Minutes of the meeting held on 4 November 2003
Thu, 5 February 2004
RIA (03) 5th meeting
NUFFIELD COUNCIL ON BIOETHICS
WORKING PARTY ON THE ETHICS OF RESEARCH INVOLVING ANIMALS
Minutes of the meeting held at the Nuffield Foundation
28 Bedford Square, London WC1B 3JS
on Tuesday 4 November 2003
PRESENT
Baroness Perry of Southwark
Professor Kenneth Boyd
Professor Allan Bradley FRS
Professor Steve Brown
Professor Robert Combes
Professor Maggy Jennings
Dr Mark Matfield
Professor Ian McConnell
Dr Timothy Morris
Professor Martin Raff FRS
Mr Nick Ross
Professor John Spencer
Ms Michelle Thew
APOLOGIES
Professor Grahame Bulfield CBE, Professor Barry Keverne FRS, Dr Judy MacArthur Clark, Dr Lewis Smith, Professor Jonathan Wolff
SECRETARIAT
Dr Sandy Thomas, Mr Harald Schmidt, Ms Nicola Perrin, Ms Caroline Rogers
INTRODUCTION BY THE CHAIR
1 The Chair welcomed the members and outlined the schedule for the meeting. In the morning, a fact finding meeting with advocates of alternative approaches to animal experimentation would be held. This would be followed by a discussion on the structure of the first draft of the Report.
MATTERS ARISING
Evidence reviews
2 An update on progress with the commissioned evidence review on animals’ capacity to experience pain, suffering and distress was provided. The review would be available in time for the next meeting. Dr Mark Matfield offered to produce the review outlining international differences in guidance on animal research. This offer was welcomed. It was agreed that it would be useful if Ms Michelle Thew could also contribute to this review, as suggested at the first meeting of the Working Party.
MINUTES OF THE (03) 4TH MEETING
3 After discussion, the minutes of the 4th meeting and of the two fact finding meetings held on 3 October were approved.
CONSULTATION WITH THE PUBLIC
4 The Secretariat reported that the consultation document had been launched on 3 October. Hard copies had been distributed to approximately 560 relevant organisations and individuals. The consultation document had since been downloaded 1,400 times from the Council’s website and more than 500 visitors had accessed the online consultation. 84 people had registered to submit comments via the website. So far, 14 online submissions had been received and 13 had been sent by mail. It was agreed that the Secretariat would circulate further comments to the Working Party in batches of approximately 20-30.
FACT FINDING MEETING
5 A note on the fact finding meeting with Professor Michael Balls, Trustee, FRAME, former Chairman of ECVAM (European Centre for the Validation of Alternatives) and Dr Gill Langley, Scientific Advisor, Dr Hadwen Trust is at Annex A.
FUTURE FACT FINDING MEETINGS
6 Members considered the possibility of future fact finding meetings at the FRAME laboratory at the Queens Medical Centre in Nottingham, and at a primate research facility. The Secretariat would explore options of arranging visits with members of the Working Party. It was agreed that for the next meeting, Dr Jon Richmond, Head of the Animals (Scientific Procedures) Division, and Professor Michael Banner, Chair of the Animals Procedures Committee, should be invited, to discuss issues raised in the context of national and international regulation. A meeting with Dr Ray Greek, President, Europeans for Medical Advancement, would be arranged for the following meeting. This would allow for consideration of a position which questioned the transferability of experimental results from animals to humans.
DRAFTS CONTRIBUTED BY MEMBERS
7 The Chair thanked Mr Nick Ross for further comments on ethical issues raised by animal experimentation, and Professor John Spencer and Dr Mark Matfield for the revisions of the draft chapter on regulation. The members then considered the paper by Dr Maggy Jennings on alternative methods. The paper was welcomed and it was agreed that it would be useful to focus on the differences between the individual strategies behind the 3Rs, as well as on differences between promoting alternatives in the context of pharmaceutical toxicology and basic research.
8 There was general discussion about the use of alternatives in the area of basic research, and the value of such research. Possibly, alternative methods could delay progress in scientific knowledge. Two different views were expressed:
• On the one hand, it could be argued that every individually approved research project involving animals was intrinsically valuable, since it contributed to the ‘jigsaw puzzle’ of scientific knowledge. It would therefore be wrong to assess experiments primarily on the basis of their direct contribution to improving specific medical treatments. It could be argued that the Home Office rightly recognised the value of basic research in its cost benefit analysis.
• On the other hand, the ‘jigsaw’-view could be used to justify almost any kind of animal research. The question could be asked whether there was a difference between ‘information’ and ‘knowledge’. In the light of the more difficult justification of basic research, it was argued that more thought should be given to the identification of alternative strategies to answer specific questions commonly sought by means of animal experimentation.
DISCUSSION OF DRAFT STRUCTURE OF THE REPORT
9 The Secretariat had produced a more detailed outline of the draft Report, taking into account those papers which had been contributed by members so far, and points raised in previous discussions. Members considered the structure and agreed that the Chapter on regulatory issues should come before the discussion of ethical issues. Overall, the earlier chapters should aim to be of a purely descriptive nature.
10 Members then discussed each Chapter in more detail and agreed necessary amendments. The Secretariat would email the Working Party in due course to suggest a schedule for the revision process so that a first full draft of the Report could be considered at the next meeting in January.
Annex A
FACT FINDING MEETING WITH REPRESENTATIVES OF ORGANISATIONS PROMOTING ALTERNATIVES TO ANIMAL RESEARCH
11 The Chair welcomed the invitees and thanked them for the written statements which they had provided in advance of the meeting. The guests were then asked to briefly outline the principal issues which they would like to bring to the attention of the Working Party.
12 From the perspective of the Dr Hadwen Trust, a registered charity, established approximately 30 years ago, the potential contribution of replacement alternatives in medical research was a primary goal. While there had been many positive developments in the area of pharmaceutical toxicology, there had been less success in the medical sciences, especially in basic research.
13 The discussion then focussed on the reasons for the promotion of replacement alternatives; science-based as well as socio-political reasons were considered. There was also discussion about the areas in which alternatives should be promoted, and about obstacles which presented barriers to the more widespread uptake and development of methods of replacement. The Dr Hadwen Trust highlighted the following aspects: a lack of ‘scientific identity’; the fear that replacement methods were scientifically inferior; the association of the approach with militant antivivisectionists; problems of changing established routines of research; lack of available scientifically sound methods to replace animal experiments. There was also discussion about the proposal for a national centre for the 3Rs, which the Trust welcomed.
14 Professor Michael Balls endorsed the importance of achieving the integration of replacement alternatives into mainstream science. The primary problem was insufficient funding for research on alternative methods. Professor Balls also pointed to a fundamental problem in the UK regulatory framework. The 1986 Act stipulated that research involving animals would only be licensed it there were no alternative methods. Frequently, this provision was quoted as a justification for animal research; after all, it was only undertaken because there were no alternatives. However, if this line of argument was to carry any moral weight, the law would also need to require the active development of the 3Rs. The factual unavailability of alternative approaches alone was insufficient to justify the use of animals.
15 Professor Balls noted that increasing support for training to promote the adoption of the 3Rs was desirable. In Europe there were several academic posts with such a focus, including one chair at the University of Konstanz in Germany, and two chairs at the University of Utrecht, the Netherlands. However, there was a danger that institutionalisation might serve as an ‘alibi’, relieving individual researchers from their duty to consider the potential of the 3Rs in their own research projects. In any event, it would be important to sustain activity on several levels, involving academia, industry and regulators.
16 The status of in vitro approaches was discussed and consideration was given as to whether these should be seen as replacement alternatives, and to their current and future contribution to toxicology testing and basic research. The welfare implications for animals used for food production were compared to those arising from their use in research and it was observed that that it was a rather unhelpful strategy to try and justify the suffering of animals in research in the light of the greater suffering of farm animals. This argument could easily be turned around to demand higher standards for farm animals, or the abolition of their use for food production.
17 The usefulness of undertaking studies on human volunteers was considered. In some instances, for example in the case of microdosing, such research was useful as a replacement method for animal experimentation. However there were also a number of ethical and scientific problems, which were discussed in more detail.
Last Updated Mon, 7 June 2004