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GB/T 35892-2018

Chinese Standard: 'GB/T 35892-2018'
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Detail Information of GB/T 35892-2018; GB/T35892-2018
Description (Translated English): Laboratory animal--Guideline for ethical review of animal welfare
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: B44
Classification of International Standard: 65.020.30
Word Count Estimation: 22,254
Date of Issue: 2018-02-06
Date of Implementation: 2018-09-01
Drafting Organization: National Institute of Health and Family Planning Science and Technology Institute, China Institute of Food and Drug Control, Peking University Cancer Hospital, Sanofi (China) Investment Co., Ltd., Chinese Academy of Medical Sciences Institute of Experimental Animal, Peking University Laboratory Animal Center, Experimental Animal Welfare Ethics Committee
Administrative Organization: National Laboratory Animal Standardization Technical Committee (SAC/TC 281)
Proposing organization: National Laboratory Animal Standardization Technical Committee (SAC / TC 281)
Issuing agency(ies): People's Republic of China General Administration of Quality Supervision, Inspection and Quarantine, China National Standardization Administration

GB/T 35892-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 65.020.30
B 44
Laboratory animal –
Guideline for ethical review of animal welfare
实验动物 福利伦理审查指南
ISSUED ON. FEBRUARY 06, 2018
IMPLEMENTED ON. SEPTEMBER 1, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword . 4 
1 Scope .. 5 
2 Normative references .. 5 
3 Terms and definitions .. 5 
4 Review agency .. 7 
4.1 Agency settings . 7 
4.2 Ethics committee requirements .. 8 
4.3 Ethics committee composition .. 8 
4.4 Ethics management . 8 
5 Review principles .. 9 
5.1 Principles of necessity .. 9 
5.2 Principles of protection .. 9 
5.3 Principles of welfare. 9 
5.4 Principles of ethics .. 9 
5.5 Principles of interest balance . 9 
5.6 Principles of fairness. 10 
5.7 Principles of legality .. 10 
5.8 Principles of being suitable for national conditions .. 10 
6 Review contents .. 10 
6.1 Personnel qualification. 10 
6.2 Facilities conditions.. 10 
6.3 Laboratory animal physicians . 12 
6.4 Animal sources .. 13 
6.5 Technical specifications . 14 
6.6 Animal feeding . 14 
6.7 Animal use . 15 
6.8 Occupational health and safety . 16 
6.9 Transportation of animals . 17 
7 Review procedure .. 18 
7.1 Application materials . 18 
7.2 Review of implementation plan .. 19 
7.3 Inspection of implementation process .. 19 
7.4 Final review .. 21 
8 Rules of review . 21 
8.1 Pass the review .. 21 
8.2 Failed to pass the review .. 21 
8.3 Appeal and answers . 22 
9 File management . 23 
Annex A (Normative) Application Format for Ethical Approval for Research
Involving Animals .. 24 
Laboratory animal –
Guideline for ethical review of animal welfare
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.
3.1 laboratory animal
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.
5.6 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
easy inspection. 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 C......
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