○Doshisha University Regulations on the Conduct of Animal Experiments and Related
Activities (Established June 30, 2007)
Doshisha University Regulations on the Conduct of Animal Experiments and Related
Activities
Established June 30, 2007

RevisedMarch 28, 2009

February 18, 2010

February 17, 2011 April 26, 2014
March 28, 2015

November 10,2017

February 13, 2020 June 9th, 2022
Chapter 1 General Provisions(Purpose)
Article 1 These regulations, based on the provisions in the Act on Welfare andManagement of Animals (Act No. 105 of October 1, 1973) (hereinafter “Animal WelfareAct”), Standards Relating to the Care and Management of Laboratory Animals and Reliefof Pain (Notice No. 88 of the Ministry of the Environment, April 28, 2006)(hereinafter “Care and Management Standards”), Standards relating to the Methods ofDestruction of Animals (Notice No. 40 of the Prime Minister’s Office, July 4, 1995)(hereinafter “Animal Destruction Standards”) and Fundamental Guidelines for Proper
Conduct of Animal Experiment and Related Activities in Academic Research Institutions(Notice No. 71 of the Ministry of Education, Culture, Sports, Science and Technology,
June 1, 2006) (hereinafter “Animal Experiment Guidelines”), set out necessary
matters for the appropriate conduct of animal experiments and related activities fromthe standpoints of scientific rationale and animal welfare, as well as ofenvironmental preservation and assurance of security of faculty, staff and students
engaging in animal experiments and related activities.
(Fundamental Principle)
Article 2 Animal experiments and related activities shall be conducted according to theprovisions of these regulations as well as the provisions of Animal Welfare Act, Careand Management Standards, Animal Destruction Standards, Animal Experiment Guidelines
and other laws and ordinances.
2. When utilizing animals for scientific purposes, it must be conducted in conformity
to the following principles on animal experiments and related activities.
(１) Methods must be employed which cause as little pain and stress as possible tothe laboratory animals, while still allowing attainment of the scientificobjective.
(２) Efforts must be made to replace laboratory animals with other researchmaterials where possible, while still allowing attainment of the scientificobjective.

(３) Efforts must be made to reduce the number of animals used to as few as
possible, while still allowing attainment of the scientific objective.
(Definitions)
Article 3 The following terms in these regulations are defined as below:(１) Animal experiments and related activities refer to utilization of animals foreducation, testing, research and development, manufacture of biological products,
or other scientific purposes.
(２) Laboratory animals refer to animals of mammalian, avian or reptilian species,
reared or maintained in animal experimentation facilities, for use in animal
experiments and related activities.
(３) Animal experiment protocol refers to a protocol planned beforehand for
conduct of an animal experiment or related activities.
(４) Animal experimentation facilities refer to laboratories for conducting animal
experiments and related activities and facilities for rearing and maintaining
laboratory animals.
(5) Director of animal experimentation facilities refers to an individual who
presides over the management of all the animal experimentation facilities, etc. of
the university.
(6) Operation director refers to an individual who manages laboratory animals aswell as animal experimentation facilities.
(7) Laboratory animal manager refers to an individual with knowledge and experiencein laboratory animals who manages laboratory animals.
(8) Animal experiment researcher refers to an individual who performs animal
experiments and related activities.
(9) Principal investigator refers to an animal experiment executor who presides over
operations related to the execution of animal experiments and related activities.
(10) Animal technician refers to an individual who engages in rearing or maintenanceof laboratory animals under the laboratory animal manager or the animal experimentresearcher.
(Responsibilities in Conducting Animal Experiments and Related Activities)
Article 4 The responsibilities at Doshisha University to appropriately conduct animal
experiments and related activities shall be as follows.
(１) The President shall ultimately assume the responsibility for all mattersconcerning the conduct of animal experiments and related activities.
(２) The director of animal experiment facilities shall be responsible for managing
all animal experimentation facilities. The vice president of the Center for
Environment and Laboratory Studies Support shall be appointed as the director ofanimal experiment facilities.
(３) The President shall appoint an operation director for each animal
experimentation facility. The operation director shall be recommended by the
director of animal experimentation facility and commissioned by the President.

(４) The operation director shall appoint a laboratory animal manager for eachanimal experimental facility. At the laboratory which the principal investigatorsupervises, the principal investigator shall assume the responsibility of thelaboratory animal manager,(5) The animal experiment researcher shall perform the animal experiment under thesupervision of the principal investigator. A principal investigator shall be afull-time faculty member of Doshisha University.
(6) The laboratory animal manager or the principal investigator shall appoint an
animal technician. Animal technicians shall engage in these duties under thelaboratory animal manager or animal experiment researcher.
(Scope of Application)
Article 5 These regulations shall apply to all animal experiments and related
activities performed at Doshisha University that use living bodies of mammals, birds
and reptiles as designated in Animal Welfare Act, Care and Management Standards,
Animal Destruction Standards, and Animal Experiment Guidelines.
２ In the event animal experiments or related activities other than described in theprevious paragraph are to be performed, efforts must be made to perform such
experiments in compliance with the purpose of these regulations.
３ These regulations do not apply to rearing and maintenance of animals that aims at
observing their ecology.
(Institutional Animal Experiment Committee)
Article 6 In order to achieve the purpose of these regulations, Doshisha University
establishes Doshisha University Institutional Animal Experiment Committee (hereinafterreferred to as “Committee”) under its Research Ethics Committee.
２ Matters concerning the Committee shall be stipulated separately.
Chapter 2 Conduct of Animal Experiments(Submission of Animal Experiment Protocol)
Article 7 The principal investigator who intends to perform an animal experiment or
related activities must prepare an animal experiment protocol based on the principles
set out in paragraph 2 of Article 2 and submit the prescribed “Animal Experiment
Protocol Form” to the President for approval.
(Preparation of Animal Experiment Protocol)
Article 8 When preparing an animal experiment protocol, the following items should betaken into consideration and proper methods of animal experiment must be selected interms of the significance of the research and the necessity of animal experiment andrelated activities, as well as within the scope that allows attainment of thescientific objective.
(１) The animal experiment protocol must be prepared based on scientificrationality and from the standpoint of assuring the reliability of data obtained
from the animal experiment and related activities.
(２) When selecting laboratory animals, it is necessary to consider what animal

species are appropriate for the purpose of the animal experiment and related
activities, the number of laboratory animals which will determine the accuracy andreproducibility of the results of the animal experiment, the genetic andmicrobiological quality, and the rearing conditions.
(Review of Animal Experiment Protocol)
Article 9 Matters concerning the review of animal experiment protocols shall be
stipulated separately.
(Safety Management)
Article 10
When an animal experiment 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, the principal investigator must pay
special attention to assurance of safety and maintenance of the health of the animal
experiment researchers and follow the respective law and/or regulation, in accordancewith the conditions of the facilities and equipment.
２ When an animal experiment and related activities that might affect the ecosystem
are to be performed, such as an animal experiment or related activities using living
modified organisms, special attention shall be given to prevention of escape or other
undesirable events of the living modified organisms, in accordance with the conditionsof the facilities and equipment.
（Acquisition, etc. of knowledge relating to zoonotic diseases)
Article 11 The principal investigator, the animal experiment researchers, as well as theanimal technicians must endeavor to acquire sufficient knowledge relating to zoonotic
diseases and to collect information. Additionally, they must endeavor to establish acommunication system with public health organizations, etc. in order to swiftly takenecessary measurements in the case of zoonotic disease outbreak.
(Experimental Procedures)
Article 12 Animal experiments and related activities must be performed using properly
maintained and managed facilities and equipment.
２ The principal investigator must give consideration to the following points when
performing the experimental procedures.
(１) Test reagents, drugs and laboratory equipment must be retained appropriately.
Particular attention should be paid to the storage of controlled substances such as
narcotics.
(２) Dead bodies of laboratory animals and laboratory waste must be disposed ofappropriately. Particular attention should be paid to the disposal of controlledwaste.
３ The animal experiment researcher must take into consideration the following points
when performing the experimental procedures.
(１) To comply with provisions in the pre-approved animal experiment protocol andother relevant guidelines.

(２) To attend the last lecture of the education and training on handlinglaboratory-animals recommended by the Committee.
(３) To perform the procedures with necessary skills in restraining laboratory
animals, administering drugs, obtaining samples, surgical procedures and so on.
(４) Highly invasive major surgery should be conducted under the guidance of a
specialist with sufficient knowledge and experience.
(５) Even when food and water restrictions are required for research reasons,animals should be supplied the minimum amount of food and water required.
(６) Measures must be taken to reduce pain suffered by laboratory animals throughthe use of appropriate anesthetics, analgesic and sedative procedures andpostoperative management.
(７) To consider the appropriate timing of termination of the experiment (humane
endpoint).
(８) To acquire knowledge and skills related to euthanasia procedures and perform
appropriate procedures.
(Reports of Animal Experiment Results)
Article 13 Immediately after the completion of the animal experiment and related
activities, the principal investigator must report the number of laboratory animals
used, whether any changes were made to the protocol, and the results of the experiment
to the President, using the prescribed “Report of Animal Experiment”.
(Suspension of Animal Experiment)
Article 14 In the case an animal experiment researcher violated these regulations, thePresident may suspend the said animal experiment.
Chapter 3 Rearing of Laboratory Animals(Fundamentals of Rearing and Maintenance)
Article 15 In rearing and maintaining laboratory animals, the operation director andthe laboratory animal manager must give consideration to the safety and health ofhumans and laboratory animals as well as influences on the ecosystem.
(Introduction of Laboratory Animals)
Article 16 The laboratory animal manager must introduce laboratory animals
appropriately in compliance with applicable laws and ordinances.
２ Each time a laboratory animal is introduced, the laboratory animal manager must
check abnormalities in its external appearance and other points and perform
appropriate quarantine and acclimatization suitable for the species and conditions of
the facilities.
(Supply of Food and Water)
Article 17 The laboratory animal manager must supply laboratory animals with food andwater appropriately, according to the animals’ physiology, ecology and behavior.
(Health Management)
Article 18 To prevent injuries and diseases unrelated to the objective of the animal
experiment, the laboratory animal manager must conduct necessary health management of

laboratory animals, including conducting quarantine as required.
２ In the event of injury or disease unrelated to the objective of the animal
experiment, the laboratory animal manager must provide affected laboratory animals
with appropriate treatment.
(Rearing Different Animal Species or Multiple Animals)
Article 19 When rearing and maintaining different animal species or multiple
laboratory animals in the same facilities, the laboratory animal manager must take
into consideration the appropriate combination of animals according to their
physiology, ecology and behavior.
(Retention and Report of Records)
Article 20 The laboratory animal manager must compile and maintain records oflaboratory animal sources, rearing history, history of disease, etc.
２ The laboratory animal manager must report to the President the species and numbersof laboratory animals that reared and maintained each year.
(Provision of Information on Delivery of Animals)
Article 21 When delivering laboratory animals, the laboratory animal manager must
provide information on the animal’s features, rearing and maintenance methods,
microbiological quality, infectious diseases, etc.
(Transportation)
Article 22 When transporting laboratory animals, the laboratory animal manager must
endeavor to take care of the health and safety of the laboratory animals and toprevent any hazard, etc. for humans occurring due to the animals.
(Prevention of Injury)
Article 23 The operation director must determine methods of capturing escapedlaboratory animals in advance.
２ If a laboratory animal that might injure or cause harm to humans escapes from afacility, the operation director must contact relevant authorities immediately.
３ To rear and maintain poisonous animals such as poisonous snakes, the operation
director must separately stipulate necessary provisions in accordance with the Careand Management Standards to prevent the animals from causing harm to humans.
４ The operation director and the laboratory animal manager must prevent animal
technicians from suffering infectious diseases and bites by laboratory animals, andmust take necessary measures immediately if any of these occurs.
５ The operation director and the laboratory animal manager must take necessary
measures to prevent people who are not involved in the rearing of laboratory animals
or in animal experiments and related activities from touching laboratory animals.
(Emergency Measures)
Article 24 The operation director must draw up plans of measures to be implemented in
the event of an emergency such as an earthquake or fire in advance and make the plans
known to relevant parties.
２ In an emergency situation, the operation director and the laboratory animal

manager must endeavor to protect laboratory animals and prevent injury or harm tohumans due to escape of laboratory animals.
Chapter 4 Animal Experimentation Facilities(Requirements for Rearing and Maintenance Facilities)
Article 25 Facilities for rearing and maintenance shall meet the following conditions,and the operation director must endeavor to appropriately maintain and manage thefacilities and equipment.
(１) Having an appropriate structure according to the requirements for conduct of
the research, as well as laboratory animals’ physiology, ecology and behavior(２) Having a structure that allows easy cleaning and disinfection of floors,
inside walls, ceilings, and auxiliary equipment in the facilities, and meets therequirements for sanitary management(３) Having a structure that maintains proper space, temperature, humidity,
ventilation, lighting, etc. that allow laboratory animals to keep their body in a
comfortable state(４) Having a structure that eliminates the possibility of laboratory animals
being injured or stressed by projections, holes, depressions, inclined planes, etc.
(５) Having a structure that enables animal technicians to perform daily
operations easily without risk
(６) Assurance of structures and strength to prevent laboratory animals fromescaping(７) Measures are taken to prevent adverse effect on the surrounding environment
caused by odor, noise and waste material(８) Having rearing equipment suitable for the animal species and the number ofanimals reared(９) A laboratory animal manager is appointed(Requirements for Laboratory)
Article 26 A laboratory shall meet the following requirements, and the operation
director must endeavor to appropriately maintain and manage the facilities andequipment.
(１) Having a structure that allows easy cleaning and disinfection to prevent
contamination by blood and excrement(２) Having a structure and strength to prevent laboratory animals from escaping,as well as maintaining the environment in which an escaped laboratory animal can beeasily recaptured.
(３) Clean, hygienic conditions should be maintained at all times, and measures
should be taken to prevent adverse effect on the surrounding environment caused byodor, noise and waste material(４) In the case an experiment in which laboratory animals are kept for more than
one day is conducted in the laboratory, it must fulfill requirements for a“rearing and maintenance facility”.

(Maintenance and Management of Facilities)
Article 27 The operation director must endeavor to properly maintain, manage andimprove the facilities and equipment to prevent laboratory animals from being harmed
by contamination of the rearing environment.
２ The operation director must take appropriate measures for managing entrance to anddeparture from the animal experimentation facilities.
(Closure of Facilities)
Article 28 In the event an animal experimentation facility is to be closed, theoperation director must, in cooperation with the principal investigator, endeavor totransfer the laboratory animals to other rearing and maintenance facilities.
Chapter 5 Education and Training, Self-inspections, Evaluations and Verification,
Information Disclosure(Education and Training)
Article 29 The President must implement necessary measures for providing the prescribededucation and training on the following matters to animal experiment researchers,
laboratory animal managers and animal technicians.
(１) Matters concerning related laws, ordinances, guidelines and these regulations(２) Matters concerning methods of animal experiment and handling of laboratory
animals(３) Matters concerning rearing and maintenance of laboratory animals(４) Matters concerning assurance of security and safety management(５) Matters concerning the use of animal experimentation facilities(６) Matters concerning zoonotic diseases(７) Other matters concerning the proper conduct of animal experiments and related
activities
２ Other necessary matters concerning education and training shall be stipulated
separately.
(Self-inspections, Evaluations and Verification)
Article 30 To promote scientific animal experiments and related activities that giveconsideration to animal welfare, the President shall periodically perform selfinspections, evaluations and verification of compliance with the regulations.
２ Other necessary matters concerning self-inspections and evaluations shall be
stipulated separately.
(Public Disclosure of Information)
Article 31 The President shall endeavor to increase the social transparency of the
conduct of animal experiments and related activities by publicly disclosing
information regarding animal experiments and related activities (Regulations on the
Conduct of Animal Experiments and Related Activities, results of self-inspections,evaluations and verification regarding animal experiments and related activities, andconditions of rearing and maintenance of laboratory animals) through appropriate
means, with consideration to protection of personal information and researchinformation.
２ Other necessary matters concerning information disclosure shall be stipulated
separately.
Chapter 6 Auxiliary Provisions(Auxiliary Provisions)
Article 32 In addition to the provisions in these regulations, other necessary mattersshall be stipulated separately.
(Administration)
Article 33 Administration of these regulations shall be handled by the Office of Center
for Environment and Laboratory Studies Support and the Office of Ethics Review.
(Amendment and Termination)
Article 34 Amendment and termination of these regulations shall be determined by the
President after discussion by the committee, the Research Ethics Committee, and theCommittee of Deans and Directors.
Additional Clause
These regulations shall come into effect on June 25, 2022.