SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Legal framework/Reference (Minors/Children)

Law 29/2006
Royal Decree 1090/2015 (Articles 4, 5, 6, 7)
Art 3, 4, 6.2 and 7.3 of Circular 7/2004

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

Art 3, 5, 6.2 and 7.3 Circular 7/2004

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

Yes
Special provisions apply

Legal framework / Reference (Emergency Situation)

Art 7.4 Circular 7/2004

Pregnant or breastfeeding women - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Pregnant or breastfeeding women)

Art 3, 6.3 Circular 7/2004

Guidelines & conventions for protection of vulnerable populations

The European Guideline "Ethical considerations for clinical trials on medicinal products conducted with the paediatric population" contains further helpful recommendations concerning minors.

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