Ethics of Research involving animals
Other issues - continuation I
comprehensive ontologies16 in the form of databases for GM animals. These databases should not be restricted to the receipt and dissemination of phenotypic information relevant to the scientific objectives of the research, but should also provide detailed description of associated implications for welfare. Established central databases such as the Mouse Genome Database (MGD) in the USA17 should be used as the primary mechanism for archiving and distributing information on GM animals. The information should be made available on freely accessible websites for the use of the scientific community and interested lay people (paragraph 15.73).
It is also important to continue to investigate and improve current methods for assessing the phenotypic and welfare status of GM animals. Any terminology and ontology for describing specific welfare implications should be integrated with the emerging phenotype ontologies. We note that current welfare-assessment systems vary with regard to the amount of information and the degree of detail being made available. We recommend that the NC3Rs should consider this variation with a view to advising on the rationalisation and development of phenotype and welfare ontologies and their interrelationships (paragraph 15.74).
We also recommend that scientific journals require the submission of phenotype and associated data about welfare to databases as a condition of acceptance of submitted papers. Although scientists often routinely submit information about new phenotypes to databases such as MGD, a more systematic approach would be useful in promoting the availability of information about both the phenotype and the implications for welfare, which would help avoid duplication and improve welfare management. Data should be provided according to the requirements of the standardised transgenic mouse nomenclature (paragraph 15.75).18
Toxicity testing
Current trends in society suggest that there is an increasing intolerance to risk, although some commentators believe we are now over-zealous in testing requirements. We described the types of procedures typically undertaken in toxicology research in Chapter 9. In view of the severity that some toxicity testing can entail, we endorse the recommendation of the House of Lords Select Committee Report on Animals in Scientific Procedures (2002) that ‘the government and the scientific community should engage more in a systematic and visible search for methods involving the Three Rs in toxicology. The Government should nominate one department to take the lead in this.’ We recommend that the Inter-Departmental Group on the Three Rs should coordinate this work (paragraph 15.81).
With regard to international initiatives the Working Party is concerned about the potential impact of recent European Union (EU) legislation for new and existing chemicals testing (Registration, Evaluation and Authorisation of Chemicals, REACH), which is likely to be implemented by 2006. According to some estimates, had the initial proposal been implemented, up to 12.8 million animals could have been involved for the testing of approximately 30,000 existing chemicals (Box 9.2).19 The conclusion that the scale of testing and use of animals did not appear to justify the additional protection afforded to society has been widely supported, and discussions about the actual implementation were still in progress at the time of writing. Whatever its final form, REACH will greatly increase animal testing across the EU. While we make no detailed recommendation in this area, it is crucial that new approaches to risk assessment that implement the Three Rs most
effectively should be explored, particularly by making maximum use of data sharing and using computational and in vitro tissue culture methods where possible (paragraph 15.82).
16 An ‘ontology’ in this context is an explicit formal specification of terms and the relationships among them, used to underpin
the construction and querying of databases.
17 See Mouse Genome Informatics (MGI) available at: http://www.informatics.jax.org. Accessed on 21 April 2005.
18 See Mouse Nomenclature Home Page, available at: http://www.informatics.jax.org/mgihome//nomen/index.shtml. Accessed
on 21 April 2005.
19 Institute for Environment and Health (2001) Testing requirements for proposals under the EC White Paper – Strategy for
future chemicals policy; available at: http://www.le.ac.uk/ieh/webpub/webpub.html. Accessed on 21 April 2005.