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Showing 241–250 of 14565 articles for “Art. L112-6”
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
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 do not come under the provisions of Art…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical inv…
Subject to the provisions of articles L. 1123-15 to L. 1123-20, the provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of a…
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 "…
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…
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…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in clinical investigations which do not involve any risk or constraint. B…
The committees are composed in such a way as to guarantee their independence and the diversity of their expertise in the field of research involving the human person and with regard to ethical, social…
The Minister for Health may withdraw the approval of a committee if the conditions of independence, composition or operation required to carry out its mission in the best possible conditions are no lo…
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