Ministry of Education, Culture, Sports, Science and Technology, Notice No. 71
Fundamental Guidelines for Proper Conduct of Animal Experiment and Related
Activities in Academic Research Institutions under the jurisdiction of the Ministry ofEducation, Culture, Sports, Science and Technology are provided as follows.
June 1, 2006
Kenji Kosaka
Minister of Education, Culture, Sports, Science and Technology
Fundamental Guidelines for Proper Conduct of Animal Experiment and Related
Activities in Academic Research Institutions under the jurisdiction of the Ministry ofEducation, Culture, Sports, Science and Technology
Preamble
A scientific understanding of the biological activities of living organisms on theplanet is essential for the solution of many issues, including human welfare, andconservation and restoration of the environment. Animal experiments and related
activities are necessary and unavoidable for gaining scientific insights into the
biological activities of living organisms, but they must be performed properly taking
into consideration the welfare of the animals.
To ensure the appropriateness of animal experiments, efforts have been made inacademic research institutions to establish and implement institutional guidelines on
animal experimentation, through establishment of institutional animal experimentcommittees which conform to the Notice of “Animal Experimentation in Universities
and Similar Institutions.” (Director General, Science and International Affairs
Bureau, Ministry of Education, May 25, 1987). In the future, animal experiments andrelated activities are expected to continue, in order to facilitate advancement of thelife sciences and the development of medical treatments and other technologies.
Since then, the Law for Partial Amendment of the Law for the Humane Treatment
and Management of Animals (Law No. 68, 2005) was promulgated in June 2005. In
this Law, in addition to the provision of Refinement (i.e., techniques to reduce painand distress to animals used, while still allowing attainment of the scientificobjective) of the so-called 3R principles of animal experiment and related activities,
the provisions of Replacement (i.e., substituting animals with non-animal researchmethods, while still allowing attainment of the scientific objective) and Reduction(i.e., minimizing the number of animals used, while still allowing attainment of thescientific objective) were included.

-1-

With these changes in the circumstances surrounding animal experiment andrelated activities, it is important for Academic Research Institutions to perform
properly animal experiment and related activities not just out of scientific necessity,
but also with consideration of both the scientific rationale and the welfare of theanimal, pursuant to the provisions of the Law for the Humane Treatment andManagement of Animals (Law No. 105, 1973; “the Law” hereinafter), as well asStandards Relating to the Care and Management of Laboratory Animals and Reliefof Pain (Notice No.88 of the Ministry of the Environment dated April 28, 2006;“Care and Management Standards” hereinafter).
On the basis of the current state of affairs, these Fundamental Guidelines for Proper
Conduct of Animal Experiment and Related Activities in Academic ResearchInstitutions (“the Fundamental Guidelines” hereinafter) are provided to ensure
proper conduct of animal experiments and related activities.
Article 1 Definitions
The following terms used in the Fundamental Guidelines are defined below:(1)Animal experiments and related activities
Utilizationofanimals

foreducation,testing,researchanddevelopment,

manufacture of biological products, or other scientific purposes.
(2)Laboratory animals
Animals of mammalian, avian or reptilian species, reared or maintained in
facilities of academic research institutions, for use in animal experiments andrelated activities.
(3)Academic Research Institutions
Any of the following institutions where testing, research or development areperformed, in science, technology, or for academic research:(i) Universities(ii) Inter-University Research Institute Corporation(iii) Colleges of Technology(iv) Facilities and institutions under the jurisdiction of the Ministry of Education,Culture, Sports, Science and Technology(v) Independent Administrative Institutes (limited to those under the jurisdictionof the Ministry of Education, Culture, Sports, Science and Technology; excluding
the Independent Administrative Corporation Institute of National Colleges ofTechnology)(vi) Corporations established pursuant to the provisions of Article 34 of the Civil-2-Code (Law No. 89 1896) (limited to those under the jurisdiction of the Ministry ofEducation, Culture, Sports, Science and Technology)(4) Animal experiment protocol
Protocol for conduct of animal experiment or related activities.
(5) Animal experiment researcher
Individual performing the animal experiment or related activities.
(6) Principal investigator
The animal experiment researcher who is responsible for all activities concerning
the animal experiment and related activities.
Article 2

Responsibilities of the director of the academic research institution

1. Responsibilities of the director of the academic research institution
The director of the academic research institution bears ultimate responsibility for
conduct of animal experiments and related activities in the institution. The director
shall establish the institutional animal experiment committee, establish theinstitutional regulations specified in Item 2 below, approve the animal experiment
protocols, comprehend the results of the animal experiments performed based on
the protocol, and implement any other necessary measures required for proper
conduct of animal experiments and related activities.
2. Establishment of institutional regulations
The director of the academic research institution shall establish the institutionalregulations (“Institutional regulations” hereinafter) specifying methods for themaintenance and management of animal experimentation facilities, as well as
methods for proper conduct of animal experiments and related activities, pursuant to
the provisions of the Law, Care and Management Standards, the Fundamental
Guidelines, and other laws and ordinances (including notices, the same hereinafter)
concerning animal experiments and related activities.
3. Approval of animal experiment protocols
The director of the academic research institution shall have the principal
investigator submit the animal experiment protocol prior to the start of the animalexperiment and related activities, and shall approve or reject the submitted animalexperiment protocol after a review by the Institutional Animal ExperimentCommittee.

-3-4. Comprehension of the results of the animal experiment and related activities.
After completion of the experiment, the director of the academic research institution
shall receive the report of results of the experiment performed according to theanimal experiment protocol, and shall implement whatever measures are necessary
for improvement in the proper conduct of the animal experiment and related
activities, as required.
Article 3 Institutional Animal Experiment Committee
1. Establishment of the Institutional Animal Experiment Committee
The director of the academic research institution shall establish the Institutional
Animal Experiment Committee.
2. Roles of the Institutional Animal Experiment Committee
The Institutional Animal Experiment Committee shall have the following duties.
(i) Upon a request from the director of the academic research institution, theCommittee shall review the animal experiment protocol submitted by the principal
investigator
Managementto

determineStandards,

whethertheit

complies

Fundamental

with

theGuidelines

Law,

Careconcerning

andanimalexperiment and related activities, and the Institutional regulations, and shallreport the results of the findings to the director of the institution.
(ii) The Committee receives a report from the director of the academic research
institution of the results of the animal experiments performed according to theanimal experiment protocol, and shall give advice as required.
3. Membership of the Institutional Animal Experiment Committee
The Institutional Animal Experiment Committee shall consist of members who areappointed from the following individuals by the director of the academic research
institution, with consideration given to achieve appropriately the roles of theCommittee.
(i) Individuals with excellent knowledge and experience regarding animalexperiments and related activities.
(ii) Individuals with excellent knowledge and experience regarding laboratory
animals.
(iii) Individuals with scholarship and experience.
Article 4 Conduct of animal experiments and related activities
1 Assurance of scientific rationale
The principal investigator shall prepare the animal experiment protocol and shall-4-

properly perform the animal experiment and related activities, based on thefollowing items, from the standpoint of assuring the reliability of data obtained fromthe animal experiment and related activities.
(1) Selection of proper methods for the animal experiment and related activities
The animal experiment and related activities shall be performed by selecting theproper methods based on the following items.
(i) Use of alternative methods (Replacement)
In the animal experiments and related activities, consideration must be given to
the proper use of laboratory animals by replacing laboratory animals with otherresearch materials where possible, while still allowing attainment of the scientificobjective.
(ii) Selection of laboratory animals (Reduction)
In the animal experiments and related activities, consideration must be given to
the appropriate use of laboratory animals by reducing the number of animals
used to as few as possible, while still allowing attainment of the scientificobjective. In these cases, it is necessary to consider the selection of laboratory
animal species appropriate for the purpose of the animal experiment and related
activities, the number of laboratory animals which will determine the accuracy
and reproducibility of the results of the animal experiment, the genetic andmicrobiological quality, and the rearing conditions.
(iii) Reduction of pain (Refinement)
In the animal experiments and related activities, methods must be employedwhich cause as little pain and distress as possible to the laboratory animals,
while still allowing attainment of the scientific objective, based on the Law andCare and Management Standards.
(2) Facilities and equipments for animal experiment and related activities
Animal experiments and related activities shall be conducted using appropriately
maintained and managed facilities and equipment.
2. Animal experiments and related activities that require special attention
concerning safety management
The director of the academic research institution shall consider the following
items when animal experiments and related activities are to be performed which
require special attention concerning safety management.
(i) When animal experiments and related activities are to be conducted which
involve physical or chemical agents or pathogens, or which may affect the safety or
health of humans or the surrounding environment, special attention to assuranceof safety and maintenance of the health of the animal experiment researchers
must be paid, while still properly maintaining facilities and equipment in the-5-

academic research institution.
(ii) The facilities and equipment shall be maintained so that the laboratory animals
are not harmed by contamination of the rearing environment, while consideration
shall also be given to maintenance of the health of the laboratory animals byimplementing quarantine or other measures as required.
(iii) When animal experiment and related activities that might affect the ecosystem
are to be

performed, such as animal experiments or related activities using

genetically modified animals, special attention shall be given to prevention of
escape or other undesirable events of the genetically modified animals, while
facilities and equipment in the academic research institution shall be managed
properly.
Article 5 Rearing and maintenance of laboratory animals
Rearing and maintenance of laboratory animals in the animal experiment andrelated activities shall be performed properly from the standpoints of both scientificrationale and animal welfare, based on the Law and Care and Management
Standards.
Article 6 Miscellaneous Provisions
1. Conduct of education and training
The director of the academic research institution shall ensure that education andtraining are provided to animal experiment researchers and workers who engage inthe rearing and maintenance of laboratory animals (“animal experimentresearchers and workers” hereinafter), with the aim of guaranteeing that animal
experiment researchers and workers shall acquire the basic knowledge required forthe proper conduct of animal experiments and other activities, and for the proper
rearing and maintenance of laboratory animals. The director shall also implement
any other necessary measures to improve the level of skills and professionalism ofanimal experiment researchers and workers.
2. Self-inspections, evaluation and verification of compliance with the Fundamental
Guidelines
To assure transparency concerning the conduct of animal experiments and related
activities, the director of the academic research institution shall periodically
implement self-inspections and evaluations of compliance with the Fundamental
Guidelines for the animal experiments and related activities in the institution.
Furthermore, the director shall endeavor to have the results of these self-inspections
and evaluations verified by a third party, independent of the research institution-6-

concerned.
3. Public disclosure of information
The director of the academic research institution shall publicly disclose
information regarding the animal experiments and related activities in theinstitution (e.g.,Institutional regulations, self-inspections and evaluations regarding
animal experiments and related activities, results of verification by a third party
independent of the institution concerned, and conditions of rearing andmaintenance of laboratory animals) through the Internet, distribution of annual
reports or by other appropriate means, approximately once a year.
Supplementary Provision
The Fundamental Guidelines shall come into effect beginning June 1, 2006.
(Reserch Promotion Bureau, Life Sciences Divisions)-7-