The Ethics of Research involving Animals
Workshop: Ethics and research involving animals (8)
Background on scientific policy and context
1 The use of animals in scientific procedures can be broadly broken down into two categories: biomedical research and drug and chemical toxicity testing. There are numerous laws that require the testing of products on animals, in some cases on two different species.
2 All animal experiments in the UK are regulated by the 1986 Animals (Scientific Procedures) Act, which is administered by the Home Office. The Act requires the licensing of any experiment or other scientific procedure carried out on living, protected animals which may cause them pain, suffering, distress or lasting harm. All procedures must take place on licensed premises, form part of a licensed programme of work (for which a project license has been granted) and be conducted by a researcher with a personal licence.
3 In addition to the statutory requirements of the 1986 Act, there are various other regulatory bodies concerned with the use of animals in experiments. These include the Advisory Committee on Genetic Modification, the Advisory Committee on Release into the Environment, and the Advisory Committee on Novel Foods and Processes, all of which are statutory bodies, and advisory bodies such as the Agriculture and Environment Biotechnology Committee.
4 Applicants for licences to use animals have to provide statistical evidence that the correct number of animals is requested given the goals of the experiment, and that the number is as low as possible to achieve the desired result. All applications are subject to an ethical review process (ERP), which is currently the subject of a review by the Home Office Inspectorate. In addition to the project licence holder, there is also a certificate holder who has ultimate responsibility for ensuring that the research undertaken complies with the terms of the Act and license, and the personal licensee who carries out the work on the animal. The Named Animal Care and Welfare Officers and Named Veterinary Surgeons are responsible for checking and advising on the health and welfare of the animals, and external checks are conducted regularly by the Home Office Inspectorate. There have been some problems with the length of time it takes for animal licenses to be granted, but these are being addressed. It is still the case that it takes longer to obtain a license in the UK than in other EU countries, but this can be seen as a reflection of the thorough nature of the UK process, which is important for building public confidence. Any comparison between countries should cover not only the quantity, but also the quality, of the research, including progress with the 3Rs and improvements in animal welfare and scientific practice.
5 The Animal Procedures Committee is currently considering the cost-benefit analysis required by the 1986 Act. Projects could be awarded temporary licences to enable the cost-benefit assessment to be revisited. Further work will be required on the problem of how to assess whether the benefits of a disease model justify the welfare implications to the animal. This assessment needs to be both robust and meaningful.
6 The severity limit for each protocol must be specified in the licence. The categories are unclassified, mild, moderate and substantial. The majority of current experiments are classed as ‘moderate’. Within a project’s severity banding, limits are stipulated to the number of animals that can be used, the intensity of their suffering and the duration of that suffering.
Last Updated Thu, 10 June 2004