Regulating tissue research: do we need additional rules to protect research participants?

This article explores whether additional rules are needed for the regulation of tissue research in Europe. A human rights-based approach (referring to international documents and illustrative examples from national legislation) is taken to address the question: what is so special about tissue, in particular when compared to personal data? The existing regimes in Europe on data protection and clinical trials are presented and examined for their suitability to govern tissue research, taking into account the differences between data and tissue. Six recommendations are outlined, highlighting important points future legislation on tissue research must take into account.