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Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis

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EU legislation on translational research

Translational biomedical research entails using human cell or tissue samples to extrapolate findings from animal models before clinical testing in humans for efficacy and toxicity. An EU-funded project will review ethical and regulatory guidelines on biobanking and biomedical research in EU countries for deficits and inconsistencies.


Using human samples for research is of paramount importance for understanding the biological mechanisms that underlie normal tissue function as well as disease development. Given the biological differences between humans and animal models, it is necessary to validate experimental findings in human tissues by translational research. EU countries’ regulations differ on the handling of human tissues and cells, presenting a serious barrier for translational research in Europe. EU legislation so far only covers the use of human samples in clinical applications. There is still a need for an EU biobanking directive. To address this issue, the EU-funded 'Evaluation of legislation and related guidelines on the procurement, storage and transfer of human tissues and cells in the European Union; an evidence-based impact analysis' (TISS.EU) initiative analysed the impact of current EU legislation and guidelines on the procurement, storage and transfer of human samples for biomedical research purposes. Five international workshops were organised in Birmingham, Dublin, Leiden, Stockholm and Vilnius in order to examine the ethical and legal regulations on human sample research in EU countries. The consortium set up a database to include 700 documents reporting on the existing guidelines governing human tissue research in all 27 EU Member States and Switzerland. An additional achievement of the project entailed the establishment of a European network of over 150 scientists working on translational research. This set the ground for future scientific exchange and collaboration. Project results were disseminated through individual and joint publications, including a book on 'Human tissue research - A discussion of the ethical and legal challenges from a European perspective' and a manuscript on 'Biobanks and tissue research: The public, the patient and the regulation'. The comparative data on the policies of human sample research across Europe is expected to help stakeholders identify shortcomings in existing regulations and take appropriate action. Overall, the work by the TISS.EU project could lead to the harmonisation of legal and ethical guidelines across the EU regarding the procurement, storage and transport of human samples.

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