Coolen, Angela M. P. http://orcid.org/0000-0001-6502-9603
Lameijer, Joost R. C.
Voogd, Adri C.
Louwman, Marieke W. J.
Strobbe, Luc J.
Tjan-Heijnen, Vivianne C. G.
Duijm, Lucien E. M.
Article History
Received: 26 April 2018
Accepted: 4 June 2018
First Online: 25 June 2018
Compliance with ethical standards
:
: The scientific guarantor of this publication is Lucien E.M. Duijm.
: The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.
: No complex statistical methods were necessary for this paper.
: Written informed consent was obtained from all subjects (patients) in this study.
: Institutional Review Board approval was not required.We have previously reported our screening studies, derived from our screening database, to the Medical Ethics Review Committee of the Catharina Hospital Eindhoven, The Netherlands (ExternalRef removed). This committee reviewed our studies and replied that according to the Medical Research Involving Human Subject Acts (WMO; ExternalRef removed ) our kind of study does not need the approval of the committee. We have contacted CCMO in the past to obtain an official letter from this institute, stating that our descriptive screening studies do not warrant ethical approval for the trial.
: • prospective• diagnostic or prognostic• performed at one institution