MEDICAL ETHICS FOR DOCTORS

IN ETHIOPIA

Produced and publicized by:

Ethiopian Medical Association (EMA)

Addis Ababa

April, 2010
 PREFACE
This edition of "Medical Ethics for Doctors in Ethiopia" consists of an up to-date
information and guideline for all practicing doctors in Ethiopia in line with the dynamic
field of ethics in general and the medical ethics in particular. Since its first publication
in 1988 entitled “Medical Ethics for Physicians practicing in Ethiopia”, no major
revision or changes were made, neither the standing Ethics committee of the
Ethiopian Medical Association had come up with opinions and position statements.

Nevertheless, EMA’s annual conferences have always put great emphasis on the
issue of medical ethics. Accordingly, the first medical ethics draft document, which is
the major resource to this edition, was produced in the year 2008. Besides, the
continued discussions and recommendations have brought about significant
improvement to the ethical principles and values that have been put together in the
Ethiopian context of medical practice.

In addition, the standing ethics committee of EMA has shouldered responsibility to

come up with timely opinions and positions that will gradually be reflected in the
course of exercising the ethical code in both medical practice and medical research
and to present it to the executive committee and the general assembly for
endorsement. Moreover, EMA believes the inputs that could be obtained from
theologians, sociologists, psychologists, philosophers, ethicists, lawyers, medical
practitioners, etc. will have great importance to further adopt the document in the
Ethiopian context.

As a final point, EMA will make an effort to carry on reviewing the document for the
years to come in order to keep it up-to-date and functional.

Executive Committee
Ethiopian Medical Association
March 2010

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 ACKNOWLEDGEMENTS
I’m greatly indebted to Professor Tilahun Teka and Dr. Yimtubezina W.Amanuel
for producing this reviewed document and for their invaluable technical advice
in the course of the process. I’m also very much thankful to those professionals
who determinedly reviewed the first draft. Their participation has helped a lot to
enrich the document. My heartfelt thank also goes to the participants of the final
review workshop. Truly the outcome of the workshop was significant that enabled
to supply the document with indispensable ideas.

Moreover, I would like to acknowledge the support of the Federal Ministry of

Health in particular Dr. Yibeltal Asefa Medical Service Directorate Director
FMoH who has encouraged members of the Ethiopian Medical Association to
come up with such fruitful document. Last but not least, I express gratitude to
EMA’s secretariat for organizing the final review workshop and for providing all
the necessary support till the final publication.

Dr Fuad Temam
EMA’s President

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 CONTENTS
PREFACE...............................................................................................................................ii
INTRODUCTION ................................................................................................................... 1
Historical Background .................................................................................................. 1
Ethics in Medicine ......................................................................................................... 2
Hippocratic Oath............................................................................................................ 3
Medical Ethics in Ethiopia ........................................................................................... 4
Code of Medical Ethics .......................................................................................................... 6
A.GENERAL CODE OF MEDICAL ETHICS ........................................................... 7
I. Doctor-patient and Doctor-community Relationships .............................................. 7
II. The Doctor as a Professional.......................................................................... 8
III. Medical Secrecy............................................................................................. 8
IV. Patients' Consent........................................................................................... 9
V. Torture and Punishment............................................................................... 9
VI. Certificates, Prescriptions and Signatures ............................................. 10
VII. Undisclosed Gains....................................................................................... 10
VIII. Advertisement and Publicity .................................................................. 10
IX. The Doctor and his Professional Colleagues......................................... 10
X. Supervisory Role of the Doctor................................................................. 11
XI. Mind and behavior control.......................................................................... 12
XII. Abortion.......................................................................................................... 13
XIII. Family Planning........................................................................................ 13
XIV. Artificial insemination .............................................................................. 13
XV. Severely handicapped children................................................................. 14
XVI. Care of children ........................................................................................ 14
XVII. Death .......................................................................................................... 14
XVIII. Euthanasia................................................................................................. 15
XIX. HIV Infection and Doctors ...................................................................... 15
B. RESEARCH ETHICS ................................................................................................... 16
Research Ethics involving human participants ................................................................. 16
I. Research in Medicine ......................................................................................... 16
II. Research Ethics – Historical Background .................................................. 16
III. Principles of Research Ethics ....................................................................... 18
IV. General Code of Ethics in Medical Research............................................ 19
A. The Role of Investigator and Ethical Norms.......................................................... 19
B. Medical Research Combined with Professional Care............................................... 21
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI................................. 24
A. Introduction .......................................................................................................... 24
B. Basic Principles for all Medical Research ............................................................. 25
C. Additional Principles for Medical Research Combined with Medical Care ......... 28
Appendix 1 - 3 ..................................................................................................................... 30
The Original Hippocratic Oath* (about 460-377 B.C.) .............................................. 30
The Chinese Code of Sun Ssu – mais*- (7th Century, A.D.) ............................................ 31
The Declaration of Geneva* (1971).................................................................................. 32
The Declaration of Lisbon on the Rights of Patients* (1981) ............................................ 33
The Declaration of Tokyo on Torture and other Cruel, Inhuman or Degrading Treatment or
Punishment* (1975) ......................................................................................................... 34
GLOSSARY......................................................................................................................... 36

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 INTRODUCTION
Historical Background
Ethics is a philosophical discipline which attempts to determine what is morally right
and what is morally wrong with regard to human action. It was described by some of
the Greek philosophers such as Socrates who said “The truly wise man will know
what is right, do what is good and therefore be happy”. Aristotle also used to say
“Rational development was considered the most important, as essential to
philosophical self-awareness and as uniquely human” (Biomedical Ethics, 4th edition,
1996).

The word ethics is derived from the Greek ethos, which means custom or culture, a
manner of acting or constant mode of behavior. Thus, ethics is defined as a
systematic or scientific study of morality (of human acts through the medium of
natural reason). It teaches us how to judge accurately the moral goodness or
badness of any human action. While general ethics is the basic course of the science
of ethics, medical ethics is a form of applied ethics concerned with the application of
general principles to the moral problems of the medical profession. In short, medical
ethics is the study of moral values and judgments applied to medical practice (WMA
Medical Ethics Manual 2005).

Ethical principles started with the Code of Laws of Hammurabl (1790 B. C.) under
which the Babylonian surgeons were rewarded or punished for the results of their
efforts. Over the years, starting with Hippocrates, the most renowned Greek
physician who is regarded as the Father of Medicine, important professional oaths
have been publicly and solemnly pledged by physicians as they are admitted to the
medical profession. The first of these professional codes was the Oath of Hippocrates
4th century, B.C. (See Appendix I)

There were few Jewish, Christian and Islamic teachings on conduct of doctors and
medical ethics. Of these, a Jewish philosopher and physician named Moses
Maimonides (born in Spain) in the Middle Ages (1135-1204) was known for
introducing the Oath of Maimonides. In this oath Maimonides acknowledges that the
eternal providence has appointed him to watch over the life, health and death of
God’s creatures. He also admits to accept the vocation and takes it as his ultimate
calling. This oath was also practiced in some medical schools upon graduation since
the middle Ages (Bulletin of the Johns Hopkins Hospital 28:260-61, 1917).

The most significant contribution to Western medical ethical history was made by
Thomas Percival, an English physician, philosopher, and writer. In those days
Percival’s personality, his interest in sociological matters and his close association
with infirmary, hospitals and charities were later reflected in his new preparation of
professional conduct. Thomas Percival was able to draft Code of Medical Ethics that
bears his name in 1803. In 1847 the American Medical Association’s first adopted
Code of Ethics was based on Percival’s code. Although the original code adopted by
the association remained the same throughout the years, there were major revisions
that took place and since 1957 the format known as the AMA Principles of Medical
Ethics was accepted. In order to lay down reasonable balance between professional

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standards and contemporary legal standards in the changing society further revisions
were mandated by the House of Delegates (AMA) to the Council on Ethical and
Judicial Affairs to prepare current periodic opinions based on the Code of Medical
Ethics of the Association (Code of Medical Ethics, Current Opinions, 2002-2003
edition).

The World Medical Association (WMA) since its establishment in1964 was sworn to
put patients’ interest first and to strive for the best possible health care for all
regardless of race, creed, political allegiance and social standing. Its major activity
was focused on medical ethics, medical education and socio-medical affairs. In 2003
WMA established an Ethics Unit with main goal to establish and promote highest
possible standards of ethical behaviour and care by doctors. The Unit was
instrumental in adopting policy statements on a large number of ethical issues related
to medical professionalism, patient care, research on human participants and public
policies. The major contribution of Ethics Unit of WMA in 2005 was the preparation of
“Medical Ethics Manual” which was distributed to medical journals and medical
schools throughout the world.

Ethics in Medicine

The ethical concerns of medical care and prevention have been an integral part of
western medicine since its inception that well known in history. However, it was the
explosion of new medical technologies and procedures, growing social concern and
human rights, major interest on moral obligation of the physician to the patient and to
the society, complex medical decisions, and similar issues that had made medical
ethics to emerge as an area of great concern beginning the late 1960s and the early
1970s until today. The existence of disparity in the distribution of health care both
curative and preventive in both developed and developing nations has also raised
serious concern about ethical issues. The major contributions of pharmaceuticals in
conducting clinical trials that may make breakthroughs globally in curing and
preventing some prevalent diseases cause to develop ethical issues when it comes
to principles of beneficence and distributive justice to mankind.

According to the World Health Organization, (WHO), constitution signed July,

1986, "Health is a state of complete physical, mental, and social well-being and not
merely the absence of disease or infirmity”. Moreover, the health status of a
population is often judged on the basis of life expectancy. Better nutrition, safe water
supplies, improved sanitation and immunization or control of infection account for
about 90% of the prolonged life expectancy in Western Europe and North America.
Behavior, lifestyle and the environment definitely influence the health of man.
Morbidity and mortality within these countries are significantly higher among low
income groups as compared to high income groups. The health status of millions of
people is unacceptable at this time, when medical knowledge is well advanced. It is
estimated that more than half of the population of the world does not have adequate
health care. As a result, the gap between the developed and the developing countries
is very wide both in the existing health status and the means of improving health
care.

Aware at the above facts, member nations of the WHO strongly affirmed that “health
is fundamental human right and that the attainment of highest possible level of health

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is the most important worldwide social goal whose realization requires the action of
many other social and economic sectors, in addition to the health sector” Therefore, it
is fair that people participate individually and collectively in the planning and
implementation of their health care (WHO International Health Conference, New
York, 19-22 June, 1946; signed on 22 July 1946).

On September 12.1978, the International conference 'On primary Health Care held in
Alma Ata. jointly sponsored by WHO and UNICEF declared that primary health care
is the key to attaining the target of health for all by the year 2000, as part of over-all
development and the spirit of social justice. This declaration called on all
governments to formulate national policies, strategies and action plans to launch and
sustain primary health care as part of a comprehensive national health system and in
coordination with other sectors. The declaration also called for urgent and effective
international action to develop and implement primary health care throughout the
world particularly in developing countries. The major ethical driving force was about
“distributive justice” and how best access to health services is available to all people
in line with the prevailing condition of inequality and human right (Declaration of Alma
Ata).

Now after thirty years of the declaration of Alma Ata, there are improvements in many
sectors, including health services in developing countries. There are also tremendous
technological advances attained in medical sciences. Some of the advancements in
health and medicine are found to be beneficial to both the developed and the
developing world, although the gap between the rich and the poor countries are so
wide that basic health services in developing countries were in a very serious
condition.

Modern health care and public health practices are now faced with extremely
complex and multifaceted ethical dilemmas. In addition to technological
advancements including stem cell researches….cloning, etc. the emerging of
pandemics like HIV infection since the late 80s have griped the whole world with
major ethical issues. As ethics is a fundamental issue of the whole world,
discussions, dialogues, position statements, declarations are needed with the help of
experts in the field in order to guide the individual and corporate practitioners in
health.

Hippocratic Oath
The Hippocratic Oath was first revised and brought up-to-date by the World Medical
Association as the Declaration of Geneva which was adopted by the Third General
Assembly of the World Medical Association at Geneva, Switzerland, September 1948
and, later, by the International Code of Medical Ethics adopted by the General
Assembly of the World Branch Association held In London, England, October, 1949.
The Declaration of Geneva was amended by the 22nd World Medical Assembly,
Sydney, Australia, In August 1968 and the 35th. World Medical Assembly, Venice,
Italy, In October 1983, (See Appendix I).

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Modern Version
The modern version was written in 1964 by Louis Lasagna, Academic Dean of the School of
Medicine at Tufts University, and used in many medical schools today. It reads as follows:

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and
gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin
traps of over treatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy,
and understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the
skills of another are needed for a patient's recovery.

I will respect the privacy of my patients, for their problems are not disclosed to me that the
world may know. Most especially must I tread with care in matters of life and death? If it is
given me to save a life, all thanks. But it may also be within my power to take a life; this
awesome responsibility must be faced with great humbleness and awareness of my own
frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being,
whose illness may affect the person's family and economic stability. My responsibility includes
these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow
human beings, those sounds of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered
with affection thereafter. May I always act so as to preserve the finest traditions of my calling
and may I long experience the joy of healing those who seek my help.

Medical Ethics in Ethiopia

Until 1980 many doctors practicing in Ethiopia were trained abroad i.e. in different parts of
the world and some of them had taken courses that train medical ethics in undergraduate
classes. However, almost all graduates of the Faculty of Medicine, Addis Ababa University
did not take courses of medical ethics during their training. The general curricula of the
existing medical schools in Ethiopia do not include medical ethics course until recently.
Nevertheless, a 1-credit hour medical ethics course was introduced at the Faculty of Medicine,
Addis Ababa University in 2004 upon recommendations made by the Ethiopian Medical

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Association and curriculum review committees of the Faculty of Medicine, Addis Ababa
University.

The Ethiopian Medical Association had also conducted panel discussions and workshops
during its annual conferences to gradually address issues of medical ethics in question.
Meanwhile, the executive committee of EMA has set up ethics committee that organizes panel
discussions and workshops whenever need arises. The committee also advises EMA on
various issues of medical ethics and also attempts to provide information to doctors and to the
media. In 1988, the Ministry of Health organized a drafting committee that consists of
representatives of different institutions, organizations and associations to prepare an ethical
code booklet entitled “Medical ethics for physicians practicing in Ethiopia“. Members of the
medical schools and EMA have actively participated and EMA in particular has played the
major role in awareness-raising mainly by means of distribution of the booklet to all doctors
in Ethiopia. EMA has also taken a major initiative in the second publication of the booklet in
1992. This booklet is still the binding ethical document that assists practicing doctors not to be
involved in malpractice and thereby protects the public at large.

The care of human life is constantly in the hands of the doctor. Some may usher life into the
world amidst many dangers. Others preserve life threatened by innumerable dangers. All see
life depart from the world in spite of all efforts to prevent it happen. Thus, the doctor who is
so intimately involved with the most noble and sacred realities of life must depend on ethical
principles and ideals. A realization and clear understanding of such principles and their
practical application will result in efficient service to man and normal satisfaction to on self.

Although medical ethics principles are universally accepted by all different countries, each
country is endowed to adopt certain modifications and devise specific interpretations
consistent with the prevailing culture, religious beliefs, social and anthropological norms,
laws of the land, and standards of medical practice in the existing health system. It is
understandable that as these conditions are sometimes in the state of fast or slow changes and
transformations, issues in medical ethics are also bound to dynamism and frequent changes in
implementations of the principles in the context of the health service environment within the
respective country and the availability the standard of care required.

These and similar issues described above bring forward medical ethics as part and parcel of
daily activities in all aspects of health services (preventive, curative etc…) in Ethiopia and the
situation obliges all doctors to abide consistently with the principles. It is also mandatory that
doctors practicing in Ethiopia themselves, and through their association (EMA) and Ethics
standing committee need to discuss and come up with a universally agreed positions and
statements that bind all of them in their respective practice. The ethical guidelines and code of
medical ethics should be revised in 5-10 years interval with deletions, modifications and new
additions. It is the duty of each and every doctor to know it and practice it accordingly. It is
also high time to set up ethics committees that play a role in the respective health services and
to use these committees to learn from each other, to exchange of views and norms with each
other, to strengthen decision making capacity, and to undertake timely action to preventing
mal practice.

We hope EMA and its standing Ethics committee will work towards the implementation of
medical ethical principles that best serves the Ethiopian people.

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 Code of Medical Ethics
The Code of Medical Ethics reflects the application of the principles of Medical Ethics in
some of the ethical issues in medical practice including doctor’s relationship to patients, to
colleagues and to the community in general. A doctor as a professional is responsible to
keeping medical secrecy, abiding by informed consent and disclosing conflict of interest at all
times. It also indicates the position a doctor need to take when encountering torture and
punishment situations, in issues related to advertisement. He/she is fully responsible to
certificates, prescriptions and signatures of practical importance in delivering medical
diagnosis and management.

This code does give an appropriate guideline and illustrates the acceptable behaviour of a
doctor with a sound mind and self-control. It directs the doctor in his/her practice to discharge
his/her responsibility in issues related to abortion, family planning, artificial insemination,
severely handicapped children. The code of medical ethics fully authorizes the doctor’s
responsibility to confirm and issue death certificate. However, no doctor in this code is
permitted to advocate or practice euthanasia.

In short, the following code of medical ethics is focused on the duties and obligations of the
doctor towards his patients on the conduct and application of his or her professional arts and
science as well as his or her association with professional colleagues.

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A.GENERAL CODE OF MEDICAL ETHICS

I. Doctor-patient and Doctor-community Relationships

Article 1: The principal objective of the medical profession is to render service

to the individual and the community with full respect for life and the
dignity of man.

Article 2: The doctor shall attend her/his patient with maximum possible care,
devotion and conscientiousness. She/he shall respect the dignity of
her/his patient and her/his attitudes shall be sympathetic, friendly and
helpful.

Article 3: In case of a female patient (client) presenting in a clinic, the doctor shall
perform her/his examinations in the presence a female nurse or a
chaperone.

Article 4: The doctor shall practice her/his profession without discrimination.

Article 5: The doctor shall provide her/his patient, the family and the whole
Community with the prevention of disease or injury, maintenance of
good health and rehabilitative services.

Article 6: The doctor shall cooperate with the public authorities in the prevention
of disease or injury and in the maintenance of good health.

Article 7: The doctor shall make use of every opportunity to teach the patient
and her/his family regarding the prevention of disease and the
promotion of health.

Article 8: In case of emergency the doctor shall extend all possible assistance to
the patient without fail.

Article 9: In the event of public danger, the doctor shall not abandon patients in
her/his immediate care until all appropriate measures have been taken
to secure the safety of the patients.

Article 10: The doctor shall do nothing wasteful or shall not do anything without
justification for the health of· the Individual or the community.

Article 11: The doctor shall be the defender of the child when she/he judges the
health of the child is not well protected.

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Article 12: The doctor is obliged to consult colleagues when it is necessary
to do so, and shall inform the patient and/or the patient’s relatives about
the consultations.

Article 13: The doctor is free to choose whom she/he will serve. The doctor should,
however, respond to the best of her/his ability in case of emergency
where first aid treatment is essential. While the doctor has the option of
withdrawing from a case, she/he shall ascertain that:
a. the patient or the relatives or responsible person are notified ahead
of time.
b. the patient will have adequate care
c. a colleague will replace her/him
d. all necessary information will be conveyed to the replacement.

Article 14: The doctor-patient relationship shall not be used as a means of

developing intimacy.

II. The Doctor as a Professional

Article 15: The doctor shall at all times conduct herself/himself in such a way that
she/he may gain the respect and the confidence of her/his fellow man
and maintain the dignity of her/his profession, and those conditions are
essential for the best practice of her/his profession.

Article 16: The responsibility of the doctor shall be strictly personal.

Article 17: The doctor shall at no time divest herself/himself of her/his professional
freedom.

Article 18: The doctor shall endeavor to improve continuously her/his knowledge
and skill and should make them available to her/his patients and
colleagues.

Article 19: The doctor shall use recognized scientific methods during her/his practice.

Article 20: The doctor shall not administer unjustified treatment.

III. Medical Secrecy

Article 21: The doctor shall maintain her/his professional secrecy in respect for all
matters which have come to her/his knowledge in the course of her/his
duties to the patients except in those situations clearly stipulated by the
law or when the patient gives written consent for the release of
information.

Article 22: The use of any medium such as: film, videotapes, or otherwise record
patient interactions with their health care providers requires the utmost
respect for the privacy and confidentiality of the patient.

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Article 23: In case of minors and unconscious patients or patients of unsound
mind, the doctor may reveal his professional secret to the patient's
relatives when such a revelation would serve any useful purpose for the
cure of the patient or when her/his condition otherwise so requires.

Article 24: The doctor shall see to it that persons working with him respect medical
secrecy.

Article 25: The doctor shall not disclose the identification of her/his patient in
her/his scientific publications or lectures unless there is a written
consent of the patient.

IV. Patients' Consent

Article 26: It is the duty of the doctor to inform the patient about the treatment
(Including surgical procedures), she/he intends to carry out. The doctor
is always obliged to obtain a written consent of the patient before
carrying out procedures. In the case of minors or persons who are
unconscious or of unsound mind, the necessary consent should be
obtained from parents or legal guardians, if there is no other legal
provision.

Article 27: On legitimate grounds, left to the discretion of the doctor, information
about serious diagnoses and/or prognosis may be withheld unless the
patient demands it. However, it is, desirable to inform the nearest
relative when the outcome is likely to be unfavorable.

Article 28: The doctor has an ethical obligation to help the patient make choices
from among the therapeutic alternatives consistent with good medical
practice.

V. Torture and Punishment

Article 29: The doctor shall not participate in the practice of torture or other cruel,
inhuman or degrading procedures. The doctor shall not provide
premises, instruments, substances or knowledge to facilitate the
practice of torture.

Article 30: Doctors may treat prisoners or detainees if doing so is in their best
interest. But doctors should not treat individuals to verify their health so
that torture can begin or continue. Doctors who treat torture victims
should not be persecuted. Doctors should help provide support for
victims of torture and, whenever possible, strive to change situations in
which torture is practiced or the potential for torture is great.

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 VI. Certificates, Prescriptions and Signatures

Article 31: Any documents of certificate issued by the doctor should bear his
legible name and signature.

Article 32: The issuance of a tendentious report or a false certificate is unethical.

Article 33: Upon request of the patient or legal authorities the doctor shall issue
certificate based solely on his medical observations. Documents or
testimonies should be issued when authorized by courts of law.

Article 34: The doctor shall formulate his prescriptions with the necessary clarity.
The doctor and/or the pharmacist make sure that the patient or his
family has well understood the ordered prescription. The doctor will try
her/his best to see that the treatment is carried out.

VII. Undisclosed Gains

Article 35: It is unethical to accept any indirect gain based on a principle of

dichotomy or undisclosed division of professional fees for a medical act
such as for prescriptions of drugs, laboratory investigations, appliance,
etc. with a medical partnership publicly known to exist.

Article 36: Complicity intended to get directly or indirectly any material benefit is
forbidden among doctors themselves, and between doctors and other
health workers, and between doctors and any other person.

Article 37: The doctor shall not allow a patient to obtain illegal or unjustified gains.

VIII. Advertisement and Publicity

Article 38: The doctor in his practice shall avoid direct or indirect self
advertisement.

Article 39: The doctor shall not use his mandate or administrative position in order
to promote his practice.

IX. The Doctor and his Professional Colleagues

Article 40: The doctor shall conduct himself in a loyal, fraternal and courteous way
towards other members of his profession.

Article 41: The doctor shall never in any way discredit the acts or words of a
colleague except where immoral words or acts directly harmful to the
health of the patient or, to the community are involved, in which case
she/he shall reveal her/his observation only to proper authorities. The
doctor shall not tolerate that third parties disparage a colleague.

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Article 42: Disputes between members of the medical profession must be resolved
quickly and amicably within the profession itself. If this fails, the dispute
shall be brought before the body administering this code of medical
ethics.

Article 43: A consulted doctor shall not take over the management of the patient
without the knowledge of the regularly attending physician.

Article 44: It shall be the duty and privileges of every doctor to attend free of
charge any sick colleague or her/his dependents.

X. Supervisory Role of the Doctor

Article 45: The doctor shall not allow any medical student and trainee paramedic to
take direct responsibility of patient’s care.

Article 46: The doctor shall closely supervise the intern in carrying out her/his
duties and responsibilities

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 XI. Mind and behavior control

Article 47: a. The patient must be given the necessary information even if
complex in order she/he reaches a decision about whether to
accept or refuse the recommended psychotropic drug.
b. In the case of the patient who is capable of comprehending the
information given to her/him about psychotropic drugs the
patient's right to refuse treatment must be respected.
c. When the patient is regarded as too disordered to arrive at
informed judgments, the physician/psychiatrists can .assume the
duty to prescribe the medication she/he considers necessary for
clinical needs, but it should be properly documented.
Article 48: In cases of social deviance, it is unethical to use psychotropic drugs as
'chemical restraint', as a form of social control or as punitive measures
in psychiatric hospitals, prison practices or elsewhere.
Article 49: In the treatment of addicts suffering from withdrawal symptoms,
appropriate care and support must be provided without discrimination.
Article 50: a. In the administration of Electro-Convulsive Therapy (ECT),
unless the patient is unable to understand what is proposed,
informed written consent is ethically required. However, the
patient may withholds the consent at any time during the course
of treatment.
b. When a patient is unable to understand what is proposed or
when a patient refuses treatment and Electro-Convulsive therapy
is considered essential, consent must be obtained from the
relative.
c. With regard to the administration of ECT, it must be properly
supervised by senior psychiatrists with a continuing interest in
treatment. The hospital must also meet internationally accepted
ethical and technical standards on ECT therapy.
Article 51: It is the duty of the doctor to explain the mode and the program of
behavioral psychotherapy to the patient and the patient must give
her/his consent.
Article 52: Aversion treatment may be used after full inter-disciplinary discussion
and after obtaining written consent from the patient.
Article 53: Psychiatrists at times necessary, in order to protect the patient the
community from imminent danger to reveal confidential information
discussed by the patient.

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 XII. Abortion

Article 54: The first moral principle imposed upon the doctor is respect for human
life from its beginning.

Article 55: An abortion is justified only when it is performed for the purpose of
saving the endangered life or health of a woman.

Article 56: Abortion is justifiable if performed by a doctor in health institutions

where appropriate facilities are available.

Article 57: It is mandatory to treat a patient who is suffering from the effect of an
abortion induced by another person.

Article 58: The doctor must never disclose the cause of her/his patient's condition
to anyone else without the consent of the patient unless ordered to do
so in court of law.

Article 59: An abortion leading to death should be reported to the concerned

authorities by the treating doctor.

XIII. Family Planning

Article 60: It is ethical for a doctor if she/he informs, educates and communicates
knowledge of family planning to individuals, families or the general
public.

Article 61: It is the duty of a doctor to prescribe scientifically acceptable means and
methods of family planning to individuals or couples who have attained
the age of 18 years and who freely and responsibly decide to postpone
or prevent pregnancy.

XIV. Artificial insemination

Article 62: It is ethical for a qualified and experienced doctor to perform artificial
insemination.

Article 63: The doctor should obtain a signed document from the wife and her
husband setting forth the desire of both parties.

Article 64: The name of the donor should not be disclosed to the husband or the
wife and the names of the married couple should not be given to the
donor.

Article 65: The doctor should provide information about screening (full range of
infectious diseases including HIV and genetic diseases) costs, and
procedures for confidentiality when applicable. .

13
 XV. Severely handicapped children

Article 66: It is unethical to withhold the means necessary for the survival of a
severely handicapped child.

XVI. Care of children

Article 67: It is the duty of the doctor to assist the parents to consent to treatment,
procedures and general care for the wellbeing of a minor child.

Article 68: In emergency situation, however, and where parents can not be
reached, the attendant, relatives, guardian (in case of orphans) can
provide verbal consent and the doctor can go ahead for emergency
intervention. Three doctors’ agreement may be an alternative for
emergency surgical intervention when parents are not reached.

Article 69: The age of consent acceptable by the family law of the land is 18 years.
Therefore, for all minors less than 18 years the doctor upon the request
of the parents can keep the interactive interviews, examination results,
counseling outcomes conducted with the minor confidential. No
information will be disclosed without the consent of the parents.

Article 70: In some situations for minors between ages 12-18 years, when the
doctor believes that without parental or guardian involvement and
guidance, the minor will face a serious health threat, and there is a
reason to believe that the parents or guardians will be helpful and
understanding, disclosing the problem to the parents or guardians is
ethically justified.

XVII. Death

Article 71: It is part of the duty of the doctor to issue a death certificate.

Article 72: The doctor should summarily reject any suggestion to modify accuracy
or to alter truth when issuing a death certificate.

Article 73: The doctor should not sign a death certificate unless she/he has
personally ascertained the facts pertaining to the death.

Article 74: The protection of the confidential nature of the medical information
stated in the certificate must be ensured as much as possible.

Article 75: It is permissible to remove organs from the cadaver provided

requirements for consent have been fulfilled.

Article 76: It is ethical to perform postmortem examination with the consent of the
immediate relatives. In the absence of claimants this holds true when
legitimate medical reasons exist.

14
 XVIII. Euthanasia

Article 77: No doctor can take life deliberately as an act of mercy even at the direct
request of the patient or the patient's family.

XIX. HIV Infection and Doctors

Article 78: Doctors should encourage patients to have HIV testing voluntarily to
enhance early diagnosis and treatment of HIV infection or of medical
conditions that may be affected by HIV.

Article 79: Doctors should ensure that HIV testing is conducted in a way that
respects patient autonomy and assures patient confidentiality as much
as possible.

Article 80: In a health facility level, when a health care provider is at risk of the
infection due to puncture injury or mucosal contact with potentially
infected bodily fluids, it is acceptable to test the patient for HIV infection
even if the patient refuses consent.

Article 81: If a doctor knows that a sero-positive individual is endangering a third

party, the doctor should, within the constraints of the law: a) attempt to
persuade the infected patient to cease endangering the third party b) if
persuasion fails, notify authorities; and c) if authorities take no action,
notify the endangered third party.

Article 82: It is unethical to refuse to treat a patient whose condition is within the
doctor’s current realm of competence solely because the patient has
HIV/AIDS.

Article 83: A doctor who knows that she/he is sero-positive should not engage in
any activity that creates a significant risk of transmission of the disease
to others. She/he should consult colleagues as to which activities
she/he can pursue without creating a risk to patients.

Article 84: Doctors should persuade all pregnant mothers to be screened and
prevent mother to child transmission of HIV.

15
B. RESEARCH ETHICS
Research Ethics involving human participants

I. Research in Medicine
Medical practice and research are dynamic. The physician shall make maximum
effort to continuously improve his/her knowledge and skill to provide patients with the
highest medical care. In order to carry out this responsibility, physicians need to use
the results of medical research and constantly upgrade their competence by keeping
up with research findings in the area of their respective specialties. Even the best
current interventions must be evaluated continually through research for their safety,
effectiveness, efficiency, accessibility and quality (DoH, 2008). As mentioned in the
ethics manual of the World Medical Association (WMA), the functions of medical
research among other things is monitoring and evaluation of even the most widely
accepted treatments, in addition to the development of new treatments, especially
drugs and medical devices. Research is the only means of answering the many
unanswered questions in Medicine. In order to carry out research or even interpret
results of research done by others, a basic familiarity with research methods is
essential for competent medical practice. The most common method of research for
practicing physicians is the clinical trial.
Distinctions between practice and research should be done, even though these two
often occur together. “Practice” involves interventions designed solely to enhance the
well-being of the patient or client. These interventions are undertaken because there
is a reasonable expectation of a successful outcome. On the other hand “Research”
constitutes activities designed to contribute to generalizable knowledge. Typically in
research a set of activities is consistently applied to groups of individuals in order to
test a hypothesis and draw conclusions. These activities do not necessarily provide
direct benefit.

II. Research Ethics – Historical Background

The ethics of human subject research has evolved over the past decades, whereby
guidelines, codes and regulations have been created, to guide the ethical conduct of
research involving human participants. Some of these guidelines were created in
response to an ethical lapse. The first one of the kind, the Nuremberg Code, a 10-

16
point statement outlining permissible medical experimentation on human participants,
came into being as a result of the prosecution of Nazi war criminals at the end of
World War II. The first provision of the code requires that “the voluntary informed
consent of the human subject is absolutely essential.”
On the other hand, several guidelines were developed in an attempt to address
solutions to the changing world of research and provide means to address new
challenges. But all of them reflect the principles of respect for persons, beneficence
and justice. The World Medical Association was established in 1947, and in the year
1964, it came up with the Declaration of Helsinki, a concise summary of research
ethics, which provides for extra protection for persons with diminished autonomy and
urges caution on the part of the physician researcher who enrolls his own patients,
and further gives emphasis to the principle that the well-being of the participant
should take precedence over the interests of science and society. Since the first
version, the Declaration of Helsinki (DoH) has been revised six times with the most
recent revision in 2008. In 1978, The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research appeared, which sets
forth the three ethical principles—respect for persons, beneficence, and justice. Over
the years several more detailed guidelines were produced. One of these guidelines is
the International Ethical Guidelines for Biomedical Research Involving Human
Subjects (CIOMS), with the purpose to indicate how the ethical principles can be
applied effectively, particularly in developing countries. This is an important guideline,
because many researches in Ethiopia are presently done in partnership with the
developed countries, many ethical issues are raised through such collaborations.
Meanwhile, researchers come for cheap access of participants to developing
countries. Like those of the 1982, 1993, and the 2002 CIOMS Guidelines are
designed to be of use to countries in defining national policies on the ethics of
biomedical research involving human subjects, applying ethical standards in local
circumstances, and establishing or improving ethical review mechanisms.
Eventually, these international regulations and recommendations need to be adapted
or transformed into institution operational guidelines to be used at the local level to
guide the planning, review, approval and conduct of human research, by applying the
fundamental principles within the context of local laws and cultural circumstances.
The ultimate responsibility for the acceptable conduct of research with human

17
subjects rests with the investigator. The Declaration of Geneva of the WMA binds the
physician with such motto, “The health of my patient will be my first consideration,”
and the International Code of Medical Ethics declares that, “A physician shall act in
the patient's best interest when providing medical care.”
When Physicians conduct research with human participants they should consider the
ethical, legal and regulatory norms and the standards for research involving human
subjects in Ethiopia as well as applicable international norms and standards.
The first National Health Researches Ethics Guideline in Ethiopia was issued in 1995,
which has subsequently been revised three times and the latest is the 2005 version.
In Ethiopia, Health Research Ethics Review Committees are established at three
levels: National, Regional and Institutional All health researches involving human
participants must be subjected to independent ethics review and this should be
conducted by the health research ethics review committee. As advocates for the
safety of our patients and as potential participants in research, the role associations
in formulation of National guidelines play should be given due attention.

III. Principles of Research Ethics

There are three fundamental principles for the ethical conduct of research involving
human participants, which are commonly embodied in national regulations and
international recommendations and guidelines. The first one is Respect for Persons
which deals with the principles of autonomy and the protection of persons with
diminished autonomy. The application of this principle is the use of the individual
informed consent which comprises the three elements: information, comprehension
and voluntariness; it requires that subjects to a degree that they are capable, should
be informed and should be freely given a chance to decide what shall and shall not
happen to them. The second ethical principle involves Beneficence, which is
synonymous with do no harm and maximize possible benefits and minimize possible
harms. The assessment of risks and benefits requires a careful arrayal of relevant
data, including, in some cases, alternative ways of obtaining the benefits sought in
the research. The third principle is Justice; translated into who ought to receive the
benefits of research and bear its burdens and issue of "fairness in distribution “, its
application is manifested during the recruitment of study subjects.

18
IV. General Code of Ethics in Medical Research
A. The Role of Investigator and Ethical Norms
Article1. A physician shall continue to study, apply, and advance scientific
knowledge, maintain a commitment to medical education, since research is
potentially of significant value when ethically conducted
Article 2: Honesty and integrity must govern all stages of research, from the initial
grant application, to publication of results. Fabrication, falsification,
plagiarism should be avoided in proposing, conducting and reporting
research.
Article 3: Medical research involving human subjects must conform to the generally
accepted current scientific principles, be based on a thorough knowledge of
the scientific literature, and supported with other relevant sources of
information.
Article 4: When conducting a clinical trail, a state of clinical equipoise must exist at
the inception of the trial, regarding the advantage of the regimens to be
tested.
Article 5: Since the ultimate responsibility of the protection and the safety of the
research participants rest upon the physician-investigator, individuals
conducting the study must have the appropriate scientific training and
qualification.
Article 6: Benefits and risks of research must be distributed fairly, and particular care
must be taken to avoid exploitation of vulnerable populations. Careful
assessment of any predictable risks in comparison with foreseeable
benefits to individuals and the community at large should be done
beforehand and the benefit-to-risk ratio must be high enough to justify the
research effort.
Article 7: In externally funded research, the research must hold the promise of direct,
tangible, and significant benefit to the host country’s population, if not to the
study subjects themselves.
Article 8: Physicians involved in research with human subjects must first write a clear
research protocol with proper design and performance of each study. As
stated in paragraph 14 of DoH, the protocol should contain a statement of

19
 the ethical considerations involved and should indicate how the ethical
principles have been addressed. Additionally, the protocol should include
information regarding funding, sponsors, institutional affiliations, other
potential conflicts of interest, incentives for subjects and provisions for
treating and/or compensating subjects who are harmed as a consequence
of participation in the research study. The protocol should describe
arrangements for post-study access by study subjects to interventions
identified as beneficial in the study or access to other appropriate care or
benefits.
Article 9: Before initiation of any study, all proposed research, should be approved
by the research ethics committee/ review board (National
/Institutional/regional) in order to assure that the research plans are
reasonable and that research participants are adequately protected. The
protocol must take the national guidelines and International norms and
standards into consideration.
Article 10: All changes, amendments of the research protocol must be approved by
the ethics committee/board before implementation of the changes.
Article 11: The nature of the research must be explained in plain and understandable
local language to research participants, and informed consent must be
obtained from the research participant or from an authorized representative
for those with diminished capacity to consent. The consent process should
reflect all the elements of consent: information, comprehension and
voluntariness: It should include basic elements such as a statement that
the study involves research and expected duration, purpose of the study
and procedures to be followed , any anticipated risks or discomforts,
description of any benefits, alternative procedures or treatment,
confidentiality, compensations to study related injury, statement that shows
voluntariness, whom to contact for responses to study related queries and
questions about participant’s rights.
Article12: The consent should be documented, by use of a consent form that has
been approved by the ethics committee, dated and signed by the study
participant or legally authorized representative. For participants who cannot

20
 read and write, a witness signature should be obtained in addition to index
finger print of the participant.
Artcle13: As paragraph 25 of DoH stipulates, for medical research using identifiable
human material or data, physicians must normally seek consent for the
collection, analysis, storage and/or reuse. There may be situations where
consent would be impossible or impractical to obtain for such research or
would pose a threat to the validity of the research. In such situations, the
research may be done only after consideration and approval of the
research ethics committee/board.
Article14: When the effectiveness of a new intervention is being tested, the physician
must adhere to the latest national and international norms and guidance.

B. Medical Research Combined with Professional Care

Article15: The physician who participates in research must protect the life, health,
dignity, integrity, right to self-determination, privacy, and confidentiality of
personal information of research subjects.
Article16: The health and welfare of the patient must always be the physician's
primary consideration. Medical research can be combined with medical
care only to the extent that the research is justified by its potential
preventive, diagnostic or therapeutic value. If the physician has good
reason to believe that participation in the research study will not adversely
affect the health of the patients who serve as research participants and that
the patient is fully informed which part is care and which part is research.
Article 17: If the research participant is in a dependent relationship with the physician-
investigator, consent should be obtained by another independent individual
who is very familiar with the study to avoid coercion.
Article 18: Physician-investigators may find themselves in dual roles with respect to
patients who are also research participants and they should avoid
situations that facilitate for them a reward for particular outcomes.
Article19: Physicians who refer patients for participation in research protocols must
be satisfied that the program follows established ethical guidelines,
provides for realistic informed consent, gives reasonable assurances of

21
 safety, and has an acceptable benefit-to-risk ratio. If the risks of the
research become too great or if continued participation cannot be justified,
the physician must be willing to immediately advise the patient to withdraw
from the study.
Article 21: Giving finder's fees to individual physicians for referring patients to a
research project generates conflict of interest
Article 22: The outcome of the consent process shall not interfere with the physician-
patient relationship.

C. Protection of Special Groups involved in Research

Article 23: The rational and details of the inclusion of vulnerable population in
research (Children, pregnant women, prisoners, mentally disabled etc.)
should be included in the research protocol.
Article 24: Special precautions must be taken when recruiting potential participants
who are incompetent or do not have the legal capacity to give consent.
They should not be included, if there is no likelihood of direct benefit from
the study to the individuals or to the health of the population represented by
the potential participant. In situations when they are included in a study,
informed consent should be taken from parents/guardians or legally
designated individual.
Article 25: Children should be included in research, only in cases where their
participation is indispensable for researches of diseases of childhood and
conditions to which children are particularly susceptible and when the risk
is justified by the anticipated benefit from participation.
Article 26: If the potential subjects are children, the consent of a parent or legal
guardian after a full explanation of the aims of the experiment and of
possible hazards, discomfort or inconvenience, is always necessary. In
addition to this, to the extent that it is possible, which will vary with age, the
assent (willingness) of the child should be sought with due respect to the
dissent of the potential participant.
Article 27: Special safeguards should be put in place when involving pregnant women
in research. Pregnant women should not be included in non-therapeutic
research that carries any possibility of risk to the fetus or neonate, unless

22
 this is intended to elucidate problems of pregnancy or lactation.
Scientifically appropriate preclinical studies and clinical studies on non
pregnant women should be done so that to provide data to assess the
potential risk in pregnant women and fetuses.

D. Scientific Publication
Article 28: Being authors of scientific publications should mean that the individuals
are sufficiently acquainted with the work being reported, that they can take
public responsibility for the integrity of the study and the validity of the
findings, and they must have substantially contributed to the research itself.
Article 29: All authors have a professional responsibility to make public their research
findings and be honest in their publications, make clear that research has
been carried out in accordance with the ethical principles.
Article 30: Plagiarism is unethical. Incorporating the words and ideas of others or
one's own published words, either verbatim or by paraphrasing without
appropriate attribution is unethical and may have serious consequences.

23
 Appendices

Appendix 1-1

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

Ethical Principles for Medical Research Involving Human Subjects

A. Introduction
1. The World Medical Association (WMA) has developed the Declaration
of Helsinki as a statement of ethical principles for medical research
involving human subjects, including research on identifiable human
material and data.

The Declaration is intended to be read as a whole and each of its

constituent paragraphs should not be applied without consideration of all
other relevant paragraphs.

2. Although the Declaration is addressed primarily to physicians, the WMA

encourages other participants in medical research involving human
subjects to adopt these principles.
3. It is the duty of the physician to promote and safeguard the health of
patients, including those who are involved in medical research. The
physician's knowledge and conscience are dedicated to the fulfilment of
this duty.
4. The Declaration of Geneva of the WMA binds the physician with the
words, "The health of my patient will be my first consideration," and the
International Code of Medical Ethics declares that, "A physician shall
act in the patient's best interest when providing medical care."
5. Medical progress is based on research that ultimately must include
studies involving human subjects. Populations that are
underrepresented in medical research should be provided appropriate
access to participation in research.
6. In medical research involving human subjects, the well-being of the
individual research subject must take precedence over all other
interests.
7. The primary purpose of medical research involving human subjects is to
understand the causes, development and effects of diseases and
improve preventive, diagnostic and therapeutic interventions (methods,
procedures and treatments). Even the best current interventions must
be evaluated continually through research for their safety, effectiveness,
efficiency, accessibility and quality.
8. In medical practice and in medical research, most interventions involve
risks and burdens.
9. Medical research is subject to ethical standards that promote respect
for all human subjects and protect their health and rights. Some

24
 research populations are particularly vulnerable and need special
protection. These include those who cannot give or refuse consent for
themselves and those who may be vulnerable to coercion or undue
influence.
10. Physicians should consider the ethical, legal and regulatory norms and
standards for research involving human subjects in their own countries
as well as applicable international norms and standards. No national or
international ethical, legal or regulatory requirement should reduce or
eliminate any of the protections for research subjects set forth in this
Declaration.

B. Basic Principles for all Medical Research

11. It is the duty of physicians who participate in medical research to protect

the life, health, dignity, integrity, right to self-determination, privacy, and
confidentiality of personal information of research subjects.
12. Medical research involving human subjects must conform to generally
accepted scientific principles, be based on a thorough knowledge of the
scientific literature, other relevant sources of information, and adequate
laboratory and, as appropriate, animal experimentation. The welfare of
animals used for research must be respected.
13. Appropriate caution must be exercised in the conduct of medical
research that may harm the environment.
14. The design and performance of each research study involving human
subjects must be clearly described in a research protocol. The protocol
should contain a statement of the ethical considerations involved and
should indicate how the principles in this Declaration have been
addressed. The protocol should include information regarding funding,
sponsors, institutional affiliations, other potential conflicts of interest,
incentives for subjects and provisions for treating and/or compensating
subjects who are harmed as a consequence of participation in the
research study. The protocol should describe arrangements for post-
study access by study subjects to interventions identified as beneficial
in the study or access to other appropriate care or benefits.
15. The research protocol must be submitted for consideration, comment,
guidance and approval to a research ethics committee before the study
begins. This committee must be independent of the researcher, the
sponsor and any other undue influence. It must take into consideration
the laws and regulations of the country or countries in which the
research is to be performed as well as applicable international norms
and standards but these must not be allowed to reduce or eliminate any
of the protections for research subjects set forth in this Declaration. The
committee must have the right to monitor ongoing studies. The
researcher must provide monitoring information to the committee,
especially information about any serious adverse events. No change to
the protocol may be made without consideration and approval by the
committee.
16. Medical research involving human subjects must be conducted only by
individuals with the appropriate scientific training and qualifications.

25
 Research on patients or healthy volunteers requires the supervision of a
competent and appropriately qualified physician or other health care
professional. The responsibility for the protection of research subjects
must always rest with the physician or other health care professional
and never the research subjects, even though they have given consent.
17. Medical research involving a disadvantaged or vulnerable population or
community is only justified if the research is responsive to the health
needs and priorities of this population or community and if there is a
reasonable likelihood that this population or community stands to
benefit from the results of the research.
18. Every medical research study involving human subjects must be
preceded by careful assessment of predictable risks and burdens to the
individuals and communities involved in the research in comparison
with foreseeable benefits to them and to other individuals or
communities affected by the condition under investigation.
19. Every clinical trial must be registered in a publicly accessible database
before recruitment of the first subject.
20. Physicians may not participate in a research study involving human
subjects unless they are confident that the risks involved have been
adequately assessed and can be satisfactorily managed. Physicians
must immediately stop a study when the risks are found to outweigh the
potential benefits or when there is conclusive proof of positive and
beneficial results.
21. Medical research involving human subjects may only be conducted if
the importance of the objective outweighs the inherent risks and
burdens to the research subjects.
22. Participation by competent individuals as subjects in medical research
must be voluntary. Although it may be appropriate to consult family
members or community leaders, no competent individual may be
enrolled in a research study unless he or she freely agrees.
23. Every precaution must be taken to protect the privacy of research
subjects and the confidentiality of their personal information and to
minimize the impact of the study on their physical, mental and social
integrity.
24. In medical research involving competent human subjects, each
potential subject must be adequately informed of the aims, methods,
sources of funding, any possible conflicts of interest, institutional
affiliations of the researcher, the anticipated benefits and potential risks
of the study and the discomfort it may entail, and any other relevant
aspects of the study. The potential subject must be informed of the right
to refuse to participate in the study or to withdraw consent to participate
at any time without reprisal. Special attention should be given to the
specific information needs of individual potential subjects as well as to
the methods used to deliver the information. After ensuring that the
potential subject has understood the information, the physician or
another appropriately qualified individual must then seek the potential
subject's freely-given informed consent, preferably in writing. If the
consent cannot be expressed in writing, the non-written consent must
be formally documented and witnessed.

26
25. For medical research using identifiable human material or data,
physicians must normally seek consent for the collection, analysis,
storage and/or reuse. There may be situations where consent would be
impossible or impractical to obtain for such research or would pose a
threat to the validity of the research. In such situations the research
may be done only after consideration and approval of a research ethics
committee.
26. When seeking informed consent for participation in a research study the
physician should be particularly cautious if the potential subject is in a
dependent relationship with the physician or may consent under duress.
In such situations the informed consent should be sought by an
appropriately qualified individual who is completely independent of this
relationship.
27. For a potential research subject who is incompetent, the physician must
seek informed consent from the legally authorized representative.
These individuals must not be included in a research study that has no
likelihood of benefit for them unless it is intended to promote the health
of the population represented by the potential subject, the research
cannot instead be performed with competent persons, and the research
entails only minimal risk and minimal burden.
28. When a potential research subject who is deemed incompetent is able
to give assent to decisions about participation in research, the physician
must seek that assent in addition to the consent of the legally
authorized representative. The potential subject's dissent should be
respected.
29. Research involving subjects who are physically or mentally incapable of
giving consent, for example, unconscious patients, may be done only if
the physical or mental condition that prevents giving informed consent
is a necessary characteristic of the research population. In such
circumstances the physician should seek informed consent from the
legally authorized representative. If no such representative is available
and if the research cannot be delayed, the study may proceed without
informed consent provided that the specific reasons for involving
subjects with a condition that renders them unable to give informed
consent have been stated in the research protocol and the study has
been approved by a research ethics committee. Consent to remain in
the research should be obtained as soon as possible from the subject
or a legally authorized representative.
30. Authors, editors and publishers all have ethical obligations with regard
to the publication of the results of research. Authors have a duty to
make publicly available the results of their research on human subjects
and are accountable for the completeness and accuracy of their reports.
They should adhere to accepted guidelines for ethical reporting.
Negative and inconclusive as well as positive results should be
published or otherwise made publicly available. Sources of funding,
institutional affiliations and conflicts of interest should be declared in the
publication. Reports of research not in accordance with the principles of
this Declaration should not be accepted for publication.

27
C. Additional Principles for Medical Research Combined with Medical
Care

31. The physician may combine medical research with medical care only to
the extent that the research is justified by its potential preventive,
diagnostic or therapeutic value and if the physician has good reason to
believe that participation in the research study will not adversely affect
the health of the patients who serve as research subjects.
32. The benefits, risks, burdens and effectiveness of a new intervention
must be tested against those of the best current proven intervention,
except in the following circumstances:

• The use of placebo, or no treatment, is acceptable in studies where no

current proven intervention exists; or
• Where for compelling and scientifically sound methodological reasons
the use of placebo is necessary to determine the efficacy or safety of an
intervention and the patients who receive placebo or no treatment will
not be subject to any risk of serious or irreversible harm. Extreme care
must be taken to avoid abuse of this option.

33. At the conclusion of the study, patients entered into the study are
entitled to be informed about the outcome of the study and to share any
benefits that result from it, for example, access to interventions
identified as beneficial in the study or to other appropriate care or
benefits.
34. The physician must fully inform the patient which aspects of the care
are related to the research. The refusal of a patient to participate in a
study or the patient's decision to withdraw from the study must never
interfere with the patient-physician relationship.
35. In the treatment of a patient, where proven interventions do not exist or
have been ineffective, the physician, after seeking expert advice, with
informed consent from the patient or a legally authorized representative,
may use an unproven intervention if in the physician's judgement it
offers hope of saving life, re-establishing health or alleviating suffering.
Where possible, this intervention should be made the object of
research, designed to evaluate its safety and efficacy. In all cases, new
information should be recorded and, where appropriate, made publicly
available.

22.10.2008

28
 Appendix 1- 2

The Nuremberg Code

1. The voluntary consent of the human subject is absolutely essential. This means that the
person involved should have legal capacity to give consent; should be so situated as to be
able to exercise free power of choice, without the intervention of any element of force, fraud,
deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should
have sufficient knowledge and comprehension of the elements of the subject matter
involved as to enable him to make an understanding and enlightened decision. This latter
element requires that before the acceptance of an affirmative decision by the experimental
subject there should be made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted; all inconveniences and
hazards reasonable to be expected; and the effects upon his health or person which may
possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each
individual who initiates, directs, or engages in the experiment. It is a personal duty and
responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society,
unprocurable by other methods or means of study, and not random and unnecessary in
nature.
3. The experiment should be so designed and based on the results of animal
experimentation; and knowledge of the natural history of the disease or other problem
under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death
or disabling injury will occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest
degree of skill and care should be required through all stages of the experiment of those
who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the
experiment to an end if he has reached the physical or mental state where continuation of
the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to
terminate the experiment at any stage, if he has probably cause to believe, in the
exercise of the good faith, superior skill and careful judgment required of him that a
continuation of the experiment is likely to result in injury, disability, or death to the
experimental subject.
from: Trials of War Criminals before the Nuremberg Military Tribunals …1949

29
 Appendix 1 - 3
Ethical Codes

INTERNATIONAL ETHICAL CODES

The Original Hippocratic Oath* (about 460-377 B.C.)

I swear by Apollo Physician, by Ascleplus, by Health, by Heal-all and by all the gods
and goddesses, making them witnesses, that. I will carry out, according to my ability
and judgment, this oath and this indenture:

To regard my teacher in the art as equal to my parents; to make him partner in my

livelihood, and when he is in need of money to share mine with him; to consider his
offspring equal to my brothers; to teach them this art, if they require to learn it, without
fee or indenture; and to impart precept, oral instruction, and all the other learning, to
my sons, to the sons of my teacher, and to pupils who have signed the indenture and
sworn obedience to the physicians' Law, but to none other.

I will use treatment to help the sick according to my ability and judgment, but I will
never use it to injure or wrong them. I will not give poison to anyone though asked to
do so; nor will I suggest such a plan. Similarly I will not give a pessary to a woman to
cause abortion. But in purity and in holiness I will guard my life and my art. I will not
use the knife on sufferers from stone, but I will give place to such as craftsmen
therein.

Into whatsoever houses I enter, I will do so to help the sick, keeping myself free from
all Intentional wrong-doing and harm, especially from fornication with woman or man,
bond or free.

Whatsoever in the course of practice I see or hear (or even outside my practice in
social intercourse) that ought never to be published abroad. I will not divulge, but will
consider such things to be holy secrets.

Now if I keep this oath and break it not, may I enjoy honor, in my life and art, among
all men for all time; but if I transgress and forswear myself, May the opposite befall
me.

*The Oath of Hippocratic has been the most enduring of all medical oaths and today is still an
inspiration to those who have dedicated themselves to the medical profession. An illustration of
th
Hippocrates and his Oath, taken from a 14 century Greek Manuscript, is found in the Bibliotheque
National Paris

30
The Chinese Code of Sun Ssu – mais*- (7th Century, A.D.)
“Aristocrat or commoner, poor or rich, aged or young, beautiful or ugly, friend or
enemy, native or foreigner, educated or uneducated, all are to be treated equally”

-------
*Spicker, Sf and Engelhardt, HT (ed.) 1977. Philosophical Medical Ethic: Its Nature and Significance.
In Proceeding of the Third Trans – disciplinary Symposium, pp. 30, D. Reidal Publishing Company,
Dordrecht – Holland/Boston, USA.

31
 APPENDIX I – 4
Ethical Codes

The Declaration of Geneva* (1971)

I solemnly pledge myself to consecrate my life to the service of humanity;

I will give to my teachers the respect and gratitude which is their due;

I will practice my profession with conscience and dignity;

The health of my patient will be my first consideration;

I will respect the secrets which are confided in me, even after the patient has died;

I will maintain by all the means in power, the honor and the noble traditions of the
medical profession;

My colleagues will be my brothers;

I will not permit considerations of religion, nationality, race, party politics or social
standing to Intervene between my duty and my patient;

I will maintain the utmost respect for human life from its beginning even under threat
and I will not use my medical knowledge contrary to the laws of humanity;

I make these promises solemnly, freely and upon my honor.

-------------
*This is the first International Code of Medical Ethics drawn by the World Medical Association as a
nd
modern version of Hippocratic Oath. It was amended by the 22 World Assembly, Sydney Australia in
th
August 1968 and the 35 World Medical Assembly, Venice, Italy in October 1983.

32
 APPENDIX I – 4
Ethical Codes

The Declaration of Lisbon on the Rights of Patients* (1981)

The patient has the right to choose his physician freely.

The patient has the right to be cared for by a physician who is free to make
clinical and ethical judgments without any outside interference.

The patient has the right to accept or to refuse treatment after receiving
adequate information.

The patient has the right to expect that his physician will respect the
confidential nature of all his medical and personal details.

The patient has the right to die in dignity.

The patient has the right to receive or to decline spiritual and moral comfort
including the help of a minister of an appropriate religion.

----------------
*This Declaration was adopted by the World Medical Association in 1981, in Lisbon, Portugal.

33
 APPENDIX I - 5
Ethical Codes

-----------~------------

The Declaration of Tokyo on Torture and other Cruel, Inhuman or

Degrading Treatment or Punishment* (1975)

The doctor shall not countenance~ condone or participate in the practice of

torture of other forms of cruel, inhuman or degrading procedures, whatever the
offence of which the victim of such procedures is suspected, accused or guilty,
and whatever the victim's beliefs or motives, and in all situations, Including armed
conflict and civil strife.

The doctor shall not provide any premises, instruments, substances or

knowledge to facilitate the practice of torture or other forms of cruel, Inhuman or
degrading treatment or to diminish the ability of the victim to resist such
treatment.

The doctor shall not be present during any procedure during which torture or
other forms of cruel, inhuman or degrading treatment is used or threatened.

A doctor must have complete clinical Independence in deciding upon the care of
a person for whom he or she is medically responsible. The doctor's fundamental
role is to alleviate the distress of his or her fellow men, and no motive, whether
personal, collective or political, shall prevail against this higher purpose.

Where a prisoner refuses nourishment and is considered by the doctor as

capable of forming an unimpaired and rational judgment concerning the
consequences of such a voluntary refusal of nourishment, he or she shall not be
fed artificially. The decision as to the capacity of the prisoner to form such a
judgment should be confirmed by at least one other independent doctor. The
consequences of the refusal of nourishment shall be explained by the doctor to
the prisoner.

The World Medical Association will support and should encourage the
international community, the national medical associations and fellow doctors. To
support the doctor and his or her family in the face of threats or reprisals resulting
from a refusal to condone the use of torture or other forms of cruel" inhuman or
degrading treatment.-
*In 1975 the World Medical Association, at its meeting in Tokyo, Japan, adopted
the above Declaration in relation to torture, cruel and inhuman or degrading
treatment or punishment

34
 REFERENCES
Reference Part 1
1. Declaration of Helsinki 2008. available on the Internet at:
http://www.fda.gov/oc/health/helsinki89.html
2. Nuremberg code, available on the Internet at:
http://ohsr.od.nih.gov/nuremberg.php3.
3. Ethiopian Review Guideline, ESTC, 2005. available on the Internet at:
www.estc.gov.et/
4. The Belmont report , The National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research , April 18, 1979
available on the the Internet at :
http://ohsr.od.nih.gov/guidelines/belmont.html
5. The International Ethical Guidelines for Biomedical research involving
Human subjects: Council for International Organizations of Medical
Sciences (CIOMS) in collaboration with WHO, Geneva, 2002. Available on
the Internet at: http://www.cioms.ch/frame_guidelines_nov_2002.htm
6. The Nullified Council on Bioethics: The ethics of research related to
healthcare in developing countries, a follow up discussion paper; 2005.
Published by Nuffield Council on Bioethics;28 Bedford Square; London
WC1B 3JS. Available on the Internet at:
http://www.nuffieldbioethics.org/fileLibrary/pdf/HRRDC_Follow-
up_Discussion_Paper001.pdf

Reference Part 2

1. Biomedical Ethics, 4th edition, by Thomas A .Mappes, and David DeGrazia,

1996.
2. Bulletin of the Johns Hopkins Hospital 28: 260-261, (1917) Translated by
Harry
Friedenwald.
3. Code of Medical Ethics, Current Opinions, American Medical Association,
2002-
2003 edition.
3. Medical Ethics for Physicians Practicing in Ethiopia, first published 1988
and
second published in 1992.
4. Operational Guidelines for Ethics Committees that review Biomedical
Research,
WHO, Geneva, 2000.
5. Protecting Study Volunteers in Research 3rd ed.; by Cynthia Dunn, and
Gary
Chadwick. 2004
6. World Medical Association, Medical Ethics Manual 2005 publication.

35
GLOSSARY
The definitions provided within this glossary apply to terms as they are used in
this document. The terms may have different meanings in other contexts

Assent - affirmative agreement of a subject/participant

Beneficence – literally, “doing good”. Doctors are expected to act in the best
interest of their patients.

Bioethics/Biomedical ethics – the study of moral issues that occur in medicine,

health care and biological sciences.

Confidentiality- prevention of an authorized disclosure of private information

that has been collected from being shared with others.

Clinical trial/study –any investigation in human subjects intended to discover or

verify the clinical, pharmacological and/or other pharmacodynamic effects of an
investigational product(s) and/or to identify any adverse reactions to an
investigational product (s). and/or to study absorption , distribution, metabolism,
and excretion of an investigational product(s) with the object o ascertaining its
safety and efficacy. The terms clinical trial and study are synonymous.

Informed consent – a process by which a potential participant voluntarily

confirms his or her willingness to participate in a particular research after having
been informed of all aspects of the study that are relevant to the participants
decision to participate. Informed consent is documented by means of a written,
signed and dated informed consent form.

Justice – fair treatment of individuals and groups

Legally authorized representative – an individual or juridical or other body

authorized under applicable law to consent on behalf of a prospective participant,
to the subjects’ participation in a study.

Minor – children, legally have not attained the age where they can grant
consent for research or treatment.

Non-maleficence – literally, “not doing wrong”. Doctors and researchers are to

avoid inflicting harm on patients and research participants.

Participant - An individual who participates in a research project, either as the

direct recipient of an intervention, as a control, or through observation. The
individual may be a healthy person who volunteers to participate in the research,
or a person with a condition unrelated to the research carried out who volunteers

36
to participate, or a person (usually a patient) whose condition is relevant to the
use of the study product or questions being investigated.

Protocol - A document that provides the background, rationale, and objective(s)

of a research project and describes its design, methodology, and organization,
including ethical and statistical considerations.

Vulnerable group - those groups that may contain some individuals who have
limited autonomy, i.e. they cannot give informed consent. Such groups include
children, some mentally incapacitated, individuals with dementia and other
cognitive disorders, prisoners etc.

37