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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 />

Ethical Review Process<br />

13.21 Since 1999, each establishment is required to have in place an ERP as a standard c<strong>on</strong>diti<strong>on</strong><br />

<strong>on</strong> all certificates <str<strong>on</strong>g>of</str<strong>on</strong>g> designati<strong>on</strong>. 21 <str<strong>on</strong>g>The</str<strong>on</strong>g> purpose <str<strong>on</strong>g>of</str<strong>on</strong>g> this process is to establish a local<br />

framework to ensure that all uses <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> are carefully c<strong>on</strong>sidered and justified. An<br />

ethical review committee should provide independent advice to certificate holders and<br />

support to other staff with resp<strong>on</strong>sibility for animal welfare.<br />

13.22 <str<strong>on</strong>g>The</str<strong>on</strong>g> provisi<strong>on</strong>s in the 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 require that the review<br />

process includes:<br />

■ a named veterinary surge<strong>on</strong>;<br />

■ representative(s) from am<strong>on</strong>g the named animal care and welfare <str<strong>on</strong>g>of</str<strong>on</strong>g>ficers;<br />

■ representative(s) <str<strong>on</strong>g>of</str<strong>on</strong>g> the project licence holder(s); and<br />

■ representative(s) <str<strong>on</strong>g>of</str<strong>on</strong>g> the pers<strong>on</strong>al licence holder(s).<br />

Facilities are also encouraged, but not required, to involve people who do not use <str<strong>on</strong>g>animals</str<strong>on</strong>g>,<br />

including <strong>on</strong>e or more lay members from outside the instituti<strong>on</strong>.<br />

13.23 Functi<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> the ERP include (where appropriate):<br />

■ promoting the development and uptake <str<strong>on</strong>g>of</str<strong>on</strong>g> Reducti<strong>on</strong>, Replacement and Refinement<br />

alternatives to animal use in procedures at the establishment;<br />

■ examining the likely costs and benefits <str<strong>on</strong>g>of</str<strong>on</strong>g> each licence applicati<strong>on</strong>;<br />

■ providing a forum for discussi<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> issues relating to animal <str<strong>on</strong>g>research</str<strong>on</strong>g>, and c<strong>on</strong>sider how<br />

staff could be updated <strong>on</strong> relevant ethical advice, best practice and relevant legislati<strong>on</strong>;<br />

■ undertaking retrospective reviews <str<strong>on</strong>g>of</str<strong>on</strong>g> licensed projects;<br />

■ c<strong>on</strong>sidering the care and accommodati<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> at the establishment and the<br />

humane killing <str<strong>on</strong>g>of</str<strong>on</strong>g> protected <str<strong>on</strong>g>animals</str<strong>on</strong>g>;<br />

■ reviewing the establishment’s managerial systems with respect to animal use;<br />

■ advising <strong>on</strong> staff training and ensuring competence. 22<br />

<str<strong>on</strong>g>The</str<strong>on</strong>g> order <str<strong>on</strong>g>of</str<strong>on</strong>g> this list is <str<strong>on</strong>g>of</str<strong>on</strong>g>ten understood to express a hierarchy <str<strong>on</strong>g>of</str<strong>on</strong>g> importance, and hence the<br />

two most important functi<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> the ERP are c<strong>on</strong>sidered to be the promoti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the Three Rs<br />

and the review <str<strong>on</strong>g>of</str<strong>on</strong>g> the costs and benefits <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>research</str<strong>on</strong>g>. However, depending <strong>on</strong> the type <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

<str<strong>on</strong>g>research</str<strong>on</strong>g> carried out at specific <str<strong>on</strong>g>research</str<strong>on</strong>g> facilities, those involved in the ERP may spend more<br />

time <strong>on</strong> other activities. In practice the review <str<strong>on</strong>g>of</str<strong>on</strong>g> protocols is <str<strong>on</strong>g>of</str<strong>on</strong>g>ten the primary focus.<br />

Other aspects <str<strong>on</strong>g>of</str<strong>on</strong>g> the A(SP)A<br />

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

13.24 Rats, mice and other comm<strong>on</strong>ly used laboratory animal species must be obtained from<br />

suppliers or breeders that have a certificate <str<strong>on</strong>g>of</str<strong>on</strong>g> designati<strong>on</strong> and are subject to the same<br />

system <str<strong>on</strong>g>of</str<strong>on</strong>g> c<strong>on</strong>trols and inspecti<strong>on</strong> as establishments using <str<strong>on</strong>g>animals</str<strong>on</strong>g> in experiments.<br />

21 See 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, Appendix J, 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 />

22 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, Appendix J, 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 />

CHAPTER 13 LEGISLATION, REGULATION AND POLICY RELATING TO SCIENTIFIC PROCEDURES<br />

229

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