SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Art 23 Scientific Research Act 2014
Art 19&20 Regulation no 433/2004
Detailed information is also provided on the NBC website in sections Home » Criteria » Vulnerable groups including Children
Yes
Special provisions apply
Art 23 Scientific Research Act 2014
Art 19&20 Regulation no 433/2004
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
The individual in question, or his/her next of kin, shall be provided with information on the study as soon as possible, and the appropriate consent shall be elicited 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
Provisions applicable to vulnerable groups are set out in Section V, Art 18-24 Scientific Research Act 2014 and Chapter IV, Art 18-21 Regulation no 433/2004.
