igniting our potential

1. igniting our potential Developing a model agreement for non-commercial research in the NHS Sue Bourne, UKCRC NHS R&D Forum Annual Conference 2006

2. What is the UK Clinical Research Collaboration (UKCRC)? • The UKCRC (www.ukcrc.org) is a partnership of organisations working with key stakeholders to effect change Shared vision: • To establish the position of the UK as a world leader in clinical research by harnessing the power of the NHS • To benefit the public and patients by improving national health and increasing national wealth • The UKCRC is also a new way of working Igniting our potential

3. Igniting our potential

4. UKCRC Activities Igniting our potential

5. UKCRC Activities Igniting our potential

6. Streamlining the Regulatory and Governance Environment Unifying theme - Consistency of Process, Interpretation and Advice • Streamlining of information management • Integrated regulatory/governance administrative systems • Information sharing for approval and reporting • Consistent authoritative advice on regulatory issues • Standardisation of contracts and agreements • NHS Approvals Igniting our potential

7. Standardised agreements – objective To develop a suite of model agreements that are appropriate to main clinical research relationships Why? • Reduce time and expense • Facilitate initiation of research • Clarify/document agreed roles and responsibilities • Requirement (Research Governance Framework, Clinical Trials Regulations) Igniting our potential

8. Standardised agreements – model agreement for non-commercial research in the NHS • Developed by the UKCRC, Council of Heads of Medical Schools (CHMS) and the Association of UK University Hospitals (AUKUH) • Draws heavily on the work by: • The R&D Forum • A number of other institutions Igniting our potential

9. Model Agreement for non-commercial research in the NHS Aim: To develop a model agreement that can be used in a range of non-commercial research studies • Useable in a range of studies e.g. • Trials for medicinal products • Studies involving new medical devices • Various bodies taking on different roles • Sponsor • Study site • Consequently FLEXIBILITY is key! Igniting our potential

10. Model Agreement for non-commercial research in the NHS What will the model agreement do? • Fulfil necessary contractual arrangements between: • The sponsor(s) of the research study (such as a university, NHS body or research council) and • the NHS body that will be carrying out the study • Document what has been agreed between the parties for the specific study Igniting our potential

11. Model Agreement for non-commercial research in the NHS What will the model agreement look like? • Main body of agreement widely applicable – useable without modification • Flexibility achieved through Schedules - allow tailoring of agreement to particular research situation (as necessary) • Aiming for simplicity (as far as possible) Igniting our potential

12. Model Agreement for non-commercial research in the NHS The finished product: • Model agreement • Guidance • Route for collecting feedback • Experience of use • Basis of revision • Identifying need for other model agreements Igniting our potential

13. Model Agreement for non-commercial research in the NHS Development plan • Workshop, document analysis and drafting (April 05 – September 05) • Need • Proposed format • First draft • Consultation 1 (October 05 – November 05) • Concept • Structure • General composition • Consultation 2 (December 05 – January 06) • Comment on detail of agreement • Finalisation (Work in progress) • Revision in light of consultation 2 • Independent legal review • Develop accompanying guidance • LAUNCH! Igniting our potential

14. Main part of agreement: Identification of the parties to the agreement Definitions Study governance Obligations of Parties Liabilities and indemnity Confidentiality, data protection and freedom of information Publicity Publication Intellectual Property Financial Arrangements Term (of Agreement) Early termination Agreement and modification Force Majeure Notices Assignment and Subletting Dispute Resolution Survival of clauses Governing law (England & Wales) Sign off Model Agreement for non-commercial research in the NHS Igniting our potential

15. Model Agreement for non-commercial research in the NHS Schedules: • Protocol and summary of management arrangements • Division of responsibilities • Between parties • Sets out agreed delegation • Intellectual property arrangements (for any variation from main body of agreement) • Material Transfer Agreement(s) • Financial arrangements Igniting our potential

16. Model Agreement for non-commercial research in the NHS – Guidance Purpose of guidance - to provide clarity and information on: • Purpose of the agreement • How to put it into practice and complete the various parts of agreement • Investigator sign-off • Division and delegation of responsibilities • Schedules Igniting our potential

17. Model Agreement for non-commercial research in the NHS – collecting feedback • Agreement is intended to be useable in a wide range of studies • Need to assess utility • Therefore will provide route for collecting feedback • Experience of use • Basis of revision (agreement and guidance) • Identifying need for other model agreements Igniting our potential

18. Model Agreement for non-commercial research in the NHS Immediate next steps • Complete independent legal review / finalisation • Develop accompanying guidance • LAUNCH! • Develop additional agreements (e.g. NI, Scotland) • Collect information on “agreement in use” • Review Igniting our potential

19. Model Agreement for non-commercial research in the NHS Any questions or comments? Igniting our potential

20. igniting our potential www.ukcrc.org Igniting our potential