Lect 2 Laik Ethik riset dengan Hewan Coba FAT

Wakil Ketua KEP UB

Direktur Lab Biosains UB

Dosen Jur Biologi FMIPA UB

Website: http://fatchiyah.lecture.ub.ac.id

3/17/2013 1 Fatchiyah

Peserta memahami tentang :

Peraturan etik penelitian kesehatan dengan menggunakan hewan coba

Prinsip dasar etik penelitian kesehatan dengan menggunakan hewan coba

Kewajiban penelitian untuk mendapat ethical approval dari Komisi Etik


Mengapa kau tega

melakukannya??


Figure 20.11

– Retroviruses

– Liposomes

– Direct DNA injection

Layak etikkah

tranfer gen seperti

ini??

3/17/2013 Fatchiyah 4

Komisi Etik Penelitian Universitas Brawijaya

diangkat menggunakan SK Rektor Nomor

057/SK/2008, dikukuhkan oleh Rektor UB 23-4-09

Ketua: Prof.Dr.drh. Aulanni’am, DESS.

Wakil Ketua: Fatchiyah, M.Kes., PhD.

Sekretaris: Dr.Ir. Gatot Ciptadi, DES.

Pengukuhan ini disertai Seminar Nasional Etik

penelitian Ilmu Hayati, dg pembicara Prof Dr dr

Amin Subandrio (Deputi Bidang Pengembangan

Sisteknas Menristek) dan diresmikan Prof Dr Ir Tien

R Muchtadi (wakil ketua Komisi Bioetik Nasional).

Tgl 23 April 2008


Menyebarluaskan dan mengawasi suatu tata laksana etik riset yg menyertakan hewan sebagai subyek penelitian

Mengembangkan kebijakan dan procedur kerja yg menjamin aplikasi ethik penelitian pada hewan

Menjamin bahwa hewan coba diperlakukan secara hewani

Menjamin tata laksana etik riset dgn hewan sbg sukyek baik keselamatan, kesehatan dan kenyamanan hewan

Melaksanakan pembahasan etik proposal penelitian secara wajar dan independen, kompeten dan tepat waktu, serta mendokumentasinya secara rapih


Biotechnology and Recombinant DNA


p.331 3/17/2013 9 Fatchiyah

Because of biomedical research both humansand animals now have: Life-saving surgical procedures;

Cancer therapies;

Organ transplantation;

Vaccines;

Safe consumer products; and

Treatments and cures for countless other medical

disorders and diseases.


"Virtually every major medical advance for both

humans and animals has been achieved through

biomedical research using animal models to study

and find a cure for a disease and through animal

testing to prove the safety and efficacy of a new

treatment.”

C. Everett Koop, M.D

Former U.S. Surgeon General


Why are animals used in research? organs and body systems similar to humans and other

animals;

susceptible to the same diseases that affect humans;

short life span allows animals to be studied throughout their entire life;

environment easily controllable to keep experimental variables to a minimum;


Di tingkat nasional

Undang-undang no. 23/1992 tentang Kesehatan

Undang-undang no. 36/2009 tentang Kesehatan

Pasal 44 ayat 4: Penelitian terhadap hewan harus dijamin kelestariannya dan mencegah dampak buruk yang tidak langsung terhadap manusia

Peraturan Pemerintah no 39 tahun 1995 tentang Penelitian dan Pengembangan Kesehatan

Buku Pedoman Nasional Etik Penelitian Kesehatan (PNEPK), Depkes RI, 2007 sesuai dengan SK Menkes 1031/2005 tentang PNEPK, dan 6 Buku Suplemennya

Cara Uji Klinik yang Baik (CUKB), BPOM 2006

SK Menkes no 1333/2002 tentang Persetujuan Penelitian Kesehatan Terhadap Manusia


yang dimaksud dengan penelitian kesehatan adalah sama dengan

biomedical research menurut WHO yang meliputi penelitian tentang

farmasetik, peralatan kesehatan, radiasi medik dan imaging, prosedur

bedah, cataatan medik, sampel biologik, penelitian epidemiologi, ilmu

sosial dan psikologi

pedoman nasional etik penelitian kesehatan 2005

- deklarasi helsinki

- suplemen i: etik pemanfaatan bahan biologi tersimpan ( bbt)

- suplemen ii: etik penggunaan hewan coba

- suplemen (dl persiapan) : tentang penelitian genetik DNA. RNA,

bbt germ cell


15

Di tingkat internasional

1. Nuremberg Code 1947: the Doctor’s Trial

2. Universal Declaration of Human Rights, UN 1948

3. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, WMA General Assembly (1964 – 2008)

4. Operational Guidelines for Ethics Committees That Review Biomedical Research, WHO 2000

5. ICH Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, WHO 1995

6. International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS 2002

7. International Ethical Guidelines for Epidemiological Studies, CIOMS 2008

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.

Pertentangan pendapat dan pandangan

tentang percobaan hewan

Percobaan pada hewan sebelum ke

manusia masih diperlukan (whole living

system)

Deklarasi helsinki para 11 - 12

(kesejahteraan hewan)

Konsep 3R:

Reduction, Refinement, Replacement


Staining method only limited in fixed sample, died specimen……

? Live specimen

Confocal Imaging

Transformed Cells

Transmitted Light

Fluorescent Light 3/17/2013 17 Fatchiyah

Pen.Kes. Dengan hewan percobaan perlu

persetujuan ilmiah dan etik

Wajib menggunakan konsep 3R

Keseimbangan manfaat dan risiko

(kosmetika)

Pilih nonsentient material dan hewan yang

paling rendah di skala evolusi

Peneliti harus memiliki kemampuan

penanganan dan pemeliharaan hewan (diklat)


Reduction: mengurangi pemanfaatan jumlah hewan sesedikit mungkin, serta tdk mengulangi penelitian hewan coba bila tidak perlu

Refinement: mengurangi rasa nyeri, ketidaknyamanan dan kesusahan hewan coba sebelum, selama, dan setelah penelitian. Dan Cara pembunuhan yang manusiawi dan cara pemusnaan bangkai

Replacement: Rep relatif, memanfaatkan sebagai donor organ, jaringan atau sel. Rep absolut, memanfaatkannya sebagai galur/cell line



One oocyte At pronuclear stage

Cloned Gene

Cloned-gene microinjection

Pseudo pregnant

Ovaductal implantation

Holding pipette

Injection pipette

Identified transgenic mice Generated transgenic mice

Production & generation for Transgenic Mice

Mendelian Inheritance

Penggunakan hewan sehat atau sakit harus

memenuhi asasasas etik penelitian yg berlaku

Principles of veracity / asas kejujuran

Principles of non Maleficence / asas tidak

merugikan

Principles of Beneficence / asas kemanfaatan

Respect of enviroment / asas respek terhadap

lingkungan


Penelitian kesehatan dengan hewan coba

secara ethis dapat dipertanggungjawabkan,

jika

1. Tujuan penelitian dinilai bermanfaat

2. Desain penelitian dapat menjamin bahwa

penelitian dapat mencapai tujuannya

3. Tujuan penelitian tidak dapat dicapai dengan

menggunakan subyek atau prosedur alternatif

4. Manfaat yang diperoleh jauh lebih berarti

dibandingkan dengan penderitaan yang

dialami hewan percobaan



Injection ES Cells into Blastocyst

Targeted-ES Cells

Disrupted-gene microinjection

Pure population of targeted-ES Cell

Embryo-derived Stem Cell Screening and/or

enrichment for

targeted-ES Cell

Implantation into foster mother

Chimeric Mouse

ES Cell

Breed with normal mouse

Germ line transmission of ES cell genome containing targeted

modification

Research should be

undertaken with a clear

scientific purpose.

There should be a

reasonable explanation

that the research will:

Increase knowledge of the

processes being studied

Provide results that benefit

the health and welfare of

humans and other animals


The scientific purpose of the research should be of sufficient potential significance to justify the use of animals.

The species chosen for study should be best suited to answer the question(s) posed.

Research on animals may not be conducted until the protocol has been reviewed by an appropriate animal care committee, to ensure that the procedures are appropriate and humane.


Animal use procedures must conform with federal regulations regarding personnel, supervision, record keeping, and veterinary care.

Ensure that all individuals who use animals under their supervision receive instruction in experimental methods and in the care, maintenance, and handling of the species being studied.


Animals are to be provided with humane care and healthful conditions during their stay in the facility.

Researchers are encouraged to consider enriching the environments of their laboratory animals and should keep current with literature on well-being and enrichment for the species with which they work.


Animals not bred in the research facility are to be acquired lawfully.

Researchers should make every effort to ensure that those responsible for transporting the animals to the facility provide adequate food, water, ventilation, space, and impose no unnecessary stress on the animals.

Endangered species should be used only with full attention to required permits and ethical concerns.



Genetically modified organism

Everything that can be invented has been invented

Fluoresescenced transgenic mice

Lect 2 Laik Ethik riset dengan Hewan Coba FAT

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