Protezione dei dati personali e ricerca biomedica

Individual data protection is a legitimate right of everybody, but an excess of zeal in preserving privacy may seriously threaten research for statistical or scientific purposes, e.g. for epidemiological research on medical records; some compromises are needed that guarantee the individual's rights while preserving validity and feasibility of research. An ethical Code for data protection in statistical and scientific research was recently signed from most Italian statistical associations, with the aim of identifying rules and criteria for legitimately and reasonably departing from general rules of Italy's Data Protection Act, when requested from aims and design of research. This paper focuses on biomedical research. The aim is to discuss ethical aspects of clinical and epidemiological research and how they are dealt with by the Code. Peculiarities of biomedical research are first presented along with underlying ethical theories; examples of injuries of legislation on research are then reported from other countries; responses of the Code are finally discussed.
Statistica; Vol 63, No 4 (2003); 663-672