Document name: Research & Development Strategy Document type: Strategy What does this policy replace? Previous version of R&D Strategy (January 2012) Staff group to whom it applies: All staff within the Trust Distribution: The whole of the Trust How to access: Intranet Issue date: August 2014 Next review: August 2016 Approved by: EMT Developed by: Medical Director Associate Director of Research Associate Medical Director for Research Research Management & Governance Manager Medical Director Director leads: Contact for advice: R&D Strategy August 2014 Associate Director of Research Associate Medical Director for Research 1 R&D STRATEGY 1. Introduction 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 R&D activity is defined as work which is designed to provide new knowledge, producing findings that are potentially of value to those facing similar problems, open to critical examination and are accessible to all who could stand to benefit from them. Research is of central importance to our understanding of illness and its management as well as promoting and maintaining good health and well being. NHS trusts will increasingly need to compete for contracts and demonstrate how they can deliver better quality, effective and efficient services. In order to compete successfully SWYPFT has to be at the forefront of implementing evidence based practice and innovative models of service delivery. This cannot be achieved without fostering a culture where staff understand the importance of research, innovation and are engaged with the research process at some level. Clinicians and managers who understand how to evaluate evidence are clearly better placed to deliver treatments and services of real benefit to patients. Engaging with the research process is key to developing such an understanding. The Trust is committed to further develop it’s multi-disciplinary research and greater involvement of staff from all disciplines. It is keen to promote an open inquisitive culture in which evidence provides drivers for change in practice and encourages staff to question. Is what we are doing right? How can we improve what we do? Such a culture will encourage staff to assess their own practice and compare it with good practice. The Trust’s R&D strategy sets the direction to progress this learning culture, develop good quality research and disseminate research findings. It also provides a framework for R&D activity tailored to the needs of services and in keeping with the Trust’s mission, vision, values and goals and relevant to the evidence based transformation and improvement of services. With the national policy and funding support from the National Institute for Health Research (NIHR) Clinical Research Network: Yorkshire and Humber there is an opportunity for our trust to widen our research base. In setting out this five year strategy the aim is for SWYPFT to take advantage of national opportunities and local strengths to substantially grow our research capacity and deliver high quality research that will translate into improvements in the quality and efficiency of our service and to deliver real improvements in physical and mental health of the population we serve. Undertake research that contributes to the wider pool of knowledge. 2. National and Regional context 2.1 The government provides almost 1 billion per year research funding and recognises the importance of long term planning and taking action to support the retention and growth of the life science industry in the UK to secure our place as a global leader (Strategy for UK life sciences: one year on, DH, 2012: Increasing research and innovation in health and social care, DH: 2013) 2.2 There have been a number of national drivers specific to healthcare research and innovation within the NHS aimed at ensuring the NHS is fully engaged in high quality research that will benefit patients and the economy: R&D Strategy August 2014 2 2.2.1 The NHS has a commitment to the promotion and conduct of research to improved the health and care of the population. “Research is a core part of the NHS. Research enables the NHS to improve the current and future health of the people it serves. The NHS will do all it can to ensure that patients, from every part of England, are made aware of research that is of particular relevance to them. The NHS is therefore putting in place procedures to ensure that patients are notified of opportunities to join in relevant ethically approved research and will be free to choose whether they wish to do so." (Handbook to the NHS Constitution, January 2009) 2.2.2 The NHS Commissioning Board’s objective is to ensure that the new commissioning system promotes and supports participation by NHS organisations and NHS patients in research funded by both commercial and non-commercial organisations, most importantly to improve patient outcomes, but also to contribute to economic growth. This includes ensuring payment of treatment costs for NHS patients taking part in research funded by Government and Research Charity partner organisations. It’s duties to promote research and innovation – the invention, diffusion and adoption of good practice. (A mandate from the Government to the NHS Commissioning Board: April 2013 to March 2015) 2.2.3 Innovation is a key driver of long term growth in the healthcare sector and key to the NHS improvement agenda. The development of the Health Research Authority will streamline regulation and improve the cost effectiveness of clinical trials. National Institute for Health Research (NIHR) funding to the NHS is conditional on meeting benchmarks, including a 70 day benchmark to recruit first patients for trials; (Plan for Growth, DH 2011) 2.2.4 97% of the public believed it's important for the NHS to support research into new treatments (Public support for research in the NHS: Ipsos MORl poll June 2011) 2.2.5 NHS organisations that are research active appear to have better overall performance that non research active trust (NHS confederation briefing, October 2010). 2.2.6 The NHS has established 15 Academic Health Science Networks (AHSN) in April 2014. Their goal is to improve patient and population health outcomes by translating research into practice, and developing and implementing integrated health care services. AHSNs deliver a step-change in the way the NHS identifies, develops and adopts new technologies and are predicated on partnership working and collaboration between the NHS, academia, the private sector and other external partners within a single AHSN context and across AHSNs. 2.2.7 From April 2014, NIHR structure has been rationalised into 15 local Clinical Research Networks across England, which will deliver studies across all therapy areas. The geographical boundaries of the Networks correlate with those of the AHSNs, although the remits of the two organisations are separate. 2.2.8 The NIHR was established by the Department of Health to transform research in the NHS. NIHR aims to maintain a health research system in which the NHS supports outstanding individuals working in world class facilities, conducting leading edge research focussed on the needs of patients. NIHR works in partnership with many sectors including academic, charities and industry. 2.2.9 NIHR structure includes: 2.2.10 Fifteen Local Clinical Research Networks which support the delivery of NIHR adopted portfolio research, to ensure patient access to research across England, integrate research into patient care, improve quality speed and co- R&D Strategy August 2014 3 2.2.11 2.2.12 2.2.13 2.2.14 2.2.15 2.2.16 2.2.17 2.2.18 2.2.19 2.2.20 2.2.21 ordination of research and increase the collaboration with industry. Locally this is the Clinical Research Network: Yorkshire and Humber (CRNYH), hosted by Sheffield Teaching Hospitals NHS Foundation Trust. The host is responsible for ensuring the effective delivery of research in the Trusts, primary care organisations and other qualified NHS providers throughout the Yorkshire and Humber area. Thirteen Collaborations for Leadership in Applied Health Research (CLAHRCS), to bring together Universities and their surrounding NHS organisations to test new treatments and new ways of working predominantly in chronic disease management. Locally, NIHR CLAHRC Yorkshire and Humber has funding of £10,000,000 until Dec 2019. Key areas include Evidence Based Transformation with the NHS (EBT), Translating Knowledge into Action (TK2A), Health Economics and Outcomes Measurement (HEOM), Telehealth and Care Technologies (TaCT), Public Health and Inequalities (PHI), Healthy Children, Healthy Families (HCHF), Primary Care-Based Management of Frailty in Older People, Avoiding Attendance and Admission in long term conditions (AAA), Mental Health and Co-Morbidities (MHCM) Standard Research Capability Funding is allocated to research active Trusts of £20,000 providing their activity is at least 500 participants recruited to noncommercial portfolio studies per annum or the Trust received sufficient NIHR income to reach the RCF allocation threshold. This allocation helps Trusts act flexibly and strategically to maintain research capacity and capability, support, develop and retain key staff undertaking research and cover other portfolio research costs not met in other ways. Two NIHR Patient Safety Translational Research Centres that bring together a wide range NHS research professionals to conduct and support research into the safety, quality and effectiveness of the service that the NHS provides to it’s patients Research Design Service which helps researchers to develop and design high quality research proposals for submission to national peer reviewed funding competition for applied health and social care research. Locally the Yorkshire and Humber Research Design Service has bases in Sheffield, Leeds and York. Five UK Public Health Research Centres of Excellence, collaboratively funded which bring together leading researchers with practitioners, policymakers and members of the public to tackle complex public health issues Experimental Medicine Resources is a central information point for the UK’s capability and expertise in experimental medicine and early-phase clinical trials. Fourteen experimental cancer medicine centres. Eleven biomedical research centres and twenty biomedical research units that conduct and support research to transform research breakthrough into life saving treatments for patients. Eight Healthcare Technology Co-orperatives to work collaboratively to develop new medical devices, healthcare technologies and technology-dependent interventions in clinical areas of high morbidity or high potential for improving quality of life. Nineteen Clinical Research Facilities for Experimental Medicine. These are purpose-built, cutting-edge facilities, with specialist clinical, research and support staff, in locations where universities and NHS Trusts work together on dedicated programmes of patient-orientated experimental medicine research. NIHR Office for Clinical Research Infrastructure has been set up to help research funders work in partnership with the NIHR Infrastructure. This is through signposting and supporting collaborative research partnerships. R&D Strategy August 2014 4 2.2.22 Four Diagnostic Evidence Co-operatives to improve the way diseases are diagnosed. 2.2.23 The MRC/NIHR Phenome Centre enables scientists to better understand and tackle diseases that are triggered by environment as well as genetic causes, and increase the potential to develop strategies for their prevention and treatment. 2.2.24 The NIHR BioResource is a panel of thousands of volunteers, both with and without health problems, who are willing to be approached to participate in research studies: to develop new treatments for a range of diseases, and to investigate the links between genes, the environment, health and disease. 2.3 Non portfolio studies will not attract funding, although trusts continue to have a statutory duty to ensure effective management and governance for such research. 2.4 Research funding is allocated to NHS trusts based largely on the amount of “NIHR adopted portfolio activity” carried out, and specifically for: the number of patients recruited to each study and the studies with timely approval and recruitment. The NIHR Clinical Research Network Portfolio is a database of high quality clinical research studies that are eligible for support from the NIHR Clinical Research Network in England. 2.5 The NIHR CRN have developed an Open Data Platform to create a way for people with a stake in clinical research in the NHS to be able to access the data held by the NIHR CRN in a meaningful way, & create an instant picture of what’s happening in research in the NHS 2.6 NIHR research programmes such as Research for Patient Benefit (RfPB), Health Services & Delivery Research (HS & DR) programme offer the opportunity to take part in high quality research linked to service priorities and improvements. This could involve research projects hosted by the Trust or as a research site for projects led by other organisations. 3. Local Context 3.1 For SWYPFT, there are opportunities to develop research capacity, deliver research and innovation and grow research income. Leading and partaking in NIHR portfolio research projects will raise our profile and reputation as a research active organisation. It is also important to prioritise research that contributes to service improvements, to improve the quality, effectiveness and efficiency of services. 3.2 The expansion of the Trust has widened the Trust’s size and geographical area as well as the range of specialities and services. This opens up many new service areas such as physical health, community services as well as new mental health subspecialities like substance misuse and CAMHS. 3.5 The Trust has long standing relationships with neighbouring Trusts and strong relationships with local Universities such as Huddersfield, York and Leeds. The expansion of the Trust has increased the number of partners, including NHS trusts like Barnsley and Sheffield as well as Universities such as of Sheffield, Nottingham etc. Universities are looking to increase partnership working with the NHS and we have an opportunity to work with them, building on our existing strengths, developing new collaborations and establishing ourselves as a Trust researchers approach to deliver on their research. R&D Strategy August 2014 5 3.6 The Trust’s new leadership and management structure of five Business Delivery Units and the Quality Academy will enable better promotion and support of research interested staff and service users. The crucial corporate level interest and support to R&D is excellent. 3.7 The Trust has some areas of strength, reflected in NIHR portfolio level research activities, for example psychological therapies, physical health therapies and some innovative models of care. The expansion of the Trust has increased the number of research active staff and from a wider range of disciplines, increasing opportunities to grow strength in other areas. 3.8 Service users and carers involvement in R&D activity and the co-production of knowledge is crucial. They have important roles throughout the research process and the Trust will strive to increase the number of service users and carers directly involved in R&D activities. 3.9 The R&D department is now established and includes a good oversight of R&D governance processes and selection of appropriate portfolio studies in terms of feasibility and alignment to the Trust’s mission, vision, values and goals and relevance to the transformation and improvement of services. 4. Strategic Objectives 4.1 Trust Board has full ownership and commitment to support and expand the research and development agenda. This will include working with partner organisations from health, social care, the voluntary sector, commercial, higher education institutions, service users and carers. 4.2 The Trust’s research will be based on sound scientific, ethical and financial standards and conducted within the national regulatory framework of governance. 4.3 As clinical services and clinical research are inseparable the business delivery units must support research to improve their services. This would include seeking research champions in each BDU and to include research in the job plans of its clinicians improving access to research for service users and carers across a range of services. 4.4 An Action Plan based on these objectives will be reviewed on an annual basis. 4.4.1 R&D culture To establish R&D as a core business of the trust. Developing and sustaining a vibrant research culture to inform and improve clinical practice and service delivery. Developing a culture that encourages staff to have an inquisitive mind and use evidence based practice. Developing a culture that adopts new evidence based interventions and learns from innovative good practice. Supporting effective dissemination of clinical practice guidance and research findings. 4.4.2 Research focus To focus our research activities on areas relevant to service provision. We will aim to lead funded research in areas where we are able to deliver quality research and service engagement. This will build on our research expertise, experience and reputation. To establish research projects and programmes of research that are nationally competitive and attract funding. R&D Strategy August 2014 6 To focus our research on areas that meet our service user and local communities needs. To focus on research that supports innovation and more effective and efficient services. To focus research in areas that increase R&D income. 4.4.3 R&D capacity and reputation Enhance R&D capacity through increasing the number of patients recruited into NIHR portfolio research studies. Increasing the number of staff participating in research activity. Increasing the number of appropriate research projects. Establishing R&D as an essential core business of the trust therefore ensuring that it is part of all the BDUs business plans. Increase the number of successful research funding bids. Increase the number of peer reviewed journal papers authored by Trust staff. Increase the number of staff undertaking research qualifications. 4.4.4 Workforce Engagement Identifying research champions in each BDU. Promoting R&D to staff through publicity and promotion. Supporting and engaging staff who show an interest in R&D. Increasing the number of research active clinicians. Attracting research active workforce through new appointments. Recognising staff time spent in research for example through job planning. 4.4.5 Partnership working Working closely with the Clinical Research Network: Yorkshire and Humber to expand involvement in NIHR portfolio studies. Strengthening existing links with institutes of higher education such as University of Huddersfield, University of Sheffield etc., Developing links with NHS and social care organisations to collaborate on joint research projects that facilitate improved and cost effective models of care. Developing links with commercial organisations on beneficial research projects. 4.4.6 Service users and carers involvement Encouraging and enhancing the service users’ and carers’ involvement in all stages of the research process including ethical approval, review of policies and governance and direct involvement in research projects. Providing support and advice to service users who develop research questions and assist them in translating them into feasible research projects. Increasing involvement of service users and carers as members of the research teams for funded projects as co-applicants. 4.4.7 Governance Ensuring that all R&D activities within the Trust are subject to appropriate management approval. Ensuring all research activities conform to the required governance and national guidelines. Ensuring all research activity funding is managed in a transparent way ensuring financial probity. R&D Strategy August 2014 7 Ensuring high quality and efficient research management complying with high clinical standards and safety of research participants. 5. R&D Accountable Director The Medical Director is the Executive Director responsible for the trusts R&D Strategy. They will incorporate the Trust’s strategic priorities into the strategy and act as a link internally with BDUs and research active individuals and externally with all relevant partners. R&D Strategy August 2014 8 Appendix 1 RESEARCH & DEVELOPMENT TAG TERMS OF REFERENCE 1. 2. Role and remit: 1.1 It is an advisory group that oversees the Trust’s R&D activities and implementation of Trust’s R&D strategy. 1.2 Assist the Trust in creating a culture that supports and facilitates the opportunities for service user, carer and staff participation in research, to enable them to contribute to service improvement and development and to apply lessons learnt from research undertaken. 1.3 Review the Trust’s R&D activities and advise on the Trust’s research and development priorities in consultation with all relevant stakeholders. 1.4 Receive as information, and addressing where appropriate, items on: approval of research and development projects; monitoring of research projects; governance issues for research activity. 1.5 Assist in the review of R&D policies and procedures to keep them up to date and complying with national guidance. 1.6 Act as link and route of communication between R&D and the BDUs thus promoting R&D awareness and activities and assisting in translating clinical and service questions into viable research projects. 1.7 Ensuring stakeholder involvement through partnership working and linkages with Universities and health and social care organisations. Accountability: The Medical Director is the accountable director for this TAG and it reports to the Clinical Governance and Clinical Risk Committee. Linkages include: Internal linkages: a. Business Delivery Units b. Drug & Therapeutic Sub Committee c. Medical Education TAG d. Research Involvement Group (patient/service user & carers) e. Creative Minds f. Change Lab g. Talent Pool R&D Strategy August 2014 9 External linkages: a. NHS Trusts within the region b. Social care organisations c. Commercial, voluntary and other provider organisations. d. Commissioners e. Primary Care f. Health Research Authority g. CLAHRC (Collaboration for Leadership in Applied Health Research & Care) h. Academic research establishments External Infrastructure Support a. Clinical Research Network: Yorkshire & Humber (CRN YH) b. Universities within the region c. Research Design Service d. Others eg specialist networks. 3. Frequency of the meetings: 3.1 Meetings will be quarterly 3.2 The Terms of Reference will be reviewed on an annual basis including the membership. An annual report will be produced which will be submitted to the Clinical Governance and Clinical Risk Committee. 4. Agenda items: All members of the meeting will be able to place items on the agenda. 5. Quorate The minimum number of attendees to ensure quorate status is 5, including the Chair/Co Chair. Members to send apologies in advance as far as possible to ensure meeting is quorate. 6. Outputs from the meeting: The meeting will produce notes of meetings, these notes will be checked by the Chair and approved by the Medical Director before they are sent to the Clinical Governance and Clinical Risk Committee and then put on the Intranet. 7. Current group members: Name Dr N H Booya Professor Mike Lucock Dr Abdullah Kraam Helen Carter Rebecca Spencer Anna Rigby-Brown Research Involvement R&D Strategy August 2014 Designation Medical Director Associate Director of Research Associate Medical Director for Research &Development / Forensic CAMHS Clinical Lead Research Administrator Research Management and Governance Manager Senior Clinical Research Officer Service User & Carer Linkage Lead Director Chair Co-chair / CAMHS Research & Development TAG Secretary Research & Development Department Research & Development Department Service User / Carer 10 Group member Professor John Playle Professor Nigel Beail Dr Prabhat Mahapatra Dr Phalaksh Walishetty Dr Keith Sands Simon Plummer Richard Clibbens Sean McDaid Diane Brown Twané Celliers Phil Walters TBC Mark Payne Julie Hickling Gillian Marley Emma Pollhill James Corson Diane Smith R&D Strategy August 2014 Dean of Human and Health Sciences Consultant and Head of Psychological Services, Barnsley Learning Disability Service Consultant Psychiatrist Learning Disabilities Wakefield Consultant Psychiatrist University of Huddersfield Associate Medical Directorfor Barnsley Community & Physical Health AHP Lead / Clinical Lead for Learning Disabilities Nurse Consultant, Older Peoples Service Wakefield Nurse Consultant, Wakefield Dual Diagnosis Speech & Language Therapist, Barnsley Weight Management Team Leader, Barnsley Head of Patient Inclusion & Involvement Chief Pharmacist Senior Clinical Pharmacist / Trust Clinical Research Pharmacist Medical Directorate Business Manager Clinical Governance Support Team Lead Finance representative HR representative Interim Director of Service Innovation and Intelligence Barnsley Community & Physical Health Services Barnsley Psychological Services / Barnsley Leaning Disabilities Service Low Secure Learning Disabilities Service Calderdale CHRT services Learning Disabilities Services Wakefield Older Peoples Service Wakefield Dual Diagnosis Service Barnsley Speech & Language Therapy Service Barnsley Weight Management Service Patient Inclusion & Involvement Pharmacy Pharmacy Medical Directorate Clinical Governance Finance HR Corporate 11 Appendix 2 Research and Development Department 1. Introduction The role of the Research and Development (R&D) department is to act as an efficient infrastructure that supports and facilitates research activities to support the implementation of the Trust’s Research and Development strategy. Portfolio research projects are National Institute for Health Research (NIHR) adopted studies, which are funded and managed through the NIHR Clinical Research Network: Yorkshire and Humber (CRNYH). Research projects that are not adopted onto the NIHR portfolio are named non-portfolio projects. Both portfolio and non-portfolio research receives support from the R&D Department. The R&D Department receives funding multiple funding streams: CRNYH mainly for portfolio research activity linked to performance, commercial research studies, research funding grants and the R&D trust budget. 2. R&D Structure R&D Strategy August 2014 12 3. Functions of the R&D Department 3.1 Management and Governance of Trust Research 3.1.1 Provide setup support, feasibility review, governance review and approval processes for all Trust research in line with performance management targets and relevant legislation, policy and guidance. 3.1.2 Ensure external researchers have appropriate research contracts to undertake research activity within the Trust and can be identified when on Trust premises. 3.1.3 Audit and monitoring of research governance compliance and recruitment activity. 3.1.4 Performance reports on research activity for Trust board, quality account and quarterly and annual performance management. 3.1.5 Set up and negotiate appropriate research agreements and commercial contracts 3.1.6 Research management policies and procedures. 3.1.7 Provide effective communication with those involved in the research process regarding the process, procedures, roles and responsibilities for effective management and governance of research. 3.1.8 In discussion with the R&D Director, prioritise research programmes within the Trust in keeping with the Trust’s R&D strategy. 3.2 Information, advice and support 3.2.1 Provide a single point of contact for all research enquiries within the Trust. 3.2.2 Provide support and guidance to staff, service users or carers with research interest and ideas; this includes providing support for the research involvement group of service users and carers. 3.2.3 Provide information on research funding opportunities and promote new funding applications. 3.2.4 Supporting researchers with applications for NHS permission and ethical review. 3.2.5 Information and signposting on other types of research approval, for instance NIGB or MHRA approval. 3.2.6 Facilitate and coordinate access to R&D training opportunities to support good research practice within the Trust. 3.2.7 Develop and maintain the Trust’s R&D intranet and website. 3.2.8 Deliver presentations, workshops and events on research involvement and activity to develop research awareness among staff. 3.2.9 Disseminate and publicise Trust research activities in appropriate publications such as intranet, Trust publications and newsletters. 3.3 Partnerships and Collaborative Working 3.3.1 Work closely with CRNYH for portfolio study set up, approval and delivery. Negotiate funding and support for portfolio research. 3.3.2 Work closely with relevant support staff in Human Resources, Finance, Pharmacy, IT, Medical Records and externally Pathology and Radiology to support R&D activity. 3.3.3 Maintain good professional relationships with Trust’s R&D related partners at all levels, CRNYH, AHSN, IHE, other NHS Trusts, etc. 3.4 Administration R&D Strategy August 2014 13 3.4.1 Collate all relevant documents necessary for the research governance approval processes. 3.4.2 Set up the site file for each study. 3.4.3 Produce and distribute R&D approval, continued permission letters and researcher contracts. 3.4.4 Archive research study paperwork appropriately. 3.4.5 Organise research meetings and produce minutes and agendas. 3.4.6 Maintain a comprehensive record of all trust clinical research activities. R&D Strategy August 2014 14