1. Module 1 About University Research Responsibilities of PI and Research Staff Research at the University of Michigan PI and Research Staff Responsibilities

2. General Information about Research at the University of Michigan Departments that oversee research involving Human Subjects: OVPR (Office of the Vice President for Research) DRDA (Division of Research Development Administration) HRPP (Human Research Protection Program Office) The UM IRB’s IRB Application Process Possible interview questions about UM Research Information about your responsibilities as a researcher

3. University Research Office of Vice President for Research oversees all aspects of research at the University of Michigan. Vice President for Research: Stephen Forrest Division of Research Development and Administration: Helps submit proposals Reviews Contracts Processes Grant Awards Makes sure that all sponsored research involving human subjects are submitted for IRB Review

4. HRPP : Human Research Protection Program Purpose: Protect the rights and welfare of human subjects participating in research at the university Promotes compliance with relevant legal requirements and ethical standards. Supports investigators in their research activities

5. 4 University IRB’s IRB Med IRB Health Sciences & Behavioral Sciences Dearborn IRB Flint IRB

6. IRB Application Process PI submits application via eResearch PI completes PEERRS Human Subjects training eResearch application goes to Reviewer If necessary reviewer requires changes to protocol to ensure adequate Human Subjects Protections are in place. When adequate protections are in place Reviewer approves the study. Reviewer may also determine that PI may not proceed with study.

7. Who has primary responsibility for protecting the rights & welfare of human subjects? The PI and Research team Safeguarding the subjects takes precedence over the goals and requirements of any research. The PI and research team are expected to know about and comply with the requirements of the ethical requirements of the Belmont Report and the Common Rule.Belmont Report Common Rule

8. Human Subjects Training & Support Resources All University of Michigan researchers must complete the relevant PEERRS Human Subjects module. Director of Research & Sponsored Programs is available to answer questions. IRB Administrator is available to answer basic questions. ORSP Human Subjects webpage HRPP Webpage

9. Resources Dearborn Office of Research & Sponsored Programs PEERRS DRDA OVPR / HRPP

10. This is the end of module 1. This is the end of Module 1. Module 2 will discuss general vocabulary and principles related to Human Subjects Research.