SSStudyParticipantsVulnerablePopulation object
Minors / Children - Studies allowed
Yes
Special provisions apply
Incapacitated persons - Studies allowed
Yes
Special provisions apply
Legal framework / Reference (Incapacitated persons)
Chapter 3 (2-3) LVFS 2003:6
Section 20-22 LVFS 2003:460
Emergency situations - Studies allowed
Yes
Special provisions apply
Emergency situation without prior consent of patient or proxy - Studies allowed
No
Conditions allowing trial participation in emergency setting without prior consent
No studies are allowed involving unconscious patients, not even with proxy approval (valid for IMP studies only).
The reason is that it is not forbidden in the ethics act, but in the drug act.
(A proxy consent would need a court decision which takes app. 2 weeks).
Legal framework / Reference (Emergency Situation)
Chapter 3 (2-3) LVFS 2003:6
Section 20-22 LVFS 2003:460
Pregnant or breastfeeding women - Studies allowed
No national legal framework available
Specific provisions
No explicit provisions for the conduct of clinical trials on pregnant or lactating women are mentioned in Swedish legislation
National legal framework for protection of vulnerable populations in place
Yes
Applicable legal framework / Reference (Vulnerable Population)
Chapter 3 (2,3) LVFS 2003:6
Section 18 resp. 20-22 LVFS 2003:460
