Meekes, Wytske M. A.
Leemrijse, Chantal J.
Weesie, Yvette M.
van de Goor, Ien A. M.
Donker, Gé A.
Korevaar, Joke C.
Article History
Received: 2 February 2021
Accepted: 31 August 2021
First Online: 21 September 2021
Declarations
:
: This study does not fall within the scope of the Medical Research Involving Human Subjects Act and therefore does not require ethical approval. General practices that participate in Nivel Primary Care Database are contractually obliged to: (1) inform their patients about their participation in Nivel Primary Care Database, and (2) to inform patients about the option to opt-out if patients object to inclusion of their data in the database. Dutch law allows the use of electronic health records data for research purposes under certain conditions. According to Dutch legislation, and under certain conditions, neither obtaining informed consent nor approval by a medical ethics committee is obligatory for this kind of observational studies (Dutch Civil Law (BW), Article 7:458; ExternalRef removed, Medical Research Involving Human Subject Act (WMO); ExternalRef removed), and General Data Protection Regulation (AVG) Article 24 (GDPR)). This study has been approved by the applicable governance bodies of Nivel Primary Care Database under no. NZR-00319.038.
: Not applicable.
: The authors declare that they have no competing interests.