The HRPP Operations Manual (OM) is designed to illuminate the system and its overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.

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Part 1: Introduction, Purpose and Ethical Principles - describes the mission of the University of Michigan, the purpose of the University's Human Research Protection Program (HRPP) and authority under which it operates, and the scope of research conducted at the University. (PDF version)

Part 2: Organization of the HRPP - describes the organization of the University of Michigan's Human Research Protection Program (HRPP) and the roles and responsibilities of the various units that guide and support the program. (PDF version)

Part 3: HRPP Policy - describes the process by which HRPP policies are developed, approved and implemented, and articulates minimum requirements for IRB standard operating policies and procedures. (PDF version)

Part 4: Activities Subject to the HRPP - explains when a researcher becomes engaged in human research and describes the University's policy on exempt research. (PDF version)

Part 5: IRB Jurisdiction and Cooperative Research - describes the scope of jurisdiction of the various University IRBs and policies on cooperative research and deferred review. (PDF version)

Part 6: Roles and Responsibilities of Investigators and Research Staff - describes the roles and responsibilities of investigators and research staff engaged in University research. (PDF version)

Part 7: Participant Protection - describes some of the ways research participants are protected under the HRPP. (PDF version)

Part 8: Use of Test Articles - describes when or under what circumstances an Investigational New Drug application or Investigational Device Exemption is needed; and describes IRB responsibilities with respect to protocols involving investigational test articles. (PDF version)

Part 9: Conflicts of Interest and Commitment (PDF version)

Part 10: Sponsored Projects - describes policies and procedures for the administration of sponsored project agreements for human subjects research. (PDF version)

Part 11: Standards, Compliance and Education - describes selected laws and regulations impacting human research conducted at the University of Michigan and the University's implementation and educational activities to promote compliance with these regulations. (PDF version)

Part 12: Quality Assurance and Research Compliance - describes the University's quality assurance, quality improvement and enforcement activities. (PDF version)

All documents published on this website comprising the Operations Manual are in Adobe Acrobat (PDF) format. Free Acrobat Reader software is available on the Adobe website.

March 2008