Léger, Mathilde
Wolff, Vanessa
Kabuth, Bernard
Albuisson, Eliane
Ligier, Fabienne
Article History
Received: 26 August 2021
Accepted: 7 March 2022
First Online: 18 March 2022
Declaration
:
: The experimental EDIPHAS protocol was approved by two French IRB, responsible for regulating medical research:the Comité Consultatif sur le Traitement de l’Information en matière de Recherche en Santé, the CCTIRS, an advisory committee for information processing in Health Research which includes Ethical considerations, andthe Commission Nationale de l’Informatique et des Libertés, the CNIL, a French national Data processing agency, under authorisation number DR-2013-042.These authorisations were extended twice to include additional hospital facilities and to approve the changes made to the data collection form. All methods were applied in accordance with the relevant guidelines and regulations.In this French study, a consent to participate was not required, as approved by the CCTIRS. However, the subjects of the study were contacted by a letter either send to their place of residence or else through their referring psychiatrist at the time. This letter contained clear, appropriate and fair information on the objectives of the study and their right to refuse access and review of their old file, while emphasizing that such a choice would have no impact whatsoever on their treatment. Two eligible subjects refused to participate.
: Not applicable.
: The authors declare that they have no competing or potential conflicts of interest.