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 ...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
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 />
<str<strong>on</strong>g>The</str<strong>on</strong>g> A(SP)A: general operati<strong>on</strong>al<br />
aspects<br />
Box 13.1: Why does the A(SP)A use the<br />
term ‘procedure’ instead <str<strong>on</strong>g>of</str<strong>on</strong>g> ‘experiment’?<br />
13.4 <str<strong>on</strong>g>The</str<strong>on</strong>g> A(SP)A 4 regulates the use <str<strong>on</strong>g>of</str<strong>on</strong>g> all <str<strong>on</strong>g>The</str<strong>on</strong>g> welfare <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> may not <strong>on</strong>ly be affected by<br />
vertebrate <str<strong>on</strong>g>animals</str<strong>on</strong>g> 5 (mammals, reptiles, the c<strong>on</strong>sequences <str<strong>on</strong>g>of</str<strong>on</strong>g> a particular scientific experiment<br />
but also by a range <str<strong>on</strong>g>of</str<strong>on</strong>g> other aspects <str<strong>on</strong>g>of</str<strong>on</strong>g> their lives. Since<br />
amphibians, birds and fish) and, by a<br />
the A(SP)A seeks to regulate any activity that involves<br />
subsequent order in Parliament, the a protected animal and may cause pain, suffering,<br />
comm<strong>on</strong> octopus in ‘any experimental distress or lasting harm, the term ‘procedure’ was<br />
introduced to refer to the broad range <str<strong>on</strong>g>of</str<strong>on</strong>g> events that<br />
or other scientific procedure...which may affect <str<strong>on</strong>g>animals</str<strong>on</strong>g>. Thus, under the A(SP)A all aspects<br />
may have the effect <str<strong>on</strong>g>of</str<strong>on</strong>g> causing that <str<strong>on</strong>g>of</str<strong>on</strong>g> the scientific experiment itself, as well as relatively<br />
minor interventi<strong>on</strong>s, such as the taking <str<strong>on</strong>g>of</str<strong>on</strong>g> a blood<br />
animal pain, suffering, distress or<br />
sample, are all termed regulated procedures and any<br />
lasting harm’. <str<strong>on</strong>g>The</str<strong>on</strong>g>se purposes are called <str<strong>on</strong>g>research</str<strong>on</strong>g> study will usually involve a number <str<strong>on</strong>g>of</str<strong>on</strong>g> these.<br />
‘regulated procedures’ (see Box 13.1), Similarly, other scientific uses <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>, for example<br />
the testing <str<strong>on</strong>g>of</str<strong>on</strong>g> vaccines, or the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> for the<br />
and may <strong>on</strong>ly be undertaken if the producti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> biological products such as antibodies,<br />
Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State has granted the are categorised as procedures, as well as the breeding<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> harmful mutants and GM <str<strong>on</strong>g>animals</str<strong>on</strong>g> (see paragraphs<br />
necessary licences (see paragraphs<br />
13.14 and 13.25).<br />
13.5–13.6).<br />
13.5 <str<strong>on</strong>g>The</str<strong>on</strong>g> regulatory scheme imposed by the A(SP)A is complex. <str<strong>on</strong>g>The</str<strong>on</strong>g>re are absolute rules that, if<br />
broken, will lead to criminal liability. For example, it is a criminal <str<strong>on</strong>g>of</str<strong>on</strong>g>fence to carry out what<br />
would qualify as a regulated procedure without the required licences. Such breaches are<br />
potentially punishable with an unlimited fine and impris<strong>on</strong>ment for a maximum <str<strong>on</strong>g>of</str<strong>on</strong>g> two<br />
years. 6 <str<strong>on</strong>g>The</str<strong>on</strong>g> Act also empowers the Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State to make regulati<strong>on</strong>s (sec<strong>on</strong>dary<br />
legislati<strong>on</strong>) to implement the principles embodied in the statute such as extending the<br />
categories <str<strong>on</strong>g>of</str<strong>on</strong>g> protected <str<strong>on</strong>g>animals</str<strong>on</strong>g>. Most crucially, the Act grants the Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State<br />
extensive discreti<strong>on</strong>ary powers in relati<strong>on</strong> to licensing <str<strong>on</strong>g>research</str<strong>on</strong>g>. This means that the Home<br />
Office necessarily develops, within limits, internal guidance and policy with regard to<br />
whether and <strong>on</strong> what terms requests for licences may be granted. <str<strong>on</strong>g>The</str<strong>on</strong>g> Act sets out the<br />
parameters within which discreti<strong>on</strong> is exercised; and in practice they are applied <strong>on</strong> a case<br />
by case basis. So, for example, Secti<strong>on</strong> 5 (6) <str<strong>on</strong>g>of</str<strong>on</strong>g> the Act directs that ‘<str<strong>on</strong>g>The</str<strong>on</strong>g> Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State<br />
shall not grant a project licence authorising the use <str<strong>on</strong>g>of</str<strong>on</strong>g> cats, dogs, primates and equidæ 7<br />
unless he is satisfied that <str<strong>on</strong>g>animals</str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> no other species are suitable for the purposes <str<strong>on</strong>g>of</str<strong>on</strong>g> the<br />
programme to be specified in the licence or that it is not practicable to obtain <str<strong>on</strong>g>animals</str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
any other species that are suitable for those purposes’. In more general terms, Secti<strong>on</strong> 5 (5)<br />
states that ‘<str<strong>on</strong>g>The</str<strong>on</strong>g> Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State shall not grant a project licence unless he is satisfied (a)<br />
that the purpose <str<strong>on</strong>g>of</str<strong>on</strong>g> the programme to be specified in the licence cannot be achieved<br />
satisfactorily by any other reas<strong>on</strong>ably practicable method not entailing the use <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
protected <str<strong>on</strong>g>animals</str<strong>on</strong>g>’.<br />
3 In 1983, the Government produced a White Paper entitled Scientific Procedures <strong>on</strong> Living Animals. This Paper led to extensive<br />
c<strong>on</strong>sultati<strong>on</strong>, and was followed by a supplementary White Paper with the same name, which appeared in 1985. <str<strong>on</strong>g>The</str<strong>on</strong>g> Bill that<br />
became the A(SP)A was based <strong>on</strong> the two White Papers. It was introduced in the House <str<strong>on</strong>g>of</str<strong>on</strong>g> Lords, where it was debated<br />
extensively and amended. <str<strong>on</strong>g>The</str<strong>on</strong>g> amended Bill then passed through the Comm<strong>on</strong>s with relatively little discussi<strong>on</strong>.<br />
4 Animal (Scientific Procedures) Act 1986 (A(SP)A), available at:<br />
http://www.archive.<str<strong>on</strong>g>of</str<strong>on</strong>g>ficial-documents.co.uk/document/hoc/321/321-xa.htm. Accessed <strong>on</strong>: 4 May 2005.<br />
5 Animals at early stages <str<strong>on</strong>g>of</str<strong>on</strong>g> development are excluded from the Act, see A(SP)A Secti<strong>on</strong> 1 (2) which states that: ‘Any such<br />
vertebrate in its foetal, larval or embry<strong>on</strong>ic form is a protected animal <strong>on</strong>ly from the stage <str<strong>on</strong>g>of</str<strong>on</strong>g> its development when (a) in the<br />
case <str<strong>on</strong>g>of</str<strong>on</strong>g> a mammal, bird or reptile, half the gestati<strong>on</strong> or incubati<strong>on</strong> period for the relevant species has elapsed; and (b) in any<br />
other case, it becomes capable <str<strong>on</strong>g>of</str<strong>on</strong>g> independent feeding.’<br />
6 See A(SP)A Schedule 3 and 22. To inflict pain or suffering <strong>on</strong> an animal in the course <str<strong>on</strong>g>of</str<strong>on</strong>g> an unlicensed experiment could also<br />
involve criminal liability under the general law against cruelty to <str<strong>on</strong>g>animals</str<strong>on</strong>g>, c<strong>on</strong>tained in the Protecti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Animals Act 1911,<br />
the Wild Mammals (Protecti<strong>on</strong>) Act 1996 and the Protecti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Animals (Scotland) Act 1912, although the maximum penalties<br />
are lower.<br />
7 <str<strong>on</strong>g>The</str<strong>on</strong>g> term ‘equidæ’ refers to the family that includes horses.<br />
222