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
- 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.
What research activity is under the remit of the RGMS Framework?
The RGMS Framework applies to all health research hosted by HSE or HSE funded services involving staff, service users or their families and carers, their data or their samples.
What are key roles in the governance and management of health research?
The Framework clarifies the roles and responsibilities of key stakeholders in the research governance and management process. You can view a full list of all of the roles and responsibilities of key stakeholders here or by clicking on the links below:
- Responsible legal entity/Sponsor
- Principal Investigator
- Research host site
- Research site responsible officer
- Research Ethics Committee
- Health Products Regulatory Authority
- Research Funder
- State Claims Agency
- Data controller
- Data processor
- RGMS function
- National R&D
What work is going on to enable the 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 will be required:
- 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 HSE National Research Governance and Oversight Board.
- Develop research related policies and standardised codes of practice for research in the HSE.
Do you have a question about the RGMS Framework?
Please submit your question using the form on our RGMS Framework FAQ page.
Answers will be regularly published here.
Do you want to feedback on the RGMS Framework?
Recognising that the implementation of the framework will require a significant process of change and that lessons will be learned along the way, the framework will be reviewed and amended on an annual basis over the next two-three years. If you want to offer feedback to contribute to this process, please use the form below.