Chiarenza, Antonio http://orcid.org/0000-0002-1773-5818
Dauvrin, Marie
Chiesa, Valentina
Baatout, Sonia
Verrept, Hans
Article History
Received: 9 December 2018
Accepted: 16 July 2019
First Online: 23 July 2019
Ethics approval and consent to participate
: The Provincial Ethics Committee of Reggio Emilia, that served the Azienda USL of Reggio Emilia at the time of this study, ruled that no formal ethics approval was required in this particular case since patients were not involved. The Ethics Committee considered the study to be outside the remit of both the Declaration of the World Medical Association of Helsinki and of the EU Regulation on clinical studies n. 536/2014 implemented in Italy with the Legislative Decree 211/2003. The present study is based on the involvement of health and social workers (professionals working for governmental and non-governmental organizations) and not patients. Furthermore, participants gave their written or verbal consent to take part in the research to the conductors of FG and interviews who had in turn formally agreed to ensuring data storage and confidentiality in accordance with the Italian code for the protection of personal data - Legislative Decree 196/03; ensuring the acquisition of written or verbal consent and providing information on the study prior to conducting FGs and interviews. When the informed consent was verbally given by the participants it was audio-recorded, while formal agreement from the FG conductors and interviews was included in the assignment letter.
: Not applicable.
: The authors declare that they have no competing interests.