SSStudyParticipantsVulnerablePopulation object

Specific provision

The consent is granted by the legal guardian(s) (in principle the parents). The consent must correspond to the minor's presumed will where such a will can be ascertained (informed assent).

Legal framework/Reference (Minors/Children)

Art 42 AMG

Legal framework / Reference (Incapacitated persons)

Art 43 AMG

Conditions allowing trial participation in emergency setting without prior consent

It is allowed - provided that approval of CA and EC is granted- to start with immediate treatment without prior consent and as soon as granting consent becomes possible, he or she (or the legal guardian) may subsequently give or withhold consent

Legal framework / Reference (Emergency Situation)

Art 43a AMG

Specific provisions

NB: No specific provisions for lactation period existing

Legal framework / Reference (Pregnant or breastfeeding women)

Art 44 AMG

National legal framework for protection of vulnerable populations in place


Applicable legal framework / Reference (Vulnerable Population)

Art 42-45 AMG