Etika Penelitian.pptrevised

7/29/2019 Etika Penelitian.pptrevised

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ETHICS 1. ETHIC*

Latin: ethicus; Yunani: ethicos(costum/kebiasaan;

disposition/aturan;

character/kepribadian)

Mengenai moral

Sistem atau filsafat perbuatan

dan prinsip2 yang dilakukan oleh

seseorang atau kelompok

2. ETHICAL/etis: Sesuai dengan

aturan2 berbuat baik

THE PRINCIPLES

OF MORALITY

THE FIELD OF

STUDY OF MORALS

OR RIGHT CONDUCT

THE STUDY AND

PHILOSOPHY OFHUMAN CONDUCT

WITH EMPHASIS ON

THE DETERMINATION

OF GOOD AND BAD•Dalam kehidupan sehari-hari: sopan santun/

tata susila/budi pekerti



ETIKA

(FILSAFATMORAL)

NILAI/NORMA

Baik-buruk/Adil/Sejahtera/

Kebajikan/Jujur/Moralitas

(susila-asusila)/ Pengabdian/

Tanggung jawab/Bijaksana dll.

WAKTU/TEMPAT/BUDAYA

MASYARAKAT

FUNGSI ETIKA: - BERGUNA/applicable

- AZAS/SENDI KEHIDUPAN (antarmanusia)

- UNTUK MENILAI PERBUATAN MANUSIA

ALASAN/AKIBAT PERBUATAN

Conversation about

questions



SCIENCE

PILAR UTAMA

ONTOLOGY(lingkup/subjek) AXIOLOGY

(terpakai/aplikasi) EPISTEMOLOGY

(caramemperoleh)

A BODY OF

KNOWLEDGE

SCIENTIFIC

METHOD

RESEARCH

ETIKA PENELITIAN = ETIKA SAIN



ETIKA PENELITIAN?

SCIENCE

• MENERANGKAN

• MERAMALKAN

• MENGENDALIKAN

FENOMENA ALAM

“KEBENARAN”

A BODY OF

KNOWLEDGE

SCIENTIFIC

METHOD PENELITIAN

SCIENCE: MENGABDI MASYARAKAT

(kesejahteraan manusia)

BENTUK TERTINGGI SCIENCE: BIJAKSANA (Aristoteles)



PIRANTI ETIKA

ABDI KEMANUSIAANSCIENCE

SUBJEK PENELITIAN

1. BINATANG (BINATANG COBA)

2. MANUSIA (NARACOBA)*

(* Pada percobaan tertentu sebelum

dicobakan pada manusia harus dicobakandulu pada binatang coba)

Aspek etika penelitian harus diperhatikan

untuk kedua macam subjek penelitian tsb.



PERKEMBANGAN ETIKA

PENELITIAN KEDOKTERAN

SUMPAH DOKTER HINDU (1500 SM):

Jangan merugikan pasien

SUMPAH HIPOCRATES (500 SM):

Utamakan kepentingan pasien(Premium non nocere)

NORMA2 ETIS DIGARISKAN DALAM PERATURAN

KEMAJUAN TEKNOLOGI KEDOKTERAN

(Sarat dengan pelanggaran nilai2 etis)

Abad XVIIIEtiologi penyakit (Pasteur/Koch)

Diagnostik (Rontgen)

Klinis (Addison/Charcot/Billroth)Obat2 baru (SA/Antibiotica/Insektisida)



KEMAJUAN… (lanj.)Transplantasi organ (manusia/hewan/buatan)

Rekayasa genetik (kloning dll.)

PENELITIAN DENGAN MANUSIA PERLU BADAN PENGAWAS

SEBAGAI NARACOBA

EKSPERIMEN PADA MANUSIA NUREMBURG CODE

PD II (Nazi) (informed consent)

Pedoman penelitian klinis, DEKLARASI HELSINKI I

terapeutik/nonterapeutik (dipatuhi!) (WMA, 1964)

Protokol penelitian perlu ditinjau DEKLARASI HELSINKI II

oleh PANITIA (pertimbangan/ (WMA, 1975)

tuntunan/komentar) ETHICAL CLEARANCE OLEH

PANITIA ETIK PENELITIAN KED.

(Internasional/Nasional/Fak. Ked./RS)



MEDICAL ETHICS or BIOETHICS

Study and application of moral values, rights, and duties

in the fields of medical treatment and research

((Medical decisions involving moral issues are made every

day in diverse situations)

(1) The relationship between patient and physician.(2) The treatment of human and animal subjects in biomedical

experimentation.

(3) The allocation of scarce medical resources.

(4) The complex questions that surround the beginning and

the end of a human life.

(5) The conduct of clinical medicine and life sciences research



YUNANI KUNO (Abad IV sM)

Hippocrates: “As to diseases, make a habit of two things –

to help and not to harm”.Hippocrates Oath:- “keep (patients) from harm and

injustice”; refuse to provide abortion or euthanasia

AKHIR ABAD 20

Current Isues in Medical Ethics

ADVANCES IN SCIENTIFIC KNOWLEDGE AND

BIOMEDICAL TECHNOLOGY

(humanity: - Progress in treating and preventing disease

- New questions and uncertainties about the

basic nature of life and death



RECENTLY

Medical ethics has struggled to keep pace

with the many complex issues raised by new

technologies for creating and sustaining life:

- Artificial respiration devices

- Kidney dialysis

- Other machines can keep patients alivewho previously would have succumbed to

their illnesses or injuries



- Advances in organ trasplantation have

brought new hope to those afflicted with

diseased organs

- New techniques have enabled prospective

parents to conquer infertility

- Progress in molecular biology and geneticshas placed scientists in control of the most

basic biochemical processes of life

With the advent of these technologies, codesof medical ethics have become inadequate or

obsolete as new questions and issues

continue to confront medical ethicists



Praktek etika kedokteran didasarkan pada

berbagai konsep/prinsip

(aliran priciplisme)

1. Deontologi

Cabang ajaran etis berpusat pada gagasan

bahwa tindakan harus dibimbing oleh prinsip

yang jelas, antara lain:

-Penghargaan atas keinginan bebas (free will).

2. Otonomi

Hak individu menentukan nasib dan hidupnya

sendiri, sesuai dengan pilihannya, sejauh tidak

mencampuri hak-hak orang lain



3. Utilitarianism

Kerangka moral dimana tindakandidasarkan terutama atas akibatnya

(Tindakan atau kebijakan yang mencapai

hasil yang baik – the greatest good for thegreatest number of people – harus didasari

oleh moral)

4. Virtue ethics (etika kebajikan):Those who are taught to be good will do

what is right



Keempat prinsip tsb. berhadapan/bertentangan satusama lain.

Keempat prinsip tsb. harus saling kerjasama dalam :

- kasus dimana pasien jatuh ke dalam koma yangirreversibel tanpa harapan sembuh

- kasus dimana hidupnya didukung oleh mesin yang

secara artifisial mempertahankan fungsi-fungsidasar hidup, misalnya denyut jantung dan respirasi.

Kontradiksi !



KONTRADIKSI:

Keluarga pasien: hentikan!Dokter/Staf RS: prinsip otonomi pasien

(prinsip beneficence/kepentingan pasien

dan non-malifecence/tidak merugikan pasien)

tidak menghentikan!

Dalam kondisi demikian (conflicting principles):

Dokter/staf RS perlu konsultasi dengan Medical

Ethicists (mempertimbangkan mana yang baik)



CASE-BASED APPROACH

Medical Ethicists lain menerapkan prinsip

kasuistik (casuistry), pendekatan berdasarkan

kasus (case-based approach)

Jika menghadapi kasus bioetis:Casuists berupaya membayangkan (to

envision) kasus yang sama tetapi lebih jelas

dimana setiap orang akan setuju terhadap satu

solusi. Berdasarkan pertimbangan terhadapkasus hipotetis tsb., casuists bekerja dalam

menyelesaikan kasus sebenarnya yang

dihadapi.



MASALAH ETIKA MEDIS MUTAKHIR

I. BIOTEKNOLOGI/REKAYASA GENETIK

Manipulasi gen (building blocks of life)

Awal 1970-an: isolasi dan manipulasi gen (unit dasar

pewarisan) terdiri atas DNA.

Manipulasi gen

Masalah etis dan praktis yang serius:

Just because scientists can perform such

wonders, does it follow that they should do so?)

Are there unforeseen dangers in altering life at

the biochemical level?

Is genetic diversity threatened by such activity?



Commercial exploitation (e.g., to patent* human gene

sequences): - can life itself be patented?

(bisa dipatenkan untuk organisme hidup selain manusia!

Mis. temuan virus HIV dipatenkan)

membawa akibat/masalah: pemilikan paten

gen menimbulkan persaingan tidak sehat, yaitu berakibat

tidak adanya berbagi pengetahuan dalam sain!

(mis. Human Genome Project (sequencing of the human

genome): Scientists should openly share the knowledge)

* Paten: melindungi investor, penemu atau lainnya dengan

melarang setiap peniruan/imitasi dari pemakaian atau memperoleh

keuntungan dari materi asli pemegang paten



II. BIOTEKNOLOGI & BIOREKAYASA STEM CELL

I. EMBRYONIC STEM CELL (ESC)

Does the end justify the means?

(Tujuan menghalalkan cara?): Robin Hood!

Tujuan penelitian/biorekayasa ESC Kemanusiaan:mengurangi penderitaan dan meningkatkan

kesejahteraan manusia (regenerative

medicine: terapi berbagai penyakit dan

pengembangan obat)No dispute !



ESCs ASCs



Kontroversi

Consumption of donated embryos CARAPenelitian ESC menggunakan donated embryos

(use donated embryos that, by virtue of donor

instructions, will never enter the uterus)*

Embryo = person ?

Embryo destructive experiment

Untuk mendapatkan ESCs blastocyst dirusak

(membunuh embryo/person

untuk menolong orang lain) ?

* Fertilisasi in vitro Embryo dimasukkan ke dalam rahim foster mother



2. CLONING

“Menciptakan” organisme secara aseksual

Dolly (domba) : produk pertama kloning

-Ilmuwan mengambil inti sel dari jaringan mammae

domba umur 6 th. Dimasukkan ke dalam sel telur domba lain yang intinya sudah diambil lebih dulu

diimplantasikan ke dalam uterus surrogate

mother:mengandung Dolly sampai a term

Dolly dilahirkan (sebagai kembar identik denganorang tuanya yang berumur 6 th.)

KLONING MANUSIA?



Kloning manusia?

Kloning binatang:

Domba, mencit, tikus,

monyet, sapi, anjing,

kucing dll.



KLONING MANUSIA ?

(Playing God ?)

Kontroversi

AS:

-Clinton: melarang pendanaan federal terhadap

penelitian kloning manusia

-US National Bioethics Advisory Committee:

merekomendasikan penelitian dengan dana federal

yang menghasilkan Dolly tidak boleh diterapkan pada

manusia

Beberapa negara lain (Australia, Austria, Denmark,

Prancis, Jerman, Norwegia, Slowakia, Afrika

Selatan, Spanyol, Swedia, Switzerland, dan Inggris):

hukum melarang kloning manusia



BIOMEDIS

KLINIS

EPIDEMIOLOGIS

ILMIAHMURNI

DIAGNOSTIKTERAPEUTIK/

NONTERA-

PEUTIK

ASPEK ETIS:

1. KESUKARELAAN/voluntir

BEBAS: Tekanan/desakan/tipuan/paksaan

2. INFORMED CONSENT (pemberian izin tertulis atas dasar

pengertian: risiko/manfaat/efek samping/prosedur)

3. KEJUJURAN

PENELITIAN PADA MANUSIA

PENELITIAN



ETIKA

PENELITIAN

TAHAP

PENELITIAN

1. PERSIAPAN

2. PENGUMPULANDATA

3. PENGOLAHAN DATA

4. PENULISAN LAPORAN/

PUBLIKASI1. PERSIAPAN

KEWAJIBAAN

* MEMBANTU ORANG LAIN

* MENELITI

* TERHADAP SUMBER CREDIT * MEMBERI KESEM-

(ide/pustaka/acuan/data) PATAN ORIGINATOR



2. PENGUMPULAN DATA

HEWAN COBA

* Viviseksi (percob.padabin. hidup):

- Kesejahteraan- Relevansi

MANUSIA

(NARACOBA)(sehat/normal**; sakit/pasien)

(Man is the final test site - Beecher)

Manusia Binatang Test tube

** Mahasiswa/pelajar/tentara/narapidana

TANGGUNG JAWAB

TERHADAP SUBJEK/OBJEK



3. PENGOLAHAN DATA

* OBJEKTIVITAS

* KEJUJURAN

(hindari: manipulasi/penciptaan/penyulapan data)

4. PENULISAN

• SUMBER: - Pengarang credit - Info./Dana

acknowledgement- Kutipan/Sitasi (Teks/gambar/tabel copyright )

• PRIVACY : Foto/nama

• ANAK TIDAK WARAS: Izin orang tua/wali



5. PUBLIKASI

• KEWAJIBAN Prinsip fundamental ilmiah

• PENULIS/PENGARANG/ AUTHOR :

- Senior/junior

- Klasifikasi besar kontribusi- Tanggung jawab isi

- Manuskrip 1 penerbit

- Dipresentasikan dulu di forum ilmiah:kritik/saran/perbaikan/penyempurnaan

• SECRECY : Personal/temporary/military/industry

(PRINSIP: secrecy is contrary to the best interest of science)



Recommendation guiding medical

doctors in biomedical research

involving human subjects

BASIC PRINCIPLES

1. Conform to generally scientific principles

Based on:

- Adequately performed laboratory and animalexperimentation

- A thorough knowledge of the

scientific literatures

DECLARATION

OF

HELSINKI(1975)



2. Design and performance of experimental procedure:

Clearly formulated in experimentalprotocol

INDEPENDENT COMMITTEE

(consideration/comment/guidance)



3. Conducted only by scientifically qualified

persons

(under the supervision/ responsibility of

clinical competent medical doctor)

4. The importance of the objective is in

proportion to the inherent risk to the subject



5. - Preceded by careful assessment

of predictable risks in comparison with

foreseeable benefits to the subjects

or to others- Concern for the interest of the

subject must always prevail over the

interest of science and society



6. – The right of the subject to safeguardhis/her integrity must always be

respected

- To respect the privacy of the subject

- To minimize the impact of the study

on the subject’s physical and mentalintegrity and on the personality of the

subject



7. The hazards involved are believedto be predictable

(hazards > potential benefits CEASED!

8. PUBLICATION

- RESULTS: Accuracy should be preserved

- REPORT:Report on experimentation not in

accordance with the principles inthis DECLARATION:

Should not be accepted for publication



9. Subject must be adequately informed of :

- The aims/methods/anticipated

benefits/potential hazards/ discomfort/

liberty to abstain from participation/free to

withdraw his/her consent to participation

- Doctor should obtain subject’s freelyinformed consent (preferably in writing)



10. If the subject is in a dependent

relationship to the doctor or may consent

under duress (paksaan):

Informed consent should be obtained by

a doctor who is not engaged in the

investigation and who is completelyIndependent on this official relationship



11.In case of legal incompetence:

- Informed consent should be obtained

from the legal guardian in accordance

with national legislation

- The subject with physical or mental

incapacity or is a minor (di bawah

umur): Permission from the reponsible

relative (in accordance of national

legislation)



12. RESEARCH PROTOCOL

- Should always contain a statement of

the ethical consideration- Should indicate that the priciples enunciated

(dimaklumkan) in the present Declaration

are compiled with (dipenuhi)



Cramer

IN THE LONG RUN IT PAYS THE

SCIENTIST TO BE HONEST, NOT

ONLY BY NOT MAKING FALSE

STATEMENTS, BUT BY GIVING FULL

EXPRESSION TO FACTS THAT

ARE OPPOSED TO HIS VIEWS.

MORAL SLOVENLINESS (teledor) IS

VISITED WITH FAR SEVERER

PENALTIES IN THESCIENTIFIC THAN IN THE

BUSINESS WORLD

Etika Penelitian.pptrevised

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