11

BIOETHICS – LAW – BIOETHICS – LAW – HUMAN RIGHTHUMAN RIGHT

Soenarto SatrowijotoSoenarto Satrowijoto

Center For Bioethics and Medical Humanities, Center For Bioethics and Medical Humanities, School of Medicine, Gadjah Mada UniversitySchool of Medicine, Gadjah Mada University

20072007

22

1.1. Moral-Ethics-Principles-Regulation-Moral-Ethics-Principles-Regulation-Professional Code of EthicsProfessional Code of Ethics

2.2. Ethics-Discipline-Law-Human RightEthics-Discipline-Law-Human Right

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3.3. Bioethics Bioethics : : 1) - Philosophy1) - Philosophy2) - Theology2) - Theology3) - Medical science & Medicine3) - Medical science & Medicine4) - Anthropology (Medical 4) - Anthropology (Medical Anthropology)Anthropology)5) - Sociology (social medicine) 5) - Sociology (social medicine) 6) - 6) - Biomedical ScienceBiomedical Science7) - Biology7) - Biology8) - Psychology8) - Psychology9) - Economy, Engineering, etc.9) - Economy, Engineering, etc. 10) - Biometricians10) - Biometricians

Interdisciplinary approach/subject.Interdisciplinary approach/subject.

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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. Philosophy2. Ethics in

Services Research Education Business

3. Professionalism

Law

1. Norms2. Declarations3. Laws/Acts4. Regulations

Respect for differences and social sensitivity Respect for differences and social sensitivity

Bioethics & Humanities

Inter Religions Pancasila

State-philosophy Inter-religions

Studies

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Penyelenggara PendidikanLocal Wisdom Kearifan lokal(Ki Hajar Dewantoro) (Ki Hajar Dewantoro)

1.1. PengabdianPengabdian2.2. KeluargaanKeluargaan3.3. KerjasamaKerjasama

Budi pekertiBudi pekerti KejujuranKejujuran

Global eraGlobal eraInternasionalisasiInternasionalisasi

1.1. ProfessionalismProfessionalism2.2. CompetenciesCompetencies3.3. CompetitionCompetition4.4. AccountabilityAccountability5.5. Quality AssuranceQuality Assurance6.6. Excellence Excellence

+

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Keluaran / Lulusan

1.1. Bijak; SantunBijak; Santun2.2. NasionalisNasionalis

- mementingkan bangsa- mementingkan bangsa- Mementingkan institusi- Mementingkan institusi

3.3. CerdasCerdas4.4. TerampilTerampil

Ranking Ranking ΘΘ

1.1. CerdasCerdas2.2. Terampil Terampil 3.3. Kurang bijak /santunKurang bijak /santun4.4. Mementingkan diri Mementingkan diri

sendirisendiri

Rangking Rangking ΘΘ, , akademikakademik

+

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Dosen / GuruDosen / Guru1.1. Mampu mendidikMampu mendidik2.2. Kemampuan Kemampuan

akademikakademik

1.1. Gelar AkademikGelar Akademik2.2. Kurang mampu Kurang mampu

mendidikmendidik+

Globalisasi Kearifan Lokal Globalisasi Kearifan Lokal

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BiotechnologyBiotechnologyMedical Science & Medical Science & technologytechnologyCloning - Cloning -

technologytechnology

Bioethics & Bioethics & HumanitiesHumanities

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Medical decision makingMedical decision making

WHAT, kind of decision WHAT, kind of decision WHO, do the decisionWHO, do the decision HOW, the situation & conditionHOW, the situation & condition

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Whatever we can do, may or could be done ?Whatever we can do, may or could be done ?(Apa yang dapat dilakukan, boleh dilakukan)(Apa yang dapat dilakukan, boleh dilakukan)

1.1. In vitro Fertilisation (IVF)In vitro Fertilisation (IVF)2.2. Surogete mother; GIFT; male/female Surogete mother; GIFT; male/female

choicechoice3.3. Organ-transplantationOrgan-transplantation4.4. Blood transfusionBlood transfusion5.5. EuthanasiaEuthanasia

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Law – provide a certainty and protectionLaw – provide a certainty and protection Law & ethics – support each other Law & ethics – support each other

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ETIKA & HUKUM ETIKA & HUKUM KESEHATANKESEHATAN

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I.I. Etika dan MoralEtika dan MoralII.II. Etika dan HukumEtika dan HukumIII.III. Etika, Disiplin, dan HukumEtika, Disiplin, dan Hukum

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I. Etika dan Moral I. Etika dan Moral 1,2,3.

LatinLatin

Morales, mos, moris, adat, istiadat,kebiasaan, cara, tingkah Morales, mos, moris, adat, istiadat,kebiasaan, cara, tingkah lakulaku

Tabiat, watak, akhlak, cara hidupTabiat, watak, akhlak, cara hidup

YunaniYunani

Ethicos, ethos-adat kebiasaan, praktek Ethicos, ethos-adat kebiasaan, praktek

Hati nurani & penilaian (judgment)Kegiatan praktis seseorang

ETIKAMORAL

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Etika dibagiEtika dibagi = 1. Etika Umum= 1. Etika Umum(klasifikasi)(klasifikasi) 2. Etika Khusus2. Etika Khusus

- Individual- Individual- Institusional- Institusional- Sosial- SosialFilsafat Filsafat : : - kajian, ilmu filsafat- kajian, ilmu filsafat- moral & moralitas- moral & moralitasPraktekPraktek : - pedoman & aturan - pedoman & aturan(profesional)(profesional) baik & benar baik & benar

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A. Moral - Etika – Asas – Aturan - Kode Etik Profesi 1

Ajaran Ajaran MoralMoralAjaran Ajaran MoralMoral

MoralMoral

Falsafah Falsafah Moral Moral

Teori2 Teori2 etikaetika

Ajaran tentang bagaimana manusia Ajaran tentang bagaimana manusia harus harus hidup dan bertindakhidup dan bertindak menjadi menjadi manusia yang baikmanusia yang baik

Sistem nilaiSistem nilai tentang perbuatan manusia tentang perbuatan manusia yang dianggap baik/ buruk, benar / salah, yang dianggap baik/ buruk, benar / salah, pantas / tidak pantas pantas / tidak pantas

Mencari penjelasan , Mencari penjelasan , mengapa mengapa perbuatan perbuatan tertentu dinilai baik/ buruk, benar/salah, tertentu dinilai baik/ buruk, benar/salah, pantas /tidak pantas pantas /tidak pantas

Kerangka berpikir Kerangka berpikir yang disusun oleh yang disusun oleh filsuf tertentu-untuk memberi filsuf tertentu-untuk memberi pembenaran, mengapa suatu perbuatan pembenaran, mengapa suatu perbuatan dinilai baik dari pendekatan moral dinilai baik dari pendekatan moral

1

2

3

4

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Moral - Etika – Asas – Aturan - Kode Etik Profesi Moral - Etika – Asas – Aturan - Kode Etik Profesi

Ajaran Ajaran MoralMoralAsasAsas22 etikaetika

AturanAturan22 etikaetika

Kode Etik Kode Etik Profesi Profesi

Asas-asas yang diturunkan dari teori-Asas-asas yang diturunkan dari teori-teori etika sebagai teori etika sebagai kaidah-kaidah dasar kaidah-kaidah dasar moralmoral bagi manusia bagi manusia

Seperangkat norma atau Seperangkat norma atau pedomanpedoman untuk untuk mengukur perbuatan, berupa aturan dan mengukur perbuatan, berupa aturan dan larangan yang didasarkan pada asas –larangan yang didasarkan pada asas –asas etika asas etika

Seperangkat aturan etika yang khusus Seperangkat aturan etika yang khusus berlaku untuk semua anggota asosiasi berlaku untuk semua anggota asosiasi profesi tertentu, sebagai konsensus profesi tertentu, sebagai konsensus bersama, yang memuat aturan dan bersama, yang memuat aturan dan larangan yang wajib di taati oleh semua larangan yang wajib di taati oleh semua anggota dalam menjalankan profesi anggota dalam menjalankan profesi

5

6

7

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B. TEORI-TEORI ETIKAB. TEORI-TEORI ETIKA1,2,3

KLASIK

1. Utilitarianisme Teologi Konsenkuensialisme Consequence-based

2. Deontologi Kewajiban Obligation-based

3. Hukum Kodrat Lex Naturalis Natural Law

KONTEMPORER

1. Budi Pekerti LuhurVirtue/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

2020

1) Teori Utilitarianisme1) Teori Utilitarianisme Utilitarianisme = usefulnessUtilitarianisme = usefulness The greatest good fix the greates numberThe greatest good fix the greates number Impact / posteriori – sesudah dilakukanImpact / posteriori – sesudah dilakukan The greatest happiness pricipleThe greatest happiness priciple Konsekuensi suatu tindakan, akhir sautu Konsekuensi suatu tindakan, akhir sautu

tindakantindakan Teori konsekuensialismeTeori konsekuensialisme Mencegah /mengendalikan /memberantas/ Mencegah /mengendalikan /memberantas/

penyakit; menghilangkan penderita, penyakit; menghilangkan penderita, memperpanjang hidup, meningkatkan memperpanjang hidup, meningkatkan kualitas hidup.kualitas hidup.

Kritik : tujuan menghalalkan cara Kritik : tujuan menghalalkan cara

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2)2) Konsekuensi Konsekuensi (utilitarianism)(utilitarianism)

Tindakan Tindakan BENAR /SALAH BENAR /SALAH tingkat tingkat konsekuensiya (nilai moral)konsekuensiya (nilai moral)

Teori manfaat (utilitarianism) Teori manfaat (utilitarianism) normatif (sesuai normatif (sesuai dengan asas manfaat)dengan asas manfaat)

Tindakan yang benar – akibat BAIK Tindakan yang benar – akibat BAIK Kasus : Kasus : - Pembunuhan - Pembunuhan

- aborsi - aborsi - pembunuhan bayi - pembunuhan bayi

Teori manfaat : Teori manfaat : - klasik - klasik - kontemporer - kontemporer

Dipertimbangkankondisi masing- Masing

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1)1) Teori DeontologiTeori Deontologi(Kantianisme, obligation –based theory)(Kantianisme, obligation –based theory)

Immanuel Kant (1724 – 1804)Immanuel Kant (1724 – 1804) Dasar hubungan : pengharagaan, kewajiban Dasar hubungan : pengharagaan, kewajiban

(deos = wajib) kepada sesama manusia(deos = wajib) kepada sesama manusia Perbuatan kepada orang lain, secara moral baik Perbuatan kepada orang lain, secara moral baik

dan benar, didasarkan pada niat-niat (good dan benar, didasarkan pada niat-niat (good intention)intention)

Kontianisme : lakukan terhadap orang lain Kontianisme : lakukan terhadap orang lain sebagaimana yang anda inginkan mereka berbuat sebagaimana yang anda inginkan mereka berbuat terhadap anda, tidak usah melihat hasilnya.terhadap anda, tidak usah melihat hasilnya.

Yang menolak dan setuju kepada Deontologi dan Yang menolak dan setuju kepada Deontologi dan Utilitarianism sama.Utilitarianism sama.

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2)2) DeontologiDeontologi : : - justifikasi theologis- justifikasi theologis-- justifikasi kemasyarakatan justifikasi kemasyarakatan- justifikasi intuisionis- justifikasi intuisionis- justifikasi murni (justifikasi kant) - justifikasi murni (justifikasi kant)

- universal, mutlak, mengikat- universal, mutlak, mengikat- rasional, otonomi, dignity- rasional, otonomi, dignity- liberal, kebetulan, martabat- liberal, kebetulan, martabat

* nilai rasionalitas * nilai rasionalitas * kontroversi, samar,* kontroversi, samar,

KASUS : PembunuhanKASUS : Pembunuhan

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Asas – Asas Etika medis Asas – Asas Etika medis TraditionalTraditional

1.1. BeneficenceBeneficence2.2. Non maleficence Non maleficence

((Primum non nocere)Primum non nocere)3.3. Menghormati hidup Menghormati hidup

manusiamanusia4.4. KonfidensialitasKonfidensialitas5.5. Kejujuran (Kejujuran (veracity)veracity)6.6. Tidak mementingkan Tidak mementingkan

diridiri7.7. Budi PekertiBudi Pekerti

Tingkah laku luhur Tingkah laku luhur

Asas-Asas Etika Medis Asas-Asas Etika Medis KONTEMPORERKONTEMPORER

1.1. - Menghormati otonomi - Menghormati otonomi pasienpasien

- - Universal Human right Universal Human right UN,UN,

- HAM - HAM 2.2. Keadilan /Keadilan /justicejustice3.3. Berkata benar / Berkata benar / truth truth

telling / veracitytelling / veracity

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C. Kaidah –Kaidah Dasar Moral C. Kaidah –Kaidah Dasar Moral 2,3,4,5,6

BeneficenceBeneficence & non maleficence & non maleficence Respect for personRespect for person Keadilan /Keadilan /justicejustice Budi pekerti Budi pekerti

Kegiatan-kegiatan :Kegiatan-kegiatan :• PendidikanPendidikan• Penelitian & pengembanganPenelitian & pengembangan• Pelayanan Pelayanan

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D. Kegiatan- kegiatan D. Kegiatan- kegiatan Bidang-bidang Life SciencesBidang-bidang Life Sciences 1)1) BiologiBiologi2)2) KedokteranKedokteran3)3) KeperawatanKeperawatan4)4) KependudukanKependudukan5)5) EpidemiologiEpidemiologi6)6) Kesehatan LinkunganKesehatan Linkungan7)7) Sosiologi – antropologi kesehatanSosiologi – antropologi kesehatan8)8) Etika institusional Rumah SakitEtika institusional Rumah Sakit

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Kesehatan : Kesehatan : WHO WHO :: Keadaaan sejahtera yang sempurna Keadaaan sejahtera yang sempurna

dari dari badan, mental, dan sosial, dan badan, mental, dan sosial, dan bukan bukan hanya tidak ada penyakit atas hanya tidak ada penyakit atas kelemahankelemahan

UU RI. No. 23 Th 1992 :UU RI. No. 23 Th 1992 : Keadaan sejahtera dari badan, jiwa, Keadaan sejahtera dari badan, jiwa,

dan dan sosial yang memungkinkan setiap sosial yang memungkinkan setiap orang orang hidup produktif secara social dan hidup produktif secara social dan

ekonomisekonomis

1948

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F. Bidang KesehatanF. Bidang Kesehatan5

1.1. Kode Etik KedokteranKode Etik Kedokteran2.2. Kode Etik KeparawatanKode Etik Keparawatan3.3. Kode Etik Rumah SakitKode Etik Rumah Sakit4.4. Majelis Kehormatan Etik Kedokteran (MKEK)Majelis Kehormatan Etik Kedokteran (MKEK)5.5. Majelis Kehormatan Etik Rumah Sakit Majelis Kehormatan Etik Rumah Sakit

(MAKERSI) (MAKERSI) 6.6. Majelis Kehormatan Majelis Kehormatan DISIPLIN DISIPLIN Kedokteran Kedokteran

Indonesia (MKDKI)Indonesia (MKDKI)

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III. ETIKA & HUKUMIII. ETIKA & HUKUM1.1. Hukum menurut standar moral yang minimal Hukum menurut standar moral yang minimal

larangan-larangan larangan-larangan Etika menurut standar moral yang tertinggi Etika menurut standar moral yang tertinggi

larangan-larangan dan hal- hal yang larangan-larangan dan hal- hal yang positif positif dokter kepada pasiennya.dokter kepada pasiennya.

2.2. Perbuatan seorang yang profesional Perbuatan seorang yang profesional a.a. Etis dan legalEtis dan legalb.b. Etis tidak legalEtis tidak legal – tidak ada – kriteria etis melanggar – tidak ada – kriteria etis melanggar

hukumhukumc.c. Tidak Etis dan legalTidak Etis dan legal – dokter mengiklankan diri – dokter mengiklankan dirid.d. Tak Etis dan tidak legalTak Etis dan tidak legal – dokter membuat tagihan – dokter membuat tagihan

palsu kepada perusahaan palsu kepada perusahaan asuransi beaya asuransi beaya pengobatan & pengobatan & perawatan perawatan

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Kasus Kasus : US Supreme Court (Makamah : US Supreme Court (Makamah Agung AS). Memutuskan – Hak Agung AS). Memutuskan – Hak konstitutional seorang wanita untuk konstitutional seorang wanita untuk dapat melakukan aborsi kehamilan dapat melakukan aborsi kehamilan trisemester pertamatrisemester pertama kontroversi moral & etika : - prochicekontroversi moral & etika : - prochice - prolife- prolife

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VI. Etika – Disiplin – Hukum VI. Etika – Disiplin – Hukum 5

EtikaEtika Hati nurani, pikiran pelakuHati nurani, pikiran pelaku Benar/salah, baik/buruk, pantas /tidak pantasBenar/salah, baik/buruk, pantas /tidak pantas Moral philosophyMoral philosophy Das sein und das sollanDas sein und das sollan

(The “oughts” and “Shoulds” of Socienty)(The “oughts” and “Shoulds” of Socienty) Klasik dan KontemporerKlasik dan Kontemporer Kode etik profesi Kode etik profesi Etika diperkuat HukumEtika diperkuat Hukum Homo homini lupusHomo homini lupus

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Etika – Disiplin - HukumEtika – Disiplin - HukumHukumHukum Hukum & etika – menyatu hubungan antar manusiaHukum & etika – menyatu hubungan antar manusia Baik/buruk, pantas /tidak pantas, salah /benar.Baik/buruk, pantas /tidak pantas, salah /benar. Moral – Indonesia – Falsafah PancasilaMoral – Indonesia – Falsafah Pancasila Pelanggaran norma & nilai-nilai etika dan hukumPelanggaran norma & nilai-nilai etika dan hukum Ringan, membahayakan masyarakat/ ketertiban umum Ringan, membahayakan masyarakat/ ketertiban umum

fungsi hukum fungsi hukum Hal-hal kecil – merebut pasien, menjelekan nama baik Hal-hal kecil – merebut pasien, menjelekan nama baik

sejawat, mengiklan diri.sejawat, mengiklan diri. De minimus non curat lexDe minimus non curat lex

Aturan /regulasi internal profesiAturan /regulasi internal profesi

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Etika – Disiplin - HukumEtika – Disiplin - HukumDisiplinDisiplin

Discipline – Discipline – jurusan ilmu Pengetahuan jurusan ilmu Pengetahuan Tata-tertib, keteraturan sikap-tindak, behaviorTata-tertib, keteraturan sikap-tindak, behavior

Dua disiplin – dapat saling berbenturanDua disiplin – dapat saling berbenturan Belanda : Belanda : Medische TuchtrechMedische Tuchtrech

mengadili dan memeberikan sangsi mengadili dan memeberikan sangsi disiplin disiplin (tucht) (tucht) Ganti rugi – Perdata, PidanaGanti rugi – Perdata, Pidana

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Etika – Disiplin - HukumEtika – Disiplin - HukumDisiplinDisiplin

GMC (GMC (General Medical Council)General Medical Council)Keputusan Keputusan : : 1) tidak melanggar disiplin1) tidak melanggar disiplin2) Kurang terampil2) Kurang terampil training training3) melanggar disiplin 3) melanggar disiplin tidak boleh tidak boleh praktek praktek sementarasementara4) Pelanggaran berat 4) Pelanggaran berat dicoret dari dicoret dari registrasi registrasi tidak boleh praktek di tidak boleh praktek di negara tersebut. negara tersebut.Gugatan ganti rugi dll - PengadilanGugatan ganti rugi dll - Pengadilan

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Pelanggaran DisiplinPelanggaran Disiplin1.1. Medical NegligenceMedical Negligence

Melakukan sesuatu yang seharusnya tidak Melakukan sesuatu yang seharusnya tidak dilakukandilakukan

Tidak melakukan apa yang di lakukan sejawat Tidak melakukan apa yang di lakukan sejawat lain lain

2.2. Serious Profesional MisconductSerious Profesional Misconduct Hubungan sex dengan pasienHubungan sex dengan pasien Angkat bagian tubuh yang keliruAngkat bagian tubuh yang keliru Melantarkan pasien Melantarkan pasien cacat atau meninggal cacat atau meninggal

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Contoh-contoh kasusContoh-contoh kasus Operasi – operasi mataOperasi – operasi mata Operasi – operasi ginjalOperasi – operasi ginjal Operasi anggota tubuhOperasi anggota tubuhKebetulan ada bagian KANAN-KIRI Kebetulan ada bagian KANAN-KIRI

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Hukum :Hukum : Keseluruhan asas dan aturan tentang perbuatan manusia Keseluruhan asas dan aturan tentang perbuatan manusia yang ditetapkan atau diakui oleh otoritas tertinggiyang ditetapkan atau diakui oleh otoritas tertinggi

Hukum Perdata : Hukum Perdata : hukum yang mengatur hubungan atar orang dengan orang hukum yang mengatur hubungan atar orang dengan orang lain.lain.

Hukum Pidana : Hukum Pidana : hukum yang mengatur perbuatan apa yang dilarang dan hukum yang mengatur perbuatan apa yang dilarang dan memberikan pidana (=hukuman) kepada siapa yang memberikan pidana (=hukuman) kepada siapa yang melanggarngamelanggarnga

Hukum Administrasi Negara : (Tata Usaha Negara)Hukum Administrasi Negara : (Tata Usaha Negara) hukum yang mengatur cara menjalankan tugas (hak dan hukum yang mengatur cara menjalankan tugas (hak dan kewajiban) dan kekuasaan alat-alat perlengkapan negara.kewajiban) dan kekuasaan alat-alat perlengkapan negara.

Hukum kebiasaan : Hukum kebiasaan : hukum tidak tertulis yang hidup dalam keyakinan hukum tidak tertulis yang hidup dalam keyakinan masyarakat dan ditaati seperti suatu peraturan perundanganmasyarakat dan ditaati seperti suatu peraturan perundangan

Hukum Yurisprudensi :Hukum Yurisprudensi :Hukum yang terbentuk karena keputusan hukum oleh hakim Hukum yang terbentuk karena keputusan hukum oleh hakim dalam prekara sejenis sebelumnya.dalam prekara sejenis sebelumnya.

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Kepustakaan Kepustakaan 1.1. Jacobalis S., 2005 Perkembangan Ilmu kedokteran, Etika Medis, dan Jacobalis S., 2005 Perkembangan Ilmu kedokteran, Etika Medis, dan

Bioetika : Tentang moral dan Etika. Cetakan ke I. Agung Seto. Jakarta Bioetika : Tentang moral dan Etika. Cetakan ke I. Agung Seto. Jakarta (pp. 62 – 84)(pp. 62 – 84)

2.2. Beauchamp TT and Children JP, 1994 Principles of Biomedical Ethics –Beauchamp TT and Children JP, 1994 Principles of Biomedical Ethics –Fourth Ed. Oxford Univ. Press. NY.Fourth Ed. Oxford Univ. Press. NY.

3.3. Kushe H and Singer P, 2004 A Companion to Bioethics. Reprinted. Kushe H and Singer P, 2004 A Companion to Bioethics. Reprinted. Blackwell Publishing Ltd. Australia.Blackwell Publishing Ltd. Australia.

4.4. Emmanuel Ej. et al, 2004 Ethical and Regulatory Aspect of Clinical Emmanuel Ej. et al, 2004 Ethical and Regulatory Aspect of Clinical Research. Reading and Communitary – The John Hopkins Univ. Press. Research. Reading and Communitary – The John Hopkins Univ. Press. Baltimore ad london. (pp. 25 – 80)Baltimore ad london. (pp. 25 – 80)

5.5. Guwandi J, 2005 Medical Error dan Hukum Medis: Etika, Disiplin, dan Guwandi J, 2005 Medical Error dan Hukum Medis: Etika, Disiplin, dan Hukum. Balai Penerbit FK UI Jakarta (pp. 125 – 134) Hukum. Balai Penerbit FK UI Jakarta (pp. 125 – 134)

6.6. Wiradharma D, 1996 Penutun Kuliah Hukum Kedokteran : Masalah Etis Wiradharma D, 1996 Penutun Kuliah Hukum Kedokteran : Masalah Etis yang berkaitan dengan hukum Kedokteran. Bima rupa Aksara. Jakarta yang berkaitan dengan hukum Kedokteran. Bima rupa Aksara. Jakarta (pp. 117 -146)(pp. 117 -146)

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I. LEGISLATION REVIEWS of I. LEGISLATION REVIEWS of

1.1. Prohibition of Human Cloning (PHC) Prohibition of Human Cloning (PHC) Act. 2002Act. 2002

2.2. Research Involving Human Embryo Research Involving Human Embryo (RIHE) Act 2002(RIHE) Act 2002

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1. Background1. Background– ART (Assisted Reproductive Technology) ART (Assisted Reproductive Technology)

– IVF (In Vitro Fertilization)– IVF (In Vitro Fertilization)– The use of Human Embryo for research The use of Human Embryo for research

purposes; should be permitted purposes; should be permitted – The committee - review website The committee - review website

- written submission- written submission- face to face meeting - face to face meeting with key steak with key steak holderholder

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BackgroundBackground

- public hearing & - public hearing & private private meetings meetings

- discussion forum - discussion forum - selected site visit.- selected site visit.

– Issues of recent scientific and Issues of recent scientific and technological advances in human technological advances in human cloning, human embryo study, including cloning, human embryo study, including stem cell technology.stem cell technology.

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2. Rationale for the 2. Rationale for the Recommendation Recommendation

Different perspectives, interests and values of Different perspectives, interests and values of divers communities.divers communities.

The perspective or “standards” vary between The perspective or “standards” vary between and within communities and over timeand within communities and over time disagreement will remain theredisagreement will remain there

Certain moral values (commitment to social Certain moral values (commitment to social justice, equity, and to care of vulnereble justice, equity, and to care of vulnereble people.people.

Medical research (for preventing or testing Medical research (for preventing or testing diseases, assisting people to have children diseases, assisting people to have children (“wastage” of some embryos)(“wastage” of some embryos)

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Rationale for the Rationale for the Recommendation Recommendation

The higher potential benefits of activity, The higher potential benefits of activity, the future the need for ethical the future the need for ethical objections objections consideration of consideration of prohibition or permission through the prohibition or permission through the legal system may be justified.legal system may be justified.

Proponent and opponents of embryo Proponent and opponents of embryo research research national legislation review national legislation review – strict control and monitoring, under – strict control and monitoring, under licenses, of human embryo research. licenses, of human embryo research.

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3. 3. Prohibited practicesProhibited practices Committee has recommended monitoring Committee has recommended monitoring

the prohibition of human reproductive the prohibition of human reproductive cloningcloning

Embryos created by Embryos created by - nuclear transfer- nuclear transfer- chimeric embryos- chimeric embryos- genetic material from - genetic material from more the two more the two person person - genetic alternative, etc- genetic alternative, etc

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the committee has recommended the committee has recommended that use of such embryo that use of such embryo embryo for reproductive purposes embryo for reproductive purposes ( that is development beyond 14 ( that is development beyond 14 days or implantation into a women’s days or implantation into a women’s reproduction tract) should remain reproduction tract) should remain prohibited. prohibited.

Prohibited practicesProhibited practices

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4. Creating a human embryo by fertilization of 4. Creating a human embryo by fertilization of an egg by sperman 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 embryoOpp. Kont : human embryo from the early stage of

development, as entity should be protected, a port from ART.

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Creating a human embryo Creating a human embryo by fertilization of an egg by spermby fertilization of an egg by sperm

Term of EMBRYO – biologically accurate – different moral Term of EMBRYO – biologically accurate – different moral interpretations, status and obligations owed to them. interpretations, status and obligations owed to them.

The acceptance that human embryos by the fertilization of The acceptance that human embryos by the fertilization of human egg by human sperm are entities of some social human egg by human sperm are entities of some social and ethical.and ethical.Significance because of their association with the start of Significance because of their association with the start of human life.human life.

Stopped research on culture & maturation of immature Stopped research on culture & maturation of immature egg (IVM = “in vitro maturation” of oocytes, storage of egg (IVM = “in vitro maturation” of oocytes, storage of frozen eggs, gemete (egg and sperm) development.frozen eggs, gemete (egg and sperm) development.Prohibition of oocytes activation (part hemogenesis) Prohibition of oocytes activation (part hemogenesis)

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Creating a human embryo Creating a human embryo by fertilization of an egg by spermby fertilization of an egg by sperm

Definition of a human embryo ; Definition of a human embryo ; a new and unique genetic entity is formed only a new and unique genetic entity is formed only after the genetic material from the male and after the genetic material from the male and female pronuclear combine, stage of as “syngamy” female pronuclear combine, stage of as “syngamy” accours about one to three hours before the first accours about one to three hours before the first cell devision (cleavage)cell devision (cleavage)

Hybrid fertilization should be permitted, under Hybrid fertilization should be permitted, under licence, up to but not including, the first cell licence, up to but not including, the first cell devision.devision.

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5. Use of excess ART 5. Use of excess ART embryosembryos

The committee has recommended that The committee has recommended that the use of excess ART embryos to be the use of excess ART embryos to be permitted, under licence, for research, permitted, under licence, for research, training an d other uses to improve the training an d other uses to improve the practice of ART.practice of ART.

Registered excess ART embryos are Registered excess ART embryos are available to facilitate the most efficient available to facilitate the most efficient use of this resource.use of this resource.

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Use of excess ART embryosUse of excess ART embryos

The status of unsuitable embryo for implantation is not clear in the current The status of unsuitable embryo for implantation is not clear in the current legislation. The committee recommended the use of this unsuitable embryo for legislation. The committee recommended the use of this unsuitable embryo for research, training, and improvement for clinical practice – NHMCR – develop research, training, and improvement for clinical practice – NHMCR – develop ethical guideline.ethical guideline.Criteria to decide suitable or unsuitable should be developed by an expert body 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 Debate regarding the relative merits of embryonic and adult stem cell research – different attitudes toward moral status of human embryos, different – different attitudes toward moral status of human embryos, different agreements agreements

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6. Creation of embryos 6. Creation of embryos other other than by than by fertilization fertilization

Creation of human embryo clones Creation of human embryo clones generate embryonic stem cells generate embryonic stem cells development of specific cellular therapy – development of specific cellular therapy – genotype genotype “therapeutic cloning”. Further “therapeutic cloning”. Further research is required.research is required.

A member of objection to SCNT- to generate A member of objection to SCNT- to generate embryonic stem cells, the argument embryonic stem cells, the argument

The technology is the same as that used for The technology is the same as that used for therapeutic cloning, to extract stem celltherapeutic cloning, to extract stem cell

To ensure that such embryo are not used for To ensure that such embryo are not used for reproduction purposes reproduction purposes should be prohibited should be prohibited

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Creation of embryos other than Creation of embryos other than by fertilizationby fertilization

Human embryo clones are human embryo Human embryo clones are human embryo the right environment the right environment develop into a develop into a human being human being implanted to women implanted to women pregnancy pregnancy not implanted not implanted potential for research potential for research to to develop treatment for serious develop treatment for serious medical medical condition. condition.

Creation of human embryo clone by SCNT Creation of human embryo clone by SCNT should be permitted, under licence, for should be permitted, under licence, for research, training, and clinical application. research, training, and clinical application.

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Creation of embryos other than Creation of embryos other than by fertilizationby fertilization

The potential benefits in creating of such entities The potential benefits in creating of such entities using – method not involving fertilization of human using – method not involving fertilization of human egg by human sperm, egg by human sperm,

SCNTSCNT Genetic material from more than two peopleGenetic material from more than two people Heritable alterations to the genomesHeritable alterations to the genomes Using precursor cells – human embryo or Using precursor cells – human embryo or

fetusfetus Should be permitted, under licence, for use in Should be permitted, under licence, for use in

research, training, and clinical application.research, training, and clinical application.Prohibition Prohibition - - human embryo for more than 14 dayshuman embryo for more than 14 days - implantation into reproductive tract of women- implantation into reproductive tract of women to prevent any reproductive purposesto prevent any reproductive purposes

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7. Egg donation 7. Egg donation 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

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8. Licensing arrangement 8. Licensing arrangement and oversight of ART and oversight of ART services. services.

Informed Consent Informed Consent for embryo and egg donation, in all for embryo and egg donation, in all stages, having an emotional component, many people stages, having an emotional component, many people inclined to donate excess embryos to research rather inclined to donate excess embryos to research rather than letting them succumb. 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 Cost of licensing from licence applicant should also considered.considered.

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9. 9. Prescriptive versus regulatory Prescriptive versus regulatory legislationlegislation

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

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10. 10. Trade and international exchange of Trade and international exchange of human embryos, gametes and stem cellshuman 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.

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11. Biotechnology and commercialization11. Biotechnology and commercialization

Participants, industry group, research Participants, industry group, research – commercialization without – commercialization without investment, new therapeutic product investment, new therapeutic product can not be developed.can not be developed.

That potentially beneficial product can That potentially beneficial product can be developed for therapeutic use.be developed for therapeutic use.

Donor should be informed about this Donor should be informed about this matters why they make their donation. matters why they make their donation.

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12. 12. Australian Stem Cell BankAustralian Stem Cell Bank

Stem cell bank world make stem Stem cell bank world make stem cells, embyronic and adult stem cells, embyronic and adult stem cells, available to researcherscells, available to researchers

Management of bank – centralized / Management of bank – centralized / decentralized systemdecentralized system

National register of donated National register of donated embryos - transparentembryos - transparent

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13. Public Education 13. Public Education The community after lack of The community after lack of

understanding – prohibited or understanding – prohibited or licensed researchlicensed research

Public education and consultation Public education and consultation are needed in the area of research are needed in the area of research and development covered by the and development covered by the Act.Act.

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Bioethics of Bioethics of “Stem Cell Studies”“Stem Cell Studies” Human CloningHuman Cloning Research Involving Human Embryo Research Involving Human Embryo

II. STEM CELL Studies : II. STEM CELL Studies :

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• Creating Human Creating Human EmbryosEmbryos1.1. Fertilization of egg by spermFertilization of egg by sperm2.2. Other than fertilizationOther than fertilization

– SCNT (Somatic Cell Nuclear Transfer)SCNT (Somatic Cell Nuclear Transfer)– Genetic material from more than two Genetic material from more than two

peoplepeople– Heritable alterations to the genomesHeritable alterations to the genomes– Using procursor cells – Human embryo Using procursor cells – Human embryo

or Fetusor Fetus

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1) Before fertilization

2) During fertilization

3) Fertilization complete

Sperm

1st polar body

1st polar body2st polar body

Oocyte chromesomesCytoplasm

Zone pellucida

Female pronucleusMale pronucleus

a.

Polar bodies

Zegote chromosomes

1. Fertilization of egg be sperma1. Fertilization of egg be sperma

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a.a. Stages of fertilisationStages of fertilisationb.b. Stages of early embryonic developmentStages of early embryonic development

- up to implementation- up to implementation- Development of the primitive streak- Development of the primitive streak

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b. b. Stages ot early embryonic developmentStages ot early embryonic developmentpre implementationpre implementation

1)

2)

3)

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4)

5)

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2. Creation of Human Embryo clone by 2. Creation of Human Embryo clone by Somatic cell nuclear transfer (SCNT) Somatic cell nuclear transfer (SCNT)

Morula3-4 days

Somatic (body) cells1. Heart disease2. Diabetes (types)3. Spinal cord injury4. Stroke5. Parkinson’s disease6. Huntington’s disease

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• Cloning TechnologyCloning Technology

1.1. Reproductive cloningReproductive cloning2.2. Therapeutic cloningTherapeutic cloning

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1.1. - Human cloning - Human cloning - Assisted Reproductive (technology) - Assisted Reproductive (technology)

Treatment (ART)Treatment (ART)- IVF (in Vitro Fertilisation)- IVF (in Vitro Fertilisation)- IVM (In Vitro Maturation) of Oocytes,- IVM (In Vitro Maturation) of Oocytes, etc etc

2.2. Therapeutic CloningTherapeutic CloningSpecial for DM, heart disease, brain Special for DM, heart disease, brain disease. etc.disease. etc.Creating Human Embryo through SCNT, Creating Human Embryo through SCNT, procursor-cells. etc.procursor-cells. etc.

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• Some examples of LegislationSome examples of Legislation(Australia)(Australia)

1.1. Prohibilition of Human Cloning (PHC) Prohibilition of Human Cloning (PHC) Act. 2002Act. 2002

2.2. Research Involving Human Embryo Research Involving Human Embryo (RIHE) Act. 2002(RIHE) Act. 2002

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• Some issues of research Some issues of research Related to human Esc (Embryonic Stem-cell)Related to human Esc (Embryonic Stem-cell)

1)1) .. In h Esc research, maximizing social utility In h Esc research, maximizing social utility remains the primary justification for issuing remains the primary justification for issuing intellectual property right. (Matthew Herder, intellectual property right. (Matthew Herder, Bioethical Inquiry (2006), 3 : 69-79 US and Bioethical Inquiry (2006), 3 : 69-79 US and European patent System)European patent System)

The fundamental question are determining what The fundamental question are determining what benefits are likely to the result from h Esc benefits are likely to the result from h Esc research.research.

Donor should have control over the Donor should have control over the stem cell stem cell lineslines derived from their embryos and gamete or derived from their embryos and gamete or ovum ovum

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2. 2. The fact that human eggs or embryos are the source The fact that human eggs or embryos are the source of cell lines for stem cells research of cell lines for stem cells research

Moral status of the or embryosMoral status of the or embryos - eggs come - eggs come from WOMEN.from WOMEN.

The third world and our women will supply those The third world and our women will supply those eggs.eggs.

Women “choice” - sell their reproductive tissues Women “choice” - sell their reproductive tissues (eggs) or labor.(eggs) or labor. - Sell their eggs, “donate” ? as a - Sell their eggs, “donate” ? as a

DONOR ? DONOR ? Increasing, such research is not drives by possible Increasing, such research is not drives by possible

cures for existing diseases, but is driven by the cures for existing diseases, but is driven by the market itself. Drug Co is – look for market with market itself. Drug Co is – look for market with patent. patent. (Rothman BK, 2006 Stem Cell research: Rethinking (Rothman BK, 2006 Stem Cell research: Rethinking the Questions – Bioethical inquiry, 3 : 15 -17)the Questions – Bioethical inquiry, 3 : 15 -17)

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• There were two systemThere were two system Newly emerging field of “system biology” X System Bioethics Newly emerging field of “system biology” X System Bioethics

Stem cell, blastommeer, stemStem cell, blastommeer, stem Characterized as responsive, regulatory Characterized as responsive, regulatory

system, much interacting with and system, much interacting with and responding to their surrounding.responding to their surrounding.

Autonomous system, interactive and Autonomous system, interactive and responsive system, not as precursor.responsive system, not as precursor.

Disciplines : philosophy, Disciplines : philosophy, religions, clinical medicine, religions, clinical medicine, biomedicine, economic, biomedicine, economic, social-politics, law systems. social-politics, law systems.

“ “Stem cell research is and should be an excersice in translational development of Biology”.Stem cell research is and should be an excersice in translational development of Biology”.

(Robert JS, Mainschein J, and Laubichles, 2006 System bioethics and stem cell study, Bioethical Inquiry. 3 : 19 -31)(Robert JS, Mainschein J, and Laubichles, 2006 System bioethics and stem cell study, Bioethical Inquiry. 3 : 19 -31)

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• Moral Status of the Human EmbryoMoral Status of the Human Embryo

1.1. Single criterion view of moral person hoodSingle criterion view of moral person hood2.2. A Pluralistic Approach, moral respect and A Pluralistic Approach, moral respect and

personhood as deriving not from one or personhood as deriving not from one or oven two criteria, but from variety of oven two criteria, but from variety of different and interacting consideration.different and interacting consideration.

(Ad Hoc Committee of Consultants to Advisory Committee to (Ad Hoc Committee of Consultants to Advisory Committee to the Director of NIH, 2004 Human Embryo and Stem cells. the Director of NIH, 2004 Human Embryo and Stem cells. Section III : Ethical and Regulatory Aspects of Clinical Section III : Ethical and Regulatory Aspects of Clinical Research : Reading and Commentary. The John Hopkins Research : Reading and Commentary. The John Hopkins Univ. Press. Baltimore & London) Univ. Press. Baltimore & London)

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1). Single Criterion View1). Single Criterion View

Embryo is a person. The moment of Embryo is a person. The moment of conception/ fertilization conception/ fertilization unique unique diploid genotype comes into being. diploid genotype comes into being. From gametes to embryo From gametes to embryo beginning beginning of personhood /lifeof personhood /life

Full moral personhood on sentience :Full moral personhood on sentience : The ability to feel or to experience painThe ability to feel or to experience pain The beginning of brain activity /functionThe beginning of brain activity /function

(brain dead/end of life)(brain dead/end of life)

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Single Criterion ViewSingle Criterion View

Well developed cognitive abilities, Well developed cognitive abilities, reasoning abilities, possession of self-reasoning abilities, possession of self-concept.concept.

Degree of moral protection given to Degree of moral protection given to children or adult human ?children or adult human ?

Consciousness, reasoning, or the Consciousness, reasoning, or the possession of self – concept possession of self – concept exclusion - exclusion -newborn – protected subject ! newborn – protected subject !

7979

2). A Pluralistic Approach 2). A Pluralistic Approach Among the quality of considerations are Among the quality of considerations are Single criterion view : genetic uniqueness, potentially for Single criterion view : genetic uniqueness, potentially for

full development, brain activities, sentience, cognitive full development, brain activities, sentience, cognitive development development

Capacity for survival outside the mother womb.Capacity for survival outside the mother womb. Transition from gametes – zygote – the beginning of Transition from gametes – zygote – the beginning of

biological uniqueness biological uniqueness Formation of Formation of primitive streak at 14 daysprimitive streak at 14 days, cellular , cellular

differentiation and organization – the onset of heart beat, differentiation and organization – the onset of heart beat, dev. Nerve system –brain activity.dev. Nerve system –brain activity.

Substantial development and independent existence Substantial development and independent existence outside the mothers womb – provide moral basis for full outside the mothers womb – provide moral basis for full and equal person hood.and equal person hood.

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• Analysis of Ethics & Regulation Analysis of Ethics & Regulation on Human Embryonic Stem Cell (h Esc)on Human Embryonic Stem Cell (h Esc)

1.1. BackgroundBackground2.2. Rational for decisionRational for decision3.3. Prohibited practiceProhibited practice4.4. Creating a human embryos by fertilization Creating a human embryos by fertilization

of an egg by spermof an egg by sperm5.5. The use excess ART embryosThe use excess ART embryos6.6. Creation of embryos other than by Creation of embryos other than by

fertilization, e.g. SCNTfertilization, e.g. SCNT7.7. Egg donationEgg donation8.8. Licensing arrangement and over sight of Licensing arrangement and over sight of

ART services, informed consent. EtcART services, informed consent. Etc

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Analysis of Ethics & Regulation Analysis of Ethics & Regulation

9.9. Perspective versus regulatory legislation. Perspective versus regulatory legislation. 10.10. Trade and international exchange of human Trade and international exchange of human

embryos, gametes, and stem cellsembryos, gametes, and stem cells11.11. Biotechnology and commercialization Biotechnology and commercialization 12.12. Stem cell bank, Indonesia ?Stem cell bank, Indonesia ?13.13. Public education Public education

(http://www.ag.gov.au/cca)

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17 June 2005 17 June 2005 Committee ConclusionCommittee Conclusion

1.1. The Committee heard strong arguments for reform The Committee heard strong arguments for reform on experimental fertilization techniques to improve on experimental fertilization techniques to improve assisted reproductive technology treatment. (ART assisted reproductive technology treatment. (ART treatment)treatment)We have recommended increased regulatory We have recommended increased regulatory flexibility to facilitate research in this important flexibility to facilitate research in this important field.field.

2.2. On the contentious issues of somatic cell nuclear On the contentious issues of somatic cell nuclear transfer (SCNT), some time know as transfer (SCNT), some time know as therapeutic therapeutic cloningcloning the committee has given its support for the committee has given its support for SCNT and the creation and the use is research of SCNT and the creation and the use is research of certain other types of experimental embryos in the certain other types of experimental embryos in the very early state very early state of their development under strict of their development under strict ethical and scientific regulation. ethical and scientific regulation.

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17 June 2005 17 June 2005 Committee ConclusionCommittee Conclusion

3. The committee agree that the existing 3. The committee agree that the existing prohibitions in place to prevent prohibitions in place to prevent reproductive reproductive cloningcloning and the placement of prohibited embryos and the placement of prohibited embryos in the body of a women should be maintained in the body of a women should be maintained

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Legislation and Ethics related to Legislation and Ethics related to stem cell studies in Indonesiastem cell studies in Indonesia

The need of such Act related to human The need of such Act related to human cloning and Research Involving Human cloning and Research Involving Human Embryo, should be considered ?Embryo, should be considered ?

Small group discussion, Task farce, draf Small group discussion, Task farce, draf of conceptof concept

Collaboration studies, internationally, in Collaboration studies, internationally, in stem cells studies – who regulate ?stem cells studies – who regulate ?