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).

Legal framework/Reference (Minors/Children)

Art 51 MPG

Specific provisions

Studies with MD involving permanently incapacitated persons are prohibited

Legal framework / Reference (Incapacitated persons)

Art 52 MPG

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 (Emergency Situation)

Art 52a MPG

Legal framework / Reference (Pregnant or breastfeeding women)

Art 53 MPG

National legal framework for protection of vulnerable populations in place


Applicable legal framework / Reference (Vulnerable Population)

Art 51-54 MPG