Section 4: Substantial changes to research.

The substantial modifications referred to in Article L. 1123-9 are those which occur after the authorisation of the research by the competent authority and the favourable opinion of the Committee for the Protection of Individuals and have a significant impact on any aspect of the research, in particular on the protection of individuals, including with regard to their safety, on the conditions for the validity of the research, where applicable…

The Committee gives its opinion under the conditions set out in Article R. 1123-23. If the Committee’s opinion is unfavourable, the sponsor may not implement the modification to the research.

With the exception of research requiring express authorisation, if the competent authority does not respond to a request for substantial modification from the sponsor, this will be deemed to constitute authorisation on expiry of a period of thirty-five days from receipt of all the information required concerning this request. The Commission may notify the sponsor of its decision before the expiry of the aforementioned period. This period may be extended…