French Public Health Code
In forceI.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to :
the protection of individuals, in particular the protection of participants;
-the adequacy, completeness and comprehensibility of the written information to be provided and the procedure to be followed for obtaining informed consent, and the justification for conducting a performance study on persons incapable of giving informed consent;
-the possible need for a reflection period;
-the possible need to include in the protocol a prohibition on simultaneous participation in another performance study or an exclusion period;
the relevance of the performance study, the satisfactory nature of the assessment of the expected benefits and risks and the soundness of the conclusions for performance studies when the competent authority is not asked to make a scientific assessment of the study;
-the appropriateness of the objectives pursued and the resources deployed;
the qualifications of the investigator(s);
- the amounts and procedures for compensating participants;
- the procedures for recruiting participants;
- the scientific and ethical relevance of plans to build up collections of biological samples during performance studies;
-the methodology of the performance study with regard to the provisions of law no. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, the need to collect and process personal data and the relevance of such data to the purpose of the performance study, prior to referral to the Commission nationale de l'informatique et des libertés. The Commission nationale de l'informatique et des libertés may, in order to carry out its duties as defined inarticle 66 of the aforementioned Act of 6 January 1978, refer the matter to the Comité d'expertise pour les recherches, les études et l'évaluation dans le domaine de la santé for an opinion.
For performance studies involving the processing of personal data as defined inarticle 72 of the aforementioned Act of 6 January 1978, the Personal Data Protection Committee may, in accordance with the procedures laid down by a decree of the Conseil d'Etat, refer the matter to the Expert Committee for Research, Studies and Evaluations in the Health Sector.
II.-The protocol for a performance study, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, submitted by the sponsor to the Committee for the Protection of Individuals and, where applicable, to the competent authority, shall indicate, giving reasons, whether or not provision has been made for an independent monitoring committee to be set up.
Before giving its opinion, the Committee shall ensure that the conditions of article L. 1126-11 have been met. The competent authority shall be informed of any changes made to the performance study protocol at the request of the Committee for the Protection of Individuals.
The Committee shall issue a reasoned opinion within a period set by regulation.
The State shall be held liable in the event of any fault on the part of the Committee in the performance of its duties.
Upon request to the relevant Committee for the Protection of Individuals, the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall have access to all relevant information relating to performance studies not covered by the second to fifth paragraphs of II of Article L. 1126-1.
