1. 4/21/2015Medical Research Center, HMC, Doha, Qatar 1 Ethical issues in Medical Research Dr. Anjum Susan John, MD 10/3/2009

2. 4/21/2015Medical Research Center, Doha, Qatar 2 Objectives oTrace the development of ethical codes by discussing some of the unethical studies documented in literature oWhat are ethics ? oDiscuss the 3 features of research ethics oFocus of research ethics over the decades o21 st century focus of research ethics oCritique the ethical aspects of a study

3. 4/21/2015Medical Research Center, Doha, Qatar 3 Objective 1 – first part To trace the development of ethical codes Hippocrates

4. 4/21/2015Medical Research Center, Doha, Qatar 4 Hypothermia studies in the 1940s  Research subjects were immersed in bath temperatures of 2-12°C.  A sub group of them were immersed in ice water tanks  They were then made to stand outside, some with and some without clothes, and their body’s reactions to cold observed and measured

5. 4/21/2015Medical Research Center, Doha, Qatar 5 What did researchers want to determine in this instance ?  How long does it take for body parts to freeze when people are kept naked outdoors in sub freezing temperatures ?  What signs & symptoms are seen when people are kept in tanks of ice water for 3 hours ?

6. 4/21/2015Medical Research Center, Doha, Qatar 6 Medical Experiments - 1933 -1945 On prisoners by exposing them to high altitudes, malaria, poisons, typhus, untested drugs and operations( without anesthesia)

7. 4/21/2015Medical Research Center, Doha, Qatar 7 Why did these researchers conduct these experiments ? Who were the people on whom these experiments were conducted ?

8. 4/21/2015Medical Research Center, Doha, Qatar 8 What happens to the healthy human body when ………….?  It is inoculated with live germ causing bacteria (disguised like vaccinations )like typhoid or paratyphoid ?  Clothes from plague victims were dropped on it ?  When wounds were infected with spores of tetanus ?  The subjects for these experiments were civilian and military people from China, Korea, Mongolia and Russia, held as prisoners.  Experiments by Dr. Shiro Ishii in Japan – The truth about unit 731)

9. 4/21/2015Medical Research Center, Doha, Qatar 9 What do you think …….  were the issues in these cases ?

10. 4/21/2015Medical Research Center, Doha, Qatar 10 Objective 1- second part  Discuss some of the unethical studies documented in literature

11. 4/21/2015Medical Research Center, Doha, Qatar 11 Handouts Research on prediction of skeletal size in Germany Research on human endurance to pain in Japan Tuskegee case in the USA Case of Edward Jenner and the small pox vaccine Willow brook case

12. 4/21/2015Medical Research Center, Doha, Qatar 12 Skeletal size experiments  What are the issues ?

13. 4/21/2015Medical Research Center, Doha, Qatar 13 Atrocities committed In Japan  What were the issues ?

14. 4/21/2015Medical Research Center, Doha, Qatar 14 Tuskegee syphilis study  Issues ?  Where were the government and health care systems that should have stopped this unethical study from continuing for 40 years ?

15. 4/21/2015Medical Research Center, Doha, Qatar 15 Edward Jenner  Deliberately exposed an 8 year old boy to cowpox to try out his new vaccine for smallpox  Issues ?

16. 4/21/2015Medical Research Center, Doha, Qatar 16 Willow brook study(1950s to 1970s) Issues ? Researchers stressed the benefits the children would receive- cleaner environment, better supervision and a higher nurse /patient ratio on the research ward

17. 4/21/2015Medical Research Center, Doha, Qatar 17 Nuremberg trials

18. 4/21/2015Medical Research Center, Doha, Qatar 18 Development of Ethical Codes  Nuremberg code, 1947(http://en.wikipedia.org/wiki/Nuremberg_code )http://en.wikipedia.org/wiki/Nuremberg_code  Helsinki Declaration 1965, rewritten 1975- WHO(http://www.wma.net/e/ethicsunit/helsinki.htm )http://www.wma.net/e/ethicsunit/helsinki.htm  Belmont report of the national commission for the protection of human subjects of biomedical and behavioral research, 1979(http://www.bop.gov/news/BelmontReport.jsp )http://www.bop.gov/news/BelmontReport.jsp  CIOMS guidelines,Council for international organizations of medical sciences 2002(http://www.cioms.ch/frame_guidelines_nov_2002. htm )http://www.cioms.ch/frame_guidelines_nov_2002. htm

19. 4/21/2015Medical Research Center, Doha, Qatar 19 Research Subjects informed Good of society Animal experiments Avoid Subject injury Qualified researcher Stop study if problems occur Informed consent Subject interest >Society interest Result accuracy IRB approval Benefit Vs Risk assessment Helsinki declaration(1964)Nuremberg code, 1947

20. 4/21/2015Medical Research Center, Doha, Qatar 20 Nuremberg Code & Helsinki Declaration  Voluntary consent  Withdrawal of subjects  Balance of risks and benefits  Differentiated between therapeutic and non therapeutic research

21. 4/21/2015Medical Research Center, Doha, Qatar 21 Belmont Report of 1979  Was developed in response to the Tuskegee and Willow brook controversies

22. 4/21/2015Medical Research Center, Doha, Qatar 22 Objective 2  What are ethics ?

23. 4/21/2015Medical Research Center, Doha, Qatar 23 What are ethics ?  These include all the rules and principles that determine which actions are right and which are wrong.

24. 4/21/2015Medical Research Center, Doha, Qatar 24 Objective 4  Discuss the 3 features of research ethics

25. 4/21/2015Medical Research Center, Doha, Qatar 25 Ethical principles guiding researchers (National Commission for the protection of human subjects of biomedical and behavioral research-1978)  Respect for human dignity  Beneficence  Justice  ( Belmont Report )  Ethical approval of a project depends on the degree to which the researcher plans to protects the rights of the patients.

26. 4/21/2015Medical Research Center, Doha, Qatar 26 # 1 :Respect for human dignity  Element 1: Right to full disclosure  Informed consent Informed consent  Element 2: Right to self determination

27. 4/21/2015Medical Research Center, Doha, Qatar 27 Violation of right to self determination ????  Coercion  Inclusion in studies without subject knowledge of participation  Deception

28. 4/21/2015Medical Research Center, Doha, Qatar 28 Special case situations  Individuals with diminished autonomy

29. 4/21/2015Medical Research Center, Doha, Qatar 29 #2 Principle of beneficence  Element 1: Freedom from harm  Element 2 : Freedom from exploitation

30. 4/21/2015Medical Research Center, Doha, Qatar 30 # 3: Principle of justice  Element 1 : Right to fair treatment  Element 2 : Right to privacy  Anonymity  Confidentiality

31. 4/21/2015Medical Research Center, Doha, Qatar 31 Objective 4  Changing focus of research ethics over the decades

32. 4/21/2015Medical Research Center, Doha, Qatar 32 Changing focus of research ethics  In the 1970s and 1980s, research ethics guidelines focused on the protection of rights of vulnerable populations like children  In the 1990s and the 2000s, the focus is on promoting research participation of all subjects’, including vulnerable subjects’.

33. 4/21/2015Medical Research Center, Doha, Qatar 33 Objective 5  Where does research ethics stand in the 21 st century?

34. 4/21/2015Medical Research Center, Doha, Qatar 34 Ethical issues in modern day research  The use of control arms (placebo)  ‘Standard of care’  Informed consent process  Community consultation  Individual and community access to research  The role & responsibility of ethics committees (ECs)  Compensation for trial injury  Patient/Participant Confidentiality and Privacy  Locating phase I, II, and III trials  Medical treatment during the course of research  Product availability  Sponsorship  Liability & Insurance  Tissues  Stem Cell Research  Gene Transfer  Data Protection  Monitoring (DSMBs)  Publication issues  Data Ownership  Proprietary Information/Knowledge  Botanical/Traditional Medicines

35. 4/21/2015Medical Research Center, Doha, Qatar 35 21 st century ethical issues Human guinea pigs ???

36. 4/21/2015Medical Research Center, Doha, Qatar 36 Cloning ???? Cloning and ethics ???

37. 4/21/2015Medical Research Center, Doha, Qatar 37 Objective 6  How to critique the ethical aspects of a research ?

38. 4/21/2015Medical Research Center, Doha, Qatar 38 Critiquing ethical aspects of a study  IRB approval ?  Respect for human dignity : 1.Autonomous decision 2. full disclosure 3. informed consent  Beneficence : 1.Any harm 2. exploitation/coercion 3. benefit > risk  Justice 1. Fair treatment 2. right to privacy /confidentiality / anonymity

39. 4/21/2015Medical Research Center, Doha, Qatar 39 Summary  How and why were ethical codes developed ?  What are the principles of research ethics ?  Critically appraise ethical aspects of a study

40. 4/21/2015Medical Research Center, Doha, Qatar 40 The best approach …… … is to prevent ethical problems from arising in the first place. - Tom Regan, North Carolina State University

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