SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
'Consent shall be in writing and freely granted after the participant has been provided with adequate information on the study, risks it may entail, potential benefits, and the nature of the participation. The participant shall be informed that he/she may decline to take part in a scientific study, or withdraw from participation at any time after it commences, without stating any reason'
Applicable national legal framework/ Reference
Art 18 Scientific Research Act 2014
Related details including provisions applicable to vulnerable groups are set out in Section V, Art 18-24 Scientific Research Act 2014 and Chapter IV, Art 18-21 Regulation no 433/2004.