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).

Additional Information

ADDITIONAL PAEDIATRIC INFORMATION

LEGAL AGE OF CONSENT:
18 Years (legal age)
14 Years for studies with minimal risks

MANDATORY / SUGGESTED AGE RANGES DEFINED FOR ASSENT:
Oral information for children up to 10 years of age
11 to 14 Years: beside oral information, written information according to the age is mandatory
14-18 Years: same information as adults, but not in informal form of address
Specifications regarding assent: On the consent form parent and investigator have to declare that the minor has been informed and consents or did not disapprove. After 14 years of age the patient consents with signature together with parent/legal representative.

NUMBER OF REQUIRED SIGNATORIES:
One parent or legal representative

OFFICIAL LANGUAGE OF INFORMED CONSENT:
German, French, Italian

INFORMATION ON MATERIAL USED TO DESCRIBE THE CLINICAL TRIAL TO THE MINOR:
11 to 14 Years: beside oral information written information according to the age is mandatory
14-18 Years: same information as adults, but not in informal form of address

ADDITIONAL INFORMATION (INCLUDING REFERENCE FOR TEMPLATE):
• Reference legislation:
o Human Research Act Art. 3 lit j,k, Art. 7, 16, 21, Art. 22-23, Art. 31 (3), Art. 32-34
o Ordinance on Clinical Trials ClinO: Art. 7-8, Art.15b, Art. 19-25, Art. 30
o Ordinance on Research in Humans HRO: Art. 7, 8, 9, 13
• IC template(s) / guidelines / information sources
https://www.swissethics.ch/templates.html

SOURCE(S):
• Human Research Act: https://www.admin.ch/opc/en/classified-compilation/20061313/index.html
• ClinO: https://www.admin.ch/opc/en/classified-compilation/20121176/index.html
• HRO: https://www.admin.ch/opc/en/classified-compilation/20121177/index.html

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395