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Showing 241–250 of 52251 articles for “Art. L112-1”
In the case of research involving the human person to be carried out in emergency situations where it is not possible to obtain the prior consent of the person who will be subjected to the research, w…
The sponsor may ask the person undergoing research to give informed consent at the time when he or she is required to agree to his or her data being used in subsequent research exclusively for scienti…
Articles L. 1121-4 and L. 1121-15 do not apply to non-interventional research involving cosmetic or food products where such research is included in a list established by order of the Minister for Hea…
Any sponsor based in France who plans to carry out research involving the human person in a non-EU country may submit its project to a committee for the protection of individuals.The Committee for the…
The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (…
Any promoter whose civil liability is not covered by the insurance provided for in the third paragraph of article L. 1125-9 shall be punished by one year's imprisonment and a fine of 15,000 euros.
Where a clinical investigation is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate…
I.-Natural persons guilty of the offence referred to in article L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
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