Article L1126-4
In the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Art…
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Showing 281–290 of 52251 articles for “Art. L112-1”
In the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Art…
Failure to comply with Article 73(1) and Article 76(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on the communication of information intended to be made…
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.…
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…
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…
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…
The research referred to in 1° of Article L. 1121-1 relating to devices incorporating products of human or animal origin, or in the manufacture of which products of human or animal origin are involved…
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…
After the start of the research, any substantial modification of the research on the initiative of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in t…
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…
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