The University of Texas Southwestern Medical Center at Dallas

Institutional Review Board

Protocol Template (for Investigator Initiated Studies)

Title:

1. Introduction and Purpose:

2. Background:

3. Concise Summary of Project:

4. Study Procedures:

5. Sub-Study Procedures:

6. Criteria for Inclusion of Subjects:

7. Criteria for Exclusion of Subjects:

8. Sources of Research Material:

9. Recruitment Methods and Consenting Process:

10. Potential Risks:

11. Subject Safety and Data Monitoring:

12. Procedures to Maintain Confidentiality:

13. Potential Benefits:

14. Biostatistics: (omit this section for peer-reviewed research such as cooperative group, or NIH- sponsored studies, and for industry-sponsored research which has been submitted to FDA)