SSStudyParticipantsInformedConsent object
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
The definition for “Informed subject consent” resp. “willing informed consent” is provided in Art 2 (9) of Rulebook Application 2011.
Informed consent must be obtained from the study participants in written form (in verbal form under special provisions) and in Serbian language according Art 61 of Rulebook Application 2011.
Additional Information
There are specific requirements to be considered for vulnerable populations such as children, pregnant and lactating women, prisoners and adults who are not able to give written consent for trial participation (according to Art 63-67 of Rulebook Application 2011).