SSStudyParticipantsInformedConsent object
Yes
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
Yes
“A decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of the nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation."
Art 2(j) modified RGD 30 May 2005
Art 3-5 modified RGD 30 May 2005
Further requirements on granting consent, in particular regarding vulnerable populations are specified in Art 3-5 modified RGD 30 May 2005.