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ethics.
1 INTRODUCTION
1.1 What does genetic modification of animals involve?
Genetic modification, or genetic 'engineering'a of animals involves the addition or
deletion of part of the genetic code (DNA) of an animal in order to change the animal's
characteristics (its phenotype). Change in phenotype can be brought about either
through expression of introduced DNA, or through addition, deletion or substitution of
some part of the animal's own genetic material. The aim is usually that the genetic
alteration should also be present in the germ line cells, so that the changes can be
passed on from generation to generation.
A range of methods is available for altering the genetic material. Techniques include
pro-nuclear micro-injection (available since 1980, and used in a range of species);
embryonic stem cell manipulation (in mice, and very recently, primates); and (also
recently) the ability to modify farm animals by nuclear transfer (1,2).
This paper is concerned with non-human vertebrate animals, which are genetically
modified and used
• in research and testing (e.g. in studying gene function and regulation, as models
of human disease and in toxicity testing);
• to synthesise medically important proteins;
• in developing animals which might, in future, be used as sources of organs and
tissues for xenotransplantation;
• as farm animals modified to have increased 'productivity' or disease resistance.
Latest Home Office statistics record that in Britain in 1997, 352 752 scientific
procedures performed under the auspices of the Animals (Scientific Procedures) Act
1986 involved the use of genetically modified animals, amounting to 13% of all recorded
scientific procedures (3). The majority (98%) of the animals involved were mice, and the
remainder mainly rats, pigs and sheep (see Table). Forty percent of the animals were
used for fundamental and applied biomedical research and testing, whilst the remainder
were 'breeding stock', used to maintain the genetically modified lines. The latter animals
were bred from genetically modified parents but were not used in research or testing
procedures - the regulations apply to such animals because their welfare may be
affected by the genetic modification itself.
Scientific procedures peformed on genetically modified animals in 1997
Source: Home Office(3)
Type of genetically No. procedures No. procedures Total number
modified animal for research & testing for breeding procedures
Mouse 137426 207556 344982
Rat 2115 2343 4458
Pig 266 1219 1485
Sheep 1472 0 1472
Fish 200 0 200
Domestic fowl 119 0 119
Rabbit 28 8 36
TOTAL PROCEDURES: 141626 211126 352752
4 CONCLUSIONS
4.1 Fundamental moral objections to genetic modification of animals
Members of the Boyd Group differ in their fundamental moral perspectives on genetic
modification of animals. For some the fundamental moral objections are sufficient to
persuade them that such work should be severely limited, or abandoned altogether. The
consequences for animal welfare, moreover, may be judged so detrimental that the
benefits of using such animals can never (or only in the most exceptional cases)
outweigh the harms.
For others, the fundamental objections do not, in themselves, provide sufficient reason
for avoiding research involving the genetic manipulation of animals, although the
majority believe that such concerns give pause, and should be addressed, since
perceptions of what is morally acceptable are contestable and can change. At a time of
rapid scientific change, it is particularly important to listen to all reasoned arguments
that highlight areas of ethical concern.
4.2 Concerns about the consequences of genetic modification of animals
Whatever their fundamental moral position, members of the Boyd Group are agreed that
whenever animals are genetically modified and used in science, there should be careful,
detailed and critical scrutiny of the consequences of that use, and serious, honest,
reflection on the need to use animals at all. This effort should involve everyone
associated with the use of genetically modified animals - researchers, funding bodies,
the institutional ethical review process, journal editors and those who care for the
animals. In addition, it is important to encourage wider public discussion leading to
greater understanding of the uses of genetically modified animals and of genetic
engineering generally.
The Boyd Group's discussions have focussed on the consequences for animal welfare
and on the necessity to produce and use genetically modified animals. It is noted that
such work can raise further controversial issues - such as those posed by cloning and
patenting genetically modified animals - but these are outside the scope of this paper.
4.2.1 Animal welfare
There is a need for more detailed analysis of the welfare problems (including mortality
rates and ages at which death occurs) caused during the production of genetically
modified animals.
Directly modifying an animal's genetic material can produce unpredictable, wide-ranging
effects, and thus the potential harms and benefits of such procedures are often
uncertain. It is therefore especially important that the justification for the work is
reassessed as it progresses. To assist in this, the welfare effects of genetic
manipulations should be documented in as much detail as possible and efforts should
be made to assess success rates in achieving desired phenotypes.
In particular, there is a need for greater commitment to monitoring, collecting and
reporting data on adverse/side effects of genetic manipulations. Good practice should
be followed, in that adverse effects should be looked for actively and data gathering
should involve those responsible for the husbandry of the animals. Welfare problems
should be recorded in databases on the characteristics of genetically modified animals,
journals should require scientists reporting novel genetic manipulations to document
fully the effects on the animals of the procedures. Reporting should include aspects
such as deaths in utero occurring during production of genetically modified animals, as
well as adverse effects experienced by the resulting animals. The latter should include
any morbidity or mortality, changes in health status, changes in weight/growth of the
animals, behavioural changes, changes in breeding success, and results of post
mortem examinations of gross morphology.
A utilitarian justification for producing and using genetically modified animals must also
take into account potential risks to humans and other animals, as well as to the wider
environment. While this is a major concern of regulatory bodies, these vary in scope
and efficacy between countries, and much more research on safety aspects is needed
to inform their decisions.
In recent years, there has been a rapid rise in the production and use of genetically
modified animals. The British Home Office statistics should include more information on
the scale of the different uses of genetically modified animals, and the extent to which
welfare is compromised.
4.2.2 Necessity to use genetically modified animals
A range of potential benefits has been derived, or is sought, from genetic modification of
animals. Case-by-case judgements about the necessity to use genetically modified
animals must take into account all the various potential harms (both to animals and
humans, and in terms of safety risks and harms which potentially might be caused
through inappropriate application of the results of the research) and benefits of the
work. Such judgements, however, are difficult, and especially so in the case of genetic
modification because of the uncertainties involved. Better documentation of the effects
of manipulations, as outlined above, should help in informing such judgements. The
judgements also depend on the perspective from which the question is asked, and in
this context there is value in widening the process of ethical review, to bring a range of
perspectives to bear.
The use of genetic modification to increase productivity in farm animals by enhancing
growth rate, or related factors such as muscling, is particularly controversial. In large-
scale production and long-term use of genetically modified animals in agriculture,
welfare-negative effects caused by genetic modification should not be tolerated, and
every effort should be made to minimise such effects. The onus should be on the
creators of such animals to prove, under practical circumstances, that welfare is not
compromised at any stage during the animal's life.
a. has increased by 66%; whereas the number of animals used in fundamental and
applied studies has increased by 61% over the period 1995-7.
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