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Ethics in research1

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  • 1. Ethics in Research Najibullah Safi, MD, MSc. HPM NPO/Health System, WHO - Afghanistan
  • 2. Presentation outline • • • • • • Why is ethics important? History Introduction (what is ethics…) General principles Codes and policies for ethics in research Conclusion Thursday, January 09, 2014 Research Methodology Course 2
  • 3. Introduction • What do you know? • What do you think you need to know? • Why? Thursday, January 09, 2014 Research Methodology Course 3
  • 4. Why is ethics important? • Required for human life • Means of deciding on a course of action • Without ethics – no way to work towards goal Thursday, January 09, 2014 Research Methodology Course 4
  • 5. Why is ethics important? • Health research has a lengthy history of abuses • The interests of research subjects have all too often been sacrificed to scientific ends or the ends of the state – Well known instances • Nazi hypothermia experiments • Tuskegee syphilis study 5
  • 6. Nazi hypothermia experiments • Research conducted by Nazi doctors on their many captives in the concentration camps in World War II – Information on hypothermia – how long a person can survive in cold water before dying? • In 1947, after World War II, at the Nuremberg trials, the Nuremberg Code for ethical conduct of research involving human subjects was developed Thursday, January 09, 2014 Research Methodology Course 6
  • 7. Tuskegee syphilis study • Longest running study ; ran from 1932 to 1972 • Studied the natural history of syphilis in 400 African American males • Syphilis untreated, even when penicillin became available in the late 1940s 7
  • 8. Why is ethics important? • Health research improves our understanding of disease, and informs practices that improve health • Both knowledge and health are important public goods • Health research depends on the voluntarism of research subjects • Government has an obligation to protect and promote the liberty and welfare interests of human research subjects 8
  • 9. What is ethics? • It comes from the Greek word “ethos”, which mean character • Dictionary meaning: – The moral principles governing or influencing conduct (OXFORD) – – (Babylon) – In Arabic Thursday, January 09, 2014 Research Methodology Course 9
  • 10. What is ethics? cont. • Moral philosophy – defining or recommending the concept of right and wrong • Ethics has to do with: – – – – Feelings (e.g. right and wrong) Law requirement Standard of behavior society accepts Religious beliefs (character traits of the human and virtuous physician are already embedded in the Qur’an and Sunna) Thursday, January 09, 2014 Research Methodology Course 10
  • 11. What is ethics? cont. • At a more fundamental level, ethics is the method by which we categorize our values and pursue them – Do we pursue our own happiness, or do we scarifies ourselves to a great cause? • Hippocratic Oath: – … “first of all, do not harm”… Thursday, January 09, 2014 Research Methodology Course 11
  • 12. Ethics in epidemiology • Ethics is a branch of philosophy that deals with distinction between right and wrong – the moral consequences of human action • The ethical principles in epidemiological practice and research includes: – – – – Informed consent Confidentiality Respect for human rights and Scientific integrity Thursday, January 09, 2014 Research Methodology Course 12
  • 13. General ethical principles • Respect for person – Autonomy, privacy, confidentiality and informed consent – Protection of persons with impaired or diminished autonomy • Beneficence – Maximize benefits and minimize harms • Nonmaleficence (do not harm) • Justice (equitable distribution of both burden and benefits) Thursday, January 09, 2014 Research Methodology Course 13
  • 14. Nuremberg Code • The result of the Nuremberg trial was the Nuremberg Code. It includes the following guidelines, among others, for researchers: – – – – – – Informed consent is essential Research should be based on prior animal work The risks should be justified by the anticipated benefits Research must be conducted by qualified scientists Physical and mental suffering must be avoided Research in which death or disabling injury is expected should not be conducted Thursday, January 09, 2014 Research Methodology Course 14
  • 15. Helsinki Declaration of 1964 • Focuses on: – Privacy and integrity of individuals protected – Adequate informed consent – Research for valid scientific benefits – Accepted scientific principles – Benefits outweigh risks – Protect control group – Individual wellbeing vs. needs of science and society Thursday, January 09, 2014 Research Methodology Course 15
  • 16. Research design • People accept risks and inconvenience to advance knowledge and to benefits others • Sufficiently rigorous that the results will be valid and generalizable • Meet ethical obligations • Adequate sample size • Appropriate end point (study outcome) • RCTs – require preliminary lab and animal research Thursday, January 09, 2014 Research Methodology Course 16
  • 17. Informed consent • Informed consent might be affected by – – – – – Personal expectation Individual benefits vs. generalizable knowledge Inadequate understanding of experiment Randomization Patients inclination to follow the advice of their health care providers – Patients trust in health care providers – Over estimation of the benefits by health care providers Thursday, January 09, 2014 Research Methodology Course 17
  • 18. Vulnerable participants • Vulnerability is defined by categories: – Children, prisoners, pregnant women, mentally disabled person, economically and educationally disadvantage persons, homosexuals, injecting drug users, minorities • Vulnerable groups require special protection from research risks Thursday, January 09, 2014 Research Methodology Course 18
  • 19. Conflict of interest • Some conflicting interest are inherent in research such as: – Gain prestige, grants, promotion, publication – This interest may conflict sometimes with the best interest of participants – It is an accepted element of research and acknowledged • Some interest e.g. financial interest may create ethical problems – Overestimate the benefits, underestimate the risks Thursday, January 09, 2014 Research Methodology Course 19
  • 20. Codes and Policies for Ethics In Research Thursday, January 09, 2014 Research Methodology Course 20
  • 21. Codes and Policies for Research Ethics • • • • • • • • Honesty Objectivity Integrity Carefulness Openness Respect for Intellectual Property Confidentiality Human subject protection Thursday, January 09, 2014 Research Methodology Course 21
  • 22. Codes and Policies for Research Ethics cont. • • • • • • • • Responsible publication Responsible mentoring Respect for colleagues Social responsibility Non-discrimination Competence Legality Animal care Thursday, January 09, 2014 Research Methodology Course 22
  • 23. Conclusion • Muslim Physician and the ethics of medicine: the Muslim physician, guided by Qur’an and Sunna (two primary sources of Islamic Law), will possess the necessary character traits of a good physician. This in turn, will lead to a healthy physician-patient relationship and will safeguard the profession of medicine. Thursday, January 09, 2014 Research Methodology Course 23
  • 24. References Materials 1. 2. 3. 4. International ethical guidelines for epidemiological studies Responsible Conduct of Research, 2nd ed. (New York: Oxford University Press) - Shamoo A and Resnik D. 2009. The Muslim physician and Ethics of Medicine , Thalia A. Arawai, PhD, JIMA: Volum 42, 2010, page 111-116 The Ethics of Muslim Physician and the Legacy of Mohammad , Thalia A. Arawai, PhD, JIMA: Volum 43, 2011, page 35 - 38 Thursday, January 09, 2014 Research Methodology Course 24
  • 25. Thursday, January 09, 2014 Research Methodology Course 25

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