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.
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…
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….
The term of office of committee members is three years, renewable, and expires at the end of the committee’s approval.
In the event of a vacancy occurring during the term of office, a replacement shall be appointed under the same conditions as the appointment for the remainder of the term of office.
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.
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…
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…
The Chairman or, in his absence, the Vice-Chairman sets the 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 the members present, within the meaning of article R. 1123-11, on the basis of a report by a member of each of the colleges mentioned in article…
The committee may involve in its work 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 specialists mentioned inarticle R. 1125-19 are also required to make the declarations mentioned in article L. 1451-1. These declarations are also attached to the activity report mentioned in article R….
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75001, Paris France
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