The Use of Non-Human Animals in Research: a Guide for Scientists the Use of Non-Human Animals in Research: a Guide for Scientists

The use of non-human animals in research: a guide for scientists The use of non-human animals in research: a guide for scientists Contents page Preparation of this guide iv 1 Introduction 1 2 Examples of medical advances dependent on the use of animals in research 3 3 From discovery to drug 7 4 Ethical approaches to the use of animals 10 5 Refinement, reduction and replacement of animals in research 13 6 Conclusion 18 7 Links to other websites 19 8 References 20 Appendix 1: Legislation 23 Appendix 2: Statement of the Royal Society’s position on the use of animals in research 27 The guide contains the fellowship case studies 1 Polio vaccine 5 2 Kidney dialysis and kidney transplants 6 3 Gastric acid secretion and histamine binding 7 4 Cystic fibrosis 9 5 Refinement 14 6 Reduction 15 7 Replacement 17 Box 1 Ethical issues surrounding the use of genetically modified animals 12 Preparation of this guide 1 Introduction replace the use of animals with non-animal alternatives where appropriate. However, the This guide has been endorsed by the Council of the Royal Society. It has been prepared by Humans have benefited immensely from use of non-animal alternatives may not be members of the Royal Society Animals in Research Committee. scientific research involving animals, with appropriate for some types of research, and virtually every medical achievement in the these experiments may be permitted provided The members of the Committee were: past century reliant on the use of animals in they are designed to keep pain and suffering Sir Patrick Bateson FRS (Chair) Biological Secretary and Vice-President, Royal Society some way. Developments in the treatment to a minimum. The majority of research of diabetes, leukaemia and heart surgery using animals (84%) involves the use of Professor Peter Biggs CBE FRS Visiting Professor of Veterinary Microbiology at the Royal transplants, amongst others, have been rodents as experimental subjects, with the Veterinary College, University of London made possible through the use of animals in use of non-human primates for research scientific research. The majority of the purposes, which are subject to particularly Professor Alan Cuthbert FRS Department of Medicine, University of Cambridge scientific community consider that the benefits rigorous control due to the special protection that have been provided by the use of animals granted to them under the 1986 Act, Professor Innes Cuthill School of Biological Sciences, University of Bristol in research justify this use. The public also accounting for less than one percent of total increasingly accepts the use of animals in animal experiments. Basic research and drug Dr Michael Festing Ex-MRC Toxicology Unit, University of Lancaster research, with a recent poll finding that development accounted for 82% of all 90% of the public accepted the need for procedures, with safety testing accounting Professor E Barry Keverne FRS Sub-Department of Animal Behaviour, University of Cambridge the use of animals, providing that certain for the remaining 18% (Home Office 2003a). research conditions were met, which are: Dr Sheila King there is no unnecessary suffering; the Opponents of the use of animals in research research is for serious medical or life-saving frequently use the availability of alternative, Professor Clive Page Guy's, King's and St Thomas' School of Biomedical Sciences purposes; and there is no reliable and nonanimal, research methods as evidence informative alternative to their use that research using animals is unnecessary. Professor Ole Petersen FRS MRC Secretory Control Research Group, University of Liverpool (MORI 2002). It is important to recognise It is true that non-animal methods, such as that although a significant proportion of tissue culture, computer modelling, research Professor Nancy Rothwell School of Biological Sciences, University of Manchester work using animals is basic research whose using human test subjects and population benefits to health are not immediately studies, are frequently used and have utility Dr Matthew Rushworth Department of Experimental Psychology, University of Oxford evident, this work is highly valuable as it for scientific and medical research. However provides the groundwork for future medical these methods are generally used in addition Dr Vince Walsh Royal Society Research Fellow, Institute of Cognitive advances. The appropriate moral stance for to animal studies, and do not replace them. Neuroscience & Department of Psychology, all use of animals in research is to minimise All the research techniques using animals University College London animal suffering and maximise the benefits described in this guide have very high Secretariat to medicine and health, agriculture and value and utility for scientific and medical Olivia Roberts Science Advice Section, Royal Society fundamental understanding. understanding and it is rarely possible to replace them with a non-animal alternative. Animal research only takes place after careful This is because a research study often Throughout this Guide, the word ’animals’ is used to indicate non-human animal research subjects. evaluation and within a framework of robust requires more than knowing how individual This distinction is required as the valuable research carried out using non-human animal studies controls. UK legislation requires that molecules, cells or tissues behave. Instead, frequently provides the groundwork to advances in scientific and medical understanding, with researchers refine their procedures to keep scientific research, and medical research in potential benefit for human and animal health. This can then be further refined through the suffering to the minimum, ensure the number particular, often depends on understanding use of human subjects in research studies. Such studies are conducted and regulated entirely of animals is reduced to the minimum not only the processes of the living body but separately to research projects using non-human animals, and are not addressed in this report. required for meaningful results, and seek to how they interact. It is unethical and illegal iv I February 2004 I The use of non-human animals in research The use of non-human animals in research I February 2004 I 1 to expose human patients to new medicines of philosophies that underpin the debate 2 Examples of medical advances conditions than could reasonably be achieved without being confident that they are likely about the use of animals in research. dependent on the use of in humans. Human patients can be highly to benefit and not be seriously harmed, so The guide is not intended to be a manual of animals in research heterogenous in disease symptoms and their the only alternative is to use the most suitable how to conduct research. Nor is it a substitute behavioural variability, such as differences in animal to study a particular disease or for good advice on experimental design, The understanding of the human body has patients’ compliance with instructions, is far biological function. Additionally, in drug statistical analysis or any of the other aspects come from more than 200 years of research more significant in human trials. In certain development, animal tests are used to of conducting a successful research project. on the function of normal cells, tissues and uses of animals as models, such as mouse establish both the benefits and the potential The Royal Society takes an active role in policy organs, and on disease processes. Much of ‘knock-out’ models, in which individual toxicity of substances and ensure that human discussions about the use of animals in this understanding has been facilitated by genes are switched off to study the effect, volunteer studies are carried out with a full research with numerous bodies, including research that was performed on animals. researchers can even control the genetic scientific understanding of the substance government departments, funding agencies, This fundamental knowledge underpins the make-up of the experimental subjects to involved, to maximise the benefits and avoid charities and discussion meetings (Royal teaching of medicine and veterinary medicine ensure homogeneity. possible serious side effects. Further discussion Society 2001 & 2002). The Society believes in and has been instrumental in the development of these issues of the refinement, reduction the importance of evidence-based discussion of medical advances for both people and Opponents to the use of animals in research and the replacement of animals in scientific and debate, with a view to refining and animals. It is no exaggeration to say that claim that using animals as models for humans research can be found in Chapter 5. strengthening best practice in the use of almost every form of conventional medical is invalidated by the differences between animals in research. We hope that this treatment, such as drugs, vaccines, radiation humans and animals. Evidence presented to Within this guide, the following issues are document will be of particular use to those or surgery, rests in part on the study of animals support this argument includes the case of considered: examples of medical advances scientists in the early stages of their research (US Department of Health and Human the unpredicted limb defects that occurred in that have been achieved through the use careers using animals, and are entering the Services 1994). However, this fundamental the children of women who took the drug of animals; the theoretical framework behind debate surrounding the use

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