A basic introductory presentation on the principles of conducting research on humans.

1. Research Ethicsأخلاقياتالبحث SohailBajammal, MBChB, MSc, FRCS(C), PhD(c) Assistant Professor & Consultant Orthopedic Surgeon Umm Al-Qura University

2. Tuskegee Syphilis Study

3. Learning Outcomes By the end of the lecture, you will be able to: Identify the importance of research ethics Anticipate ethical issues in research Identify the components of informed consent Know where to ask for help

4. Dark History Tuskegee Syphilis Experiment 1932-1972; Tuskegee, Alabama Natural history of “untreated” syphilis Subsequent Nuremberg Trials: 1946-1949; Nuremberg, Germany 12 trials, criminals of World War II The Doctors’ Trial: 23 involved in unethical experimentation on POW

6. Code of Ethics Nuremberg Code (1947) Declaration of Helsinki (1964)

7. Declaration of Helsinki WMA.net

8. Good Clinical Practice ICH.org

9. Tri-Council Policy Statement ethics.gc.ca

11. bioethics.kacst.edu.sa

12. Ethical Issues in Research

13. Research Problem Research Question Research Design Data Collection Data Analysis Research Dissemination

14. Ethical Principles of Research Justice الإنصاف Competence الكفاءة Non-maleficence عدمالإيذاء Integrity الاستقامة Participants Researchers Dignity الكرامة Beneficence الإحسان Autonomy الاستقلالية Responsibility المسؤولية Confidentiality السرية Honesty النزاهة Privacy الخصوصية

15. Research Problem Responsibility المسؤولية Is it a significant problem that will benefit others? Does it worth the public money? Have you done a thorough literature review to see if other studies exist? Is it ethical to repeat the study if it has been done before? Confirming Extending Refuting Competence الكفاءة Non-maleficence عدمالإيذاء Beneficence الإحسان

16. Research Question Non-maleficence عدمالإيذاء Does it expose the participants to unacceptable risks or invasion of privacy? Clearly identify the purpose of the study to participants Beneficence الإحسان

17. Research Problem Research Question

18. What study needs ethics approval?www.pre.ethics.gc.ca

19. If in doubt….. Check it out Check with your institutional ethics review board (IRB)

20. Research Design Research Design Non-maleficence عدمالإيذاء Is your choice of the study design an ethical choice? Observational versus Interventional Benefits/Risks ratio Is it methodologically sound? Do you have the expertise to do it? ? Pilot Beneficence الإحسان Competence الكفاءة Honesty النزاهة

21. Types of Possible Harm Physical Psychological Social Economic Legal Non-maleficence عدمالإيذاء Beneficence الإحسان

22. Vulnerable Populations Justice الإنصاف Minors Minority groups Mentally incompetent Prisoners Individuals with AIDS Dignity الكرامة Autonomy الاستقلالية

23. Informed Consent About you & the research: Who are the researchers & their contact information? Who is sponsoring? What is the purpose of the research? Competence الكفاءة Integrity الاستقامة Responsibility المسؤولية Honesty النزاهة

24. Informed Consent Justice الإنصاف About the participants: How were they selected? Assurance that: Their participation is voluntary They can withdraw at any time What are the benefits & risks for them? What is the level and type of their involvement? How will you ensure their confidentiality? Autonomy الاستقلالية Non-maleficence عدمالإيذاء Confidentiality السرية

25. Data Collection Respect participants & research sites Respect privacy & confidentiality MONITOR

26. Data Analysis How will you protect the anonymity of participants? How will you analyze the data? Do you have the experience? How long will you keep the data once analyzed? Where & how will you keep it?

27. Research Dissemination Authorship: Who will do what & when? Authorship order Conflicts of interests: financial Integrity الاستقامة Honesty النزاهة

28. Research Dissemination Reporting: Fabrication Falsification Plagiarism: Copying without citing Paraphrasing without citing Using other’s ideas without citing Integrity الاستقامة Honesty النزاهة

33. Retractions Wager: 1988 and 2008: 529 retractions Woolley: 1978 to 2008: 463 retractions in English-language literature 40% due to misconduct in the 80s 60% due to misconduct in the 2000s Nicola Jones. Nature Medicine. 2009

34. Resources

35. If in doubt….. Check it out Check with your institutional ethics review board (IRB)

36. bioethics.kacst.edu.sa

37. King Saud University

38. kaimrc.med.sa

39. Summary

40. Summary Ethical principles of research Anticipate ethical issues during: Research problem, question & design Data collection, analysis, and dissemination Components of informed consent Consult IRB: “If in doubt, check it out” ssbajammal@uqu.edu.sa