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Showing 261–270 of 43820 articles for “Art. L112-2”
I.- Before carrying out research involving the human person, the sponsor submits the project for the opinion of a personal data protection committee designated at random from among the available commi…
Research involving the human person does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, wher…
For research, clinical investigations or performance studies covered by national defence confidentiality, the sponsor must notify the competent authority of all relevant information relating to the sa…
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…
I.- For research, clinical investigations or performance studies involving national defence secrets, the sponsor submits the project for the opinion of a specific committee for the protection of indiv…
In the event of a refusal of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation…
For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
No clinical investigation may be carried out on a deceased person, in a state of brain death, without his or her consent expressed during his or her lifetime or through the testimony of his or her fam…
The Minister for Health approves one or, as required, several personal protection committees for a fixed period. Their members are appointed by the Director General of the Regional Health Agency for t…
The members of the Committees, the persons called upon to collaborate in their work, and the agents covered by the general statute of civil servants or the general statute of military personnel who ar…
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