Vieira, Bruno http://orcid.org/0000-0001-6045-9233
Demirtas, Derya
B. van de Kamer, Jeroen
Hans, Erwin W.
van Harten, Wim
Funding for this research was provided by:
KWF Kankerbestrijding (2014-6078)
Article History
Received: 21 March 2019
Accepted: 6 September 2019
First Online: 24 October 2019
Ethics approval and consent to participate
: This study was conducted as part of a logistical improvement project where data is anonymized from the source (MOSAIQ system, Department of Radiation Oncology of the NKI), and as such did not require separate ethical approval. At the time the study was initiated, in 2017, Dutch legislation with regard to data protection applied, in particular the Dutch Act on Data Protection of Individuals (Wet Bescherming Persoonsgegevens). Pursuant to this legislation, which was superseded by the General Data Protection Regulation (GDPR) as of 25 May 2018, this study conducted the necessary steps to comply with the applicable legislation. By rendering data anonymously, the requirements as regards the use of data have been fully complied with. Given the fact that no information about patients has been provided, no formal ethics approval was required to access the raw historical data from 2017. Clinicians (RTTs, radiation oncologists, managers, appointment schedulers) who participated in this study gave their informed verbal consent to participate, adhering to the applicable legislation, thus a written consent has been deemed unnecessary. A full-time data protection officer employed by the NKI, together with an internal auditor, verify the checks and balances of data protection in the institute. In the context of this study, they concluded that no formal ethics approval was required with regard to data use and obtaining only verbal consent from participants was sufficient to comply with the applicable legislation mentioned previously. Since all the involved individuals (patients, clinicians, RTT’s, radiation oncologists, managers, logisticians) have never been identifiable during the project and the project has received a continuous monitoring with regard to data protection, this project fulfills all the necessary requirements, both at the time of the Dutch legislation and at the time of the GDPR.
: Not applicable.
: The authors declare that they have no competing interests.