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Operations Manual, June 2012 - 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 mission of the University of Michigan, the purpose of the University's Human Research Protection Program (HRPP), the authority under which it operates, and the scope of research conducted at the University.

  1. Mission Statement and Organizational Summary
  2. Scope of Human Research at the University
    1. Types of Human Research Conducted
    2. Categories of Participants
  3. Institutional Authority
  4. Limitation on Institutional Authority
  5. Protection from Undue Influence
  6. Ethical Principles

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.

  1. Key Organizational Representatives
  2. Organizational Entities that Support the HRPP
    1. Office of the Vice President for Research
      1. Policy Implementation, Communication and Education
      2. Recordkeeping and Reporting
      3. Monitoring and Oversight
      4. Organization
        1. HRPP
        2. ORSP (formerly DRDA)
        3. OHRCR
        4. Committees and Working Groups
          1. Human Research Coordinating Council
          2. IRB Council
          3. eResearch
          4. Research Associate Deans
    2. The Academic Units
    3. The IRBs
      1. Authority of the UM IRBs
      2. Primary Responsibility to Human Subjects
      3. SOPs, Procedures and Guidance
    4. Other Research Review Units
      1. Biomedical Engineering
      2. Comprehensive Cancer Center
        1. Clinical Trials Office
        2. Protocol Review Committee
        3. Tissue Procurement Service
      3. Conflict of Interest Committees
      4. Michigan Institute for Clinical and Health Research
      5. Institutional Biosafety Committee
      6. Investigational Drug Service
      7. Radiation Safety Servce
      8. Research Centers
    5. Roles and Responsibilities of Other Units Supporting the HRPP
    6. Independence of Research Review Units to Undue Influence
  3. Resources

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.

  1. Introduction
  2. The Operations Manual
  3. IRB Standard Operating Policies and Procedures
    1. General Provisions
    2. Organization and Personnel
    3. IRB Functions and Operations
      1. Application Submissions
      2. General Review and Approval Procedures
        1. Determining whether and under what authority the research is regulated
        2. Initial and continuing review and review of other applications
        3. Frequency of review
        4. Monitoring and verification
        5. Reporting changes in research
        6. Lapses in approval
      3. Criteria for Expedited Review
      4. Criteria for IRB Approval
        1. Minimizing risk
        2. Risk-benefit analysis
        3. Equitable subject selection
        4. Informed consent
          1. Informed consent waivers, alterations, exceptions, ans substitutions
          2. Studies subject to FDA regulations
          3. Studies subject to both HHS and FDA regulations
          4. Studies subject to HIPAA regulations
        5. Data monitoring
        6. Privacy and confidentiality protection
        7. Vulnerable subjects
        8. Institutional approval
        9. Test article accountability procedures
        10. Resources
      5. IRB Meetings
      6. Notification of Decisions
      7. Response to Complaints and Allegations of Noncompliance and Related Reporting Requirements
    4. IRBs Reviewing and Monitoring FDA-Regulated Research
    5. IRB Member and Consultant Conflicts of Interest
    6. Records and Reports
    7. Educational Activities
    8. Quality Assurance and Quality Improvement
    9. Other Review Units

Part 4: Activities Subject to the HRPP - (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.

  1. Determining What is Research and What is Not
  2. Determining Whether Research Involves Human Subjects
  3. Determining Whether the University is Engaged in Human Research
  4. Determining When Research Begins and Ends
  5. Authority to Make Regulated/Not Regulated Determinations and Notification of Decisions
    1. Authority to Make Human Research/Not Human Research Determinations
    2. Illustrations
    3. Student Practicum and Internships
    4. Notification of Decisions
  6. Policy on Exempt Research
    1. Introduction
    2. Categories of Eligibility for Exempt Determination
    3. Authority to Grant Exempt Status
    4. Notification and Documentation of Exempt Status

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.

  1. Which UM IRB
    1. IRB-Flint
    2. IRB-Dearborn
    3. IRB-Health Sciences and Behavioral Sciences
    4. IRBMED
    5. Ensuring Adequate IRB Capacity
  2. Cooperative Research
    1. Engagement in Human Research
    2. Default Position on Outside Entities Engaged in University Research
    3. Researcher and IRB Responsibilities with Regard to Performance Sites not Engaged in Research
    4. Special University IRB Responsibilities for Multi-Site Research in Which the University is Involved
      1. Generally
      2. UM as a Lead or Operations Coordinating Center
  3. Coordinated or Joint Review
    1. IRB of Record
      1. Statement of Principles
      2. Procedures for a UM IRB to Become IRB-of-Record for Another Institution
      3. Procedures for Ceding Authority to Another IRB
    2. Responsibilities of the HRPP and Local IRB in Multi-Site Research
  4. Unaffiliated Investigators
  5. 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.

  1. Eligibility to Perform Research at the University of Michigan
    1. Who May Apply to Serve as Principal Investigator on IRB Applications
    2. Other Key Personnel
  2. Roles and Responsibilities of Investigators and Research Staff
    1. Generally
      1. Minimizing risks to subjects and protecting subject rights and welfare
      2. Compliance with IRB and other review unit requirements
      3. Obtaining and documenting informed consent
      4. Conflict of interest disclosures
      5. Accountability and additional administrative requirements
    2. Studies Regulated by the FDA
  3. Education

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

  1. HRPP Protection Extends to All Subjects
  2. Data and Safety Monitoring Plans
  3. Payment to Research Subjects
  4. Vulnerable Subjects
    1. Research Involving Pregnant Women, Fetuses, and Neonates
      1. Research involving pregnant women or fetuses
      2. Research involving neonates
      3. Research involving, after delivery, the placenta, the dead fetus, or fetal material
      4. Research not otherwise approvable
    2. Research Involving Prisoners
      1. Who is a prisoner?
      2. IRB composition
      3. Additional conditions on research involving prisoners
      4. Permitted categories of research
    3. Research Involving Children
      1. Research involving no more than minimal risk
      2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
      3. Research involving greater than minimal risk and with no prospect of direct benefit to individual subjects
      4. Otherwise unapprovable research
    4. Research Involving Adults with Cognitive Impairment or Otherwise Impaired Decision-Making Capacity
      1. Research involving no more than minimal risk
      2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
      3. Otherwise unapprovable research
  5. Compensation for Injuries
  6. Advertising Materials

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.

  1. Investigator Responsibilities
  2. Determination that an IND or IDE is Required
    1. Investigational Drugs and Biologics
    2. Investigational Devices
      1. Generally
      2. Significant risk (SR)/non-significant risk (NSR) determinations
      3. Device studies exempt from IDE requirements
  3. Withholding Final Approval Pending Verification of IND or IDE Acquisition
  4. Institutional or Employee Sponsorship of INDs and IDEs
  5. Early and Expanded Access to Test Articles
    1. Investigational Drugs
      1. Single patient INDs for emergency or compassionate use
      2. Treatment INDs
      3. Parallel track studies
      4. Open label protocols or open protocol INDs
    2. Investigational Devices
      1. Emergency use
      2. Compassionate use
      3. Treatment use
    3. Continued Access
    4. Additional Exceptions
  6. Charging for Test Articles
    1. Investigational Medical Devices and Radiological Health Products
    2. Charging for Investigational Drugs and Biologics
      1. Clinical Trials
      2. Treatment Protocols and Treatment INDs
  7. Electronic Records and Electronic Signatures

Part 9: Conflicts of Interest and Commitment

  1. Applicable Policies
  2. Conflict of Interest of Investigators and Research Staff
    1. Identification of Significant Financial or Outside Management Interests in Human Research That Could Form the Basis of a Conflict of Interest
      1. Sponsored projects
      2. Human subject protocol application
      3. Disclosures first received by schools and colleges pursuant to COI/COC policies
      4. Sponsored project and technology transfer negotiations
      5. IRB, sponsored project, and technology transfer consultants to Conflict of Interest committees
    2. Conflict Review and Management
  3. Conflict of Interest of IRB Members, Consultants and Staff
  4. Institutional Conflicts of Interest

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

  1. Role of the Division of Research Development Administration
  2. Agreements with Sponsors
    1. Human Research Protection Program
    2. Medical Care for Human Research Participants with A Research-Related Injury
    3. Communication of Findings that May Affect the Safety of Human Research Participants or Their Willingness to Continue in the Research Study
    4. Finder's Fees and Bonus Payments
  3. Dissemination of Findings from the Research
  4. Additional Information

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.

  1. Introduction
  2. Governing Laws, Regulations and Other Standards
    1. Federal Research Laws and Regulations
      1. Department of Health and Human Services
        1. Office of Human Research Protections
        2. Food and Drug Administration
        3. National Institutes of Health, Office of Biotechnology Activities
        4. Office of Research Integrity
      2. Other Federal Agencies
      3. Additional Federal Regulations
        1. Department of Defense (DoD)
          1. Education
          2. IRB Review
          3. International Research
          4. Collaborative Agreements
          5. Research Monitors
          6. Research Involving U.S. Military Personnel
          7. Disclosure and Consent
          8. Prisoners of War
          9. Non-Compliance
        2. Department of Justice (DoJ)
          1. Research Conducted with the Bureau of Prisons
          2. Research Conduct with the National Institute of Justice
        3. Environmental Protection Agency (EPA)
          1. Prohibited Research
          2. Observational Research
    2. Other Legal Standards That Impact Human Research
    3. International Research
    4. ICH-GCP
      1. Investigator Responsibilities Regarding Subject Medical Care and Safety
      2. Investigator Responsibilities to the IRB and Sponsoring Agency
      3. Consent Process
    5. Access to Legal Counsel
  3. Other Related Laws, Regulations, and Standards
    1. Informed Consent and Legally Authorized Representatives
      1. General Requirements for Informed Consent
      2. Who May Give Consent
        1. Children as subjects
        2. Incompetent and incapacitated people
      3. Michigan Law Requiring Special Consent
        1. Breast cancer treatment
        2. Electroconvulsive therapy
        3. Genetic testing
        4. HIV/AIDS testing
        5. Pregnancy termination
        6. Surgery for mental health patients
        7. Terminal illness
    2. Confidentiality of and Access to Research Records and Other Information
      1. Confidentiality of Research Records Generally
      2. Research Involving Use or Disclosure of Patient Health Information
        1. HIV/AIDS and Other Serious Communicable Diseases
        2. Mental health treatment
        3. Substance abuse treatment
      3. Research Involving Student Records
      4. Research Involving Department of Education-funded Surveys, Analysis, or Evaluation
      5. Mandatory Disclosure Requirements
        1. Michigan Freedom of Information Act
        2. Public health reporting: disease surveillance
        3. Standards for reporting abuse, neglect and domestic violence
          1. Child abuse and neglect
          2. Vulnerable adults
          3. The "Gun and Knife Law"
        4. Court orders and subpoenas
      6. Protecting Against Disclosure: Certificates of Confidentiality
    3. Research Involving Prisoners and Other Detained Persons
    4. Research Involving Pregnant Women, Fetuses and Neonates
    5. Stem Cell Research
    6. Data and Specimen Repositories
    7. Document Control and Record Retention and Destruction
      1. Generally
      2. Investigator and Sponsor-Investigator Responsibilities
      3. IRB Responsibilities
    8. State Professional Licensing Laws and Institutional Credentialing Policies
    9. Registration of Clinical Trials
  4. Education and Training
    1. Educational Initiatives for the Research Community
    2. Tracking and Communicating New Developments
    3. Outreach Activities for Human Research Participants, Prospective Participants and Their Communities

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

  1. Quality Assessment, Improvement, and Assurance
    1. Performance Measurement and Quality Assessment
    2. Quality Improvement
  2. Compliance Oversight
    1. Response to Complaints or Allegations of Noncompliance
    2. Noncompliance Review Procedures
      1. Definitions
      2. Process Summary
      3. Rights of faculty, staff, or others accused of noncompliance
      4. Assurances of appropriate confidentiality
      5. Policy against retaliation for reporting
    3. How Compliance Concerns are Brought Forward
    4. Receipt and Initial Handling of Allegations of Noncompliance
    5. Chair and Board Considerations and Determinations
    6. Detailed Procedures for Investigating Allegations of Noncompliance
    7. Response to Determinations of Noncompliance
    8. Institutional Notification and Reporting Requirements
  3. Procedures for Review and Reporting of Unanticipated Problems Involving Risks to Subjects or Others, Serious or Continuing Noncompliance, or Suspension or Termination of IRB approval
    1. Background
    2. Roles and Responsibilities
      1. Researchers
      2. The IRBs
      3. Office of the Vice President for Research
      4. Office of Human Research Compliance Review

June 2012