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Showing 231–240 of 43820 articles for “Art. L112-2”
I.- The committee gives its opinion on the conditions for the validity of the research, particularly with regard to :-the protection of individuals, in particular the protection of participants ;the a…
I.-The performance reviews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the…
The research referred to in 1° of Article L. 1121-1 may only be carried out after a favourable opinion has been obtained from the Committee for the Protection of Individuals referred to in Article L.…
The sponsor is responsible for compensation for the harmful consequences of research involving the human person for the person who undergoes the research and for those of his successors in title, unle…
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d'Etat and in particular: 1° The procedures applicable to the coordinated assessment procedure d…
It is punishable by one year's imprisonment and a fine of 15,000 euros to carry out or cause to be carried out research involving the human person: 1° Without having obtained a favourable opinion from…
Before a clinical investigation is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this i…
Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Ar…
No clinical investigation may be carried out on a person without his free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
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