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 />
this area, it is crucial that new approaches to risk assessment that implement the Three Rs most<br />
effectively should be explored, particularly by making maximum use <str<strong>on</strong>g>of</str<strong>on</strong>g> data sharing and using<br />
computati<strong>on</strong>al and in vitro tissue culture methods where possible (paragraph 15.82).<br />
<str<strong>on</strong>g>The</str<strong>on</strong>g> internati<strong>on</strong>al c<strong>on</strong>text <str<strong>on</strong>g>of</str<strong>on</strong>g> animal <str<strong>on</strong>g>research</str<strong>on</strong>g><br />
Many tests <str<strong>on</strong>g>involving</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> are c<strong>on</strong>ducted to provide safety or efficacy data for regulatory<br />
authorities, in compliance with nati<strong>on</strong>al or internati<strong>on</strong>al legislati<strong>on</strong>. Thus, if various authorities require<br />
testing to be carried out using different study designs, a single chemical that is marketed in a number<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> countries might need to be tested several times. Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> test guidelines, so that a single<br />
study design is acceptable to regulatory authorities in many countries, is a very valuable means <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
reducing the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in safety and efficacy testing. <str<strong>on</strong>g>The</str<strong>on</strong>g> Internati<strong>on</strong>al C<strong>on</strong>ference <strong>on</strong><br />
Harm<strong>on</strong>isati<strong>on</strong> (ICH) has managed to improve mutual acceptance for the pharmaceutical industry, but<br />
much still needs to be d<strong>on</strong>e to extend this approach to other product areas (paragraph 15.84).<br />
Increased efforts must be made to standardise and harm<strong>on</strong>ise testing requirements, in order to ensure<br />
that the minimum number <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> is used at the global level. We therefore recommend that the<br />
UK through its Nati<strong>on</strong>al Coordinators at the Organisati<strong>on</strong> for Ec<strong>on</strong>omic Cooperati<strong>on</strong> and<br />
Development (OECD) makes it a priority to identify areas in which harm<strong>on</strong>isati<strong>on</strong> c<strong>on</strong>tinues to be<br />
difficult and initiates steps to increase adopti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> scientifically valid protocols that entail the least<br />
adverse welfare costs to the <str<strong>on</strong>g>animals</str<strong>on</strong>g> involved. We also note that under the Inter-Departmental<br />
C<strong>on</strong>cordat <strong>on</strong> data sharing, regulatory authorities aim to ‘press for agreement <strong>on</strong> behalf <str<strong>on</strong>g>of</str<strong>on</strong>g> the UK<br />
Government for fullest provisi<strong>on</strong>s and procedures which enable data sharing when negotiating,<br />
updating and transposing relevant European Directives and when taking part in other internati<strong>on</strong>al<br />
harm<strong>on</strong>isati<strong>on</strong> processes.’ In order to support the proposed initiative by the Nati<strong>on</strong>al Coordinators at<br />
the OECD, we recommend that the UK Inter-Departmental Group <strong>on</strong> the Three Rs should produce or<br />
commissi<strong>on</strong> a report <strong>on</strong> cases where less severe protocols are not recognised internati<strong>on</strong>ally, whether<br />
for scientific or other reas<strong>on</strong>s, and make suggesti<strong>on</strong>s for improving acceptance (paragraph 15.86).<br />
SUMMARY AND RECOMMENDATIONS<br />
Internati<strong>on</strong>al guidelines also have a crucial role with regard to welfare standards <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g><br />
involved in <str<strong>on</strong>g>research</str<strong>on</strong>g>. <str<strong>on</strong>g>The</str<strong>on</strong>g>re is evidence that relevant OECD guidelines do not use important c<strong>on</strong>cepts<br />
such as what defines a maximum tolerated dose, severe distress, obvious pain or a moribund<br />
c<strong>on</strong>diti<strong>on</strong> c<strong>on</strong>sistently. Several <str<strong>on</strong>g>of</str<strong>on</strong>g> the existing OECD test guidelines could also be improved with<br />
regard to issues such as envir<strong>on</strong>mental enrichment, and c<strong>on</strong>diti<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> housing, as, for example,<br />
some do not specify the requirement for group housing where this would be possible. All these<br />
factors can act as potential sources <str<strong>on</strong>g>of</str<strong>on</strong>g> avoidable suffering for the <str<strong>on</strong>g>animals</str<strong>on</strong>g>, and we recommend that<br />
the OECD review and revise relevant guidelines to achieve greater c<strong>on</strong>sistency and to c<strong>on</strong>tribute<br />
to a wider applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the Three Rs in view <str<strong>on</strong>g>of</str<strong>on</strong>g> current knowledge (paragraph 15.87).<br />
UK <str<strong>on</strong>g>research</str<strong>on</strong>g>ers commissi<strong>on</strong>ing or undertaking <str<strong>on</strong>g>research</str<strong>on</strong>g> or testing abroad<br />
<str<strong>on</strong>g>The</str<strong>on</strong>g>re are a number <str<strong>on</strong>g>of</str<strong>on</strong>g> scientific, Three R-related and logistical reas<strong>on</strong>s why <str<strong>on</strong>g>research</str<strong>on</strong>g>ers may<br />
collaborate with overseas scientists, outsource <str<strong>on</strong>g>research</str<strong>on</strong>g> work or obtain <str<strong>on</strong>g>animals</str<strong>on</strong>g> or animal-derived<br />
products (such as m<strong>on</strong>ocl<strong>on</strong>al antibodies) from other countries. This interacti<strong>on</strong> can provide a<br />
useful means <str<strong>on</strong>g>of</str<strong>on</strong>g> disseminating good practice developed within the UK. But there is also a need<br />
to ensure that the internati<strong>on</strong>al nature <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>research</str<strong>on</strong>g> is not used to introduce double standards. We<br />
note the positi<strong>on</strong> statement by the Wellcome Trust, which, as a general rule, we endorse:<br />
‘Internati<strong>on</strong>al <str<strong>on</strong>g>research</str<strong>on</strong>g> supported by the Trust is expected to be carried out in the spirit<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> the UK legislati<strong>on</strong> as well as being compliant with all local legislati<strong>on</strong> and ethical<br />
review procedures.’ 20<br />
20 <str<strong>on</strong>g>The</str<strong>on</strong>g> Wellcome Trust Policy <strong>on</strong> the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in medical and veterinary <str<strong>on</strong>g>research</str<strong>on</strong>g>, available at: http:<br />
//www.wellcome.ac.uk/doc%5Fwtd002764.html. Accessed <strong>on</strong> 21 April 2005.<br />
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