The ethics of research involving animals - Nuffield Council on ...
The ethics of research involving animals - Nuffield Council on ...
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<br />
11.2) 11 . Sec<strong>on</strong>dly, the nature <str<strong>on</strong>g>of</str<strong>on</strong>g> these tests suggests that it is easier to make progress in this field,<br />
as toxicity testing required by regulati<strong>on</strong> asks defined questi<strong>on</strong>s and tends to involve a limited<br />
number <str<strong>on</strong>g>of</str<strong>on</strong>g> standardised tests, which are repeated (<strong>on</strong> different chemicals) many times. <str<strong>on</strong>g>The</str<strong>on</strong>g>re is<br />
also an established instituti<strong>on</strong>al structure for the validati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> alternatives (see paragraph 11.32).<br />
11.16 Most toxicity testing required by regulati<strong>on</strong> is carried out by industry which has devoted<br />
c<strong>on</strong>siderable resources and managed effort to the development and implementati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
Replacements. <str<strong>on</strong>g>The</str<strong>on</strong>g>se developments have occurred partly in resp<strong>on</strong>se to activities by animal<br />
protecti<strong>on</strong> organisati<strong>on</strong>s, and partly because many alternative approaches are developed as<br />
‘advanced methods’ to solve specific problems (paragraph 8.42). Added impetus has recently<br />
been given by the amendment <str<strong>on</strong>g>of</str<strong>on</strong>g> the EU Cosmetics Directive 12 to impose a marketing ban <strong>on</strong><br />
cosmetics that have been tested or have had any <str<strong>on</strong>g>of</str<strong>on</strong>g> their ingredients newly tested <strong>on</strong> <str<strong>on</strong>g>animals</str<strong>on</strong>g>.<br />
11.17 Standard test methods are also used in the safety and efficacy assessment <str<strong>on</strong>g>of</str<strong>on</strong>g> biologicals,<br />
including vaccines. <str<strong>on</strong>g>The</str<strong>on</strong>g> technical problems in replacing these tests are quite different from<br />
those encountered in the testing <str<strong>on</strong>g>of</str<strong>on</strong>g> chemicals. Further efforts are required to develop and<br />
validate methods that allow replacement <str<strong>on</strong>g>of</str<strong>on</strong>g> the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>, particularly in highly<br />
distressful challenge tests (see paragraph 8.24 and Box 8.5). 13<br />
CHAPTER 11 REPLACEMENTS<br />
Biomedical <str<strong>on</strong>g>research</str<strong>on</strong>g><br />
11.18 In c<strong>on</strong>trast to tests for safety and efficacy, the development <str<strong>on</strong>g>of</str<strong>on</strong>g> Replacements to current uses<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in biomedical <str<strong>on</strong>g>research</str<strong>on</strong>g> is generally perceived as more difficult. <str<strong>on</strong>g>The</str<strong>on</strong>g> scientific<br />
questi<strong>on</strong>s that are addressed in biomedical <str<strong>on</strong>g>research</str<strong>on</strong>g> are more diverse and open-ended, with<br />
less-predictable outcomes. Moreover, the animal model itself is <str<strong>on</strong>g>of</str<strong>on</strong>g>ten the focus <str<strong>on</strong>g>of</str<strong>on</strong>g> the<br />
<str<strong>on</strong>g>research</str<strong>on</strong>g> (see Chapters 6 and 7). <str<strong>on</strong>g>The</str<strong>on</strong>g> objectives and designs <str<strong>on</strong>g>of</str<strong>on</strong>g> biomedical <str<strong>on</strong>g>research</str<strong>on</strong>g> projects<br />
are extremely diverse. It may sometimes be possible to identify certain basic, widely used<br />
techniques that would be amenable to replacement <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>. <str<strong>on</strong>g>The</str<strong>on</strong>g> replacement <str<strong>on</strong>g>of</str<strong>on</strong>g> the<br />
ascites method <str<strong>on</strong>g>of</str<strong>on</strong>g> producti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> m<strong>on</strong>ocl<strong>on</strong>al antibodies is <strong>on</strong>e such example (see paragraph<br />
5.26). In general, however, opportunities for replacement or avoidance <str<strong>on</strong>g>of</str<strong>on</strong>g> animal use in<br />
every project need to be explored <strong>on</strong> a case by case basis, with due regard to the specific<br />
objectives and the scientific barriers to the use <str<strong>on</strong>g>of</str<strong>on</strong>g> n<strong>on</strong>-animal methods.<br />
Barriers to developing Replacements and how these could be overcome<br />
11.19 <str<strong>on</strong>g>The</str<strong>on</strong>g>re are some general principles regarding the c<strong>on</strong>straints <strong>on</strong> the development <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
Replacements. <str<strong>on</strong>g>The</str<strong>on</strong>g>se are well documented in the case <str<strong>on</strong>g>of</str<strong>on</strong>g> toxicity testing required by regulati<strong>on</strong> 14<br />
but many <str<strong>on</strong>g>of</str<strong>on</strong>g> the same principles apply to biomedical <str<strong>on</strong>g>research</str<strong>on</strong>g>. We now c<strong>on</strong>sider some general<br />
features <str<strong>on</strong>g>of</str<strong>on</strong>g> scientific and n<strong>on</strong>-scientific barriers to developing Replacements. In Chapter 15<br />
(paragraphs 15.61–15.67) we set out recommendati<strong>on</strong>s about how they might be overcome.<br />
11 See <str<strong>on</strong>g>The</str<strong>on</strong>g> Boyd Group (1998) <str<strong>on</strong>g>The</str<strong>on</strong>g> use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> for testing cosmetics: A discussi<strong>on</strong> paper from the Boyd Group, available at:<br />
http://www.boyd-group.dem<strong>on</strong>.co.uk/cosmetics.htm. Accessed <strong>on</strong>: 29 Apr 2005; <str<strong>on</strong>g>The</str<strong>on</strong>g> Boyd Group (2002) <str<strong>on</strong>g>The</str<strong>on</strong>g> use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in<br />
testing household products: A discussi<strong>on</strong> paper and statement <str<strong>on</strong>g>of</str<strong>on</strong>g> principle, available at http://www.boydgroup.dem<strong>on</strong>.co.uk/householdproducts.pdf.<br />
Accessed <strong>on</strong>: 29 Apr 2005.<br />
12 European Commissi<strong>on</strong> (2003) Directive 2003/15/EC <str<strong>on</strong>g>of</str<strong>on</strong>g> the European Parliament and the <str<strong>on</strong>g>Council</str<strong>on</strong>g> Official Journal <str<strong>on</strong>g>of</str<strong>on</strong>g> the European<br />
Uni<strong>on</strong> 11 March 2003.<br />
13 See Hendriksen CFM, Spires J-M, Akkermans A et al. (1998) Validati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Alternative Methods for the Potency Testing <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
Vaccines: ECVAM Workshop Report 31, ATLA 26: 747–61, and Weissler K and Hechler U (1997) Animal Welfare Aspects in the<br />
Quality C<strong>on</strong>trol <str<strong>on</strong>g>of</str<strong>on</strong>g> Immunobiologicals: A critical evaluati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the animal tests in Pharmacopoeial M<strong>on</strong>ographs (L<strong>on</strong>d<strong>on</strong>:<br />
FRAME).<br />
14 European Commissi<strong>on</strong> (2004) Opini<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the Scientific Committee <strong>on</strong> Toxicity, Ecotoxicity and the Envir<strong>on</strong>ment <strong>on</strong> <str<strong>on</strong>g>The</str<strong>on</strong>g> BUAV-<br />
European Coaliti<strong>on</strong> to End Animal Experiments Report: <str<strong>on</strong>g>The</str<strong>on</strong>g> Way Forward – Acti<strong>on</strong> to End Animal Toxicity Testing, available at:<br />
http://europa.eu.int/comm/health/ph_risk/committees/sct/documents/out217_en.pdf. Accessed: 26 Apr 2005.<br />
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