The ethics of research involving animals - Nuffield Council on ...

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What is the appropriate role <strong>of</strong> regulation for <strong>research</strong> <strong>involving</strong> <strong>animals</strong>?...............................55 Two views about moral agency .............................................................................................55 Should regulations be relaxed or tightened to achieve least risk and best moral practice? ...55 Summary............................................................................................................................................57 Chapter 4 – <strong>The</strong> capacity <strong>of</strong> <strong>animals</strong> to experience pain, distress and suffering....59 Introduction.......................................................................................................................................61 Philosophical problems with regard to assessing the welfare <strong>of</strong> <strong>animals</strong>....................................62 <strong>The</strong> evolutionary continuum............................................................................................................64 Pain, suffering and distress: meaning and function in <strong>animals</strong> and humans...............................66 Subjective and objective elements <strong>of</strong> assessing welfare: a correlative approach......................................................................................................................68 Summary <strong>of</strong> paragraphs 4.3–4.28 ....................................................................................................72 Sources <strong>of</strong> harm for laboratory <strong>animals</strong>..........................................................................................73 Summary............................................................................................................................................81 SECTION 2: USE OF ANIMALS IN SCIENTIFIC RESEARCH . . . . . . . . . . . . . . . . .83 Introduction to Section 2.......................................................................................85 Chapter 5 – <strong>The</strong> use <strong>of</strong> <strong>animals</strong> in basic biological <strong>research</strong> .............................87 Introduction.......................................................................................................................................89 Behavioural studies...........................................................................................................................89 Physiological studies .........................................................................................................................90 Studies <strong>of</strong> animal development .......................................................................................................95 Genetic studies ..................................................................................................................................96 Research tools and techniques.......................................................................................................100 Summary..........................................................................................................................................103 Chapter 6 – <strong>The</strong> use <strong>of</strong> <strong>animals</strong> in the study <strong>of</strong> human disease......................105 Introduction.....................................................................................................................................107 <strong>The</strong> pathogenesis <strong>of</strong> disease ..........................................................................................................107 New therapeutic strategies for rheumatoid arthritis...................................................................108 <strong>The</strong> transmissible spongiform encephalopathies ........................................................................110 <strong>The</strong> discovery <strong>of</strong> the hepatitis C virus using the chimpanzee .....................................................113 Study <strong>of</strong> polio and the development <strong>of</strong> polio vaccine.................................................................114 Diseases for which treatments and cures have been difficult to develop..................................116 Summary..........................................................................................................................................118 Chapter 7 – Genetically modified <strong>animals</strong> in the study <strong>of</strong> human disease.....119 Introduction.....................................................................................................................................121 <strong>The</strong> mouse as a model for human disease....................................................................................122 Disease models in the mouse.........................................................................................................123 Zebrafish and rats as disease models ............................................................................................128 Summary..........................................................................................................................................129 Chapter 8 – <strong>The</strong> use <strong>of</strong> <strong>animals</strong> for <strong>research</strong> in the pharmaceutical industry ...131 Introduction.....................................................................................................................................133 <strong>The</strong> development <strong>of</strong> the pharmaceutical industry .......................................................................133 Use <strong>of</strong> <strong>animals</strong> in pharmaceutical <strong>research</strong> and development....................................................134 VIII
Stages 1–2: discovery and selection <strong>of</strong> compounds that could be effective medicines...136 Stages 3–4: the characterisation <strong>of</strong> promising candidate medicines ................................137 Stage 5: selecting candidate medicines and ensuring their safety ...................................140 Stages 6–8: clinical studies on humans................................................................................142 Support for the marketed medicine....................................................................................144 <strong>The</strong> validity <strong>of</strong> animal models used in pharmaceutical <strong>research</strong>.................................................146 Summary..........................................................................................................................................151 Chapter 9 – Animal use in toxicity studies ........................................................153 Introduction.....................................................................................................................................155 <strong>The</strong> current approach .....................................................................................................................155 Principal types <strong>of</strong> animal based toxicity tests ...............................................................................158 Acute toxicity ........................................................................................................................158 Repeated-dose toxicity studies ............................................................................................160 Carcinogenicity......................................................................................................................160 Genotoxicity ..........................................................................................................................160 Effects on reproduction and development.........................................................................161 Safety pharmacology............................................................................................................161 Ecotoxicity .............................................................................................................................162 Issues concerning the welfare <strong>of</strong> laboratory <strong>animals</strong> in toxicity testing ....................................163 Effects due to toxicity...........................................................................................................164 General observations concerning the assessment <strong>of</strong> animal welfare in toxicity studies......165 Summary ..........................................................................................................................................167 Chapter 10 – Summary <strong>of</strong> Section 2 ...................................................................169 Basic <strong>research</strong> (Chapter 5) ..............................................................................................................171 Animals in the study <strong>of</strong> human disease (Chapter 6) ....................................................................173 GM disease models (Chapter 7) .....................................................................................................174 Animal use by the pharmaceutical industry (Chapter 8)..............................................................175 Animal use in toxicity testing (Chapter 9).....................................................................................176 Extrapolating the results <strong>of</strong> animal studies to humans: the scientific validity <strong>of</strong> animal <strong>research</strong>.....177 General arguments about scientific validity.......................................................................177 All modelling approaches face limitations concerning transferability and predictability....179 Critical evaluation <strong>of</strong> scientific validity ...............................................................................181 Summary ..........................................................................................................................................184 SECTION 3: ALTERNATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185 Chapter 11 – Replacements.................................................................................187 Introduction.....................................................................................................................................189 <strong>The</strong> current debate .........................................................................................................................189 Use <strong>of</strong> the concepts ‘Alternatives’ and ‘Replacements’ ...............................................................190 <strong>The</strong> potential for Replacement <strong>of</strong> <strong>animals</strong> in different areas <strong>of</strong> <strong>research</strong> .................................194 Biomedical <strong>research</strong> ........................................................................................................................195 Barriers to developing Replacements and how these could be overcome.................................195 Making progress – some national and international activities ...................................................199 Summary ..........................................................................................................................................200 IX
Page 1 and 2: The ethics
Page 3: The ethics
Page 7 and 8: Foreword The issue
Page 9: Table of contents
Page 13: Conclusions and recommendations ...
Page 17: 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 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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Section 3 Alternatives
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Section 4 Legal, ethical and policy
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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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