SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Informed consent form: For minors, additionally section 40 subsection 4 No. 3 AMG has to be considered. The consent is granted by the legal representative(s)/guardian(s) (generally both parents). The consent must correspond to the minor’s presumed will where such a will can be ascertained. If the minor is capable of understanding the nature, significance and implications of the clinical trial and able to form a rational intention in the light of these facts, his/her written consent is also necessary.
Yes
Special provisions apply
Clinical studies involving incapacitated persons are regulated by § 41 AMG
Yes
Special provisions apply
Exceptions to the procedure of informed consent can be found in section 41 subsection 1 AMG (case of emergency) and section 3 subsection 2b GCP-V (consent in presence of a witness). However, there is no harmonised procedure accepted by ethics committees in case of informed consent in emergency.
With limitations
NB! Court involvement might be needed.
Section 41 subsection 1 AMG (case of emergency) and section 3 subsection 2b GCP-V (consent in presence of a witness).
No national legal framework available
No special provisions provided in German law
