ABMU Health Board Research and Development Strategy

Appendix 1 ABMU Health Board Research and Development Strategy 2015-18 Policy Owner: Medical Director Approved by: ABMU Health Board Issue Date: January 2015 Review Date: January 2016 1

Contents Section Page Policy Statement 4 Strategic Aims 5 Roles & Responsibilities 10 Glossary of Terms 12 2

Policy Statement Abertawe Bro Morgannwg University Health Board (ABMU) is committed to further developing the U in ABMU. This means developing a culture of innovation, delivering high quality research, development, teaching and learning for the benefit of current and future healthcare based on principles of prudence and co-production. As a University Health Board, we are committed to leading and hosting world-class innovation, recognising the regional health and economic benefits to be gained. The 2015-2018 ABMU Research Strategy aligns with clinical services across the Health Board. The intent is actively to support a culture of clinical and academic excellence to deliver continuously improving patient outcomes and experience. This strategy builds on our strategic alliance with Swansea University and strong collaboration with national R&D infrastructure networks, Industry & Third sector partners. ABMU intends to develop similarly strong partnerships with other Universities including Cardiff University, Cardiff Metropolitan University, Trinity St Davids, and the University of South Wales,. ABMU will lead the South West Wales Regional hub of the Academic Health Science Collaboration (AHSC). We will seek to build strong partnerships with the life sciences industry to capitalise on our status as an Integrated Health Board with access to outcomes data. This strategy recognises the benefits from working together with academic colleagues and existing regional research networks to support our clinical teams to deliver high quality research programmes across all specialities. Through strategically targeted investment of the R&D budget, we will develop new areas of research consistent with our integrated medium term plan (IMTP) and enhance our existing areas of clinical research excellence in Burns & Plastic Surgery, Cardiology, Cancer, Diabetes, Haemostasis & Renal Medicine. The 2015-2018 ABMU Research Strategy facilitates regional collaboration and integration across healthcare themes. We will build on the well-established local clinical & academic research partnerships which have been driving forward research excellence within the region. Established partnerships include Swansea University Colleges of Medicine and Human & Health Sciences. There are existing strong partnerships with Swansea University within the College of Medicine, through its Institute of Life Sciences Phases 1 & 2 (ILS) which encompass the ILS2 Joint Clinical Research Facility (JCRF), ILS2 Centre for NanoHealth and the Centre for improving Population through e-health Research (CIPHER).and within the College of Human & Health Sciences through its Wales Centre for Practice Innovation, Swansea Centre for Health Economics and Centre for Innovative Ageing, the partnership also includes Swansea University s Clinical Trials Unit. In the near future, 3

partnerships will include the Farr Institute at Swansea University. We will develop our collaborations with the National Institute for Social Care & Health Research (NISCHR) and supporting infrastructure. Working in partnership with Industry is a key national aim. ABMU is recognised as an organisation which engages with Industry sponsored research. The vision is to continuously improve our active engagement with local, national and international Industrial partners (technical & pharmaceutical). Working together with Pharma in this way will ensure full access to novel treatments for our patients. We also recognise our responsibility to generate employment through innovation and deliver regional economic benefits through the pipeline developments arising from local Small and Medium Enterprises (SMEs) and healthcare spin-out companies. Equally, collaboration with the Third sector will be a key aspect of our research focus to deliver the improved patient outcomes from application of the principles of prudent healthcare and co-production. The ABMU Research Strategy recognises the importance of translational research, innovation and effective Intellectual Property management as defined outputs of a vibrant research culture. There will be a focus to ensure, wherever possible, the population of ABMU and our staff gains optimum benefit from our engagement with Industrial partners. Strategic Aims High Level Strategic Aims To improve & innovate through engagement with multi-sectoral research & innovation programmes focussed on principles of prudence and coproduction. Development of curricula for pre-registration training of doctors, nurses, health scientists, therapists and psychologists to embed co-creation, innovation, research and development in core practice. Make joint appointments of staff between ABMU and University partners and deliver research collaboration from undergraduate to postgraduate level to help attract and retain the very best staff including medical staff in shortage specialties and develop our staff to become internationally leading academics. Maximise the potential of an Integrated Health Board to increase participation in research projects and drug trials by improving ability to recruit large numbers of participants, complete studies rapidly at minimal cost. 4

Increase the quality and quantity of research generated to support the health and social care decisions that matter to people in ABMU. Embed a system of working where clinical teams generate their own knowledge through research, development and innovation and use this for continuous improvement Widen the active participation in research, development and innovation by involving people and building innovation and research capacity in health and social care services in ABMU Increase income for the Health Board and its University partners from research grant and commercial funding. Develop clinical and research networks between the Health Board, University and Commercial Partners; Develop a culture of continuous learning within Health Board staff; accelerating healthcare innovation; and wealth creation from intellectual property. Develop and embed the co-creating health framework through fostering coproduction and co-design in all of the service provision, service design, education, research, enterprise and partnership work of the Health Board. Develop cross-cutting themes to support: knowledge management, integration and sustainability, population healthcare, commercial and non commercial trials of pharmaceuticals, health technology assessment, and service delivery and organisation, genomics, informatics and technology, and patient and public engagement and involvement in research and innovation. Rapidly translate innovation into meaningful outcomes for patients. Deploy the financial benefits from full engagement with research programmes to pump prime local research initiatives and infrastructure. Maintain effective governance models for the management of R&D. 5

Strategic Aims & Objectives Strategic Aim 1 : Establish the ABMU Area as a leading health economy for Innovation, Research and Development We will achieve this by: Employing collaborative and integrated approaches to developing regional research activity for the benefit of improved patient outcomes, with particular focus on prudence and co-production. Delivering on NISCHR Key Indicators. Supporting implementation of Practice Innovation techniques and involvement in health and social care research programmes. Achieving Centre of Excellence status with Pharmaceutical companies and maintaining preferred site status. Ensuring rapid start up times and completion on target for research programmes. Delivering on target for 1 st patient recruitment within 30 days. Increasing primary care involvement in research through engagement with the NISCHR Primary Care Incentive Scheme PiCRIS. Increasing the number of ABMU staff awarded protected time for research via the NISCHR clinical research fellowship programme. Increasing the number of ABMU Chief/Principal Investigators and attraction of research grants across both clinical and non-clinical research programmes. Strategic Aim 2 : Maintain and enhance effective joint research governance and collaboration with Universities including Swansea, Cardiff, University of South Wales, Trinity St Davids and Cardiff Metropolitan University We will achieve this by: Ensuring operational success of the Joint Clinical Research Facility (JCRF). The JCRF is a joint clinical research initiative between the Health Board and Swansea University, housed within the ILS2 and Morriston Hospital and will offer new opportunities to engage in early stage clinical trials, in partnership with SIMBEC, a Phase 1 specialist clinical research company and other companies where appropriate. 6

Enabling increased capacity for research programmes requiring imaging via the dedicated imaging suite within ILS2, thereby easing the pressure of clinical trial radiology requirements within the clinical service. Maintaining robust collaborative sponsorship and effective governance arrangements with Swansea University through the continued use and development of Joint Standard Operating Procedures and delivery of a consistent approach to research governance management issues. Developing robust collaborative sponsorship and governance arrangements with other Universities through the continued use and development of Joint Standard Operating Procedures and delivery of a consistent approach to research governance management issues Maintaining and enhancing R&D Quality Assurance processes to monitor and govern cross-organisational R&D activity. Develop a Joint Communications Strategy for Innovation. Develop a Joint Commercialisation Strategy for Innovation Develop plans for new facilities for the JCRF at Morriston: ILS@Morriston. Strategic Aim 3 : Actively support innovation within ABMU and maximise benefit from associated Intellectual Property Rights (IPR). We will achieve this by:- Increasing the Intellectual Property (IP) portfolio of the Health Board, through successful application to national innovation schemes such as the NISCHR INVENT scheme and building on existing collaborations with academic partners. Developing shared JCRF IP management processes with Swansea University to facilitate greater benefits from IPR exploitation. Actively promoting ABMU Health Board as an Organisation open for business - keen to engage with the business community on collaborative research programmes and commercial collaborative investigator-led studies. Actively engaging with academic partners to explore and develop collaborative research programmes involving novel technology & service design. 7

Strategic Aim 4 : Maintain current clinical areas of innovation, research excellence and identify and support areas of growth for new activity We will achieve this by: Strategically allocating the R&D budget to support clinician s access to necessary resource to develop areas of research expertise, aligned to NISCHR priorities. Supporting the development of research through the provision of a research design service provided by our Partner Clinical Trials Unit in Swansea University and the AHSC funded methodology specialist posts. Delivering an effective research governance sponsorship service for in-house research. Maintaining a robust scientific peer review process for in-house research, as delivered by the Joint Sponsor Review Committee, a joint Committee with Swansea University. Providing specialist training opportunities for ABMU staff on research methodologies and good clinical practice. Supporting researchers with external grants through effective use of networking and membership within various national groups such as MediWales. Strategic Aim 5 : Support the development of a learning culture which actively promotes innovation and research in promoting the U of ABMU. We will achieve this by: Increasing capability and capacity through successful bidding to NISCHR investment schemes and performance management of posts funded by NISCHR. Supporting NISCHR funded posts using the R&D budget and through the strategic investment of R&D funds according to research priority areas. Supporting clinicians and managers to introduce and evaluate service improvement & innovation initiatives. 8

Supporting and training staff to engage in research activity, in particular, by attracting commercially sponsored research to the Health Board, thereby offering opportunities for new Investigators to gain exposure to research and enhance their skills within a structured programme of activity. Identifying the budget lines for the income generated and cost savings from commercial research activity and actively encouraging clinical teams to utilise this benefit to engage in further research programmes. Ensuring all senior medical and non-medical staff job plans have the potential for R&D activity and active University involvement via both University and R&D funding streams. Roles & Responsibilities Chief Executive Medical Director The Chief Executive, as Accountable Officer, has the responsibility for ensuring that the Health Board delivers on its R&D Strategy and implements effective R&D Governance to manage R&D consistent with applicable legislative standards. Responsibility for delivery is delegated through the reporting line as defined below. The Medical Director is the Health Board Executive Lead for R&D, reporting to the Chief Executive on the delivery & implementation of the R&D Strategy and Policy. Assistant Medical Director (R&D) The Medical Director is supported by an Assistant Medical Director (AMD) with specific responsibility for R&D. The AMD R&D is required to coordinate strategically all aspects of research delivery within the Health Board including acting as Strategic Lead for the Swansea University Partnership. The AMD R&D is required to provide expert advice and support to the Chief Executive and Medical Director, including operational support through the following activities: Overseeing the allocation and management of the R&D Budget Acting as Lead Signatory for all research-related contracts and study approvals 9

Responsible for all R&D related reports including R&D reports to Welsh Government Identifying and managing risks associated with R&D Delivery of the Corporate Plan in relation to R&D In undertaking the above role, the AMD R&D is supported by the Deputy AMD R&D. Executive Director of Therapies and Health Science The Director of Therapies and Health Science (DoTHS) is a member of the ABMU Board with specific responsibility for developing academic partnerships and health science links with Universities and the life science/pharma industry. Reporting to the Medical Director, the role coordinates the partnership working between the Health Board and its University and Commercial Partners within the terms of agreed Memoranda of Understanding. The DoTHS manages the R&D Department. R&D Department The R&D Department is headed by the R&D Manager reporting to the DoTHS within the Medical Directors Directorate. The R&D department provides the operational support and assurance to the Health Board that all R&D operates within a framework of effective governance consistent with UK & Wales R&D specific guidance and legislation. The R&D Manager has responsibility for the achievement of Healthcare Standard 21 and has devolved responsibility for the management of the R&D budget ensuring decisions are made in accordance with UK guidance on Attributing Costs associated to R&D (ACORD). The R&D Manager is supported by a R&D Finance Manager in this process. Central governance processes managed by the R&D Department include: Support for the R&D Committee Support for the Joint Scientific Review Committee Management of the R&D Permissions Process Management of a Quality Assurance programme for research, ensuring studies are conducted in accordance with applicable standards, notably Good Clinical Practice (GCP). 10

Enabling delivery of NISCHR Welsh Government R&D Key Indicators (Appendix 1) Contract management & review Cost attribution Performance management of internal/external investment awards R&D budget management Facilitating research support Facilitating University collaboration Management of intellectual property Provide twice yearly R&D reports to Board management Glossary of Terms ACORD : Attributing Costs to Research and Development AHSC : Academic Health Science Collaborative AMD : Assistant Medical Director CIPHER : Centre for improving Population through e-health Research DoTHS : Executive Director of Therapies and Health Science GCP : Good Clinical Practice ILS : Institute of Life Sciences IMTP : Integrated Medium Term Plan IP : Intellectual Property JCRF : Joint Clinical Research Facility NISCHR : National Institute for Social Care and Health Research R&D : Research and Development SME : Small and Medium Enterprises 11