THE ETHICS AND GOVERNANCE OF HUMAN DATABASES

Vol. 18 No. 3 (March, 2008) pp.208-211 (also available in Spanish)

THE ETHICS AND GOVERNANCE OF HUMAN DATABASES: EUROPEAN PERSPECTIVES, by Matti Häyry, Ruth Chadwick, Vilhjálmur Árnason and Gardar Árnason (eds.). Cambridge University Press, 2007. 296pp. Hardback £50.00/$95.00. ISBN: 9780521856621. eBook format. $76.00. ISBN: 9780511282584.

Reviewed by Ricardo Chueca, Department of Law, University of La Rioja, Spain, e-mail: ricardo.chueca [at] unirioja.es.

The need to store large quantities of genetic and health data for scientific research is something relatively new. Given the current status quo of the scientific knowledge, this circumstance is necessary because diseases are the result of our own way of life and the environment in which we live. However, all this happens because these factors interact with our individual genetic makeup.

Hence, to explore how these interrelationships, and the need and utility of general laws, is the primary aim of much contemporary biomedical and genetic research.

All the above mentioned shows a huge, difficult and new cargo of problems. THE ETHICS AND GOVERNANCE OF HUMAN DATABASES is an exploration of those problems from an interdisciplinary perspective and from four Human Genetic Database (HGD) experiences. They are the deCODE’s database of Iceland, the State Genome Project, the UK Biobank and the Swedish Medical Biobank of Umeå. All the relevant aspects from a social, legal, ethical or political approach are treated, and research of specialists in law, philosophy and sociology is included in the collection. The book is the final outcome of a Project financed by the European Commission, (Ethical, Legal and Social Aspects of Human Genetic Databases: A European Comparison. ELSAGEN). And it offers comparison of the four HGDs. However, the title – European perspectives – is not so correct, as not all European perspectives and experiences are presented, neither all the important ones.

The sociological perspective, treated in Part II, is extremely important, because we are in an area in which anticipating regulation is so important. In addition, therefore, the perceptions of citizens about the nature and purpose of related practices help to anticipate future legal regulations and socially dominant ethical criteria. Moreover, these perceptions condition the financing of specific lines of investigation on these matters. Confidence in the investigators is generally very high, but there are interesting national differences. In addition, concern regarding protection of privacy is the most significant result arising from the various surveys. Nevertheless, they are perceptions which have not been considered systematically, and they can provide some guidance for the general role of scientific and therapeutic uses of genetic databases.

The legal issues studied in Part III reflect the most problematic and disturbing aspects of this general enterprise, because we find very serious regulatory [*209] problems. The current rules are inadequate, in general terms, albeit with some exceptions which are not always reflected in the book, perhaps because two years had passed between the end of the investigation and the publication of the results. In the area of regulation of HGDs two years is too much time. The book does not include, for example, the Spanish Ley de Investigación Biomédica (Biomedical Research Act) in 2007, which includes detailed regulation of HGDs as well as of a range of practices considered to be in the vanguard of genetic research.

In spite of some proposals which do not seem to be very sensible (p.241), the role of the market and of the free initiative on these matters has not been resolved. From the analysis contained in the book we cannot conclude a clear position: whether to choose a private initiative model, a public model, or a mixed one. Indeed there are problems associated with all of them. However it seems clear that the trend involving use of HGDs is to depend, in more or less measure, on public decisions.

Among the legal questions associated with exploitation of scientific findings in certain cases, intellectual property and patent issues present special difficulties, and the problem of how to guarantee security has not been solved either.

The problems of regulation of consent are quite varied and strikingly complex, due to the capacity of genetic issues to exponentially increase the difficulty of these classic legal issues. On the other hand, the legal systems analyzed tend to confuse the nature of informed consent. In fact, the authors do not seem to be very concerned about the special circumstances for ownership and informed consent presented by stored genetic samples. In many jurisdictions and in the international instruments of reference on this matter there are often two distinct rights – of the individual donor and the database proprietor – which thus require two acts of consent with different purposes. Nonetheless, as it frequently happens, all is recorded in a single document.

The privacy of donors is another major legal obstacle which must be considered in any governance of HGD testing. It is not easy to find a balance between the demands of the investigation and those associated with protection of individual privacy. However, the solution may never be obtained through a decrease of the level of privacy protection, which is undoubtedly an ongoing issue of conflict. Despite what some of the authors suggest (p.183), making a distinction between sensitive and unsensitive data may be improper when it comes to genetic and individualized information.

Given the nature and the uniqueness of the genetic information, overcoming the problem of truly informing individual donors and obtaining their consent seems rather insurmountable. Moreover, and also of great importance, because third parties have an interest and can been affected by the same information, the issues quickly become increasingly complex.

In this respect, it is not strange that, in such cases, the legal regulations change for each country, introducing considerable variations in an area which require a highly homogeneous regulation, at least at the state level. [*210]

The potential discrimination that may result from genetic research is another of the threats that can gain importance because of the information that the HGDs collect. When a research decision introduces ethnic discriminatory criteria, or when these criteria are scientifically justified, a policy decision option is neither neutral nor straightforwardly simple. To gain consensus necessary to build general rules about this issue also does not seem to be easy.

Without intention of being thorough, the examples selected from the many legal and judicial obstacles associated with HGDs mentioned by the authors are perhaps enough to reveal an obvious reality: the legal regulatory mechanisms are the result of repeated practice in typical scenarios related to the traditional doctor-patient relationship. However, the positions and categories developed in such cases collide head-on with the new scenarios. Privacy, informed consent and confidence are terms that, in regulation of raw genetic environment, need to be strengthened. The question is whether those concepts remain useful or whether it is necessary to rebuild them entirely.

Even so, the most difficult and pressing need is to have a body regulations that is relatively homogeneous. Certainly, we have a series of documents and international declarations that are moving in the direction of harmonizing standards. Nevertheless, a key problem is the unequal starting position of each society in the field of biomedical research and genetics. Only the European Convention on the Protection of Human Rights and Dignity of the Human Beings with regard to the Application of Biology and Medicine (1997) represents a proposal for a binding legal rule with European regional scope for those States which have ratified it. Greater harmonization is without doubt, the key.

However, there are other significant problems. Although differences are minor in terms of content between the European standard and the American Values collected in the Georgetown model, as the authors (p.28-36) call it, the approximation of more global rules is not as yet close.

On the issue of ethical considerations, Part IV, the most recurrent problems are related to benefit sharing and with options in which justice and fairness criteria come into play. However, the difficulty is lower because, due to the nature of ethical review, the larger good is generally given considerable weight beyond the specific problem under study.

The final pages of the book, Part V, before the closing Conclusions, deal with a set of political considerations in a wide sense. Gardar Árnason devotes particularly instructive effort to defend genetic research from the crippling rhetoric which surrounds it: “Human genetic databases will doubtless contribute to the progress of science and possibly lead to the discovery of new drugs, but science and medicine will also do very well within them.”

How to organize and regulate the functioning of the HGDs is a question that currently does not have an unequivocal answer. On the one hand, the scientific research, whose purpose they now primarily serve, advises a kind of intervention which does not condition [*211] the carrying out of an activity that is only fruitful if it is free. Nevertheless, it seems that freedom of research and free market cannot naturally live together in this area. Because they pursue aims which are not always compatible, they represent activities from which we can perceive efforts that are contradictory.

As it always happens when human knowledge achieves qualitative advances – and the genetic research is accumulating knowledge in an incredible manner – activities associated with human genetic databases have a double side: HGDs represent first important instruments of scientific progress, and for this reason they must be favored; but at the same time they must only be used for the common good, not for other purposes that should be expressly and solidly banned.

Rarely does a book comprise so many large and growing legal questions. THE ETHICS AND GOVERNANCE OF HUMAN DATABASES is a very worthy book which addresses issues that are opening up every day – sometimes under our feet.

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