SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Specific provision

Same rules as for IMP trials

Legal framework/Reference (Minors/Children)

Section 4 of Legislative Decree n. 211

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Specific provisions

Same rules as for IMP trials

Legal framework / Reference (Incapacitated persons)

Section 5 of Legislative Decree n. 211.

Emergency situations - Studies allowed

No national legal framework available

Specific provisions

Same rules as for IMP trials:
The involvement of subjects in emergency situations in a clinical trial is not explicitly mentioned in Italian law (see sections on vulnerable persons in Legislative Decree n. 211).

Pregnant or breastfeeding women - Studies allowed

No national legal framework available

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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