Ethics of Research involving animals
The role of legislation and regulation
15.53 We learned from some of our discussions with representatives of patient groups that reference frequently is being made to the provisions of the A(SP)A, so as to allay concerns by members and non-members about animal research. Whether or not such referrals are suitable for the purpose depends not only on the formal provisions of the law, but also on its application in practice. Many animal protection organisations and respondents to the Consultation expressed concerns about the implementation of the provisions of the A(SP)A and quoted what they believed to be examples of ineffective regulation.25 In contrast, many members of the research community who submitted comments were concerned about what they perceived to be overly detailed and burdensome regulation.26 A thorough review of regulation is beyond the scope of this Report and is being considered by other bodies.27 Nonetheless, we offer some general observations below.28
Cost-benefit assessment and moral agency
15.54 The cost-benefit assessment is at the heart of the regulation of research on animals in the UK. There is sometimes the view that the assessment is only being carried out by the Home Office, which ‘tells the researchers what to do’ once it has decided on whether or not a licence application fulfils the criteria of the A(SP)A and is thus, from the regulator’s point of view, acceptable. The APC’s 2003 Report Review of cost-benefit assessment in the use of animals in research observed that this interpretation would be simplistic, since other individuals and committees are involved in assessing directly or indirectly the costs and benefits of a project (paragraph 13.16). The APC therefore emphasised that: ‘project licence holders and others involved in study design and initiation bear responsibility for clearly setting out the costs and benefits of their research and carrying out cost-benefit assessments of their work, including critical evaluation of the need for animal studies at all. The roles of other bodies, such as the Home Office, ERP, and, where relevant, APC, are to evaluate, advise, and in some cases adjudicate the researchers’ own cost-benefit assessments.’29
15.55 We welcome this clarification, which is compatible with our discussion about moral agency (paragraph 3.69). As we have said, it would be wrong to perceive acting morally simply as following rules. Instead, active and continued scrutiny of the costs and benefits is required from all those involved, before, during and after research. This responsibility cannot be devolved to regulators, and, as the APC has emphasised, the system is not intended to function in this way.
15.56 The APC’s clarification underlines the importance of clear guidance on how to make costbenefit assessments. Furthermore, it implies that both funding bodies and peer reviewers who may be involved in assessing licence applications have to take their responsibilities in the review process seriously. We recommend that those involved in reviewing research proposals (see Figure 13.1) at every stage prior to submission to the Home Office consider not only the scientific aspects, but also animal welfare in appropriate detail. Good science and good animal welfare are closely interrelated, and it would be wrong for the scientific review process to ignore animal welfare issues. We are aware that many funding bodies recognise this fact. In addition to assessments by internal review boards, some, such as the Wellcome Trust and the MRC routinely invite external reviewers to comment on welfare issues and the way the Three Rs are considered in research proposals involving the use of animals. However, there is anecdotal evidence that this practice is not universal, and we recommend that other funding bodies review their approach.
Footnotes25 Those critical of the implementation of the A(SP)A point to a number of reports which draw attention to claimed inadequacies
in the implementation of the A(SP)A and they emphasise that the House of Lords Report concluded that the Home Office
Inspectorate should be subject to periodic review, by a body other than the Inspectorate itself. See House of Lords Select
Committee (2002) Animals in Scientific Procedures (Norwich: TSO), paragraph 5.13, Chapter 2, Box 2.9, and Lyons D (2004) In a
collapsed state – Imutran xenotransplantation research: a case study of Home Office enforcement of animal experimentation legislation, Uncaged campaigns, available at: http://www.uncaged.co.uk/. Accessed on 21 April 2005.
26 In support of claims that the implementation of the A(SP)A leads to excessive bureaucracy, researchers involved in animal
experimentation have drawn attention to a number of recent reports including the House of Lords Select Committee Report,
which concluded that ‘The UK should strive not for the tightest regulation, but for the best regulation, properly enforced’,
They have also highlighted several recommendations made in this area by the Select Committee including the simplifying and
shortening of project licences forms, and allowing the ERP to have the authority to approve routine or minor amendments. see
House of Lords Select Committee (2002) Animals in Scientific Procedures (Norwich: TSO), paragraphs 5.33, 5.40, 6.11; Expert
Group on Efficient Regulation (2001) The Regulation of the Use of Animals in Scientific Procedures (London).
27 See, for example, Reports by the APC (available at: http://www.apc.gov.uk), or the Boyd Group (available at: http://www.boydgroup. demon.co.uk).