North & South Bank NHS R&D Consortium

Research Processing Training DayIntroductionBest Research for Best HealthImplication for N&S Bank R&D Consortium: redress last 10 years of funding deficiencyConsortium Web Resourceswww.hull.ac.uk/consortium

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 Consortium’s 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 2nd Edition

DH Research Strategy: Re-Assessment • 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 • 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: www.dh.gov.uk/researchstrategy • - 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 • 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 • 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: www.dh.gov.uk/researchstrategy • - 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

R&D Challenges

National Institute for Health Research

Release call/ outline applicationsShortlisting for outline applications/ call for full proposalsDeadline for full proposalsAwards

Technology Platforms • 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 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

www.hull.ac.uk/consortium

Is this a Charity / Research Council application or a Commercial Trial? Timescale PI 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 Day 1 Dept Admin Dept Trials Manager AUC send appropriate template CTA to Funder \ Complete Application Form Include contacts (N Dunham, E Lindstrom, G Byron, J Cant) 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 Dept Admin, Trust R&D, G Byron, J Cant Negotiate Contract, ensure cost and recruitment is realistic Negotiate Overhead, Travel Costs, Trust Costs, VAT etc Ensure version numbers are used on contracts If Company will not accept CTA then G. Byron must approve their version of contract Dept Admin Complete RAR form Set Budget Staff Costingfrom University Research Office, Obtain Quotes Dept Admin, Trust R&D, G Byron, J Cant Dept Admin Send copy of contract from Funder to Nina\Elaine (Trust R&D) and J. Cant\G. Byron (University) Obtain Signatures on RAR form: Lead Investigator S Giddings Prof Stafford J Cant 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) Dept Admin Contract Agreed Final contracts signed by Funder to AUC Dept Admin Return Contracts to AUC AUC: Academic Unit Contact CTA: Clinical Trials Agreement Sponsor is someone who will monitor or who has legal responsibility, Funder can be sponsor Trust R&D Contracts /Grant Application to Trust R&D for D Hepburn Signature Trust Approval Dept Admin Post Contract to Funder / Submit Grant Application Use colours to tie in RAR forms and Specify names of those responsible at each step Post Award Finance Team Contract \ Grant announced by Post Award team (S Marsters) Version 1.3 Day 90

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!

North & South Bank NHS R&D Consortium