peserta memahami tentang : dengan menggunakan hewan coba · menkes 1031/2005 tentang pnepk, dan 6...
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Wakil Ketua KEP UB
Direktur Lab Biosains UB
Dosen Jur Biologi FMIPA UB
Website: http://fatchiyah.lecture.ub.ac.id
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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
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Figure 20.11
– Retroviruses
– Liposomes
– Direct DNA injection
Layak etikkah
tranfer gen seperti
ini??
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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
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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
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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.
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"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
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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;
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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
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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
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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
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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)
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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
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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
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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
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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
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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.
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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.
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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.
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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.
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Genetically modified organism
Everything that can be invented has been invented
Fluoresescenced transgenic mice
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