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National Framework for Governance, Management and Support of Research
GOVERNANCE
The HSE National Framework for the Governance, Management and Support of Research (RGMS Framework) was launched recently by Dean Sullivan, Chief Strategy O cer. The RGMS Framework is the first key output of the 10-year HSE Strategic Action Plan for Research.
The RGMS framework aims to protect research participants and to support health and social care sta to do research in a very complex ethical, legal and regulatory environment. Health research is crucial to find better ways to prevent and treat diseases and to contribute to improve the way healthcare systems work. Research enables evidencebased practice, and together with innovation, teaching and training, it is key to deliver the best outcomes for patients, carers, service users and their families.
At the launch of the framework, Dr Philip Crowley, National Director of Strategy and Research, said, “As we move towards a system of integrated care, the HSE wants to ensure that research becomes a key enabler of evidence-based practice, which contributes to the delivery of better services and to attracting the best of research active sta , nationally and internationally.”
Dr Ana Terrés, Assistant National Director, Head of Research and Evidence, explained that international evidence indicates that research active health and social care services deliver better care.
“It is therefore in the interests of patients and service users to ensure that the transformation of the health service makes provisions to embed research as part of our normal practice. This has to be done in the context of appropriate governance to ensure that we can guarantee the trust of the public and with appropriate supports for our sta . This Framework provides the foundation to do just that,” she said.
As outlined in a benchmark report published by HSE National R&D in 2019 (www.hsereserach. ie), a significant number of clinical and nonclinical HSE sta are engaged in research activities, often involving collaboration with academic partners and other organisations. Hence, the HSE has an obligation to ensure that research is safe and conducted to the best international standards, and to manage any potential risks.
The RGMS Framework lays the foundation for the performance of good quality research in healthcare organisations, within a context of good governance that is essential to guarantee public trust. The implementation of the framework will develop national cohesiveness with regards to the processes required to manage research activity, creating e ective and e cient research management systems that support sta and encourage rather than hinder research.
The framework highlights the importance of patients as equal partners in the research process and the value of patient and public involvement (PPI) in research. Patients, service users, carers, and the public must be given more opportunities to be involved in research as they can help to expand its impact, by helping researchers to focus on issues that are of greatest importance to them and their families.
The HSE National RGMS framework is built around the following key principles: • Research activity needs to be registered and risk assessed before it commences • Research ethical opinion should be independent and separate from institutional governance • Institutional governance for individual research studies should be proportionate to the level of risk, and span the lifetime of the research study • Both ethical and governance approval is
The RGMS Framework and a video of the event are available on the HSE R&D website (https://hseresearch.ie/).
required before proceeding • The roles and responsibilities of the various parties involved in research studies need to be articulated and agreed before the research commences • Research studies need to comply with relevant legislation and regulatory requirements • Oversight is required through the lifetime of the research study • Research participants and patients are key partners in the research process and their opinions and needs should be considered though the life cycle of the research
Implementation of the RGMS Framework
The implementation of the Framework will take time and require collective e ort and commitment from all parties involved. Its implementation will require the reform of the current Research Ethics Committee System, and the establishment of Research and Development O ces throughout the organisation.
These o ces will be essential to facilitate e ective research governance and collaboration between di erent legal entities (Section 38 and 39 healthcare providers, academic institutions, charities, industries, etc), and to support sta to navigate the complex regulatory environment of health research. In order to achieve national cohesiveness, there is also a requirement for the development of standard legal agreement and data sharing templates for research, and additional research policies and protocols to streamline, standardise and simplify approval processes. The implementation of the framework will ultimately help embed research as part of organisational practices.
Dr Terrés concluded by noting, “It is acknowledged that the RGMS Framework represents a significant programme of change, but it will act to strengthen a culture of research and innovation in the Irish health service for the good of patients, their families and carers, sta , the public and the economy.”
