SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Informed Consent is covered in the Act 154 of 1997 on Health Care as well as in Decree No 35/2005 in detail.
Legal representatives give the consent on behalf of the vulnerable patient who may be involved into the trial only if there is a direct benefit for them. This is the same for trials both with investigational medicinal products and other biomedical ones.
Applicable national legal framework/ Reference
Act 154 of 1997 on Health Care
Art 6 Decree No 35/2005