SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Studies with minors (i.e. under 18 years old) are possible under special provisions.
Article L1121-7 Chapter 1 CSP
Article L1122-2 CSP covers specific requirements for the informed consent of minors.
Yes
Special provisions apply
Yes
Special provisions apply
No
Under current legislation, it is not possible to start the study in acute emergency settings without the informed consent of the legal representative if the latter is "present" (pursuant to L1122-1-2 Chapter 2 CSP).
However, the current legislation (Jardé law) allows research in emergency situations to start without informed consent of the legal representative in immediately life-threatening situations. (in French: "recherches en situation d'urgence vitale immédiate") (pursuant to L1122-1-3 Chapter 2 CSP)
Yes
Special provisions apply
Yes
Special conditions apply for the inclusion of vulnerable persons (e.g. children, pregnant and lactating women and adult protected by the law) pursuant to L1121-5 to 9 (Chapter 1 CSP), L1122-1 & 2.
