Is indemnity needed?
Not all studies require review by AON Ireland for example, applications for ethics review for students completing a research thesis as part of an Irish Academic Institution programme taking place in a DSA.
State Claims Agency (SCA) & AON
The State Claims Agency operates two State indemnity schemes, namely the Clinical Indemnity Scheme (CIS) and the General Indemnity Scheme (GIS).
- The Clinical Indemnity Scheme (CIS) covers personal injury risks and associated liability exposures and subsequent claims arising from the negligent act(s) or omission(s) consequent upon the provision of, or failure to provide, professional medical services on the part of Delegated State Authorities (DSAs). Additional guidance and definitions can be found HERE
- The General Indemnity Scheme (GIS) covers personal injury and third party property damage risks and associated liability exposures and subsequent claims/liabilities arising from the negligent act(s) or omission(s) on the part of DSAs (arising from the provision of non-medical services);
Research that falls outside the provision of professional medical services, can be covered under the GIS. The GIS extends to cover all HSE business activities including research, once the following criteria are met:
· The research has received formal approval from the site/DSA management;
· The research has been appropriately risk assessed;
· The researchers are DSA employees;
· The research is taking place in a DSA;
· The third parties involved have provided appropriate insurance;
· A formal agreement is in place including DPIA where relevant;
· The research has Research Ethics Committee (REC) approval;
State indemnity does not extend to cover the negligence of third parties and the HSE should therefore ensure that the third parties involved in conducting the research have adequate insurance in place to cover liabilities associated with their negligence.
In addition, the roles and responsibilities of all parties involved and the insurance and indemnity arrangements for the research should be outlined and documented in a formal agreement.
The State Indemnity Confirmation Statement, found here, can be provided as evidence of State indemnity, in lieu of an insurance policy and may be issued as such.
AON Ireland act as an agent for the SCA on clinical research only, for any queries in relation to research that falls outside the scope of the CIS, the SCA can be contacted directly.
Sponsor Insurance Certificate
Typically, the insurers (AON) require a letter from the host institution confirming that the specific study has been assessed and logged by the Host Sponsorship Office and Innovation and that the study is covered under the institutional clinical trials insurance policy for protocol risks. Alternatively, please see comments below regarding a CTIF (Clinical Trials Indemnity Form)
Research and Ethics Approval
Ethics Committee documents are required and confirmation of Ethical Approval having been granted for the study
Clinical Trial Indemnity Form
If evidence of the study being logged by the sponsors office of research is not provided a CTIF may be required (see above).
HPRA/Regulatory Approval
Confirmation of HPRA Approval needs to be supplied with the submission. However if HPRA approval is not required – confirmation of same must be provided.
If Approval is required, the confirmation email from the HPRA or alterative evidence of approval is required.