The Cost/Benefit Assessment and the Animals (Scientific Procedures) Act 1986

The Cost/Benefit Assessment and the Animals (Scientific Procedures) Act 1986

The Cost/Benefit Assessment and the Animals (Scientific Procedures) Act 1986

The Royal Society of Edinburgh (RSE) is pleased to respond to the Animal Procedures Committee's (APC) consultation on the Cost/Benefit Assessment and the Animals (Scientific Procedures) Act 1986. The RSE is Scotland’s premier Learned Society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled by the General Secretary with the assistance of a number of Fellows with substantial experience in this area.

One important facet of the debate is the provision of adequate information to the public to enable them to form an opinion about costs and benefits. This is proving harder to do due to the current levels of intimidation by certain elements of the animal rights movement. Such intimidation makes it difficult for scientists and scientific administrators to speak openly about their view that biomedical experimentation can be beneficial for fear of becoming personal targets. If nothing else, a clear statement by the APC to the effect that illegal intimidating tactics undermine free and open debate, would be extremely helpful.

The development of alternatives to animal studies are likely to stem from the scientists who are currently involved in animal studies, as these will be the people who realise any current limitations and, as a consequence, will seek to improve alternatives. However, it should be recognised that the pressure to provide alternatives has come largely from animal welfare critics.

The specific questions identified in the consultation paper are addressed below:

The Scientific validity of Animal Experiments

Can the validity of experiments on animals be argued in absolute terms or should this be considered on a case by case basis taking into account a range of factors? It would be helpful if you could explain the criteria you believe should be used to assess the scientific validity of animal experiments.

The validity of experiments on animals is not a matter that can be argued in absolute terms, as it will always depend on the question to which an answer is sought and the methods chosen to answer the question. Therefore, the validity of any experiment on animals should be considered case by case. This should also lead to a body of 'case law' which can inform subsequent decisions.

Animal experiments are like any other form of human activity in having costs and benefits. Public acceptance of the benefits of findings that might emerge from such work and public tolerance of the possible costs involved in carrying it out, however well informed, are both subjective and both subject to change over time. There is no universal agreement about either the benefits or the costs, nor is there ever likely to be. The right answer to such an ethical question can never be reached by a purely scientific method but will depend upon our ethical emotions to matters whose factual characters should be understood as fully as possible.

There are numerous criteria that should be used to assess the validity of animal experimentation. In terms of experimental design, there is the central issue of avoiding unnecessary suffering. Experiments vary greatly in their severity; every effort should be made to avoid a higher level of severity than is absolutely necessary. Unnecessary duplication is also an issue, but the international nature of research, the need for statistical replication and differing views about the quality of certain work make this very difficult to monitor and police. A key element of any experimental design is the number of animals used. With too few animals, an experiment will lack the power to establish any but the most major effects, and consequently there will be little benefit. With too many, however, the increase in costs will show little benefit in terms of increased statistical confidence in the results. The optimum choice will depend on many factors, including the predicted benefits from identifying different sizes of effect and the variability within and between animals. Variability can be reduced through good experimental practice, including good choice of design.

The availability of alternative techniques should be a major factor. Certain areas of biomedical research can be addressed using in vitro tissue and tissue-culture techniques rather than work on whole animals. However, this is also controversial and some would argue that, in many biomedical fields, tissue-culture techniques can be even more misleading than the use of an inappropriate animal model.

Many experiments, although not always medically justified, are well worth doing because of the information they provide on fundamental mechanisms and in advancing knowledge and understanding. In some experiments, the full eventual benefit can only be realised after the trial has been completed. However, the chancethat a piece of research might be useful in some unexpected way is not, in itself, a sufficient justification for painful experimentation (especially on primates) and reasonable judgements can be made as to whether a particular research programme is likely to yield useful information.

Do you consider that the cost-benefit assessment adequately addresses the scientific validity of projects and individual experiments within these? Who do you consider has/should have responsibility for assessing validity (e.g. the researcher, the funding body, the Animal Scientific Procedures Inspectorate, Ethical Review Process, regulators, other)?

The cost -benefit assessment does adequately address the scientific validity of projects in virtually all cases since each series of experiments has undergone review by an Ethics Committee, by the grant-giving body and by the Home Office for Project Licence approval.

Different aspects of the scientific validity will be assessed by different bodies. The researcher should believe in the purpose of conducting the experiment and should know the limitation of the results obtained. The peer review process of the funding body will take into account existing evidence and how this relates (or otherwise) to any novel findings that may or not be important. The Ethical Review Process (ERP) will assess the complex arguments related to welfare concerns, and the Animal Scientific Procedures Inspectorate should retain a monitoring brief and an overview, through consideration of subsequent licence applications, and conduct periodic appraisal of validity to inform the APC.

The Identification and Weighing of Harms and Benefits

Are there additional categories of uses of animals, or particular types of procedure, which should be viewed as unacceptable either in terms of the level of suffering involved or the species of animal that is used regardless of the benefit that comes from such use or procedures?

The Society endorses the decision to rule out certain types of animal experimentation and species on moral grounds. However, the UK is already more restrictive than other countries in terms of the type of work which can be conducted on animals and this has resulted in the exportation of some types of tests to other countries where animals are not afforded the same level of protection as that given in the UK. While the UK cannot isolate itself from the international legal position with regard to the safety testing of novel pharmaceuticals, and the global pattern of the acceptability of animal experimentation, it can and should take a lead in these matters, as all moral advances come at first from one or a few countries.

Are there some types of benefit (the overall purpose of the experiment) that might be held as not justifying the use of animals or justifying it only in exceptional circumstances regardless of whether or not the animals would suffer?

In general no, other than those purposes already ruled out by the Home Office (e.g. to test offensive weapons, alcohol, cosmetics and tobacco products), provided the studies have clear-cut scientific validity, although consideration could be given to ruling out the use of animals in household product testing.

Are all relevant harms and benefits identified by current Home Office practice? Even if, by its nature, the weighing of costs and benefits always has to be a matter of opinion, is there need for further clarification of the criteria which have been or should be employed in particular cases?

By and large, all relevant harms and benefits are identified by current Home Office practice. The weighing of costs and benefits, however, will remain essentially a matter of opinion and the value judgement of individual arbiters will be influenced greatly by their personal view of the entire practice of animal experimentation. Nevertheless, there would be merit in clarification of the relative weightings of costs and benefits as such weightings are not absolute and will change over time.

Are costs other than those involved in, or consequent upon, the actual procedures given their due weight? These include the physical and psychological harms/sufferings associated with capture, confinement, transportation, social isolation, husbandry systems and general handling of animals. Should death in itself be considered a harm and what weight should be given to this in the cost-benefit assessment?

Many of these considerations are very difficult to quantify, as there are considerable differences between the natural environment and animal facilities. There is increasing recognition that experiments that use rodents benefit from an enriched environment which presumably in principle could also translate to larger mammals. These general welfare issues merit closer discussion, informed by appropriate research. There is also a moral argument that there should be a serious attempt to give each animal what might be described as a life worth living. From this point of view, the conditions in which they are housed, and the amount of appropriate socialisation allowed, are clearly important.

Death could be considered to be a harm. However, pathological examination of tissues of animals is a common requirement of animal experiments and the humane killing of an animal bred for research should not be a major factor. For example, comparison would need to be made with the numbers of animals bred and killed for food in this country. If experimental animals were not humanely killed, consideration would need to be given to their fate after the experiments were concluded.

Are there costs to animals, for example, aspects of poor welfare or undesirable changes in animals, which could be specific to transgenic animals or animals treated with products from genetically modified organisms? Do you consider that any of these costs could never be justified by benefits?

There are aspects of welfare specific to transgenic animals and such aspects should be addressed in the Project Licence which authorises their breeding, including appropriate end-points. The cost and benefit of creating such animals should be agreed, as for any other area of experimental work, and transgenic animals or products from genetically modified organisms should not be put in a separate category to their conventional counterparts. In every case the same criteria and consideration for the animals should apply. Special concern should, however, be given to the production of transgenic animals incapable of escaping serious discomforts throughout their lives and their resulting quality of life.

Please give detailed examples of benefits specific to the use of transgenic animals, or to the treatment of animals with products from genetically modified organisms, which are likely to be very great. Are there, or will there be, benefits whose magnitude is too small, or whose likelihood of accruing is too remote or too distant in time, to outweigh the costs?

Work on transgenic animals is still in its infancy and, therefore, it would be premature to make judgement. However, one could cite benefits gleaned from the understanding of Motor Neurone disease (ALS), the genesis and treatment of diseases such as cancer and the generation of free radicals and the associated cellular damage. Further, work on transgenic animals have shown how Ab plaques (similar to Alzheimer's disease) are deposited and how the system may be manipulated to prevent this from occurring with improvement in their recognition.

In general, transgenesis should be treated no differently to any other experimental procedure. While the current legislature was not written with a view to the use of these procedures, the relevant sections of the Project Licence application include the opportunity for their costs and benefits to be described.

Research is increasingly a multinational process and UK researchers often collaborate with scientists abroad who are operating under different regulatory regimes which may have much less regard for animals and their welfare. Do you believe that this is a significant problem? If so, what might be done to address it?

While this will not be a significant problem when the collaboration is within Europe, or between Europe and North America, it can be a problem with collaborations with other countries in the world. It is apparent that the standards for animal experimentation are largely set in Europe and in North America where, although there are differences, the standards are remarkably similar. A rapid way by which standards could be improved throughout the world is for this issue to be driven by journal editorial offices, which determine criteria for the design and conduct of experiments, with deviation from agreed standards resulting in the work not being published. In addition, while not wishing to diminish collaborative research, UK investigators could be encouraged only to participate in studies which would have UK approval.

Another aspect of this issue is that the timescale required to secure Personal Licences for foreign visitors (rarely less than 3 months) is a considerable impediment to research collaborations, many of which are time limited. The legal solution might be ‘vicarious liability’. The idea is that, at the discretion of an appropriate Home Office Inspector, certain foreign visitors with demonstrable skills and respect for UK Law should be allowed to conduct joint research in a UK laboratory under terms that would convey vicarious responsibility to the relevant Project Licence holder. In practice, this would mean that such a Licence Holder would be legally liable for any procedure carried by such a visitor. The usual terms of Home Office Inspection (unannounced visits) would apply. This would also be an opportunity to illustrate the approach to legislation taken in this country and its merits, and thereby inform and influence other countries.

Additional Information

In responding to this inquiry the Society would like to draw attention to the following Royal Society of Edinburgh responses which are of relevance to this subject: Review of the Framework for Overseeing Developments in Biotechnology (February 1999) and Agriculture and Environment Biotechnology Commission Work Plan (November 2000).

 

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