PCT RM&G AS A MODEL OF GOOD PRACTICE

1. PCT RM&G AS A MODEL OF GOOD PRACTICE Rhian Hughes - Chair Gill Sarre - Facilitator Primary Care Working Group

2. BACKGROUND • Proposed national system of expert centres and networks to support delivery of RM&G • Aim is to reduce duplication by having unified process for NHS R&D approval within NHS health communities (new SHAs)

3. Best Research for Best Health A vibrant efficient research environment that commands public confidence and protects research participants, through World-class networks for R&D management and governance Action to simplify processes that use research time Governance, advice, ethics Do only once in a single place, whatever does not have to be done in many places Maximise the joint use of standardised systems and processes Support local decisions with national standards, templates and datasets Give active support to high quality research Aims for R&D management and governance

4. Expert support, joined-up systems • Network of expert centres serving each health economy • National advice service • Research passports Supported by • NIHR web site, portal to information services • Unified IT systems: • Input information once • Populate ethics and NHS R&D applications, NRR • Published papers, repository

5. Networked R&D offices SHA-led local implementation planning to: • Define health economies for networks in SHA area • Identify network R&D offices to coordinate resources • Decide which other well-established R&D offices will provide R&D management and governance functions: • network functions • care organisations’ functions including governance checks • one-stop shop to serve each research-active site Planning in 2006-07; implementation from 2007-08

6. RM&G in Primary Care • Consortia of PCTs were established to deliver RM&G in 2003 • Their development provides a model of good practice which could inform the NHS Implementation Plan for Governance

7. Workshop aim • To characterise good practice models for RM&G established in primary care • Share examples of good working methods • Highlight potential problems in running shared arrangements • Agree feedback to DH

8. Characteristics of good practice: 1. Shared arrangements • Based on a formal agreement • Explicit roles and responsibilities distributed across • Member PCTs • R&D office • R&D leads vis a vis R&D Officer • Sign up to a shared system and the procedures that support it • Clear system of delegation • R&D officer can provide approvals

9. 2. Streamlining the process • Link R&D and COREC documentation • Check for evidence rather than review again • Distinguish between projects that need • Permission - Notification and registration • Approval – Formal checks • Accept the approvals (and Honorary Contracts) of others • Target timescales for approval of valid applications

10. 3. Adding value to the process • Support for novice researchers • Research design • Writing a good ethics and R&D application • Common procedures across the NHS interface (GPs, Community Services, PCTs, DGHs, Teaching Hospitals • Stronger infrastructure to host research

11. TURNING MODELS INTO GOOD PRACTICE:SOME EXAMPLES

12. 1. Shared Arrangements • Formal SLAs between partners (ToolKit model) • Merged RM&G Partnerships (Essex, Manchester) • ‘One stop shop’ • Lead R&D Office (LNR SHA) • Responsible for co-ordinating review process • Across all NHS organisations in area • Supported by agreed SOPs

13. 2. Streamlining • Standard Operating Procedures (Herts RM&G Collaborative) • Explicit procedures, agreed with partners • Computerised management systems (Nottingham RM&G) • Monitoring timescales • Alerts and checks • Clear audit trail

14. 3. Adding Value • Agreements across NHS Trust / University partnerships • Shared systems and defined roles & responsibilities; supported by Peer Review committee for “on-account” research • Agreements & guidance emerging from cross organisational working • E.g. Research Governance Best Practice Group (Notts, Lincs, Derby) – Data Management in Research

15. Annual Reports - 2005 • Approaches to awareness raising, dissemination, training • Specific RG guidance - manual, handbook, leaflets • Reciprocal monitoring & audit arrangements with neighbouring trusts • Responsibility for approvals delegated to RG Manager if criteria met. • SHA wide approval process for multi-site studies

16. Annual Reports - 2005 • Regional forum – R&D Managers, OREC manager, REC chairs • Use of Standard R&D Approval form – widespread commitment to use • Piloting of turn-around times

17. Some unresolved issues • Can assessment of local issues be delegated to other care organisations? • Simple methodology for risk assessment, to filter projects that need registration as opposed to approval • Excess treatment costs • Drug costs

18. Discussion • Models and working examples of good practice • Specific issues that need policy development • Feedback to DH

19. CONTACT DETAILS NHS R&D Forum website: www.rdforum.nhs.uk Further information on the Tool-kit or PCWG from: • Rhian Hughes, Chair, PCWG r.w.hughes@cphc.keele.ac.uk • Gill Sarre - Facilitator, PCWG gill.sarre@nottingham.ac.uk