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Showing 221–230 of 52251 articles for “Art. L112-1”
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…
The procedures for applying the provisions of this chapter are determined by decree in the Conseil d'Etat, and in particular : 1° The composition and conditions of approval, financing, operation and a…
For each type of research involving the human person, the investigator records the adverse events or abnormal analysis results defined in the protocol as decisive for the evaluation of safety, keeps a…
No one may impose restrictions on the rights of individuals or on individual and collective freedoms that are not justified by the nature of the task to be performed or that are not proportionate to t…
The competent authority may, at any time, ask the sponsor for additional information about the research. If there is a risk to public health or if the sponsor fails to respond, or if the competent aut…
If the research is to be carried out in one or more public or private establishments, the sponsor must inform the director(s) of these establishments before the research is carried out.
Research involving the human person and the results thereof, with the exception of those relating to national defence secrets, are entered in a public access register in accordance with rules laid dow…
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…
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…
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…
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