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Study
CHU Caen Normandy

“Sensors” study of the Project Partage Pro

Information for visitors

"Predict the dissemination of interhuman and intra-host antibiotic resistance by combining mathematical modeling, genomics and epidemiology: a prospective cohort study"

Madam, Sir,

You are offered to participate in a study entitled Partage Pro - Sensors. This information document aims to explain this project exactly to you and what is asked to participate.

Why this study?

Multi -relief bacteria pose a problem in resuscitation where fragile patients are hospitalized. The prevention measures put in place make it possible to control their distribution in part only, demonstrating the existence of poorly identified modes of transmission.

Sensor

How will the sensors work and what will work?

In this context, a study will be carried out for four days in this resuscitation service in order to anonymously characterize the dynamics of contacts between patients, visitors and caregivers working there by means of sensors that will be entrusted to them. These sensors make it possible to detect in real time the various remote sensors of less than 1 m and therefore the dynamics (frequency and duration) of proximity between the people present in the service.

The data collected by the sensors will be pseudo anonymized via an identifier of participant in the study which will be awarded to you. The data collected will be hosted on the Ennov Clinical platform. CHU Caen Normandie is responsible for data processing. For any questions relating to data processing, you can contact the data protection officer: dpd@chu-caen.fr .

What will your participation in the study consist of?

Your participation will simply consist in carrying this sensor during your hospitalization in resuscitation. The sensor can be worn as a pendant or be placed in a clothing pocket. We will have to get it when you leave the service.

What are the expected benefits in your participation in the study?

By participating in this research, you will contribute to a better knowledge of the factors which explain how multidistant bacteria disseminate in resuscitation and therefore to develop new prevention strategies. Your participation in this research project is free and voluntary. You can refuse to participate without any damage to you.

Note concerning the ethical and regulatory (legal) aspects of the study

This research received the favorable opinion from the Local Committee of Ethics of Health Research (Clers) of the University of Caen Normandy on December 8, 2023.

In accordance with the provisions of law n ° 2018-493 of June 20, 2018 relating to the protection of personal data, you have the right to access and rectify your personal data as well as the right to erasure, forgetting and the right to data portability. You also have a right of opposition to the transmission of data covered by professional secrecy likely to be used within the framework of this research and to be processed. This automated processing of your health data complies with the European regulation of April 27, 2016 relating to the protection of natural persons with regard to the processing of personal data and the free movement of this data.

You have a right of complaint with the National Commission for Data Protection (CNIL): 3, Place de Fontenoy - TSA 80715 - 75334 Paris Cedex 07 · 01 53 73 22 22.

You can contact the resuscitators or the referring doctor of the study in your service for any point that would not seem clear to you. Do not hesitate to question him in order to obtain more details.