Keywords

1 Introduction

Laboratory animals are used in research and testing all over the world. The global research communities acknowledge the ethical concerns of modern societies in the use of animals in experiments. To ensure the humane care and use of laboratory animals, most of the countries have evolved their own regulatory framework. Almost every country has made exemplary progress in laws, regulations and guidelines that ultimately supported the regular improvements in the welfare of research animals as well as the quality of science [1]. However, there are still a few nations that do not have legal framework for animals in research and need to rise to meet the international harmonization [2]. This chapter seeks to discuss the laws, regulations and guidelines governing laboratory animal welfare across the globe. Apart from this, this chapter also attempts to cover the guidelines related to safety and occupational hazard, 3Rs and ethics for reliable and authentic knowledge in scientific writings related to laboratory animal research publications.

2 Laws, Regulations and Guidelines for Laboratory Animal Welfare

The use of laboratory animals in experimentations has fostered a diverse range of attitudes since the nineteenth century. The first law relating to animal protection and protection of experimental animals (Cruelty to Animals Act) was published in 1822 and 1876 by the United Kingdom [3, 4]. Thereafter, other countries have also made laws for the care and protection of animals used for experimental purposes. In the North American region, the United States enacted the Animal Welfare Act (AWA) and the Health Research Extension Act (1985). The AWA was revised in July 2020 and named as Animal Welfare Act and Regulations “Blue Book” (July 2020). In Canada, the Canadian Council on Animal Care (CCAC) plays a central role in setting and sustaining standards for the ethical use and care of animals in research [5]. In Latin America, Brazil has laws and regulations relating to research animal care and use. The rest of Latin American countries are yet to form any legal framework in this area [6].

In Europe, the European Directive (Directive 2010/63/EU) was amended in 2010 to harmonize the standards for animal care, animal housing, training, project reviews and authorization across all member countries [7]. Japan, China and Korea have enacted the regulations, laws and guidelines in 1983, 1973 and 1991, respectively, for the care and use of laboratory animals. The incorporation of the principles of the 3Rs is common to these countries [8]. Singapore, Thailand, Indonesia and Malaysia known as other Pacific Rim countries have varied levels of regulatory frameworks. Singapore has a strong research environment and has published the “Guidelines on the Care and Use of Animals for Scientific Purposes”, in 2004 by the National Advisory Committee for Laboratory Animal Research (NACLAR 2004) encompassing the responsibility of animal care staff, scientist and institutions when researching animals based on concepts of the 3Rs.

In India, the Prevention of Cruelty to Animals Act was enacted in 1960. Subsequently, the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) was formed to ensure the humane care of animals before, during and after the experiment on animals based on five founding principles including 3Rs [9]. In Australia, the protective legislation for animals varies from state to state. However, all the states follow the Australian Code of Practices for the Care and Use of Animals for Scientific Purposes enacted in 1969 and last amended in 2013 including the principles of the 3Rs [10]. Most of the African and Middle Eastern countries still have not framed the legislation nor established regulatory oversight, policies or guidelines except for some exceptions [11]. The details of key acts, regulations and guidelines on laboratory animal welfare are provided in Table 2.1.

Table 2.1 Details of key acts, regulations and guidelines on laboratory animal welfare
Full size table

3 Guidelines on Safety and Occupational Hazards in Laboratory Animals

The occupational safety and health considerations of the personnel involved in the care and use of laboratory animals is the legal and ethical obligation of the facility provider/management of the organizations. To provide appropriate measures for safety and health of the personnel involved, a successful management plan is to be employed that identifies the hazards and eliminates or minimizes the risk of injury or illness to employees and staff members and damage to equipment, property and environment. The details of various guidelines related to safety and occupational hazards in lab animals are provided in Table 2.2.

Table 2.2 The details of various guidelines related to safety and occupational hazards in lab animals and workers
Full size table

4 Guidelines on Alternatives to Animals in Research and Testing

The concept of 3Rs (Replacement, Reduction and Refinement) given by William Russell and Rex Burch (1959) have revolutionized the thinking on modern laboratory animal science research and quality of animal studies. The principles and techniques of 3Rs are broadly adopted by various national and international organizations across the world. Several 3Rs centres and institutes are continuously working for developing as well as confirmation of alternative methods to replace animal experimentations. The various guidelines on alternatives to research and testing on animals are detailed in the chapter “Alternatives to Animals Experiments in Research and Testing” of this book.

5 Education Training and Regulatory Guidelines on Laboratory Animals

Everyone involved in animal experimentation and care must be adequately trained before working with lab animals. The training programme should be like that it can accommodate a range of educational qualifications frequently encountered in research institutions. Before 1985, training programmes for veterinarians and animal technicians were available in Europe and the United States. Two laws on the care and use of animals were made by the US Congress [31]. According to these laws, all animal research funded by PHS (Public Health Service) should comply with the PHS Policy on Humane Care and Use of Laboratory Animals [32]. All persons having responsibilities for the use of animals must have adequate qualification and training including researchers and members of Institutional Animal Care and Use Committees (IACUCs).

Europe adopted the Directive 86/609/EEC in 1986 for the Protection of Animals Used for Experimental and Other Scientific Purposes (EU Directive) [33]. The Council of Europe (CoE) in the same year accepted the Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Procedures [34, 35]. Both these directives have provisions on the competence of persons involved in animal experimentation. Several other countries including Canada and New Zealand have developed guidelines on the competence of personnel. The training course should include subjects such as animal husbandry, gnotobiology, experimental techniques, anaesthesia and ethical features. The European Science Foundation (ESF), an organization from 30 European countries, stated that courses on laboratory animals should also include information on animal alternatives, welfare and ethics [36]. In countries like Denmark, Sweden, Finland, the Netherlands, France, Belgium and the United Kingdom, a training course has been made mandatory by law. In other countries like Germany, Spain, Portugal and Italy, training courses are not mandatory as per law, but they conduct the training.

According to the US Animal Welfare Act, 1996, institutions are responsible of providing training in areas like the proper use of anaesthetics, tranquilizers and analgesics, humane methods of animal maintenance and experimentation and the availability and use of methods that limit the use of animals or minimize animal distress [37, 38]. Despite the guidelines published on Care and Use of Laboratory Animals by the National Research Council of Education and Training [39], the training courses of many institutions have major differences. The International Council for Laboratory Animal Science (ICLAS) has considered harmonizing training courses. In this regard, a subcommittee of the Working Group on Harmonization examines general principles for training that have been formed. FELASA Accreditation is recognized as the premier accreditation and was introduced in 2003 and is recognized as the premier accreditation scheme in Europe for laboratory animal science (LAS) courses [40]. This scheme necessitates the development of quality training programmes on laboratory animals in Europe and internationally.

FELASA encourages professional competence of all personnel working with animals and the implementation of 3Rs. A Certificate Course on Laboratory Animal Science (CCLAS) that started in India in 2013 promotes judicious and scientific handling and management of laboratory animals. A MoU was signed between TANUVAS (Tamil Nadu Veterinary and Animal Sciences University), CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals), NIAW (National Institute of Animal Welfare) and Laboratory Animal Scientists’ Association (India) (LASA India) to start this course in India. This course aims to bridge the quality standards prescribed by the FELASA for personnel involved in animal experimentation in India. Based on the success of this course, FELASA has accredited this course for rodents and fish species. Outside Europe, this is the only course accredited and audited by experts from FELASA. The objective of this programme is to guide the judicious use of laboratory animals to achieve scientific results in animal experimentation.

6 Guidelines on Publications Related Work on Animals

Clear and accurate reporting of data is very important for the reproducibility of results. To address this issue, ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines were framed in 2010. These guidelines instruct the authors and journals to report minimum necessary information for in vivo experiments. But still, the impact of these guidelines in reporting has been limited. Many in vivo researchers are not aware of reporting the information as per ARRIVE guidelines. The revised ARRIVE provides information about 21 items. It covers best practices of conduct of animal studies for improving standards of the experimental process and publication. The ARRIVE guidelines apply to all studies involving live animals. These are also to be used by funding institutions and ethical review boards to ensure best practices and reporting in animal research.

The ARRIVE guidelines prescribe the “Essential 10” for minimum reporting requirements. The initial focus is to instruct authors, journal staff, editors and reviewers on “10 critical information”. Once the “Essential 10” is regularly reported in publications, the information on other items may be added until reaching all 21 items. The ARRIVE Essential 10 are study design, sample size, inclusion and exclusion criteria, randomization, blinding, outcome measures, statistical methods, experimental animals, experimental procedures and results. As per revised ARRIVE guidelines, the recommended items to be described are abstract, background, objectives, ethical statement, housing and husbandry, animal care and monitoring, interpretation, generalization, protocol registration, data access and declaration of interests. It is the responsibility of authors to fulfil the requirements of guidelines and regulations related to the use of animals. They must have approval for the study from the relevant ethics committee and provide the institution details where the research was approved. The protocol licence numbers should also be indicated [41].

7 Conclusion

The harmonization in laboratory animal welfare and use programmes has been made largely due to the globalization of science. A group of few countries yet have not adopted the guidelines, regulations and policies directing the care and use of laboratory animals. Further, there are still many pressing issues with the long-standing legal regimes as established by countries like the European Union, the United States and Australia. Therefore, additional efforts have to be required to form international organizations to set up harmonized global laboratory animal laws, policies and regulations. This chapter can be a catalyst for further improvement and implementation of legislations, policies and guidelines in the sphere of laboratory animal use and care as aspired globally for quality science.