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THE OHIO STATE UNIVERSITY
Institutional Review Board
APPENDIX T
All Other Research Changes
PROTOCOL NUMBER
Complete this form to request changes to IRB approved research, except changes in study personnel or participant
numbers. Use Appendix O to request changes in study personnel and Appendix Q to request changes in participant
numbers.
Depending on the requested changes, you may also need to complete additional appendices.
As applicable, provide the currently approved materials (marked as “current”), and the revised materials, one copy with
change(s) underlined (or “tracked”) and one copy with change(s) incorporated (clean). All materials should be submitted
single sided.
To request changes before the next continuing review, include the Amendment/Changes to Research form.
1. Will changes be made to any of the following? (check all that apply)
No changes to any Appendices.
Children  Complete Appendix I
Pregnant women/fetuses/neonatesComplete Appendix K
Do not complete Appendix K unless pregnant women will
be intentionally recruited and/or studied.
Data repositories  Complete Appendix C
Prisoners  Complete Appendix L
Deception  Complete Appendix D & Appendix M1
Radiation  Complete Appendix V
Adults with decisional impairmentComplete Appendix
W
Research in international settingsComplete Appendix U
Devices  Complete Appendix E
Storage of biological materials  Complete Appendix H
Drugs or biologics  Complete Appendix F
Waiver or alteration of consent/parental permission process
 Complete Appendix M1
Genetic testing  Complete Appendix G
Waiver of consent/parental permission documentation 
Complete Appendix M2
Non-English speaking  Complete Appendix J
Waiver or alteration of HIPAA research authorization 
Complete Appendix N
2. Describe the change(s) to the research and provide a rationale for each change.
3.
Will there be any change in the risk(s) to participants?
Yes
No
If Yes  Explain:
4.
Will there be any change in the benefit(s) to participants? Compensation is not to be considered a benefit.
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Yes
No
Form Date: 09/04/13
Version 3.1
Appendix T – ALL OTHER RESEARCH CHANGES
If Yes  Explain:
5.
Could the proposed change(s) affect participants’ willingness to take part in the research?
Yes
No
If Yes  How will information be communicated to currently enrolled subjects (e.g., revised consent form, letter to
participants, etc.)?
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Form Date: 09/04/13
Version 3.1