the ethics for animal research - faculty of medicine siriraj … · 2015-07-14 · on ethics,...
TRANSCRIPT
Surachai Chantip, DVM. Research and Academic Support
Office of Academic Service National Laboratory Animal Center,
Mahidol University
The ethics for animal research
Topic of the presentation Ethical for the use of animal
- 3’R
- Definition
- Ethical Principles and Guidelines for the Use of Animals in
THAILAND
- Animal welfare
Animals toxicology in NLAC
- IACUC
- NLAC Protocol
Introduction
For the improvement of the quality of life of man and animals.
In research, drug testing, biological product and education in the field of medical science, have been used
- Numerous species of animals
- millions in numbers
Introduction
For instance, in 1876 (B.E.2419) the United Kingdom was
the first country which outlawed any form of animal
torturing.
In 1986 the law has been amended and it is now known
that the UK has a very stringent law for the use of
animals for scientific purposes.
Introduction
The three year period (1982-1984);
- The international biomedical community including
experts of the WHO and animal welfare groups.
- The Council for International Organizations of
Medical Science or CIOMS has distributed a publication.
- in 1985, The International Guiding Principles
for Biomedical Research Involving Animals.
The 3 Rs
William M.S. Russell & Rex Burch:
The Principles of Humane
Experimental Technique
1959
http://altweb.jhsph.edu/publications/humane_exp/het-
toc.htm
Reduction
Refinement
Replacement
What are the alternatives?
The 3 Rs
Reduction - fewer animals
Refinement - less painful procedures
Replacement - alternative techniques
3’s R
Replacement
the substitution of conscious living vertebrates by non-
sentient material.
Reduction
any decrease in the numbers of animals used to obtain
information of a given amount and precision.
Refinement
any decrease in the incidence or severity of procedures
applied to animals necessarily used.
Replacement alternatives (1) What are replacement alternatives?
Efficient use of existing information
Structure-activity relationships, mathematical models, computer simulations
In vitro methods: isolated organs
tissue slices
tissue cultures
cell cultures
subcellular fractions
Lower organisms
Early stages of development (?)
Replacement alternatives (2)
In vitro methods are not primarily “replacements” of in
vivo methods. Typically these methods have different
roles in research, and they are complementary for each
others. Depending on the objective of the study in vitro
methods may be the most appropriate methods for
certain areas of interest, because they can more
accurately provide the information required (e.g. cellular
and molecular events).
Replacement alternatives (3)
Absolute replacement: no need to use animals (cell lines, human or invertebrate cells and tissues)
• no need to test for skin irritation if pH <2.0 or >11.5
• no need to test for eye irritation if the chemical is a skin irritant
Relative replacement: humane killing of animals to provide cells or tissues for in vitro studies
Replacement alternatives (4)
Direct replacement: e.g. human or guinea pig skin is
used in vitro to replace guinea pig tests in vivo
Indirect replacement: e.g. Limulus amoebocyte lysate
(LAL) test or a test based on whole human blood is used
to replace rabbit pyrogen tests
Replacement alternatives (5)
Total replacement: also a decision not to conduct an
animal experiment because of lack of justification or
reliability of the method
Partial replacement: e.g. use of non-animal methods as
prescreens in toxicity testing
Replacement alternatives have been
successfully used for:
Safety testing of chemicals:
• Local toxicity
• Genotoxicity
Quality control and potency testing of vaccines
Production of monoclonal antibodies
No relevant replacement alternatives for:
Pharmacokinetics / toxicokinetics
Systemic toxicity
Organ systems toxicity (CNS, respiratory,
cardiovascular, gastrointestinal etc.)
Immuno-toxicity
Male and female reproduction toxicity (fertility tests,
developmental toxicity tests, peri- and postnatal
toxicity tests)
Sub chronic and chronic toxicity
Carcinogenicity tests
Reduction alternatives
Good planning of experiments
Rational and efficient use of animals
no wasting
screening tests
pilot studies
Proper statistical design
Use of inbred strains (some study types)
Refinement alternatives
Minimized potential pain or distress
Enhanced animal well-being
Improved housing conditions and experimental
techniques
19
Refinement alternative
Minimized potential pain or
distress
Enhanced animal well-being
Improved
Procedures
Routine care
Housing environment
20
Habituation to handling
Ethical Principles and Guidelines for
the Use of Animals
Ethics
“ the principles of the right conducts with express the virtue
and morality of professional practices of which the
groups of various professions have agreed upon as their
standard ways of professional practices, which enhance
their goodwill and credit of their professions.”
Ethical Principles and Guidelines for
the Use of Animals
An animal
“A vertebrate being, i.e., a laboratory animal or a
wildlife.”
Ethical Principles and Guidelines for
the Use of Animals
Laboratory animals
“The animals that are procreated and nurtured in
confinement, and are used by humans for the benefit of
any branch of science and technology.”
Ethical Principles and Guidelines for
the Use of Animals
Wild animals
“Every kind of animals that are born in their natural
habitats.”
Ethical Principles and Guidelines for
the Use of Animals
Animal users
“Individuals in any branches of science and technology
who use animals in researches, testing, teaching and in
producing biological products.”
Ethical Principles and Guidelines for
the Use of Animals
Institute
“Educational institutions of all levels, state enterprises,
governmental and private sector.”
Ethical Principles and Guidelines for
the Use of Animals
Ethical Guidelines for the Use of Animals
“The protocols by which animal users and animal
breeders are to abide, so that the processes are based
on ethics, virtue, humanity, and appropriate academic
principles, as well as the universal standard of
methodology.”
Ethical Guidelines for the Use of Animals
Ethical Principles and Guidelines for the Use of Animals
1. Animal users are to be aware of the value of life of
animals.
Animals are to be used only for specific purposes,
which have been carefully considered as beneficial and
most necessary for the development of the quality of life
of both humans and animals and/or the progress of
science, which is well considered that there is no other
available equivalent or option.
Ethical Principles and Guidelines for the Use of Animals
2. Animal users are to be aware of the accuracy of the
research outcome using the minimal number of animals
Animal users are to be aware that the objective and
goal of the project can be achieved accurately with the
least number of animals depending on the genetics and
health quality of the animals and the appropriate
planning and techniques used in the experimental
design.
Ethical Principles and Guidelines for the Use of Animals
3. The Use of wild animals must not violate laws or
policies for wildlife conservation The use of wildlife is to
be restricted to scientific research that cannot be
replaced by any other kind of animals, and it is to abide
by the laws and policies for wildlife conservation.
Ethical Principles and Guidelines for the Use of Animals
4. Animal users need to be aware that animals are living
beings just as humans are living beings
Animal users have to be aware that animals
experience a sense of pain and respond to their
surroundings in the same way that humans do. Animals
are to be treated with caution to avoid stress, pain and
suffering by providing optimum conditions for
transportation, animal husbandry, environmental
enrichment, prevention of diseases and appropriate
experimental techniques.
Ethical Principles and Guidelines for the Use of Animals
Animal users should acquire the following basic skills
regarding the animals before performing experiments:
1) Handling and restraining
2) Identification
3) Sexing
4) Drug and substance administration
5) Samplings of blood, stool, urine and tissues from living animals
6) Anesthesia and Anesthetizing Procedures
7) Euthanasia
8) Autopsy
Ethical Principles and Guidelines for the Use of Animals
5. Animal users must keep detailed data and records of
animal experiments.
Animal users must strictly follow the protocol
described in their proposal, and all the details of the
experiments are to be recorded in full and made
available for public release or investigation at all times.
Ethical Principles and Guidelines for the Use of Animals
Animal welfare
Definition Mental and physical health status
So, animal welfare include; 1. Physical health 2. Mental health 3. Well being
Five freedoms
1. freedom from hunger and thirst 2. freedom from discomfort 3. freedom from pain, injury, and disease 4. freedom from fear and distress 5. freedom to express normal behavior
Animal welfare
Environmental control in animal
rooms
Preventive
measurement
Daily observation ;
feeding /watering /behavior
Daily observation ;
feeding /watering /behavior
Animal welfare
Laboratory animal; rodent
Laboratory animal; primate, dog, cat
Laboratory animal; livestock animals
Animal research protocol
1. NLAC-IACUC committee
2. NLAC Protocol
Animal toxicity in NLAC-MU
NLAC-IACUC committee compose of
1. Chairman
2. Attending veterinarian
3. Scientist
4. Non affiliate scientist
5. Non affiliate non scientist
6. Secretary
Animal toxicity in NLAC-MU
NLAC-IACUC committee
Animal toxicity in NLAC-MU
NLAC-IACUC committee; Responsibility
Animal toxicity in NLAC-MU
NLAC-IACUC committee; Responsibility
Animal toxicity in NLAC-MU
NLAC-IACUC committee; Responsibility
Animal toxicity in NLAC-MU
NLAC-IACUC committee; Responsibility
Animal toxicity in NLAC-MU
NLAC-IACUC committee; Responsibility
Animal toxicity in NLAC-MU
NLAC-IACUC committee; Responsibility
Animal toxicity in NLAC-MU
NLAC Protocol
Animal toxicity in NLAC-MU
NLAC Protocol
Animal toxicity in NLAC-MU
“ขอตกลงในหมประชาชนและประเทศตางๆเปนทยอมรบวา สตวเปนสงมชวตทมความรสก และสามารถรบรถงความทกขทรมาน โดยทเราในฐานะมนษยทมความเมตตา จ าเปนตองใสใจสวสดภาพสตว และหยดยงการท าทารณกรรมสตวตลอดไป”