Research Processing Training Day Research Processing Training Day Introduction Best Research for Best Health Implication for N&S Bank R&D Consortium: redress last 10 years of funding deficiency Consortium Web Resources

North & South Bank NHS R&D Consortium The Consortium is as NHS R&D partnership between Hull & East Yorkshire Hospitals NHS Trust, Humber Mental Health Teaching Trust, North Lincolnshire & Goole Hospitals NHS Trust, along with University of Hull. The Consortiums R&D programmes are: Assessment and interventions for long-term child mental health problems Bio-psycho-social interventions in primary care for mental health problems of older people Evaluating new mental health services Musculo-skeletal injuries and disorders Technologies for serious mental illness User-centred research Cancer: investigation, diagnosis and treatment – optimisation of primary, secondary and tertiary care services input Cardiovascular & pulmonary: a comprehensive approach to the natural history, diagnosis, and care of heart failure, cardiovascular disease, mechanisms and management of cough Metabolism in health and disease First episode research network Psychological therapies in health service settings

DH Research Strategy: Background 1997Assumption that Routine NHS Funding Supporting R&D - R&D levy defined (Culyer, Budget1) - N&S Bank Consortium 2006/07 ~ £1.1m c.f. Sheffield ~ £8m, Leeds ~ £10m, London ~ £302m 1998 National Programmes - Cochrane Collaboration & Centre for Reviewers & Dissemination - Health Technology Assessment (HTA) - Service Delivery & Organisation (SDO) - New & Emerging Applications Technology (NEAT) 2001 Research Governance Framework to ensure that health and social care research is conducted to high scientific and ethical standards that earn public confidence 2002– Legislative Framework - Data Protection Act - Mental Capacity Act - Human Tissue Act - Local research ethics committees COREC - EU Clinical Trials Directive - Medicines for Human Use (Clinical Trials) Regulations - Research Governance Framework 2 nd Edition

DH Research Strategy: Background 1997Assumption that Routine NHS Funding Supporting R&D - R&D levy defined (Culyer, Budget1) - N&S Bank Consortium 2006/07 ~ £1.1m c.f. Sheffield ~ £8m, Leeds ~ £10m, London ~ £302m 1998 National Programmes - Cochrane Collaboration & Centre for Reviewers & Dissemination - Health Technology Assessment (HTA) - Service Delivery & Organisation (SDO) - New & Emerging Applications Technology (NEAT) 2001 Research Governance Framework to ensure that health and social care research is conducted to high scientific and ethical standards that earn public confidence 2002– Legislative Framework - Data Protection Act - Mental Capacity Act - Human Tissue Act - Local research ethics committees COREC - EU Clinical Trials Directive - Medicines for Human Use (Clinical Trials) Regulations - Research Governance Framework 2 nd Edition

DH Research Strategy: Background 1997Assumption that Routine NHS Funding Supporting R&D - R&D levy defined (Culyer, Budget1) - N&S Bank Consortium 2006/07 ~ £1.1m c.f. Sheffield ~ £8m, Leeds ~ £10m, London ~ £302m 1998 National Programmes - Cochrane Collaboration & Centre for Reviewers & Dissemination - Health Technology Assessment (HTA) - Service Delivery & Organisation (SDO) - New & Emerging Applications Technology (NEAT) 2001 Research Governance Framework to ensure that health and social care research is conducted to high scientific and ethical standards that earn public confidence 2002– Legislative Framework - Data Protection Act - Mental Capacity Act - Human Tissue Act - Local research ethics committees COREC - EU Clinical Trials Directive - Medicines for Human Use (Clinical Trials) Regulations - Research Governance Framework 2 nd Edition

DH Research Strategy: Background 1997Assumption that Routine NHS Funding Supporting R&D - R&D levy defined (Culyer, Budget1) - N&S Bank Consortium 2006/07 ~ £1.1m c.f. Sheffield ~ £8m, Leeds ~ £10m, London ~ £302m 1998 National Programmes - Cochrane Collaboration & Centre for Reviewers & Dissemination - Health Technology Assessment (HTA) - Service Delivery & Organisation (SDO) - New & Emerging Applications Technology (NEAT) 2001 Research Governance Framework to ensure that health and social care research is conducted to high scientific and ethical standards that earn public confidence 2002– Legislative Framework - Data Protection Act - Mental Capacity Act - Human Tissue Act - Local research ethics committees COREC - EU Clinical Trials Directive - Medicines for Human Use (Clinical Trials) Regulations - Research Governance Framework 2 nd Edition

2003 Academy of Medical Sciences -consequences for health from inadequate support or R&D -need for NHS/industry collaboration -need for supportive public and regulatory environment for innovation -requirement for sufficient and sustainable funding 2004 The Walport Report on Clinical Academic Careers Government Science and Innovation Investment Framework Research for Patient Benefit Working Party -UK Clinical Research Collaboration (UKCRC) -need for NHS R&D strategy 2006 Best Research for Best Health: - Vision: to improve the health and wealth of the nation through research - Mission: 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 - Funding: Phase out Budget1 over 3 year period DH Research Strategy: Re-Assessment

2003 Academy of Medical Sciences -consequences for health from inadequate support or R&D -need for NHS/industry collaboration -need for supportive public and regulatory environment for innovation -requirement for sufficient and sustainable funding 2004 The Walport Report on Clinical Academic Careers Government Science and Innovation Investment Framework Research for Patient Benefit Working Party -UK Clinical Research Collaboration (UKCRC) -need for NHS R&D strategy 2006 Best Research for Best Health: - Vision: to improve the health and wealth of the nation through research - Mission: 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 - Funding: Phase out Budget1 over 3 year period DH Research Strategy: Re-Assessment

2003 Academy of Medical Sciences -consequences for health from inadequate support or R&D -need for NHS/industry collaboration -need for supportive public and regulatory environment for innovation -requirement for sufficient and sustainable funding 2004 The Walport Report on Clinical Academic Careers Government Science and Innovation Investment Framework Research for Patient Benefit Working Party -UK Clinical Research Collaboration (UKCRC) -need for NHS R&D strategy 2006 Best Research for Best Health: - Vision: to improve the health and wealth of the nation through research - Mission: 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 - Funding: Phase out Budget1 over 3 year period DH Research Strategy: Re-Assessment

R&D Challenges

National Institute for Health Research

Release call/ outline applications Shortlisting for outline applications/ call for full proposals Deadline for full proposals Awards Jan FebMarAprMayJunJulyAugSepOctNovDec Technology Platforms (Imaging) - Implementation plan 5.3 Overview of NIHR Research Projects, Programmes Units and Centres - Implementation plan 6.1 Research for Patient Benefit (RFPB) Project Scheme - Implementation plan 6.2 Research for Innovation, Speculation and Creativity (RISC) Project Scheme - Implementation plan 6.2 Health Technology Assessment (HTA) Programme - Implementation plan 6.3 Service Delivery and Organisation (SDO) Programme - Implementation plan 6.3 Invention for Innovation Programme - Implementation plan 6.4 Programmes Grants for Applied Research - Implementation plan 6.5 Research Centres for NHS Service Quality and Safety - Implementation plan 6.7 Biomedical Research Centres - Implementation plan 6.7

Purpose: To establish a dedicated funding stream to support NHS costs of selected technology platforms for health research in NHS providers Budget: Rising from £8m - £50m p.a. Implementation: - Diagnostic imaging (MRI, fast multi-slice CT & PET) - Must have established project portfolio - Support to increase R&D capacity (i.e. sessional time) - Bid Deadline: May 25 Technology Platforms Networks Purpose: To support and conduct RCTs of interventions funded by commercial and grant sources Budget: not specified Implementation: - Cancer in place - March 06: comprehensive research network across all non-topic specific areas. - April 06: new networks for Diabetes, Stroke, Dementias & Neurodegenerative Diseases - £2m

Purpose: To establish a dedicated funding stream to support NHS costs of selected technology platforms for health research in NHS providers Budget: Rising from £8m - £50m p.a. Implementation: - Diagnostic imaging (MRI, fast multi-slice CT & PET) - Must have established project portfolio - Support to increase R&D capacity (i.e. sessional time) - Bid Deadline: May 25 Technology Platforms Networks Purpose: To support and conduct RCTs of interventions funded by commercial and grant sources Budget: not specified Implementation: - Cancer in place - March 06: comprehensive research network across all non-topic specific areas. - April 06: new networks for Diabetes, Stroke, Dementias & Neurodegenerative Diseases - £2m

Commercial Trial Verbally agreed with PI \ PI Defines Study Information received (Protocol contract etc) (either company approached us or we approached company) Decide if audit, donation (MOU and annexe 1 required), clinical trial (drug or device), service AUC send appropriate template CTA to Funder \ Complete Application Form Include contacts (N Dunham, E Lindstrom, G Byron, J Cant) Send copy of contract from Funder to Nina\Elaine (Trust R&D) and J. Cant\G. Byron (University) Contact AUC and Trust R&D PI Complete Trust R&D resource form CORREC MREC etc Apply for Ethics\Audit if required (copy ethics to AUC & Research Office, Resource form to R&D Protocol etc to R&D, AUC, G.Byron, J Cant) Risk Assessment if required Annexe 1 if required Negotiate Contract, ensure cost and recruitment is realistic Negotiate Overhead, Travel Costs, Trust Costs, VAT etc Contract Agreed Final contracts signed by Funder to AUC Complete RAR form Set Budget Staff Costing from University Research Office, Obtain Quotes Obtain Signatures on RAR form: Lead Investigator S Giddings Prof Stafford Forward RAR & Contracts to Research Office Team Mark Hawksworth & J Cant negotiate Annexe 1 if required Sign contracts (only signed if all documentation inc Ethics approval is with the Research Office) Return Contracts to AUC Contracts /Grant Application to Trust R&D for D Hepburn Signature Trust Approval Post Contract to Funder / Submit Grant Application Contract \ Grant announced by Post Award team (S Marsters) Timescale Is this a Charity / Research Council application or a Commercial Trial? AUC: Academic Unit Contact CTA: Clinical Trials Agreement Sponsor is someone who will monitor or who has legal responsibility, Funder can be sponsor PI Dept Trials Manager Dept Admin Dept Admin, Trust R&D, G Byron, J Cant Dept Admin J Cant Trust R&D Dept Admin Post Award Finance Team Dept Admin Ensure version numbers are used on contracts If Company will not accept CTA then G. Byron must approve their version of contract Day 1 Day 90 Use colours to tie in RAR forms and Specify names of those responsible at each step Version 1.3

Summary DH R&D Strategy – Best Research for Best Health Tremendous opportunities Highly competitive Challenge Get in early Focus initially on our current strengths Consortium Website Aimed at being centralised resource base Feedback encouraged and welcome!