Evy Suryani Arodes, S.Pd, M.

Biomed
Dept. Microbiology, Faculty of Medicine, UKI
• Feasible
• Interesting
• Novel
• Etichal
• Relevant
Rancangan Penelitian Jenis Contoh

Observasional (non- Deskriptif Lap kasus

eksperimen) Studi kasus
Survei
Analitik Cross sectional
Kasus kontrol
Kohort
Eksperimen Laboratorium Biomedik
Klinik Trial klinik
Epidemiologi Intervensi komunitas
 Biomedical Research

• Biomedical research is the broad area of science that

involves the investigation of the biological process and
the causes of disease through careful experimentation,
observation, laboratory work, analysis, and testing.
• Scientists expand this knowledge base to discover ways
to prevent ill-health, and to develop beneficial products,
medications, and procedures to treat and cure diseases
• Biomedical research requires the input and
participation of many individuals from both the
life and physical sciences, with many different
backgrounds and skills.
• Such a research team might include medical
doctors, veterinarians, computer scientists,
engineers, technicians, researchers, and a
variety of scientists from the different fields of
the life sciences.
Study of the processes of life; the prevention
and treatment of disease; and the genetic
lifestyle and environmentmental factors
related to disease and health
• In vitro
• In vivo
• Latin for within the glass
• the technique of performing a given procedure in a
controlled environment outside of a living organism,
inside glass (test tubes or Petri dishes)
• In in vitro experiments, researchers optimise
the conditions very similar to cellular
conditions to study the actual activities.
• However, in vitro experiments have less
success due to the inability to provide the
precise cellular conditions of the cells or the
organisms under laboratory conditions.
• Artificial conditions are formed by mixing the
necessary components and reagents under controlled
conditions inside a glassware in the laboratory.
• Compared to in vivo experiments, it is less expensive
and provides quicker results.
• In vitro methods are widely used in pharmaceutical
industry to produce large scale pharmaceuticals using
microorganisms due to its ease of production and
economic benefits.
• Allow scientists to study a single effect in isolation
• Less expensive, less time, more accurate, and easier to
control than in vivo (whole animal) systems
• More precise results as a result of ability to control
temperature, acidity, oxygen levels and environmental
conditions
• Critical to the study of viruses which grow only in
living cells
Cell Culture
Pluripotent Immortal
• Latin for “within the living”
• experimentation using a whole, living organism →
animal model.
• Animal studies and clinical trials are two forms of in
vivo research.
• Animals provide the best known surrogate for
humans in the lab
• Similarities between animals and humans outweigh
differences
• It is the experiment or observations done on the
living tissue of the whole living organism in a
controlled environment.
• Another is animal testing which is an experiment
which is done on animals usually rats, mice, rabbit,
etc. where the drugs are directly injected into
body(drug testing).
• So in in vivo experiments, conditions are not
manipulated or controlled.
• In vivo testing is often employed over in
vitro because it is better suited for observing the
overall effects of an experiment on a living subject.
• In vivo studies are crucial for the development of
medical devices, surgical instruments, procedures
and novel therapeutics.
• Tahapan percobaan yang dilakukan terhadap
binatang sebelum obat dicobakan kepada
manusia → untuk mendapatkan data
farmakodinamik, farmakokinetik dan
toksikologik.
• Tujuan : mengetahui pengaruh obat, batas
keamanan obat, dosis obat dll → sebagai dasar
percobaan selanjutnya pada manusia.
❑Pemilihan hewan percobaan
❑Jumlah hewan percobaan
❑Kesehatan hewan percobaan
❑Dosis dan cara pemberian perlakuan
❑Pemilihan model rancangan penelitian
❑Analisis hasil
 Prinsip Dasar Etik Pelaksanaan Penelitian
Biomedis menggunakan Hewan Coba

• Memperlakukan hewan coba secara humane

• Prinsip, kriteria dan prosedur pemantauan bertujuan utk
1. Menghindarkan penggunaan hewan coba secara
tidak pantas atau berlebihan
2. Mencegah perlakuan yang kejam, sebelum, selama
dan sesudah percobaan
 3 Prinsip Dasar Etik Penelitian

• Respect : Menghormati hewan coba sbg makhluk

hidup/bernyawa → bukan sebagai benda mati!!
• Benefeciary : Bermanfaat bagi manusia & makhluk lain
• Justice : Bersikap adil dalam memanfaatkan hewan coba
→Setiap subyek mempunyai kesempatan yang sama
untuk mendapat perlakuan atau tidak → dipilih secara
acak
 3R
• Reduction :
- Memanfaatkan hewan dalam jumlah sekecil
mungkin yang dapat memberikan hasil penelitian
yang sahih.
- Tidak menggunakan hewan lebih dari jumlah
minimal
- Menambah jumlah harus dengan alasan yang
dapat dibenarkan
- Menggunakan hewan seefisien & seefektif
mungkin
• Replacement
- Relatif, yaitu menggunakan sel, jaringan
atau organ dari hewan vertebrata yang
dimatikan secara manusiawi, (isolated
organ)
- Absolut, yaitu sama sekali tidak
menggunakan hewan
• Refinement
- Mengurangi atau menghilangkan rasa
nyeri dan penderitaan sehingga
menjamin kesejahteraan hewan coba.
 5 F (Freedoms)
• Freedom from Hunger and thirst
- Memberikan akses makanan & air minum yang sesuai &
memadai untuk kesehatannya (jumlah dan komposisi
nutrisi).
• Freedoms from Discomfort
- Menyediakan lingkungan yang bersih dan paling sesuai
dengan biologi spesies (siklus cahaya, suhu & kelembaban
lingkungan; fasilitas fisik)
- Ukuran kandang (Guide for the Care and Use of Laboratory
Animals) dan komposisi kelompok (social vs solitaire;
hierarchy)
• Freedoms from Pain, injury, & disease
- Program kesehatan, pencegahan penyakit,
pengobatan, dan meminimalkan/ meniadakan
rasa sakit.
- Pemilihan prosedur dengan pertimbangan
meminimalkan rasa sakit (non-invasive).
- Penggunaan anesthesia dan analgesia apabila
diperlukan
- Euthanasia dengan metoda yang “humane”
untuk meminimalkan/ meniadakan
penderitaan hewan
• Freedoms from Fear and distress
- Memberi kondisi (lingkungan, perlakuan) yang
mencegah/ meminimalkan stress (aspek husbandry,
care, penelitian)
- Memberikan masa adaptasi dan pengkondisian
(misalnya training) bagi hewan terhadap prosedur
penelitian, lingkungan baru, dan personnel
- Semua prosedur pada hewan dilakukan oleh
personnel yang qualified, dan terlatih
• Ethical alternative to using humans
• Animals provide a whole, integrated complex biological
system
• Animals share the same structures (cells, tissues, organs,
and systems) as humans and function in much the same
way.
• Scientists can design experiments where they can
control for more variables than with humans
• Animals are NOT humans so results must be
extrapolated
• Research animals are expensive to purchase, house,
feed and provide with veterinary care
• Use of animals are governed by federal regulations
Monoclonal Ab
Thank you
 References
• European Convention for the Protection of Vertebrate Animals used for
Experimental and other Scientific Purposes, ETS 123 Appendix A.
• Public Health Service Policy on Humane Care and Use of Laboratory
Animals. National Institutes of Health. Revised 2002.
• Pedoman Nasional Etik Penelitian Kesehatan. Suplemen II Etik
Penggunaan Hewan Percobaan. Komisi Nasional Etik Penelitian
Kesehatan, Departemen Kesehatan RI. Jakarta. 2011.
• International Guiding Principles for Biomedical Research Involving
Animals, Council for International Organizations of Medical Sciences
(CIOMS), WHO, 1985.
• The Guide for the Care and Use of Laboratory Animals (National
Research Council, National Academy of Sciences, 2010).
• Euroguide on the accommodation and care of animals used for
experimental and other scientific purpopaoses (based on the Revised
Appendix A of The European Convention ETS 123)