The University of Tennessee Health Science Center College of Medicine, Knoxville


The Institutional Review Board

IRB Forms, Guides, and Documents

Non-Human Subjects Research Forms

NOTE: Non-Human Subjects Research Forms should be typed, signed as indicated on the form, scanned, and emailed to clangley@utmck.edu

Case Report Form
Not Human Subjects Form
Quality Improvement Form

Pre-Application Forms

UHS HIPAA Data Collection Preparatory to Research Form
UTHSC COM-Knoxville HIPAA Data Collection Preparatory to Research Form

Submitting an Application to the IRB

DR IRB Information

To submit applications to the IRB, please follow the link to DR IRB

Please note: Current completion of CITI Group 3, Group 4, or equivalent is required for all study team members at the time of submission.

Collaboration Forms:

Protocols, Templates and Appendices

Consent Form Template

Exempt 4 ONLY Protocol Template

Exempt Protocol Template

Expedited and Full Board Protocol Template

Study Personnel Appendix

Medical Devices Appendix

Drug Appendix

HIPAA Appendix

Blood Draws and Biosamples Appendix

Waiver or Alteration of Consent Appendix

Continuing Review Form

External IRB Approval Form

Reportable New Information Form

IRB Guides

Survey Consent Guide

Resident Travel Guide

DSMB Guide

IRB Documents

Data Sharing - Data Use Agreement (De-identified)

Sample IRB Budget Excel Spreadsheet

Routine Costs in Clinical Trials

Outside Interest Disclosure Form - Faculty and Staff

Privacy Rule

Glossary of Lay Terms

Translator's Declaration Form

Getting Started with Research Packet

 

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