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Article History

Received: 23 April 2024

Accepted: 2 September 2024

First Online: 18 September 2024

Declarations

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: Ethical clearanceThe protocol has been performed in accordance with the Declaration of Helsinki and approved by the institutional ethics committee: the GERM (Groupe Ethique et Recherche Médicale) from the Hospital Paris Saint-Joseph (institutional review board number IRB00012157, initial agreement 624) on April 21, 2023.In the context of the present study, French research regulation (Journal Officiel de la République Française [Official Journal of the French Republic] 0160, July 13, 2018; paragraph 110, MR-004) states that the patient’s written consent is not mandatory but investigators are required to give the patient an information leaflet explaining the purpose of the research. The patients’ non-opposition to the use of their data for research was also collected in accordance with European regulations (General Data Protection Regulation). The data recorded on the occasion of this research have been the subject of computerized processing in compliance with Law no. 78 − 17 of January 6, 1978 relating to information technology, files and freedoms, amended by Law no. 2018 − 493 of June 20, 2018 (Decree no. 2018 − 687 of August 1, 2018) and Order no. 2018 − 1125 of December 12, 2018, as well as in compliance with the General Data Protection Regulation (GDPR, Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016).The Clinical Research Department for Groupe hospitalier Paris Saint-Joseph, sponsor of this research, handled the regulatory procedures (registration on the Health Data Hub website, N° F20230526151924, law no. 2019 − 774 of July 24, 2019, Order of November 29, 2019).Data protectionThis research was subject to Law no. 78 − 17 of January 6, 1978 relating to information technology, files and freedoms as amended by Law no. 2018 − 493 of June 20, 2018 (Decree no. 2018 − 687 of August 1, 2018) and Order no. 2018 − 1125 of December 12, 2018, as well as to the GDPR.Information on the rights of people taking part in this research (right of access and rectification, right to object to the transmission of data covered by professional secrecy likely to be used in the context of this research) was included in the patient information form.Information and non-objection form.In accordance with Articles 13 and 14 of Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 (GDPR), individuals who undergo research must be informed. This information is the subject of a written document.The investigator gave the information form to the patient during the consultation in the department. If the patient did not object, he or she was included in the study. The non-objection was recorded in the patient’s medical record. Patients were free to participate or withdraw from the study at any time in accordance with Article 21 of the GDPR. The person undergoing the research were informed of the overall results of the research in the manner specified in the information document.

: The authors declare no competing interests.