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Article L1114-3 of the French Public Health Code

Employees who are members of an association referred to in article L. 1114-1 are entitled to the representation leave provided for by L. 3142-51 of the Labour Code when they are called upon to sit on : 1° Either on the supervisory board, or on the body authorised for this purpose, of a public or private health establishment, or on the statutory commissions and bodies of the said establishment; 2°…

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Article L1114-6 of the French Public Health Code

A Union nationale des associations agréées d’usagers du système de santé (National Union of Approved Associations of Users of the Healthcare System) may be set up, made up of associations of users of the healthcare system approved at national level which join the union. This union is constituted under the terms of the law of 1st July 1901 relating to the contract of association. Its articles of association and regulations…

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Article L1114-7 of the French Public Health Code

The Union nationale des associations agréées d’usagers du système de santé is administered by a board whose members are elected in accordance with the conditions defined in its articles of association. No person may be a member of the Board of Directors if he or she is disqualified from exercising his or her civic, civil and family rights. A decree in the Conseil d’Etat shall determine the procedures for implementing…

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Article L1115-1 of the French Public Health Code

The service of hosting personal health data collected from natural or legal persons at the origin of the production or collection of this data or directly from the persons concerned without holding the authorisation or certificate of compliance provided for in article L. 1111-8 or processing this data without complying with the conditions of the authorisation obtained is punishable by three years’ imprisonment and a fine of 45,000 euros.

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Article L1115-2 of the French Public Health Code

Legal entities declared to be criminally liable, under the conditions set out inarticle 121-2 of the French Criminal Code, for the offences defined in article L. 1115-1 shall incur, in addition to the fine set out in article 131-38 of the French Criminal Code, the penalties set out in 2°, 3°, 4°, 5° and 9° of article 131-39 of the same code. The ban imposed in this respect relates to…

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Article L1121-1 of the French Public Health Code

Research organised and carried out on human beings with a view to developing biological or medical knowledge is authorised under the conditions set out in this Book and is hereinafter referred to as “research involving the human person”. There are three categories of research involving the human person: 1° Interventional research involving an intervention on a person that is not justified by the person’s usual care; 2° Interventional research involving…

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Article L1121-2 of the French Public Health Code

No research involving the human person may be carried out : – if it is not based on the latest scientific knowledge and on sufficient pre-clinical experimentation ; – if the foreseeable risk incurred by the persons who take part in the research is out of all proportion to the anticipated benefit for these persons or the interest of this research; – if its aim is not to extend scientific…

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Article L1121-3 of the French Public Health Code

Research may only be carried out under the following conditions: – under the direction and supervision of a doctor with appropriate experience ; – in material and technical conditions appropriate to the research and compatible with the requirements of scientific rigour and the safety of the persons undergoing the research. In the human behavioural sciences, a qualified person, together with the investigator, may direct the research. Research in the field…

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