Pitter, János G. http://orcid.org/0000-0002-6784-9215
Csanádi, Marcell
Szigeti, Annamária
Lukács, Gábor
Kovács, Árpád
Moizs, Mariann
Repa, Imre
Zemplényi, Antal
Czypionka, Thomas
Kraus, Markus
Rutten-van Mölken, Maureen P. M. H.
Kaló, Zoltán
Funding for this research was provided by:
H2020 European Research Council (634288, 634288, 634288, 634288, 634288, 634288, 634288)
Article History
Received: 21 April 2018
Accepted: 18 February 2019
First Online: 21 February 2019
Ethics approval and consent to participate
: The evaluation of OnkoNetwork consists of a qualitative and a quantitative research phase.The quantitative research phase (not reported in this paper) evaluates multiple patient-level outcomes related to health, patient experience and healthcare costs in a large sample of OnkoNetwork and control patients. The quantitative phase of the research is accomplished in an observational study with a study protocol that has been reviewed and approved by the competent National Ethics Committee in Hungary (TUKEB, Decision No. 12412–2/2017/EKU) before the start of enrolling patients.The qualitative research described in this paper preceded the quantitative research phase and was focusing on how the OnkoNetwork model has been initiated, conceptualized, implemented and was operating from the perspectives of various stakeholder groups. For this reason, 20 interviews have been conducted including two interviews with patients and two interviews with informal caregivers. The aim of patient and caregiver interviews was not to evaluate unique patient paths or outcomes but to understand how these stakeholder groups think about the key features of 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. In agreement with the approved research plan, all interview participants were informed in writing and also by word about the research aims, their role in the research, their rights including data protection aspects, anonymity and withdrawal, and consequently signed their written informed consent before starting the interview. Since the reviewers of the original manuscript raised that the ethical approval of the conducted research needs to be clarified further, the Institutional Ethics Committee of the hospital where the interviews were conducted double-checked the research and publication plan and confirmed that no ethical concerns were emerging related to this research and to the publication of findings. This conclusion was released on 10th October 2018, in Hungarian language, reference number IKEB_IG_04125-000_2018.
: Not applicable.
: Some of the co-authors were selected to contribute to this research also as interview participants, due to their unique insight and role in the planning, implementation and operation of OnkoNetwork (IR, MM, GL, and ASz). To avoid study bias from competing interests, the content analysis of the interviews and study report preparation was conducted by researchers not being associated with OnkoNetwork and not employed by the corresponding Institutions.
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