Tschigg, Katharina https://orcid.org/0000-0001-5146-3492
Consoli, Luca
Brüggemann, Norbert https://orcid.org/0000-0001-5969-6899
Hicks, Andrew A. https://orcid.org/0000-0001-6320-0411
Staunton, Ciara https://orcid.org/0000-0002-3185-440X
Mascalzoni, Deborah https://orcid.org/0000-0003-4156-1464
Biasiotto, Roberta https://orcid.org/0000-0002-8845-9670
Funding for this research was provided by:
Uppsala University
Article History
Received: 30 April 2024
Accepted: 4 September 2024
First Online: 26 September 2024
Declarations
:
: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). The study protocol for this research has received approval from the Ethics Committee of the South Tyrolean Health Care System (Azienda Sanitaria dell’Alto Adige), reference number “Punto 9 seduta 16/04/2022”. The CHRIS participants invited in the RbG2 study were informed by an invitation letter with information material explaining the details of the RbG study about the research project focus, study background and location, examination program and process of receiving feedback from the examination with the doctors, confidentiality, risks and voluntary participation, funding and collaborations, data protection and privacy, benefits and foreseen impact of the study and the participant rights. For the survey with RbG2 study participants (Step 1), written informed consent was obtained from all participants before the RbG study commenced. The consent process included providing detailed information about the study, its objectives, the data collection procedures, and the potential risks and benefits of participation. Participants were informed of their rights, including the right to withdraw from the study at any time without consequences. Further, they could address considerations or ask for clarifications from the study personnel throughout the informed consent process. For Step 4, written informed consent was obtained from participants through the original CHRIS consent and through specific consent to participate in the survey (integrated into the survey platform, before starting the survey). For the FGDs with study personnel (Step 2) and researchers (Step 3), verbal consent was obtained from all participants. Participants were provided with information about the purpose of the discussions, the topics to be covered, and the voluntary nature of their participation. During the FGD data analysis, identifiable information was replaced with nonidentifiable titles. Both RbG studies mentioned here (RbG1 and RbG2) received ethical approval and all participants gave written informed consents.
: The authors declare no competing interests.