SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Art 23 Scientific Research Act 2014
Detailed information is also provided on the NBC website in sections Home » Criteria » Vulnerable groups including Children.
Yes
Special provisions apply
Yes
Special provisions apply
In case that prior consent of the patient or of the next of kin can not be obtained, the study can be commenced if specific criteria are met:
a) patient’s risk and burden are minor
b) patient is not opposed to participation
c) similar results cannot be achieved by research on individuals able to grant consent
d) the study is justified with regard to the potential for its findings being beneficial for the individual in question or individuals with the same disease, or promoting important preventive measure, diagnoses or cures
e) prior approval by the National Bioethics Committee or Institutional Review Board
Consent shall be obtained as soon as possible for continuation of the study.
Yes
Special provisions apply
Specific requirements for vulnerable groups (as described on the NBC website in sections Home » Criteria » Vulnerable groups including Children) also apply to pregnant women (Art 15 Scientific Research Act 2014)
Yes
Section V (Art 18-24) Scientific Research Act 2014
