Verberne, Lisa D. M. http://orcid.org/0000-0002-8860-0275
Nielen, Markus M. J.
Leemrijse, Chantal J.
Verheij, Robert A.
Friele, Roland D.
Article History
Received: 6 February 2018
Accepted: 6 November 2018
First Online: 17 November 2018
Ethics approval and consent to participate
: This study was approved by the applicable governance bodies of the NIVEL Primary Care Database (NZR-00316.052) and by the AMIGO cohort Steering Committee. Permission was obtained to access the NIVEL-PCD database and to use the baseline data of the AMIGO cohort.Dutch law allows the use of EHRs for research purposes under certain conditions. According to this legislation, neither obtaining informed consent from patients nor approval by a medical ethics committee are obligatory for this type of observational study containing no directly identifiable data from the NIVEL-PCD (Dutch Civil Law, Article 7:458).For the AMIGO study, official approval from the Medical Ethics Research Committee (MERC) was not required under the Dutch Medical Research Involving Human Subjects Act as this Act does not apply to the baseline AMIGO data (i.e., non-invasive research with human subjects).
: Not applicable.
: The authors declare that they have no competing interests.
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