GB/T 35892-2018Laboratory animal—Guideline for ethical review of animal welfare (English PDF)
实验动物 福利伦理审查指南
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
February 6, 2018
Implementation date
September 1, 2018
Scope
GB/T 35892-2018 is the English-translated version of 实验动物 福利伦理审查指南.
GB/T 35892-2018 is the Chinese guideline for the ethical review of animal welfare in the production, transport and use of laboratory animals.
It describes the review body, with the requirements, composition and management of the ethics committee, and the review principles of necessity, protection, welfare, ethics, balance of interests, fairness, legality and suitability to national conditions.
The review contents include staff qualifications, facilities, laboratory animal veterinarians, animal sources, standard operating procedures, feeding, animal use, occupational health and safety and transport.
It then sets the review procedure, from the application and the review of the project plan to inspections during the work and the final review, the rules for passing, failing and appealing, and file management, with the application form in Annex A. It was issued on 6 February 2018 and has applied since 1 September 2018.
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Document preview — GB/T 35892-2018
National Standard of the People's Republic of China
- ICS
- 65.020.30
- Classification
- B 44
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword4
- 1 Scope5
- 2 Normative references5
- 3 Terms and definitions5
- 4 Review agency7
- 4.1 Agency settings7
- 4.2 Ethics committee requirements8
- 4.3 Ethics committee composition8
- 4.4 Ethics management8
- 5 Review principles9
- 5.1 Principles of necessity9
- 5.2 Principles of protection9
- 5.3 Principles of welfare9
- 5.4 Principles of ethics9
- 5.5 Principles of interest balance9
- 5.6 Principles of fairness10
- 5.7 Principles of legality10
- 5.8 Principles of being suitable for national conditions10
- 6 Review contents10
- 6.1 Personnel qualification10
- 6.2 Facilities conditions10
- 6.3 Laboratory animal physicians12
- 6.4 Animal sources13
- 6.5 Technical specifications14
- 6.6 Animal feeding14
- 6.7 Animal use15
- 6.8 Occupational health and safety16
- 6.9 Transportation of animals17
- 7 Review procedure18
- 7.1 Application materials18
- 7.2 Review of implementation plan19
- 7.3 Inspection of implementation process19
- 7.4 Final review21
- 8 Rules of review21
- 8.1 Pass the review21
- 8.2 Failed to pass the review21
- 8.3 Appeal and answers22
- 9 File management23
- Annex A (Normative) Application Format for Ethical Approval for Research Involving Animals24
1 Scope
This standard specifies the requirements for ethical review of welfare and management during the production, transportation, and use of laboratory animal.
This standard is applicable for ethical review of laboratory animal welfare, as well as its quality management.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated versions apply to documents. For undated reference documents, the latest versions (including all amendments) apply to this document.
GB 14922.1, Laboratory animal - Standards and monitoring for parasitology
GB 14922.2, Laboratory animal - Microbiological standards and monitoring
GB 14923, Laboratory animal - Genetic quality control of mammalian laboratory animals
GB/T 14924.2, Laboratory animal - Hygienic standard for formula feeds
GB 14924.3, Laboratory animal - Nutrients for formula feeds
GB 14925, Laboratory animal - Requirements of environment and housing facilities
Guidance on the humane treatment of laboratory animal (G. K. F. C. Zi [2006] No.398)
3 Terms and definitions
The following terms and definitions apply to the document. […]
4 Review agency
4.2 Ethics committee requirements
4.2.1 General requirements
According to the relevant laws, regulations and quality-technology standards of laboratory animal, it is responsible for the ethical review and supervision of the laboratory-animal-related welfare of the laboratory animal working units within its jurisdiction, and accepts relevant reports and complaints.
4.2.2 Specific requirements
4.2.2.1 Inspect the management norms and implementation of the laboratory animal working units every half year; conduct project prior review, project in-progress supervision and inspection, project end review; investigate the violation of laws and regulations.
4.2.2.2 Independently carry out review and supervision work, be responsible for issuing review and inspection reports, and be responsible for reporting to unit-supervisors and higher authorities.
4.3 Ethics committee composition
4.3.1 The Ethics Committee shall at least be composed of such experts from different fields -- laboratory-animal experts, doctors, laboratory-animal managers, animal-using researchers, and public representatives. Committee number from the same field shall not be more than 3 persons. The Ethics Committee has one chairman, several vice-chairmen and members. The number of vice-chairmen and members shall be determined based on the actual needs of the review work.
4.3.2 The term of office of each Ethics Committee is 3 to 5 years. The competent authority, in charge of its establishment, is responsible for the appointment, pre-post training, dismissal and timely addition of members.
4.3.3 All Ethics Committee members must promise to abide by laws, regulations, and standards; and maintain the ethics of laboratory animal welfare.
4.4 Ethics management
The Ethics Committee shall formulate statutes, review procedures, supervision systems, regular meeting systems, work disciplines, and professional training programs, etc., and be responsible for reporting to higher management institutions. The Ethics Committee's decision adopts the principle of the minority obeying the majority, but the minority opinions shall be recorded.
5 Review principles
5.6 Principles of fairness
The review and supervision work shall be independent, equitable, fair, scientific, democratic, transparent, non-disclosure and free from political, commercial, and self-interest influences.
5.7 Principles of legality
For project objectives, animal sources, facility environment, personnel qualifications, and operation methods, etc. as a whole, there shall not be any violation of laws, regulations or related standards.
5.8 Principles of being suitable for national conditions
Welfare ethical review shall follow internationally accepted norms and China's traditional public order and good customs, suitable for China's national conditions, and oppose all kinds of radical ideas and extreme practices.
6 Review contents
6.1 Personnel qualification
6.1.1 Laboratory animal employees shall obtain professional qualifications and skills through professional technical training.
6.1.2 The laboratory animal working units shall, according to the actual needs, formulate a laboratory animal welfare-ethic professional training program, and conduct it, to ensure that the employees are familiar with the relevant regulations and technical standards for Laboratory Animal Welfare Ethics, understand the knowledge and requirements of humane treatment to laboratory animals, and master the habits of relevant species of animals, as well as correct operating techniques.
6.1.3 Technical training for newcomers or trainees, where living animals and related experiments are needed, shall under technical personnel's guidance and supervision until the newcomers or trainees are skilled in operation.
6.1.4 Laboratory-animal technical training and welfare-ethic teaching practices, if non-animal experimental methods can effectively reduce or replace the use of living animals, while ensure the achievement of training objectives, shall use living-animals replacement teaching methods as much as possible.
6.2 Facilities conditions
6.2.1 Animal facilities
The facilities conditions and environmental indicators for laboratory animal […]
6.4 Animal sources
Making marks on animals shall use reliable and methods of least pain or harm.
6.4.3 If there must use wild animals in experiments, it shall capture those animals through legal channels and by humane technologies, and take into account health, welfare and safety of human and animal.
6.4.4 Field studies shall not cause disturbance to animal habitats, or adverse effects to target and non-target species.
6.4.5 Conduct welfare ethical review of the interference possibility of wild animals, and take effective measures to minimize the interference. such as capture, transport, sedation, anesthesia, marking, sampling, and other stress responses, as well as the accumulation of potential stressors, which may cause serious and even fatal consequences to the animal.
6.4.6 Endangered species can only be obtained and used in accordance with the law in extremely exceptional circumstances; when there are scientific reasons that they are irreplaceable, and the expected results cannot be achieved by using any other species, then, only after review-approval, may the project be implemented.
6.5 Technical specifications
For the laboratory animal's feeding management, facility management, as well as various types of animal experiment operations (including determination of humane endpoint and euthanasia), experimental environment control, and the implementation of various types of laboratory animal projects. It shall formulate the laboratory animal's welfare ethical quality standards, management regulations, Standard Operating Procedure (SOP), which shall be submitted to the Ethics Committee for review and implementation supervision.
6.6 Animal feeding
6.6.1 The employees shall not tease or abuse laboratory animals. When grabbing at animals, they shall use proper methods, with a mild attitude and gentle movements to avoid causing unrest, panic, pain, and injury to animals.
6.6.2 In daily feeding management, they shall observe the animals regularly. If there is any abnormality, they shall search for the reason promptly, and take targeted measures to improve it.
6.6.3 The feeders shall, based on animal's feeding habits and nutritional needs, give animals sufficient fodder and clean drinking water. Its nutritional components shall meet the requirements of GB/T 14924.2.
The fodder microbiology, physical-chemical control, and other indicators shall meet the requirements of GB 14924.3.
6.7 Animal use
6.7.3 To conduct surgery and dissection on living animals (including motor […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 14923Laboratory animal - Genetic quality control
- GB/T 14924.2Laboratory animals--Hygienic standard for formula feeds
- GB 14924.3Laboratory animals - Nutrients for formula feeds
- GB 14925Laboratory animal - Environment and housing facilities
GB 14922.1 · GB 14922.2
Cited by
- GB/T 47139-2026Laboratory animals - Technical specification for the identification and evaluation of experimental animal models
- GB/T 27406-2025Criterion on the quality control of laboratories - Food toxicology testing
- GB/T 43776-2024Technical specification of sample collection and processing for single cell sequencing
- GB/T 43051-2023Laboratory animal - General requirements for biosafety in animal experiment
- GB/T 42011-2022Laboratory animals - General code of animal welfare
- GB/T 39760-2021Laboratory animal—Guidelines for euthanasia
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Related Standards
GB 14923-2022 — Laboratory animal - Genetic quality control
GB 14924.3-2010 — Laboratory animals - Nutrients for formula feeds
GB 14925-2023 — Laboratory animal - Environment and housing facilities
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