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Institutional Research Board

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Contents

  1. Research Subject to Institutional Review Board (IRB) Review:  Scope of IRB Review
    1. Research Conducted by "Affiliated" Faculty
    2. Projects for which the Researcher is a Consultant
    3. Research Conducted in Courses
    4. Individual Research Projects Conducted by Students
    5. Research Conducted at non-Viterbo University Sites
    6. Research in Multicenter Clinical Trials
    7. Pilot and Feasibility Studies
    8. Research involving a Secondary Use of Data
    9. Research using "Waste" or "Extra" Material
  2.  Fundamental Guidelines
    1. Ethical Principles
    2. Definitions and Policies
    3. Human Subject
    4. Research
    5. Responsible Project Investigator
    6. Voluntariness and Recruitment
    7. Informed Consent
    8. Confidentiality
    9. Research Risks and Benefits
    10. Adverse Events and Unanticipated Problems
    11. Adverse Events from Exercise Testing
    12. Record Retention
    13. Viterbo University Policy Statement
  3. Distribution of Responsibility
    1. Responsible Project Investigator
    2. Departmental Executive Officer
    3. Institutional Review Board(s)
    4.  Institutional Oversights
    5.  Individual or Institution Providing Access to Subjects
  4.  Review Procedures
    1.  Review of Human Subjects Research
    2. Exempt Research
    3. Grant Submissions that Involve Human Subjects
    4. Research Involving Special Subject Groups
    5. Children
    6. Prisoners
    7. Pregnant Women, Human Fetuses (and fetal material), and Neonates
    8. Research in Foreign Countries
  5.  Glossary of Terms