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Operations Manual - Contents Page
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.
Part 1: Introduction, Purpose and Ethical Principles
Describes the scope of human research conducted at the University of Michigan, the mission and purpose of the University’s Human Research Protection Program (HRPP), and the authority and ethical principles under which the HRPP operates.
- Mission and Purpose of the HRPP
- Scope of Human Research at the University
- Authority Under Which the HRPP Operates
- Ethical Principles
- Protection from Undue Influence
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. This section also describes the general allocation of resources to the various units involved in the HRPP.
- Key Organizational Representatives
- Organizational Entities that Support the HRPP
- The U-M Office of Research (UMOR)
- Policy Implementation, Communication, and Education
- Recordkeeping and Reporting
- Monitoring and Oversight
- Organization
- Leadership of the Human Research Protections Program (HRPP)
- Office of Research and Sponsored Programs (ORSP)
- Office of Research Compliance Review (ORCR)
- IRB Council
- eResearch
- Research Associate Deans (RADs)
- The Academic Units
- The Institutional Review Boards (IRBs)
- Other Research Review Units
- Independence of Research Review Units and Response to Undue Influence
- Resources
- The U-M Office of Research (UMOR)
Describes the process by which HRPP policies are developed, approved and implemented, and articulates minimum requirements for IRB standard operating policies and procedures.
- Introduction
- HRPP Operations Manual
- IRB Standard Operating Policies and Procedures
- IRB Authority and Guiding Principles
- IRB Organization and Personnel
- IRB Review Policies and Procedures
- IRB Jurisdiction and Authority
- Institutional Approval/Disapproval of IRB Decisions
- Submission of IRB Applications and Reports
- General Review and Approval Procedures
- Expedited Review
- Criteria for IRB Approval
- IRBs Reviewing and Monitoring FDA-Regulated Research
- IRB Administrative Functions
- Quality Assurance and Quality Improvement
- Other Review Unit Standard Operating Policies and Procedures
Part 4: Activities Subject to the HRPP
The conduct of human research triggers a broad array of regulatory and institutional requirements, including advance approval from IRBs and other review units. To determine whether a particular activity is subject to the University’s HRPP or when the requirements of the HRPP are triggered, four questions must be answered: (i) is it human research under the Common Rule; (ii) is it human research under FDA regulations; (iii) is the University of Michigan engaged in the research; and (iv) when does the research begin and end.
- Determining What Is and What Is Not Human Research
- Determining Whether Research Involves Human Subjects
- Determining Whether the University Is Responsible for IRB Oversight of Human Research
- Determining When Research Begins and Ends
- Authority to Make Regulated/Not Regulated Determinations and Notification of Decisions
- Policy on Exempt Research
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.
- Introduction
- Which U-M IRB
- Cooperative Research
- Coordinated or Joint Review
- Unaffiliated Investigators
- Research Involving Community Members in the Research Process
Part 6: Roles and Responsibilities of Investigators and Research Staff
Describes the roles and responsibilities of investigators and research staff engaged in University research.
- Eligibility to Perform Research at the University of Michigan
- Roles and Responsibilities of Investigators and Research Staff
Part 7: Participant Protection
Describes some of the ways research participants are protected under the HRPP.
- HRPP Protection Extends to All Subjects
- Data and Safety Monitoring Plans and Boards
- Payment to Research Subjects
- Vulnerable Subjects
- Compensation for Injuries
- Advertising Materials
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.
- Introduction
- Research Involving INDs or IDEs
- Expanded Access to Investigational Drugs, Biologics, and Devices
- Emergency Use of Investigational Articles
- Planned Emergency Research Using Investigational Articles
- Humanitarian Use Devices (HUD) and Humanitarian Use Exemptions (HDE)
- FDA Sponsors and Sponsor-Investigators
- Investigator and IRB Responsibilities for FDA-Regulated Research
- Ensuring Review by Appropriate IRB
- Verification of IND or IDE Acquisition Prior to Release of Final IRB Approval
- Oversight of FDA-Regulated Research
- Investigational Article Accountability
- Charging for Investigational Articles
- Records and Documentation
- Required Reporting
- ICH-E6 and GCP
- FDA Inspections of FDA-Regulated Research and Related Activities
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.
- Applicable Policies
- Conflict of Interest of Investigators and Research Staff
- Conflict of Interest of IRB Members, Consultants and Staff
- Institutional Conflicts of Interest
Describes policies and procedures for the administration of sponsored project agreements for human subjects research.
- Role of the Division of Research Development Administration
- Agreements with Sponsors
- Assurance of Compliance with Human Research Protection Requirements
- Medical Care for Research-Related Injury
- Communication of Findings that May Affect the Safety of Research Participants, or Their Willingness to Participate, or Influence the Conduct of Research
- Dissemination of Findings from the Research
- Finder Fees and Bonus Payments
- Additional Information
Part 11: Laws, Regulations, and Standards
Describes selected laws and regulations impacting human research conducted at the University of Michigan.
- Legal and Regulatory Bodies
- Federal Agencies: Federal Research Laws and Regulations
- State Governments and Laws: Other Contractual Requirements
- International Research
- Laws, Regulations, and Standards Commonly Applicable to Research
- Informed Consent and Legally Authorized Representatives
- Confidentiality of and Access to Research Records and Other Information
- Research Involving Prisoners and Other Detained Persons
- Research Involving Pregnant Women, Fetuses and Neonates
- Stem Cell Research
- Document Control and Record Retention and Destruction
- State Professional Licensing Laws and Institutional Credentialing Policies
- Clinical Trials Disclosure Requirements
- Access to Legal Counsel
Part 12: Quality Assurance and Research Compliance
Describes the University’s quality assurance, quality improvement and research compliance oversight.
- Quality Assessment and Improvement
- Reportable Events: Adverse Events, Unanticipated Problems, and Suspension or Termination of IRB Approval
- Background
- Definitions
- Roles and Responsibilities for Required Reporting of Reportable Events
- Compliance Oversight
- Response to Complaints or Allegations of Noncompliance
- Noncompliance Review Procedures
- How Compliance Concerns are Brought Forward
- Receipt and Initial Handling of Allegations of Noncompliance
- Chair and Board Considerations and Determinations
- Actions of the HRPP Director as Delegated by the Institutional Official
- Response to Determinations of Noncompliance
- Institutional Notification and Reporting Requirements
Part 13: Education and Training
Describes educational resources available at the University and outreach activities to research participants and their communities.
- Education in General
- HRPP Leadership Tracking and Communicating New Developments
- IRB Chairs, Members, and Staff Education
- Researchers and Research Staff Education
- Research Participants and Their Communities: Engagement, Education, and Outreach Activities
- Quality Assessment of Community Outreach Programs
Questions?
To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to hrppumich@umich.edu.