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 />
N<strong>on</strong>-animal methods as adjuncts<br />
11.13 N<strong>on</strong>-animal methods may act as an adjunct to animal experiments rather than replace<br />
them, but in so doing, they may serve to reduce the total number <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used in a<br />
programme <str<strong>on</strong>g>of</str<strong>on</strong>g> work. A classic example is the screening <str<strong>on</strong>g>of</str<strong>on</strong>g> anti-cancer drugs in nude 9 mice<br />
with human tumours. An initial screen using cell cultures can be used to dem<strong>on</strong>strate basic<br />
tumour cytotoxicity, and <strong>on</strong>ly the active toxins are tested in vivo. <str<strong>on</strong>g>The</str<strong>on</strong>g> same principle is used<br />
in high-throughput screening <str<strong>on</strong>g>of</str<strong>on</strong>g> potential medicines (see paragraph 8.6). This approach<br />
involves testing a large range <str<strong>on</strong>g>of</str<strong>on</strong>g> potentially useful candidate chemicals for a particular<br />
purpose in n<strong>on</strong>-animal systems (especially computer predicti<strong>on</strong> studies and in vitro tissue<br />
culture) using techniques that can be carried out very rapidly. Those chemicals with<br />
desirable biological activity (efficacy) and devoid <str<strong>on</strong>g>of</str<strong>on</strong>g> undesirable activity (toxicity) can then<br />
be selected for further study. In this way, it is possible to reduce the numbers <str<strong>on</strong>g>of</str<strong>on</strong>g> animal<br />
tests required to assess a given number <str<strong>on</strong>g>of</str<strong>on</strong>g> chemicals. <str<strong>on</strong>g>The</str<strong>on</strong>g> severity <str<strong>on</strong>g>of</str<strong>on</strong>g> animal tests can be<br />
minimised by screening out substances that are likely to be toxic at an early stage. In recent<br />
years, high-throughput screening has become widely adopted by the pharmaceutical<br />
industry (see paragraphs 8.4–8.6).<br />
Alternative approaches<br />
11.14 Another equally important c<strong>on</strong>cept is the use <str<strong>on</strong>g>of</str<strong>on</strong>g> an alternative approach to an experimental<br />
goal enabling the avoidance <str<strong>on</strong>g>of</str<strong>on</strong>g> animal use. Even where there are no obvious alternatives,<br />
any proposed scientific study should c<strong>on</strong>sider at an early stage not <strong>on</strong>ly whether the animal<br />
experiment is the most appropriate and <strong>on</strong>ly method <str<strong>on</strong>g>of</str<strong>on</strong>g> addressing each <str<strong>on</strong>g>research</str<strong>on</strong>g> questi<strong>on</strong>,<br />
but also whether the questi<strong>on</strong> is worth asking, and whether it justifies causing pain and<br />
suffering to a sentient animal. In other words, the first alternative to c<strong>on</strong>sider is the opti<strong>on</strong><br />
not to carry out the experiment at all. For example, within the REACH testing programme<br />
(see Box 9.2) the first c<strong>on</strong>siderati<strong>on</strong> might be whether a particular test is actually necessary,<br />
regardless <str<strong>on</strong>g>of</str<strong>on</strong>g> whether there are, for example, adjunct Replacement methods that could be<br />
used in <str<strong>on</strong>g>research</str<strong>on</strong>g>.<br />
<str<strong>on</strong>g>The</str<strong>on</strong>g> potential for Replacement <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in different areas <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>research</str<strong>on</strong>g><br />
Toxicity testing required by regulati<strong>on</strong> as a special case<br />
11.15 <str<strong>on</strong>g>The</str<strong>on</strong>g>re is a tendency for discussi<strong>on</strong> <strong>on</strong> the potential for replacing <str<strong>on</strong>g>animals</str<strong>on</strong>g> to focus solely <strong>on</strong><br />
toxicity testing required by regulati<strong>on</strong> and efficacy testing (which comprises around 16 percent<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> all animal use in science). Tests for regulatory purposes have received the most obvious and<br />
specific attenti<strong>on</strong> with respect to the development <str<strong>on</strong>g>of</str<strong>on</strong>g> Replacements. 10 Two factors have been<br />
influential in this respect: first, over the past 30 years public c<strong>on</strong>cern about the types <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
substances tested, such as cosmetics, household products and chemicals, and the type <str<strong>on</strong>g>of</str<strong>on</strong>g> tests<br />
carried out has increased (for example, the LD 50 and Draize tests; see paragraph 9.14 and Box<br />
9 ‘Nude mice’ are mice born without any T lymphocytes, which means that they effectively have no immune resp<strong>on</strong>ses.<br />
10 <str<strong>on</strong>g>The</str<strong>on</strong>g> British Toxicology Society (BTS) produced a report <strong>on</strong> the use <str<strong>on</strong>g>of</str<strong>on</strong>g> in vitro methods for toxicity testing in 1997, see Fielder R,<br />
Atterwill CK, Anders<strong>on</strong> D et al. (1997) British Toxicology Society (BTS) Working Party Report <strong>on</strong> in vitro toxicology Hum Exp<br />
Toxicol 16: S1–40. <str<strong>on</strong>g>The</str<strong>on</strong>g> Third FRAME Toxicity Committee has also published a comprehensive discussi<strong>on</strong> <strong>on</strong> the development <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
replacement methods for toxicity testing over the last decade, see Combes R, Schechtman L, Stokes WS and Blakey D (2002)<br />
<str<strong>on</strong>g>The</str<strong>on</strong>g> internati<strong>on</strong>al symposium <strong>on</strong> regulatory testing and animal welfare: recommendati<strong>on</strong>s <strong>on</strong> best scientific practices for<br />
subchr<strong>on</strong>ic/chr<strong>on</strong>ic toxicity and carcinogenicity testing ILAR J 43, Supplement: S112–17; see also Salem H and Katz SA (1999)<br />
Toxicity Assessment Alternatives – Methods, issues, opportunities (Totowa, NJ: Humana Press); Castell JV and Gómez-Lechón MJ<br />
(Editors) (1997) In vitro Methods in Pharmaceutical Research (L<strong>on</strong>d<strong>on</strong>: Academic Press); Knight DJ and Breheny D (2002)<br />
Alternatives to animal testing in the safety evaluati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> products Alternat Lab Anim 30: 7–22; Combes RD (2002) <str<strong>on</strong>g>The</str<strong>on</strong>g> ECVAM<br />
workshops: a critical assessment <str<strong>on</strong>g>of</str<strong>on</strong>g> their impact <strong>on</strong> the development, validati<strong>on</strong> and acceptance <str<strong>on</strong>g>of</str<strong>on</strong>g> alternative methods ATLA<br />
30, Supplement 2: 151–65.<br />
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