Nindya Aryanty

 Bioethics
 bios = life
 ethicos = good or bad, right or wrong

 Ethicsdeals with values and bioethics should

therefore deal with values related to life and
life processes
 Medical ethics is only one of its branches
 The field of bioethics is as wide as the facts
of life. Its study is divided in many branches.
 Ecological or environmental bioethics
 Medical bioethics
 Clinical bioethics
 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
 Student should be able to explain the
principles of bioethics and how to balance
these principles in practice
 Physicians and other health care
professionals have to make health care
decisions  principles of bioethics
 The UNESCO Universal Declaration on
Bioethics and Human Rights identifies
15 bioethical principles
 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
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
 Human dignity: 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 !
 - https://www.cbsnews.com/video/rare-look-
inside-chinas-internment-camps-holding-more-
than-1-million-muslims/#x
 - https://www.bbc.com/news/world-asia-
41566561
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Dalam menerapkan dan memajukan
pengetahuan ilmiah, praktik medis dan
teknologi terkait, manfaat langsung dan tidak
langsung bagi pasien, peserta penelitian, dan
individu lain yang terkena dampak harus
dimaksimalkan dan kemungkinan bahaya apa
pun pada individu tersebut harus
diminimalkan.
 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 :

 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  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
Otonomi seseorang untuk membuat
keputusan, sambil mengambil tanggung
jawab untuk keputusan itu dan menghormati
otonomi orang lain, harus dihormati. Bagi
orang-orang yang tidak mampu menjalankan
otonomi, perlu diambil tindakan-tindakan
khusus untuk melindungi hak-hak dan
kepentingan-kepentingan mereka
kapasitas individu untuk penentuan nasib sendiri dan evaluasi

 Autonomy  kapasitas individu untuk

penentuan nasib sendiri dan evaluasi

 Responsibility adalah kesadaran seseorang

akan kewajibannya untuk membuat
keputusan dan untuk bertindak dengan tepat
berdasarkan komitmen tertentu (misalnya,
terhadap otoritas eksternal, diri sendiri,
status seseorang, keterlibatan, atau
kesepakatan, orang lain yang dihormati,
prinsip dan aturan yang diterima)
 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. Setiap intervensi medis preventif, diagnostik dan terapeutik harus
dilakukan hanya dengan persetujuan sebelumnya, bebas dan
diinformasikan dari orang yang bersangkutan, berdasarkan informasi
yang memadai. Persetujuan harus, bila perlu, diungkapkan dan dapat
ditarik kembali oleh orang yang bersangkutan setiap saat dan untuk
alasan apapun tanpa merugikan atau merugikan.
2. Penelitian ilmiah hanya boleh dilakukan dengan persetujuan
sebelumnya, bebas, tersurat dan diinformasikan dari orang yang
bersangkutan. Informasi harus memadai, disediakan dalam bentuk yang
dapat dipahami dan harus mencakup modalitas untuk penarikan
persetujuan. Persetujuan dapat ditarik kembali oleh yang
bersangkutan setiap saat dan dengan alasan apapun tanpa merugikan
atau merugikan. Pengecualian terhadap prinsip ini harus dibuat hanya
sesuai dengan standar etika dan hukum yang diadopsi oleh Negara,
konsisten dengan prinsip dan ketentuan yang ditetapkan dalam
Deklarasi ini, khususnya dalam Pasal 27, dan hukum hak asasi manusia
internasional.
3. Dalam kasus penelitian yang sesuai yang dilakukan pada sekelompok
orang atau komunitas, persetujuan tambahan dari perwakilan hukum
dari kelompok atau komunitas yang bersangkutan dapat diminta.
Dalam hal apa pun kesepakatan komunitas kolektif atau persetujuan
dari pemimpin komunitas atau otoritas lain tidak boleh menggantikan
persetujuan berdasarkan informasi individu
 Sesuai dengan hukum domestik, perlindungan khusus harus diberikan
kepada orang-orang yang tidak memiliki kapasitas untuk memberikan
persetujuan :

(a) otorisasi untuk penelitian dan praktik medis harus diperoleh sesuai
dengan kepentingan terbaik dari orang yang bersangkutan dan sesuai
dengan hukum nasional. Namun, orang yang bersangkutan harus
dilibatkan semaksimal mungkin dalam proses pengambilan keputusan
persetujuan, serta penarikan persetujuan;
(b) penelitian hanya boleh dilakukan untuk keuntungan kesehatan
langsungnya, tunduk pada otorisasi dan kondisi perlindungan yang
ditentukan oleh undang-undang, dan jika tidak ada alternatif
penelitian dengan efektivitas yang sebanding dengan peserta
penelitian yang dapat menyetujuinya. Penelitian yang tidak memiliki
potensi manfaat kesehatan langsung hanya boleh dilakukan dengan
pengecualian, dengan pengekangan maksimal, memaparkan orang
tersebut hanya pada risiko minimal dan beban minimal dan, jika
penelitian diharapkan berkontribusi pada manfaat kesehatan orang
lain. dalam kategori yang sama, tunduk pada kondisi yang ditentukan
oleh hukum dan sesuai dengan perlindungan hak asasi manusia
individu. Penolakan orang-orang tersebut untuk mengambil bagian
dalam penelitian harus dihormati.
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