Animal research

In recent years, the use of animals in research has become one of the most important questions in research ethics. On the one hand, experiments using animals are important when, for example, testing medicine to ensure that it will not harm people. On the other hand, many feel that we have an obligation to these animals and that we cannot let them suffer for our sake. Already in the Declaration of Helsinki of 1964 it is stated that medical research is to respect the well-being of laboratory animals. How this is to be achieved is regulated by laws, rules and voluntary declarations from various sources. It is not only the experiment itself that can be morally uncertain: the animals are sometimes raised under hard conditions, and are then transported to research institutions to be kept under varying conditions. They are often finally destroyed, which naturally can be done in different ways. It is thus important to safeguard many aspects of laboratory animals' situations.

Animal experiments

What is an animal experiment? It is what the animal is used for that determines whether an activity is an animal experiment. The Animal Welfare Act's §1 describes what is considered to be an experiment: when an animal is used for scientific research or in instruction (given certain prerequisites), disease diagnosis, development of medicine or chemical products or for other comparable purposes. To create genetically modified animals with the help of gene technology or comparable methods also counts as animal experimenting. The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes also defines what is to be considered animal research. Note that these definitions do not always coincide: That which is considered an animal experiment in one case is not necessarily considered so in the other. For this reason, one-to-one comparisons between Sweden and the rest of Europe can easily be misleading.

Which animals may be used? 'Animals used for research' refers to animals used in experimentation, or animals bred, kept or supplied for such experimentation (§1 of the Animal Welfare Act). The types of animals that occasion ethical consideration are mammals, birds, reptiles, Anura, fish and cyclostomes. The animals must come from special breeders authorized by the Board of Agriculture. These animals are called "bred animals". Certain exceptions are granted according to the Authority regulations.

Permission to experiment

In Sweden, it is above all the Animal Welfare Ordinance and the Animal Welfare Act that rule on questions regarding animal research. According to §19 of the Animal Welfare Act (SFS 1988:534), it is an absolute necessity that animal research only be carried out if the work's objective cannot be attained through another satisfactory method not involving the use of animals.

How is research involving animal experimentation scrutinized? The Board of Agriculture (earlier the Animal Welfare Authority) is responsible for issuing regulations and general advice. Ethical review of animal experimentation has been obligatory in Sweden since 1979; there are seven ethical committees across the country. Each committee is chaired by a member of the legal profession, and of its twelve members half are scientiests or staff who work with laboratory animals and half are laymen, some representing animal welfare oganizations. As a rule, members are appointed for a period of four years. The examination is to be carried out only from an ethical perspective, thus rendering things such as economic aspects irrelevant. The committees' decisions are binding but may be appealed.

According to the Animal Welfare Act the ethical committee shall weigh the importance of the experiment against the suffering inflicted to the animal. The committee can only approve of an experiment if it is important for the public and if three demands in 19 § 1-3 are met, i.e. if the aim of the experiment cannot be satisfied by use of another method not involving animal experimentation ('replacement'), if as few animals as is possible are used ('reduction'), and if the animals are not exposed for more suffering than absolutely neccessary ('refinement'). These demands are known as the three Rs.

According to Swedish Animal Welfare Ordinance (SFS 1988:539) §49: "In the investigation of a matter the committee shall take into consideration, on the one hand, the significance of the research and, on the other, the animal's suffering." A committee must advise against an experiment if it is not considered of sufficient scientific significance or as being in the public interest, or if the relevant data can be obtained by other means. The regulations states that in a choice between procedures, selection should be based on which procedure uses a minimum number of animals and causes the least pain, suffering, distress or lasting harm. Among reasons for selection are mentioned likeliness to provide satisfactory results, use of animals with low neurophysical sensitivity, and inclusion of as few animals as possible. In his or her application, the applicant should especially consider, motivate and describe the end- and breakpoints, how the judgement of pain, suffering, and distress will be made, and how to supervise animals during and after the experiment.

The Natonal Board of Occupational Safety and Health (now the Swedish Work Environment Authority) regulations concerning work with laboratory animals (AFS 1990:11) address above all premises, fixtures and equipment, waste management, personal protection equipment and hygiene, as well as vaccination and medical checkups. The Board of Agriculture has enacted a number of regulations regarding the handling of laboratory animals; you can find an introduction to Board of Agriculture activities as well as a list of regulations here.

International standards

Sweden is obliged to follow two European provisions regarding animal research. In 1988 we ratified the European Convention with addenda for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, which, among other things, regulates when animal experiments are allowed and when they are to be reported to the appropriate authority. The European Union has several regulations regarding animal research, primarily The Council's directive 86/609/EEG regarding the approximation of member states' laws and other statutes on protection of animals used in research and for other scientific purposes, which seeks to implement the European Convention. Further recommendations are given in the commissions guidelines for the accommodation and care of animals used for experimental and other scientific purposes, with instructions on the physical facilities, the environment and its control, education and training, animal care, humane killing, and various species-specific guidelines. An action plan on the protection and welfare of animals in the EU has been adopted. See also the Note for Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use from EMEA.

The EU is now working on a revision of the Animal Protection Directive. The work can be followed on the EU webpage on laboratory animals. The proposal from the Commission, Proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes, states that it will be compulsory to carry out ethical evaluations and contains a ban on the use of great apes (chimpanzees, bonobos, gorillas and orangutans) in scientific procedures. The European Science Foundation has issued an ESF-EMRC Position on the Proposed Revision of the Directive on the Protection of Animals Used for Experimental and Other Scientific Purposes.

Some other issues

In a report on xenotransplants, WHO has taken up the issue of the prevention of cruelty to animals. The Good Clinical Practice guideline discusses when and how animal research is to be conducted. The European Science Foundation has published a policy briefing document on the use of animals in research (no 9). The International Association for the Study of Pain has published Ethical Guidelines for Investigations of Experimental Pain in Conscious Animals. Ethicists and scientists have offered advice for testing human brain cells in primates ("Moral Issues of Human-Non-Human Primate Neural Grafting")

How far can we go in genetically modifying animals? The EU Commission's Group of Advisers on the Ethical Implications of Biotechnology has issued a statement on Ethical Aspects of Genetic Modification of Animals. Research in the area of veterinary medicine has its own rules, and The European Agency for the Evaluation of Medicinal Products provides a large number of guidelines for this area. The Federation of European Laboratory Animal Science Associations (FELASA) provides various policies and recommendations.

Last updated: 2010-03-09