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Introduction to Research Ethics

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An introductory presentation on the principles of research ethics

Published in: Health & Medicine

Introduction to Research Ethics

  1. 1. Research Ethicsأخلاقياتالبحث<br />SohailBajammal, MBChB, MSc, FRCS(C), PhD(c)<br />Assistant Professor, Faculty of Medicine<br />Vice Dean, Academic Development, Faculty of Dentistry<br />Umm Al-QuraUniversity<br />ssbajammal@uqu.edu.sa<br />
  2. 2. Tuskegee Syphilis Study<br />
  3. 3. Learning Outcomes<br />By the end of the lecture, you will be able to:<br />Identify the importance of research ethics<br />Anticipate ethical issues in research<br />Identify the components of informed consent<br />Know where to ask for help<br />
  4. 4. Dark History<br />Tuskegee Syphilis Experiment<br />1932-1972; Tuskegee, Alabama<br />Natural history of “untreated” syphilis<br />Subsequent Nuremberg Trials:<br />1946-1949; Nuremberg, Germany<br />12 trials, criminals of World War II<br />The Doctors’ Trial: 23 involved in unethical experimentation on POW<br />
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  6. 6. Code of Ethics<br />Nuremberg Code (1947)<br />Declaration of Helsinki (1964)<br />
  7. 7. Declaration of Helsinki<br />WMA.net<br />
  8. 8. Good Clinical Practice<br />ICH.org<br />
  9. 9. Tri-Council Policy Statement<br />ethics.gc.ca<br />
  10. 10.
  11. 11. bioethics.kacst.edu.sa<br />
  12. 12. Ethical Issues in Research<br />
  13. 13. Research Problem<br />Research Question<br />Research Design<br />Data Collection<br />Data Analysis<br />Research Dissemination<br />
  14. 14. Ethical Principles of Research<br />Justice<br />الإنصاف<br />Competence<br />الكفاءة<br />Non-maleficence<br />عدمالإيذاء<br />Integrity<br />الاستقامة<br />Participants<br />Researchers<br />Dignity<br />الكرامة<br />Beneficence<br />الإحسان<br />Autonomy<br />الاستقلالية<br />Responsibility<br />المسؤولية<br />Confidentiality<br />السرية<br />Honesty<br />النزاهة<br />Privacy<br />الخصوصية<br />
  15. 15. Research Problem<br />Responsibility<br />المسؤولية<br />Is it a significant problem that will benefit others? Does it worth the public money?<br />Have you done a thorough literature review to see if other studies exist?<br />Is it ethical to repeat the study if it has been done before?<br />Confirming<br />Extending<br />Refuting<br />Competence<br />الكفاءة<br />Non-maleficence<br />عدمالإيذاء<br />Beneficence<br />الإحسان<br />
  16. 16. Research Question<br />Non-maleficence<br />عدمالإيذاء<br />Does it expose the participants to unacceptable risks or invasion of privacy?<br />Clearly identify the purpose of the study to participants<br />Beneficence<br />الإحسان<br />
  17. 17. Research Problem<br />Research Question<br />
  18. 18. What study needs ethics approval?www.pre.ethics.gc.ca<br />
  19. 19. If in doubt…..<br />Check it out<br />Check with your institutional ethics review board (IRB)<br />
  20. 20. Research Design<br />Research Design<br />Non-maleficence<br />عدمالإيذاء<br />Is your choice of the study design an ethical choice?<br />Observational versus Interventional<br />Benefits/Risks ratio<br />Is it methodologically sound?<br />Do you have the expertise to do it?<br />? Pilot<br />Beneficence<br />الإحسان<br />Competence<br />الكفاءة<br />Honesty<br />النزاهة<br />
  21. 21. Types of Possible Harm<br />Physical<br />Psychological<br />Social<br />Economic<br />Legal<br />Non-maleficence<br />عدمالإيذاء<br />Beneficence<br />الإحسان<br />
  22. 22. Vulnerable Populations<br />Justice<br />الإنصاف<br />Minors<br />Minority groups<br />Mentally incompetent<br />Prisoners<br />Individuals with AIDS<br />Dignity<br />الكرامة<br />Autonomy<br />الاستقلالية<br />
  23. 23. Informed Consent<br />About you & the research:<br />Who are the researchers & their contact information?<br />Who is sponsoring?<br />What is the purpose of the research? <br />Competence<br />الكفاءة<br />Integrity<br />الاستقامة<br />Responsibility<br />المسؤولية<br />Honesty<br />النزاهة<br />
  24. 24. Informed Consent<br />Justice<br />الإنصاف<br />About the participants:<br />How were they selected?<br />Assurance that: <br />Their participation is voluntary<br />They can withdraw at any time<br />What are the benefits & risks for them?<br />What is the level and type of their involvement?<br />How will you ensure their confidentiality?<br />Autonomy<br />الاستقلالية<br />Non-maleficence<br />عدمالإيذاء<br />Confidentiality<br />السرية<br />
  25. 25. Data Collection<br />Respect participants & research sites<br />Respect privacy & confidentiality<br />MONITOR<br />
  26. 26. Data Analysis<br />How will you protect the anonymity of participants?<br />How will you analyze the data? Do you have the experience?<br />How long will you keep the data once analyzed? Where & how will you keep it?<br />
  27. 27. Research Dissemination<br />Authorship:<br />Who will do what & when?<br />Authorship order<br />Conflicts of interests: financial<br />Integrity<br />الاستقامة<br />Honesty<br />النزاهة<br />
  28. 28. Research Dissemination<br />Reporting:<br />Fabrication<br />Falsification<br />Plagiarism: <br />Copying without citing<br />Paraphrasing without citing<br />Using other’s ideas without citing<br />Integrity<br />الاستقامة<br />Honesty<br />النزاهة<br />
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  33. 33. Retractions<br />Wager:<br />1988 and 2008: 529 retractions<br />Woolley:<br />1978 to 2008: 463 retractions in English-language literature<br />40% due to misconduct in the 80s<br />60% due to misconduct in the 2000s<br />Nicola Jones. Nature Medicine. 2009<br />
  34. 34. Resources<br />
  35. 35. If in doubt…..<br />Check it out<br />Check with your institutional ethics review board (IRB)<br />
  36. 36. bioethics.kacst.edu.sa<br />
  37. 37. King Saud University<br />
  38. 38. kaimrc.med.sa<br />
  39. 39. Summary<br />
  40. 40. Summary<br />Ethical principles of research<br />Anticipate ethical issues during: <br />Research problem, question & design<br />Data collection, analysis, and dissemination<br />Components of informed consent<br />Consult IRB: “If in doubt, check it out”<br />ssbajammal@uqu.edu.sa<br />

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