The ethical and legal regulation of human tissue and biobank research in Europe

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Human tissue and biobank research is crucial for understanding diseases and developing therapies. The success of this research relies on a large number of samples, and consolidating collections across borders is beneficial for researchers. However, the legal and ethical requirements for procuring, storing, and using human tissue samples vary significantly among countries. The absence of comprehensive supranational regulations poses a serious challenge to transnational biomedical research. In this context, the EU-funded Tiss. EU project aimed to analyze the ethical and legal frameworks surrounding human tissue and biobank research in the 27 European Member States and Switzerland. This volume compiles findings from nine international workshops and three conferences. Country reports assess the implementation of ethical and legal guidelines at the national level, highlighting strengths and weaknesses, and providing an evidence base for potential legislative revisions. Additionally, the conference reports explore broader ethical and legal issues in the field. The volume concludes with a presentation of the project's overall results, contributing valuable insights into the regulation of human tissue and biobank research in Europe.