Ethics of Research involving animals
Other issues
Motivating and monitoring Reduction of research involving animals
One way of motivating and monitoring reduction of animal experiments would be to set targets. The most radical form of target would be to aim to abandon or phase out a specific area of animal experimentation. Members of the Working Party disagree about the setting of targets. Those who favour the approach argue that without targets there tends to be drift and fatalism (paragraph 15.65). Those who have major reservations question the feasibility of the approach and assert that those accountable can be unfairly held responsible for unrealistic expectations (paragraph 15.66).
We accept that setting targets is not straightforward:
- We welcome the concept of targets as a useful and universally used means of measuring progress towards specific aims. But we also see problems in applying such a strategy to research involving animals, where, in many cases, the setting of specific quantitative (numerical) targets is felt by those using animals in research to be unhelpful. Instead, we suggest that Reduction could be encouraged and monitored by means of a more flexible approach. One way would be to consider qualitative markers of reduction, for example, aimed at reducing research that causes substantial suffering. The Government’s Inter-Departmental Group on the Three Rs should undertake or commission a feasibility study to identify which kinds of reduction marker could be set in particular areas of applied and/or basic research.
- In principle, reduction markers should only be set if they can be linked to a realistic strategy for developing the necessary Replacement methods that will not compromise the amount and quality of basic and applied biomedical research and testing that would otherwise be licensed by the Home Office. Reduction markers that ‘ration discovery’ are not compatible with the scientific approach.
- The development of any strategy should primarily be the responsibility of legislative bodies and governments, as should the task of providing the infrastructure and some of the funding to facilitate the process, in close consultation with stakeholders from academia, industry and animal protection groups.
- In implementing reduction markers it is crucial that initiatives at the national level are complemented, although not limited by, initiatives at the international level (paragraph 15.67).
Duplication of research
Another area where there may be potential for reduction concerns the avoidance of duplication of research or testing (paragraphs 12.6 and 15.16). There is a range of views about whether or not research is duplicated frequently (paragraph 15.69). However, we have not explored in this Report the question of the extent to which duplication occurs, or the feasibility of devising mechanisms that help to avoid the duplication of research. But we are clear that, in principle, duplication of harmful research is unacceptable (paragraph 15.16) and we therefore welcome the approach underlying the UK Government’s Inter-Departmental Data Sharing Concordat (paragraph 12.6). The Concordat has recently been reviewed by the Government who commented that the agreement had ensured that ‘regulators promote data sharing within the scientific community’, noting also that there was no evidence that duplication was ‘a significant problem in the UK’.12 The Working Party has not been able to study the review, and is hence not in a position to comment on the Government’s view.13 We also note that the APC welcomed the Concordat in its 2003 Report Review of Cost-Benefit Assessment in the Use of Animals in Research14 but cautioned that it is not yet clear how effective it will be in preventing duplication of animal studies. In particular, the APC was concerned about the voluntary nature of the Concordat, and considered whether more binding measures, such as legislation, will be needed to achieve the Concordat’s aims. We endorse the APC’s conclusion that the operation and effectiveness of the Concordat should be monitored carefully and reports placed in the public domain. The Concordat will be reviewed again in 2006. Depending on the outcome of the reviews,15 Ministers should explore whether it would be useful to request the APC to undertake a systematic study addressing in more detail specific issues raised by the possible duplication of research. Such a study could complement and develop further the review of the Concordat (paragraph 15.70).
The scientific validity of animal research and the use of animals in the study of human disease
The question about the scientific validity of animal experimentation for medical purposes is often confused with questions about complex ethical issues. Separation of scientific and ethical questions is essential if greater clarity is to be achieved in the debate about animal research. At present, there is a relatively limited number of useful systematic reviews and meta-reviews that address the question of the scientific validity of animal experiments and tests. In principle, it would therefore be desirable to undertake further systematic reviews and meta-analyses to evaluate more fully the predictability and transferability of animal models (paragraph 10.39). We recommend that the Home Office in collaboration with major funders of research such as the Wellcome Trust, the MRC, the Biotechnology and Biological Sciences Reserach Council (BBSRC), animal protection groups and industry associations such as the Association of the British Pharmaceutical Industry (ABPI) should consider ways of funding and carrying out these reviews. In devising a strategy, priorities should be identified which, in order to respond to concerns of the public, consider, among other things, the validity of research that falls in the substantial category and research that involves primates (paragraph 15.80).
The use of genetically modified (GM) animals in basic research
Specific problems in relation to assessing welfare may be raised by relatively novel ways of producing animals, such as genetic modification or cloning. We take the view that the focus of concern, in the case of all deliberate attempts to influence the genetic basis of animals, should be on the welfare implications in terms of the likely pain, suffering or distress.
Documentation of the phenotypic outcomes of genetic modification (i.e. documentation about the way in which animals are affected) can facilitate the future monitoring and assessment of welfare implications experienced by animals produced in the context of ‘forward’ or ‘reverse’ genetics (paragraph 5.23). A systematic approach to the description of GM phenotypes is crucial for assessing and monitoring welfare implications, and for undertaking thorough cost-benefit assessments. For this reason, we recommend that more efforts should be made to establish
12 Home Office (2005) Ministerial Response on the Report by the Animals Procedures Committee – Review of Cost Benefit
Assessment in the use of animals in research, p10, available at:
http://www.homeoffice.gov.uk/docs4/jw280305flint_banner_report_by_the_animal_procedures_committee.pdf. Accessed on: 21 April 2005.
13 Parliamentary Under Secretary of State Caroline Flint commented in the Government’s response of 28 March 2005 to the
APC’s Report on the cost-benefit assessment that ‘the outcome of the review’ would be published as an Annex to the
Minutes of the Inter-Departmental Group on the Three Rs, see Home Office (2005) Ministerial Response on the Report by
the Animals Procedures Committee – Review of Cost Benefit Assessment in the use of animals in research, p10, available at:
http://www.homeoffice.gov.uk/docs4/jw280305flint_banner_report_by_the_animal_procedures_committee.pdf. Accessed on:
21 April 2005. However, the Working Party was not able to consider this document before finalising this Report.
14 Animal Procedures Committee (2003) Review of cost-benefit assessment in the use of animals in research, p52, available at:
http://www.apc.gov.uk/reference/costbenefit.pdf. Accessed on: 4 April 2005. 15 See footnote 14.