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 />
licences are not time-limited but are required to be reviewed at no more than five year<br />
intervals. Species or techniques may be added or removed in the course <str<strong>on</strong>g>of</str<strong>on</strong>g> the review.<br />
13.13 <str<strong>on</strong>g>The</str<strong>on</strong>g> pers<strong>on</strong>al licence holders are obliged to ensure that any pain, suffering or distress to the<br />
<str<strong>on</strong>g>animals</str<strong>on</strong>g> is minimised and they bear primary resp<strong>on</strong>sibility for the welfare <str<strong>on</strong>g>of</str<strong>on</strong>g> the <str<strong>on</strong>g>animals</str<strong>on</strong>g><br />
they use. Proper records must be kept for each project showing the number <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used<br />
and the procedures that have been carried out, and giving informati<strong>on</strong> about the<br />
supervisi<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>.<br />
Project licences and the cost-benefit assessment<br />
13.14 Project licences can <strong>on</strong>ly be granted for the following permitted purposes:<br />
■ ‘the preventi<strong>on</strong> (whether by the testing <str<strong>on</strong>g>of</str<strong>on</strong>g> any product or otherwise) or the diagnosis or<br />
treatment <str<strong>on</strong>g>of</str<strong>on</strong>g> disease, ill-health or abnormality, or their effects, in man, <str<strong>on</strong>g>animals</str<strong>on</strong>g> or plants;<br />
■ the assessment, detecti<strong>on</strong>, regulati<strong>on</strong> or modificati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> physiological c<strong>on</strong>diti<strong>on</strong>s in man,<br />
<str<strong>on</strong>g>animals</str<strong>on</strong>g> or plants;<br />
■ the protecti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the natural envir<strong>on</strong>ment in the interests <str<strong>on</strong>g>of</str<strong>on</strong>g> the health or welfare <str<strong>on</strong>g>of</str<strong>on</strong>g> man<br />
or <str<strong>on</strong>g>animals</str<strong>on</strong>g>;<br />
■ the advancement <str<strong>on</strong>g>of</str<strong>on</strong>g> knowledge in biological or behavioural sciences;<br />
■ educati<strong>on</strong> or training otherwise than that in primary or sec<strong>on</strong>dary schools;<br />
■ forensic enquiries;<br />
■ the breeding <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> for experimental or other scientific use’. 13<br />
13.15 <str<strong>on</strong>g>The</str<strong>on</strong>g> project licence has a number <str<strong>on</strong>g>of</str<strong>on</strong>g> functi<strong>on</strong>s, including:<br />
■ defining the objectives <str<strong>on</strong>g>of</str<strong>on</strong>g> the project;<br />
■ outlining the likely benefits <str<strong>on</strong>g>of</str<strong>on</strong>g> the project;<br />
■ describing the work to be c<strong>on</strong>ducted to achieve the objectives;<br />
■ listing the specific procedures to be used;<br />
■ identifying the likely adverse effects that may be experienced by the <str<strong>on</strong>g>animals</str<strong>on</strong>g> and how<br />
these will be avoided, recognised and alleviated; and<br />
■ placing an upper limit <strong>on</strong> the severity <str<strong>on</strong>g>of</str<strong>on</strong>g> the adverse effects to the <str<strong>on</strong>g>animals</str<strong>on</strong>g> (see Box 13.3<br />
for how the severity <str<strong>on</strong>g>of</str<strong>on</strong>g> procedures is c<strong>on</strong>sidered in the licensing process). 14<br />
Box 13.3: How is the severity <str<strong>on</strong>g>of</str<strong>on</strong>g> procedures c<strong>on</strong>sidered by the Home Office?<br />
Severity to the <str<strong>on</strong>g>animals</str<strong>on</strong>g> involved is assessed prospectively, before a licence is granted. <str<strong>on</strong>g>The</str<strong>on</strong>g>re are two main types <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
assessment, supplied by the licence applicant and evaluated by the Home Office, as follows.*<br />
i) <str<strong>on</strong>g>The</str<strong>on</strong>g> overall severity band <str<strong>on</strong>g>of</str<strong>on</strong>g> a <str<strong>on</strong>g>research</str<strong>on</strong>g> project is intended to reflect the number <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used <strong>on</strong> each<br />
protocol and the suffering likely to be caused as a result. It is based <strong>on</strong> the overall level <str<strong>on</strong>g>of</str<strong>on</strong>g> cumulative suffering<br />
expected to be experienced by each animal, rather than the single worst possible case. It takes into account the<br />
proporti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> expected to reach the severity limit <str<strong>on</strong>g>of</str<strong>on</strong>g> the protocol and the durati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the exposure to<br />
that severity limit, the nature and intensity <str<strong>on</strong>g>of</str<strong>on</strong>g> the adverse effects, and the acti<strong>on</strong>s to be taken to relieve the<br />
suffering. It is therefore a qualitative and quantitative assessment <str<strong>on</strong>g>of</str<strong>on</strong>g> the anticipated average suffering<br />
experienced by all the <str<strong>on</strong>g>animals</str<strong>on</strong>g> used (see paragraph 15.27). In 2003, 39 percent <str<strong>on</strong>g>of</str<strong>on</strong>g> project licences were assigned<br />
C<strong>on</strong>tinued<br />
CHAPTER 13 LEGISLATION, REGULATION AND POLICY RELATING TO SCIENTIFIC PROCEDURES<br />
13 A(SP)A, Secti<strong>on</strong> 5 (3).<br />
14 Guidance <strong>on</strong> the Operati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the A(SP)A 1986, Chapter 5, available at: http://www.archive.<str<strong>on</strong>g>of</str<strong>on</strong>g>ficialdocuments.co.uk/document/hoc/321/321.htm.<br />
Accessed <strong>on</strong>: 4 May 2005.<br />
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