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 />
13.9 <str<strong>on</strong>g>The</str<strong>on</strong>g> Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State may add c<strong>on</strong>diti<strong>on</strong>s to any licences or certificates as c<strong>on</strong>sidered<br />
reas<strong>on</strong>able and appropriate. A series <str<strong>on</strong>g>of</str<strong>on</strong>g> standard c<strong>on</strong>diti<strong>on</strong>s are routinely added to every<br />
licence and certificate. 10 <str<strong>on</strong>g>The</str<strong>on</strong>g> Home Office employs Inspectors who assess all applicati<strong>on</strong>s for<br />
licences and certificates and visit designated establishments to verify that procedures are<br />
c<strong>on</strong>ducted in accordance with the licences (see paragraph 13.20).<br />
13.10 <str<strong>on</strong>g>The</str<strong>on</strong>g> Home Office also issues a Code <str<strong>on</strong>g>of</str<strong>on</strong>g> practice <strong>on</strong> housing and care <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used in<br />
scientific procedures (published in 1989). It is widely agreed that the code does not identify<br />
best practice. Rather, it sets out the minimum standards expected <str<strong>on</strong>g>of</str<strong>on</strong>g> designated<br />
establishments, including minimum cage sizes, envir<strong>on</strong>mental c<strong>on</strong>diti<strong>on</strong>s, animal health and<br />
welfare, and special c<strong>on</strong>siderati<strong>on</strong>s for individual species. Compliance with the code <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
practice is required by making it a c<strong>on</strong>diti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> granting the certificate <str<strong>on</strong>g>of</str<strong>on</strong>g> designati<strong>on</strong>. <str<strong>on</strong>g>The</str<strong>on</strong>g>re<br />
are separate codes and guidelines for housing and breeding, as well as for animal euthanasia<br />
and a number <str<strong>on</strong>g>of</str<strong>on</strong>g> specific procedures. 11 As in the case <str<strong>on</strong>g>of</str<strong>on</strong>g> the Code <str<strong>on</strong>g>of</str<strong>on</strong>g> practice <strong>on</strong> housing and<br />
care <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used in scientific procedures, these documents set out minimum standards.<br />
13.11 <str<strong>on</strong>g>The</str<strong>on</strong>g> penalties for c<strong>on</strong>travening the provisi<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> the A(SP)A, licences or certificates include<br />
formal adm<strong>on</strong>iti<strong>on</strong>s, requirements for retraining, the placing <str<strong>on</strong>g>of</str<strong>on</strong>g> restricti<strong>on</strong>s <strong>on</strong> licences,<br />
revocati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> licences, fines and impris<strong>on</strong>ment. 12 Normally, the most effective deterrent is<br />
the Home Office’s authority to revoke certificates or licences, which could have serious<br />
c<strong>on</strong>sequences for universities or pharmaceutical companies (in cases where certificates <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
designati<strong>on</strong> are revoked), or individual scientists (where a project or pers<strong>on</strong>al licence is<br />
revoked, see Box 2.5).<br />
Pers<strong>on</strong>al licences<br />
13.12 Before a scientist or animal technician can be granted a pers<strong>on</strong>al licence, they must<br />
successfully complete a training course covering the legislati<strong>on</strong>, ethical aspects <str<strong>on</strong>g>of</str<strong>on</strong>g> animal<br />
use, animal biology, husbandry, care and welfare and, where appropriate, surgery and<br />
anaesthesia. <str<strong>on</strong>g>The</str<strong>on</strong>g> licence is specific for the designated establishment(s) where <str<strong>on</strong>g>research</str<strong>on</strong>g> is to<br />
be c<strong>on</strong>ducted, and applicants must specify the <str<strong>on</strong>g>animals</str<strong>on</strong>g> for which they are seeking authority<br />
to use. <str<strong>on</strong>g>The</str<strong>on</strong>g> licence also lists the range <str<strong>on</strong>g>of</str<strong>on</strong>g> techniques to be used, such as giving injecti<strong>on</strong>s, or<br />
carrying out specific types <str<strong>on</strong>g>of</str<strong>on</strong>g> surgery. <str<strong>on</strong>g>The</str<strong>on</strong>g> use <str<strong>on</strong>g>of</str<strong>on</strong>g> any other combinati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> species,<br />
technique or <str<strong>on</strong>g>research</str<strong>on</strong>g> locati<strong>on</strong> not specified in the licence is a legal <str<strong>on</strong>g>of</str<strong>on</strong>g>fence. Pers<strong>on</strong>al<br />
10 For example, since 1999, certificates have not been granted unless there is an ERP in place (see House <str<strong>on</strong>g>of</str<strong>on</strong>g> Comm<strong>on</strong>s (2002)<br />
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 (Norwich: Stati<strong>on</strong>ary Office)). Other standard c<strong>on</strong>diti<strong>on</strong>s include the<br />
requirement that the establishment should be appropriately staffed at all times to ensure well-being <str<strong>on</strong>g>of</str<strong>on</strong>g> the <str<strong>on</strong>g>animals</str<strong>on</strong>g> (see<br />
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).<br />
11 See Code <str<strong>on</strong>g>of</str<strong>on</strong>g> practice for the housing <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in designated breeding and supplying establishments (1995), Humane killing<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> under Schedule 1 to the A(SP)A 1986 (1997) and Housing and care <str<strong>on</strong>g>of</str<strong>on</strong>g> pigs intended for use as xenotransplant<br />
source <str<strong>on</strong>g>animals</str<strong>on</strong>g> (draft). See Home Office website UK and European legislati<strong>on</strong> and guidance, available at:<br />
http://www.home<str<strong>on</strong>g>of</str<strong>on</strong>g>fice.gov.uk/comrace/<str<strong>on</strong>g>animals</str<strong>on</strong>g>/legislati<strong>on</strong>.html. Accessed <strong>on</strong>: 1 Apr 2005.<br />
12 <str<strong>on</strong>g>The</str<strong>on</strong>g> Home Office reports summary details <str<strong>on</strong>g>of</str<strong>on</strong>g> infringements to the APC, and informati<strong>on</strong> with respect to the cases reported are<br />
set out in the APC’s Annual Reports. For example, in its Annual Report for 2002, the APC reported that the Home Office had<br />
revealed that there had been 20 ‘Class Three’ (the most serious) infringements during the period November 2000–December<br />
2001. <str<strong>on</strong>g>The</str<strong>on</strong>g> same report also specifically referred to <str<strong>on</strong>g>research</str<strong>on</strong>g> that had g<strong>on</strong>e bey<strong>on</strong>d licensed procedures and recorded: ‘One such<br />
serious infringement [that impacted negatively <strong>on</strong> animal welfare] was reported to the Committee… This involved [loud] music<br />
being played to over 200 mice dosed with methamphetamine. Some <str<strong>on</strong>g>of</str<strong>on</strong>g> the mice were said to have suffered ‘seizures’ and at<br />
least 19 <str<strong>on</strong>g>of</str<strong>on</strong>g> them died as a result <str<strong>on</strong>g>of</str<strong>on</strong>g> the procedures. <str<strong>on</strong>g>The</str<strong>on</strong>g> study arose from a larger programme <str<strong>on</strong>g>of</str<strong>on</strong>g> work c<strong>on</strong>ducted as part <str<strong>on</strong>g>of</str<strong>on</strong>g> a<br />
licensed project c<strong>on</strong>cerning Huntingt<strong>on</strong>’s disease, but it went bey<strong>on</strong>d the procedures covered by the licence authorities. <str<strong>on</strong>g>The</str<strong>on</strong>g><br />
infringement had come to light through the publicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> a scientific paper <strong>on</strong> the work. …the project licensee had been<br />
adm<strong>on</strong>ished [by the Home Office] and required to undergo training; a pers<strong>on</strong>al licence holder had been adm<strong>on</strong>ished; and the<br />
certificate holder was asked to remedy defects in the record keeping systems in the department c<strong>on</strong>cerned.’ No prosecuti<strong>on</strong><br />
was brought and the APC noted that it was ‘particularly c<strong>on</strong>cerned about this case’. In 2003, sancti<strong>on</strong>s used by the Home Office<br />
were adm<strong>on</strong>ishment, ordering retraining and requiring reviews <str<strong>on</strong>g>of</str<strong>on</strong>g> operati<strong>on</strong>al procedures. Revocati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> licences was<br />
recommended in two cases; both a licence and a certificate were voluntarily returned to the Home Office in advance <str<strong>on</strong>g>of</str<strong>on</strong>g> any<br />
formal acti<strong>on</strong>. Home Office (2004) Statistics <str<strong>on</strong>g>of</str<strong>on</strong>g> Scientific Procedures <strong>on</strong> Living Animals Great Britain 2003 (L<strong>on</strong>d<strong>on</strong>: HMSO).<br />
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