Memorandum by Dr David King, Editor, GenEthics
A DEMOCRATIC MODEL FOR RESEARCH USING GENE
1. This submission is based upon several
years' experience as a member of the Ethics Committee of the North
Cumbria Community Genetics Project, as well as personal contact
with indigenous people's organisations protesting against the
Human Genome Diversity Project (HGDP) and with people opposing
the Icelandic gene bank.
2. First, it is important to use the correct
terminology. The term "genetic databases" is inaccurate
and misleading. What is actually referred to is collections of
tissue samples from which DNA can be and sometimes is extracted.
A database is composed purely of information, and tissue banks
often have associated databases of relevant medical information
about people from whom the samples are taken. However, these are
not databases of genetic information. The term "genetic databases"
suggests that it is possible to search the database to "fish
out" information about someone's genes, but this can only
be done by performing tests on the tissue samples. The term genetic
database gives an exaggerated impression of what can be done with
these collections and tends to conflate them with gene sequence
databases, such as GenBank. It is therefore preferable to use
the term gene banks.
3. The vehement opposition of indigenous
people's groups and of many Icelanders to the proposed research
projects there, is highly unusual: people do not often object
to scientific research as such. This should alert us to the possibility
that there is something fundamentally wrong with the basic research
model which these specific proposals exemplify.
4. At the root of the objections to the
HGDP and the Icelandic gene bank is people's perception that they
are being treated as mere objects. This is not only offensive
to them, but they sense correctly, that this reduction in their
status arises from their being in a less powerful position than
scientists and corporations and they also fear, correctly, that
this situation puts them at risk of harm, both as individuals
5. It is not surprising that people feel
that they are being treated as objects, because the conventional
paradigm of scientific research dictates that this should be the
case. Within the conventional paradigm, scientists place themselves
outside the system which they are studying, in the name of "objectivity",
and they study that system as an object. When the objects of study
are human beings and social groups there is obviously a possibility
for harm, and the conventional role of medical ethics is to try
and prevent this harm, whilst preserving the basic structure of
the paradigm. Nonetheless, tensions remain, and in the case of
population genetics research are becoming unmanageable.
6. In the case of the HGDP and Iceland,
the objectification of people and groups, which is inherent in
the research paradigm, is manifest in a number of obvious ways.
In the HGDP, objectification originated in the very language used:
indigenous tribes were described as "isolates of historical
importance". There is a persistent tendency in such projects
for scientists to descend suddenly on an isolated group, collect
samples and leave, often never to be heard of again. Clearly,
such people are regarded by the scientists as an interesting and
useful resource, as little more than data points. The people are
not consulted in a serious way prior to the research, and the
samples and data derived from them are often used in ways which
directly contradict the worldviews and values of those groups.
In the Icelandic case, people's sense of vulnerability and of
being used has been exacerbated by the scientists' apparent willingness
to abrogate even those basic protections normally afforded by
medical ethics, when it appears that they are inconvenient to
the scientists: the requirement for informed consent has been
turned on its head. Of course, this is made even worse because
of the apparently undemocratic way in which the gene bank was
established, and the granting of a monopoly to a commercial company.
7. As noted, the root of this problem is
that scientists tend to do research on people, rather than with
them. The situation has already began to erode the altruism which
prompts people's participation in medical research. Whilst the
strongest reactions to population genetics research have been
from indigenous people, there is no reason to think that there
could not be a similar reaction in the UK after the GM food experience,
especially if commercial interests become too heavily involved
in gene bank projects. It is time to change the paradigm of medical
research to a far more democratic and participatory model. This
will also necessitate changing the institutional basis of research.
A DEMOCRATIC MODEL
8. An alternative way of doing genetic research
on populations must start from the idea of doing research with
people, rather than on them, and treating them as equal participants
in research. In this conception, the research project is a joint
enterprise of the community as a whole, with scientists acting
as the servants of the community, rather than as outsiders using
it. This approach is very suited to the creation of gene banks,
since they require thousands of people to altruistically participate
for the good of the community, as they do in blood donation. Such
an approach would make the term "community genetics"
a reality. These kind of approaches are increasingly common in
social science research but have not been used in medical research.
9. To make such an approach work in practice
would require a change in the institutional organisation and control
of research. Before any gene bank was created there would be an
extensive public consultation process, including a social impact
assessment conducted by independent academics or consultants.
The community must be asked whether it wants such a project, not
merely how the project should be implemented. Since they are community
projects, gene banks would have to be managed and controlled by
the community, in partnership with scientists. Typically, a gene
bank would have a management committee comprised of a majority
of community representatives, which would control the use of funds.
Decisions would need to be consensual. The committee would set
ethical guidelines for the type of research that could be done,
and set conditions on the transfer of samples to third parties.
Wherever possible, the gene bank would be located in the geographical
area in which the particular community lived. The operation of
gene banks would be as transparent as possible, and there would
be the maximum amount of consultation with the community about
important decisions. Of course, the management body must also
be subject to external audit.
10. Within the conventional medical research
paradigm an attempt has been made to deal with the difficult issues
arising from population genetics research through the concept
of "community consent". However, this concept has also
been strongly criticised as incoherent and impracticable. Within
a democratic model of research some of these difficulties could
be avoided because there would be a higher level of trust by research
participants and there would be mechanisms in place for them to
express their wishes beyond the consent process.
11. Treating people as genuine participants
in research requires a higher standard of consent than is common
in conventional medical research, and means that their wishes
must be respected to a high degree.
12. Most importantly, participants' wishes
about how their samples are used must be respected. There are
many possible harms, or other outcomes that people might object
to that might arise from research on gene banks, such as stigmatisation
of people with particular behaviours or ethnic or other social
groups, development of genetic "enhancement" technologies,
patenting of genes (see below), use for biological warfare and
the genetic engineering of animals (this is not a comprehensive
list). For particular ethnic and social groups there may be additional
concerns. The managing body should decide which types of research
are acceptable, but participants must be able to set conditions
on the use of their individual samples, as part of the consent.
Since the aim should be to respect participants' wishes, not merely
to prevent direct harm to individuals (as assumed in conventional
medical ethics guidelines such as the MRC's), if the original
consent is inadequate, it is not possible to do further research
with samples even by anonymising them: the scientists must re-contact
the person for consent. This is particularly important with already-established
older sample collections, where the standards of consent were
probably far worse than are supposed to be used today.
13. Part of the nature of gene banks is
that it is impossible to inform donors fully about all possible
research projects. However, a general consent to any research
is not valid, since it is not even slightly informed. People must
be informed of the broad types of research that could be done
but they will be reassured by the existence of detailed ethical
guidelines drawn up by the managing body.
14. A major source of the difficulties with
existing gene banks has been the perception and reality that they
will be exploited for commercial gain. This raises a variety of
15. An underlying problem is uncertainty
about the ownership of biological samples. Whilst it appears that
the individuals from whom the samples were taken do not own them,
it has been possible for companies and researchers to not only
own them, but claim patents on them. Examples include the patenting
of cell lines from indigenous people, the John Moore case, and
the recent case involving PPL Therapeutics. This is clearly unfair,
and there is evidence that sample donors in the USA are already
beginning to demand financial compensation for donation.
16. The best solution to this problem is
for samples to be held in trust by the managing body of a gene
bank. Samples should not be sold or patented, but the gene bank
could claim expenses if third parties wished to use them.
17. There remains the issue of the patenting
of genes and polymorphisms discovered as a result of research,
either by the gene bank or by companies who may be allowed access
to the samples. In my view, patenting of genes should not be permitted
under any circumstancesthe EU Directive and other relevant
legislation should be changed to make this clear. However, if
it remains legal to patent genes, publicly or charitably funded
gene banks should not permit the patenting of genes by companies
that use the banks. If gene patenting does occur, it is not enough
to merely inform donors that commercial companies may use the
gene bank. Since many donors would object to patenting per se,
it is vital that they are aware of this possibility: if they are
not then consent is not valid.
18. I am not opposed to companies using
gene banks, but this must be strictly regulated. No companies
should be allowed exclusive access to a gene bank, and it is vital
that the gene bank be financially and managerially independent.
In particular, the scientists and doctors must not have any financial
interests in companies that use the gene bank since this will
produce conflicts of interest which would have disastrous consequences
for people's trust in the medical profession.
19. If commercial companies develop products
based on research using gene banks, this is only possible because
of the community initiative. Therefore, they should share the
financial benefits arising by donating a fair percentage of their
profits to the healthcare systems of the gene bank community.
The HUGO ethics committee has suggested that this percentage be
1 to 3 per cent. I would argue that a fairer figure would be a
minimum of 10 per cent. In addition, companies should be forced
to price these products fairly, and perhaps provide them at a
discount or free to the community upon which their research was
20. I am very concerned by the suggestions
in the Medical Research Council's recent guidelines that feedback
of genetic research results to donors would be common. In my view
this is an extremely dangerous policy. Feedback should only occur
under exceptional circumstances. If it is done on a regular basis
then the whole project becomes genetic screening not research,
and will have to budget for the necessary genetic counselling
for all donors. In the North Cumbria Community Genetics Project
the ethics committee looked at this carefully and decided that
the only case where feedback would be justified was if one found
a genetic predisposition in someone to a disease that would cause
them to collapse suddenly with serious consequences. The US National
Bioethics Advisory Commission has also stated that feedback should
only occur in exceptional circumstances.
21. The Select Committee, and no doubt many
scientists, may feel that the suggestions in this submission are
restrictive of research. However, in my view it is important to
get the ethical basis correct before proceeding with any research.
It is the failure to do this, and inadequate self-regulation by
scientists, that has led to many problems in the past. In the
present climate, where commercial companies are increasingly involved
in research with human subjects and tissue samples, the need for
strict standards is even more apparent. At present such research
is only possible because of people's altruism/social conscience
and their trust in the medical profession and medical researchers.
This is rapidly eroding, due to continuing medical research scandals
in the UK and abroad, particularly the USA. A business-as-usual
approach to the establishment of major new scientific projects
will no longer work. What is needed is a re-thinking of the whole
basis of medical research, so that it is put on a new, democratic
footing. While this may be difficult in the short term, and will
require scientists to give up a significant amount of control
over how they do their research, the establishment of a genuine
partnership with communities, on the basis of high ethical standards,
will pay dividends in the long run, both for scientists and society.
Dr David King has a PhD in molecular biology
from Edinburgh University. He is the Editor of GenEthics News
and a member of the North Cumbria Community Genetics Project Ethics
Advisory Group. This is a personal submission,
29 September 2000