1. From the Hippocratic Oath to the Helsinki Declaration: Where are we?
Prof. Berna ARDA (MD, MedSpec, PhD)
Ankara University School of Medicine
History of Medicine and Ethics Department
Prof.Dr. Berna Arda

2. From Hippocratic Oath to the Helsinki Declaration
The entire process; from design to publication
Changes in the research process itself
Changes of the research’s sides
Prof.Dr. Berna Arda

3. The milestones of medical ethics
Oaths
Enlightenment Era,
Declaration of Human and Citizen Rights,
Nuremberg Code ,
Universal Declaration of Human Rights,
Declarations of World Medical Association,
Biomedicine Convention(Council of Europe)
Universal Norms on Bioethics (Unesco)
Prof.Dr. Berna Arda

4. What are the rationals? Several principles have been cristalized,
Rights and responsibilities,
Priority of humanbeing
Description of duties,
Responsibility content and borders have been mentioned.
Prof.Dr. Berna Arda

5. What is Oath?
A formal declaration to fulfil a pledge, often calling upon sacred things as witness.
It depends on old tradition in Mongolia. Person who belongs two different tribes, add their blood into sweet liquid and drink each other as a decisiveness proof on the convention.
Prof.Dr. Berna Arda

6. From Imhotep to Hippocrates
Prof.Dr. Berna Arda

7. Basic item is trust
Aim; emphasizing the trust in the physician-patient relationship.
A kind of guarantee to patients. A kind of social contract “..I will prescribe treatment to the best of my ability judgement for the good of the sick, and never for a harmful or illicit purpose...”
Prof.Dr. Berna Arda

8. Content As main values; Respect for human life, Aware of harm,
Respect for human personality,
Respect for secrecy,
Respect for occupation and solidarity
Prof.Dr. Berna Arda

9. Changes in centuries
From“ I swear by Apollo the physician, and by Asklepios, Hygeia and Panacea, and all the gods and goddesses...” to different approach “... by all my sacred beliefs..”
From“...free or slave..” to egalitarian/nondiscriminative approach
Prof.Dr. Berna Arda

10. The Approach of Enlightenment Era
Realise the presence of human being,
Borning of «bourgeoisie»,
Decline of monarchies,
Rationalism, Encyclopedians,
From“Divine Law” to “Natural Law”
French Revolution, Declaration of Human and Citizen Rights
Prof.Dr. Berna Arda

11. The years of 1930s,1940s…
Three different places on the world A. Nazis’ trials B. Tuskegee experiment C. Manchuria trials
Prof.Dr. Berna Arda

12. a.Trials of Nazis Period(1933-1945)
to proof the superiority of Arian race
to detect the borders of human beings... freezing, high altitude...
antropological experiments
compulsory sterilizations of mentally handicapped, epileptic, alcoholics
studies on twins
Prof.Dr. Berna Arda

13. The other face of the war
Prof.Dr. Berna Arda

14. Nuremberg Trials ( )
Prof.Dr. Berna Arda

15. Nuremberg Code, 1947 Voluntary consent and participation
Must be necessary for the good of society
Not simply a matter of scientific curiosity
Must be justified by the results of previous study
Design to prevent all suffering and injury
Be free to terminate an experiment at any point
Prof.Dr. Berna Arda

16. Steven Spielberg,1993
Prof.Dr. Berna Arda

17. b.Tuskegee Experiment (1932 - 1972)
USA Public Health Service and Tuskegee Institute
“To determine the natural prognosis and racist differences untreatment syphilis in negros”
Syphilis group; 399 black, men
Control group; 201 black, men
Prof.Dr. Berna Arda

18. 1947
Penicillin started to use effective therapeutic drug, but, there is no any change on the design of trial.
Prof.Dr. Berna Arda

19. “Dirty little secret of US”
Only negros subjects,
There is no informed consent,
Keeping secret the disease,
Motivating offers to participate,
Deprivation of the patients effective treatment.
Prof.Dr. Berna Arda

20. “Nuremberg of US”
Tuskegee trial, is one of the experiment which conduct with ignorance the basic medical ethics principles and there is no any therapeutic application in the history of medicine.
Prof.Dr. Berna Arda

21. 8 subjects alive, official apology
“The US government did something that was wrong—deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens clearly racist”.
Bill Clinton;
President
1997
Prof.Dr. Berna Arda

22. Joseph Sargent, 1997
Prof.Dr. Berna Arda

23. c. Manchuria Trials
1936, Emp. Hirohito, Unit 731 “epidemic prevention and water supply unit”
Bacterial warfare; anthrax, dysentery, typhoid, cholera, plague.. “to kill the world population several times over”
Shiro İshii, director
Trials on “Marutas”
Prof.Dr. Berna Arda

24. Shiro İshii (1892-1959) Japon microbiologist
Responsible for human experiment and war crimes during 2nd China-Japon War
General of Unit 731 – biological war unit of Army
Never arrested
Prof.Dr. Berna Arda

25. Remnants of Unit 731 …
Prof.Dr. Berna Arda

26. To the memories of dying local people in Ping Fan
Prof.Dr. Berna Arda

27. “Nightmare in Manchuria” http://www.youtube.com/watch?v=IgtIyNRv3g8
* disturbing scenes…
Prof.Dr. Berna Arda

28. Turning points
Recent history has many examples in the 1930’s where ignorance of or blindness to the principle of autonomy was evident. Such abuses represent turning points in the development of medical ethics, leading to discussion of ethical principles and then to practical regulations and laws.
Prof.Dr. Berna Arda

29. Declaration of Human Rights
10 Dec UN
Universality idea
Definition of civil, political, economical, cultural rights
priority of human being
«Magna Carta for everyone»
Prof.Dr. Berna Arda

30. World Medical Association (WMA)
July countries
Confederation of National Medical Associations
A discussion forum to general and theoretical issues in medicine
Guidance for physicians
Prof.Dr. Berna Arda

31. Themes (WMA Declarations)
Directly interested in medicine (Geneva Declaration)
Physician-patient relationship and preventive medicine (Lisbon, ...)
Research and new facilities in medicine (Helsinki;...)
Others: Environment, sports, issues different age groups, traffic security... etc.
Prof.Dr. Berna Arda

32. Today
Oviedo Convention, 1997, devoted to protect human rights in biology and medicine
Unesco Declaration of Universal Norms on Bioethics the respect for human dignity and protection of human rights and fundamental freedoms in decision making in the sphere of bioethics.
Prof.Dr. Berna Arda

33. Ethical issues arise in medical research
Justification in conducting particular study.
Research design.
Identifying and recruiting research subjects.
Assessing harms and benefits.
Obtaining informed consent.
Protecting privacy and confidentiality.
Prof.Dr. Berna Arda

34. Informed Consent
To provide potential subjects with all the relevant information they need to decide whether or not to participate in the proposed procedure.
Prof.Dr. Berna Arda

35. Informed Consent
Voluntariness: The potential subject should decide freely whether to participate or not. (no coercion, no persuasion)
Disclosure: One has to give the relevant information to the potential research subject.
Comprehension: This information has to be completely understandable for the individual (no technical terms, no Latin)
Prof.Dr. Berna Arda

36. Decision-making capacity: It should be assessed carefully
Decision-making capacity: It should be assessed carefully. If the person is incapable, surrogate decision should be sought.
Consent: Has to be written for the clinical research, must be signed by the subject, the investigator, the witnesses, and the person who obtains the consent.
Prof.Dr. Berna Arda

37. Informed consent is more than a form that is to be completed; rather it is the result of an ongoing process between investigator and subject.
Prof.Dr. Berna Arda

38. Three safeguards for ethical research
International codes
National approach for ensuring ethical research.
Research Ethics Committees (RECs)
Prof.Dr. Berna Arda

39. International codes of ethics
* Helsinki Declaration
( for human research subjects )
* Declaration of Strasbourg
( for animal research )
* Oviedo Convention
(protect human rights)
Prof.Dr. Berna Arda

40. As a result
*Research cannot be justified as therapy, so different ethical reflection is necessary.
*There are international, national and institutional (local) rules that govern research conducts.
*Informed consent is the key element to an ethically justifiable research.
*Not a single scientific knowledge is more valuable than a single human life and suffering
Prof.Dr. Berna Arda

41. Globalization of medical research
Export of clinical trials to underdeveloped countries by huge pharmaceutical industry
Fast increase the number of foreign researchers; 271(1990) to 4458(1999)
The number of the countries; 28 to 79 ; Latin America and Eastern Europe.
Prof.Dr. Berna Arda

42. Trovan case, Nigeria, 1996 Kano, was struck by an epidemic meningitis.
While thousands of children were treated in an ill-equipped hospital, Pfizer came in to a test a new antibiotics drug Trovafloxacin.
Trovan had never before been administered to kids orally. Parents not aware that children were included in a clinical trial. No permission was asked to test the drug. Pfizer argued that IC could not be obtained from parents, because they were illiterate.
11 children died, 200 permanently disabled
in 2002 families sued Pfizer, (USD 75 million compensation in 2011)
Kano; Nijerya’ nın 2. büyük şehri Binlerce çocuk oldukça yetersiz olanaklara sahip hastanelerde tedavi edilmeye çalışılırken, Pfizer bir antibiyotiği denemeye gelir; Trovafloxacin.
200 çocuğa uygulanır, 11 çocuk ölür, bir çoğunda engellilikler kalır.
Sonuçlar; Trovan hiçbir zaman ABD’de çocuklar üzerinde kullanılmaz. FDA 1998te yetişkinler için izin verir, ama sonra hastalarda KCYetmezliği bildirimleri üzerine sınırlama getirir.
AB 1999’da Trovan’ ı yasaklar.
Aileler bir ilaç araştırması olduğunun farkında bile olmamıştır. 2011de ailelerin açtıkları dava 15 yıl sonra sonuçlanır, Pfizer 75 milyon USD tazminat ödemeye mahkum olur.  
Prof.Dr. Berna Arda

43. From today to next From medical ethics to bioethics,
From theoretical approach to functional ethics one
“bioethical imperialism”
Prof.Dr. Berna Arda

44. Summary
Prof.Dr. Berna Arda

45. The first written oath belongs to
A) Hammurabi B) Imhotep C) Hippocrates D) Aristoteles E) Hypatia
Prof.Dr. Berna Arda

46. Choose the item which does not connected with Hippocratic medicine?
secular medicine
anamnesis, careful examination
natural cause – natural result
pirimum nihil nocere
sacred disease
Prof.Dr. Berna Arda

47. Which one does not interested in human rights and medical ethics?
a) Tokyo Declaration b) Malta Declaration c) Oviedo Convention d) Kyoto Protocol e) Helsinki Declaration
Prof.Dr. Berna Arda

48. Choose the item which does not connected with informed consent?
Voluntariness
Disclosure
Comprehension
Decision-making capacity
Deceive
Prof.Dr. Berna Arda

49. Thanks for your participation
Prof.Dr. Berna Arda