Laboratory Animal Center for Biomedical Research


Contents


(in Japanese)

Guidelines for Animal Experimentation, Nagasaki University

Decision of the University, Council December 22, 1989

Animal experiments have made a great contribution to the formation and advance of human culture and will continue to do so in the future. Their contribution to natural science has been especially remarkable. However, animal experiments should be conducted taking into consideration the maintenance of animal welfare from the basic viewpoint that the life of animals should be respected, but, at the same time, fulfilling various experimental requirements so that reproducibility, which forms the basis of objective results and evaluations, can be obtained by conforming to the general principles of scientific research.

 The necessity of thoughtful consideration for animal welfare has been specified in the "Law Concerning the Protection and Control of Animals" (Law No. 105, October 1, 1973) and in "Standards Relating to the Care and Management, etc. of Experimental Animals" (Notification No. 6, 1978 of the Prime Minister's Office), and furthermore this necessity has been stated specifically in connection with animal welfare and animal experimentation in the recommendation entitles "Concerning the Establishment of Guidelines for Animal Experimentation" resolved at the 80th General Assembly of the Science Council of Japan and in the report named "Concerning the Basic Policy of the Performance of Animal Experimentation in Universities, etc.," issued by the Scientific Data Section of the Scientific Information and Data Subcommittee, Science Council.

 Nagasaki University lays down the Guidelines for Animal Experimentation, duly recognizing the fact that the animal experiments performed by researchers of the University should conform to these principles.

1 (Purpose)

 The purpose of the Guidelines is to prescribe matters to be observed at the time of planning and executing animal experiments at Nagasaki University (hereafter called "the University") so that experiments can be conducted properly not only from a scientific viewpoint but also from an ethical one with due consideration for animal welfare.

2 (Range of Application)

 The Guidelines should be applied to all the experiments conducted at the University using mammals and birds. It is to be desired that experiments using animals other than mammals and birds should be conducted in adherence to the spirit of the Guidelines.

3 (Basic Principle)

 Persons who conduct animal experiments (hereafter called "experimenters") should take the responsibility for entire experiments including formulation of experimental plans, execution of experiments and adoption of necessary post-experimental measures, and pay close attention to the maintenance of proper experimental environments.

4 (Consolidation of Facilities, Equipment and Organization Structure)

  1. Sections properly equipped for the right and smooth execution of experimental animal care and animal experimentation (hereafter called "exclusive sections") should be secured.
  2. Appropriate facilities for the care and use of animals in experiments should be established taking into consideration the habits, ecology, etc. of the animals.
  3. The deans, etc. in whose faculties, etc. animal experiments are conducted should endeavor to consolidate experimental facilities, equipment organizational structure necessary for the management and operation of them.

5 (Formulation of Experimental Plans)

  1. Experimenters should refer to literature, etc. when planning animal experiments, and endeavor to refrain from experiments conducted for the mere reconfirmation of established facts.
  2. Experimenters should formulate experimental plans after making a close examination of respective research purpose and taking into careful consideration the presence of any possible alternative to animal experiments
  3. Experimenters, when selecting animals suitable for experimental purposes, should take into account their species, strain, quality, numbers and the conditions of their care and use in experiments, in order to reduce the scope of animal experiments to the minimum necessary for the achievement of research purposes.
  4. Experimenters should also give careful attention to the methods and environment of experiments from an ethical viewpoint, endeavoring, for instance, to alleviate as much as possible the anguish inflicted on animals, throughout experiments.
  5. Experimenters should check experimental plans on each of the items in the annexed list. In addition, experimenters should, in case of nee, seek the advice of experts on laboratory animals or animal experiments (hereafter called "experts") or the judgment of the Animal Care and Use Committee, Nagasaki University, organized according to the provision of paragraph 1, Article 12 (hereafter called "the Committee") as to the conformability of the experimental plans with the Guidelines.
  6. Experimenters should keep written experimental plans in custody and either submit them to the Committee or report the progress of the experiments, etc. to the Committee in compliance with the Committee's request.

6 (Introduction of Experimental Animals into Facilities)

  1. Experimenters should not only confirm the condition of order given for animals and the presence of abnormalities of deaths, but also record the sate of animals and the means and time of transportation, etc. when the animals state introduced into the facilities.
  2. Experimenters should quarantine experimental animals when they are brought in. In case of abnormalities are found in some animals, experimenters should take proper measures and avoid using the abnormal animals until the abnormalities have become extinct.
  3. Experimenters should endeavor to acclimatize to new environments, as occasion arise.
  4. Experimenters may substitute certificates of general and microbiological quality issued by animal breeders for part of quarantine work, in case of breeder are highly reliable.
  5. Experimenters may seek the advice or cooperation of experts regarding the confirmations and records provided for in paragraph 1 and the quarantine work prescribed in paragraph 2.

7 (Care and Rearing of Experimental Animals)

  1. Experimenters should make a close observation of the state of animals all the time from the time of their introduction until the completion of experimenters and take proper measures according to the needs of the case.
  2. Experimenters should endeavor to maintenance and manage exclusive sections and facilities for animal rearing and experimentation. To secure this end, experimenters should pay attention to physico-environmental factors---atmospheric conditions (temperature, humidity, air-flow, wind velocity, ventilation, light, smell, dust, etc.) of animal rooms and laboratories; living conditions (species, strains, sex, age, number, density of animal population, etc.); microbiological contamination; unnecessary addition of stress; etc.
  3. Experimenters should endeavor to attend to the care and rearing of experimental animals, supplying food water, etc. in an appropriate manner.
  4. Experimenters may seek the advice or cooperation of experts regarding the care and rearing stipulated in the three preceding paragraphs.

8 (Access to Exclusive Section)

 Persons other than experimenters, experts and others related to experiments should, as a role, be prohibited from entering exclusive sections.

9 (Experimental Procedures)

 Experimenters should take care not to inflict unnecessary anguish on animals by using proper restrains and anesthetics. To ensure this end, experimenters should seek the advice of experts or the judgment of the Committee, as occasion requires.

10 (Measures to Be Taken after Experiments, etc.)

  1. When disposing of experimental animals on which experiments have been concluded or discontinued, experimenters should endeavor to release the animals from anguish immediately by administration of a lethal dose of an anesthetic, cervical dislocation, inhalation of carbon dioxide, or other proper means of euthanasia.
  2. Experimenters should endeavor to prevent environmental pollution by the carcasses, etc., of experimental animals.
  3. Experimenters may seek advice or cooperation from experts regarding the measures provided for in the two preceding paragraphs.

11 (Experiments using Hazardous Substances, etc.)

  1. Experimenters using pathogens or recombinant DNA should be under the application of "Regulations Concerning the Prevention of Biohazards, Nagasaki University" (Regulation No. 14, September 16, 1983) or "Regulations Concerning the Safety Control of Recombinant DNA Experimentation, Nagasaki University" (Regulation No. 15, September 16, 1983) respectively.
  2. Experimenters using radioactive substances and radiation should be under the application of "Radiation Injury by X-ray Units for Educational and Research Purposes, Nagasaki University" (Regulation No. 16, October 25, 1983).
  3. When conducting animals experiments using hazardous substances for carcinogenecity or mutagenecity tests, etc., or substances whose safety is not yet confirmed, or other hazardous substances, experimenters should take appropriate measures to prevent the contamination of the environments using hazardous substances, experimenters should seek advice from experts, or submit plans to the Committee for deliberation.

12 (Animal Care and Use Committee)

  1. The Committee shall be organized in the University in order to enforce the Guidelines in an appropriate manner.
  2. The items necessary for the operation of the Committee shall be prescribed elsewhere.
  3. Supplementary Provision

    The Guidelines shall come into forces from December 22, 1989.

Annex List

  1. Environmental conditions of exclusive sections
  2. Duration of animal experiments
  3. Conditions for the introduction of animals into facilities
  4. Experimental animals used; species; strain; general and microbiological quality; sex; age; number; etc.
  5. Methods of experiments: administrational; sampling; observational; surgical; etc.
  6. Methods used for the alleviation and elimination of animal's anguish: kinds and doses of anesthetics/analgesics, etc.; methods of administration; restraints; etc.
  7. Methods of animal disposal after experiments: euthanasia; etc.
  8. Preventive procedures against any possible interanimal and environmental contamination by physically, chemically, and biologically hazardous substances used for animal experiments
  9. Reasons for the necessity of animal experiments (Reasons for not using alternatives to animal experiments)


(in Japanese)

Regulations of the Animal Care and Use Committee

Regulation No. 41 December 22, 1989

Article 1 (Purpose)

 The regulation shall stipulate the item necessary for the organization and man agent of the Animal Care and Use Committee, Nagasaki University (hereafter called "the Committee") according to the provision of Paragraph 2, Article 12, of the Guidelines for Animal Experimentation, Nagasaki University (hereafter called "the Guidelines") (Decision of the University Council, December 22, 1989).

Article 2 (Office)

 The Committee shall take charge of matters relating to the Guidelines.

Article 3

 The Committee shall deliberate on the conformity to the Guidelines of experimental plans submitted for approval to the Committee by persons who conduct animal experiments (hereafter called "experimenters"), and may request them to present reports on the progress of the experiments as occasion demands.

 2. In the case the Committee deems it necessary after following the procedure stipulated in the preceding paragraph, it may give experimenters advice, request them to make some change in the plan, urge them to suspend the experiments, or order a complete ban on them.

 3. As for animal experiments whose plans have not been submitted for approval, in case the Committee deems it necessary, it may request experimenters to present experimental plans or report on experimental progress, and may take the measures stipulated in the preceding paragraph.

Article 4 (Organization)

 The Committee shall consist of persons stipulated in the following items.

  1) One person each who is elected from among the professors, associate professors and full-time lectures of each Faculty (Faculty of Economic excepted), Faculty of Liberal Art, Institute of Tropical Medicine, Hospital attached to School of Medicine, Hospital attached to School of Dentistry, and School of Allied Medical Sciences.

  2) A certain number of persons who are elected from among the experts on laboratory animals or animal experiments stipulated in paragraph 5, Article 5, of the Guidelines.

  3) Some others whom the President of Nagasaki University deems it necessary to appoint.

 2. The Committee members shall be appointed by the President.

Article 5 (Term of Office)

 The term of office shall be two years. However, reappointment may be made.

 2. In case a vacancy occurs in the members provided for in paragraph 1 of the preceding Article, the term of office for the substitute member shall be the remainder of the predecessor's term.

Article 6 (Chairperson)

 A chairperson shall be appointed to the Committee through the mutual election of the members.

 2. The chairperson shall call a Committee meeting and preside over the meeting.

 3. In case the chairperson is unable to attend a Committee meeting, the member appointed in advance by the chairperson shall act in his/her place.

Article 7 (Preceding)

 A Committee meeting may not be held without the attendance of simple majority.

 2. The decision of matters shall be made with the consent of two-thirds or more of the members present.

Article 8 (Hearing)

 In case the Committee deems it necessary, it may request the attendance of persons other than the members in order to listen to their explanation or options.

Article 9 (General Affairs)

 The general affairs of the Committee shall be transacted at the General Affairs Department, Nagasaki University.

Article 10 (Addition)

 The items necessary for the Committee but not yet stipulated here shall be prescribed elsewhere.

  1. The Regulations shall become effective from December 22, 1989.
  2. The term of office for the first Committee members to be appointed after the establishment of the Regulation shall be until March 31, 1991, notwithstanding the provision of paragraph 1, Article 5.