UHL R&D Roadshows Thursday 8 March LRI – RMO Teaching Room Thursday 15 March LGH - Seminar Rooms A&B Education Centre

Programme of events John Hampton Introduction to the event & Overview of Comprehensive Local Research Networks – CLRNs Elizabeth Kettle NHS R&D Strategy - Best Research for Best Health Clare O’Neill & Elizabeth Kettle NHS R&D Funding Elizabeth Kettle UHL R&D Office Today’s Session

Introduction National National changes: funding, staffing, functions & structures Regional Regional changes – Networks, including CLRNs, UHL Host bid Local Facilitating Local changes – R&D across all Trust, and R&D Administration and Management – R&D Office

UKCRN - Comprehensive Research Networks Background  Infrastructure for World Class Research  Topic Specific and Primary Care Research Networks established  CRNs to ensure that support is provided for research into all diseases and areas of clinical need

To undertake the local management of the UKCRN’s research portfolio: CLINICAL TRIALS AND OTHER WELL DESIGNED STUDIES FUNDED BY: –DH and other Government Departments –Research Councils –AMRC Charities where funding is awarded following open national competition and subject to peer review –Industry UKCRN – Local CRN’s

 National:  Screen applications to ensure they meet criteria for adoption  Check approvals in place  Performance manage CLRNs  Standardised risk assessment and SOPs to guide local approval  Local CRNs:  Set up and provide resource for clinical arrangements  Operate passport scheme  Provide R&D management for local Trust-level sign-up  Trust offices  Sign-up to and host CRN studies  Provide all R&D and service support for on-account research Conceptual Framework & Functions

GEOGRAPHY  Within the SHA boundaries  Minimum number based on:  Natural health economies  R&D activity, collaborations  Geography STAFFING  Most research management and clinical support will be distributed across organisations  CLRN staff sited in Trusts according to requirements  Develop a core, flexible standing research workforce Broad Principles (1)

Broad Principles (2) REMIT  Only support projects within the UKCRN portfolio  Work with Topic Specific Networks/PCRNs

 Common processes for approval (streamlined/faster)  Guarantee that service support costs will be met for all projects  Transition period will be challenging For UKCRN Portfolio Projects

 No service support costs for ‘own account’ work (or local charities)  No R&D management costs for Trusts to manage these projects  Trusts encouraged to use the CRN research management “centres” to fulfil these functions  Trusts will need to support on-account activity through other funding streams For Non-UKCRN Portfolio Projects

 Geography agreed for East Midlands  Selection of host organisations  Call to be announced in next few days  Identification of host Trust  Track record of managing research  Track record of managing shared arrangements and distributed resources  Evidence of sign-up by NHS partners  Identification of leadership  Phased implementation from April 2007 Timescale – April 2007

New NHS R&D Strategy New NHS R&D Strategy – Elizabeth Kettle New Priorities and Focus Best Research for Best Health " Our new health research strategy Best Research for Best Health sets out the direction that NHS research and development will take to ensure a vibrant, world-class environment for conducting and using NHS health research." Professor Sally C Davies, Director of Research and Development Department of Health

Best Research for Best Health National Institute for Health Research A Virtual National Institute for Health Research, comprising Faculty, Infrastructure, Programmes, Systems

Best Research for Best Health New Infrastructure provision  NIHR Infrastructure Research Networks – Topic specific & comprehensive Advice centres Experimental Medicine Technology Platforms National Schools  NIHR Faculty Funding Paid as “Sessions” Depending on the Level of Contribution Membership Categories: –Senior Investigators – Leaders of Research –Investigators – Key Collaborators in Research –Trainees - Lecturers, Fellows and Students

NHS R&D Funding Elizabeth Kettle R&D Manager University Hospitals of Leicester NHS Trust Clare O’Neill R&D Facilitator University Hospitals of Leicester NHS Trust

Outline current NHS R&D Systems Explain terminology – demystify Discuss new funding opportunities: - Programmes - Networks - Faculty Session Objectives

Research Funding in the NHS Charities: 2 sub-categories A range of different organisations from small, lesser known charities to larger more familiar names in the research field, such as Diabetes UK, Alzheimer's Society Large Research Institutes, e.g. MRC, Wellcome Trust Pharmaceutical Industry, e.g. GlaxoSmithKline Universities, themselves funded by a range of grants Department of Health, primarily via one of 3 main national programmes: Service Delivery & Organisation (SDO), Health Technology Assessment (HTA) and New and Emerging Applications of Technology (NEAT). NHS R&D funding – from central government, via the Department of Health, flowing through NHS Trusts

Culyer money Budget 1 R&D Levy Own account Current system- terminology Paid to NHS Trusts to fund R&D Breakdown of Budget 1, approx 80/20 Support for Science (SfS) Priorities & Needs Funding (PNF)

To fund research costs – cost of doing R&D To fund research support costs – incurred due to R&D activity To fund the management of research To support both local and national research priorities What is Budget 1 for?

Research costs Costs directly associated with the R&D – costs of the Research activity The costs of data collection & analysis Pay & indirect costs of staff employed to carry out the R&D Registration of studies Costs associated with making results accessible, e.g. providing information for publications

Research (NHS) Support Costs Additional patient related costs associated to research which would end once the R&D activity ends (even if patient care activity was decided to continue) e.g. - extra pathology, radiology - extra in-patient stays - extra nursing time

Treatment Costs & Excess Treatment Costs Patient care costs that would continue if the patient service in question continued after the R&D activity stopped – i.e. if R&D activity became routine Treatment costs which are incurred due to R&D activity which are over the existing or standard treatment are referred to as Excess Treatment Costs Both Treatment costs & Excess Treatment costs are normally met through commissioning arrangements for patient care, not via R&D funding of any type

That was then…… This is now! New Research Strategy – Best Research for Best Health New Priorities and focus New Funding schemes New Infrastructure provision

Best Research for Best Health New Funding systems All “Budget 1” money is now classed as transitional funding, and will be paid to Trusts on a reducing basis until 2008/09, when this funding will be replaced by new schemes – if bids successful

Best Research for Best Health Existing DH Programmes Health Technology Assessment (HTA) Service Delivery and Organisation (SDO) New and Emerging Applications of Technology (NEAT) INVOLVE NEW NIHR Funding Research for Patient Benefit (RfPB) Programme grants for Applied Research Invention for Innovation

Research for Patient Benefit Responsive Scheme Best Research for Best Health Overview of scheme High quality, Investigator led research Fund research into areas identified by health service staff with high quality academic input The programme will fund individual projects rather than research units Nationally coordinated funding stream for regionally commissioned research. National budget will be £25 million per annum. Each project can be up to £250k, over 3 years; small grants of up to £50k available for pilot studies/feasibility studies no longer than 12 months duration

Best Research for Best Health Research for Patient Benefit Responsive Scheme Application information All researchers across England can apply Managed by the National Institute for Health Research (NIHR) Central Commissioning Facility (CCF) All applications are made on-line at Applications reviewed by RfPB Local Funding Committee, 3 times per year

Best Research for Best Health Research for Patient Benefit Responsive Scheme Application information Currently two consecutive competitions Competition 3 Registration of Intent to Submit 11 April 2007, 5pm Submission Deadline 23 May 2007, 5pm Submission Outcome 05 October 2007, 5pm Competition 4 Registration of Intent to Submit 07 August 2007, 5pm Submission Deadline 12 October 2007, 5pm Submission Outcome 08 February 2008, 5pm DH Implementation Plan 6.2

Overview of scheme Areas of high priority or need for the NHS - to replace current Priorities and Needs Programmes Will have an annual budget of £75 million once it reaches full capacity, budget in the first year will be £15 million Grants will be substantial awards - maximum £2.0 million per programme over five years. Selection criteria used at application stage Each programme will consist of a series of related projects Best Research for Best Health Programme Grants for Applied Research

Best Research for Best Health Programme Grants for Applied Research Feedback from the first round Scale of the application - less than 3 years duration, less than £300k over 3 years or less than £500k over 5years Relevance to stated priority areas Breadth & Coherence - Small number of projects, loosely related projects Applied Health Research - Did not meet criteria - No clear indication of benefit to patients Academic Partner/NHS Service Manager

Best Research for Best Health Application information Managed by the NIHR CCF Registration via for access to extranet There will be an annual national competition Call for outline applications – April 2007 DH Implementation Plan 6.5 Programme Grants for Applied Research

Best Research for Best Health New investment New and Emerging Applications of Technology (NEAT) Health Technology Devices (HTD) Invention for Innovation NEAT – Aims to deliver research that has the potential to generate Intellectual Property and Cost-Reducing Products/Interventions Calls for proposals usually annual (last call was in July 2006 with deadline in September 2006)

Best Research for Best Health Invention for Innovation HTD – Supports collaborative research that leads to technology that supports patient needs and supports independence and dignity Project teams must contain at least one industrial partner and at least one research-based partner. Projects are limited to a maximum of 3 years. Government support is typically up to 50% of the total project value, with the remaining support provided by the project industrial partners through either cash or in-kind contributions.

Summary of existing & new systems Currently - money flows to Trust for a range of costs – research related, support costs & management. Managed and reported at Trust level New – money for research costs to go directly to research projects & programmes, money allocated regionally for support costs and management costs. Different streams to be managed at different levels.

Conclusions Understand how R&D should be costed Work with your research partner(s) – cross-NHS, University, charity, other Maximise the linkages with other activity, including education/training Disseminate this message to colleagues Apply nowApply now for new funding opportunities.

UHL R&D Office Update Elizabeth Kettle R&D Manager University Hospitals of Leicester NHS Trust

Current processes Programme Board Co-ordinators processing studies with their programme boards Responsible for:  R&D Review & Approval  NHS REC Submissions  Support for MHRA submissions  Undertaking SSAs  Processing amendments  Administration of Boards

Time for a change A need to focus on primary functions of the R&D Office – –NHS R&D Approval, thus ensuring all research is well governed and well managed –To facilitate compliance with all statutory requirements –Maintaining the R&D database and co- ordinating with the National Research Register (NRR) –Raise the local and national profile of research within the Trust and develop appropriate collaborations

Time for a change A need to align ourselves with national systems - Submission processes - SSAs - Annual Reports A need to utilise limited resource most efficiently and manage risk effectively

Changes will include (1) Research applications will receive an appropriate and proportional level of review Clear processes for R&D Review – what we will be reviewing, what we will be asking you about REC Advice for some studies – UHL Sponsored CT-IMP studies, and some UHL Sponsored Interventional studies, e.g. surgery With the exception of the above studies REC Submissions to be made directly to the REC, rather than via the R&D Office – fitting in with national models

Changes will include (2) R&D Co-ordinators focusing on types of studies, rather than organised around Programme Boards R&D Co-ordinators will become experts in CT-IMP studies, in qualitative and student research and in Interventional studies Commencing 1 April 2007 More structured information will follow shortly