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

More documents

Recommendations

Info

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 Box 10.1 : Toxicity studies in humans: number <strong>of</strong> trial participants required to be 95 % certain* <strong>of</strong> detecting cases <strong>of</strong> adverse events directly related to the medicine under study Incidence 1 case 2 cases 3 cases 1 in 100 300 480 650 1 in 200 600 980 1,300 1 in 1,000 3,000 4,800 6,500 1 in 2,000 6,000 9,600 13,000 1 in 10,000 30,000 48,000 65,000 * A confidence limit <strong>of</strong> 95% (P
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 Critical evaluation <strong>of</strong> scientific validity 10.37 We have observed that, in principle, animal studies can be scientifically valid. Nevertheless, there is a need for continuing review <strong>of</strong> the scientific case for using <strong>animals</strong> in <strong>research</strong> and testing. It is axiomatic that any such use should be accompanied by active and critical reflection on the validity and relevance <strong>of</strong> the models and <strong>research</strong> studies. 16 Although scientific claims in favour <strong>of</strong> the validity <strong>of</strong> animal <strong>research</strong> are not usually made in absolute terms, some public statements can over-generalise and tend towards the absolute. 17 It is important, for a number <strong>of</strong> reasons, not to overstate the predictive value and transferability <strong>of</strong> animal <strong>research</strong> to humans, because: ■ Critical reflections are a vital part <strong>of</strong> good scientific practice, having value in determining directions and priorities for future <strong>research</strong>, as well as in interpreting the results <strong>of</strong> particular studies and refining models. ■ Better understanding <strong>of</strong> the differences between animal models and the human organism can in itself be instructive and can prompt beneficial lines <strong>of</strong> <strong>research</strong> (paragraph 7.10). ■ It is possible that lack <strong>of</strong> critical evaluation <strong>of</strong> the validity <strong>of</strong> animal models can on occasion be misleading (paragraph 6.32). ■ Over-emphasising the predictive value <strong>of</strong> animal tests can make acceptance <strong>of</strong> alternative approaches unnecessarily difficult. In toxicity testing, for example, existing animal methods have been validated by the OECD ‘by experience’ and have not been subject to the same formal validation processes as those now required for new non-animal Replacements (see paragraphs 9.4 and 11.24). ‘Claiming too much’ for the predictive value <strong>of</strong> existing animal methods can sometimes put unnecessary barriers in the way <strong>of</strong> regulatory acceptance <strong>of</strong> new in vitro methods. 18 CHAPTER 10 SUMMARY OF SECTION 2 10.38 It is clear that continuing critical evaluation <strong>of</strong> the scientific validity <strong>of</strong> animal models makes good scientific sense, and as our description in Chapters 5–9 shows, is usually a part <strong>of</strong> good scientific practice. For example, the majority <strong>of</strong> the scientific community takes the view that similarities between mouse and human genomes are sufficient to permit informative comparisons between GM mouse models <strong>of</strong> human diseases and the human clinical conditions in specific cases. Nevertheless, such models require careful analysis in order to assess their relevance and effects (see Box 10.2). 16 This argument also applies to the use <strong>of</strong> <strong>animals</strong> in studies that are extrapolated to other animal species. 17 See Animal Procedures Committee (2003) Review <strong>of</strong> the cost-benefit assessment in the use <strong>of</strong> <strong>animals</strong> in <strong>research</strong> (London: HO) for further discussion. 18 Some commentators claim that it is easier to achieve OECD approval for new animal, as compared to non-animal methods, see: Written evidence submitted by Dr Gill Langley to the House <strong>of</strong> Lords Select Committee, page 100 based on references from the OECD. 181
Page 1 and 2:
The ethics
Page 3:
The ethics
Page 7 and 8:
Foreword The issue
Page 9 and 10:
Table of contents
Page 11 and 12:
Stages 1-2: discovery and selection
Page 13:
Conclusions and recommendations ...
Page 17:
Terms of reference
Page 20 and 21:
T h e e t h i c s o f r e s e a r c
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 41:
Chapter 1 Introduction
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 51:
Chapter 2 The cont
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 69:
Chapter 3 Ethical issues raised by
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 97:
Chapter 4 The capa
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 121:
Section 2 Use of <
Page 125:
Chapter 5 The use
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 143:
Chapter 6 The use
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167: T h e e t h i c s o f r e s e a r c
Page 171 and 172: T h e e t h i c s o f r e s e a r c
Page 223: Section 3 Alternatives
Page 255: Section 4 Legal, ethical and policy
Page 269 and 270:
Page 271 and 272:
Page 273 and 274:
Page 275 and 276:
Page 277:
Chapter 14 Discussion of</s
Page 280 and 281:
Page 282 and 283:
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
Page 299 and 300:
Page 301 and 302:
Page 303 and 304:
Page 305 and 306:
Page 307 and 308:
Page 309 and 310:
Page 311 and 312:
Page 313 and 314:
Page 315 and 316:
Page 317 and 318:
Page 319 and 320:
Page 321 and 322:
Page 323 and 324:
Page 325:
Appendices
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 376:
Genetic screening: ethical issues P
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?