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Human Genetic Databases: Towards a Global Ethical Framework

Annual Call for Projects 2003

Summary

The Department of Ethics, Trade, Human Rights and Health Law of the World Health Organization and the Bioethics Unit of the Faculty of Medicine of the University of Geneva have joined together to study the conditions under which genetic databases can be established, kept and used in an ethically acceptable way. Financial support for this project is provided by the Geneva International Academic Network (GIAN).

The technical possibilities for automated analysis of large DNA sample collections and the bio-informatic processing of the resulting data have developed dramatically during the past several years and are constantly being improved. Protecting the data available in such databases has consequently emerged as a highly complex ethical issue in the arena of health policy. The ethical issues become even more acute when genetic data are combined with information on individuals' health, lifestyle or genealogy.

Population genomics research drawing on genetic databases has been expanding rapidly. Since the sustained and intense international debate on this topic began, particularly with Iceland's Act on a Health Sector Database (adopted in 1998), various databases have been established, some on a national basis (Estonia, Iceland, UK), others focusing on a district or region (in Sweden and Canada, for example). The political processes leading up to the establishment of these databases, as well as their particular legal and ethical arrangements, have stirred considerable controversy, which underscores the urgent need for an ethically grounded, global regulatory framework.

Several countries have addressed the problems presented by genetic databases. Some (such as Iceland and Estonia) have passed laws; in others - including France, Canada, the UK, and the US - national bioethics advisory committees have issued reports and recommendations. International organizations (among them UNESCO, the World Medical Association, and the Council of Europe) have also started to tackle the issue and have prepared declarations and other normative texts. Despite the value of such guidance, no regulatory framework for genetic databases has been developed to date that is global in scope, yet developed with regional input, and specific enough to provide practical guidance. WHO and the University of Geneva aim to bridge this gap.

Four basic issues related to the establishment, maintenance and use of human genetic databases comprise the basis of the current project inquiry: consent; ownership/benefits, including property rights, access to and commercial use of the data; risks to security and privacy of individuals' genetic information, including the possibility of stigmatisation and discrimination; and communication of individual results of genetic testing and health risk factors to study participants. Issues of trust, fairness, and exploitation are even more pronounced when the researchers and the populations being studied come from different cultural or socio-economic backgrounds.

The project will unfold in several steps. A comprehensive review of the scientific literature will be followed by a comparative analysis of existing normative frameworks. Unresolved or controversial issues will be taken up in the development of interview guides that will also contain case vignettes modelled on existing databases. Interviews will be held with 25-30 respondents - both advocates and critics of human genetic databases - from countries selected to ensure diversity of regions and levels of economic development, including those that have such databases, those that have rejected the prospect and those that have not yet taken action regarding the issue. The respondents will be chosen from among the experts in the field working in various international organisations and from among other stakeholders. The results of these interviews will be combined with the prior analytic work to produce draft practice guidelines, which will in turn be refined in a consultative process, fostering intercultural dialogue on this intricate and controversial topic. Final steps will include the dissemination of the revised guidelines to legislators, researchers, review boards and those responsible for the management and maintenance of human genetic databases. A training module for researchers and members of research ethics committees worldwide will also be developed.

Population genomics research can advance in ways that respect human rights and fairly distribute risks and benefits only with the recognition of commonly shared principles. Furthermore, there is a need to adopt guidelines that are sensitive to problems arising from discrepant economic standards and cultural diversity.

The grant provided by the GIAN for this project totals SFr 285,000

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Project Team

Dr. Nikola Biller-Andorno , Principal Member, Ethics and Health , World Health Organization (WHO) .

Ms Agomoni Ganguli , Principal Member, University of Z├╝rich (Unizh) .

Dr. Alexander M. Capron , Former Coordinator, Ethics and Health , World Health Organization (WHO) .

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Related Conferences

Genetic Databases: Towards a Global Ethical Framework: Experts' Consultation Meeting - 8 and 9 May 2006
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Research Output

Charitable Trusts and Human Research Genetic Databases: The Way Forward?
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Human Genetic Databases: Towards a Global Ethical Framework
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Consent and Anonymization in Research Involving Biobanks
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Human Genetic Databases – Between Global Principles and Local Concerns
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Comparing Guidelines on Biobanks: Emerging Consensus and Unresolved Controversies
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Human Genetic Databases: Towards a Global Ethical Framework
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The Ethics and Regulation of Human Genetic Databases - Global Perspectives
(available in English only)
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