SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Specific provision

Informed Consent Form: The consent is granted by the legal representatives (generally both parents). The consent must correspond to the minor’s presumed will where such a will can be ascertained. If the minor is capable of understanding the nature, significance and implications of the clinical trial and able to form a rational intention in the light of these facts, his/her written consent is also necessary.

Legal framework/Reference (Minors/Children)

§22 (4) MPG

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

§21 MPG

Emergency situations - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Emergency Situation)

§21 MPG

Pregnant or breastfeeding women - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Pregnant or breastfeeding women)

§22 (5) MPG

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