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

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

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

Drivers for change

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

UKCRC Partners

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 2007-2012 (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”

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

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

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

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

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.

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!”

igniting our potential www.ukcrc.org