Aetiological observational studies and ethical clearance. An Italian co-created study in Tuscany Region (Central Italy); Studi eziologici osservazionali e approvazione etica. Uno studio italiano co-creato in Toscana

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 high-light the need for specific national guidelines in non-clin-ical observational studies. To this end, a practical example is provided concerning the ethical approval process adopted in the co-created environmental epidemiological study en-titled “Aria di Ricerca in Valle del Serchio” (Tuscany Region, Central Italy). © 2022, Inferenze Scarl. All rights reserved.