Simon, Maïa
Pereira, Ouarda
Constant, Marie-Louise
Guillet-Thibault, Julie
Pulcini, Céline
Thilly, Nathalie
Article History
Received: 4 October 2022
Accepted: 10 January 2023
First Online: 18 January 2023
Declarations
:
: In France, the Jardé law (decree n°2016–1537 of 16th November 2016, relating to researches involving the human person) [CitationRef removed] defines the different research categories for which the approval of an Ethics Committee is mandatory. Researches that do not modify the medical care of patients and use retrospectively collected data are not covered by the Jardé law (as in the present study). In this case, the approval of an Ethics Committee is optional. Considering the difficulty of understanding our particular national legislation for anyone who is not French, we have decided to submit this study protocol to the Ethics Committee of the University Nancy Hospital. This committee has highlighted that the study had been carried out in accordance to current French and European standards, as well as the code of ethics of the World Medical Association. The need for informed consent was waived by the Ethics Committee of the University Nancy Hospital, because of the retrospective nature of the study. Moreover, all methods of this study were performed in accordance with the relevant guidelines and regulations (Declaration of Helsinki), and with the reference methodology of the National Commission of Informatic and Liberties for this study’s category (reference methodology MR-004) [CitationRef removed]. The identification number of declaration of conformity to this reference methodology is 221122v0.
: Not applicable.
: The authors declare that they have no competing interests.