Ethical issues in Medical Research

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

2. Objectives • Trace the development of ethical codes by discussing some of the unethical studies documented in literature • What are ethics ? • Discuss the 3 features of research ethics • Focus of research ethics over the decades • 21st century focus of research ethics • Critique the ethical aspects of a study Medical Research Center, Doha, Qatar

3. Objective 1 – first part To trace the development of ethical codes Hippocrates Medical 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 Medical 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 ? Medical 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) Medical Research Center, Doha, Qatar

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

9. What do you think ……. • were the issues in these cases ? Medical Research Center, Doha, Qatar

10. Objective 1- second part • Discuss some of the unethical studies documented in literature Medical 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 Medical Research Center, Doha, Qatar

12. Skeletal size experiments • What are the issues ? Medical Research Center, Doha, Qatar

13. Atrocities committed In Japan • What were the issues ? Medical 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 ? Medical 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 ? Medical 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 Medical Research Center, Doha, Qatar

17. Nuremberg trials Medical Research Center, Doha, Qatar

18. Development of Ethical Codes • Nuremberg code, 1947(http://en.wikipedia.org/wiki/Nuremberg_code ) • Helsinki Declaration 1965, rewritten 1975-WHO(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 ) • CIOMS guidelines ,Council for international organizations of medical sciences 2002(http://www.cioms.ch/frame_guidelines_nov_2002.htm ) Medical Research Center, Doha, Qatar

19. Nuremberg code, 1947 Helsinki declaration(1964) Informed consent Benefit Vs Risk assessment Subject interest >Society interest IRB approval Result accuracy Medical Research Center, Doha, Qatar

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

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

22. Objective 2 • What are ethics ? Medical 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. Medical Research Center, Doha, Qatar

24. Objective 4 • Discuss the 3 features of research ethics Medical 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. Medical Research Center, Doha, Qatar

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

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

28. Special case situations • Individuals with diminished autonomy Medical Research Center, Doha, Qatar

29. #2 Principle of beneficence • Element 1: Freedom from harm • Element 2 : Freedom from exploitation Medical Research Center, Doha, Qatar

30. # 3: Principle of justice • Element 1 : Right to fair treatment • Element 2 : Right to privacy • Anonymity • Confidentiality Medical Research Center, Doha, Qatar

31. Objective 4 • Changing focus of research ethics over the decades Medical 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’. Medical Research Center, Doha, Qatar

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

34. 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 Ethical issues in modern day research Medical Research Center, Doha, Qatar

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

36. Cloning and ethics ??? Cloning ???? Medical Research Center, Doha, Qatar

37. Objective 6 • How to critique the ethical aspects of a research ? Medical Research Center, Doha, Qatar

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

41. Medical Research Center, Doha, Qatar

42. Thank you Medical Research Center, Doha, Qatar