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Protection of Human Research Subjects

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Presentation by David L. Passmore in Penn State graduate course, Scholarly Inquiry in Workforce Education & Development

Presentation by David L. Passmore in Penn State graduate course, Scholarly Inquiry in Workforce Education & Development

Published in Education , Health & Medicine
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  • 1. Protection of Human Research Participants Scholarly Inquiry in Workforce Education & Development
  • 2. today…
    • History of protection of human research participants
    • Principles and practices in protecting human research participants
    • Difficult issues
    • Penn State policy for review, approval, and monitoring of use of human research participants
  • 3. History Protection of Human Research Subjects
  • 4. Progression
    • In the 1950s, the federal government had a minimal role in regulating research with human participants
    • Now, federal oversight of human subjects participation is substantial
  • 5. Milestones
    • 1948 - Nuremburg trials
    • 1955 - Wichita jury study
    • 1963 - Thalidomide experience
    • 1964 - NIH ethics committee
    • 1964 - World Medical Association Declaration of Helsinki
  • 6. Milestones (cont.)
    • 1973 - Congressional hearings
      • Willowbrook hepatitis study
      • Milgram study of obedience to authority
      • Tearoom trade study
      • Tuskegee syphilis study
  • 7. Milestones (cont.)
    • National Research Act of 1974
      • Established Commission on Protection of Human Subjects of Biomedical and Behavioral Research
      • Wrote landmark Belmont Report that delineated principles and practices for protecting human participants in research
  • 8. Principles & Practices Protection of Human Research Subjects
  • 9. Sound principals lead to good practices
    • Respect for persons
    • Beneficence
    • Justice
    • Informed consent
    • Benefits > risks
    • Selection of participants
  • 10. Respect for persons / Informed consent
    • Treat individuals as autonomous agents
    • Protect individuals with limited autonomy
    • Voluntary consent to participate
    • Obtain informed consent
    • Protect privacy and confidentiality
  • 11. Beneficence / Benefits > risks
    • Do good
    • Do no harm
    • Risks justified by potential benefits to individual or society
    • Study is designed to minimize risks
    • Conflicts of interest are managed
  • 12. Justice / Selection of subjects
    • Distribute burdens and benefits of research fairly
    • Vulnerable subjects are not targeted for convenience
    • People likely to benefit from research are not excluded from participation
  • 13. Difficult Issues Protection of Human Research Subjects
  • 14. Issues
    • Study design
    • Conflict of interest
    • Advertising
    • Denying access to outcomes
    • Paying participants
    • Deception
    • No written informed consent
    • Passive consent
    • Exculpatory language
    • Use of placebo
    • Research involving children or prisoners
  • 15. Penn State Policy Protection of Human Research Subjects
  • 16. Required review and approval
    • All research involving human participants must be reviewed and approved by the Institutional Review Board (IRB) before research begins
    http://www.research.psu.edu/orp/areas/humans/
  • 17. Levels of review
    • Exemption -
    • Expedited
    • Full
  • 18. Training http://www.research.psu.edu/orp/education/modules/irb/
  • 19. What you must do…
    • Complete training, pass Human Participant Quiz, and submit certificate of completion
    • Create hypothetical informed consent document
  • 20. Protection of Human Research Participants Scholarly Inquiry in Workforce Education & Development