Ethics Service Redesign Background and Developments

1. Ethics Service Redesign Background and Developments Moira Nolan Chief Scientist Office

2. Aim of Presentation • Reflect on (recent) journey for Research Ethics Committees • Consider drivers for change • Update on ethics review in Scotland • Development of integrated form systems

3. Background UK developments to the system for ethical review • central support • common application form • one approval for the UK • Standard Operating Procedures, including timelines • training, guidance and accreditation

4. Drivers for Change • research community • PICTF • Medicines for Human Use (Clinical Trials) Regulations 2004 • Ad Hoc Review

5. Background To Ad Hoc Review • Lord Warner announced review of operation of the ethics committee system in England before the National Patient Safety Agency (NPSA) took on COREC’s functions on 1 April 2005 • Ad Hoc Advisory Group established to conduct the review published report in June 2005 • Contained 9 recommendations all of which were of relevance to Scotland • Most significant was for the merger and rationalisation of NHS RECs leading to a smaller number working more efficiently and consistently

6. Scottish Position • Ministers recognised expectation of the REC community for a consultation to be conducted in Scotland • Also a need to review some of the research provisions of the Adults with Incapacity (Scotland) Act 2000 due to inconsistencies with subsequent legislation Medicines for Human Use (Clinical Trials) Regulations 2004. • Scottish Ethics Advisory Group (SEAG) set up to assess the extent to which recommendations of the Warner Report were valid in Scotland and consider the consequences of their implementation

7. Scottish Ethics Advisory Group (1) SEAG consisted of key stakeholders from throughout Scotland and was chaired by the Chief Scientist Consultation with following members of the REC community in Scotland July-Sept 2005: • Chairs of NHS RECs • Directors of Public Health • NHS REC Administrators • R&D Directors • Wider public

8. Scottish Ethics Advisory Group (2) • After discussing the content of the Warner Report and views expressed in the consultation exercise, SEAG was generally supportive of the findings • Report on outcome of review of NHS RECs in Scotland approved by the Minister and published in December 2005 • Consultation report can be downloaded from Scottish Executive website www.scotland.gov.uk/Publications/2006/

9. Scottish Ethics Advisory Group (3) • REC activity data for the period 2002 through to 2005 identified overcapacity in the system • SSAs formed a significant proportion of submissions, workload could be expected to drop by approx 40% across Scotland if removed and transferred to R&D • If reduction in workload accompanied by RECs working close to optimal activity levels then the number of committees could be reduced significantly

10. Implementation in Scotland • SEAG proposed the creation of scientific officer-led management centres within NHS Glasgow, NHS Grampian, NHS Lothian and NHS Tayside providing support for their wider geographical area • Improve efficiency and effectiveness of ethics service and facilitate closer integration with related R&D functions • The geographicalsupport arrangements by these four centres should be determined in consultation with NHS Boards • CSO agreed to support and manage the Scottish redesign of the Research Ethics Service and to act as an interface with the wider changes being introduced throughout the UK

11. Scottish Ethics Implementation Group (SEIG) SEIG was set up in September 2006 to oversee the implementation of the SEAG proposals Advise specifically on: • Timing, structure and financial plans relating to the four ethics management centres • Development of an expedited review process to deal with lower risk studies • Terms of the proposed AWI public consultation

12. Local Implementation (1) • Address issues of over capacity by integrating RECs-supporting discussion of non-lead HBs linking in with 4 management centres • Grampian and Tayside have now have scientific officers in post-Lothian and Greater Glasgow and Clyde working towards this • Fife and Forth Valley RECs had already amalgamated, now becoming part of Fife, Forth Valley and Tayside Research Ethics Service managed by NHS Tayside • North of Scotland Research Ethics Service will go live from 1 April. REC activity in the North of Scotland will be managed by NHS Grampian through 2 RECs

13. Local Implementation (2) • West of Scotland ethics service proposed, discussions underway with Lanarkshire, Ayrshire and Arran and Dumfries and Galloway • Borders REC likely to amalgamate with NHS Lothian RECs

14. Scottish MRECs (1) • Review of RECs recommended distinction between MRECs and LRECs be removed with multicentre studies considered by any REC in future • In England, MRECs will be subsumed within the new SHA REC systems • In Scotland, MREC A must be retained due to the Adults with Incapacity (AWI) legislation and must continue to exist until any decision is made on future legislative changes • Workload of MREC B will be greatly reduced when multicentre studies no longer allocated to MRECs

15. Scottish MRECs (2) • CSO has discussed way forward with MREC Chairs • MREC A and B work closely together, benefits in continuing to utilise expertise built up rather than to subsume within local R&D systems • Ministers have agreed that the two MRECs integrate their membership from April 2007 and operate as the AWI REC i.e. current MREC A with expanded membership • Minor changes to AWI regulations have taken place to allow AWI REC to have up to 30 members

16. Expedited review • Principle of expedited review of lower risk studies accepted throughout UK • SEAG agreed that all research should continue to be submitted to a REC, early identification through triage could identify no/lower risk proposals • Screening/triage of all applications-conducted by Scientific Officer in Scotland • COREC have invited RECs to participate in pilot screening of which fast track review is one element-Grampian and Tayside have agreed to take part

17. Expedited review • Pilot will inform definition and identification of projects which appear to pose lower risk to participants • Framework for review-England propose sub-committee of NREAs and lay involvement employed independent of NPSA • Scotland developing plans for the pilot of expedited review proposals • Can then consult Scottish REC community informed by practical experience

18. Other Issues • Accreditation-legitimate activity under UKECA as part of Clinical Trials Regulations, some RECs in Scotland have already successfully participated in the accreditation process • Appraisal and performance management of Chairs-not planning to go down this route in Scotland • REC Chairs may be subject to Nolan Principles when appointed in future as currently the case with MREC Chairs • OREC manager for Scotland-jury still out. Will decide once all Scientific Officers are in post whether national co-ordination is required

19. Development of Integrated Form Systems • Recognition across the UK of the benefits of creating integrated systems for approvals – one dataset to generate forms for ethics, R&D, MHRA etc. • Integrated Study Information Form being developed by COREC • Scotland considering options for moving forward in this area

20. Site Specific Information Form • Launched for use and consultation January 2007 - Site Specific Assessment • NHS sites • Non NHS sites • R&D Management Approval

21. Summary • Coming months will see a number of changes to the management and operation of NHS RECs both in Scotland and in the rest of the UK • Continued collaboration to maintain UK wide system for ethical review