Ethics of Research involving animals
Regulation
Cost-benefit analysis and moral agency
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,6 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 therefore 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 a number of other individuals and committees are involved in assessing directly or indirectly the costs and benefits of a project. Furthermore, we concluded that 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 also not intended to function in this way (paragraph 15.55).
We therefore welcome the APC’s clarification and recommend that those involved in reviewing research proposals (Fig 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 (paragraph 15.56). 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 Medical Research Council (MRC) and the Wellcome Trust, routinely invite external reviewers to comment on welfare issues and the way the Three Rs are considered in research proposals that involve the use of animals. However, there is anecdotal evidence that this practice is not universal, and we strongly recommend that other funding bodies review their approach (paragraph 15.56).
Information about the cost-benefit assessment
The APC’s 2003 Report, Review of cost-benefit assessment in the use of animals in research, provides very useful information about the application of the cost-benefit assessment in practice.7 The Report also observes that relevant information is spread across several different documents, and recommends that ‘there is a need for an easy-to-use, comprehensive list of factors to be taken into account in assessing costs, benefits and scientific validity, that could guide researchers and others engaged in ethical review under the act, such as members of Ethical Review Processes (ERPs).’8 We endorse this recommendation. Since Ethical Review Processes (ERPs) should, ideally, also include lay people, it is important that this information is provided in a way that is accessible to non-experts. Such a document would also be of use to the general public and the same information therefore should be provided in an accessible manner on the websites of the Home Office for the general public. These materials should include specific case studies and also a summary of the process of how decisions are made in practice (paragraph 15.38).
Information about licensed research projects
We note that, following an announcement by the Government in 2004, the Home Office has made available the first anonymised information in the form of Abstracts of Project Licences9 in January 2005. We welcome the principle of publishing more information, and the decision to make it available in a searchable and publicly accessible database in due course. We also note that the information provided in the first Abstracts varies in content, level of detail and style of presentation. We therefore recommend that the current form of presentation be reconsidered, to ensure that, as far as possible, meaningful information about the following categories is provided:
- the goals and predicted benefits of research;
- the probability of achieving these goals;
- the numbers and species of animals to be used, and an explanation of why they are needed at this stage in the project;
- what is likely to happen to the animals during the course of the project, including adverse effects from husbandry, supply, transport and procedures;
- what consideration has been given to the Three Rs to achieve all or part of the research objective(s), and how they have been applied;
- on what grounds possible alternatives have been rejected;
- source(s) of funding (i.e. public, private or both) (paragraph 15.35).
Footnotes
7 The criteria for making cost-benefit assessments are discussed in Chapters 3 and 4 of the APC’s Report (see especially Chapter 4,
Boxes 4.4, 4.5 and 4.6); Animal Procedures Committee (2003) Review of the cost-benefit assessment in the use of animals in
research, available at: http://www.archive.official-documents.co.uk/document/hoc/321/321.htm Accessed on: 4 May 2005.
8 Animal Procedures Committee (2003) Review of the cost-benefit assessment in the use of animals in research, p73, available at:
http://www.archive.official-documents.co.uk/document/hoc/321/321.htm. Accessed on: 4 May 2005.
9 Home Office (2005) Abstracts of project licences granted under the 1986 Act, available at:
http://www.homeoffice.gov.uk/docs4/abs_projectlicences0.pdf. Accessed on: 21 April 2005. The Home Office has previously
released details of ten project licences under a Code of Practice which preceded the Freedom of Information Act 2000, see
Box 13.46 The Home Office Inspectorate carries out this assessment and advises the Secretary of State who takes formal responsibility
for the granting of licences.