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The Northern Ireland Clinical Research Resilience and Growth (NI CRRG) Oversight Group

To support resilience and growth in Health and Social Care (HSC) research in Northern Ireland (NI), an Oversight Group has been established to support the uptake of Northern Ireland’s implementation plan for Clinical Research Recovery, Resilience and Growth. The implementation plan was launched in May 2022 and endorsed by NI’s Minister for Health. Actions are focused on improving the effectiveness and efficiency of HSC research studies, and building on the willingness of patients to be involved in research, not only as participants but also in their design, conduct, interpretation and dissemination.

The NI CRRG Oversight Group aims to facilitate closer collaboration of those responsible for research, practice and the data infrastructure in health and social care (HSC) in NI (including the City Deals).

Core objectives of the group include:

  • Assist with the delivery of actions from the implementation plan across the NI HSC research infrastructure, in order to build resilience and promote growth in research activity.
  • Identify and commission NI CRRG sub-groups required for effective delivery and oversight of actions in the implementation plan.
  • Oversee the activity of NI CRRG sub-groups and provide guidance and support where necessary.
  • Ensure alignment and optimal coordination with other UK initiatives that contribute to the research environment and address major disruptions.

The NI CRRG Oversight consists of a wide range of stakeholders from across Northern Ireland and includes representatives from:

Read more about some of the key stakeholders and their role within the Northern Ireland research ecosystem

HSC R&D Division

The Health and Social Care Research and Development (HSC R&D) Division is part of the Public Health Agency. Established in 2009, it is responsible for the administration and coordination of the HSC R&D budget on behalf of Department of Health, Northern Ireland (DoH NI). Its work is based on the principle that the best health and social care must be underpinned by knowledge, based on well conducted research, which can then be applied in the delivery of care.

The HSC R&D Division supports researchers based in Northern Ireland as well as those in Health and Social Care Trusts or other bodies who use the outputs from research findings. While the effectiveness of research performance and application depends ultimately on the skill and ability of individual researchers and users of research, the HSC R&D Division ensures that researchers can work within an environment that supports, encourages and facilitates them.

For example, HSC R&D Division:

  • funds essential infrastructure for research such as information databanks, tissue banks, clinical research facilities clinical trials units and research networks
  • builds research capacity in Northern Ireland through research training opportunities
  • enables research governance processes to be as efficient as possible
  • creates opportunities for researchers to compete for research funding on a wider UK or international basis
  • supports innovation as a means of transferring HSC R&D findings into practice
  • ensures personal and public involvement (PPI) in HSC R&D

Click here to download the Research and Development (R&D) Strategy for the Health and Social Care (HSC) sector

Public Involvement Enhancing Research (PIER)

As part of the Strategy for PPI in HSC Research, HSC R&D Division has established a group of Personal and Public Involvement (PPI) representatives who support it in its activities. The name of this group is PIER (NI). PIER stands for Public Involvement Enhancing Research. The purpose of PIER (NI) is to assist HSC R&D Division with implementing PPI in its decision-making processes and to raise awareness of the benefits of PPI in research among HSC researchers and the wider public.

Margaret Grayson (PIER member) says:

“PIER members continue to meet online in relation to ongoing training and to hear about relevant research updates, and the opportunities with Dr Janice Bailie to input into strategy areas. Involvement opportunities are circulated to us and PIER members partner in a varied range of research studies throughout HSC R&D Division, and sit on the Doctoral Fellowships panel. Over the last few years several long serving PIER members have retired and we are aware of the need to build up the membership and to make plans to have a more diverse membership. Members believe a more inclusive membership within involvement will in turn encourage more diverse participation in research studies.

PIER values and takes all opportunities to raise awareness of the importance of research among the population of NI and feels research needs to be core and not an add-on within HSC. Communications is an area that concerns us; NI needs to know that research happens. PIER is aware of the need to further develop strategy to raise awareness with all researchers.”

PIER is aware of the need to build communications that help reach out and raise awareness with all researchers, the general public, service users, research funders, businesses and healthcare professionals and help further develop strategy to enhance communications further with those interested in research.

Health and Social Care Research & Development Research Governance Approvals Service (HSC R&D Approvals).

The HSC R&D Approvals Service aims to streamline research approvals in-line with other UK Nations and prepare Northern Ireland Research Infrastructure to support the forthcoming UK policy aspiration for one UK Research Governance and Ethics approval. The central team will be responsible for assessing research applications to ensure they comply with UK Wide Study Wide Governance Standards and Northern Ireland Legislation.

The Approvals team are responsible for the HSC Research Approvals process including co-ordinating and validating research application documentation and routing throughout the HSC Trusts depending on which site the research will be taking place. Co-ordination will continue to be supported by the Research Gateway team and has now moved to the HSC R&D Approvals Service in the Public Health Agency. Co-ordination of UK wide process supported by the Research Gateway include pharmacy assurance and radiation assurance when selected by a sponsor with leads in Northern Ireland sites.

The team of three research assessors will review HSC research applications including completion of study-wide governance reports and ensure costing information provided is sufficient.

The team are responsible for non-commercial research costing AcoRD authorisation, and will undertake the National Contract Value Review (NCVR) for Northern Ireland Lead Commercial Studies.

National Contract Value Review (NCVR) is a standardised National approach to costing for commercial contract research that aims to improve efficiency of research set-up activities across the UK and implementation and adoption of this process is overseen by the Approvals Service, including escalation of queries to reduce set up delays supporting both sites and sponsors. NCVR provides a transparent approach to contract value negotiations between commercial research sponsors and HSC/NHS study sites through use of UK Standardised Tariffs.

For more information on the HSC R&D Approvals Service, please contact: Research.Approvals@hscni.net

For more information on National Contract Value Review Northern Ireland, please contact: NCVR@hscni.net

Role of HSC Trust Research Offices

While the HSC central governance function remains in development, Trust Offices currently perform a challenging hybrid role completing study-wide governance reviews alongside organisational checks and facilitation of sponsors and clinical teams to set-up and deliver studies safely, effectively, and efficiently via the capacity and capability (C&C) process. Under a central governance model that will perform study-wide checks, site-level R&D governance and the C&C process will continue to be a key responsibility of Offices.

Under the incoming central governance model, it is anticipated that the wide-ranging Office role will be collated under two key functions.

(i) Functions to assure a supportive & safe environment

(ii) Functions to specifically support individual research studies

 

HSC Research Manager Forum (RMF)

The RMF members includes Research Managers/Research Governance Managers from the six HSC Trusts within NI. The RMF support the continued development and administration of HSC Research Governance and the capacity and capability (C&C) program.

The RMF:

  • Identify and resolve issues of common interest in the area of research management
  • Support the integration of National research governance processes and systems into regional operational frameworks.
  • Support the continued development and administration of HSC Research Governance and the capacity and capability (C&C) program
  • Work toward common, transparent, streamlined processes that meet regulatory, governance, scientific and ethical requirements for research while recognising specific needs of individual Trusts and other partner agencies.
  • Identify and resolve issues of common interest in the area of research management
  • Support the integration of National research governance processes and systems into regional operational frameworks.

 

Northern Ireland Clinical Research Network

The Northern Ireland Clinical Research Network (NICRN) was established to provide an enabling, dedicated infrastructure of highly skilled staff across both the tertiary care and primary care structures of Health and Social Care (HSC). This supports not only the HSC clinical teams to participate in clinical trials and other high-quality research but more importantly offers the opportunity for participants from across NI to benefit from access to new and novel therapies.

The NICRN are organised within clusters of linked clinical specialities to maximise the efficiencies that scale within NI facilitates. Dedicated staff have been deployed across the HSC Trusts, with the exception of the ambulance service and to date approximately 68 Whole Time Equivalent posts are embedded across all five HSC Trusts and within the primary care network. NICRN accounts for around 170-200 new, open recruiting studies per year and successfully recruit approx. 2000 participants to open studies, with a median percentage target recruitment attained across the total NICRN study portfolio ranging between 75% and 92%.

 

Northern Ireland Cancer Trials Network (NICTN)

The Northern Ireland Cancer Trials Network (NICTN) is part of NICRN and facilitates the delivery of cancer clinical trials and other high quality clinical research throughout Northern Ireland and aims to:

  • co-ordinate and promote cancer clinical trials, and run the full range of first-in-human phase I to phase IV trials, along with genetic epidemiology, questionnaire, quality of life, translational and other high-quality studies. 
  • provide cancer research nurses working in all five Health and Social Care (HSC) Trusts in Northern Ireland.
  • promote high quality cancer care in Northern Ireland by inclusion of patients on a geographically more equitable basis into cancer clinical trials, translational research and other well-organised cancer research studies.
  • be integral to the Belfast Experimental Cancer Medicine Centre (ECMC), one of 18 such centres appointed within the UK.

NICTN also receives funding from Friends of the Cancer Centre, Prostate Cancer UK, and Bloodwise. (The ECMC is jointly funded by HSC R&D Division and Cancer Research UK)

The current facilities for clinical research in Belfast City Hospital include space within the existing 40-chair day hospital for cancer patients, and in-patient beds for patients on research protocols are provided in wards in the Northern Ireland Cancer Centre, Belfast City Hospital Haematology Unit and in the Royal Belfast Hospital for Sick Children.

Cancer clinical trials have dedicated pharmacy support and chemotherapy reconstitution facilities alongside the existing NHS facilities. These facilities are supported by a recently expanded laboratory for sample processing and storage for pharmacokinetic, pharmacodynamic and pharmacogenetic studies.  In addition, the NICTN is supported by a dedicated clinical trials radiology service within the Radiology Department at Belfast City Hospital.

Clinical Research is also delivered within the outpatient facilities of the Cancer Units at Antrim, Craigavon and Ulster Hospitals and the North West Cancer Centre at Altnagelvin Hospital.

 

 

Northern Ireland Clinical Trials Unit (NICTU)

The Northern Ireland Clinical Trials Unit (NICTU) is specialist unit with a specific remit to Design, Conduct, Analyse and Publish clinical trials and other well-designed studies.

NICTU is fully registered with UK Clinical Research Collaboration (UKCRC*) CTU network, which means NICTU has:

  • A track record of co-ordinating multi-centre RCT
  • Core team of expert staff to develop studies
  • Robust quality assurance systems and processes to meet relevant regulations
  • Longer term capacity for trials co-ordination

*UKCRC: This is intended to help improve the quality and quantity of available expertise to carry out UK clinical trials.

The NICTU team consists of 46 members of staff across the specialist areas of

  • Trial management
  • Data management
  • Monitoring
  • Database development
  • Statistics
  • Health economics
  • Quality assurance

Although currently based at Lennoxvale, NICTU is hosted by Belfast Health and Social Care Trust so that it can provide a regional service. NICTU has over 40 active studies within its portfolio, across 14 different clinical areas. High proportion of critical care, ophthalmology and public health studies.

There are two strands of funding income for NICTU: core support from the HSC R&D Division, and research grants. The main research grant funder is the National Institute for Health and Care Research (NIHR) with grant awards across all of their different programmes. NICTU also has funding awards from other funders such as MRC, Wellcome Trust and Cancer Research UK.

 

Northern Ireland Public Health Research Network

The Northern Ireland Public Health Research Network (NIPHRN) is an online forum, launched in March 2012 by the Centre of Excellence for Public Health Northern Ireland and the HSC Research and Development (HSC R&D) Division. The network brings together researchers in public health from sectors that include academia, health services, voluntary and community sector and user members, to help form high quality research teams and grants.

NIPHRN uses a Research Development Group (RDG) model to bring people together from a range of backgrounds in public health to focus on developing a specific research protocol to attract external funding.

Any member can suggest a research idea which can then be circulated to other network members.

 

Northern Ireland Clinical Research Facility

 

The Wellcome Trust-Wolfson Northern Ireland Clinical Research Facility (NICRF) is a joint venture involving Queen’s University Belfast (QUB), Belfast Health and Social Care Trust (BHSCT), and Ulster University (UU), and the Health and Social Care Research and Development Division of the Public Health Agency (HSC R&D Division).

The NICRF was established in 2013 with capital funding from the Wellcome Trust and Wolfson Foundation, as well as recurrent infrastructure support from HSC R&D Division. It provides state-of-the-art facilities for clinical research within NI and importantly, supports access for patients and the public to take part in clinical research. Facilities include; clinical rooms with emergency call buttons, piped oxygen & suction; a blood processing room with refrigerated centrifuges & -20oC freezer; a diet kitchen available for nutrition studies; a wide range of specialist equipment available for research purposes. Specific staff support is provided for clinical trials includes; clinical trial coordinator support, technical support, set-up support, operational support, and administration support.

The NICRF is available to researchers from multi-disciplinary backgrounds providing their research study has received the necessary ethical and HSC Trust governance approvals. Currently NICRF provides access to over 2,500 people a year to participate in clinical research.

Personalised Medicine Centre, Ulster University

Within the School of Medicine, the Personalised Medicine Centre (PMC) aims to develop treatments and clinical tools that consider a person’s individual genetic and molecular signatures. By understanding the interplay of disease with the sequence, expression level, and activation states of genes and other molecules within our bodies, we are creating a new generation of treatments and robust diagnostics to inform clinical decision making across a range of chronic and degenerative diseases.

Since its inception in 2013, the PMC has secured more than £24m in competitive grant funding and published more than 380 peer-reviewed articles in prestigious top quartile journals (correct as of May 2022). At the forefront of innovation in personalised and precision medicine, the centre has secured 14 patent applications in novel therapeutic and diagnostic advances.

The PMC, based on the Altnagelvin Hospital site in Derry/Londonderry in the C-TRIC building, was established in October 2013 by Professor Tony Bjourson with the award of an £11.5 million grant (European Union Regional Development Fund (ERDF) EU Sustainable Competitiveness Programme for Northern Ireland, InvestNI, the Northern Ireland Public Health Agency (HSC R&D), ILEX & Ulster University).

The PMC has the largest single critical mass of researchers solely focused on personalised medicine in Ireland with 23 core staff, 49 Research Associates/Assistants and PhD researchers, and 36 NHS Clinicians affiliated with our Research Centre linking General Practitioners (GPs) and NHS Health Trusts (from the Western Health & Social Care Trust at Altnagelvin Hospital).

 

The Association of the British Pharmaceutical Industry (ABPI)

The ABPI exists to make the UK the best place in the world to research, develop and use medicines and vaccines. ABPI represents companies of all sizes who invest in discovering the medicines of the future. ABPI’s members supply cutting edge treatments that improve and save the lives of millions of people. ABPI works in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines.

Clinical trials are an essential part of the research and development (R&D) of new medicines and vaccines, bringing benefits to patients, the NHS and the economy. To fully realise these benefits and achieve the Government’s science superpower ambitions, the UK must improve its ability to set-up and delivery industry clinical trials to time and target. Read more about ABPI’s work in this report: Rescuing patient access to industry clinical trials in the UK.

 

Health Innovation Research Alliance Northern Ireland

Since 2019, the Health Innovation Research Alliance Northern Ireland (HIRANI) has been the informed voice of NI health and life sciences and has built on the strengths of the region to form a strong cluster organisation in line with other clusters across the rest of the UK and Ireland such as Medcity, the Northern Health Science Alliance and Health Innovation Hub Ireland.

HIRANI signposts using its links, contacts, and connections and convenes stakeholders to encourage collaboration and cross-sector partnerships. It has projects with innovators in healthy aging, precision medicine, mental health, and regulatory and is a delivery partner in the NHS Clinical Entrepreneurs’ program in Northern Ireland which allows innovators from the health service to connect to the innovation ecosystem.

HIRANI hosts workshops as part of the delivery partnership for the NHS Clinical Entrepreneurs’ Programme, with the UK Medicines Catapult, with ABHI and many others and hosted, for the first time in NI, a Medical Innovation and Technology Summit in Northern Ireland in April 2023. HIRANI has produced four Sector reports and led numerous consultations (for example, the NI response on MHRA medical devices new regulatory framework). They engage globally to align NI strengths with global investment opportunities.

In conjunction with the Northern Ireland NHS Confederation for Health and Social Care (NICON), HIRANI produced an independent report on health and wealth in Northern Ireland; Capitalizing on the opportunities, this report has a series of recommendations to guide the development of a world class ecosystem for health and care innovation, adoption and spread in Northern Ireland. (www.hira-ni.com ) HIRANI is also producing, in conjunction with project partners, a framework and guidance for SME MedTech adoption and Procurement into hospital systems on the island of Ireland (Summer 2023).

As Northern Ireland does not have an Academic Health Science Network (AHSN), HIRANI convenes academic, industry and health stakeholders to support knowledge exchange. HIRANI runs monthly networking sessions with the NI Health and Life Sciences Sector (NI Health Service, Universities, and all companies). This allows innovators networking opportunities with relevant stakeholders and enables connections for growth. They also provide vision and strategic advice to convene groups and write successful proposals for multidisciplinary bids which have attracted over £50 million investment in the region.