Peacock, Hanna M.
van Walle, Lien
Silversmit, Geert
Neven, Patrick
Han, Sileny N.
Van Damme, Nancy
Article History
Received: 28 September 2023
Accepted: 23 April 2024
First Online: 7 May 2024
Declarations
:
: Approval of the Ethical Committee was not necessary, considering that this study was performed within the legal framework of the Belgian Cancer Registry (BCR). Based on the Coordinated Law of 10 May 2015 (art. 138), BCR has a legal task to collect data on cancer, subject it to quality control, process and analyze it, encrypt and store it, report on it, make it accessible for research and protect it. Its activities are monitored and evaluated by the Advisory Committee of Users, an independent committee whose duly qualified members are appointed by law. Secondly, this retrospective study does not fall under the Belgian Law of 7 May 2004 regarding experiments on human persons (art. 3,ยงย 2). The research on human data for this study was conducted in compliance with the applicable national guidelines. Approval of the Ethical Committee was not necessary for the linkage between data of the BCR and the Intermutualistic Agency (IMA) as in Belgium the Information Security Committee has the authority to approve linkage of secondary health data coming from different data providers (art. 42 Law 13 December 2006). For the linkage between data from BCR and IMA an approval was obtained (art. 39 Law 13 December 2006).Patient consent was waived due to the law stating that the data controller shall be exempt from the obligation to disclose information to the persons whose data are processed where notification to the data subject is impossible or takes disproportionate effort; in particular when data are processed for statistical purposes or for historical or scientific research (art. 14.5, b. GDPR EU 2016/67).
: The authors declare no competing interests.