SSStudyParticipantsVulnerablePopulation object

Minors / Children - Studies allowed

Yes
Special provisions apply

Specific provision

The prerequisites are that the research can’t be conducted on adults and the legal representatives (parents) or the child him/herself gave his/her consent.

Legal framework/Reference (Minors/Children)

Art 7 of Decree No 35/2005
Section 169(5) of Act 154 of 1997 on Health Care

Incapacitated persons - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Incapacitated persons)

Section 9-11 of Decree No 35/2005
Section 159(4) of Act 154 of 1997 on Health Care

Emergency situations - Studies allowed

Yes
Special provisions apply

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

Yes
With limitations

Conditions allowing trial participation in emergency setting without prior consent

In special urgent cases, when the study is expected to be of direct benefit for the health of the research subject, it may be done without consent.

Legal framework / Reference (Emergency Situation)

Section 9-11 of Decree No 35/2005
Section 160 of Act 154 of 1997 on Health Care

Pregnant or breastfeeding women - Studies allowed

Yes
Special provisions apply

Legal framework / Reference (Pregnant or breastfeeding women)

Section 161(1) of Act 154 of 1997 on Health Care

National legal framework for protection of vulnerable populations in place

Yes

Applicable legal framework / Reference (Vulnerable Population)

Section 7, 9-11 of Decree No 35/2005
Section 159-161 Act 154 of 1997 on Health Care

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395