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Showing 4801–4810 of 56695 articles for “Art. comité juridique of 9 January 2019”
The committee's opinion includes :1° The identification and title of the research ;2° The name of the investigator or, where applicable, the coordinating investigator;3° The name of the sponsor;4° The…
…file on the research involving the human person including, in particular, the protocol in the form of a dated document, incorporating, where applicable, successive amendments and describing the objec…
…person, the Committee gives its opinion :1° On substantial modification projects ;2° In application of the second paragraph of Article L. 1211-2 .
Within one month of being notified of the committee's unfavourable opinion, the sponsor may use the information system for research involving the human person to request that his dossier be re-examine…
…e agenda for Committee meetings.Committee meetings are not public. They may be held for all or some of the members by telephone or audiovisual conference.Opinions are issued by a simple majority of th…
…rk one or more experts, without voting rights, whose particular expertise is required by the nature of the research project.The experts' opinions must be set out in a written report.The experts and sp…
If, within two years of the opinion of the Committee for the Protection of Human Rights and Fundamental Freedoms, the research involving the human person has not begun, this opinion lapses. However, i…
The accounting operations of the personal protection committees are carried out by a single accounting agency set up as an accounting group under the conditions laid down inarticle 188 of decree no. 2…
…pinions are kept by the committee, under conditions that ensure their confidentiality, for a period of twenty-five years after the end of the research or its early termination.
When the Minister for Health intends to withdraw the approval of a committee, he will inform the Director General of the Regional Health Agency, who will notify the committee chairman. The latter has…
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