SSStudyParticipantsVulnerablePopulation object

Not specified

Clinical trials including minors are possible under special provisions according to the section 4, 6 and 13(e) of WMO (en)
The WMO applies the “no, unless” principle.

Related information and specific documents (“Non-therapeutic research on minors and incapacitated subjects: 'no, unless” and “Code of conduct involving minors”) are provided on the CCMO website in section: Home>Investigators>Types of research>Research with minors

Section 4, 6 and 13(e) of WMO (en)

Clinical trials including minors are possible under special provisions according to the section 4, 6 and 13(f) of WMO (en)
The WMO applies the “no, unless” principle.

Related information and specific documents (“Non-therapeutic research on minors and incapacitated subjects: 'no, unless”) are provided on the CCMO website in section: Home>Investigators>Types of research>Research with incapacitated adults

Section 4, 6 and 13(f) of WMO (en)

Witnessed oral consent

Clincial trials in emergency situations are possible under special provisions specified in section 6(4) WMO (en)

„If the clinical trial can be conducted only in medical emergencies in which the consent required pursuant to subsection 1 cannot be given and if inclusion in the trial may benefit the person in urgent need of medical treatment, procedures to implement the trial may be undertaken without such consent for as long as circumstances continue to prevent the giving of consent.“

Section 6(4) WMO (en)

No legal reference