SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Legal framework/Reference (Minors/Children)

Article L1121-7
Article L1122-2 CSP

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

Article L1121-6/8/9 CSP
Article L1122-2 CSP

Emergency situations - Studies allowed

Yes
Special provisions apply

Emergency situation without prior consent of patient or proxy - Studies allowed

No

Conditions allowing trial participation in emergency setting without prior consent

Under current legislation, it is not possible to start the study in intensive care patients in acute emergency settings without the informed consent of the legal representative if the latter is "present" (see L1122-1-2 Chapter 2 CSP)
However, the future legislation (Jardé law) will allow 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")

Legal framework / Reference (Emergency Situation)

L1122-1-2 Chapter 2 CSP

Pregnant or breastfeeding women - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Pregnant or breastfeeding women)

L1121-5 Chapter 1 CSP

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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