Funding for this research was provided by:
Horizon 2020 (635056)
Article History
Received: 11 December 2018
Accepted: 12 June 2019
First Online: 21 June 2019
Ethics approval and consent to participate
: All interviewees were informed about anonymity and voluntariness of participation prior to giving their consent to participate. All participants consented, written during face-to-face interviews and verbally during phone interviews. Verbal consent was recorded on tape. Personal data and other information were kept confidential and the results did not identify the interviewees personally. Ethical approval was not deemed necessary because the study is a non-interventional or observational study. A reference to national legislation in all six investigated countries follows.Belgium:Ethical approval was not deemed necessary because this study does not fall under the scope of the ‘Belgian Human Experimentation Act’ of May, 7th, 2004 (ExternalRef removed) which is applicable to clinical trials on human subjects. Our study makes use of expert interviews and is considered a non-interventional or observational study.Finland:Ethical approval was not deemed necessary because this study does not fall under the scope of the Medical Research Act and Decree (488/1999) of April, 9th, 1999 (ExternalRef removed) which is applicable to medical research involving intervention in the integrity of a person, human embryo or human fetus for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general. This act is not applicable to this study which makes use of expert interviews without intervention in the integrity of these individuals.Germany:Ethical approval was not deemed necessary because this study does not fall under the scope of the ‘Ordinance on the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for use in humans’ of August, 9th, 2004 (ExternalRef removed) which is applicable to clinical trials on human subjects. Our study makes use of expert interviews and is considered a non-interventional or observational study.Ireland:Ethical approval was not deemed necessary because this study does not fall under the scope of the ‘European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, No 190’ of the 1st of May 2004 (ExternalRef removed) which is applicable to clinical trials on human subjects. Our study makes use of expert interviews and is considered a non-interventional or observational study.Italy:Ethical approval was not deemed necessary because this study does not fall under the scope of the ‘Legislative Decree no. 211’ of 24 June 2003 (ExternalRef removed) which is applicable to clinical trials on human subjects. Our study makes use of expert interviews and is considered a non-interventional or observational study.Netherlands:Ethical approval was not deemed necessary because this study does not fall under the scope of the ‘Medical Research Involving Human Subjects Act’ of February 26th, 1998 (ExternalRef removed) which states in article 1 that ethical approval is only required when the study is subjecting human research subjects to procedures or imposing rules of behavior. Our study makes use of expert interviews and does not subject research subjects to procedures nor does it impose rules of behavior.
: Not applicable.
: The authors declare that they have no competing interests.