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Article History

Received: 24 January 2020

Accepted: 12 November 2020

First Online: 30 November 2020

Ethics approval and consent to participate

: Austria: In Austria, approval by an ethics committee is necessary for the following four types of evaluations/interventions: 1) Clinical trial on human subjects according to the law on medicines – Arzneimittelgesetz (AMG), 2) Clinical trials on human subjects according to the law on medical products – Medizinproduktegesetz (MPG), 3) Clinical trial on human subjects according to the law on genetic engineering – Gentechnikgesetz (GTG), 4) New medical methods (e.g. new surgical techniques) as well as applied medical research according to the law of hospitals and sanatoriums – Krankenanstalten- und Kuranstaltengesetz (KAKuG). As none of the above categories applied to this research, approval by an ethics committee was not necessary.Croatia: Approval by an ethics committee for conducting interviews was not necessary according to the Ordinance on Clinical trials and Good Clinical Practice (Official Gazette No. 121/07) and Ordinance on Clinical Trials of Medicinal Products and Good Clinical Practice (Official Gazette No. 25/15).Germany: Approval by an ethics committee for conducting interviews was not necessary according to the following guidelines: .Hungary: A) Onkonetwork: Non-interventional studies in Hungary are regulated by Government Decree No. 235/2009 and by Decree of the Health Minister No. 23/ 2002, also referring to Law 154/1997 (CLIV/1997). Non-interventional studies of pharmaceuticals are also regulated by Law 95/2005 (XCV/2005) and Decree of Human Resources Minister No. 15/2012. Human medical research is defined in the Healthcare Law (CLIV/1997) and non-interventional studies are defined in Government Decree No. 235/2009 as a specific kind of human medical research. In line with the above national laws, conducting interviews with patients, family members, and other stakeholders was not classified as non-interventional human medical research. Therefore, as requested by the Hospital’s regulation for other types of research, the research plan was submitted for approval to the Director General of Moritz Kaposi General Hospital. Based on the positive opinion of the Institutional Research Committee and the responsible person of the Hospital for data protection, the research has been authorized under approval No. IG/03092–000/2016, considering both its scientific merit and data protection aspects. B) Palliative Care Consult Service: Ethics approval was granted by the Regional and Local Research Ethics Committee at the University of Pécs (File number 6302).Netherlands: The Medical Ethical Committee of the Erasmus Medical Centre Rotterdam declared that this research was exempt from the Medical Research Involving Human Subjects Act (MEC-2016-318, July 4, 2016).Norway: The regional ethics committee decided that no formal ethics approval was required for this research, according to the Norwegian Health Research Act (REK vest, 2016/308). The ethics committee advised us to seek approval from the Data Protection Office at University of Bergen, which was granted (NSD 47499).Spain: Approval by an ethics committee conducting interviews was not necessary. Overall ethics approval for research in the SELFIE project was granted by Clinic Research Ethical Committee (Comité Ético d’Investigación Clínica - CEIC) of the Clinic Hospital of Barcelona, Ref: CIF-G-08431173, Reg. HCB 2017/0451, 14-6-2017 and Ref: CIF-G-08431173, Reg. HCB 2017/0452, 19-6-2017.UK: Ethics approval was granted by the NHS Health Research Authority Research Ethics Committee (SELFIE REF: 16/WM/0295; CLASSIC REF: 14/NW/0206).In all countries, interviewees provided written informed consent to the interviews, to the recording of the interviews and to the subsequent use of the collected data. They were reassured that interviews were confidential and voluntary.

: Not applicable as no personal information is divulged.

: Johnathan Stokes is associate editor of BMC Health Services Research. Apart from that, the authors have no competing interests.