Title: Biobanks in Europe: Prospects for Harmonisation and Networking
Authors: ZIKA EleniPACI DanieleSCHULTE IN DEN BÄUMEN TobiasBRAUN AnetteRIJKERS-DEFRASNE SylvieDESCHÊNES MylèneFORTIER IsabelLAAGE-HELLMAN JensA. SCERRI ChristianIBARRETA RUIZ Dolores
Publisher: Publications Office of the European Union
Publication Year: 2010
JRC N°: JRC57831
ISBN: 978-92-79-15783-7
ISSN: 1018-5593
Other Identifiers: EUR 24361 EN
OPOCE LF-NA-24361-EN-C
URI: http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=3259
http://publications.jrc.ec.europa.eu/repository/handle/JRC57831
DOI: 10.2791/41701
Type: EUR - Scientific and Technical Research Reports
Abstract: Biobanks (i.e. the organised collections consisting of biological samples and associated data, have gained great significance for research and personalised medicine) are increasingly recognised as a crucial infrastructure for research. However, at the same time the widely varied practices in biobanking regarding for example collection, storage and consent procedures may also pose a barrier to cross-border research and collaboration by limiting access to samples and data. In this context, a recent study indicates that the limited sharing and linkage of samples is a key barrier for research, such as pharmacogenetics. Wide variation is observed in the implementation of relevant existing regulation, which may add further burden to harnessing the public health benefit of these collections. Therefore, it has been suggested that there is a strong need for a harmonised approach on biobanking practices and improved networking of existing and new collections. This Report shows information on the extent of biobanking in Europe, collected through a survey of existing European biobanks regarding both technical aspects (e.g. storage conditions) and aspects of governance and ethics (e.g. sample and data sharing, consent procedures, collaborations etc.). In total, 126 biobanks from 23 countries in Europe were surveyed. Significant lack of harmonisation has been found, especially in the legal aspects (e.g. data protection, consent). This may be partly attributed to the varied interpretation and implementation of EC directives covering aspects of biobanking by national authorities. One of the main complications is that, although the field of data protection is harmonised through the EC directive on data protection, the collection, storage, and sharing of samples is not. Furthermore, in countries that have introduced special biobanks acts it is not always clear where the borderline lies between the scope of these acts and that of the Directive. Indeed, according to the survey, biobanks within the same country reported different practices, suggesting that the problems of harmonization might be higher than expected and claimed. Not only are there different national laws, but apparently within EU member states biobanks do not implement homogenous practices on privacy and data protection issues. Desk research and expert interviews were done to complete the picture presented by the survey. Experts widely recognised the need to improve collaboration and networking among the numerous existing biobanks, as well as new initiatives in Europe (and world-wide). Efficient organisation of these resources through the development, for example, of an infrastructure would potentially facilitate financial sustainability and greatly contribute to the rapid progress of research and development of better diagnostic and therapeutic approaches. The most favoured model involved the development of a virtual biobank that would allow networking of biobanks across different countries and centralisation of data rather than samples. However, several organisational challenges (wide variation in biospecimen collection, storage techniques, data comparability, etc.) may hamper such an effort. The lack of uniform regulatory and ethical requirements and/or practices may pose an additional barrier. The European Commission has already recognised the importance of international biobank projects and many of them have been funded and established in the context of the EU Framework Programmes. To help promote networking of biobanks and thus maximise public health benefits, at least some degree of harmonisation must be achieved. Whether this should be achieved solely at the level of legal/regulatory requirements and practices and/or by technical standardisation requires further investigation. Experts suggested the establishment of an international (rathen than just a European) umbrella (or network) organization, which would establish common operating procedures.
JRC Institute:Institute for Prospective Technological Studies

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