SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Legal framework/Reference (Minors/Children)

Section 8 of Act No. 488/1999

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

Section 7 of Act No. 488/1999

Emergency situations - Studies allowed

Yes
With limitations

Specific provisions

In Finland is allowed to include patients to clinical trial without his/her prior consent.
However, proxy consent is required (close relativ, other person closely connected, or legal representative) according to ClinicalTrialsFinland:
'Also patient in intensive care may not able to give their consent themselves due to their condition.
In case the person does not have the capacity to give consent, as mentioned above, he/she may be entered into the trial as a research subject only when written consent for this has been given by his/her close relative or some other person closely connected with the subject or by his / her legal representative after having been provided essential study information.'

Emergency situation without prior consent of patient or proxy - Studies allowed

No

Legal framework / Reference (Emergency Situation)

Information available on the ClinicalTrialsFinland website in section: Persons not Able to Consent
Section 7 of Act No. 488/1999

Pregnant or breastfeeding women - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Pregnant or breastfeeding women)

Section 9 of Act No. 488/1999

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