SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Emergency situations - Studies allowed

Yes
Special provisions apply

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

Special provisions apply

Conditions allowing trial participation in emergency setting without prior consent

Conditions for the conduct of trials if the patient is unable to give consent, and where it is
impossible to obtain prior consent of that person's next of kin:
a) any risk or inconvenience to the person is insignificant
b ) the person does not oppose it, and there is no reason for scientists or other personnel to believe that she/he would have opposed the plan if he had had to consent ,
c ) it is only possible to carry out research in clinical emergencies
d ) research is undoubtedly justified by the prospect of results with great preventive, diagnostic or therapeutic value.
The person or his/her next of kin shall as soon as possible be given information about the research
and consent should be obtained as soon as possible .

Pregnant or breastfeeding women - Studies allowed

Not specified

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