SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
English translation for Portuguese definition for informed consent (“Consentimento informado”):
'Permission obtained voluntarily from a study participant or his/ her legal representative after being informed in detail about the nature, the consequences and risks as well as the right to withdraw participation at any time without any consequences.'
Applicable national legal framework/ Reference
Chapter 1, Art 2(j) Law 21/2014 - Definition
Art 7 & 8 Law 21/2014 (pt)- Vulnerable persons
Additional Information
Specific provisions apply to vulnerable persons such as minors and adults incapable of giving informed consent.