Subsection 3: Organisation and operation

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….

The committee adopts internal regulations in accordance with a standard document defined by order of the Minister for Health. These rules are forwarded to the National Commission for Research Involving the Human Person, which ensures that they are compliant and makes them public.

The files, reports, deliberations and opinions 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.

Each committee has its headquarters in a public establishment with whose legal representative the Director General of the Regional Health Agency and the Data Protection Committee enter into an agreement for the purpose of providing the committee with the premises, equipment and secretarial staff required to carry out its duties, in return for a fixed fee.

The duties of a member of a personal data protection committee are performed free of charge. Committee members who suffer a loss of income as a result of attending meetings, members included on a list defined by order of the Minister for Health due to their responsibilities or their volume of activity within the Committee, experts, specialists and rapporteurs receive an allowance, the amount and conditions of which are set…

I.-As an exception to the provisions of Article 3 of Decree No. 2012-1246 of 7 November 2012 on public budgetary and accounting management, the Committees for the Protection of Individuals are subject to the budgetary, financial and accounting regime defined by Titles I and III of this same Decree, with the exception of 1° and 2° of Article 175, Articles 178 to 185, 204 to 208, the last sentence of…

I. – The members of the Committee, meeting under the conditions laid down in article R. 1123-11, shall deliberate on the proposal of the Chairman of the Committee on : 1° The initial budget, no later than 1st November of the calendar year preceding that for which it is drawn up; 2° The amending budget or budgets; 3° The financial account; 4° the activity report. The Committee’s decisions are adopted…

The Chairman of the Personal Data Protection Committee is the authorising officer for expenditure and revenue.