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 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.
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 Ch., § 4 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, as does, in cases where animals might suffer, cases of preserving species through breeding them after genetic alteration.
Animals used for research' refers to animals used in experimentation or animals intended to be used, or animals alraedy used or having been intended for such use. The types of animals that occasion ethical consideration are mammals, birds, reptiles, Anura, fish, cyclostomes and octopuses.
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 (and Statens Jordbruksverks föreskrifter och allmänna råd om försöksdjur - SJVFS 2019:9). There is also an ordinance from the Medical Products Agency: Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på djur - HSLF-FS 2016:78.
How is research involving animal experimentation scrutinized? There are seven ethical committees across the country. For more information, see Djurförsök.info where more extensive information can be found. 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 to the central animal ethics committee, that also can examine already performed animal experiments.
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 Chapter 7 § 1 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. An animal experiment cannot be approved if it means great and extended suffering that is not possible to relieve (says the ordinance).
Researchers need in their projects indicate clear, predictable, and irreversible criteria for determining the humane endpoints for experiment animals. Humane endpoints indicate the limit of suffering or distress to which the animals may be subjected. If animals give signs of having reached that point, and no remedy is possible, they should be immediately removed from the experiment and euthanized (see here further the Guidance document from OECD).
Animal research cannot be initiated before a course in animal testing procedures has been completed. Every facility with animals for research must now also have an animal welfare body, that promotes animal welfare and the three Rs.
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 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes Further recommendations are given in the commission's 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.
- ARRIVE guidelines 2.0: Updated guidelines for reporting animal research
- ECVAM search guide: Good search practice on animal alternatives
- European Partnership for Alternative Approaches to Animal Testing
- Nordic Consortium for Laboratory Animal Science Education and Training
- Webpage of European Animal Research Association
- Final Opinion on The need for non-human primates in biomedical research, production and testing of products and devices (Scientific Committee on Health Environmental and Emerging Risks, EU)
- UN Convention on animal health and protection