GIS State Indemnity Guidance 10
Clinical Trials Health Research
The State Claims Agency released a revised version of the General Indemnity Scheme - State Indemnity Guidance 10 (link to State Claims Agency website) related to Indemnity and Insurance Arrangements for Clinical Trials Health Research between DSA Healthcare Enterprises and Academic Institutions in May 2022.
This replaces the 2021 version of this guidance and requires the Principal Investigator to be a DSA 'medical practititioner' - the 2021 guidance had required the Chief Investigator to be a DSA clinician, clinican meaning authorised healthcare professional.
The guidance applies to clinical trials as defined in the HSE Framework for the Governance, Management and Support of Research (launched September 2021) definitions as follows: -
'A clinical trial is a type of health research. The term 'Clinical Trial'...includes regulated and non-regulated trials as well as clincial investigations of medical devices. Regulated clinical trials or medical device investigations are those that fall under the remit of the Competent Authority. DSAs should consult the Health Products Regulatory Authority if in doubt as to whether the clinical trial is regulated or not regulated.'
'A clinical trial is a study which seeks to assign participants to one or more interventions.'
Please contact the HSE for a copy of the Framework
Clinical Studies other than a Clinical Trial
'The SCA intend to publish further guidance on clinical studies other than a 'clinical trial' - For more information, please contact firstname.lastname@example.org
For non-interventional research, 'the conditions / requirements of cover are not as extensive as those listed in SIG 10:
- Researcher is a DSA employee
- Research is conducted on DSA patients in a DSA
- Research Ethics (REC) approval
- Research Site Approval (DSA management approval)
- Complies with requirements of RGMS Framework'
In addition, 'Non-interventional DSA-led research does not require a CTIF'
Pending release of further guidance, it is advisable for research teams to check if their studies comply with the RGMS Framework. This draft RGMS Compliance Checklist drafted by Beaumont Ethics may assist as a starting point.