SSStudyParticipantsInformedConsent object
Not specified
Yes
Informed Consent is specified in Section 2-5 of Legislative Decree n. 211:
It is the decision to take part in a clinical trial which must be written, dated and signed, taken freely after being duly informed of its nature, significance, implication, risks and right to revoke any time without detriment to the subject.
If the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases. When the person is not capable of giving consent, the informed consent can be obtained by his or her legal representative if the subject’s presumed will is represented.
For genetic or genotype/phenotype studies a specific informed consent is required and the aim of the study should be stated when the informed consent is obtained. If the stored material is later used for other purpose than the originally stated ones, a new informed consent should be obtained again from the participants.