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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 />

animal patient or a group <str<strong>on</strong>g>of</str<strong>on</strong>g> such patients. <str<strong>on</strong>g>The</str<strong>on</strong>g>re is no <str<strong>on</strong>g>research</str<strong>on</strong>g> functi<strong>on</strong>; these are essentially<br />

applied studies, predominantly <str<strong>on</strong>g>involving</str<strong>on</strong>g> the producti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> biological reagents, for example<br />

antibodies and clotting factors.<br />

Toxicological procedures<br />

■ Procedures for toxicological purposes accounted for 16% <str<strong>on</strong>g>of</str<strong>on</strong>g> all procedures started in 2003.<br />

■ Some <str<strong>on</strong>g>of</str<strong>on</strong>g> these procedures are included in the categories Fundamental biological <str<strong>on</strong>g>research</str<strong>on</strong>g> and<br />

Applied studies: human medicine or dentistry, and veterinary medicine. Others are included<br />

under Protecti<strong>on</strong> (see Figure 2).<br />

Severity <str<strong>on</strong>g>of</str<strong>on</strong>g> Procedures<br />

Figure 3: Number <str<strong>on</strong>g>of</str<strong>on</strong>g> licences by severity banding<br />

One <str<strong>on</strong>g>of</str<strong>on</strong>g> four levels <str<strong>on</strong>g>of</str<strong>on</strong>g> severity is assigned to project licenses, based <strong>on</strong> protocols that are:<br />

Mild: procedures that give rise to slight or transitory minor adverse effects, including taking<br />

infrequent blood or tissue samples from an animal, c<strong>on</strong>ducting skin-irritati<strong>on</strong> tests with<br />

substances that are expected to be n<strong>on</strong>-irritant or mildly irritant.<br />

Moderate: procedures such as injecting substances to produce antibodies, toxicity tests that do<br />

not involve lethal end points, and the implantati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> a microtransmitter to m<strong>on</strong>itor blood<br />

pressure. In general, <str<strong>on</strong>g>research</str<strong>on</strong>g>ers must ensure that pain is minimised, and <str<strong>on</strong>g>animals</str<strong>on</strong>g> must be given<br />

pain relief. Animals that undergo surgery are given anaesthetics.<br />

Substantial: procedures including major surgery, toxicity testing leading to significant morbidity<br />

or death and the use <str<strong>on</strong>g>of</str<strong>on</strong>g> some <str<strong>on</strong>g>animals</str<strong>on</strong>g> as disease models.<br />

Unclassified: protocols in which <str<strong>on</strong>g>animals</str<strong>on</strong>g> are anaesthetised before a procedure starts and are<br />

killed without recovering c<strong>on</strong>sciousness.<br />

GM <str<strong>on</strong>g>animals</str<strong>on</strong>g><br />

■ In 2003 there were 764,000 procedures <str<strong>on</strong>g>involving</str<strong>on</strong>g> GM <str<strong>on</strong>g>animals</str<strong>on</strong>g>.<br />

■ More than a quarter <str<strong>on</strong>g>of</str<strong>on</strong>g> all procedures in 2003 involved GM <str<strong>on</strong>g>animals</str<strong>on</strong>g>.<br />

■ Ninety-seven percent <str<strong>on</strong>g>of</str<strong>on</strong>g> these procedures involved mice, 2% fish, 0.3% rats, 0.2% amphibians,<br />

0.03% sheep and 0.03% domestic fowl.<br />

APPENDIX 2: STATISTICS - RESEARCH INVOLVING ANIMALS IN THE UK, EU, USA AND JAPAN<br />

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