FORM: Modifications Required to Secure Approval of Human Research

FORM: Response to IRB review

NUMBER DATE PAGE HRP-214 12/27/2012 1 of 3

Use to respond when modifications are required to previous IRB submission IRB Number: Protocol Name: Investigator: Primary

Contact: Check whether this form is in response to: Request for modifications to secure approval. If so, provide a point-by-point response to the required modifications. Deferral. If so, provide a point-by-point response to reasons for deferral and the recommendations. Disapproval. If so, provide a point-by-point response to the reasons for disapproval. Please address below each of the issues identified by the IRB by listing the IRB’s reasons and/or recommendations(s) with your response underneath each item (you may also attach your response to this form):

©2009 Huron Consulting Services, LLC. Huron Consulting Group Use and distribution subject to End User License Agreement at Experience. Redefined.™ http://www.huronconsultinggroup.com/SOP [email protected] FORM: Response to IRB review

Provide copies of the following when they have been modified or are now applicable . Application Application for Human Research Note: If any of the modifications impact the content of your application, you must revise it to be reflective of these changes. Highlight/bold all changes from previous version Appendix A: Internal Departmental Approvals Appendix B: External Site Approvals Appendix C: Children Appendix D: Drugs/Biologics Appendix E: Devices Documents Protocol AEHN Protocol/ Summary Note: If any of the modifications impact the content of this form, you must revise it to be reflective of these changes. Highlight/bold all changes from previous version Data Collection Instruments (if investigator initiated research with waiver of consent/authorization) Contact Information Form (for all individuals who do not already have a form on file in the IRB Office and any individuals with updated information) COI Screening Form (for all new individuals and any individuals with updated disclosure information) All written material to be provided to or meant to be seen or heard by subjects, including: Evaluation Instruments (to be completed by subjects) and Surveys Advertisements (printed, audio, and video) Recruitment Materials (letters, phone scripts, posters) Consent Documents or Information Sheets Foreign language version of any written material to be provided to or meant to be seen or heard by subjects. If consent will not be documented in writing, a script of information to be provided orally Provide the following documents when they exist: Investigator’s brochure for each investigational drug/biologic Package insert for each marketed drug/biologic Product information for each investigational device Other:

Investigator Acknowledgement I agree to conduct this Human Research in accordance with applicable regulations and the organization’s policies and procedures. Investigator Signature Date

©2009 Huron Consulting Services, LLC. Huron Consulting Group Use and distribution subject to End User License Agreement at Experience. Redefined.™ http://www.huronconsultinggroup.com/SOP [email protected] FORM: Response to IRB review

©2009 Huron Consulting Services, LLC. Huron Consulting Group Use and distribution subject to End User License Agreement at Experience. Redefined.™ http://www.huronconsultinggroup.com/SOP [email protected]