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 />
12.6 In the UK, in 2002 the inter-Departmental Group <strong>on</strong> the 3Rs 9 was formed, as a successor to<br />
the Inter-Departmental Data Sharing Group, which produced and published in 2000 the<br />
inter-Departmental Data Sharing C<strong>on</strong>dordat. <str<strong>on</strong>g>The</str<strong>on</strong>g> C<strong>on</strong>cordat is a voluntary scheme which<br />
seeks to ‘promote opportunities for encouraging agencies, industry and other stakeholders<br />
to endorse the principle <str<strong>on</strong>g>of</str<strong>on</strong>g> data sharing and to extend its scope by looking to overcome the<br />
practical, legal, commercial and cultural barriers to its effective implementati<strong>on</strong>.’ 10 Am<strong>on</strong>g<br />
other things, the C<strong>on</strong>cordat encourages minimisati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> data requirements for tests as far<br />
as possible, and the reviewing <str<strong>on</strong>g>of</str<strong>on</strong>g> procedural and legal barriers to data sharing. Under the<br />
C<strong>on</strong>cordat, ‘UK regulatory authorities, as lead agencies, [will] press for agreement <strong>on</strong> behalf<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> the UK Government for fullest provisi<strong>on</strong>s and procedures which enable data sharing<br />
when negotiating, updating and transposing relevant European Directives and when taking<br />
part in other internati<strong>on</strong>al harm<strong>on</strong>isati<strong>on</strong> processes.’ We return to issues raised by the<br />
possible duplicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>research</str<strong>on</strong>g> in different areas in Chapter 15, where we rec<strong>on</strong>sider the<br />
nati<strong>on</strong>al and internati<strong>on</strong>al c<strong>on</strong>text <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>research</str<strong>on</strong>g> (paragraphs 15.68–15.70 and 15.83). We also<br />
explore ways in which the avoidance <str<strong>on</strong>g>of</str<strong>on</strong>g> duplicati<strong>on</strong> can be ensured especially in relati<strong>on</strong> to<br />
<str<strong>on</strong>g>research</str<strong>on</strong>g> <str<strong>on</strong>g>involving</str<strong>on</strong>g> GM <str<strong>on</strong>g>animals</str<strong>on</strong>g> (paragraphs 15.71-15.75).<br />
Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> internati<strong>on</strong>al test guidelines<br />
12.7 We have noted that 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<br />
efficacy data for regulatory authorities, in compliance with nati<strong>on</strong>al or internati<strong>on</strong>al<br />
legislati<strong>on</strong> (see paragraphs 9.4 and 13.48). If different authorities require testing to be<br />
carried out using their own specific study designs, a single chemical that is marketed in a<br />
number <str<strong>on</strong>g>of</str<strong>on</strong>g> countries might need to be tested several times for toxic effects. Harm<strong>on</strong>isati<strong>on</strong><br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> test guidelines, so that a single study design is acceptable to regulatory authorities in<br />
many countries, is a very valuable means <str<strong>on</strong>g>of</str<strong>on</strong>g> reducing 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 in safety<br />
and efficacy testing worldwide. Harm<strong>on</strong>isati<strong>on</strong> has many advantages: it can reduce the<br />
need for repeat testing; eliminate the requirement for redundancy in testing (where more<br />
than <strong>on</strong>e test provides the same informati<strong>on</strong>); minimise group sizes (e.g. by agreement to<br />
use a single sex) and lead to the adopti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> shortened protocols, reduced animal numbers<br />
and less-severe treatments and procedures.<br />
12.8 A relatively high level <str<strong>on</strong>g>of</str<strong>on</strong>g> harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> test methods for chemicals has been achieved by<br />
the Test Guidelines Programme <str<strong>on</strong>g>of</str<strong>on</strong>g> the OECD. Similarly, in the area <str<strong>on</strong>g>of</str<strong>on</strong>g> pharmaceuticals, the<br />
ICH has achieved a substantial decrease in the numbers <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used globally in the preclinical<br />
safety assessment <str<strong>on</strong>g>of</str<strong>on</strong>g> new pharmaceuticals (about a 50 percent reducti<strong>on</strong> overall for<br />
a typical package <str<strong>on</strong>g>of</str<strong>on</strong>g> tests). 11 Examples <str<strong>on</strong>g>of</str<strong>on</strong>g> reducti<strong>on</strong> in regulatory testing include:<br />
9 <str<strong>on</strong>g>The</str<strong>on</strong>g> Group is led by Home Office <str<strong>on</strong>g>of</str<strong>on</strong>g>ficials and has members from the Department <str<strong>on</strong>g>of</str<strong>on</strong>g> Health, the Department for the<br />
Envir<strong>on</strong>ment, Food and Rural Affairs, the Department <str<strong>on</strong>g>of</str<strong>on</strong>g> Trade and Industry, the Office <str<strong>on</strong>g>of</str<strong>on</strong>g> Science and Technology, the Food<br />
Standards Agency, the Health and Safety Executive, the Medicines and Healthcare Products Regulatory Agency and other<br />
agencies. Its terms <str<strong>on</strong>g>of</str<strong>on</strong>g> reference are ‘to improve the applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the 3Rs and promote <str<strong>on</strong>g>research</str<strong>on</strong>g> into alternatives, reducing<br />
the need for toxicity testing through better sharing <str<strong>on</strong>g>of</str<strong>on</strong>g> data, and encouraging the validati<strong>on</strong> and acceptance <str<strong>on</strong>g>of</str<strong>on</strong>g> alternatives.’<br />
See http://www.home<str<strong>on</strong>g>of</str<strong>on</strong>g>fice.gov.uk/docs2/interdept3rs.html. Accessed <strong>on</strong>: 3 May 2005.<br />
10 Home Office (2002) <str<strong>on</strong>g>The</str<strong>on</strong>g> Inter-Departmental c<strong>on</strong>cordat <strong>on</strong> data sharing, available at:<br />
http://www.home<str<strong>on</strong>g>of</str<strong>on</strong>g>fice.gov.uk/docs/datac<strong>on</strong>cordat.html. Accessed <strong>on</strong>: 3 May 2005; see also Animal Procedures Committee<br />
(2003) Review <str<strong>on</strong>g>of</str<strong>on</strong>g> the cost-benefit assessment in 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 <str<strong>on</strong>g>research</str<strong>on</strong>g> (L<strong>on</strong>d<strong>on</strong>: HO), p52-6.<br />
11 <str<strong>on</strong>g>The</str<strong>on</strong>g> Internati<strong>on</strong>al C<strong>on</strong>ference <strong>on</strong> Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Technical Requirements for Registrati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Pharmaceuticals for Human<br />
Use (ICH) brings together the regulatory authorities <str<strong>on</strong>g>of</str<strong>on</strong>g> Europe, Japan and the United States and experts from the<br />
pharmaceutical industry in the three regi<strong>on</strong>s to discuss scientific and technical aspects <str<strong>on</strong>g>of</str<strong>on</strong>g> product registrati<strong>on</strong>. <str<strong>on</strong>g>The</str<strong>on</strong>g> purpose is<br />
to make recommendati<strong>on</strong>s <strong>on</strong> ways to achieve greater harm<strong>on</strong>isati<strong>on</strong> in the interpretati<strong>on</strong> and applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> technical<br />
guidelines and requirements for product registrati<strong>on</strong>, in order to reduce the need to duplicate the testing carried out<br />
during the <str<strong>on</strong>g>research</str<strong>on</strong>g> and development <str<strong>on</strong>g>of</str<strong>on</strong>g> new medicines; Lumley CE and van Cauteren H (1997) Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
internati<strong>on</strong>al toxicity testing guidelines for pharmaceuticals: c<strong>on</strong>tributi<strong>on</strong> to refinement and reducti<strong>on</strong> in animal use EBRA<br />
Bulletin November: 4–9.<br />
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