LAUSR

In recent years, there has been an increase in ethical concern regarding the privacy of identifiable personal data and human biospecimens. Moreover, recent developments in active citizen participation in scientific research has highlighted ethical issues. This has reinforced the need for an adequate ethical and normative framework for observational studies. This paper focuses on the Italian situation and aims to highlight the need for specific national guidelines in non-clinical observational studies. To this end, a practical example is provided concerning the ethical approval process adopted in the co-created environmental epidemiological study entitled "Aria di Ricerca in Valle del Serchio" (Tuscany Region, Central Italy).