Introduction to Research Ethics

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An introductory presentation on the principles of research ethics

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  • Privacy: the rights of individuals to hold information about themselves free from the knowledge of othersConfidentiality: the assurance that information about identifiable persons will not be disclosed without consent except as allowed by law
  • If a similar study of yours exist, why do you need to repeat it?? Maybe the conclusion was not clear & you want to confirm it, extend it, or refute it.
  • Plagiarism is the use of someone else’s words or ideas as your own without giving appropriate credit or without the person’s consent to use his or her words or ideas without acknowledgment
  • 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 />
    5. 5.
    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 />
    29. 29.
    30. 30.
    31. 31.
    32. 32.
    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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