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 ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
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 />
inappropriate analysis <str<strong>on</strong>g>of</str<strong>on</strong>g> experimental results and to the c<strong>on</strong>duct <str<strong>on</strong>g>of</str<strong>on</strong>g> experiments which<br />
yield results that are not even amenable to proper statistical analysis. A survey <str<strong>on</strong>g>of</str<strong>on</strong>g> 78<br />
experiments, described in papers published in two leading toxicology journals between<br />
1989 and 1990, showed that over 60 percent had obvious statistical errors. About <strong>on</strong>e<br />
third <str<strong>on</strong>g>of</str<strong>on</strong>g> the experiments involved far more <str<strong>on</strong>g>animals</str<strong>on</strong>g> than necessary to achieve the stated<br />
aims <str<strong>on</strong>g>of</str<strong>on</strong>g> the <str<strong>on</strong>g>research</str<strong>on</strong>g>. 4 Where statistical analysis is crucial to the outcome <str<strong>on</strong>g>of</str<strong>on</strong>g> a <str<strong>on</strong>g>research</str<strong>on</strong>g><br />
project, it is vital that careful c<strong>on</strong>siderati<strong>on</strong> is given to the design <str<strong>on</strong>g>of</str<strong>on</strong>g> experiments to take<br />
account <str<strong>on</strong>g>of</str<strong>on</strong>g> the degree <str<strong>on</strong>g>of</str<strong>on</strong>g> variati<strong>on</strong> to be expected, the required statistical power, and the<br />
method <str<strong>on</strong>g>of</str<strong>on</strong>g> statistical analysis to be used. Ways <str<strong>on</strong>g>of</str<strong>on</strong>g> improving experimental design by<br />
c<strong>on</strong>trolling variability and allowing the use <str<strong>on</strong>g>of</str<strong>on</strong>g> more-sophisticated statistical methods<br />
have been suggested. 5 One way <str<strong>on</strong>g>of</str<strong>on</strong>g> using these methods in practice would be to improve<br />
training <str<strong>on</strong>g>of</str<strong>on</strong>g> scientists; a more practical and reliable opti<strong>on</strong> may be to ensure that scientists<br />
have the opportunity to c<strong>on</strong>sult at an early stage with a statistical expert.<br />
12.5 <str<strong>on</strong>g>The</str<strong>on</strong>g> two approaches above are <str<strong>on</strong>g>of</str<strong>on</strong>g> special relevance for ensuring that numbers <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g><br />
intended to be used in a specific <str<strong>on</strong>g>research</str<strong>on</strong>g> project are reduced as far as possible. But<br />
Reducti<strong>on</strong> also has another dimensi<strong>on</strong> in the sense that it is desirable to reduce the total<br />
number <str<strong>on</strong>g>of</str<strong>on</strong>g> experiments which are undertaken. In this c<strong>on</strong>text, data sharing is an<br />
important means <str<strong>on</strong>g>of</str<strong>on</strong>g> avoiding duplicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> testing in toxicology as well as<br />
pharmaceutical and academic <str<strong>on</strong>g>research</str<strong>on</strong>g>. In the case <str<strong>on</strong>g>of</str<strong>on</strong>g> toxicology testing and<br />
pharmaceutical <str<strong>on</strong>g>research</str<strong>on</strong>g> the results <str<strong>on</strong>g>of</str<strong>on</strong>g> tests are <str<strong>on</strong>g>of</str<strong>on</strong>g>ten commercial property, and the need<br />
for c<strong>on</strong>fidentiality may sometimes lead to duplicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> testing. In basic <str<strong>on</strong>g>research</str<strong>on</strong>g>,<br />
duplicati<strong>on</strong> 6 may occur when <str<strong>on</strong>g>research</str<strong>on</strong>g>ers are unaware that a particular experiment or test<br />
has already been carried out by other <str<strong>on</strong>g>research</str<strong>on</strong>g>ers. <str<strong>on</strong>g>The</str<strong>on</strong>g>re have been claims and counterclaims<br />
about the extent to which studies are duplicated. 7 Nevertheless, ensuring that<br />
results from <str<strong>on</strong>g>research</str<strong>on</strong>g> are shared as much as possible is a useful way <str<strong>on</strong>g>of</str<strong>on</strong>g> reducing the total<br />
number <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> involved in <str<strong>on</strong>g>research</str<strong>on</strong>g>. <str<strong>on</strong>g>The</str<strong>on</strong>g> principal way in which data are currently<br />
shared is by publicati<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 peer-reviewed journals. However, not all <str<strong>on</strong>g>research</str<strong>on</strong>g><br />
actually undertaken is published. Some therefore argue that it would be desirable to<br />
ensure greater availability <str<strong>on</strong>g>of</str<strong>on</strong>g> reports <str<strong>on</strong>g>of</str<strong>on</strong>g> ‘negative’, or unsuccessful, <str<strong>on</strong>g>research</str<strong>on</strong>g> results. 8 But<br />
there are problems in publishing <str<strong>on</strong>g>research</str<strong>on</strong>g> findings that are not peer reviewed. <str<strong>on</strong>g>The</str<strong>on</strong>g> peerreview<br />
process helps to ensure that <strong>on</strong>ly findings from properly c<strong>on</strong>ducted <str<strong>on</strong>g>research</str<strong>on</strong>g> are<br />
published, and publicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> poorly c<strong>on</strong>ducted <str<strong>on</strong>g>research</str<strong>on</strong>g> may lead to c<strong>on</strong>fusi<strong>on</strong>.<br />
CHAPTER 12 REDUCTION AND REFINEMENT<br />
4 See also Festing MFW (1996). Are animal experiments in toxicological <str<strong>on</strong>g>research</str<strong>on</strong>g> the "right" size? in Statistics in Toxicology<br />
Morgan BJT (Editor) (Oxford: Clarend<strong>on</strong> Press), pp3-11; Festing MFW and Lovell DP (1996) Reducing the use <str<strong>on</strong>g>of</str<strong>on</strong>g> laboratory<br />
<str<strong>on</strong>g>animals</str<strong>on</strong>g> in toxicological <str<strong>on</strong>g>research</str<strong>on</strong>g> and testing by better experimental design J R Stat Soc 58: 127-140; see also: Editorial:<br />
Statistically significant (2005) Nat Med 11: 1.<br />
5 See Festing MF (1990) Use <str<strong>on</strong>g>of</str<strong>on</strong>g> genetically heterogeneous rats and mice in toxicological <str<strong>on</strong>g>research</str<strong>on</strong>g>: a pers<strong>on</strong>al perspective Toxicol<br />
Appl Pharmacol 102:197-204; Festing MF (2001) Guidelines for the design and statistical analysis <str<strong>on</strong>g>of</str<strong>on</strong>g> experiments in papers<br />
submitted to ATLA Altern Lab Anim 29:427-46; Festing MF (2002) <str<strong>on</strong>g>The</str<strong>on</strong>g> design and statistical analysis <str<strong>on</strong>g>of</str<strong>on</strong>g> animal experiments<br />
ILAR J 43: 191-3; Festing MF and Altman DG (2002) Guidelines for the design and statistical analysis <str<strong>on</strong>g>of</str<strong>on</strong>g> experiments using<br />
laboratory <str<strong>on</strong>g>animals</str<strong>on</strong>g> ILAR J 43 244-58; Shaw R, Festing MF, Peers I and Furl<strong>on</strong>g L (2002) <str<strong>on</strong>g>The</str<strong>on</strong>g> design and statistical analysis <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
animal experiments ILAR J 43:191-3; Howard BR (2002) C<strong>on</strong>trol <str<strong>on</strong>g>of</str<strong>on</strong>g> variability ILAR J 43: 194-201.<br />
6 It is important to distinguish between duplicati<strong>on</strong> and replicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> experiments, see paragraph 15.16.<br />
7 See, for example BUAV (2001) BUAV Submissi<strong>on</strong> to the House <str<strong>on</strong>g>of</str<strong>on</strong>g> Lords Select Committee <strong>on</strong> Animals in Scientific Procedures,<br />
available at: http://www.buav.org/pdf/BUAV_HOL_Evidence.pdf. Accessed <strong>on</strong>: 9 May 2005; see also Home Office (2005) Report<br />
by the Animal Procedures Committee (APC) 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>:<br />
Government Resp<strong>on</strong>se by Caroline Flint MP, Parliamentary Under-Secretary <str<strong>on</strong>g>of</str<strong>on</strong>g> State for the Home Department, available at:<br />
http://www.home<str<strong>on</strong>g>of</str<strong>on</strong>g>fice.gov.uk/docs4/jw280305flint_banner_report_by_the_animal_procedures_committee.pdf. Accessed <strong>on</strong>:<br />
9 May 2005.<br />
8 See paragraphs 35-37 <str<strong>on</strong>g>of</str<strong>on</strong>g> Animal Procedures Committee (2001) Report <strong>on</strong> openness, available at:<br />
http://www.apc.gov.uk/reference/openness.pdf. Accessed <strong>on</strong>: 9 May 2005.<br />
207