Bio-legal Issues in the Establishment of a Historical Collection of Human Tissues: The case of the Umbria Biobank Project

The aim of the Umbria Biobank Project is to set up a biobank of human tissues for research purposes. The Umbria Biobank includes a historical archive put together from the 1940s onwards by the former Institute of Pathological Anatomy of the University of Perugia, which consists of at least 2.5 million tissue blocks and approximately 8 million cytological and histological slides, with accompanying documentation. This valuable collection, which has been maintained and improved over time, has remained largely unused because of various ethical issues and a lack of specific regulation. In particular, as with other historical archives of diagnostic documentation, the materials and data were collected at a time when there was neither an awareness about the need for patient authorisation, nor any idea that the materials and data would be useful for further research activities. This paper describes the attempt by the Project’s bio-legal team to avoid the destruction of these important historical archives and to recover them for scientific research in a legitimate way that respects fundamental rights. The solutions were worked out within the context of European Union, international and national legal regulations.