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 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)

'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.'

See also Clinical Trial Indemnity Form and Self Assessment Checklist and State Claims Agency webinar 10th May 2022

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 stateclaims@ntma.ie

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 - see Checklist Compliance RGMS Framework