SSStudyParticipantsVulnerablePopulation object

Specific provision

Studies with minors (children and adolescents < age of 18) are possible under special provisions (Art 11, 21-23 HRA).

Legal framework/Reference (Minors/Children)

Art 11, 21-23 HRA

A detailed guidance for research with minors, a related checklist and template for Informed Consent Form are provided on the Swissethics website in section Templates > Research with Children.

An interesting opinion on research involving children has been published by the Swiss National Advisory Commission on Biomedical Ethics NEC-CNE – Zur Forschung mit Kindern, Nr. 16/2009 (English: NEC-CNE - Research involving children (en), Nr. 16/2009).

Specific provisions

Studies including incapacitated persons are possible under special provisions (Art 11, 21, 24 HRA)

Specific provisions

Studies with participants being in emergency situation are possible under special provisions (Art 11, 30, 31 HRA; Art 15-17 KlinV/ClinO).

Conditions allowing trial participation in emergency setting without prior consent

Human Research Act: Art. 31 Post hoc or proxy consent
“1 The person concerned must be duly informed about the research project as soon as this becomes possible. He or she may subsequently give or withhold consent.
2 If the person concerned refuses to give post hoc consent, the biological material and data may no longer be used for the research project.
3 The Federal Council shall specify the procedure for the procurement of post hoc or proxy consent, in particular with regard to the involvement of children, adolescents and adults lacking capacity.”

Specific provisions

Studies with pregnant women (and IVF Embryos and Foetuses) are possible under special provisions (Art 11, 25-27 HRA).
No explicit provisions are provided for breast-feeding women.

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