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Article R1123-15 of the French Public Health Code

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.

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Article R1123-17 of the French Public Health Code

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.

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Article R1123-18 of the French Public Health Code

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…

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Article R1123-19 of the French Public Health Code

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…

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Article R1123-19-1 of the French Public Health Code

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…

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Article R1123-19-3 of the French Public Health Code

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. 2012-1246 of 7 November 2012 on public budgetary and accounting management. An order of the ministers responsible for health and the budget specifies the operating procedures and the registered office of this group. The group’s accounting officer is…

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Article R1123-20 of the French Public Health Code

I. – The request for an opinion on a research project involving the human person is filed by the sponsor on the information system mentioned in article R. 1123-20-1, which assigns it to a personal data protection committee under the conditions provided for by this same article. The file requesting an opinion on a research project involving the human person includes : 1° An administrative file ; 2° A file…

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Article R1123-20-1 of the French Public Health Code

I.-An information system for research involving the human person enables: 1° Exchanges between sponsors and committees for the protection of individuals. To this end, it receives requests for advice from sponsors, informs them of additional documents and modifications requested by the committees for the protection of individuals, as well as any questions they may have and indicates the deadlines set for them to respond. In addition, it informs the personal…

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