Protection of Human Research Participants Scholarly Inquiry in Workforce Education & Development
today… <ul><li>History of protection of human research participants </li></ul><ul><li>Principles and practices in protecti...
History Protection of Human Research Subjects
Progression <ul><li>In the 1950s, the federal government had a minimal role in regulating research with human participants...
Milestones <ul><li>1948 - Nuremburg trials </li></ul><ul><li>1955 - Wichita jury study </li></ul><ul><li>1963 - Thalidomid...
Milestones (cont.) <ul><li>1973 - Congressional hearings </li></ul><ul><ul><li>Willowbrook hepatitis study </li></ul></ul>...
Milestones (cont.) <ul><li>National Research Act of 1974 </li></ul><ul><ul><li>Established Commission on Protection of Hum...
Principles & Practices Protection of Human Research Subjects
Sound principals lead to good practices <ul><li>Respect for persons </li></ul><ul><li>Beneficence </li></ul><ul><li>Justic...
Respect for persons / Informed consent <ul><li>Treat individuals as autonomous agents </li></ul><ul><li>Protect individual...
Beneficence / Benefits > risks <ul><li>Do good </li></ul><ul><li>Do no harm </li></ul><ul><li>Risks justified by potential...
Justice / Selection of subjects <ul><li>Distribute burdens and benefits of research fairly  </li></ul><ul><li>Vulnerable s...
Difficult Issues Protection of Human Research Subjects
Issues <ul><li>Study design </li></ul><ul><li>Conflict of interest </li></ul><ul><li>Advertising </li></ul><ul><li>Denying...
Penn State Policy Protection of Human Research Subjects
Required review and approval <ul><li>All research involving human participants must be reviewed and approved by the Instit...
Levels of review <ul><li>Exemption -  </li></ul><ul><li>Expedited </li></ul><ul><li>Full </li></ul>
Training http://www.research.psu.edu/orp/education/modules/irb/
What you must do… <ul><li>Complete training, pass Human Participant Quiz, and submit certificate of completion </li></ul><...
Protection of Human Research Participants Scholarly Inquiry in Workforce Education & Development
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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

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Protection of Human Research Subjects

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

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