SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Yes
Special provisions apply
Section 5 of Legislative Decree n. 211
No national legal framework available
The involvement of subjects in emergency situations in a clinical trial is not explicitly mentioned in Italian law (see sections on vulnerable persons in Legislative Decree n. 211)
In Italy studies can be conducted, in the absence of a legal representative, provided that:
1.The clinical trial has been approved by a National, independent EC created ad hoc for the study and including scientific, legal and ethic experts and patient representatives
2.the patient has never expressed a negative will to participation in a clinical trial
3. the investigators commit themselves to obtain patient consent whenever (and if) the patient comes back to a conscious state
NB: Despite this recommendation issued in 2012 by the Consiglio Nazionale di Bioetica, in most cases Investigators are reluctant to participate in clinical studies involving unconscious patients incapacitated to provide their consent because court involvement may be needed in many cases.
No national legal framework available
The involvement of pregnant or lactating women in a clinical trial is not explicitly regulated in Italian law (see sections on vulnerable persons in Legislative Decree n. 211).
