Article L1123-9 of the French Public Health Code
After the start of the research, any substantial modification of the research on the initiative of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in the case of research mentioned in 1° of Article L. 1121-1, authorisation from the competent authority. In this case, the Committee ensures that a new consent is obtained from the persons participating in the research if this is…