Legal aspects in animal experimets
Zebrafish is an excellent biological model for scientific investigation of numerous human diseases. However, the use of Zebrafish as experimental model requires an authorisation of the local competent authorities. The authorisation has to cover any experimental treatment, that could potentially cause pain, suffering, or harm to the animals. Their use for the respective experimental purposes is subject to regulatory approval. No matter, if the animals will actually experience a burden. For instance, even a temporary singly housing (one animal per tank) of the schooling Zebrafish could induce isolation stress and is thus subject to authorisation. Any scientist, who wants to perform animal experiments and to prepare an application, has to make sure, that all parts of the respective project are in full compliance with the principles of the 3R. The 3R stand for Replacement, Reduction and Refinement.
The use of animals for experimental purposes is authorised in cases where no satisfactory substitute method exists. Otherwise alternative methods have to be applied (Replacement). The number of animals used in a project must be reduced to a minimum (Reduction) without however compromising the objectives of the project. Refinement requires the application of procedures that are least burdening for the animals. Practically it requires e.g. the application of an effective analgesia during painful procedures or singly housed Zebrafish should have visual contact with conspecifics in nearby tanks to reduce isolation stress.
The protection and welfare of animals is an area covered by a wide range of EU legislation. This includes the protection of wildlife, zoo animals, farm animals, animals in transport and animals used for scientific purposes. Animal studies, whether for the development or production of new medicines, for physiological studies, for studying environmental effects or for the testing of chemicals or new food additives, has to be carried out in compliance with EU legislation.
Since 1986, the EU has had in place specific legislation covering the use of animals for scientific purposes. On 22 September 2010 the EU adopted Directive 2010/63/EU which updated and replaced the 1986 Directive 86/609/EEC on the protection of animals used for scientific purposes. The aim of the new Directive is to strengthen legislation, and improve the welfare of those animals still needed to be used, as well as to firmly anchor the principle of the Three Rs, to Replace, Reduce and Refine the use of animals, in EU legislation. Directive 2010/63/EU took full effect on 1 January 2013.
Source: https://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm
National regulations
Experiments must be authorized under national regulations. Licenses are given for the institutes and for individual areas of research. All partners operate a local ethical review procedure. Critical to ethical review is a cost / benefit analysis; the welfare cost to the animals must be balanced by the benefit of knowledge gained into gene function and the role of genes in human health and disease. These consider factors such as:
- The design of the procedures and their relevance to human and / or animal health and their advancement of knowledge
- The appropriate use of species, number and quantity of animals
- Adherence to the principles of the 3Rs: reduction, refinement and replacement
- Avoidance or minimization of discomfort, distress and pain
- Use of appropriate analgesia or anaesthetics
- Appropriate animal husbandry