From the Hippocratic Oath to the Helsinki Declaration

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

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 2

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 3

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 4

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 5

From Imhotep to Hippocrates Prof. Dr. Berna Arda 6

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 7

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 8

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 9

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 10

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

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 12

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

Nuremberg Trials (1945 - 1946) Prof. Dr. Berna Arda 14

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 15

Steven Spielberg, 1993 Prof. Dr. Berna Arda 16

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 17

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

“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 19

“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 20

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 21

Joseph Sargent, 1997 Prof. Dr. Berna Arda 22

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 23

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

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

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

“Nightmare in Manchuria” http: //www. youtube. com/watch? v=Igt. I y. NRv 3 g 8 * disturbing scenes… Prof. Dr. Berna Arda 27

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 28

Declaration of Human Rights • 10 Dec. 1948 - UN • Universality idea • Definition of civil, political, economical, cultural rights • priority of human being • «Magna Carta for everyone» Prof. Dr. Berna Arda 29

World Medical Association (WMA) • July 1945 - 27 countries • Confederation of National Medical Associations • A discussion forum to general and theoretical issues in medicine • Guidance for physicians Prof. Dr. Berna Arda 30

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 31

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 32

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 33

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 34

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 35

• 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 36

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 37

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

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 39

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 40

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 41

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) Prof. Dr. Berna Arda

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

Summary Prof. Dr. Berna Arda 44

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

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

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 47

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

Thanks for your participation arda@medicine. ankara. edu. tr Prof. Dr. Berna Arda 49