Vision: to improve the health and wealth of the nation through research

1. Vision: to improve the health and wealth of the nation through research “To create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research, focused on the needs of patients and the public.” Strategic goals Establish NHS as a world-class centre of research excellence Support research professionals Commission research Manage research and governance Use resources well

2. Best Research for Best Health A vibrant efficient research environment that commands public confidence and protects research participants, through World-class networks for R&D management and governance Action to simplify processes that use research time Governance, advice, ethics Do only once in a single place, whatever does not have to be done in many places Maximise the joint use of standardised systems and processes Support local decisions with national standards, templates and datasets Give active support to high quality research R&D Management and Governance: Aims

3. Networked Expert Centres Best Research for Best Health “ We aim to promote a regulatory and governance environment that both facilitates high-quality research and protects the rights, dignity and safety of those who agree to take part. We will promote research governance processes that are proportionate to risk. We will unify and streamline administrative procedures associated with regulation, governance, reporting, research administration and approvals, and ensure that procedures and decisions are rationalised. To achieve this, we will set up centres of expertise in R&D management, closely linked to the comprehensive NHS research networks. Each centre will coordinate the research management and governance resources in its health economy. Together the centres will operate as a network, sharing common procedures, and supported by integrated national R&D information systems. Other key elements of this system will be research passports and a national expert advice system.”

4. Comprehensive Research Networks Aim: To improve the quality, speed and efficiency of research Purpose: Provide support to clinical researchers – research expertise, research and NHS infrastructure Functions: • Provide support to funded research • Management of clinical research support by liaising with local TCRNs, PCRNs,RDSUs, CTUs, CRFs • Organise training of clinical research staff • Management and funding of NHS research infrastructure • Promoting services available through the whole clinical research infrastructure

5. Comprehensive Research Network (3)NHS R&D Finance Role Aim: to facilitate NHS funding support for research activity • Manage the ‘support for patient research’ NHS R&D funding – NHS infrastructure • Allocated to network population basis • Provide advice and assistance with centrally held ad hoc funding • To liaise with commissioners in planning of treatment costs of research

6. Comprehensive Research Networks Location and Management • Comprehensive geographical coverage • Liaise with SHAs on transition process • Co-location with one or more other clinical research infrastructure elements - TCRNs, PCRN,CRF, RDSU • Managed by the UKCRN CC • Too many – risk imbalance of r.infrastructure/r.funding

7. NHS R&D Networked Expert Centres SHA-led local implementation planning to: • Define health economies for networks in SHA area • Identify network R&D offices to coordinate resources • Decide which other well-established R&D offices will provide R&D management and governance functions: • network functions • care organisations’ functions including governance checks • one-stop shop to serve each research-active site Planning in 2006-07; implementation from 2007-08

8. NHS R&D Networked Expert Centres Aims • To provide a research governance environment that commands public confidence • To simplify and harmonise processes for researchers • To enable procedures and decisions to occur once only • To provide assistance in obtaining regulatory approvals and permissions • To improve user satisfaction with NHS R&D

9. NHS R&D Network Expert Centres Functions National system of network based R&D management centres • advise on all aspects of regulation and governance • liaise with RECs to arrange site-specific assessments • liaise with University governance offices on sponsorship issues • assist researchers with REC& MHRA forms • work with employers to facilitate research passports • manage the new single IT system • undertake research governance checks on behalf of care organisations

10. Expert support, joined-up systems • Network of expert centres serving each health economy • National Advice service • National Ethics service Supported by • NIHR web site, portal to information services • Unified IT systems: • Input information once • Populate ethics and NHS R&D applications, NRR • Published papers, repository

11. East of England Health R&D Strategy Process to date • Conference in December 2005 agreed strategy was needed • Working group set up to oversee development of a Steering Group and several Workstreams • Membership to reflect UKCRC • All sectors have responded well • First meeting in June, chaired by the EofE SHA

12. East of England Health R&D Strategy Purpose To contribute to the health and wealth of the East of England by increasing the volume and quality of research and development in health and social care through collaborative working between health and social care employers, academia, industry, regulators, patients and service users

14. East of England Health R&D Strategy Purpose of Steering Group • Oversee the development of a regional research and development Strategy for health and social care • Promote the EofE as a centre for research • Maximise the region’s influence on national policy development and ensure continuity with national initiatives • Act as an advisory group to the new SHA • Oversee a series of workstreams to facilitate the delivery of the strategy • Set strategy targets and measure progress and outcomes

15. East of England Health R&D Strategy Proposed Strategy Workstreams • Streamlining Research Governance • Research Infrastructure • Capacity Building • Collaboration with Industry • Knowledge Transfer

16. East of England approach • Streamlining research governance workstream • Membership and terms of reference for worksteam • Building our R&D ‘intelligence’ in liaison with the R&D Forum and the RDSU

17. Intelligence gathering - R&D Management • Establishing a baseline to facilitate discussion and development • Survey of all NHS Trusts (67 in EoE) • Questionnaire Responses – 91%* 100% PCTs 100% care trusts 95% acute trusts 43% mental health partnership trusts 33% ambulance trusts * 26 returns received representing 61 organisations

18. Staffing in EofE • 67 WTE staff in R&D offices • Over 53% of returns reported that some staff are funded from non-NHS R&D monies

19. Reciprocal arrangements in EofE • 81% of returns revealed that organisations have some form of reciprocal arrangements for RM&G in place • Primary Care has county-wide RM&G arrangements mostly in place • 3 clusters of secondary care providers • Norfolk primary, secondary care and mental health reciprocal arrangements • 5 “clusters” use SLAs • 30% of returns showed that organisations do site specific assessments

20. RM&G Map Primary Care KINGS LYNN N&W MHPT Acute Trusts GT. YARMOUTH PETERBOROUGH NORWICH Mental Health HUNTINGDON Ambulance PAPWORTH BURY ST EDMUNDS CAMBRIDGE BEDFORD BEDFORD IPSWICH COLCHESTER LUTON CHELMSFORD SOUTHEND

21. Information Systems in EofE • ReDA 50% • EPS 30% • In-House 15% • RADOS 5%

22. Individual Organisation Approve policy and procedure Legal requirements (Financial probity, data protection etc.) Indemnity Trust approval/permission Link to clinical governance and risk assessment Act on monitoring information Adverse events R&D Network Expert Centre Developing policies and procedures (e.g. misconduct & fraud) Notification, registration and assessment of applications Hold and maintain database Co-ordination of approval process including ethics Honorary contracts Peer review Costings, Monitoring & Audit and Reporting Dissemination of research findings/impacts Patient and public involvement Training on research governance Administration of collaborative meetings Shared Arrangements

23. Good Practice • Streamlined processes/standard operating procedures • Some R&D Offices offer combined roles: facilitation, advice and support to researchers and in the research process, training programmes on research methodology and governance issues • Dissemination: newsletters, translational services • Patient and public involvement • Performance measures and targets • Intellectual Property management • Policies: fraud and misconduct, research audit, research databases • Involvement in national initiatives

24. Concerns and questions Clarity • Unclear how the proposed system will work • How will quality be monitored? • Patient and service user involvement Local vs Centralised • Local knowledge, engagement, duty of care and accountability • Potential loss of local expertise • Virtual or real? • Support for single-site research • Excess treatment costs handled centrally Process of Change • R&D Office staff employment future • Long-term stability of research programmes • Time required to develop and maintain effective collaboration

25. Next Steps • DH consults nationally on implementation plan - May-July 2006 • UKCRN supports a review of each health economy’s R&D management capacity May-July 2006 • SHA R&D Leads Group • Defining transition tasks 2006-7 • Stocktake exercise in each new SHA • Intelligence gathering – infrastructure & activity • R&D Forum Training Group • Change management programme

27. Systems underpinning NIHR

28. NHS R&D Network Centres (4) New Research Support Functions Aim: To improve the quality of research Purpose: Provide professional support to clinical researchers Functions: • One-stop shop for researchers at all stages of the research process – referring to RDSU, PCRN,CTU,CRF • Grant application costing • Promoting services available through the whole clinical research infrastructure