Ethics of Research involving animals
Summary
13.53 We have described important aspects of the national and international regulatory framework governing research involving animals. In doing so, we have focused on legislation for the protection of animals, briefly summarised regulation relating to the requirement of animal tests, and highlighted difficulties in the harmonisation of different national policies. We described the historical background to the A(SP)A, its principal provisions, and the three types of licence that govern all animal research in the UK: personal licences, project licences and certificates of designation. In carrying out the cost-benefit assessment, which is fundamental to the A(SP)A, the primary responsibility lies with the researchers planning a new project. In addition, a number of other people and processes are involved, and it would be fallacious to assume that only the inspectors of the Home Office are responsible for carrying out this assessment. The Home Office publishes annual statistics about the numbers of animals used in research. These contain information about prospectively assigned severity banding of granted project licenses but `do not provide details about the levels of pain, suffering and distress actually experienced by animals. The ERP is critically important. Three of its most significant functions are to act as a forum for discussion of the Three Rs, to consider ethical and regulatory issues raised by animal research and to undertake an initial cost-benefit assessment before a licence application is passed to the institute’s certificate holder.
13.54 As has become clear during the discussions of members of the Working Party and also from responses to our Consultation, views differ on whether the provisions of the A(SP)A are sufficient in scope and detail; whether they are always interpreted correctly; and whether, in its practical application, the legal requirements are always implemented effectively. For example, respondents to the Consultation made the following observations: ‘I’m not sure that present regulations are appropriate. For one thing how can researchers tell if there will be welfare problems in advance?’
Anonymous
‘Current provisions for the assessment of welfare of animals are rigorous and of high quality, but must be continuously revised and improved as our knowledge and understanding increases… Assessments of welfare should be conducted before, during and after a project.’
Biosciences Federation
‘Although inspection is important, it is the culture of care at a particular establishment which is paramount. In this regard, the Ethical Review Process mandated by A(SP)A is I believe unique to UK legislation. The Home Office Inspectors play a valuable role in education and sharing of best practice in this activity.’
Anonymous
‘Legal protection for GM animals is inadequate and changes in the law are required in order to afford them due consideration. This is, not least, because their use, certainly on its current scale, was not foreseen when that legislation was introduced.’
Animal Aid
‘The current licensing system proscribes everything which is not specifically permitted on an individual project basis, rather than legislating what may and may not be done by everybody in order to maintain standards of welfare. This has generated a vast bureaucracy which undoubtedly impedes the progress of science.’
Dr R M Ridley and Dr H F Baker
‘Significant tightening of regulation would make either research more difficult, increase costs and delay patient benefits or move research off shore to less detailed regulatory climates, at a significant cost to the UK’s science base as well as to the welfare of the animals involved.’ Genetic Interest Group
13.55 The Working Party’s conclusions and recommendations with regard to regulatory aspects of animal research are presented in Chapter 15 (see paragraphs 15.53–15.56 and 15.84–15.87). So far we have reviewed the wide scope of costs and benefits arising from the uses of animals in different areas (Chapters 4–9), as well as the current state and potential of the Three Rs (Chapters 11 and 12) and the regulatory framework. We now consider how these findings should be viewed from an ethical perspective.