Ethics approval and consent to participate
All procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on medical research and with the Helsinki Declaration of 1975, as revised in 2008.
Moreover, Italian national CME providers have to follow rules of good practice included in the guidelines of the Italian Continuing Medical Education (CME) system (link https://ape.agenas.it/documenti/Normativa/Manuale_formazione_continua_professionista_sanitario/Manuale_sulla_formazione_continua_professionista_sanitario.pdf, also present as reference 10).
Ethics approval is not required by regulatory authorities in Italy [23,24,25,26,27] due to:
- the nature of study (analysis of the participation and satisfaction data about an e-learning course developed as an online questionnaire without any analysis of the individual achievements);
- full anonymization of the study participants and of their activities on the platform. In addition, the participants agreed to their anonymous responses to the questionnaire and data being used for statistical purposes;
- enrollment of health professionals and not of patients, without any collection of health-related data.
Consistently, the Ethics Committee of the University of Milan is informed of the study without envisaging the need for any ethical approval due to its design and conduction.
In addition, ethics approval during this pandemic was not required according to the “Ethics and data protection” regulations of the European advisory body and European Commission.
Also according to the Italian Data Protection Authority in the context of the COVID-19 health emergency, it is indicated that, in the event of the impossibility of obtaining the informed consent of the interested parties, observational studies take advantage of a derogation regime for the duration of the COVID-19 emergency (art. 110 of the Code regarding the protection of personal data, link http://www.privacy.it/archivio/privacycode-en.html#sect110). However, all participants, when registering for the course gave informed consent to their anonymous data being used for statistical purposes.
Consent for publication
Availability of data and materials
The datasets generated and analysed during the current study are not publicly available as they include personal data of users registered on the platforms. The use of the data is regulated by the GDPR 2018 in application of EU Regulation 2016/679. Upon registration, the user agrees on data processing in terms of collection, recording, organisation, storage, processing, modification, selection, extraction, comparison, use, interconnection, blocking, communication, dissemination, cancellation, destruction of the same including the combination of two or more of the above activities. However, they can be made available in anonymous form from the corresponding author on reasonable request.
The authors report no conflict of interest
The authors confirm that they have not received any funding to support this work
All authors contributed to the project and the study design. MRV, NS, and PD contributed to data collection and analysis. MRV drafted the original manuscript. FP, PD, NS contributed to subsequent revisions and editing. All authors read and approved the final manuscript.
The authors acknowledge Raffaella Daghini,b Christian Deligant,b Silvia Emendi,b for their work on the e-learning project and Lucia Massi for her assistance as medical writer.
Pregliasco Fabrizio Associate Professor at the Department of Biomedical Sciences for Health at the University of Milan, Italy; Healthcare Director at the IRCCS Orthopedic Institute Galeazzi, Milan; and National President of ANPAS (Associazione Nazionale Pubbliche Assistenze). He is currently studying the aetiological, epidemiological and preventive aspects of several viral diseases.
Valetto Maria Rosa Medical doctor and scientific lead in continuing medical education for the Italian national provider Zadig.
Anelli Filippo Medical doctor and President of the Italian Federation of Medical Professional Associations (FNOMCeO).
Mandelli Andrea Pharmacist and President of the Federation of Orders of Italian Pharmacists (FOFI).
Nicoletta Scarpa Pharmacist and responsible for continuing medical education for the Italian national provider Zadig.
Dri Pietro Medical doctor, specialist in infectious diseases, professional journalist and editor in chief of all e-learning courses about COVID-19 on FadInMed, SAEPE and FORMARS platforms.