INTRODUCTION

  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.

WHY THE CONVENTIONAL MODEL OF SCIENTIFIC RESEARCH IS INAPPROPRIATE FOR POPULATION GENETICS

  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 and groups.

  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 FOR POPULATION GENETICS RESEARCH

  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.

CONSENT TO RESEARCH AND USES OF SAMPLES

  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.

COMMERCIAL INVOLVEMENT AND OWNERSHIP

  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 issues.

  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 circumstances—the 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 based.

FEEDBACK OF INFORMATION TO DONORS

  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.

CONCLUSION

  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