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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/neonatesComplete 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 impairmentComplete Appendix W Research in international settingsComplete 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. Page 1 of 2 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.)? Page 2 of 2 Form Date: 09/04/13 Version 3.1