SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Legal framework/Reference (Minors/Children)

Art 63-65 Law on MP & MD 2010

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

Art 66 Law on MP & MD 2010

Emergency situations - Studies allowed

Yes
Special provisions apply

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

No

Legal framework / Reference (Emergency Situation)

Art 66 Law on MP & MD 2010

Pregnant or breastfeeding women - Studies allowed

Yes
With limitations
Special provisions apply

Specific provisions

Clinical trials on healthy pregnant or lactating women are prohibited.

Legal framework / Reference (Pregnant or breastfeeding women)

Art 63 Law on MP & MD 2010

National legal framework for protection of vulnerable populations in place

Yes

Applicable legal framework / Reference (Vulnerable Population)

Art 63-67 Law on MP & MD 2010

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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