In particular, we apply the Italian Data Protection Act (Law 196 30th June 2003 and any further modifications).

This Italian legislation is the implementation of the Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and the free movement of data. Important ethical principles with regard to medical and genetic data are the protection of privacy, and the respect for dignity and rights regardless of genetic characteristics.
The project was notified to the Italian Data Protection Authority on 11th October 2002 as “genetic data treatment”. The study was approved on February 24th, 2003  by the local ethics committee of ASLNA1, Naples and on October 28th, 2013 by the ethics committee for biomedical activities “C. Romano” University of Naples “Federico II”.

Conferences in each village have been organized to explain in detail the scope of the project. A booklet with a description of the project and the different phases of the research has been distributed to the population.
An informed consent signed by each participant provides a confirmation of whether or not he or she wishes to know any result coming from genetic and health status analysis. Data are stored without any indication of the personal identity of any individual.

Genotypes/Phenotypes/Genealogies are stored in a dedicated database with a different barcode, obtained by a special algorithm, the purpose of which is to disaggregate data and to protect the personal identity of participants in the study. Only authorized personnel can have access to the Database using provided personal credentials/authorizations. All personnel are instructed to keep all the information as “confidential and private information” and a special agreement must be signed after an explanation of operational procedures.