SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
The Portuguese definition for informed consent and its related provisions (“Consentimento livre e esclarecido”) are provided in Art 3.m) and Annex XVI (15). DL 145/2009 (pt)
Applicable national legal framework/ Reference
Art 3.m) and Annex XVI (15) DL 145/2009 (pt) - Definition
Annex XVI (16) & (17) DL 145/2009 (pt) and Art 7 & 8 Law 21/2014 (pt) - Vulnerable population
Additional Information
Specific provisions apply to vulnerable persons such as minors and adults incapable of giving informed consent according to Annex XVI (16) & (17) DL 145/2009 (pt) and Art 7 & 8 Law 21/2014 (pt)