Human genetic databases: towards a global ethical framework

With the support of the Geneva International Academic Network (GIAN), the Ethics and Health Unit of the World Health Organization (WHO/DGO/ETH) and the Bioethics Unit of the Medical Faculty of Geneva University (Unité de recherche et d'enseignement en bioéthique) have joined together to study the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way.

The technical possibilities for automated analysis of large DNA sample collections and the bio-informatic processing of the resulting data, which have developed dramatically during the past several years, are constantly being improved. Protecting the data available from 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 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 county or region (Sweden, Canada). 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. 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.

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, preparing 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, while being specific enough to provide practical guidance. WHO and the University of Geneva aim to bridge this gap.

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 (from countries selected to ensure diversity of regions and levels of economic development). 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 and production of a training module for researchers and members of research ethics committees worldwide.

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 practice guidelines that are sensitive to problems which arise out of discrepant economic standards and cultural diversity.

Project Team:

WHO
Alexander M. Capron, Director, Ethics and Health Unit (ETH/DGO/WHO), Project Coordinator
Dr. Nikola Biller-Andorno, Ethicist, Ethics and Health Unit (ETH/DGO/WHO)

University of Geneva
Prof. Alex Mauron, Unité de recherche et d'enseignement en bioéthique
Dr. Bernice Elger, Unité de recherche et d'enseignement en bioéthique
Andrea Boggio, Unité de recherche et d'enseignement en bioéthique