Archived Tissue

The potential use for research, under the General Data Protection Regulation (GDPR), of archived tissue specimens obtained in a diagnostic or therapeutic context is a topic of interest. This chapter explores the concept of an ‘archive’ and its legal implications in the context of the GDPR. While the GDPR provides limited definitions, European legislation refers to archives as records of historical or administrative value. In the medical field, archiving involves preserving diagnostic reports and related documents, including tissue specimens. The chapter discusses different types of archives, including historical and current ones, and their relevance to the use of biological material for research. Informed consent plays a crucial role in research biobanks, but consent for healthcare treatment does not necessarily cover consent for research purposes under the GDPR. The chapter examines the challenges of obtaining consent for the use of archived materials, particularly for historical archives where obtaining consent may be impractical or impossible. It also explores exceptions to the consent requirement under certain circumstances. The implications for current tissue archives and the conservation obligation are also discussed. Overall, the chapter provides insights into the potential uses of archived tissue specimens, and the legal considerations surrounding their use for research, under the GDPR.