Ethics of Research involving animals
Development and implementation of the Three Rs
15.57 We have observed that the Three Rs have a crucial role in the ethical justification of research. With regard to Replacements we concluded that it is necessary to ask the question of why Replacements in specific research areas are not available, and what is required to make them so (paragraph 3.63 and 11.19–11.30). A slightly different situation prevails with regard to Refinement and Reduction in that relevant information about these strategies exists in many areas, but their use and application is not sufficiently widespread. We referred to research showing that there is some variance in the application of Refinement,30 and we also identified possible barriers, highlighting scientific, regulatory, organisational, and resource factors (paragraphs 12.23–12.28), all of which can have impact on the implementation of Refinement methods. Below we present our conclusions and recommendations with regard to improving the application of the Three Rs.
Publishing information about the Three Rs
15.58 Many members of the research community emphasise that, wherever possible, they implement the Three Rs, often exceeding regulatory requirements. In some cases, advances are made by individual researchers, but knowledge of improved practices tends to be limited to colleagues in the research establishment, and may not always be disseminated nationally or internationally in a systematic manner. In order to improve knowledge about and awareness of the Three Rs we recommend that all journals publishing results of research involving animals consider the inclusion of a category on the Three Rs in the methodology section.31 Many journals now also provide supplementary information for articles on websites, and details about the implementation on Three Rs could be provided in this way.
Coordination of efforts between funding bodies and the NC3Rs
15.59 Medical research charities and research councils fund a large amount of animal research and should be encouraged to take more responsibility for the promotion and implementation of the Three Rs. Further to recommending that external reviewers comment on the way the Three Rs have been implemented in funding proposals (paragraph 15.56), we consider that those who fund research have two additional responsibilities. First, in order to improve a systematic application of the Three Rs, funding bodies should request that for each project that receives funding, a short summary be submitted to the NC3Rs which describes the way in which the Three Rs were implemented in the project, which obstacles were encountered and how they might be overcome in the future. This information would be useful to the NC3Rs in promoting exchange of experience and fostering best practice. Secondly, based on this information, and in consultation with the NC3Rs, funding bodies should encourage funding applications for
Three R-related research in areas that pose challenges.
Enhancing the role of the Ethical Review Process (ERP)
15.60 The ERP has the potential to make a greater contribution to the identification, promotion and implementation of the Three Rs and could play a more proactive role in identifying best practice and helping to facilitate exchange of information. When the ERP was established in 1999, one of its main objectives was to promote the application of the Three Rs (see paragraph 13.23). However, in practice, many ERPs focus on the review of licence applications, and although this includes consideration of the Three Rs in relation to the specific project, there is potential for a more general contribution. For example, some ERPs have dedicated Three Rs groups that review husbandry and procedural issues. We acknowledge that some organisations, particularly the LASA and the RSPCA, have organised meetings for ERP members in the past to assist this process. We support this approach and recommend that these two organisations, together with other stakeholders where appropriate, identify a systematic and sustainable strategy to ensure that the ERP contributes most effectively to developing best practice in the Three Rs.
Examination of new technologies for Three R potential: Chair of the Three Rs
15.61 We have described the complex interplay leading to the development of Replacements in Chapter 11. Strategic examination of new scientific technologies for Replacement potential, their adaptation for general use and transfer of the technology could help to ensure further progress. Scientists working in basic research who develop new methods for specific research questions often do not have the Refinement, Reduction or Replacement of animal experiments as their main objective and tend not to adapt or promote new methods for this purpose. Much more ‘horizon scanning’ is needed. The Working Party has therefore considered whether it would be useful to institute at least one Chair of the Three Rs, to undertake research on new technologies for Refinement, Reduction and Replacement potential and to encourage students to carry out research with an emphasis on alternative methods. Several issues would need to be assessed in more detail before such a proposal could be developed further. First, the relationship of the Chair to existing initiatives and organisations that seek to promote the Three Rs would need to be clarified, to avoid duplication of effort, and to ensure that funds to promote the Three Rs are spent most effectively. Secondly, the exact profile of the Chair would need to be carefully defined, to assess whether it would be more appropriate to focus the review of the wide range of new technologies in different areas of research on one of the Three Rs only, for example on Replacement. We have therefore not been able to agree on whether or not a Chair would advance and contribute to increased implementation of the Three Rs. However, we consider that it would be of value if the MRC, the Wellcome Trust and other major funders of research, in consultation with the NC3Rs, review and explore further the proposal of establishing and funding such a Chair.
Thorough analysis of scientific barriers to Replacements
15.62 We have considered in Chapter 11 a range of different barriers to Replacements, including regulatory, organisational and resource constraints (paragraphs 11.19–11.30). These difficulties are sometimes cited to dismiss further consideration of Replacement as unfeasible, regardless of the exact objectives of a particular research project. We also observed that some of those opposed to research involving animals claim that a far wider range of research than is commonly assumed could be replaced by alternative non-animal methods, if there was sufficient will to do so (paragraph 11.3). In order to make further progress in the development and the implementation of Replacements, and in order to address the range of associated expectations it would be desirable to undertake a thorough analysis of the scientific barriers to Replacement and how they might be overcome. This task cannot be addressed in general terms, but requires an in-depth analysis of specific projects in particular areas of research. Since the unavailability of non-animal methods plays a central role in the cost-benefit assessment carried out under the A(SP)A,32 we recommend that Ministers request the APC to undertake or commission such an analysis for a series of projects with a wide range of scientific objectives. A clear exposition of obstacles, and strategies for overcoming them would, first, allow research efforts to be focused on problems that must be overcome if animals are to be replaced for a particular purpose. Secondly, such an analysis would identify publicly the scientific problems which are thought to be insurmountable.