French Public Health Code
In forceI.-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 data protection committees of withdrawals and suspensions of authorisations for research sites taken in application of Article R. 1121-15 and provides them with the information provided for in Article R. 1123-41;
2° Exchanges between the personal data protection committees and the Agence nationale de sécurité du médicament et des produits de santé. To this end, it informs the Agency of the opinions issued by the committees for the protection of individuals.
For these purposes, it has a secure storage space.
II.-The Minister for Health is responsible for the information system for research involving the human person, which he implements and manages in accordance with the procedures laid down by decree. This information system draws lots to designate the committee for the protection of individuals competent to give an opinion on the requests for opinions provided for by articles L. 1123-6 and L. 1124-1 as well as 2° and 3° of article R. 1123-21. The date of the draw confers a definite date on the application.
By way of derogation from the first paragraph of this II, research consisting of the extension of previous research or ancillary research is addressed to the Committee for the Protection of Individuals which gave its opinion on the initial research. When several committees for the protection of individuals have issued opinions on studies related to the proposed extension or ancillary research, the project is submitted to the committee for the protection of individuals which was the first to issue an opinion on one of these related studies.
For the draw provided for in the first paragraph of this II, the information system puts out to tender only those committees for the protection of individuals which are available and have the necessary competence to examine the project. An order by the Minister for Health specifies the procedures for implementing this draw.
If the designated personal data protection committee is unable to process the request for an opinion that has been allocated to it, the chairman or vice-chairman of the committee concerned may ask the Minister for Health within two working days to refer the case to another personal data protection committee designated at random.
