SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Freely given informed consent shall be obtained from every subject prior to clinical trial participation (pursuant to Regulation 10, Part 2, S.I no. 374 of 2006).
Detailed legal requirements are specified in Schedule 1, Conditions and Principles for the Protection of Clinical Trials Subjects, of S.I No. 190 of 2004.
Applicable national legal framework/ Reference
Regulation 10, Part 2, S.I no. 374 of 2006
Schedule 1 (Conditions and Principles for the Protection of Clinical Trials Subjects) of S.I No. 190 of 2004.