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The HRPP Operations Manual (OM) describes the overarching rules governing the University of Michigan's Human Research Protections Program (HRPP) and serves as a policy and procedural reference for investigators, IRBs, administrators, and others.
HRPP Operations Manual
The HRPP Operations Manual has 13 parts. Click a link to review a particular part, or download the OM from the References & Resources section below.
Part 1: Introduction, Purpose and Ethical Principles - Describes the scope of human research conducted at the University of Michigan (U-M), the mission and purpose of the HRPP, and the authority and ethical principles under which the HRPP operates.
Part 2: Organization of the HRPP - Describes the organization of the U-M HRPP and the roles and responsibilities of the various units that guide and support the program. This section also describes the general allocation of resources to the various units involved in the HRPP.
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.
Part 4: Activities Subject to the HRPP - Describes when a particular activity is subject to the U-M HRPP, provides examples of not regulated activities, and outlines the policy on exempt research.
Part 5: IRB Jurisdiction, Cooperative Research, and Reliance Agreements - Describes the scope of jurisdiction of the various University IRBs and policies on cooperative research and IRB reliance agreements.
Part 6: Roles and Responsibilities of Researchers and Research Staff - Describes the roles and responsibilities of researchers and research staff engaged in University research.
Part 7: Participant Protection - Describes some of the ways research participants are protected under the HRPP, including: special protections for vulnerable populations, requirements for Data and Safety Monitoring Plans and Boards; review of advertising and recruitment materials, payment to research participants, and compensation for injuries.
Part 8: Studies Regulated by the FDA and Use of Investigational 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.
Part 9: Conflicts of Interest and Commitment - Describes how conflicts of interest and commitment in research can adversely impact the integrity of research results and the confidence of prospective volunteers in the research enterprise. The University seeks to identify, disclose, and eliminate or manage conflicts to avoid these negative repercussions.
Part 11: Laws, Regulations, and Standards - Describes selected laws and regulations impacting human research conducted at the U-M by faculty, staff, students, and other trainees.
Part 12: Quality Assurance and Research Compliance - Describes the HRPP's quality assurance and quality improvement activities and objectives, reportable events, and research compliance oversight.
Part 13: Education and Training - Describes educational resources available at the University and outreach activities to research participants and their communities