The HSE National Framework for the Governance, Management and Support of Health Research (RGMS Framework) articulates the requirements for appropriate governance and management of research in health services.
Health Research in Ireland takes place within a very complex regulatory and legislated environment, and staff involved in research need to be supported to comply with the requirement in order to guarantee public trust.
- Scope of the RGMS Framework
- RGMS Framework Principles
- Key roles and responsibilities in the governance and management of research
- Implementation of the RGMS Framework
Scope of the RGMS Framework
The RGMS Framework applies to all health research This Framework applies to all health research* activities taking place in the HSE and its funded organisations involved in the provision of health and social care services, when the research activities involve any of the following factors: health service users, their personal data and/or their biological samples, health and social care staff, or the use of healthcare services, premises or infrastructure. It also applies to health research taking place in third-level collaborative institutions and/or clinical research facilities (CRFs) when the research activities involve any of the aforementioned factors.
Further information available about activities under the scope of the HSE RGMS Framework
RGMS Framework Principles
- Research activity needs to be registered to enable coordination of local functions engaged in research governance.
- Projects should be risk assessed before they commence and the level of oversight should be proportionate to the risk.
- The organisations responsible for legal, data protection, insurance and regulatory compliance should be identified up front.
- Both the host institution and the research ethics committee have a role in research governance, and their roles is distinct and complementary.
- Proportionate oversight should take place through the life cycle of the project, not just before project start.
- Research participants and patients are key partners in the research process and their opinions and needs should be considered throughout.
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Key roles and responsibilities in the governance and management of research.
The RGMS Framework also includes a description of the roles and responsibilities of key stakeholders in the research governance and management process.
Implementation of the RGMS Framework
The implementation of the RGMS Framework will require a significant process of reform in the way we deal with research in the HSE. The following projects of national scale have commenced and are currently ongoing:
- Reform of the HSE Research Ethics Committee System
- Develop institutional Capacity for research governance and support services for research
- Roll out of the National Electronic Research Management System
- Establish the National Committee for the Governance, Management and Support of Research
- Develop research related policies and standardised codes of practice for research in the HSE
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