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 oral toxicity and skin sensitisation are no longer harmonised with those <strong>of</strong> other OECD Member States. 15.86 <strong>The</strong> lack <strong>of</strong> stringent international harmonisation poses problems. In the UK, the Home Office may only grant a project licence for safety assessment according to the use <strong>of</strong> procedures that are less severe to the <strong>animals</strong> involved than those described in a relevant OECD test guideline. This approach means that any company intending to register a product such as an agrochemical formulation in the USA is unable to conduct in the UK a substantial number <strong>of</strong> the tests required by the EPA. In addition, as most companies have policies for animal welfare that encourage the conduct <strong>of</strong> a single set <strong>of</strong> safety tests for global registration, the more severe protocols required by the EPA 48 are usually used and, in the case <strong>of</strong> UK-based companies, some or all <strong>of</strong> the testing has to be exported to other countries. <strong>The</strong>re are many other examples <strong>of</strong> individual countries having different safety requirements. 49 Increased efforts must be made to standardise and harmonise testing requirements, in order to ensure that the minimum number <strong>of</strong> <strong>animals</strong> is used at the global level. We therefore recommend that the UK through its National Coordinators at the OECD makes it a priority to identify areas in which harmonisation continues to be difficult and initiates steps to increase adoption <strong>of</strong> scientifically valid protocols that entail the least adverse welfare costs to the <strong>animals</strong> involved. We also note that under the Inter- Departmental Concordat on data sharing, regulatory authorities aim to ‘press for agreement on behalf <strong>of</strong> the UK Government for fullest provisions and procedures which enable data sharing when negotiating, updating and transposing relevant European Directives and when taking part in other international harmonisation processes’. In order to support the proposed initiative by the National Coordinators at the OECD, we recommend that the UK Inter-Departmental Group on the Three Rs should produce or commission a report on cases where less severe protocols are not recognised internationally, whether for scientific or other reasons, and make suggestions for improving acceptance. 15.87 International guidelines also have a crucial role with regard to welfare standards <strong>of</strong> <strong>animals</strong> involved in <strong>research</strong>. <strong>The</strong>re is evidence that relevant OECD guidelines do not use important concepts such as what defines a maximum tolerated dose, severe distress, obvious pain or a moribund condition consistently (paragraph 9.35). 50 Several <strong>of</strong> the existing OECD test guidelines could also be improved with regard to issues such as environmental enrichment, and conditions <strong>of</strong> housing, as, for example, some do not specify the requirement for group housing where this would be possible. 51 All these factors can act as potential sources <strong>of</strong> avoidable suffering for the <strong>animals</strong>, and we recommend that the OECD reviews and revises relevant guidelines to achieve greater consistency and to contribute to a wider application <strong>of</strong> the Three Rs in view <strong>of</strong> current knowledge. UK <strong>research</strong>ers commissioning or undertaking <strong>research</strong> abroad 15.88 <strong>The</strong>re are a number <strong>of</strong> scientific, Three R-related and logistical reasons why <strong>research</strong>ers may collaborate with overseas scientists, outsource <strong>research</strong> work or obtain <strong>animals</strong> or animal- 48 For example, the use <strong>of</strong> higher dose levels in the acute oral toxicity tests and additional <strong>animals</strong> in the local lymph node assay. 49 For example, certain non-OECD countries can still demand an LD50 test, and Japan requires additional safety pharmacology tests (both in vitro and in vivo) <strong>of</strong> active ingredients for pesticides. 50 Koeter HBWM (1999) <strong>The</strong> OECD Test Guidelines Programme and animal welfare concern: how to avoid major animal suffering, in Humane Endpoints in Animal Experiments for Biomedical Research, Hendriksen CFM and Morton DB (Editors) (London: Royal Society <strong>of</strong> Medicine Press), pp13–14. 51 Combes RD, Gaunt I and Balls M (2004) A scientific and animal welfare assessment <strong>of</strong> the OECD health effects test guidelines for the safety testing <strong>of</strong> chemicals under the European Union REACH system ATLA 32: 163–208. 284
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 derived products (such as monoclonal antibodies) from other countries. This interaction can provide a useful means <strong>of</strong> disseminating good practice developed within the UK. But there is also a need to ensure that the international nature <strong>of</strong> <strong>research</strong> is not used to introduce double standards. We note the position statement by the Wellcome Trust, which, as a general rule, we endorse: ‘International <strong>research</strong> supported by the Trust is expected to be carried out in the spirit <strong>of</strong> the UK legislation as well as being compliant with all local legislation and ethical review procedures.’ 52 15.89 Further to the requirement implied in this statement, some members <strong>of</strong> the Working Party would like to see formal provisions in place which ensure that <strong>research</strong> and testing, both nationally and internationally, are always carried out in accordance with the least-severe protocols, in order to minimise harm to <strong>animals</strong> used in <strong>research</strong>. <strong>The</strong>y would also welcome the introduction <strong>of</strong> regulations that would prevent UK <strong>research</strong>ers from importing or outsourcing <strong>research</strong> or <strong>research</strong> products that it would not be possible to obtain in the UK. Since the extent to which this may be occurring is uncertain, they would like to recommend that Ministers request the APC to undertake a systematic study to clarify the matter, exploring perhaps also whether a system <strong>of</strong> certification or voluntary codes <strong>of</strong> conduct would be suitable devices to ensure that UK-based <strong>research</strong>ers adhere to the same standards abroad as in the UK. From their point <strong>of</strong> view, whenever UK <strong>research</strong>ers are involved in international collaborations they should seek to adopt protocols that meet the highest international standards <strong>of</strong> best practice. As a minimum they should meet UK requirements, which in most cases are likely to be stricter than those <strong>of</strong> other countries. <strong>The</strong> group would also like to recommend that multinational companies that undertake part <strong>of</strong> their <strong>research</strong> in the UK should enforce a single global policy on animal care and welfare that meets the highest international standards <strong>of</strong> best practice. 15.90 However, other members <strong>of</strong> the group, while welcoming the aspiration behind such proposals, have reservations about their appropriateness and feasibility. <strong>The</strong>y argue that because <strong>of</strong> the differences in regulatory systems it would be very complicated to ensure that <strong>research</strong> facilities abroad, or products sourced from outside <strong>of</strong> the UK met with Home Office approval. If such approval could not be attained, there would be a risk that <strong>research</strong> and testing facilities in the UK would be disadvantaged, since the exchange <strong>of</strong> products such as antisera, passaged tumours or GM lines is crucial to collaboration in fundamental <strong>research</strong>. Accordingly, they do not see a need to recommend that the APC be asked to undertake a study to advance the debate. Similarly they point out that practical problems may prevent multinational companies from implementing a single harmonised policy on animal care and welfare, both in the medium and long term. CHAPTER 15 DISCUSSION AND RECOMMENDATIONS 15.91 Members also briefly discussed, but were not able to agree on, the question <strong>of</strong> whether UKbased <strong>research</strong> might be driven abroad because <strong>of</strong> the current, or likely future, regulatory provisions and practice. During our fact-finding meetings and discussions we heard conflicting evidence about this possibility. Some <strong>research</strong>ers observed that several <strong>research</strong> projects, and some laboratories, have been moved abroad while others, more frequently pharmaceutical companies, consider that the attractiveness <strong>of</strong> scientific talent in the UK generally outweighs any regulatory burdens. A range <strong>of</strong> views was represented among members <strong>of</strong> the Working Party, with some agreeing with the evidence presented during the fact-finding meetings, and others disagreeing. <strong>The</strong> latter group found arguments 52 <strong>The</strong> Wellcome Trust Policy on the use <strong>of</strong> <strong>animals</strong> in medical and veterinary <strong>research</strong>, available at http://www.wellcome.ac.uk/doc%5Fwtd002764.html. Accessed on: 21 Apr 2005. 285
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The ethics
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The ethics
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Foreword The issue
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Table of contents
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Stages 1-2: discovery and selection
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Conclusions and recommendations ...
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Terms of reference
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T h e e t h i c s o f r e s e a r c
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Chapter 1 Introduction
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Chapter 2 The cont
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Chapter 3 Ethical issues raised by
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Chapter 4 The capa
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Section 2 Use of <
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Chapter 5 The use
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Chapter 6 The use
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Section 3 Alternatives
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Section 4 Legal, ethical and policy
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Genetic screening: ethical issues P
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