Creation and Governance of Human Genetic Research Databases
The Icelandic Health Sector Database was started in 1998 to develop improved methods of achieving better health, and prediction, diagnosis and treatment of disease. Worthwhile goals, yet it was stalled by controversy over the issue of consent. The CARTaGENE project, a proposed 50-year genetic profile of the Quebec population, got started in 1999, and is still awaiting ethics and privacy approval from the government.
The ever-expanding content of genetic and biological data, the increasing facility to share them, and the importance of genetics in understanding human health have created a brave new world of issues and concerns. Who owns the data, information and biological samples contained in a genetic database project? What criteria should be used to determine whether a bio-bank should be a public or private undertaking? Should participants be remunerated? What constitutes informed consent? Should children be included in genetic studies, and if so, what safeguards should be considered?This report, Creation and Governance of Human Genetic Research, kick-starts the process of considering international policy challenges associated with the establishment, management and governance of human genetic research databases.One of the most consistent themes that emerges is the importance of gaining and respecting the public’s trust. Losing this, as seen with the controversy over genetically modified organisms, can have a profound impact on research and the acceptance of new technologies. Furthermore, commercial use raises tensions between free access to data and the desire for commercial benefits.Certainly not all efforts at developing genetic banks are being held back. The GenomEUtwin project, supported by the European Commission, is focusing on twin and other population cohorts to pull out the genetic, environmental and lifestyle components indicated in health problems such as obesity, migraine, stature, heart disease, stroke and longevity. It has collected data from all across Europe, including Danish, Dutch, Finnish and Italian twins, among many other sources. Tens of thousands of DNA samples have been collected and stored since 2002, and the information is accessible to investigators worldwide.Large-scale studies of populations like this may contribute to science’s understanding of the complex diseases and improvements in prevention and cure, but as Creation and Governance of Human Genetic Research Databases shows, the policy implications have to be dealt with seriously.
ISBN 9264028528©OECD Observer No 258/259, December 2006