1. An elegant solution to a complex problem – the power of partnership
Liam O’Toole
UK Clinical Research Collaboration

2. Summary of Presentation
Background to UK Clinical Research Collaboration
UKCRC Regulatory and Governance Workstream
Streamlining the research approval process

3. Key issues that needed addressing
Decline in clinical academic community
Decline in infrastructure
Complex regulatory environment
Needs for R&D in the UK
Speed
Quality
Cost
Not yet realising the potential of a single National Health Service

4. Drivers for change

5. UK Clinical Research Collaboration
To re-engineer the environment for clinical research in the UK
To harness the research potential of the National Health Service
To benefit the public and patients by improving national health and increasing national wealth

6. UKCRC Partners

7. Government R&D Strategies
The UK Health Departments are implementing a series of measures to unify and streamline research administration and management.
These are stated in their respective R&D Strategy Documents:
England - Best Research for Best Health (2006)
Northern Ireland - Research for Health and Wellbeing (2007)
Scotland - Research strategy for Health and Healthcare (2003) – under revision
Wales - A Health and Social Care Research and Development Strategic Framework for Wales (2002)
Remember – from run through: 2008 = 60 years since NHS was set up i.e. mention what was happening before and therefore what prompted these R&D Strategies
“So much has happened in the last decade”

8. UKCRC Activities
UKCRC has 5 areas of activity – today concentrating on one element – Streamlining the Regulatory and Governance Environment

9. Streamlining the R&G environment
Bottle-necks and barriers
Lack of consistency and duplication with administration and IT processes
Variation in interpretation of regulations
Focus of activities under UKCRC umbrella
Suite of model agreements
Streamlined approach for R&G Applications
Restructuring NHS R&D Permissions
Research Passport for Honorary Contracts
Consistent approach to advice provision
Early engagement with regulatory change
Theme throughout R&G = encouraging consistency and standardisation; removing duplication and unnecessary variation
But still protect rights, dignity and wellbeing of participants
Several complementary activities in R&G – today concentrating on aspect – streamlining the research application process

10. Unprecedented Opportunity
Many forms and much duplicated information required
Long Term Vision – a seamless ‘cradle to grave’ approach for research projects
Stepwise approach needed
Starting point – gaining political buy-in
UKCRC Working Group chaired by Sir John Lilleyman
UKCRC provided the forum and leadership to get everyone together

11. Working under the UKCRC umbrella
Initiative is supported by:
These are the organisations represented on Sir John’s Working Group and who supported the initiative to streamline the research application process.
From run-through agreed you would ***Congratulate the organisations on their foresight*** - Sir John will talk more about the Working Group and the process etc
Particular acknowledgement for the leadership role of the Janet Wisely of the National Research Ethics Service.
Academy of Medical Sciences (AMS)
Administration of Radioactive Substances Advisory Committee (ARSAC)
Cancer Research UK (CRUK)
Medical Schools Council, formerly Council of Heads of Medical Schools (CHMS)
Department of Health for England
Gene Therapy Advisory Committee (GTAC)
Human Fertilisation and Embryology Authority (HFEA)
Ministry of Justice for the National Offender Management Service (NOMS)
Medical Research Council (MRC)
Medicines and Healthcare products Regulatory Agency (MHRA)
National Institute for Health Research (NIHR)
National Research Ethics Service (NRES)
NHS R&D Forum
Patient Information Advisory Group (PIAG)
R&D Office Northern Ireland
Scottish Government Health Directorates
UK Clinical Research Collaboration (UKCRC)
UK Clinical Research Network (UKCRN)
Welsh Assembly Government
Wellcome Trust

12. Review Bodies
Administration of Radioactive Substances Advisory Committee (ARSAC)
Gene Therapy Advisory Committee (GTAC)
Medicines and Healthcare products Regulatory Agency (MHRA)
Ministry of Justice (National Offender Management Service)
NHS / HSC research offices
NRES/ NHS / HSC Research Ethics Committees
Patient Information Advisory Group (PIAG)
Organisations whose information requirements are included in this phase of the streamlining application process initiative.

13. Summary Large body of work Multiple stakeholders
A lot of progress already made
Clear communication needed
Monitoring and evaluation will be crucial
This is just the start!
Remember – from run through:
“Challenge – if you like it you need to tell other people!”

14. igniting our potential