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 />
circumstances can be due to indirect effects such as dehydrati<strong>on</strong> leading to a heart attack.<br />
Similar effects can be caused by starvati<strong>on</strong> which might occur when food becomes<br />
unpalatable during dietary administrati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the test substance.<br />
9.40 It has also been stressed that the design <str<strong>on</strong>g>of</str<strong>on</strong>g> toxicity experiments should be related to the way<br />
in which the resulting experimental data are going to be used. 24 Thus, if it is intended to<br />
label a substance as hazardous <strong>on</strong> the basis <str<strong>on</strong>g>of</str<strong>on</strong>g> adverse reacti<strong>on</strong>s detected in <strong>on</strong>e or a few<br />
<str<strong>on</strong>g>animals</str<strong>on</strong>g>, there is little point in subjecting additi<strong>on</strong>al <str<strong>on</strong>g>animals</str<strong>on</strong>g> to treatment and potential<br />
toxicity. <str<strong>on</strong>g>The</str<strong>on</strong>g> use <str<strong>on</strong>g>of</str<strong>on</strong>g> pilot studies in which the unknown effects <str<strong>on</strong>g>of</str<strong>on</strong>g> a treatment can be assessed<br />
in a few <str<strong>on</strong>g>animals</str<strong>on</strong>g> prior to c<strong>on</strong>ducting a full-scale experiment are also desirable in order to<br />
reduce numbers <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used, and the potential suffering. This approach is,<br />
unfortunately, not routinely practised by toxicologists.<br />
9.41 It is important that those who care for and subject <str<strong>on</strong>g>animals</str<strong>on</strong>g> to toxicity testing should become<br />
aware <str<strong>on</strong>g>of</str<strong>on</strong>g> the behavioural, emoti<strong>on</strong>al and physiological c<strong>on</strong>diti<strong>on</strong>s and requirements <str<strong>on</strong>g>of</str<strong>on</strong>g> the<br />
<str<strong>on</strong>g>animals</str<strong>on</strong>g> (see paragraph 4.18). <str<strong>on</strong>g>The</str<strong>on</strong>g> ability <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> to anticipate negative events such as<br />
experimental procedures can increase anxiety levels and alter horm<strong>on</strong>al producti<strong>on</strong> which<br />
might also compromise the scientific quality <str<strong>on</strong>g>of</str<strong>on</strong>g> the data.<br />
9.42 Several factors are expected to increase the numbers <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> being used in toxicity<br />
testing, as well as the severity <str<strong>on</strong>g>of</str<strong>on</strong>g> testing, including:<br />
■ the High Producti<strong>on</strong> Volume chemicals testing programme in the USA; 25<br />
■<br />
■<br />
■<br />
■<br />
the new Registrati<strong>on</strong>, Evaluati<strong>on</strong> and Authorisati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Chemicals (REACH) legislati<strong>on</strong> in<br />
the EU 26 (see Box 9.2);<br />
pesticide regulati<strong>on</strong>s in the EU that require more-extensive testing;<br />
the development and attempted validati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> several animal tests to screen chemicals for<br />
endocrine (horm<strong>on</strong>e)-disrupting activity; 27 and<br />
the very substantial increase in the generati<strong>on</strong> and utilisati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> novel GM animal strains<br />
in toxicity studies. 28<br />
Effective implementati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the Three Rs in these areas is crucial (see Chapters 11 and 12).<br />
9.43 Finally, it must be acknowledged that toxicity tests in laboratory <str<strong>on</strong>g>animals</str<strong>on</strong>g> have limitati<strong>on</strong>s as<br />
a means <str<strong>on</strong>g>of</str<strong>on</strong>g> identifying hazards for human health, and managing risks to human health (see<br />
also Box 9.3). <str<strong>on</strong>g>The</str<strong>on</strong>g> example given in Box 9.4 also shows that different species may resp<strong>on</strong>d<br />
differently to the same compound. It has been argued that such problems fundamentally<br />
undermine the scientific and ethical justificati<strong>on</strong> for using <str<strong>on</strong>g>animals</str<strong>on</strong>g> to assess chemical safety.<br />
We have c<strong>on</strong>sidered these questi<strong>on</strong>s briefly in paragraphs 8.39–8.41 and return to issues<br />
raised by the scientific validity <str<strong>on</strong>g>of</str<strong>on</strong>g> using <str<strong>on</strong>g>animals</str<strong>on</strong>g> in Chapter 10.<br />
24 Mort<strong>on</strong> DB (2002) <str<strong>on</strong>g>The</str<strong>on</strong>g> importance <str<strong>on</strong>g>of</str<strong>on</strong>g> n<strong>on</strong>-statistical experimental design in refining animal experiments for scientists,<br />
IACUCs, and other ethical review panels, in Applied Ethics in Animal Research: Philosophy, regulati<strong>on</strong>, and laboratory<br />
applicati<strong>on</strong>s, Gluck JP, DiPasquale A and Orlans FB (Editors) (West Lafayette, IN: Purdue University Press), pp149–78.<br />
25 Nichols<strong>on</strong> A, Sandler J and Siedle T (2004) An evaluati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the US High Producti<strong>on</strong> Volume (HPV) chemical-testing<br />
programme. A study in (ir)relevance, redundancy and retro thinking ATLA 32 Supplement 1: 335–41.<br />
26 Combes R, Dandrea J and Balls M (2003) A critical assessment <str<strong>on</strong>g>of</str<strong>on</strong>g> the European Commissi<strong>on</strong>’s proposals for the risk<br />
assessment and registrati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> chemical substances in the European Uni<strong>on</strong> ATLA 31: 353–64.<br />
27 Combes RD and Balls M (2003) How much flexibility is possible when validating new in vivo and in vitro toxicity test<br />
methods? Alternat Lab Anim Exp 31: 225–32.<br />
28 van Zeller A-M and Combes RD (1999) Transgenic mouse bioassays for carcinogenicity testing: a step in the right directi<strong>on</strong>?<br />
Alternat Lab Anim Exp 27, Supplement 1: 839–46.<br />
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