Biobanks: ethical and legal aspects of the collection and storage of human biological material in Italy

This chapter discusses the Italian framework for research with human tissues. There are some main ethical and legal issues that should be considered: the definition of the biological samples, object of the collection and storage; the way through which these samples are collected; the content of information and the consent form; privacy and confidentiality; and the owner of the biological sample. Due to the lack of specific rules and regulations concerning this field of research in Italy, biobanks have been outlined by national committee, such as the National Committee for the Biosafety and Biotechnologies. The need for deeper reflection on this aspect, is particularly necessary because of the different ways of regulating privacy — with dissimilar standards of safety in each country — but also in the light of promoting a new way of solidarity between groups and generations based on the voluntary sharing of sample and information for a common resource.