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Authors
Busani, Stefano https://orcid.org/0000-0003-0150-4967
Tosi, Martina
Mighali, Pasquale
Vandelli, Paola
D’Amico, Roberto
Marietta, Marco
Forfori, Francesco
Donati, Abele
Cinnella, Gilda
De Monte, Amato
Pasero, Daniela
Bellani, Giacomo
Tascini, Carlo
Foti, Giuseppe
Ranieri, Marco
Girardis, Massimo
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Article History
Received: 29 July 2020
Accepted: 30 July 2020
First Online: 17 August 2020
Ethics approval and consent to participate
: Approved by Comitato Etico dell’Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” IRCCS, Rome, Italy, on May 15th, 2020 with reference number 112/2020.The Authors certify that this trial has received ethical approval from the appropriate ethical committee as described above.Before inclusion in the study, conscious patients must be informed of the purpose and of clinical procedures required by the protocol. The investigators in each centre will explain the purpose, risks and benefits associated with study participation. In addition, patients will be informed of his right to withdraw from the study at any time without explanation and without losing the right to future medical care.If the patient will be unable to comprehend or to give his consent (because of compromised neurological status), the following consent options are acceptable: (i) A priori consent by a legal representative (ii) delayed consent from a legal representative; (iii) Delayed consent from the patient; (iv) waiver of consent; (v) consent provided by an ethics committee or other legal authority.The approach to patients unable to provide an informed consent before enrolment will be to consider whether participation is in the best interests of each individual patient and as soon as it is practical and reasonable to do so, to seek the advice of persons interested in the patient’s welfare (e.g. family member) to establish that study participation is consistent with the patient’s wishes. All participants who recover sufficiently will be given the opportunity to provide informed consent for ongoing study participation and for the use of data collected for the study. Every patient is free to leave the study protocol at any state of the study and can request to retire his consent and, consequently, to ask the elimination of all his data from the database.
: Not applicable.
: The authors declare that they have no competing interests.
