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IRB Member Orientation: Guidance, Documents, Regulations and Local Policy

  1. Staff and Contact Information
  2. UTHSC Standard Operating Procedures
  3. The Belmont Report
  4. World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
  5. OHRP IRB Guidebook
    • Institutional Administration
    • Regulation and Policies
    • Basic IRB Review
    • Considerations of Research Design
    • Biomedical and Behavioral Research
    • Special Classes of Subjects
  6. 45 CFR 46
  7. 45 CFR 160 and 164
  8. ICH Guidelines for Good Clinical Practices E-6, E7, E8, E10, E11, E12a
  9. 21 CFR 50, 56, 312, 601, 812, and 814
  10. FDA Information Sheets for IRBs and Clinical Investigators (1998 Update)
    • Background
    • General
    • Drugs and Biologics
    • Medical Devices
    • FDA Operations