SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Yes
Standard IC form (ICF)
Templates for informed consent forms (available in French, German and English) are provided on the CNER/NREC website in section Procedures > Submission of a new study
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Written informed consent must be obtained from study participant or legal representative according to Art 78 of the Medical Deontology Code (approved by the Ministerial Decree of 1st March 2013).
Applicable national legal framework/ Reference
Art 78 of the Medical Deontology Code (approved by the Ministerial Decree of 1st March 2013)