When accident is culpable and negligence fortuitous: international repercussions of national legal contortions in clinical trials.

摘要

On 14 March 2010 the new ministerial decree "Minimal requirements for the insurance policies for the protection of participants in clinical trials" [1 ] entered into force in Italy. The decree is about interventional clinical studies. During the evaluation of new protocols, Ethics Committees are required to take into account the insurance policy drafted to protect trial participants and to verify adherence to minimal requirements (listed in the decree).