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 />
has harm<strong>on</strong>ised the testing <str<strong>on</strong>g>of</str<strong>on</strong>g> new chemical compounds across member countries, including<br />
the UK, USA, Japan, France and Germany. Certain OECD testing guidelines require the use<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>. 46 <str<strong>on</strong>g>The</str<strong>on</strong>g>se are a collecti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> methods developed by OECD member countries for<br />
identifying the hazards <str<strong>on</strong>g>of</str<strong>on</strong>g> chemical substances (see paragraphs 9.5 and 12.8).<br />
Differences in internati<strong>on</strong>al test guidelines<br />
13.52 <str<strong>on</strong>g>The</str<strong>on</strong>g>re is some variati<strong>on</strong> in the data and methods that different nati<strong>on</strong>al regulatory<br />
authorities are willing to accept, when assessing, for example, the safety or efficacy <str<strong>on</strong>g>of</str<strong>on</strong>g> new<br />
medicinal or agrochemical products. Although organisati<strong>on</strong>s such as ICH and OECD aim to<br />
achieve a certain degree <str<strong>on</strong>g>of</str<strong>on</strong>g> harm<strong>on</strong>isati<strong>on</strong>, it is <str<strong>on</strong>g>of</str<strong>on</strong>g>ten the case that a single chemical that is<br />
marketed in a number <str<strong>on</strong>g>of</str<strong>on</strong>g> countries might need to be tested several times for toxic effects,<br />
in order to satisfy nati<strong>on</strong>al standards. For example, during the Working Party’s fact finding<br />
meeting with experts from the Home Office, reference was made to a licence that had been<br />
granted for vaccine trials <strong>on</strong> primates <str<strong>on</strong>g>involving</str<strong>on</strong>g> procedures <str<strong>on</strong>g>of</str<strong>on</strong>g> substantial severity. This type<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> animal use typically involves the immunisati<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> with a candidate vaccine, and<br />
subsequent exposure to the infective organism. A range <str<strong>on</strong>g>of</str<strong>on</strong>g> different doses <str<strong>on</strong>g>of</str<strong>on</strong>g> the vaccine<br />
are then administered, to assess its efficacy and safety. <str<strong>on</strong>g>The</str<strong>on</strong>g> test requirements and methods<br />
are generally set at European or higher supra-nati<strong>on</strong>al levels and usually require that the<br />
test be c<strong>on</strong>tinued until it becomes clear that the <str<strong>on</strong>g>animals</str<strong>on</strong>g> have not survived the disease. <str<strong>on</strong>g>The</str<strong>on</strong>g><br />
Home Office took the view that trials should be stopped at an earlier stage if the scientific<br />
objective can be achieved. At the time <str<strong>on</strong>g>of</str<strong>on</strong>g> writing, the matter was being discussed with<br />
relevant stakeholders and regulators to encourage the development and adopti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> such<br />
measures, and to identify earlier endpoints for studies. 47 However, different c<strong>on</strong>cepti<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
what qualifies as sufficient scientific evidence for the safety and efficacy <str<strong>on</strong>g>of</str<strong>on</strong>g> new chemicals,<br />
different frameworks for liability and compensati<strong>on</strong>, as well as general political<br />
disagreements between nati<strong>on</strong>s, all c<strong>on</strong>tribute to complicati<strong>on</strong>s in the harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
laws and guidelines <strong>on</strong> animal testing. We c<strong>on</strong>tinue the discussi<strong>on</strong> <strong>on</strong> the internati<strong>on</strong>al<br />
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> in paragraphs 15.84–15.87.<br />
Summary<br />
13.53 We have described important aspects <str<strong>on</strong>g>of</str<strong>on</strong>g> the nati<strong>on</strong>al and internati<strong>on</strong>al regulatory<br />
framework governing <str<strong>on</strong>g>research</str<strong>on</strong>g> <str<strong>on</strong>g>involving</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>. In doing so, we have focused <strong>on</strong><br />
legislati<strong>on</strong> for the protecti<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>, briefly summarised regulati<strong>on</strong> relating to the<br />
requirement <str<strong>on</strong>g>of</str<strong>on</strong>g> animal tests, and highlighted difficulties in the harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> different<br />
nati<strong>on</strong>al policies. We described the historical background to the A(SP)A, its principal<br />
provisi<strong>on</strong>s, and the three types <str<strong>on</strong>g>of</str<strong>on</strong>g> licence that govern all animal <str<strong>on</strong>g>research</str<strong>on</strong>g> in the UK: pers<strong>on</strong>al<br />
licences, project licences and certificates <str<strong>on</strong>g>of</str<strong>on</strong>g> designati<strong>on</strong>. In carrying out the cost-benefit<br />
assessment, which is fundamental to the A(SP)A, the primary resp<strong>on</strong>sibility lies with the<br />
<str<strong>on</strong>g>research</str<strong>on</strong>g>ers planning a new project. In additi<strong>on</strong>, a number <str<strong>on</strong>g>of</str<strong>on</strong>g> other people and processes are<br />
involved, and it would be fallacious to assume that <strong>on</strong>ly the inspectors <str<strong>on</strong>g>of</str<strong>on</strong>g> the Home Office<br />
are resp<strong>on</strong>sible for carrying out this assessment. <str<strong>on</strong>g>The</str<strong>on</strong>g> Home Office publishes annual statistics<br />
about 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 in <str<strong>on</strong>g>research</str<strong>on</strong>g>. <str<strong>on</strong>g>The</str<strong>on</strong>g>se c<strong>on</strong>tain informati<strong>on</strong> about<br />
prospectively assigned severity banding <str<strong>on</strong>g>of</str<strong>on</strong>g> granted project licenses but `do not provide<br />
46 See OECD (1993) Chemicals Testing: OECD Guidelines for the Testing <str<strong>on</strong>g>of</str<strong>on</strong>g> Chemicals – Secti<strong>on</strong>s 1–5, available at:<br />
http://www.oecd.org/document/22/0,2340,en_2649_34377_1916054_1_1_1_1,00.html. Accessed <strong>on</strong>: 4 Apr 2005.<br />
47 This is c<strong>on</strong>sistent with the current general approach <str<strong>on</strong>g>of</str<strong>on</strong>g> the Home Office, which requests that a trial should be stopped if<br />
signs occur that reliably predict the death <str<strong>on</strong>g>of</str<strong>on</strong>g> the animal. If such signs manifest themselves, the animal is to be humanely<br />
killed, instead <str<strong>on</strong>g>of</str<strong>on</strong>g> dying from the disease, see Home Office (2003) Animals (Scientific Procedures) Act 1986: Guidance <strong>on</strong> the<br />
C<strong>on</strong>duct <str<strong>on</strong>g>of</str<strong>on</strong>g> Regulatory Toxicology and Safety Evaluati<strong>on</strong> Studies, revised June 2003, available at:<br />
http://www.home<str<strong>on</strong>g>of</str<strong>on</strong>g>fice.gov.uk/docs2/regtoxicologydraftrevisi<strong>on</strong>4_03.html. Accessed <strong>on</strong>: 5 May 2005.<br />
CHAPTER 13 LEGISLATION, REGULATION AND POLICY RELATING TO SCIENTIFIC PROCEDURES<br />
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