1 Ethics

Chapter one
Introduction to Health Ethics

Yemane G/mariam, Assistant professor
(MPH in HSM)
E-mail:yemimu07@gmail.com
Mob.:o913036399
Office:room 238
School of Public Health
Outline
• Definition and origin
• Types of ethics
• Fundamental ethical principles
• Early records in ethics
• Major ethics codes
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Definition and origin
• Ethics
– Derived from the Greek ethos meaning
“moral character or custom” “the set of
moral principles” or “a system of moral
principles” or “rules of behaviour”.
• Morality
– comes from the Latin word moralis –
“custom or manner”.

Definition and origin…
• Both words deal with the customs or
the manner in which people do things.
• Their modern meanings relate to the
way people act - either good or bad.
• Ethics - a branch of philosophy that
deals with moral principles that may be
connected to beliefs about what may be
considered wrong or right.

• Exercise
• What are wrong and right practice?
• List some of them based on your perception
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• Morality carries the concepts of:
1. Moral standards, with regard to behavior;
2. Moral responsibility, referring to our
conscience; and
3. A moral identity, or one who is capable of
right or wrong action.
• Morality describes the principles that govern
our behavior.
• In today's world, morality is frequently

thought of as belonging to a particular
religious point of view, but by definition,
we see that this is not the case.
• Everyone adheres to a moral doctrine of
some kind.

• Morality relates to our behavior, has
important on three levels. (C.S. Lewis):
1.To ensure fair play and harmony b/n
individuals;
2.To help make us good people in order to
have a good society;
3.To keep us in a good relationship with
the power that created us.

• Morality is looking at how good or bad
our conduct is, and our standards about
conduct.
• Ethics is used to refer to the formal study
of those standards or conduct.
• Morals are the concepts of what is “good”
and what is “bad” & how should behave.
• Moral are a subjective phenomenon, since
most of their rules do not follow from
objective necessity and advisability.
• Ethical principles are objective. They
follow from real necessity and advisability.
• They are based on the understanding of
the Path to the Perfection, to God.

Definition…
• The necessary pre-conditions of
morality are rationality, sociality
and freedom – all defining
attributes of humans.

Definition…
• Ethics is a branch of moral
philosophy concerned with the
rational evaluation of right and
wrong, justice and injustice,
good and bad, and related
concepts and principles.

Definition…
• Ethics, ethical principles and
rules need constantly to be
discussed, debated,
reviewed/reformulated to rid
them of purely spatio-temporal
and contingent or accidental
elements.

…
To Be Continued
Thank you

Types of ethics
• According to various subject
matters such as:
–Bioethics,
–Medical ethics,
–Economic ethics,
journalistic ethics, sexual
ethics, etc.

PUBLIC HEALTH
Types…
• According to the approach or method
used in dealing with it:
– Descriptive or non-normative ethics
which deals with factual investigations of
moral conduct and belief systems, and
– Normative or prescriptive ethics which
deals with moral norms and their
justification,
– Meta-ethics which is concerned with the
language, concepts and types of
reasoning used in ethical discourse.
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Descriptive ethics
• It simply involves describing how people behave
and/or what sorts of moral standards they claim to
follow.
• Incorporates research from the fields of anthropology,
psychology, sociology and history as part of the
process of understanding what people do or have
believed about moral norms.
• Also studies the codes of conduct created by
professional organizations.
• Sometimes referred to as comparative ethics
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Descriptive ethics…
• In short, descriptive ethics asks questions:
1. What do people claim as their moral norms?
2. How do people actually behave when it comes
to moral problems?
• Here are some examples of statements from
Descriptive Ethics:
1. Most Ethiopians think that racism is wrong.
2. Among certain cultures, there is no stigma
attached to homosexuality.
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Normative ethics
• It involves creating or evaluating moral standards.
Thus, it figure out what people should do or whether
their current moral behavior is reasonable.
• Involves examining the moral standards people
currently use in order to determine if they are
justifiable, as well as attempting to construct new
moral standards which might be better.
• In either case, the philosopher is critically
investigating the nature and grounds of moral
standards, moral principles, moral rules, and moral
conduct.

PUBLIC HEALTH
Normative ethics…
• In short, it addresses questions like:
1. What should be our moral obligations?
2. What is Right and what is Wrong?
3. What should be our moral values?
4. What is Good and what is Evil?
• Examples of statements:
1. Do unto others as you would have them do unto
you. (Golden Rule)
2. That which God wills is the Good.
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Meta-ethics
• Involves reasoning about the presupposition
behind the moral systems developed under the
category of normative ethics.
• Whenever a moral system is created, it is based
upon certain premises about reality, human
nature, values, etc.
• Meta ethics is all about questioning the validity of
those premises and arguing that perhaps we don't
really know what we are talking about after all.
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Meta-ethics…
• Analytic ethics asks quite a lot of questions, like:
– How are moral judgments even possible?
– Why be moral at all?
– Do moral values exist objectively or only
subjectively?
– Are moral values relative to something, like culture
or individuals?
– Can morality exist independently of religion?
– Do people have a free will which would make moral
judgments possible?

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Fundamental ethical principles
• Four fundamental principles of
ethics have usually been
recognized and widely discussed
in moral literature:
– Autonomy,
– Beneficence,
– Non-maleficence and
– Justice

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Autonomy
• Two Greek words: nomos (“rule”)
and autos (“self”), giving it the
literal meaning of “self-rule” or
“self-governance”.
• Implies an individual who is master

of himself/herself and can act, make
free choices and take decisions
without the constraint of another.

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Autonomy…
• Respect for Persons:
– Autonomous agents, and
– Persons with diminished autonomy are entitled to
protection.
• The application of this principle is seen in the informed
consent process.
• The application starts with the respect for a person’s
right by providing them with adequate and relevant
information.
• The process of informed consent is begun when initial
contact is made with a prospective subject and
continues throughout the course of the study.

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Autonomy…
• Pre-conditions of autonomy are
– Competence (the capacity to be a moral
agent) and
– Liberty or freedom
• Individual autonomy may be diminished

or completely absent, as in the case of
minor children, mentally handicapped or
incapacitated persons, prisoners, etc.

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Autonomy…
• Personal autonomy and freedom are

ethically limited by the autonomy and
freedom of other persons; that is why
in every society/community
discussion, compromise, legislation
is essential.

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Autonomy…
• In health care and health research
ethics, the principle of autonomy
issues directly to the requirement of
informed consent/refusal, which is
the necessary though not sufficient
condition for ethical medical
research/practice on humans.

PUBLIC HEALTH
Autonomy…
Informed consent, Which was the main concern of
the
• Nuremberg Code, and which is equally central in
other regulatory documents, such as the
• Declaration of Helsinki,
• Belmont Report,
• CIOMS International Guidelines for Biomedical
Research.

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Beneficence and non-maleficence
• In simple terms, beneficence means doing
good and non-maleficence means avoiding
evil/harm.
• The principles of beneficence and non-

maleficence translate into the duties to
maximize benefits while minimizing harms,
especially for the research subjects.

PUBLIC HEALTH
Beneficence and non-maleficence…
• Medicine aims at achieving good/benefits
(beneficence) goes without saying but
non-maleficence has been emphasized
and protect in the medical slogan (above
all/first do no harm!).
• Generally, research, like other human
activities, to be ethical, must, at least aim
at achieving good while avoiding harm.

PUBLIC HEALTH
Beneficence and non-
maleficence…
• Some people consider non-maleficence
to be the most basic of all the cardinal
principles of ethics; it lays down the
minimum condition for ethical
correctness, as if to say: “even if you
would not do good, at least do no harm”.
• The principle most directly implemented
through a favourable risk/benefit
assessment during design and review of
the study protocols.

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Justice
• Justice is “fairness” or “entitlement”;
it implies giving to each his/her due.
• Justice requires that “equals be
treated equally and un-equals
unequally”.

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Justice…
• Implies that human beings as moral equals
should be treated equally unless there is a
reasonable justification for treating them
differently.
• The general moral idea underlying the
principle of justice is that which states: “Do
unto others as you would have them do unto
you if you were in their place and they in
yours”.

PUBLIC HEALTH
Justice…
• The principle of justice demands
– Fairness in the treatment of
individuals and communities and
• The equitable distribution of the
burdens and benefits of research.
Has important implications for such
issues as
– Choice of study population,
– Recruitment into study,
– Study and post-study benefits, etc.
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Fundamental ethical…
• The four fundamental principles of
ethics are equally relevant and
important within all possible
contexts and perspectives

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Fundamental ethical…
• They are cross-culturally valid,
although the emphasis given to each
and the way they are operationalise
may differ slightly
• From culture to culture,
• From place to place,
• From context to context, and even
• From time to time within the same
context

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Basic Principles For Good Research
Practice
• Principles combined from various guidelines
1.Social and/or scientific value
2.Scientific validity
3.Fair subject selection
4.Favorable risk-benefit ratio
5.Independent review
6.Informed consent
7.Respect for potential and enrolled subjects

PUBLIC HEALTH
Summary
• Autonomy
• Beneficence
• Non-malficence
• Justice

Early records on ethics
• The Hippocratic Oath (400 BC) is
probably the earliest document
that related to morals and code of
medical conduct for physicians.

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Early records…
Thomas Parcival (1803)
• His writing is probably the earliest
statement directing to peer-review:
• “Before proceeding with therapeutic

innovation, a physician ought to
consult with peers”.

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Early records…
• Thomas went further to identify the
concept of vulnerable groups.
• And NO such trials should be

instituted, without a previous
consultation of the physicians or
surgeons, according to the nature
of the case.”

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Early records…
• In between the Hippocrates and
Parcival times:
– Much unethical research seems to
have taken place with very poor
documentation of the details.
– Uncontrolled, unscientific human
experiments which were purely
empirical were done

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Early records…
• Vivisection(experiment) was common
without consent;
• Experiments on condemned criminals
and underprivileged;
• Prisoners could be offered repetitively
on participation in “inoculations”; and
• The famous inoculation of cowpox to an
8 yr old boy by Jerner happened during
this period (1776)

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Early records…
• William Beaumont (1833)
– Records what some consider to

be the oldest American
document dealing with research
ethics.

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Early records…
• He identified key issues which may be
summarized as follows:
– Experimentation is needed;
– Investigator must be careful& responsible
– Investigations must have good
methodological approach & there should
be no random studies;
– Voluntary consent is necessary;
– Discontinuation of experiment when it
causes distress to the subject or the
subject objects or becomes dissatisfied
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Early records…
• 1900- Prussian Directive
– Response to public debate on human subject
experimentation.
– Prohibited experiments in minors and those not
fully competent.
– Unequivocal consent required after explanation of
the experiment and possible adverse
consequences.
– Only certain people were allowed to do the
research and must keep written records.

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Early records…
Prussian Directive…
• For the first time in history informed consent, the
research process, and explicit clarification of personal
responsibility for the experiment were required to be
included in the medical record.
• In addition, issues of written research plans with a
risk-benefit assessment, the need for previous animal
experimentation, and medical self experimentation
were raised.
• Ethical issues are required to be assessed by peers on
institutional review boards

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Research History Tragedies and
Major Codes of Ethics
• Much of what we have as ethical
codes and guideline have been
influenced by tragic events which
cause public concerns.
• During the 1900, accounts of
many atrocities (murder) in the
name of biomedical research are
documented.

PUBLIC HEALTH
Research History…
• Experiments were liberally done on
underprivileged children, poor &
prisoners.
• Cases of vivisection have been
reported.
• Genetic, height simulation, racial
hygiene experiments were conducted,
and in all cases,
• There is little doubt that the subjects
were not volunteers.
PUBLIC HEALTH
The Nazi Experiments
(World War II 1939-1944)
• Prisoners in Nazi concentration

camps were forced to undergo
experiments that included exposing
them to extreme temperatures,
mutilating surgery, and lethal
pathogens.

PUBLIC HEALTH
The Nazi Experiments
• The gruesome(horrible) experiments
that hurt and killed helpless prisoners.
• This outraged (irritate) the world and

resulted in criminal condemnation
against senior Nazi doctors, as well as
calls for international regulation of
medical experiments.

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The Nazi Experiments…
• Public outcry (protest) culminated (end) in the
1946: Nuremberg Doctors’ Trial
• The individuals who conducted Nazi experiments
during WWII were tried separately from other war
criminals because of their professional status as
physicians and the terrible and unique nature of
their crimes
• Found guilty of murder, torture, & other atrocities.
• During the trial at Nuremberg, the judges codified
fundamental ethical principles for the conduct of
research
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• In 1947, the Nuremberg Code thus
resulted with a set forth 10
conditions to be met before research
could be deemed ethically
permissible.
• Nuremberg Code became the first
international standard for the
conduct of research and introduced
the modern era of protection for
human research participants

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• In 1948, The Universal Declaration

of Human Rights was adopted by
the United Nations.
• The Universal Declaration
asserted the principle that each
human being was entitled to
certain rights and freedoms.

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Human Radiation Experiments
• The US government also sponsored
many radiation experiments
involving humans during the period
1944–1974.
• In the majority of cases, the
experiments were conducted to
advance biomedical science;
however, some experiments were
conducted purely to advance
national interests in defence or
space exploration.
PUBLIC HEALTH
Human Radiation…
• Attention was not given to issues
of fairness in the selection of
participants.
• Further, research was conducted
on participants without their
awareness or consent and on
participants not likely to derive
direct medical benefit.

PUBLIC HEALTH
The Jewish Chronic Disease Hospital
Study
• In 1963, studies were undertaken
at New York’s Jewish Chronic
Disease Hospital to understand
whether the body’s inability to
reject cancer cells was due to
cancer or debilitation.

PUBLIC HEALTH
The Jewish Chronic Disease…
• These studies involved the injection
of foreign, live cancer cells into
patients who were hospitalized with
various chronic debilitating diseases.
• Consent had been given orally, but

did not include a discussion on the
injection of cancer cells, and
consent was not documented.

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• The researchers felt that
documentation was unnecessary
because it was customary to
undertake much more dangerous
medical procedures without the use
of consent forms.
• Further, patients were not told that
they would receive cancer cells,
because the researchers felt it
would unnecessarily frighten them.

PUBLIC HEALTH
• Board of Regents of the State
University of New York found that
the study had not been presented to
the hospital’s research committee
and that the physicians responsible
for the patients’ care had not been
consulted.

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The Willow brook Study
• In a series of studies conducted
from 1963 to 1966 at the Willow
brook State School, a New York
institution for “mentally defective”
children.
• To gain an understanding of the
natural history of infectious
hepatitis under controlled
circumstances, newly admitted
children were deliberately
infected with the hepatitis virus.

PUBLIC HEALTH
The Willow brook Study
• Researchers defended the
deliberate injection
– The vast majority of them would
acquire the infection anyway while at
Willowbrook, given the crowded and
unsanitary conditions, and
– Only children whose parents had given
consent were included

PUBLIC HEALTH
The Willowbrook Study
• But Parents found they were

unable to admit their children to
Willowbrook unless they agreed
to their participation in the
studies.

PUBLIC HEALTH
The Tuskegee Syphilis Study (1932-1972)
• Study of the natural evolution of
syphilis infection in the long-term
• Conducted at Tuskegee by the
United States Public Health
Service.
• More than 400 black men with
syphilis participated, and about
200 men without syphilis served as
controls

PUBLIC HEALTH
The Tuskegee Syphilis…
• The men were recruited without
informed consent and, in fact,
were misinformed that some of the
procedures done in the interest of
research (e.g., spinal taps) were
actually “special free treatment.”

PUBLIC HEALTH
• As early as 1936, it was clear that
many more infected men than
controls had developed
complications, and 10 years later,
a report of the study indicated
that the death rate among those
with syphilis was about twice as
high as it was among the controls.

PUBLIC HEALTH
• In the 1940s, penicillin was found to be effective
in the treatment of syphilis.
• This study continued, nonetheless, and the men
were neither informed nor treated with the
antibiotic.
• In 1997 that a public acknowledgement of
Government responsibility was made by
President Bill Clinton, and the compensation of
surviving participants and the families of
deceased participants continues.

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Reading assignment

AFRICAN CASE EXAMPLES
• The Jezierski papers
• The Trovan controversy
• AZT Trial in Uganda
• “Tuskegee All Over Again in
Uganda”

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MAJOR ETHICS CODES
• The Nuremberg Code
• Declaration of Helsinki
• CIOMS Guidelines
• Belmont Report
• The ICH GCP

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Declaration of Helsinki
• Like the Nuremberg Code, the

Declaration made informed
consent a central requirement for
ethical research
– Allowed for surrogate consent
when the research participant is
incompetent, physically or
mentally incapable of giving
consent, or a minor.
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Declaration of Helsinki
• The Declaration also states that
research with these groups
should be conducted only when
– the research is necessary to
promote the health of the population
represented and
– this research cannot be performed
on legally competent persons.

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CIOMS Guidelines
• The Council for International
Organizations of Medical
Sciences (CIOMS) is an
international, nongovernmental,
not-for-profit organization
established jointly by WHO and
UNESCO in 1949.

PUBLIC HEALTH
CIOMS Guidelines
• CIOMS serves the scientific
interests of the international
biomedical community in general
and has been active in
promulgating guidelines for the
ethical conduct of research,
among other activities.

PUBLIC HEALTH
CIOMS Guidelines
• The Guidelines relate mainly to
– ethical justification and scientific validity of research;
– ethical review;
– informed consent;
– vulnerability of individuals, groups, communities and
populations;
– equity regarding burdens and benefits;
– confidentiality;
– strengthening of national or local capacity for ethical
review;
– obligations of sponsors to provide health-care services.

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1 Ethics

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Chapter one

Introduction to Health Ethics

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• In today's world, morality is frequently

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• Implies an individual who is master

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• Individual autonomy may be diminished

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• Personal autonomy and freedom are

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• The principles of beneficence and non-

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• “Before proceeding with therapeutic

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• And NO such trials should be

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– Records what some consider to

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• Prisoners in Nazi concentration

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• This outraged (irritate) the world and

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• In 1948, The Universal Declaration

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• Consent had been given orally, but

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