Nindya Aryanty

 Students should be able to explain the

difference between medical ethics and
bioethics
 Students should be able to differentiate
bioethics, law, culture, and religion
 Students should be able to explain the
principles of bioethics and how to balance
these principles in practice
 Theword “bioethics” appeared for the first
time in 1970. It was coined by Van Rensselaer
Potter, an American biochemist and professor
of oncology at the McArdle Laboratory for
Cancer Research at the University of
Wisconsin-Madison (U.S.A.) for more than 50
years.
 Potter conceived this new discipline,
bioethics, as a “bridge” between “facts” and
“values”. During the second half of the
twentieth century, he said that biological
sciences had been increasing their knowledge
and technical power continuously, but
reflection about the values at stake has not
progressed in the same proportion.
 Potter said that he coined the word bioethics
using two Greek words, bíos, life,
representing the facts of life and life
sciences, and éthos, morals, referring to
values and duties.
 The only profession dealing with life during
centuries and millennia, especially with
human life, has been medicine. But today
there are many sciences and professions
working in this field.
 Therefore, bioethics should not be confused
with medical ethics, which is only one of its
branches. The field of bioethics is as wide as
the facts of life, and its study is divided in
many branches, each one with its specificity:
Ecological or environmental bioethics,
Medical bioethics, Clinical bioethics
 The idea of Potter, and in general of
bioethics, is that:
 not all what is technically possible is morally
right,
 and that some control of our intervention on
nature and environment, on animals and on
human beings, is needed.
 The future of life and of mankind is at stake
 Bioethics is the first attempt of thinking
“globally” in ethics
 Global bioethics includes, therefore:
 All actual human beings
 Future human beings
 All living organisms and the environment
 Physicians and other health care
professionals have always taken health care
decisions, mixing facts and values, clinical
facts with personal values
 Our duties are always the promotion and
implementation of values. The duty of
promoting values is the origin of norms.
When these norms are wide and general,
they are called principles
 The UNESCO Universal Declaration on
Bioethics and Human Rights identifies
15 bioethical principles
 The 33rd session of the General Conference of
UNESCO
 19 October 2005
 Universal declaration on bioethics and human
rights
 Agreed by 191 member states of UNESCO
 a set of bioethical principles  provides a
common global platform by which bioethics
can be introduced & strengthened within
each member state
1. Human dignity and human rights
2. Benefit and harm
3. Autonomy and individual responsibility
4. Consent
5. Persons without the capacity to consent
6. Respect for human vulnerability and personal integrity
7. Privacy and confidentiality
8. Equality, justice and equity
9. Non-discrimination and non-stigmatization
10. Respect for cultural diversity and pluralism
11. Solidarity and cooperation
12. Social responsibility and health
13. Sharing of benefits
14. Protecting future generations
15. Protection of the environment, the biosphere and biodiversity
 Many of these values and principles have not
been respected through history. For instance,
physicians took into account traditionally their
own values, but not the values of their patients.
Patients are weak -they thought-, and therefore
they are in need of direction. In fact, they are
like children, in need of fathers or tutors in
charge of conducting them and looking for their
best interest or benefit.
 This has been the traditional value introduced by
physicians in their decision making process.
 Today, this is considered inadequate, and called
paternalism
 Paternalism is a normal behavior that can be
taken as morally right, when societies are
very homogeneous from the point of view of
values.
 This was the case in old times, and it is also
today in many parts of the world. People in
traditional societies shared the same values.
When physicians, therefore, made medical
decisions taking into account only their own
values, they could suppose they were
respecting also the values of their patients
 But this situation has changed drastically during the last
centuries.
 One of the reasons for this change has been the continuous
mobility of people and the mix of different values, beliefs,
and traditions in modern societies.
 There are many societies where physicians can assume
that patients share their values. They, therefore, must ask
patients for their values.
 This is the origin of the doctrine of the “informed
consent”, opposite to the traditional paternalism of the
medical profession.
 The moral principles here involved are Human dignity and
human rights, Autonomy and individual responsibility,
Consent, Respect for human vulnerability and personal
integrity, Privacy and confidentiality, and Respect for
cultural diversity and pluralism
 The situation of present day health care is
much more conflictual than any other
before.
 Traditional medical ethics used to work with
the moral principle of beneficence,
understood in a paternalistic way.
 The only decision maker was the
professional, and the only moral principle to
be taken into account was beneficence.
 Therefore, the possibility of moral conflict
was very remote
 On the contrary, there are different moral
principles and values to be respected in each
specific situation.
 Often, these principles conflict among each
other. There are potentially conflicts
between all of them
 The main goal of bioethics, to train people in
the management of moral conflicts, in order
to take wise decisions and, in this way,
increase the quality of health care
 In order to reach this goal, bioethics uses
deliberation as the way of approaching and
thinking about moral conflicts.
 People can work individually with this
procedure, especially when problems are not
very complex.
 But when conflicts are difficult, or when
they involve many people, deliberation
should be done collectively.
 This is the origin of the so-called “bioethics
committees”
 Bioethics committees are platforms for
deliberations in order to take wise decisions and
to make policy recommendations.
 There are different types of ethics committees,
as described in the UNESCO Guides Establishing
Bioethics Committees and Bioethics Committees
at Work: Procedures and Policies:
i. Policy-Making and Advisory Committees (PMAs)
ii. Health-Professional Association (HPA)
Bioethics Committees
iii. Health Care Ethics Committees (HECs)
iv. Research Ethics Committees (RECs)
 HEC committees do important work in clinical
bioethics.
 They consist of physicians, nurses, social
workers, and lay members, both men and
women. Different backgrounds, expertise and
experiences allow a better understanding of
cases, enriching all the individual perspectives
and facilitating decision-making
 HEC committees are not judicial bodies with the
responsibility of sanctioning wrong conduct and
imposing disciplinary measures.
 This is one of the biggest differences between
ethics committees and legal tribunals
 The goal of ethics is not to compete with
law, but to promote wise decisions among
people and professional excellence.
 Bioethics does not look for what is legally
right but for what is humanly best.
 The goal of bioethics is to promote
excellence
1. Human dignity, human rights and
fundamental freedoms are to be fully
respected
2. The interest and welfare of the individual
should have priority over the sole interest
of science or society
 The notion of human dignity expresses the
intrinsic value of the person  capable of
reflection, sensitivity, verbal communication,
free choice, self-determination in conduct and
creativity
 All human being are equal in dignity irrespective
of gender, age, social status or ethnicity
 Recognition of a person’s dignity  active
respect for one’s human rights, self-esteem and
self-determination, one’s privacy, protecting one
from illegitimate intrusions and preserving one’s
valid public space
 The person’s dignity and rights are proved by
others’ obligation to treat a person respectfully,
that is :
 to cause no harm
 not to abuse
 to be fair
 not to impose unwelcome models of personal
good and happiness
 not to treat one merely as a means
 not to consider the interest and welfare of the
individual as subordinate to others’ interest and
welfare, to ‘the sole interest of science and
society’
 Mention some examples or situation that
against human dignity and human rights !
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In applying and advancing scientific
knowledge, medical practice and associated
technologies, direct and indirect benefits to
patients, research participants and other
affected individuals should be maximized
and any possible harm to such individuals
should be minimized
 Health (WHO definition) : a state of
complete physical, mental and social well
being and not merely the absence of disease
or infirmity

 Health
benefit  relief of suffering; care;
prevention of disease, illness, disability;
enhancement, psychological benefit, etc.
Harm :
Identify what can be harm in the health care
settings:
 Physical harm
 Psychological harm
 Moral harm (harm to interest, harm as
unfairness, harm as disrespect)
 Social/economic harm (consequences for
social role, stigmatization)
 Health care decisions :
 Assessment has to be made between risk of
harm and potential benefits
 Where the risk of harm outweighs possible
benefit  the treatment is not indicated
 Two or more patients  when time or
material resources are scarce, different
priorities can be selected  focusing on
patients who are most in need because of
the harm they are suffering or on patients
for whom treatment will produce the
greatest benefit
The autonomy of persons to make decisions,
while taking responsibility for those decisions
and respecting the autonomy of others, is to
be respected. For persons who are not
capable of exercising autonomy, special
measures are to be taken to protect their
rights and interests
 Autonomy as individual capacity for self-
determinations and evaluations

 Responsibility is one’s awareness of one’s

obligation to make decisions and to act
appropriately on the basis of certain
commitments (for example, toward an
external authority, oneself, one’s status,
engagement, or agreements, respected
others, accepted principles and rules)
 Patient autonomy and responsibilities in
health care
A. Responsibility for consequences of freely
taken decisions
B. Responsibility to avoid infringement of
another person’s autonomy
ex. One is free to decide to smoke and
endanger his own health, but he can’t
endanger the health of others
1. Any preventive, diagnostic and therapeutic medical intervention is
only to be carried out with the prior, free and informed consent of the
person concerned, based on adequate information. The consent
should, where appropriate, be express and may be withdrawn by the
person concerned at any time and for any reason without disadvantage
or prejudice.
2. Scientific research should only be carried out with the prior, free,
express and informed consent of the person concerned. The
information should be adequate, provided in a comprehensible form
and should include modalities for withdrawal of consent. Consent may
be withdrawn by the person concerned at any time and for any reason
without any disadvantage or prejudice. Exceptions to this principle
should be made only in accordance with ethical and legal standards
adopted by States, consistent with the principles and provisions set
out in this Declaration, in particular in Article 27, and international
human rights law.
3. In appropriate cases of research carried out on a group of persons or a
community, additional agreement of the legal representatives of the
group or community concerned may be sought. In no case should a
collective community agreement or the consent of a community leader
or other authority substitute for an individual’s informed consent.
 In accordance with domestic law, special protection is to be given to
persons who do not have the capacity to consent:

(a) authorization for research and medical practice should be obtained

in accordance with the best interest of the person concerned and
in accordance with domestic law. However, the person concerned
should be involved to the greatest extent possible in the decision-
making process of consent, as well as that of withdrawing consent;
(b) research should only be carried out for his or her direct health
benefit, subject to the authorization and the protective conditions
prescribed by law, and if there is no research alternative of
comparable effectiveness with research participants able to
consent. Research which does not have potential direct health
benefit should only be undertaken by way of exception, with the
utmost restraint, exposing the person only to a minimal risk and
minimal burden and, if the research is expected to contribute to
the health benefit of other persons in the same category, subject
to the conditions prescribed by law and compatible with the
protection of the individual’s human rights. Refusal of such persons
to take part in research should be respected.
In applying and advancing scientific
knowledge, medical practice and associated
technologies, human vulnerability should be
taken into account. Individuals and groups of
special vulnerability should be protected and
the personal integrity of such individuals
respected
Several aspect of vulnerability :
1. Biological or corporeal vulnerability
- natural threats are coming from our
biology, ageing, susceptibility to illness and
disease, and death
- environment and other natural and man-
made threats : pollutions, earthquake, etc
2. Social vulnerability : war and crime,
prejudice and discrimination, etc
3. Cultural vulnerability
Respect for personal integrity  respect for
the patient’s understanding of his or her own
life and illness, for his/her interests and free
will.
The privacy of the persons concerned and
the confidentiality of their personal
information should be respected. To the
greatest extent possible, such information
should not be used or disclosed for purposes
other than those for which it was collected
or consented to, consistent with
international law, in particular international
human rights law
The fundamental equality of all human
beings in dignity and rights is to be respected
so that they are treated justly and equitably.
 Equality: the right of different groups of
people to have a similar social position and
receive the same treatment

 Justice : fairness in the way people are dealt

with

 Equity: when everyone is treated fairly and

equally
No individual or group should be
discriminated against or stigmatized on any
grounds, in violation of human dignity,
human rights and fundamental freedoms
The importance of cultural diversity and
pluralism should be given due regard.
However, such considerations are not to be
invoked to infringe upon human dignity,
human rights and fundamental freedoms, nor
upon the principles set out in this
Declaration, nor to limit their scope
 Thevalue of cultural diversity may be in
conflict with other human rights values
 it is necessary to analyze and balance
wisely the values in conflict
Solidarity among human beings and
international cooperation towards that end
are to be encouraged
 Example: in Europe, everyone is obliged to
make a fair financial contribution to a
collectively organised insurance system that
guarantees equal access to health and social
care for all members of society
1. The promotion of health and social development for their people is
a central purpose of governments that all sectors of society share

2. Taking into account that the enjoyment of the highest attainable

standard of health is one of the fundamental rights of every human
being without distinction of race, religion, political belief,
economic or social condition, progress in science and technology
should advance:
(a) access to quality health care and essential medicines,
especially for the health of women and children, because
health is essential to life itself and must be considered to be a
social and human good;
(b) access to adequate nutrition and water;
(c) improvement of living conditions and the environment;
(d) elimination of the marginalization and the exclusion of persons
on the basis of any grounds;
(e) reduction of poverty and illiteracy.
1. Benefits resulting from any scientific research and its applications
should be shared with society as a whole and within the international
community, in particular with developing countries. In giving effect to
this principle, benefits may take any of the following forms:
(a) special and sustainable assistance to, and acknowledgement of, the
persons and groups that have taken part in the research;
(b) access to quality health care;
(c) provision of new diagnostic and therapeutic modalities or products
stemming from research;
(d) support for health services;
(e) access to scientific and technological knowledge;
(f) capacity-building facilities for research purposes;
(g) other forms of benefit consistent with the principles set out in this
Declaration.
2. Benefits should not constitute improper inducements to participate in
research
 The impact of life sciences on future
generations, including on their genetic
constitution, should be given due regard

Ex : - prescription of medication without any

rationale is a threat to future generation
- genetically modified food
Due regard is to be given to the
interconnection between human beings and
other forms of life, to the importance of
appropriate access and utilization of
biological and genetic resources, to respect
for traditional knowledge and to the role of
human beings in the protection of the
environment, the biosphere and biodiversity
 Discuss
which principles that are involved in
those examples of health decision making