Overbeek, Jetty A. http://orcid.org/0000-0003-0935-5193
Kuiper, Josephina G.
van der Heijden, Amber A. W. A.
Labots, Mariette
Haug, Ulrike
Herings, Ron M. C.
Nijpels, Giel
Funding for this research was provided by:
VU University Medical Center
Article History
Accepted: 5 November 2018
First Online: 12 November 2018
Compliance with ethical standards
:
: JO, JK, and RH are employees of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies. AH, ML, and GN declare no conflicts of interest. UH is working at the Leibniz Institute for Prevention Research and Epidemiology, BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. Almost exclusively, these are post-authorization safety studies (PASS) requested by health authorities. The studies and the resulting publications are not influenced by the pharmaceutical industry.
: As the NCR and the PHARMO Database Network contains de-identified data from existing databases without any direct enrolment of subjects, ethical approval or informed consent is not necessary according to the Dutch law regarding human medical scientific research (Wet medisch-wetenschappelijk onderzoek met mensen (WMO)), which is enforced by the Central Committee on Research involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO).