Ethics in research involving human subjects

1. Public Health & Primary Care Unit Paraclinical Sciences Faculty of Medical Sciences UWI, St Augustine, T&T Ethics in research involving human subjects presented by: Celia M Poon-King medical epidemiologist lecturer in epidemiology

2. what do you know? • what do you think you need to know? • why? ethics in research involving human subjects

3. Outline • history • knowledge - principles, IRB • attitude ethics in research involving human subjects

4. Outline • skills - application framework of principles • practice - learning objectives, research project ethics in research involving human subjects

5. History • 1947 - Nuremberg code ethics in research involving human subjects

6. History • 1964 - Helsinki declaration ethics in research involving human subjects

7. History • 1979 - Belmont report ethics in research involving human subjects

8. History • 1993 - CIOMS ethics in research involving human subjects

9. History • 2005 - UNESCO ethics in research involving human subjects

10. Knowledge • ethics • principles • professional conduct ethics in research involving human subjects

11. What are the ethical principles in research involving humans? • beneficence - promotion of well being • maximize benefit • non-maleficence - do no harm (commission or omission) • minimize harm ethics in research involving human subjects

12. What are the ethical principles in research involving humans? • respect for persons • privacy, confidentiality • autonomy - make own decisions • informed consent ethics in research involving human subjects

13. What are the ethical principles in research involving humans? • justice -fairness • risks and benefits • is it justifiable to ……. ethics in research involving human subjects

14. Attitude • what are the attitudes that are needed? • ethics is essential to research and clinical practice • research should be a part of everyday clinical practice • know when to ask for help • see it, do it, teach it ethics in research involving human subjects

15. Issue • HIV – It is 1970; developing world; vertical transmission: mother to child; clinical trials showing gain for intense Antiviral Treatment Regimes; A trial for a less intense regime • ethical issues • beneficence • non-maleficence • autonomy • justice ethics in research involving human subjects

16. Beneficence • maximize benefits • individual • family • community • researcher ethics in research involving human subjects

17. Non-Maleficence • minimize risk of harm • physical • psychological • social • individual vs community ethics in research involving human subjects

18. Autonomy • informed consent • sufficient information Belmont Report ethics in research involving human subjects

19. Autonomy • capacity • understand • appreciate consequences of participation • free power Belmont Report ethics in research involving human subjects

20. Autonomy • actions: • ethics committee - community • investigators • participants Paddi O’hara ethics in research involving human subjects

21. Vulnerable populations(sufficient knowledge, capacity, free power) • children (assent) • mentally disabled ethics in research involving human subjects

22. Vulnerable populations(sufficient knowledge, capacity, free power) • prisoners ethics in research involving human subjects

23. Justice • fairness • share risks → share benefits ethics in research involving human subjects

24. Role of EC/IRB ethics committee (EC) institutional review board (IRB) • safeguard - dignity rights, safety and well being ethics in research involving human subjects

25. Ethics committee Institutional review board • review & approval • beneficence, autonomy, justice, non-maleficence ethics in research involving human subjects

26. Ethics committee Institutional review board • membership • non-scientist, community participant ethics in research involving human subjects

27. Ethics committee Institutional review board • scientifically sound research? • scientific review board ethics in research involving human subjects

28. Responsible conduct of researchscientific misconduct • to maintain honesty & integrity • examples of failure - plagiarism, fabrication, falsification • regulation: professions, legal • outcome of failure: • damage science, society • credibility ethics in research involving human subjects

29. Learning objectives • principles • beneficence, non-maleficence, justice, respect for persons (including autonomy) ethics in research involving human subjects

30. Learning objectives • informed consent • components, deception - procedures ethics in research involving human subjects

31. Learning objectives • institutional review board/ethics committee • responsibilities, composition • responsible conduct of research ethics in research involving human subjects

32. Implication - research project • protocol • undertaking study • interpretation • making recommendations • presenting your findings ethics in research involving human subjects

33. Summary • ethical conduct of research with human subjects • responsible conduct of research ethics in research involving human subjects

34. Issue • use of statins • diabetics • your country • 2007 • a clinical trial to examine the efficacy of statins in the treatment regimes in diabetics ethics in research involving human subjects

35. the end thank you ethics in research involving human subjects