There is no general legal framework applicable to biobanks for scientific research in Italy. Some of the most important issues are not addressed by Italian legislation, such as, informed consent issue with particular reference to research carried out on human tissue samples and the legal status of samples stored in biobanks. The only applicable regulation is the General Authorisation for the processing of genetic data issued by the Italian Data Protection Authority, which does not distinguish between genetic data and human samples since the latter are considered only in their informational dimension, as genetic data containers. This situation creates uncertainty which affects research. Therefore, a systematic regulatory framework able to support genetic research starting from basic concepts and definitions is especially needed in Italy.
[This article was presented at the SCRIPTed “Governance of New Technologies” conference held in Edinburgh on 29-31 March 2009.]