Subsection 4: Notification procedure.

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…

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…

In addition to requests for an opinion on initial research projects involving the human person, the Committee gives its opinion : 1° On substantial modification projects ; 2° In application of the second paragraph of Article L. 1211-2 .

I.-The Committee to which a request for an opinion on a research project involving the human person has been submitted shall give its opinion within a period of forty-five days. If the Committee remains silent at the end of this period, the request will be rejected. This period runs from the date on which the Protection Committee notifies the applicant that it has received the complete application. This notification must…

The committee’s opinion includes : 1° The identification and title of the research ; 2° The name of the investigator or, where applicable, the coordinating investigator; 3° The name of the sponsor; 4° The dated identification of the documents on which the Committee has given its opinion, and in particular the protocol, the information document referred to in Article L. 1122-1 and, where applicable, the brochure for the investigator; 5°…

Within one month of being notified of the committee’s unfavourable opinion, the sponsor may use the information system for research involving the human person to request that his dossier be re-examined by another committee. The sponsor must inform the competent authority. Such a request may only be made once. The newly appointed committee will examine the request under the conditions laid down in article R. 1123-23. A member of the…

If, within two years of the opinion of the Committee for the Protection of Human Rights and Fundamental Freedoms, the research involving the human person has not begun, this opinion lapses. However, if justification is provided before the expiry of this period, it may be extended by the committee concerned for a further two years.