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This page can be accessed directly at
www.oecd.org/sti/biotechnology/hbgrd
The ability to effectively use these vast amounts of knowledge will depend in part on the bringing together of different strands of information, data and biological materials within human biobanks and genetic research databases (HBGRDs).
The OECD Working Party on Biotechnology is developing Council Guidelines on human biobanks and genetic research databases (HBGRDs) through an expert group of member countries. The Guidelines are intended to assist both OECD and non-OECD governments in the development of policies applicable to HBGRDs and to provide guidance for private and public sector HBGRDs.
The establishment, harmonisation and broad use of research involving data and samples from human biobanks and genetic research databases analysed in conjunction with personal or health data is important for research and will be increasingly important not only for healthcare but also for drug discovery.
There are many different types of HBGRDs being established, including cross-sectional, longitudinal, large-scale, disease-specific, or population-based. Such resources will provide platforms for international collaboration on a scale not previously attained.
The Guidelines provide guidance for the establishment, governance, management, operation, access, use and discontinuation of HBGRDs. They cover governance structure and oversight mechanisms; privacy and confidentiality; terms of participation; access; funding mechanisms; benefit sharing, intellectual property and commercialisation; protection and security of human biological materials and data; the qualifications, education and training of staff; disposal of materials and data and the discontinuation of a HBGRD.
In Spring – Summer 2008, the draft Guidelines were put out to broad international consultation. The response, from a broad spectrum of stakeholders representing OECD member countries and non-member economies, was very positive. The draft Guidelines are in the process of being revised with the aim that they will be adopted by Council in 2009. The next stage is for the Working Party on Biotechnology to approve a final version in November.
Background
As background work, a report was produced which provides an analysis of a number of complex issues that arise in the establishment, governance, management and use of HBGRDs.
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