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.
- RGMS Framework Principles
- Scope of the RGMS Framework
- Key roles and responsibilities in the governance and management of research
- Implementation of the 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.
Scope of the RGMS Framework
The RGMS Framework applies to all health research hosted by HSE or HSE-funded healthcare services involving staff, service users or their families and carers, their data, or their samples. This include, for example, health research projects :
- which recruit participants via the HSE or HSE-funded healthcare services,
- that require the use of personal data of participants recruited via the HSE or HSE funded healthcare services
- that require the use of biological samples of participants recruited via the HSE or HSE-funded healthcare service
- which involve health and social care staff in the HSE and the HSE-funded services as participants
- which are hosted within HSE or HSE funded healthcare services and/or make use of healthcare services infrastructure or require support by healthcare services staff.
Other activities such as clinical audits, standard service evaluations, public health work or advanced health analytics routinely carried out by the HSE and its funded organisations for the purpose of discharging their legal obligations for the planning and delivery of health and social health care services, are outside the scope of this framework.
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