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Surachai Chantip, DVM. Research and Academic Support Office of Academic Service National Laboratory Animal Center, Mahidol University The ethics for animal research

The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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Page 1: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Surachai Chantip, DVM. Research and Academic Support

Office of Academic Service National Laboratory Animal Center,

Mahidol University

The ethics for animal research

Page 2: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 3: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 4: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 5: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 7: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 8: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

What are the alternatives?

The 3 Rs

Reduction - fewer animals

Refinement - less painful procedures

Replacement - alternative techniques

Page 9: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 10: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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 (?)

Page 11: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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).

Page 12: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 13: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 14: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 15: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 16: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 17: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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)

Page 18: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Refinement alternatives

Minimized potential pain or distress

Enhanced animal well-being

Improved housing conditions and experimental

techniques

Page 19: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

19

Refinement alternative

Minimized potential pain or

distress

Enhanced animal well-being

Improved

Procedures

Routine care

Housing environment

Page 20: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

20

Habituation to handling

Page 21: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.”

Page 22: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Ethical Principles and Guidelines for

the Use of Animals

An animal

“A vertebrate being, i.e., a laboratory animal or a

wildlife.”

Page 23: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.”

Page 24: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Ethical Principles and Guidelines for

the Use of Animals

Wild animals

“Every kind of animals that are born in their natural

habitats.”

Page 25: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.”

Page 26: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Ethical Principles and Guidelines for

the Use of Animals

Institute

“Educational institutions of all levels, state enterprises,

governmental and private sector.”

Page 27: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.”

Page 29: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 30: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 31: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 32: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 33: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 34: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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.

Page 35: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Ethical Principles and Guidelines for the Use of Animals

Page 36: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Animal welfare

Definition Mental and physical health status

So, animal welfare include; 1. Physical health 2. Mental health 3. Well being

Page 37: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 38: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 39: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 40: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Environmental control in animal

rooms

Page 41: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 42: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 43: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 44: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Preventive

measurement

Page 45: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 46: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard
Page 47: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Daily observation ;

feeding /watering /behavior

Page 48: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Daily observation ;

feeding /watering /behavior

Page 49: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Animal welfare

Page 50: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Laboratory animal; rodent

Page 51: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Laboratory animal; primate, dog, cat

Page 52: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Laboratory animal; livestock animals

Page 53: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

Animal research protocol

1. NLAC-IACUC committee

2. NLAC Protocol

Animal toxicity in NLAC-MU

Page 54: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

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

Page 55: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee

Animal toxicity in NLAC-MU

Page 56: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee; Responsibility

Animal toxicity in NLAC-MU

Page 57: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee; Responsibility

Animal toxicity in NLAC-MU

Page 58: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee; Responsibility

Animal toxicity in NLAC-MU

Page 59: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee; Responsibility

Animal toxicity in NLAC-MU

Page 60: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee; Responsibility

Animal toxicity in NLAC-MU

Page 61: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC-IACUC committee; Responsibility

Animal toxicity in NLAC-MU

Page 62: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC Protocol

Animal toxicity in NLAC-MU

Page 63: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

NLAC Protocol

Animal toxicity in NLAC-MU

Page 64: The ethics for animal research - Faculty of Medicine Siriraj … · 2015-07-14 · on ethics, virtue, humanity, and appropriate academic principles, as well as the universal standard

“ขอตกลงในหมประชาชนและประเทศตางๆเปนทยอมรบวา สตวเปนสงมชวตทมความรสก และสามารถรบรถงความทกขทรมาน โดยทเราในฐานะมนษยทมความเมตตา จ าเปนตองใสใจสวสดภาพสตว และหยดยงการท าทารณกรรมสตวตลอดไป”