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Showing 221–230 of 43820 articles for “Art. L112-2”
I.-The competent authority for the research involving the human person provided for in article L. 1121-1 is the Agence nationale de sécurité du médicament et des produits de santé (French National Age…
If a person likely to assist in a research project mentioned in 1° or 2° of article L. 1121-1 falls into more than one of the categories mentioned in articles L. 1121-5 to L. 1121-8, those of these pr…
Carrying out or causing to be carried out research involving the human person in breach of the provisions of Articles L. 1121-5 to L. 1121-8 and Article L. 1122-1-2 and in breach of Articles 31 to 34…
The procedures for applying the provisions of this chapter are determined by decree in the Conseil d'Etat, and in particular : 1° The minimum guarantees for the insurance provided for in the third par…
Minors may be asked to take part in the research referred to in 1° or 2° of Article L. 1121-1 only if research of comparable effectiveness cannot be carried out on adults and under the following condi…
For each piece of research mentioned in 1° or 2° of Article L. 1121-1, the dossier submitted to the Committee for the Protection of Individuals and, where applicable, to the competent authority, shall…
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…
No performance study may be carried out on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 201…
Adults under legal protection or unable to give their consent may only be asked to take part in the research mentioned in 1° or 2° of Article L. 1121-1 if research of comparable effectiveness cannot b…
Pregnant women, women in labour and breast-feeding mothers may only be asked to take part in the research mentioned in 1° or 2° of Article L. 1121-1 under the following conditions:-either the importan…
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