SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Witnessed oral consent

Specific provision

Clinical trials involving minors are possible under special provisions

Legal framework/Reference (Minors/Children)

Art 4 modified RGD 30 May 2005

Specific provisions

Clinical trials involving incapacitated adults are possible under special provisions

Legal framework / Reference (Incapacitated persons)

Art 5 modified RGD 30 May 2005

Conditions allowing trial participation in emergency setting without prior consent

Clinical trials involving subjects incapable of granting consent themselves are only permitted if the legal representative signs the consent form.

Legal framework / Reference (Emergency Situation)

Art 5 (a) modified RGD 30 May 2005

Specific provisions

Not referenced in national law

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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