Bustaffa, Elisa
Mangia, Cristina
Cori, Liliana
Bianchi, Fabrizio
Cervino, Marco
Minichilli, Fabrizio
Funding for this research was provided by:
Regione Molise (Determination of the General Director for Health n° 60/2019-08-01)
Article History
Received: 31 March 2023
Accepted: 6 October 2023
First Online: 18 October 2023
Declarations
:
: Considering that (i) the study is not invasive towards the patients since we only used patients’ routine health data without ever getting in contact with them and (ii) “the competence of each ethical committee may concern, in addition to clinical trials of medicines, any other matter on the use of medicines and medical devices, on the use of surgical and clinical procedures or related to the study of products food on man generally remitted, by international practice, to the evaluations of the committees” (Law 8 November 2012, n. 189, article 12, paragraph 10, letter c), the Ethical review and approval were not necessary since our study does not fall within the remit of the ethics committees. Given that (i) in the Val Venafro area there have been environmental criticalities for some time (numerous PM<sub>10</sub> exceedances), (ii) the non-profit Mothers for Health and the Environment Association of Venafro recalled the “worrying” results of a previous epidemiological research conducted in the area, (iii) the Municipality of Venafro approved a residential cohort study based on the reconstruction of the mortality and morbidity profile in association with environmental risks with the purpose of identifying possible solutions to health problems affecting citizens and proposing possible solutions to the competent Authorities (iv) the Molise region, recognizing the criticalities of the territory, has determined the transfer of funds for the realization of the cohort study as it has been considered a priority objective and of national importance, (v) the Ministry of Health, General Directorate of Health Prevention, underlined the criticality of the Venafro area due to exposure to pollutants and therefore the need to implement a residentialcohort study, (vi) the Mayor of a municipality is defined as the local health authority and he is responsible for the health condition of the population of his territory, the study was held as of significant public interest. For the aforementioned reasons the informed consent was not requested since the purposes of data processing fall within the case of significant public interest and for this reason data processing is lawful. In fact, it falls within the case set out in EU Regulation 2016/679, article 6, paragraph 1, letter e) “Processing shall be lawful only if and to the extent that at least one of the following applies: […] e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; […]”. Furthermore, given the importance of the study, as requested by the mayor of the municipality of Venafro as data controller, the Molise Region financed the study. The Municipality of Venafro publicized the study on institutional channels. The Institute of Clinical Physiology of the National Research Council, as external managers, analyzed completely anonymised data and therefore not attributable to the identification of the single individual.
: Not applicable.
: The authors declare no competing interests.