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T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s Neurobiology 10.5 Animal studies have also contributed to our knowledge <strong>of</strong> the human nervous system (see paragraph 5.11). Primates have been used in <strong>research</strong> aimed at understanding how complex brains work, as their neurological development and higher cognitive functions are very similar to humans. Members <strong>of</strong> the Working Party observed <strong>research</strong> being undertaken on macaque monkeys which sought to investigate how activity in groups <strong>of</strong> brain cells in the motor cortex controlled specific hand and finger movements. <strong>The</strong> purpose <strong>of</strong> this <strong>research</strong> was to increase understanding <strong>of</strong> how stroke can impair use <strong>of</strong> the human hand. Similar <strong>research</strong> has led to the development <strong>of</strong> treatment to reduce the symptoms <strong>of</strong> Parkinson’s disease (see Box 5.4). With regard to welfare implications arising from the experimental procedure itself, the introduction <strong>of</strong> very fine microelectrodes into the brain is not painful for the animal, because the brain itself has no pain receptors. Animal development 10.6 <strong>The</strong> study <strong>of</strong> animal development has contributed to our knowledge <strong>of</strong> basic processess in human embryonic development. Chick, zebrafish, rodent and frog embryos are <strong>of</strong>ten used to gain a better understanding <strong>of</strong> the roles <strong>of</strong> single genes or groups <strong>of</strong> genes in developmental processes (paragraph 5.12). GM mammalian embryos have also been created for this purpose (paragraph 5.13). Research on juvenile and adult <strong>animals</strong> has also been important, especially in mammals, where major development occurs after birth (paragraph 5.15). Genetic <strong>research</strong> 10.7 Genetic studies constitute a significant part <strong>of</strong> animal <strong>research</strong> and are likely to increase dramatically in future, with experts in the field estimating that over the next two decades 300,000 new transgenic mouse lines could be created (paragraph 5.22). Spontaneous mutants, deliberate random mutations and targeted mutations have all provided useful information on gene function (paragraphs 5.16-5.22). Large programmes <strong>of</strong> mutagenesis in mice have been initiated, which aim to characterise the functions <strong>of</strong> both individual and combinations <strong>of</strong> mouse genes (see paragraph 7.5). With regard to the welfare <strong>of</strong> <strong>animals</strong> used in such <strong>research</strong>, the defects that may result from a genetic manipulation cannot usually be predicted in advance. In many cases gene knock-outs produce no obvious abnormality, although in others, they may lead to serious effects. Studies vary considerably in design and conduct and the likelihood <strong>of</strong> negative welfare effects including minor or severe discomfort and increases in mortality and susceptibility to disease varies accordingly (paragraph 4.57). Methods <strong>of</strong> producing GM <strong>animals</strong> also have the potential to be painful and distressing. In mice, this usually involves hormone injections, surgical embryo transfer (which may be undertaken without pain relief) or surgery to produce vasectomised males, tail biopsy or ear notching. Where possible, the use <strong>of</strong> pain relieving medicines can help to reduce the effects for the <strong>animals</strong> (see paragraphs 4.12 and 4.58). <strong>The</strong> methods used to produce GM <strong>animals</strong> are relatively inefficient (3-5%), and substantial numbers <strong>of</strong> <strong>animals</strong> do not have the desired genetic traits and are usually euthanised (see Box 5.6). Animal cloning 10.8 <strong>The</strong> process <strong>of</strong> cloning <strong>animals</strong>, which aims to create genetically near-identical <strong>of</strong>fspring (paragraph 5.26), has a range <strong>of</strong> potential uses. <strong>The</strong>se include medical applications such as facilitating the provision <strong>of</strong> organs for xenotransplantation, or pharming (paragraph 5.31). In principle, the technology can also be used for other purposes, for example to produce ‘copies’ <strong>of</strong> farm or sport <strong>animals</strong> with desirable traits, or to replace deceased pets. <strong>The</strong> technology is still very inefficient and there is a high probability <strong>of</strong> malformations. <strong>The</strong> longterm implications for welfare are not yet known for most <strong>animals</strong> (see paragraphs 3.41–3.43). 172
T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s Production <strong>of</strong> <strong>research</strong> tools 10.9 Animals are widely used for the production <strong>of</strong> antibodies, which can be employed to identify, localise, quantify or purify a substance. To produce antibodies against an antigen <strong>of</strong> interest, an animal is repeatedly immunised with the antigen together with an immunostimulant (an adjuvant), and the antibodies are then harvested from the blood. <strong>The</strong> use <strong>of</strong> adjuvants in <strong>animals</strong> (which are not always required) can lead to the development <strong>of</strong> sterile abscesses or lameness after intramuscular injections into the leg. Immunisation can sometimes cause anaphylaxis which can be lethal. <strong>The</strong> use <strong>of</strong> mice, primed with an irritant, to produce large amounts <strong>of</strong> a monoclonal antibody in ascitic fluid in the peritoneal cavity is now rarely used in the UK; it has been replaced by an in vitro method. Animals in the study <strong>of</strong> human disease (Chapter 6) 10.10 Animals are used for the study <strong>of</strong> diseases affecting <strong>animals</strong> and humans to learn about causal factors, development and infectivity, and to explore therapeutic and preventative strategies. Many diseases induce complex and dynamic interactions between molecular, cellular and organ systems. Although in vitro experiments form an important part <strong>of</strong> <strong>research</strong> on diseases, scientists whose work involves <strong>animals</strong> emphasise that their work is crucial in understanding the interactions <strong>of</strong> these complex processes. Disease models can be obtained by discovery <strong>of</strong> spontaneous mutations, by selective breeding or by means <strong>of</strong> more targeted interventions such as genetic modification (paragraphs 10.16-10.18). If <strong>animals</strong> are to provide useful models, it is only important that relevant elements <strong>of</strong> their bodily processes are similar to those <strong>of</strong> humans. In some cases this may mean that although <strong>animals</strong> can be useful models for the study <strong>of</strong> diseases that cause great suffering in humans, the <strong>animals</strong> used may not experience the same level <strong>of</strong> discomfort. In others, <strong>animals</strong> may spend much (or all) their lives suffering from the animal form <strong>of</strong> the disease under study. CHAPTER 10 SUMMARY OF SECTION 2 10.11 We described two recently developed disease models for rheumatoid arthritis (RA) and transmissible spongiform encephalopathies (TSEs). RA is one <strong>of</strong> the most common human autoimmune diseases. It is a crippling disease resulting in chronic inflammation <strong>of</strong> the joints, the cause <strong>of</strong> which remains unknown. In the last ten years there have been major advances in the understanding <strong>of</strong> the disease process. Both animal and non-animal approaches to <strong>research</strong> have been pursued simultaneously and <strong>of</strong>ten by the same <strong>research</strong>ers (paragraph 6.5). Study <strong>of</strong> rodent models with induced arthritis helped to contribute to the discovery that an immune molecule called TNF plays a crucial role in the inflammatory process. <strong>The</strong> <strong>animals</strong> experienced a painful swelling <strong>of</strong> the paws, and damage to the cartilage which would have affected the <strong>animals</strong>’ welfare since rodents use their front feet extensively for grooming, holding food, eating and moving around. Various interventions were tested on the models, aimed at neutralising the inflammatory reactions by blocking the molecule through administration <strong>of</strong> antibodies. This strategy had dramatic effects on reducing the inflammation and damage caused by the disease in mice. In the early 1990s, clinical trials were carried out in humans and proved successful (see paragraphs 6.9-6.10). Some 200,000 people have since been treated effectively with the antibody therapy. 10.12 When BSE emerged in cattle in the mid-1980s little was known about its causes and infectivity (paragraph 6.12). Experimental <strong>animals</strong> were used to test the novel hypothesis that the disease was caused by abnormal forms <strong>of</strong> a protein, called prions. Transmission <strong>of</strong> BSE to monkeys by injecting bovine prions into their brains was the first demonstration that the disease was able to cross the species barrier to primates, and ultimately also to humans. In 1996, the first cases <strong>of</strong> vCJD occurred in people in the UK who had been exposed to the BSE agent. Experiments using mice were used to define important stages in the development <strong>of</strong> spongiform encephalopathies. <strong>The</strong> mice typically experienced progressive 173
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The ethics
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The ethics
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Foreword The issue
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Table of contents
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Stages 1-2: discovery and selection
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Conclusions and recommendations ...
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Terms of reference
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T h e e t h i c s o f r e s e a r c
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Chapter 1 Introduction
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Chapter 2 The cont
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Chapter 3 Ethical issues raised by
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Chapter 4 The capa
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Section 2 Use of <
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Chapter 5 The use
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Chapter 6 The use
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Chapter 14 Discussion of</s
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Appendices
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Genetic screening: ethical issues P
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