[Autom. eng. transl.] The recent decree of the Minister of Labor, Health and Social Policies of 14 July 2009 on the Minimum Requirements for Insurance Policies to Protect Subjects Participating in Clinical Trials of Medicines represents an important and awaited regulatory reference for the purpose of identifying the criteria that they must be satisfied in the insurance coverage of clinical trials and must be followed by both the promoters of experimental studies and the ethics committees. The A., after a general framing of the normative references on the subject, provide a critical analysis of the decree, highlighting the most critical aspects from the application point of view and the problems that may arise in the evaluation by the ethical committees. In particular, they underline that the insurance certificate, drawn up in accordance with a standard model attached to the decree, may be insufficient to fully guarantee the adequacy of the insurance coverage of the experimental protocol and in any case it must faithfully report all the essential conditions provided for in the contract of policy. They also point out that some of the requisites envisaged in the decree, particularly as regards the ceilings and the posthumous guarantee, are difficult to satisfy by means of policies that are not specific to the individual experimental protocols. Other critical aspects concern the evaluation of the opportunity to extend the minimum posthumous guarantee limits, foreseen in the decree, in those experiments potentially suitable for causing damage to patients that can be seen at a greater distance of time; the failure to provide for the prohibition of withdrawal from the guarantee by insurance companies, which in the opinion of the authors should be claimed by the ethics committees, at least for specific policies for a single experimental protocol; the difficulty of meeting the insurance requirements indicated in non-profit trials promoted by hospitals or university institutions. Finally, the A's wish that the ethics committees will not limit their task of guaranteeing the verification of compliance with the minimum requirements indicated in the decree, but will evaluate case by case the possible additions that should be required in the insurance coverage for a more effective protection of the subjects involved in clinical trials.
|Translated title of the contribution||[Autom. eng. transl.] ASSESSMENT CRITERIA OF THE INSURANCE COVERAGE OF CLINICAL EXPERIMENTS IN THE LIGHT OF THE DECREE OF THE MINISTRY OF WORK, HEALTH AND SOCIAL POLICIES OF 14 JULY 2009|
|Number of pages||17|
|Journal||RIVISTA ITALIANA DI MEDICINA LEGALE|
|Publication status||Published - 2010|
- Comitato etico