Sample, Data Use and Protection in Biobanking in Europe: Legal Issues

Abstract

The sharing of samples and data stored in biobanks for research has implications for donor privacy, but also raises questions on the regulation of research within Europe. Many legal documents and principles within Europe, with a direct impact on biobanking, have not been developed specifically to support this activity. Moreover, while some new regulations have been set up at national level, there are many variations in the definitions, scope and purpose of these legal instruments. This has resulted in unnecessary hurdles for genome-based research, particularly if samples are shared across national borders. The question is also raised on whether new, specific legislative and governance frameworks designed for biobanking are needed, or whether it is sufficient to modify current general law and to develop specific guidelines, or to accommodate issues raised by biobanking in the current regulation. A workshop with experts from academia and industry, lawyers, national data protection authorities, representatives from the European Commission and the European Data Protection Supervisor was held to review the existing legal bottlenecks and future needs of biobanking, with special regard to the collection, exchange and linkage of samples and data. This report presents highlights of the presentations and discussions from the workshop held in Sevilla, Spain, in March 2007 and the conclusions that followed. The workshop focused on the internal linkage of data and samples stored in a biobank, and the external linkage of biobanks with secondary information resources, such as cancer registries.

The Tension Between Data Sharing and the Protection of Privacy in Genomics Research

“…However, in the case of international data sharing this is extremely difficult, if not impossible, to achieve when data and samples are shared widely. Computer data sets containing personal information must be continually archived, and it is difficult to claw back minute segments of sequence spread over a global network when they are used in multiple research projects (80). The various deidentification and aggregation methods that have been put in place to protect privacy may also make it difficult to trace and remove individual derived data (10, 54).…”

Pharmacogenetics in Europe: Barriers and Opportunities

“…Biobanks in Europe have a great potential for medical research including the facilitation of PGx research. However, difficulties for networking and sharing of their samples, in part reflecting lack of harmonization of legal and ethical guidelines across European member states, hinder turning this potential into reality [21]. Against this background, an often mentioned obstacle is the high complexity of data protection requirements: researchers report a mounting bureaucratic burden associated with clinical trials undertaken in the EU, as well as increasing difficulty in meeting ethical and regulatory requirements.…”

A European Survey on Biobanks: Trends and Issues

“…regarding sample handling procedures, ethics, genotyping, database information, and data sharing practises, etc.) and an improved networking of existing and new collections [1,11]. Nevertheless, the extent of the activity and the need for networking and/or harmonisation has not yet been fully explored [12].…”