SSInsurance object

Sponsor
Hospital/ trial center

Appropriate insurance/indemnity for the research study at each site, as well as for the organisation legally responsible for the initiation and management of the study (if different) will be required.
Evidence, including certificates of insurance, will be subject to assessment by the local ethics committee.

Of note, public health facilities will be covered under the state sponsored Clinical Indemnity Scheme (CIS) for the majority of research. In the case of clinical investigations sponsored by external organisations, such as medical device manufacturers, the CIS cover extends to treatment only and does not cover product liability or claims arising from investigation design or protocol. Cover against such claims remains the responsibility of the body conducting the clinical investigation, thus, an appropriate indemnity should be secured between the site and the external sponsor(s). Private healthcare facilities are also outside of the CIS cover, and must provide their own privately held medical/clinical malpractice insurance policy.
Related information is provided on the MMI website in the Standard Application Form Guidance Manual For Applicants (version 5.6) or the HPRA Guide for Ethics Committees on Clinical Investigation of Medical Devices.

In all clinical investigations involving medical devices, it is a condition precedent to CIS cover that the relevant agencies and Ethics Committee have approved the investigation. Further information is available from the State Claims Agency.