Pacurari, Nadia
De Clercq, Eva
Dragomir, Monica
Colita, Anca
Wangmo, Tenzin
Elger, Bernice S.
Article History
Received: 18 April 2021
Accepted: 21 October 2021
First Online: 18 November 2021
Declarations
:
: The study was approved by the leading ethics committee, the Ethics Committee northwest/central Switzerland (EKNZ), Hebelstrasse 53, 4056 Basel (Switzerland), Committee reference number: 51/12. The study received further approval from the institutional Ethics Committees of every participating paediatric centre in Romania. Interviews with health care professionals (not patients) fall outside of the Swiss human research act and do not require research ethics committee (REC) approval. In spite of approval not being required, the project was submitted to the REC and approved. From an ethical point of view, for minimal risk research involving interviews or questionnaire studies with “non-patients” such as health care personnel whose data (transcripts or questionnaires) are anonymized, oral consent and active participation are ethically considered sufficient and proportionate. To make sure that our experts were clearly informed, we did the following, and this procedure is in line with ethics approval provided by the competent ethics committees (see above), for all national and international expert interviews and FG (minimal risk):a) We sent a letter with information on the study, the voluntary nature of their participation to each focus group participant before the actual group discussionb) We reiterated the content and the aim of the study before the start of the focus groupc) We registered the oral informed consent of each participantd) Transcripts were returned to participants for revisionAll methods were performed in accordance with the Declaration of Helsinki and have been approved by an ethics committee.
: N/A
: The authors declare no conflict of interest