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• 1 ???????????????????????????????????????????????
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3
Law concerning the Protection and Control
ofAnimals
(Revised June 22,2007)

• Section 41
• Use of experimental animals for scientific
  purposes
• 1. Anyone who uses animals for scientific
  purposes should carry out the experiment under
  following considerations.
• If the reason for the experiment has not been
  detrimental
• use the replacement other than animals. ?
  (Replacement)
• Reduce the numbers of animals used. ? (Reduction)
• 2. Anyone who uses animals for scientific
  purposes must carry out the experiment with a
  method which caused the least possible suffering.
  ? (Refinement) --------gt Existing

New addition
4
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????? ?????????????????
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WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKI(Adopted by1964, amended by 2000)
Ethical Principles for Medical Research Involving
Human Subjects

• B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
• 11. Medical research involving human subjects
  must conform to generally accepted scientific
  principles, be based on a thorough knowledge of
  the scientific literature, other relevant sources
  of information, and on adequate laboratory and,
  where appropriate, animal experimentation.
• 12. Appropriate caution must be exercised in the
  conduct of research which may affect the
  environment, and the welfare of animals used for
  research must be respected.

7
) INTERNATIONAL GUIDING PRINCIPLES FOR
BIOMEDICAL RESEARCH INVOLVING ANIMALS (1985 CIOMS)

• 1. BASIC PRINCIPLES
• V. Investigators and other personnel should never
  fail to treat animals as sentient, and should
  regard their proper care and use and the
  avoidance or minimization of discomfort,
  distress, or pain as ethical imperatives.
• VI. Investigators should assume that procedures
  that would cause pain in human beings cause pain
  in other vertebrate species, although more needs
  to be known about the perception of pain in
  animals.
• VII. Procedures with animals that may cause more
  than momentary or minimal pain or distress should
  be performed with appropriate sedation,
  analgesia, or anesthesia in accordance with
  accepted veterinary practice. Surgical or other
  painful procedures should not be performed on
  unanesthetized animals paralysed by chemical
  agents.

8
EU DirectiveCouncil Directive 86/609/EEC(1986)
Article1. The aim of this Directive is to ensure
that where animals are used for experimental or
other scientific purposes the provisions laid
down by law, regulation or administrative
provisions in the Member States
EU MEMBER STATES 25

1. Austria
2. Belgium
3. Cyprus
4. Czech Republic
5. Denmark
6. Estonia
7. Germany
8. Greece
9. Finland
10. France
11. Hungary
12. Ireland
13. Italy

• Latvia
• Lithuania
• Luxembourg
• Malta
• Poland
• Portugal
• Slovakia
• Slovenia
• Spain
• Sweden
• Netherlands
• United Kingdom
• (2004 new member)

9

• Article 8
• 1. All experiments shall be carried out under
  general or local anaesthesia.
• 2. Paragraph 1 above does not apply when
• (a) anaesthesia is judged to be more traumatic to
  the animal than the experiment itself
• (b) anaesthesia is incompatible with the object
  of the experiment. In such cases appropriate
  legislative and/or administrative measures shall
  be taken to ensure that no such experiment is
  carried out unnecessarily.
• Anaesthesia should be used in the case of serious
  injuries which may cause severe pain.
• 3. If anaesthesia is not possible, analgesics or
  other appropriate methods should be used in order
  to ensure as far as possible that pain,
  suffering, distress or harm are limited and that
  in any event the animal is not subject to severe
  pain, distress or suffering.
• 4. Provided such action is compatible with the
  object of the experiment, an anaesthetized
  animal, which suffers considerable pain once
  anaesthesia has worn off, shall be treated in
  good time with pain-relieving means or, if this
  is not possible, shall be immediately killed by a
  humane method.

10
German Animal Welfare Act
Section V Experiments on Animals

• Only persons with the requisite expertise may
  conduct experiments on animals.
• Animal experiments involving surgical operations
  on vertebrates may be performed only by persons
  who have completed university studies in
• 1) veterinary medicine or medicine or
• 2) biology (specializing in zoology), provided
  these persons are employed at universities or
  other scientific establishments.
• Vertebrates which have not been anaesthetized may
  not be subjected to operations causing serious
  injuries.
• The anaesthetic may be administered only by, or
  under the supervision of, a person meeting the
  conditions2-1), or 2).

11
Animal Welfare Act as Amended (7 USC, 2131-2156)

• Section 13.
• (C) in any practice which could cause pain to
  animals-
• (i) that a doctor of veterinary medicine is
  consulted in the planning of such procedures
• (ii) for the use of tranquilizers, analgesics,
  and anesthetics
• (iii) for presurgical and postsurgical care by
  laboratory workers in accordance with established
  veterinary medical and nursing procedures
• (iv) against the use of paralytics without
  anesthesia and
• (v) that the withholding of tranquilizers,
  anesthesia, analgesia, or euthanasia when
  scientifically necessary shall continue for only
  the necessary period of time

12
U.S. Government Principles for the Utilization
and Care of Vertebrate Animals Used in Testing,
Research, and Training

• I. The transportation, care, and use of animals
  should be in accordance with the Animal Welfare
  Act (7 U.S.C. 2131 et seq.) and other applicable
  Federal laws, guidelines, and policies.1
• IV. Proper use of animals, including the
  avoidance or minimization of discomfort,
  distress, and pain when consistent with sound
  scientific practices, is imperative.
• V. Procedures with animals that may cause more
  than momentary or slight pain or distress should
  be performed with appropriate sedation,
  analgesia, or anesthesia. Surgical or other
  painful procedures should not be performed on
  unanesthetized animals paralyzed by chemical
  agents.
• VI. Animals that would otherwise suffer severe or
  chronic pain or distress that cannot be relieved
  should be painlessly killed at the end of the
  procedure or, if appropriate, during the
  procedure.

13

• ANESTHESIA, PAIN, AND SURGERY
• References
• Animal Pain. Perception and Alleviation. R. L.
  Kitchell. H. H. Erickson. E. Carstens. and L. E.
  Davis. 1983. Bethesda. Md. American
  Physiological Society. 231 pp.
• Categories of Invasiveness in Animal Experiments.
  Canadian Council on Animal Care. 1993. Guide to
  the Care and Use of Experimental Animals. Vol.
  1(2nd ed.). Appendix SV-B, pp.201-202.

• Guidelines on the recognition of pain, distress
  and discomfort in experimental animals and an
  hypothesis for assessment. D. B. Morton and P. H.
  M. Griffiths. 1985. Vet. Rec. 116431-436.
• Laboratory Animal Anesthesia An Introduction for
  Research Workers and Technicians. P. A.
  Flecknell. 1987. San Diego Academic Press. 156
  pp.

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Medical College of GeorgiaOffice of Laboratory
Animal Services

• Management of Pain and Distress
• Pain and distress greater than that induced by
  injections or simple percutaneous blood sampling
  should be relieved by the use of anesthetics
  and/or analgesics. The use of ether is
  prohibited.
• The following charts describe the commonly used
  anesthetics and analgesics at MCG. You must have
  a DEA License to purchase controlled drugs
  (barbiturates, valium, butorphanol,
  buprenorphine, morphine, etc.) Ketamine is a
  Schedule III controlled drug as of August 12,
  1999.  Paralytic agents (pancuronium,
  succinylcholine, etc.) are not analgesics and
  must be used in combination with anesthetics
  during painful procedures.

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Practice of Animal Welfare in Each Country
Country Law enact revise Law enact revise Invest. accredit Protocol approve Institute IACUC Exp. Vet. Institute IACUC Exp. Vet.
UK 1876 1999 Nation Nation Yes No
Germany 1972 1998 State State No No
US 1966 1985 No IACUC Yes Yes
Canada No No No IACUC Yes No
Japan 1973 2005 No IACUC Yes No
21
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22
Claude Bernard (18131878)French Physiologist
Introduction a la medecine experimentale(1865)
There were no anesthetics in his era. He carried
out vivisection of dogs without anesthesia. His
wife and daughter went on anti-vivisection group
after his dead.
Rene Descartes (15961650) French Philosopher
23
Jeremy Bentham (17481832) British Philosopher
Painless Childbirth with Chloroform(1853) Cruelty
to Animal Act (1876)
Utilitarianism Pain is most enemy against ethics