Overview of Medical Ethics

Temidayo O Ogundiran MBBS (Ibadan), MHSc (Toronto), FACS, FRCS (Edinburgh), FWACS
Division of Oncology, Department of Surgery, University of Ibadan and University College Hospital, Ibadan West African Bioethics Programme, University of Ibadan

Overview of Medical Ethics

Historical issues in Bioethics Relevance to Clinical Care Relevance to Medical Education Relevance to Research on Human Participants

Ethics.Whats an Ethic?
A set of values, principles, and beliefs that guides the behaviour of a specified group What we should do Standards of conduct

Ethics
should

Policy
usually

Law
must

Bioethics what is it?

Morality is the general term for an individuals or a societys standard of conduct, both actual and ideal, and of the character traits that determine whether people are considered good or bad The scientific study of morality is called descriptive ethics in this case, a scientist describes the moral judgments, beliefs or actions of individuals or societies in empirical terms and the reasons given for actions and beliefs

Bioethics - what is it
Ethics is different from morals. Ethics tries to probe the reasoning behind our moral life, by examining and analyzing the thinking used to justify our moral choices and actions in particular situations Bioethics is a specific discipline that probes the reasoning behind our moral life within the context of the life sciences; how we decide what is morally right or wrong in bioscience

Bioethics what is it
Bioethics is normative ethics applied to the practice of science and medicine. It falls under the general group of applied and professional ethics It is predicated on an assumption that some solutions to the ethical problems that arise in science and medicine are more moral than others and that these solutions can be arrived at by moral reasoning and reflections
7

Bioethics what is it
It is a branch of knowledge like mathematics, and thinking in this field is not wholly different from thinking in those other fields, however it cannot be reduced to them Bioethical conclusions cannot be unambiguously proved like mathematical theorems

Ancient history of ethics in medicine

2700 BCE - Third Dynasty (Egypt)
Have an expectant attitude and trust in nature's healing Be observant of the patient's condition

400 BCE - Oath of Hippocrates (Greece)

Give no deadly medicines, only benefit the sick and maintain confidentiality "First, do no harm! (Hippocrates On Epidemics)
9

Ethical Principles early CE

1st c. CE - Oath of Initiation (Caraka Samhita) (India)
Save lives and behave morally Have compassion for all creatures Thou shalt not desert or injure thy patient for the sake of thy life or thy living Thou shouldst speak words that are gentle, pure and righteous, pleasing, worthy, true, wholesome, and moderate
10

Ethical Principles early CE

3rd c. CE - Hebrew Oath of Asaph
-From the Book of Asaph the Physician, the oldest Hebrew medical text

-Serve the poor and the needy; heal them 9th c. CE - Ishaq bin Ali Rahawi -Adab al-Tabib (Conduct of a Physician) - twentychapter treatise on medical ethics -doctors as "guardians of souls and bodies

11

Ethical Principles Middle Ages

12th c. CE - Jewish Daily Prayer of a Physician (Egypt) -attributed to Moses Maimonides, a twelfth-century
Jewish physician in Egypt

- Don't let desire for profit, fame, or admiration interfere

with your work

14th c. CE - Ming Dynasty (China) (1368 to 1644) (Empire of the Great Ming)
Appreciate the value of life. Rescue the dying. Heal the wounded. Acknowledge that all patients are equal to the physician

12

Do no harm to your patients Be observant, kind and respectful Behave morally Have compassion Do not allow a desire for profit or fame to affect your judgment The patient is always equal to the physician
13

Summary of Ethical Principles Set Forth in the Ancient Times

Contemporary Medical Ethics

the central hub around which the practice of health sciences revolves since Hippocrates The hidden curriculum curriculum appeared as a recognizable academic discipline in the 19th century, as a professional ethic compulsory part of medical curriculum in the UK since 1993 (GMC, 1993)
14

Contemporary Medical Ethics (2)

Medical ethics traces its roots to several early codes of ethics: Ancient Greek Hippocratic oath- most famous The professional code of ethics written by English physician, Thomas Percival in the 18th century The Nuremberg code for research ethics

15

World Medical Association

Declaration of Geneva (1948)- update the Hippocratic oath for 20th century use International Code of Medical Ethics (1949) Declaration of Helsinki (1964)- ethical guidelines for research on human subjects

16

Core issues in Medical Ethics

prescribing ethics of the doctor-patient relationship duty to maintain patient confidentiality the need to obtain fully informed consent

17

Clinical and Research Ethics

Sir William Osler said Medicine arose out of the primal sympathy of man with man and out of the desire to help those in sorrow, need and sickness (1892 The principles and practice of
Medicine. D Appleton New York)

This is also the fountain from which medical research sprang forth to cure plagues; to bring relief to those suffering and provide a dignified death
18

Research Ethics

The analysis of ethical issues that are raised when people are involved as participants in research

19

Research Ethics
a subset of applied ethics (bioethics), concerned with responsible conduct of biomedical research in conformity to norms these norms were written partly in response to unpleasant events in the history of biomedical research These norms have developed into codes /guidelines that are now widely applicable in many jurisdictions

20

Research Ethics
Objectives Protection of human participants Conduct of research in a way that serves interests of individuals, groups and/or society as a whole Examining specific research activities and projects for ethical soundness, protection of confidentiality and the informed consent process
21

Research Ethics
The goal of all medical research is to improve human well being But: How can the rights of individual persons be reconciled with the demands of the scientific enterprise? Can such a laudable collective goal be pursued with full protection of the rights and dignity of individuals?
22

1ST CENTURY EXPERIENCE

Celsius, a 1st century Roman historian wrote about research. Celsius justified experiments on condemned criminals on the following grounds:

it is not cruel to inflict on a few criminals sufferings which may benefit multitudes of innocent people through all centuries.

This reflects an imbalance between the two goals of research: that of medical progress and the protection of the rights and welfare of human subjects.

In the type of case cited above, a concern for medical progress is made to override the concern for human welfare and protection

23

History of research ethics

Max Bockhart inoculated a patient suffering with paralysis with a pure culture of gonococus- the patient died ten days later Ernst Bumm introduced a pure culture of gonococcus to the urethra of 2 healthy woman who subsequently developed painful gonococcal urethritis

24

History of research ethics

Many other cases of gonococcal inoculation occurred: four paralytic patients a woman suffering from malignant VVF 14 hopeless patients with consumptives eyes of infants 6 blind adults inoculated with muco-purulent discharge of pregnant parturient women
25

History of research ethics

1887 Eugene Hahn of Berlin removed a portion of a womans breast cancer and transplanted it into the healthy one 1887 Dr Stickler inoculated children with the blood of horses and cows and later inoculated them with blood from scarlet fever patients Roberts Bartholow of Ohio conducted series of galvanic irritation of the exposed cerebrum of a woman with cancer of the skull skin
26

History of research ethics

1897- Italian bacteriologist Guiseppe Sanarelli isolated Yellow fever organism and inoculated 5 persons with his isolate to prove his claim

27

History of research ethics

Perhaps the earliest clinical trial was that of Lind conducted over a 6 year period in the 18th century when sailors were allocated to receive or not receive fruits and vegetables during an investigation of the etiology of scurvy About 25 years after that in 1796, Edward Jenner conducted his famous chickenpox vaccination studies for prevention of smallpox, using children in his neighborhood including his own children
28

History of research ethics

In 1900, U.S. surgeon general used 22 Spanish immigrant workers in Cuba to prove that mosquitoes transmitted yellow fever He introduced use of healthy participants in research and use of written contract to confirm informed consent Walter Reeds Yellow Fever Board sketched some guidelines for research ethics including
Self experimentation Enrollment of only adults Signed contract with sliding scale compensation

29

History of research ethics

William Beaumont, an army surgeon, who pioneered gastric medicine through his studies of Alexis St Martins posttraumatic gastric fistula in 1833 wrote the oldest American document on ethics of research. His principles were: The need for experimentation must be demonstrated This need is justified when information cannot be obtained by other means Investigator must be conscientious and responsible Use a well considered and methodological approach Obtain voluntary consent Discontinue studies when they cause distress to the participants Abandon studies if participants become dissatisfied
30

History of research ethics

Marion Sims father of gynecology in 1845 performed medical experiments on enslaved African women without anesthesia and many of them died from infections soon after surgery Claude Bernard wrote
It is our duty and our right to perform an experiment on a man whenever it can save his life, cure him or gain him some personal benefit. The principle of medical and surgical morality, therefore, consists in never performing on man an experiment which might be harmful to him to an extent, even though the result might be highly advantageous to the health of others

31

History of research ethics

First national guideline on health research ethics was a ministerial directive issued by the Prussian Ministry of Health in 1900 The guideline was precipitated by the work of Professor Neisser of the Neisseria sp fame In 1898, he tried to develop an anti-syphilis agent by injecting cell-free serum from syphilitic patients to other patients mostly prostitutes without their consent. Some of the participants developed syphilis as a result In 1900, the Royal Disciplinary Court fined him the equivalent of 2/3 of his annual income

32

History of research ethics

On February 28, 1931 Germany enacted arguably the first national research ethics regulations Regulations on New Therapy and Human Experimentation This was largely in response to the increasing use of human participants in research being driven by the strength of the German health research and chemical industry The very strict Richtlinien outlined how to conduct human experimentation and the use of innovative therapies in medicine

33

History of research ethics

The Nuremberg trials that followed the Second World War experiments focused attention on the need for a code of research ethics Prosecutors argued that the experiments violated fundamental ethical standards of civilized society The defendants argued that voluntary participation by human subjects in medical experimentation was not the norm at that time
34

Nuremberg code 1948

The judges agreed with the prosecution and in addition to sentencing the defendants also enunciated what is now known as the Nuremberg Code The main components of the code are
Requirement for voluntary participation Informed consent Favorable risk/benefit analysis Right to withdraw without penalty

35

1950 Willowbrook Hepatitis Study

Researchers deliberately exposed children and adolescents with disabilities to hepatitis virus in order to discover a way of preventing the disease Critics claimed the study was coercive because
New admission into the institution was closed Parents of children on the waiting list were written to inform them that their children could be placed on a research ward after which they could be transferred to the facility

The researchers argued that almost all the children admitted into the facility develop hepatitis anyway and this mitigated the deliberate exposure for the benefit of science

36

1950 Willowbrook Hepatitis Study

Researchers argued that they had obtained consent from the parents and various university, state and U.S. Armed Forces Epidemiological Board (which funded the study) committees had reviewed and approved the study Critics argued that because the participants were severely mentally retarded children whose parents wanted placement in one of few public institutions available rendered the consent invalid Researchers argued that the mental retardation was besides the point while critics retorted that that was precisely the point

37

Jewish Chronic Diseases Hospital Studies

In July 1963, 2 physicians at the Brooklyn Jewish Chronic Disease Hospital injected ill elderly patients with live hepatic cancer cells without their informed consent The aim of the study was to study rejection of human cancer cells Background studies suggest that such cells would be rejected by immune reaction leading to their rejection from the body It was then argued that the experiments present no risk to the participants

38

Jewish Chronic Diseases Hospital Studies

The researchers argued that informing participants about details of the research would have caused them needless psychological distress so failure to inform was based on the need to minimize distress The Governing Council of the University of the State of New York argued that while therapeutic privilege may justify non-disclosure in a physician-patient relation, same is not true of researcher-participant relationship This case, among other things, highlighted the problem of conflicting loyalties for physicianresearchers

39

Tuskegee
Study was initiated in Macon County, Alabama in 1932 Designed to take advantage of an epidemic of syphilis among the black population to take study the natural history of syphilis Over 400 sharecroppers were recruited Neither they nor their partners were informed about the nature of the research or about their condition When penicillin became available, they were not given an opportunity to use it They were in fact prevented from accessing it or obtaining information about it

40

Tuskegee
Papers from the study were regularly published in medical journals and it did not evoke any ethical response In 1972, press reports finally prompted an investigation and stoppage of the study 74 of the original participants remained alive Some saw no reason for the outrage after all, the study was not secret and was well known Others contented that the issues at stake were more about racism In the 70s participants were compensated and in 1997, U.S. government apologized for the study

41

Development of bioethics
Bioethics, as known and practiced today is traceable to three different but interrelated events: a set of scandals in biomedical research advancement in medical technology the civil rights movement

42

Development of bioethics
The scandals and the events thereafter led to some developments: imperative to become sensitive and adherent to ethics of the profession decline of paternalism and the rise of liberalism, individual rights and autonomy socialization of medicine and the biomedical sciences

43

Development of bioethics
Thus bioethics was born as a child of necessity partly in response to unhealthy practices involving experimentation with human subjects with consequent development of regulatory policies and documents

However, its scope and horizon continue to expand in the face of the increasing complexities of societal dynamics, medical technology and health care practices

44

The domain of bioethics

Bioethics has developed alongside medical ethics as a complimentary and often overlapping area of inquiry It is concerned not just with issues of medical practice, but with wider issues of medical and scientific practice, advancement and capability in the socio-political context
45

The domain of bioethics

consists largely of health care, health policy and biological research political and economic forces that shape medicine and access to it societal issues addressed by bioethics usually involve access and allocation new subjects arise from scientific advances, most recently in genetics

46

More issues in bioethics

New genetic technologies Cloning Public health ethics Organizational Ethics Animal ethics Environmental ethics Ethics and natural disasters Cultural pluralism, ethics and science

47

Globalization of bioethics
Bioethics addresses bioethical issues in the global context taking into account many factors-economic, social, political, religious, cultural- and adopting many ethical methodologies Examples: genetics and genomics, international research ethics, reproductive technologies, access to basic health care in developing countries, etc

48

Is bioethics a subset of philosophy?

Fundamentally a discursive, reflective activity carried out in the Socratic tradition Philosophical reflection on medicine The relationship between philosophy and bioethics is likened to that between theoretical science and technological fields

49

Nigerias famous contribution to history of research ethics

In 1996, the largest epidemic of CSM ever, occurred in Nigeria with 300,000 cases and 30,000 deaths Pfizer, then in process of registering Trovafloxacin with the US FDA for treatment of infections including bacterial meningitis saw an opportunity for a Phase II clinical trial of the safety and efficacy of the drug in pediatric CSM
50

Nigerias famous contribution to history of research ethics

Pfizer flew in a clinical team that included physicians unlicensed to practice medicine in Nigeria under weak local leadership and conducted a randomized trial with 98 patients of trovafloxacin and 100 on I.V. ceftriaxone the latter at doses subsequently shown to be lower than therapeutic Case fatality was 6% for ceftriazone and 5% for trovafloxacin
51

Nigerias famous contribution to history of research ethics

Study raised several ethical questions including
Propriety of conducting such a trial in the middle of an epidemic usually known to have a high case fatality Participants claimed they were not adequately informed that they were enrolling in a clinical trial; about the risks; voluntariness and they did not provide informed consent
52

Nigerias response
Increased awareness of clinical and research ethics Increased local and international training in research ethics Setting up of the National Health Research Ethics Committee Issuance of a standardized code for health research ethics Establishment and training of institutional health research ethics committees

53

Scandals fed Regulations

Nuremberg Code 1949 World Medical Associations Declaration of Helsinki 1964 National Research Act and the Belmont Report 1974/79 The Council for International Organizations of Medical Sciences (CIOMS) guidelines (1993/2002) ICH-GCP Guidelines 1996 Nigerian National Code of Health Research Ethics 2007 And lots more..............

54

Bioethics Education
Medical ethics education: hidden versus open curriculum Present day bioethics education: teaching the cognitive and behavioural aspects of ethics

55

Bioethics Education
Goals improving the quality of care in terms of both the process and outcome of care enhances the ability to integrate the technical and moral components of the decision making process in clinical practice prepares the recipients for the ethical challenges of clinical practice and biomedical research
56

Research ethics education in Nigeria

On-site short courses conducted at invitation of institutions basically for ethics committee members. Online courses such as
CITI https://www.citiprogram.org/default.asp TRREE - http://elearning.trree.org/ NIH/NCI http://phrp.nihtraining.com/users/login.ph p

57

WAB
http://www.westafricanbioethics.net
MSc Bioethics
3 semesters 2 on-campus and 1 research semester offcampus Course work in Philosophy; Foundations of Modern Bioethics; Informed Consent, Composition and Management of Ethics Committees; Research Designs; Qualitative Research Methods; Quantitative Research Methods; Culture and Ethics; Law, Medicine and Ethics; Communications and Writing in Ethics; Research Misconduct among others Previous students have come from Public Health; Obstetrics and Gynecology; Anesthesia; Law; Pharmacy; Science and Technology; Library Sciences etc.

58

WAB
http://www.westafricanbioethics.net
Diploma in Research Ethics
2 months course based on the Foundations of Modern Bioethics and Informed Consent courses Later this year, this course will be migrated online so that people can take advantage of it without needing to come to Ibadan Online advanced diploma in Research Misconduct is also slated for early next year in order to accommodate expected increase in demand for these instructions because of the new NIH requirement that all those working on NIH funded research must receive at least 8 hours of such instruction
59

WAB Activities
Academic programs- MSC/MPhil/PHD, Diploma/Certificate Research Ethics workshops Research Ethics Committees (REC) training Bioethics Seminar Online presence-CITI training, WABTP website, hosting of seminar presentations Empirical research Publications Bioethics consultancy services
60

Clinical and Research Ethics in Nigeria

Increased capacity for conduct of ethical research in Nigeria Improved and standardized protocol approval process Increase in numbers of Clinical and Research Ethics Committees in our research institutions Increased number of high quality clinical and epidemiological research that contributes to knowledge and national economic development
61

THANKS

62

Acknowledgement
This presentation uses information extensively from many authors and resources including books, journal articles, slides and online information

63