Affiliated staffMairi Levitt, Paul Fearnhead
BackgroundThe overall objective of this project was to explore the ethical, regulatory and governance issues arising out of the use of genetic databases. This involved a number of strands around which individual projects are developed. These strands include comparative, statistical, ethical, regulatory and global dimensions. The rapid developments in molecular diagnostics and ever expanding wealth of biological data have provoked issues concerning the deciphering, storing, validating, annotating and integrating of information in different kinds of genomic databases. The use of genetic databases has come to the fore because of the magnitude of the available information, and the speed with which health care is transforming its basis to molecular medicine. These databases can be based on physical collections of (all kinds of) biological materials – ‘biobanks’ - or simply processed information in computers. They provide multiple research opportunities in the understanding of variability in human health, understanding of complex interactions such as gene-gene, genes–environment, and genotype-phenotype. Genetic databases provide new dimensions and new niches to examine the ethics of different traditions of research and to undertake a comparative analysis in different societies of the world and its implications on global health.
AimsThe Database project was developed under the theme of genomics, ethics and governance, focusing on ethical, legal and also the scientific/statistical validity of creating large scale, population based genomic databases. The project was framed into four strands to develop a bigger picture and challenging ethics and law. Issues considered included
- How biobanking is shaping ethics at personal and community level and the need to bring new ethical principles to accommodate changing trends in genomics.
- The publics’ expectations of genetic databases and biobanks and how they might shape future choices for individuals and families.
- The typology of databases and the different governance mechanisms established in different countries for databases and the ethical underpinning of those frameworks.
- The global trends in biobanking and how it is influencing research priorities and ethical frameworks in poor countries.
- Statistical validity of databases and the ethics of advice based on figures. How science shapes clinical research and health care?
MethodsGiven the broad reach of the four strands associated with the Databases project, the methodology involved an array of techniques. These included focus groups, statistical modelling and analysis, literature reviews and interviews.
- At the conceptual level there are parallel shifts in framing of the ethical questions as the focus of medicine is shifting from individuals to populations, and the role of ‘individual’ in medicine and ethics is contested. As genetic research has moved from Mendelian genetics to sequence maps to the study of human genetic variation at the level of the genome, there is an accompanying shift in emphasis in ethical framings of the issues - towards reciprocity, mutuality, solidarity, and citizenry.
- The new emphasis on ethics in medicine in Asia is corresponding with the global debate to be inclusive of different cultural values, and since the role of the family is central in decision-making in Asia, new principles such as family based individual informed consent and collective confidentiality are developed.
- Different countries have different models of governance of databases. From a policy-making point of view, biobanks with a firm legislative framework (model 1) enjoy a superior level of enforceability and the greater certainty attached to governance frameworks. Biobanks created independently of legislation (model 2) enjoy a greater adaptability. In attempting to legislate for circumstances that are currently unpredictable it can be argued that model 1 biobanks are insufficiently flexible.
- The empirical work showed that the requirement for individual informed consent does not address wider concerns over the type of society genetic applications could bring about, the commercialization and commodification of information and the privatization of public goods. Individual consent assigns control to other people. In order to place their trust well, people need evidence of a relationship with obligations and expectations on both sides.
- Biobanks intend to focus on gene-environment association using genetic association studies models. However, definitions of environment are still unclear raising concerns over statistical validity of databases. The confounding factors that may affect results and the reliability and reproducibility of results need to be considered for such long-term large-scale population based studies. Concerns are also raised over managing expectations in the healthcare system, the dangers of over enthusiasm and misreporting of the data.
PublicationsBhardwaj, M. (2006) ‘Looking back, looking beyond: revisiting the ethics of genome generation’, Journal of Biosciences, 31: 1 pp. 167-176Levitt M. and Weldon S. (2005) 'A well placed trust? Public perceptions of the governance of DNA databases', Critical Public Health, 15:4, pp.311-321Knoppers, B., Chadwick, R., (2005) ‘Human genetic research: emerging trends in ethics’, Nature Reviews Genetics, 6: 1 pp75-79 Bhardwaj, M. (2004) ‘Global Bioethics and International Governance of Biotechnology’, Asian Biotechnology and Development Review, 6: 1 Bhardwaj, M. (2004) ‘Rich databases and poor people: opportunities for developing countries’ TRAMES, The Official Journal of Estonian Academy of Sciences, 8: 1Cutter, A., Wilson, S., Chadwick, R. (2004) ‘Balancing Powers: Examining models of Biobank Governance’ Journal of International Biotechnology Law, 1: 5 pp 187-192 Chadwick, R. (2004) ‘Telling the truth about genomics’, Communication & Medicine, 1: 2 pp 193-199
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