SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Specific provision

Same provisions as for IMP studies.

Legal framework/Reference (Minors/Children)

Art 4 modified RGD 30 May 2005

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Specific provisions

Same provisions as for IMP studies

Legal framework / Reference (Incapacitated persons)

Art 5 modified RGD 30 May 2005

Emergency situations - Studies allowed

Yes
Special provisions apply

Specific provisions

Only permitted if the legal representative signs the consent form. For studies with no IMP, it depends on the design of the study.

Legal framework / Reference (Emergency Situation)

Art 5 (a) modified RGD 30 May 2005

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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