Ethical considerations
Developed as a consequence of the Declaration of Helsinki, Ethical
Principles regarding the conduct of clinical research involving humans
(World Medical Association-WMA, 1964) and of the Oviedo Convention (EU,
1997) are required by the Italian NHS Research Ethics Committee.
Participants involved will be completely informed about the aim of the
study and will be asked to sign an individual paper consent form. Women
will be free to decline participation or to retire any moment. Data will
be stored securely on hospital storage and IT platform protected by
password (Data Protection Code, 2003; GDPR, 2018).
Ethical approval for this study was obtained from the Milano Area 1
Ethics Committee (N°46091, November 7th, 2018) prior
to the commencement of the research. All respondents will be provided
the name, telephone number, and email of the Principal Investigator and
the Iocal Review Board’s contact details, in case of any question about
the study.