French Public Health Code
In forceI.-For the activities referred to in 2°, 3°, 4° and 6° of the I of article R. 1261-17, the project sponsor must send the head of the body's host structure a file describing the project by any means that provides a date certain upon receipt.
The file must enable the educational or scientific interest of the project to be assessed. It must include the following documents:
1° A description of the purpose, title and duration of the project;
2° Identification of the persons in charge of and participants in the project, together with their titles and positions;
3° The nature of the teaching activities and research work envisaged, together with information enabling compliance with the relevant legal and regulatory conditions to be ascertained.
In addition, when the project includes a request for temporary removal from the body of the authorised establishment or for segmentation of the body, the project sponsor must justify the need for this removal or segmentation in order to carry out the project described in the application.
II. -The person in charge of the body reception facility will issue an acknowledgement of receipt when the application is complete.
If the application is incomplete, the person in charge will ask for any additional documents or information that he/she deems necessary, by any means that gives a certain date to this request, indicating the deadline for providing this information.
III.- The person in charge will send the application to the ethics, scientific and educational committee, in accordance with I of article R. 1261-16, with, where applicable, the draft agreement provided for in article R. 1261-22. It informs the project sponsor under the conditions set out in II of article R. 1261-16.
IV.-The project sponsor must be able to provide information on the progress of the project at any time, at the request of the head of the body reception facility.
The head of the body reception facility must be informed immediately of any changes to the information contained in the file mentioned in I during the implementation of the project. He may refer these changes to the Ethics, Science and Education Committee for its opinion.
He may suspend or oppose the changes made to the project if the conditions for authorising access to the bodies are no longer met and after the organisation has been invited to present its observations.
Before suspending or prohibiting access to the bodies, the person responsible will give formal notice to the organisation responsible for implementing the project to put an end to its shortcomings or to submit its observations within the time limit set.
The period of suspension may not exceed six months.
V.-If, within six months of notification of the decision provided for in II of article R. 1261-16, the activity referred to in the first paragraph of I of this article has not begun, it may no longer be carried out.
