Lefèvre, Noémie Capucine
Le Gouez, Morgane
Lesage, Fabrice
Rousseau, Véronique
Giuseppi, Agnès
Abadie, Véronique
Lapillonne, Alexandre
Kermorvant-Duchemin, Elsa
Article History
Received: 11 October 2022
Revised: 18 November 2022
Accepted: 27 November 2022
First Online: 14 December 2022
Declarations
:
: Patients and their families were informed by a note at the end of all reports that their child’s clinical data could be collected for research purposes and of their right to decline such research. According to French law, the study was declared to the National Data Protection Authority (Commission Nationale de l’Informatique et des Libertés) as meeting the reference methodology (MR-004) (). The protocol was reviewed, approved, and registered in the institutional register of data processing of the Assistance Publique-Hopitaux de Paris under the number 2021–0312112531. The reference methodology MR-004 provides a framework for the processing of personal data for the purposes of study, evaluation, or research not involving the human person. More specifically, this concerns studies that do not meet the definition of research involving the human person, in particular, studies concerning the reuse of data, which is the case of our study. The data controller undertakes to collect only data that is strictly necessary and relevant to the objectives of the research. The reference methodology MR-004 does not require an approval by an ethics committee provided an information is given that clinical data is collected for research purposes and information of patient’s right to oppose to such research and right of access, rectification, or deletion of their data. Data were anonymized for processing. The processing of personal data was carried out in accordance with the EU Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free circulation of such data.
: The authors declare no competing interests.