SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Prior to the commencement of a clinical investigation with MD, informed consent must be obtained from study subjects according to the provisions specified in the national law.
Applicable national legal framework/ Reference
• Art 40 (4) and 56 Medical Device Act 2010 (en)
• Art 37b (2) and Art. 37f Pharmaceutical Law 2001 (en)
• Art 25 (1) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz.152)
Additional Information
Special provisions apply to vulnerable populations such as minors, incapacitated adults and subjects in emergency situations (Art 40 (4,10,11,13) Medical Device Act 2010).