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

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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 conclusions and recommendations xxvi–xxviii, 265–6 consensus statement xx, 264 context 8–9 current context in UK 28–9 facilitation <strong>of</strong> public, recommendations xxvii–xxviii, 270–1 groups involved 16 historical context 15–28 involvement <strong>of</strong> <strong>research</strong>ers xxviii, 28, 273 range <strong>of</strong> views xvii, 5–6 recent issues 232 see also defenders <strong>of</strong> animal <strong>research</strong>; ethical issues; opponents <strong>of</strong> animal <strong>research</strong> deep brain stimulation (DBS) 94, 95 defenders <strong>of</strong> animal <strong>research</strong> xvii, 5–6, 16, 232 organisations 22 on scientific validity 178 dentistry 296 deontological/rights-based view 48, 51, 241 hybrids 52 deontology 49 Department for Education and Skills xxviii, 270 Department <strong>of</strong> Trade and Industry (DTI) 53 dermal route, in toxicity studies 159 Descartes, Rene 42, 63, 246 design, study critical evaluation 180 improving 205, 206–7 toxicity tests 166 designated establishments 223, 228 development, animal 95–6, 128, 172 developmental toxicity studies 161 diabetes 93, 97, 123–4, 127, 128 diagnosis <strong>of</strong> disease 296–7 diarrhoea 165 diphtheria potency test 146 disease alleviation <strong>of</strong> suffering 36–7 diagnosis 296–7 human see human disease pathogenesis 107 distress 61–81 assessment xxiii, 61–73, 81 defined 62 meaning and function 66–8 severe 164 sources 73–81 see also welfare dogs capacity to flourish 44 cognitive capacities 43 euthanasia 81 handling 77–8 history <strong>of</strong> use 18 inhumane treatment 24 regulation <strong>of</strong> <strong>research</strong> 222 statue in Battersea Park 19 toxicity studies 157, 159, 160, 161–2, 164 welfare needs 71, 76–7 Dolly the sheep 28, 101–2 dose maximum tolerated 159–60, 164–5 no observed adverse effect level 160 dosing volumes 163, 164 welfare issues 79, 163–4 Draize eye-irritancy test 192–3 Dr Hadwen Trust 20, 197 Drosophila see fruit flies drug discovery and development 36, 133, 134–46, 175–6 clinical studies in humans 142–6 history 133–4 identification <strong>of</strong> possible compounds 136–7 lead identification 137–8 lead optimisation 138–40 limitations <strong>of</strong> safety studies 179–80 overview <strong>of</strong> process 135 pre-clinical phases 142 Replacements for <strong>animals</strong> 194 selecting candidates and ensuring safety 140–2 target identification 136 value <strong>of</strong> animal studies 182–3 see also pharmaceutical <strong>research</strong> drug disposition 138 drugs see medicines dualism, mind–body 63, 246 duplication, experimental 207, 208 consensus statement xix, 264 recommendations xxxii–xxxiii, 279–80 ear markings 78, 81 ecological data 70–1 Economic and Social Research <strong>Council</strong> (ESRC) xxviii, 271 economic demand theory 70 ecotoxicity studies 162 education Replacement methods 200 use <strong>of</strong> <strong>animals</strong> 291, 296 young people, recommendations xxviii, 270 embryonic stem (ES) cells 93, 97, 98, 99, 102 embryos animal 95–6 human 102 empathy 62–3, 251, 253 emphysema 102–3 endangered species, conservation 101 endocrine-disrupting chemicals 166 endocrine studies 91–2 endophenotypes 126 endpoints humane 213–14 Refinement 213–14 toxicity tests 159, 164–5, 209 vaccine tests 140, 142, 145–6, 176 enrichment, environmental 44, 76, 211, 212, 214 entertainment 52, 251, 253 Environmental Protection Agency (EPA) (US) 159, 283–4 environments ecotoxicity studies 162 enrichment 44, 76, 211, 212, 214 housing 76–7 identifying suitable 70–1 naturalness 44, 70–1 Refinement 211–12 epilepsy 18, 144 epistemic modesty 250 equidae, regulation <strong>of</strong> <strong>research</strong> 222 erythema nodosum leprosum 145 escape, attempts to 43, 69 ethical issues xxi–xxv, 9–10, 33–57, 241–58 'abolitionist' view 244–5, 252–5 absence <strong>of</strong> Working Party consensus xxiv, 242–3 'anything goes' view 244, 246–7 any use <strong>of</strong> <strong>animals</strong> by humans 38–53 326
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 comparing different uses <strong>of</strong> <strong>animals</strong> 54–5 facts, values and reflective equilibrium 33–4 four possible stances xxiv, 244–55 'moral dilemma' view 244, 249–52 need for special justification 35–8 'on balance justification' view 244, 247–9 public policy and xxiv–xxv, 255–8 questions raised xxi, 33 regulation 55–7 unavailability <strong>of</strong> alternatives 53—4 'weakness <strong>of</strong> morality' view 245, 255 ethical review committee 229 Ethical Review Process (ERP) 223, 229 cost-benefit assessment 226, 229 recommendations xxix, xxx–xxxi, 269, 276 <strong>ethics</strong> 6 ethological data 70–1 etiology, disease 107 Europe (EU) harmonisation <strong>of</strong> international test guidelines 283–4 history <strong>of</strong> animal <strong>research</strong> 15, 16–18 regulation <strong>of</strong> animal <strong>research</strong> 27–8, 233–5 statistics on animal <strong>research</strong> 298, 299 toxicity testing requirements xxxiv–xxxv, 155–6, 166, 282–3 European Centre for the Validation <strong>of</strong> Alternative Methods (ECVAM) 20, 21, 199, 200 European Coalition to End Animal Experiments (ECEAE) 22 European Consensus Platform on Alternatives (ECOPA) 199 European Directives animal <strong>research</strong> (EEC 86/609) 25, 27–8, 221, 233–5 new medicines (EC 2001/83) 236 toxicity testing 155–6 European Directorate for the Quality <strong>of</strong> Medicines 199 European Medicines Agency (EMEA) 103 European Union Resource Centre for Alternatives in Higher Education (EURCA) 200 euthanasia (humane killing) 6, 81 animal models 109, 111, 118 recommendations 267 regulatory control 230 use <strong>of</strong> improper methods 24 evasive behaviour 43 evolution continuum <strong>of</strong> relatedness 64–6, 178 function <strong>of</strong> pain 66–7 moral justification and 40 experimental design see design, study experimental procedures see procedures, scientific experiments, in A(SP)A 222 extrapolation <strong>of</strong> data to humans see scientific validity extremism, animal rights xxvii, 26–7, 271–3 eye-irritancy tests 158, 159, 163, 209 Replacement 192–3 faces, perception <strong>of</strong> 92 facts, and values 33–4 familiarity, animal behaviour 62–3, 251 farm <strong>animals</strong> pharming 102–3 selective breeding 96–7 veterinary medicine testing 143 Federation <strong>of</strong> European Animal Science Associations (FELASA) 21 Feldberg, Wilhelm 24 fertility 161 fetal mortality 81 fish, toxicity studies 157, 162 fixed dose procedure (FDP) 209 fleeing 43 flourish, capacity to 44–6 fluorescent proteins 100 focus groups 9 food production 54, 248, 251, 253, 291 provision, laboratory <strong>animals</strong> 76 food additives 160 Food and Drug Administration (FDA) 236, 283 foraging 76 forced consequentialist sacrifice xxiv, 242, 250, 252 forensic enquiries 296 forward genetics 97 <strong>The</strong> Four Stages <strong>of</strong> Cruelty (Hogarth) 17 FRAME see Fund for the Replacement <strong>of</strong> Animals in Medical Experiments FRAME Alternatives Laboratory (FAL) 20 France 17, 18, 234, 235, 237 Freedom <strong>of</strong> Information (FoI) Act 2000 230, 231, 268 frogs, identification 78 fruit flies 65, 71–2, 97, 122 Fry (Private Member's) Bill 1979 27 Fund for the Replacement <strong>of</strong> Animals in Medical Experiments (FRAME) 20, 27, 197 funding recommendations xxvii, 270, 271 <strong>research</strong> into Replacements 197 funding bodies Chair <strong>of</strong> the Three Rs proposal and xxxi, 276 cost-benefit assessments xxix, 274–5 promoting use <strong>of</strong> Three Rs xxx, 275 reviews <strong>of</strong> scientific validity xxxiii, 282 Galen 15 gavaging 163–4 General Medical <strong>Council</strong> 18 genes in animal development 96 circadian regulation 90 shared between species 65, 121, 123 genetically modified (GM) <strong>animals</strong> 7 in basic <strong>research</strong> xxxiii–xxxiv, 97–100, 172, 280–1 consequences <strong>of</strong> producing 46 databases xxxiv, 281 developmental studies 96 ethical issues 45–6 methods <strong>of</strong> creating 98–9, 172 models <strong>of</strong> human disease 121–9, 174–5 in pharmaceutical <strong>research</strong> 137, 138, 151 public opinion 9 recommendations xxxiii–xxxiv, 280–1 regulatory control 230 scientific validity 181 statistics on use 297, 298 in toxicity testing 166 welfare 80–1, 99, 103–4, 126, 129, 280–1 genetic diseases, animal models 121–9, 174–5 genetic fallacy 253 genetics basic <strong>research</strong> 96–100, 103–4, 172 comparative 126 forward 97 reverse 97–9 genotoxicity studies 155, 160–1 INDEX 327
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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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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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