SSStudyParticipantsVulnerablePopulation object
Specific provision
Studies with minors are possible under special provisions
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).
Specific provisions
Studies with MD involving permanently incapacitated persons are prohibited
Specific provisions
Studies with subjects being in emergency situations are possible under special provisions.
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 (pursuant to Art 52a MPG).
Legal framework / Reference (Pregnant or breastfeeding women)
Art 53 MPG
National legal framework for protection of vulnerable populations in place
Yes
