SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Specific provision

Main criteria: the investigation is directly related to the clinical condition of the child, or is nature, and can only be carried out on minors; legal representative gave consent or the child him/herself

Legal framework/Reference (Minors/Children)

Art 11 Decree No 33/2009 of the Minister of Health

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

Art 12-15 Decree No 33/2009 of the Minister of Health

Emergency situations - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Emergency Situation)

Art 13 & 15 Decree No 33/2009 of the Minister of Health

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
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