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BIOETHICS LAW
HUMAN RIGHT
Soenarto Satrowijoto
Center For Bioethics and Medical Humanities,
School of Medicine, Gadjah Mada University
2007
2
1. Moral-Ethics-Principles-Regulation-
Professional Code of Ethics
2. Ethics-Discipline-Law-Human Right
3
3. Bioethics : 1) - Philosophy
2) - Theology
3) - Medical science & Medicine
4) - Anthropology (Medical
Anthropology)
5) - Sociology (social medicine)
6) - Biomedical Science
7) - Biology
8) - Psychology
9) - Economy, Engineering, etc.
10) - Biometricians
Interdisciplinary approach/subject.
4
Social Culture &
Behavior
1. - Anthropology
(Medical anthrop)
- Sociology
(Social Medicine)
2. - Emotion
- Life style & risk
- Interpersonal
relationship
- Professional Behavior
Philosophy, Religions, Law, Civics/Pancasila
Bioethics
1. Philosophy
2. Ethics in
Services
Research
Education
Business
3. Professionalism
Law
1. Norms
2. Declarations
3. Laws/Acts
4. Regulations
Respect for differences and social sensitivity
Bioethics & Humanities
Inter Religions
Pancasila
State-philosophy
Inter-religions
Studies
5
Penyelenggara Pendidikan
Local Wisdom
Kearifan lokal
(Ki Hajar Dewantoro)
1. Pengabdian
2. Keluargaan
3. Kerjasama
Budi pekerti
Kejujuran
Global era
Internasionalisasi
1. Professionalism
2. Competencies
3. Competition
4. Accountability
5. Quality Assurance
6. Excellence
+
6
1. Bijak; Santun
2. Nasionalis
- mementingkan bangsa
- Mementingkan institusi
3. Cerdas
4. Terampil
Ranking
1. Cerdas
2. Terampil
3. Kurang bijak /santun
4. Mementingkan diri
sendiri
Rangking ,
akademik
+
7
Dosen / Guru
1. Mampu mendidik
2. Kemampuan
akademik
1. Gelar Akademik
2. Kurang mampu
mendidik
+
Globalisasi Kearifan Lokal
8
Biotechnology
Medical Science &
technology
Cloning -
technology
Bioethics &
Humanities
9
WHAT, kind of decision
WHO, do the decision
HOW, the situation & condition
10
Whatever we can do, may or could be done ?
(Apa yang dapat dilakukan, boleh dilakukan)
1. In vitro Fertilisation (IVF)
2. Surogete mother; GIFT; male/female
choice
3. Organ-transplantation
4. Blood transfusion
5. Euthanasia
11
Law provide a certainty and protection
Law & ethics support each other
12
13
ETIKA & HUKUM
KESEHATAN
14
I. Etika dan Moral
II. Etika dan Hukum
III. Etika, Disiplin, dan Hukum
15
1,2,3.
Latin
Morales, mos, moris,
adat, istiadat,kebiasaan,
cara, tingkah laku
Tabiat, watak, akhlak,
cara hidup
Yunani
Ethicos, ethos-
adat kebiasaan,
praktek
Hati nurani & penilaian (judgment)
Kegiatan praktis seseorang
ETIKA
MORAL
16
Etika dibagi = 1. Etika Umum
(klasifikasi) 2. Etika Khusus
- Individual
- Institusional
- Sosial
Filsafat : - kajian, ilmu filsafat
- moral & moralitas
Praktek : - pedoman & aturan
(profesional) baik & benar
17
A. Moral - Etika Asas Aturan - Kode Etik Profesi
1
Ajaran
Moral
Ajaran
Moral
Moral
Falsafah
Moral
Teori2
etika
Ajaran tentang bagaimana manusia
harus hidup dan bertindak menjadi
manusia yang baik
Sistem nilai tentang perbuatan manusia
yang dianggap baik/ buruk, benar / salah,
pantas / tidak pantas
Mencari penjelasan , mengapa perbuatan
tertentu dinilai baik/ buruk, benar/salah,
pantas /tidak pantas
Kerangka berpikir yang disusun oleh
filsuf tertentu-untuk memberi
pembenaran, mengapa suatu perbuatan
dinilai baik dari pendekatan moral
1
2
3
4
18
Moral - Etika Asas Aturan - Kode Etik Profesi
Ajaran
Moral
Asas2
etika
Aturan2
etika
Kode Etik
Profesi
Asas-asas yang diturunkan dari teori-
teori etika sebagai kaidah-kaidah dasar
moral bagi manusia
Seperangkat norma atau pedoman untuk
mengukur perbuatan, berupa aturan dan
larangan yang didasarkan pada asas
asas etika
Seperangkat aturan etika yang khusus
berlaku untuk semua anggota asosiasi
profesi tertentu, sebagai konsensus
bersama, yang memuat aturan dan
larangan yang wajib di taati oleh semua
anggota dalam menjalankan profesi
5
6
7
19
B. TEORI-TEORI ETIKA
1,2,3
KLASIK
1. Utilitarianisme
Teologi
Konsenkuensialisme
Consequence-based
2. Deontologi
Kewajiban
Obligation-based
3. Hukum Kodrat
Lex Naturalis
Natural Law
KONTEMPORER
1. Budi Pekerti Luhur
Virtue/character/Value-based
Compassion
Discernment
Dapat di dipercaya
Integritas moral tinggi
2. Etik mengasuh
Caring/relation -based
3. Penalaran praktis
Kasuistik, care - based
4. Pancasila, filsafat moral dan
teori etika
20
1) Teori Utilitarianisme
Utilitarianisme = usefulness
The greatest good fix the greates number
Impact / posteriori sesudah dilakukan
The greatest happiness priciple
Konsekuensi suatu tindakan, akhir sautu
tindakan
Teori konsekuensialisme
Mencegah /mengendalikan /memberantas/
penyakit; menghilangkan penderita,
memperpanjang hidup, meningkatkan
kualitas hidup.
Kritik : tujuan menghalalkan cara
21
2) Konsekuensi
(utilitarianism)
Tindakan BENAR /SALAH tingkat
konsekuensiya (nilai moral)
Teori manfaat (utilitarianism) normatif (sesuai
dengan asas manfaat)
Tindakan yang benar akibat BAIK
Kasus : - Pembunuhan
- aborsi
- pembunuhan bayi
Teori manfaat : - klasik
- kontemporer
Dipertimbangkan
kondisi masing-
Masing
22
1) Teori Deontologi
(Kantianisme, obligation based theory)
Immanuel Kant (1724 1804)
Dasar hubungan : pengharagaan, kewajiban
(deos = wajib) kepada sesama manusia
Perbuatan kepada orang lain, secara moral baik
dan benar, didasarkan pada niat-niat (good
intention)
Kontianisme : lakukan terhadap orang lain
sebagaimana yang anda inginkan mereka berbuat
terhadap anda, tidak usah melihat hasilnya.
Yang menolak dan setuju kepada Deontologi dan
Utilitarianism sama.
23
2) Deontologi :
- justifikasi theologis
- justifikasi kemasyarakatan
- justifikasi intuisionis
- justifikasi murni (justifikasi kant)
- universal, mutlak, mengikat
- rasional, otonomi, dignity
- liberal, kebetulan, martabat
* nilai rasionalitas
* kontroversi, samar,
KASUS : Pembunuhan
24
Asas Asas Etika medis
Traditional
1. Beneficence
2. Non maleficence
(Primum non nocere)
3. Menghormati hidup
manusia
4. Konfidensialitas
5. Kejujuran (veracity)
6. Tidak mementingkan
diri
7. Budi Pekerti
Tingkah laku luhur
Asas-Asas Etika Medis
KONTEMPORER
1. - Menghormati otonomi
pasien
- Universal Human right
UN,
- HAM
2. Keadilan /justice
3. Berkata benar / truth
telling / veracity
25
C. Kaidah Kaidah Dasar Moral
2,3,4,5,6
Beneficence & non maleficence
Respect for person
Keadilan /justice
Budi pekerti
Kegiatan-kegiatan :
Pendidikan
Penelitian & pengembangan
Pelayanan
26
D. Kegiatan- kegiatan
Bidang-bidang Life Sciences
1) Biologi
2) Kedokteran
3) Keperawatan
4) Kependudukan
5) Epidemiologi
6) Kesehatan Linkungan
7) Sosiologi antropologi kesehatan
8) Etika institusional Rumah Sakit
27
Kesehatan :
WHO : Keadaaan sejahtera yang sempurna dari
badan, mental, dan sosial, dan bukan
hanya tidak ada penyakit atas
kelemahan
UU RI. No. 23 Th 1992 :
Keadaan sejahtera dari badan, jiwa, dan
sosial yang memungkinkan setiap orang
hidup produktif secara social dan
ekonomis
1948
28
F. Bidang Kesehatan
5
1. Kode Etik Kedokteran
2. Kode Etik Keparawatan
3. Kode Etik Rumah Sakit
4. Majelis Kehormatan Etik Kedokteran (MKEK)
5. Majelis Kehormatan Etik Rumah Sakit
(MAKERSI)
6. Majelis Kehormatan DISIPLIN Kedokteran
Indonesia (MKDKI)
29
1. Hukum menurut standar moral yang minimal
larangan-larangan
Etika menurut standar moral yang tertinggi
larangan-larangan dan hal- hal yang
positif dokter kepada pasiennya.
2. Perbuatan seorang yang profesional
a. Etis dan legal
b. Etis tidak legal tidak ada kriteria etis melanggar
hukum
c. Tidak Etis dan legal dokter mengiklankan diri
d. Tak Etis dan tidak legal dokter membuat tagihan
palsu kepada perusahaan
asuransi beaya pengobatan &
perawatan
30
Kasus : US Supreme Court (Makamah
Agung AS). Memutuskan Hak
konstitutional seorang wanita untuk
dapat melakukan aborsi kehamilan
trisemester pertama
kontroversi moral & etika : - prochice
- prolife
31
VI. Etika Disiplin Hukum
5
Etika
Hati nurani, pikiran pelaku
Benar/salah, baik/buruk, pantas /tidak pantas
Moral philosophy
Das sein und das sollan
(The oughts and Shoulds of Socienty)
Klasik dan Kontemporer
Kode etik profesi
Etika diperkuat Hukum
Homo homini lupus
32
Etika Disiplin - Hukum
Hukum
Hukum & etika menyatu hubungan antar manusia
Baik/buruk, pantas /tidak pantas, salah /benar.
Moral Indonesia Falsafah Pancasila
Pelanggaran norma & nilai-nilai etika dan hukum
Ringan, membahayakan masyarakat/ ketertiban
umum fungsi hukum
Hal-hal kecil merebut pasien, menjelekan nama
baik sejawat, mengiklan diri.
De minimus non curat lex
Aturan /regulasi internal profesi
33
Etika Disiplin - Hukum
Disiplin
Discipline jurusan ilmu Pengetahuan
Tata-tertib, keteraturan sikap-tindak, behavior
Dua disiplin dapat saling berbenturan
Belanda : Medische Tuchtrech
mengadili dan memeberikan sangsi
disiplin (tucht)
Ganti rugi Perdata, Pidana
34
Etika Disiplin - Hukum
Disiplin
GMC (General Medical Council)
Keputusan : 1) tidak melanggar disiplin
2) Kurang terampil training
3) melanggar disiplin tidak boleh
praktek sementara
4) Pelanggaran berat dicoret dari
registrasi tidak boleh praktek di
negara tersebut.
Gugatan ganti rugi dll - Pengadilan
35
Pelanggaran Disiplin
1. Medical Negligence
Melakukan sesuatu yang seharusnya tidak
dilakukan
Tidak melakukan apa yang di lakukan sejawat
lain
2. Serious Profesional Misconduct
Hubungan sex dengan pasien
Angkat bagian tubuh yang keliru
Melantarkan pasien cacat atau meninggal
36
Operasi operasi mata
Operasi operasi ginjal
Operasi anggota tubuh
Kebetulan ada bagian KANAN-KIRI
37
Hukum :
Keseluruhan asas dan aturan tentang perbuatan manusia
yang ditetapkan atau diakui oleh otoritas tertinggi
Hukum Perdata :
hukum yang mengatur hubungan atar orang dengan orang
lain.
Hukum Pidana :
hukum yang mengatur perbuatan apa yang dilarang dan
memberikan pidana (=hukuman) kepada siapa yang
melanggarnga
Hukum Administrasi Negara : (Tata Usaha Negara)
hukum yang mengatur cara menjalankan tugas (hak dan
kewajiban) dan kekuasaan alat-alat perlengkapan negara.
Hukum kebiasaan :
hukum tidak tertulis yang hidup dalam keyakinan
masyarakat dan ditaati seperti suatu peraturan perundangan
Hukum Yurisprudensi :
Hukum yang terbentuk karena keputusan hukum oleh hakim
dalam prekara sejenis sebelumnya.
38
1. Jacobalis S., 2005 Perkembangan Ilmu kedokteran, Etika Medis, dan
Bioetika : Tentang moral dan Etika. Cetakan ke I. Agung Seto. Jakarta
(pp. 62 84)
2. Beauchamp TT and Children JP, 1994 Principles of Biomedical Ethics
Fourth Ed. Oxford Univ. Press. NY.
3. Kushe H and Singer P, 2004 A Companion to Bioethics. Reprinted.
Blackwell Publishing Ltd. Australia.
4. Emmanuel Ej. et al, 2004 Ethical and Regulatory Aspect of Clinical
Research. Reading and Communitary The John Hopkins Univ. Press.
Baltimore ad london. (pp. 25 80)
5. Guwandi J, 2005 Medical Error dan Hukum Medis: Etika, Disiplin, dan
Hukum. Balai Penerbit FK UI Jakarta (pp. 125 134)
6. Wiradharma D, 1996 Penutun Kuliah Hukum Kedokteran : Masalah Etis
yang berkaitan dengan hukum Kedokteran. Bima rupa Aksara. Jakarta
(pp. 117 -146)
39
40
I. LEGISLATION REVIEWS of
1. Prohibition of Human Cloning (PHC)
Act. 2002
2. Research Involving Human Embryo
(RIHE) Act 2002
41
ART (Assisted Reproductive
Technology) IVF (In Vitro Fertilization)
The use of Human Embryo for research
purposes; should be permitted
The committee - review website
- written submission
- face to face meeting
with key steak holder
42
Background
- public hearing & private
meetings
- discussion forum
- selected site visit.
Issues of recent scientific and
technological advances in human
cloning, human embryo study, including
stem cell technology.
43
2. Rationale for the Recommendation
Different perspectives, interests and values
of divers communities.
The perspective or standards vary between
and within communities and over time
disagreement will remain there
Certain moral values (commitment to social
justice, equity, and to care of vulnereble
people.
Medical research (for preventing or testing
diseases, assisting people to have children
(wastage of some embryos)
44
Rationale for the
Recommendation
The higher potential benefits of activity,
the future the need for ethical
objections consideration of
prohibition or permission through the
legal system may be justified.
Proponent and opponents of embryo
research national legislation review
strict control and monitoring, under
licenses, of human embryo research.
45
Committee has recommended
monitoring the prohibition of human
reproductive cloning
Embryos created by
- nuclear transfer
- chimeric embryos
- genetic material from
more the two person
- genetic alternative, etc
46
the committee has recommended
that use of such embryo
embryo for reproductive purposes (
that is development beyond 14
days or implantation into a womens
reproduction tract) should remain
prohibited.
Prohibited practices
47
4. Creating a human embryo by fertilization of
an egg by sperm
Human Embryos : status, creation, use in research, and
development of therapeutic cloning.
Pro and cons (Proponent & Opponent)
Pro = potential benefits
- a such technology (is) of embryo
research.
- ART with the ponibelity destruction
of embryo
Opp. Kont : human embryo from the early stage of
development, as entity should be
protected, a port from ART.
48
Creating a human embryo
by fertilization of an egg by sperm
Term of EMBRYO biologically accurate different
moral interpretations, status and obligations owed to
them.
The acceptance that human embryos by the fertilization
of human egg by human sperm are entities of some
social and ethical.
Significance because of their association with the start of
human life.
Stopped research on culture & maturation of immature
egg (IVM = in vitro maturation of oocytes, storage of
frozen eggs, gemete (egg and sperm) development.
Prohibition of oocytes activation (part hemogenesis)
49
Creating a human embryo
by fertilization of an egg by sperm
Definition of a human embryo ;
a new and unique genetic entity is formed only
after the genetic material from the male and
female pronuclear combine, stage of as
syngamy accours about one to three hours
before the first cell devision (cleavage)
Hybrid fertilization should be permitted, under
licence, up to but not including, the first cell
devision.
50
The committee has recommended that
the use of excess ART embryos to be
permitted, under licence, for research,
training an d other uses to improve the
practice of ART.
Registered excess ART embryos are
available to facilitate the most efficient
use of this resource.
51
Use of excess ART embryos
The status of unsuitable embryo for
implantation is not clear in the current
legislation. The committee
recommended the use of this unsuitable
embryo for research, training, and
improvement for clinical practice
NHMCR develop ethical guideline.
Criteria to decide suitable or unsuitable
should be developed by an expert body
Debate regarding the relative merits of
embryonic and adult stem cell research
different attitudes toward moral status
of human embryos, different agreements
52
Creation of human embryo clones
generate embryonic stem cells
development of specific cellular therapy
genotype therapeutic cloning. Further
research is required.
A member of objection to SCNT- to
generate embryonic stem cells, the
argument
The technology is the same as that used for
therapeutic cloning, to extract stem cell
To ensure that such embryo are not used for
reproduction purposes should be
prohibited
53
Creation of embryos other than
by fertilization
Human embryo clones are human
embryo the right environment
develop into a human being
implanted to women pregnancy
not implanted potential for
research to develop treatment for
serious medical condition.
Creation of human embryo clone by
SCNT should be permitted, under
licence, for research, training, and
clinical application.
54
Creation of embryos other than
by fertilization
The potential benefits in creating of such
entities using method not involving
fertilization of human egg by human sperm,
SCNT
Genetic material from more than two
people
Heritable alterations to the genomes
Using precursor cells human embryo
or fetus
Should be permitted, under licence, for use in
research, training, and clinical application.
Prohibition - human embryo for more than 14 days
- implantation into reproductive tract of
women
to prevent any reproductive purposes
55
argument against SCNT - requires the use
of donated human eggs.
egg donation should be managed by strict
ethical guidelines (payment to donors
should not be permitted beyond
reimbursement of reasonable expenses).
reduce the need for human eggs during
the developmental stages of nuclear
transfer research, under licence, and are
not implanted into the body of women
56
Informed Consent for embryo and egg
donation, in all stages, having an emotional
component, many people inclined to
donate excess embryos to research rather
than letting them succumb.
Creating embryonic stem cell lines that are
immortal and will be used in various other
ongoing research contexts.
Fully informed about the commercial
potential should be considered,
improvement of guideline for consent in
these circumstance is important.
Cost of licensing from licence applicant
should also considered.
57
9. Prescriptive versus regulatory legislation
The ability of legislation to respond to
research needs in a fast-moving area of
technology inevitable ambiguities in the
legislation and unfair exposure of researchers
to prosecution.
Reproductive cloning, should remain
prohibited.
More flexible system : grant licences for
research that is not expressly permitted by
the Acts, by committee, to protect researcher
from prosecution
58
10. Trade and international exchange of
human embryos, gametes and stem cells
controversy around trade and international
exchange related to ethical concern about
sources and uses of materials. (human issues)
commercialization of any therapeutic product.
Export of human tissus is prohibited, for personal
reproductive use streamlined for ART
consumer.
Import and export of ethicaly derived human
embryo clones and h Esc should be permitted after
approval by the appropriate authority.
59
11. Biotechnology and commercialization
Participants, industry group,
research commercialization
without investment, new therapeutic
product can not be developed.
That potentially beneficial product
can be developed for therapeutic
use.
Donor should be informed about this
matters why they make their
donation.
60
Australian Stem Cell Bank
Stem cell bank world make stem
cells, embyronic and adult stem
cells, available to researchers
Management of bank centralized /
decentralized system
National register of donated
embryos - transparent
61
The community after lack of
understanding prohibited or
licensed research
Public education and consultation
are needed in the area of research
and development covered by the
Act.
62
63
Bioethics of
Stem Cell Studies
Human Cloning
Research Involving Human Embryo
II. STEM CELL Studies :
64
1. Reproductive cloning
2. Therapeutic cloning
71
1. - Human cloning
- Assisted Reproductive (technology)
Treatment (ART)
- IVF (in Vitro Fertilisation)
- IVM (In Vitro Maturation) of Oocytes, etc
2. Therapeutic Cloning
Special for DM, heart disease, brain
disease. etc.
Creating Human Embryo through SCNT,
procursor-cells. etc.
72
Some examples of Legislation
(Australia)
1. Prohibilition of Human Cloning (PHC)
Act. 2002
2. Research Involving Human Embryo
(RIHE) Act. 2002
73
Some issues of research
Related to human Esc (Embryonic Stem-cell)
1) .
In h Esc research, maximizing social utility
remains the primary justification for issuing
intellectual property right. (Matthew Herder,
Bioethical Inquiry (2006), 3 : 69-79 US and
European patent System)
The fundamental question are determining
what benefits are likely to the result from h
Esc research.
Donor should have control over the stem
cell lines derived from their embryos and
gamete or ovum
74
2.
The fact that human eggs or embryos are the source
of cell lines for stem cells research
Moral status of the or embryos - eggs come
from WOMEN.
The third world and our women will supply those
eggs.
Women choice - sell their reproductive tissues
(eggs) or labor.
- Sell their eggs, donate ? as a
DONOR ?
Increasing, such research is not drives by possible
cures for existing diseases, but is driven by the
market itself. Drug Co is look for market with
patent.
(Rothman BK, 2006 Stem Cell research: Rethinking
the Questions Bioethical inquiry, 3 : 15 -17)
75