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Chapter III: Committee for the Protection of Individuals, National Commission for Research Involving the Human Person and Competent Authority

Article R1123-1 of the French Public Health Code

Approval for a committee is granted by the Minister for Health on a proposal from the Director General of the Regional Health Agency for the region concerned. The application for approval must state the address of the committee’s registered office and be accompanied by a provisional budget and, in the case of applications for renewal, an activity report for the period since the previous approval. The content of the provisional…

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Article R1123-3 of the French Public Health Code

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 thirty days in which to make its observations. Withdrawal of approval is made after obtaining the opinion of the Director General of the Regional Health Agency.

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Article R1123-4 of the French Public Health Code

The committees for the protection of individuals comprise thirty-six members divided into two colleges, each with 18 members: 1° The first college is made up of at least: a) Eight people with qualifications and in-depth experience in research involving the human person, including at least four doctors and two people qualified by virtue of their expertise in biostatistics or epidemiology; b) Two doctors specialising in general medicine; c) Two hospital…

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Article R1123-6 of the French Public Health Code

In order to appoint the members of the Committee by the Director General of the Regional Health Agency, a call for candidates for each of the categories mentioned inArticle R. 1123-4 is circulated by any appropriate means. The same person may be a member of one or more other committees. A member of a committee may attend sessions of another committee of which he or she is not a member….

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Article R1123-9 of the French Public Health Code

If a member is absent from three consecutive Committee meetings without justification, that member is deemed to have resigned. The Director General of the Regional Health Agency will replace the member under the conditions laid down inarticle R. 1123-8.

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Article R1123-10 of the French Public Health Code

The members elect the Chairman of the Committee from among their number by an absolute majority of those present. If this majority is not achieved after two ballots, the Chairman is elected by relative majority. In the event of a tie between the two best-placed candidates, the chairmanship of the committee is awarded to the oldest of these two candidates. The Vice-Chairman is elected under the same conditions. The quorum…

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Article R1123-11 of the French Public Health Code

In order to be valid, the deliberations of the Committee require the presence of at least five members, at least two of whom belong to the first college mentioned in article R. 1123-4, comprising at least one person qualified by virtue of their expertise in biostatistics or epidemiology, and two of whom belong to the second college, comprising at least one representative of the associations approved in accordance with the…

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