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
Yes
Applicable legal framework / Reference (Vulnerable Population)
Art 42-45 AMG
