University of Wisconsin-Stevens Point
Institutional Review Board for the Protection of Human Subjects
Request for Change(s)to an Exempt or Expedited Approved Protocol
(For Exempt or Expedited Protocols Only)
The IRB requires that if you are making minor or major changes to your expedited protocol after you have obtained approval (within
the first 12 months) or to your exempt protocol (within the first five years) that you submit the following form. Please submit 2 hard
copies to ORSP and email an electronic copy to the IRB Chair dpalmer@uwsp.edu and Sharon Courtney scourtne@uwsp.edu.
Minor changes to protocols that do not increase the risk(s) to participants (i.e. changes in research team) do require the approval of
the IRB Chair, Dr. Debbie Palmer.
Major changes to the protocol are those that may change the potential risk(s) to the participants (i.e. changes in research procedures).
It may be advisable to submit a new protocol application file rather than this form as the changes you request may alter the
categorization of the protocol (i.e. from exempt or expedited to full board reviews).
Principal Investigator(s)
Faculty Sponsor(s) (when appropriate)
Department/Division:
Title of Original Protocol
Date of Original Approval
Project Period Starting Date:
Project was oringinally approved as:
Ending Date:
Exempt
Expedited
What is the currrent status of this research?
Ongoing Data Collection - Estimated completion date:
Pending -- not yet started - Expected start date:
Please complete all of the questions on the next page. If you do not properly complete and file
this report, the IRB will not renew your protocol.
(Signature of Principal Investigator(s))
(Signature of Faculty Sponsor if required)
****************************** Do not write below this line – for IRB use only ***********************
IRB approval
__________________________________
(Signature of IRB Chair)
Date
________________
_
Form revised: January 2016
1. What changes are you proposing to your protocol? Please explain those changes here.
2. How will the changes potentially affect the risk(s) to individuals participating in this research?
What safeguards will you use to address the risk(s)?
3.
Please attach a copy of your protocol application highlighting any changes since the last
approval.
Form revised: January 2016