Research Processing Training DayResearch Processing Training DayIntroduction
Best Research for Best HealthImplication for N&S Bank R&D Consortium:
redress last 10 years of funding deficiency
Consortium Web Resourceswww.hull.ac.uk/consortium
North & South Bank NHS R&D ConsortiumNorth & 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: BackgroundDH Research Strategy: Background
1997 Assumption 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: BackgroundDH Research Strategy: Background
1997 Assumption 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: BackgroundDH Research Strategy: Background
1997 Assumption 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: BackgroundDH Research Strategy: Background
1997 Assumption 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
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: 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-AssessmentDH 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: 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-AssessmentDH 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: 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-AssessmentDH Research Strategy: Re-Assessment
R&D ChallengesR&D Challenges
National Institute for Health ResearchNational Institute for Health Research
Release call/ outline applicationsShortlisting for outline applications/ call for full proposals
Deadline for full proposalsAwards
JanFeb Mar Apr May Jun July Aug Sep Oct Nov Dec
Technology Platforms (Imaging) - Implementation plan 5.3Overview 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 ofselected 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 PlatformsTechnology Platforms
NetworksNetworksPurpose: 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 ofselected 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 PlatformsTechnology Platforms
NetworksNetworksPurpose: 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/consortiumwww.hull.ac.uk/consortium
Commercial Trial Verbally agreed with PI \ PI Defines StudyInformation 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 FormInclude 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&DPI 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 realisticNegotiate Overhead, Travel Costs, Trust Costs, VAT etc
Contract AgreedFinal 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 GiddingsProf Stafford
Forward RAR & Contracts to Research Office TeamMark 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 SignatureTrust Approval
Post Contract to Funder / Submit Grant Application
Contract \ Grant announced by Post Award team (S Marsters)
TimescaleIs 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 ManagerDept Admin
Dept Admin, Trust R&D, G Byron, J Cant
Dept Admin, Trust R&D, G Byron, J Cant
Dept Admin
Dept Admin
J Cant
Trust R&D
Dept Admin
Post Award Finance Team
Dept Admin
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
SummarySummary
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!
