SSStudyParticipantsVulnerablePopulation object
Minors / Children - Studies allowed
Yes
Special provisions apply
Specific provision
The informed consent given by a person with parental responsibility or a legal guardian to a minor taking part in a clinical trial shall represent the minor’s presumed will.
Legal framework/Reference (Minors/Children)
Schedule 1, Part 4 of the Medicines for Human Use (Clinical Trials) Regulations 2004
Incapacitated persons - Studies allowed
Yes
Special provisions apply
Legal framework / Reference (Incapacitated persons)
Schedule 1, Part 5 of the Medicines for Human Use (Clinical Trials) Regulations 2004
Emergency situations - Studies allowed
Yes
Special provisions apply
Emergency situation without prior consent of patient or proxy - Studies allowed
No
Legal framework / Reference (Emergency Situation)
Schedule 1, Part 5 of the Medicines for Human Use (Clinical Trials) Regulations 2004
Pregnant or breastfeeding women - Studies allowed
Not specified
National legal framework for protection of vulnerable populations in place
Yes
Applicable legal framework / Reference (Vulnerable Population)
Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations 2004
