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Article History

Received: 25 September 2023

Accepted: 29 September 2023

First Online: 16 October 2023

Declarations

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: The study is conducted with the highest ethical standards, and the confidentiality of all study participants will be protected in accordance with Good Clinical Practice (GCP) Guidelines, national and EU regulations. The study complies with the Declaration of Helsinki, GCP requirements, Human Subject Protection, and Data Protection Acts, or with the local law and regulation, whichever affords greater protection of human subjects.To safeguard the confidentiality of study participants, data are pseudonymised, and patients are provided with a unique patient identification (PID) number, which serves as the identification of the patient. The PID is assigned by the centre coordinator/treating physician, who safely stores the de-coding list according to local regulations. Each patient has the same PID throughout the EuCARE project. If one patient is involved in different studies in different WPs of the EuCARE project, the centre coordinator/treating physician holds the responsibility to ensure consistent use of the patients' PID across the various studies.Data sent to EuResist solely includes the PID number, and personal information from patient records are only released in accordance with the institutional Ethic Committee instructions on data release including the patient's written permission where required. Participants are informed about these conditions in any Informed Consent forms, when applicable. Before initiating of the study at each clinical research site, the protocol, all informed consent forms, and the participant information materials have been submitted to and approved by the following site's Ethics Committee: the Swedish Ethical Review Authority, Karolinska Institutet, Stockholm, Sweden; Comissao de Etica para a Saudè, Centro Hospitalar Lisboa Ocidental, Lisbon, Portugal; Ethic Committee at the Medical Faculty of the Heinrich-Heine University of Dusseldorf, Düsseldorf, Germany; Comitato Etico Milano Area 1, ASST Fatebenefratelli Sacco, ASST Santi Paolo e Carlo, Milan, Italy; NHS Health Research Authority – HRA and Health and Care Research Wales, Imperial College London, London, United Kingdom and University Hospital Dorset, Poole, United Kingdom; Vilniaus regioninins biomedicininiu tyrimu etikos komitetas, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania; Fondazione Policlinico Tor Vergata, Comitato Etico Indipendente, University of Rome Tor Vergata (UNITOV), Rome, Italy; Kenya Medical Research Institute and Ethics Review Unit, Nairobi, Kenya; Comité de Etica en Invest, Salud, Regional Hospital Dr. Juan Graham Casasús, Villahermosa, Mexico; Comissao de Etica IHMT – ITQB, Federal University of Minas Gerais, Minas Gerais, Brazil; Ethic Committee of Pomeranian Medical University Szczecin, Poland. The protocol has been submitted and the approval is ongoing at Bach Mai Hospital Bach Mai Hospital, Hanoi, Vietnam. Each enrolled subjects sign a written informed consent for study participation and personal data handling before enrolment.Furthermore, in the event of any future amendments to the study protocol, these changes will be submitted to and approved by each site's Ethics Committee. It is the responsibility of each participating site to ensure that all necessary documents and approvals are obtained in accordance with local/national regulations.

: Not applicable.

: The authors declare no competing interests.