOR’S ASSURANCE STATEMENT & SIGNATURE PAGE

This page is to be read and signed by the Faculty/Academic Professional Staff member acting as principal investigator or faculty advisor for a student-directed project.
Principal Investigator (Faculty/Academic Professional Staff/Faculty Advisor)
I certify that the information provided in this application is correct and complete. I have read and understand Chapman University’s policies concerning research involving human subjects and I agree to comply with all IRB policies, decisions, conditions, and requirements and that all procedures will meet relevant local, state and federal regulations regarding the use of human subjects in research.
Name of Principal Investigator (Please Print)
Signature of Principal Investigator	Date

Application for Approval for Research Involving Human Subjects REQUEST FOR MODIFICATION OF APPROVED PROJECT
CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD APPROVAL
☐	The modification/amendment described in this Request qualifies for and has been approved by expedited review
☐	The modification/amendment described in this Request has been reviewed and approved by full committee review
☐	The modification/amendment described in this Request requires additional changes to secure approval
COMMENTS:
Comments from IRB Chair

Signature IRB Chair/Co-Chair, IRB Administrator, or Designated IRB Representative Chapman University (FWA) 00011020, valid through: September 4, 2017	Date