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OECD recommendations on biobanks and genetic databases

23 November 2009   |   By Dr Sowmiya Moorthie   |   News story
The Organisation for Economic Co-operation and Development (OECD) launched a public consultation on draft Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs) last year (see previous news). The draft Guidelines were developed by experts from OECD member states, including individuals from national and international HBGRDs, along with policy makers, researchers, lawyers, ethicists, and private sector representatives.  Comments were invited from any member of the public and a Recommendation on Human Biobanks and Genetic Research Databases was adopted in October 2009 by the OECD Council.

The document defines HBGRDs as “structured resources that can be used for the purpose of genetic research and which include: (a) human biological materials and/or information generated from the analysis of the same; and (b) extensive associated information”. The recommendations provide guidelines for the establishment, governance, management, operation, access, use and discontinuation of HBGRDs and are intended to be applied  broadly. Although primarily targeted at new HBGRDs, the principles contained may also be applied to existing databases and to some extent to those which are established for non-research purposes, such as public surveillance. The document also links with other OECD biotechnology recommendations, such as those relating to quality assurance in molecular genetic testing among others.

The OECD state that these guidelines are intended to be “evolutionary” and relevant scientific and societal developments will lead to their review. Accordingly they state a need to review these Recommendations and Guidelines five years after its adoption in the first instance and periodically thereafter.

Keywords: Genetic Databases, Genetic Tests, Testing & Screening, Regulatory Framework

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