SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Investigator(s)
Sponsor
Study participants

Responsible for covering insurance

Sponsor

Additional Information

Insurance is required for all clinical trials in Italy in order to protect trial subjects and cover the third-party liability of the investigator and the sponsors in the event of claims form damages by trial subjects.
If the sponsor is a public body the cost of the insurance shall be covered by the budget allocated to it. (Section 3.1f9 and 3.4 Legislative Decree n. 211).

NB: For non-commercial clinical trials (ie, not sponsored by for profit enterprises) the general insurance contract of the hospital of the participant can cover the participant (according to a specific decree on non-for-profit trials).
However, the specific ministerial decree released on insurance does not distinguish commercial and non-commercial trials. Thus, in some cases the EC could require a specific insurance also for a non-commercial trial. It just a matter of different interpretation of two laws.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395