Building on Improvement Establishing a National Research Ethics Service Dr Janet Wisely Operations D

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Building on ImprovementEstablishing a National
Research Ethics ServiceDr Janet
WiselyOperations DirectorCentral Office for
Research Ethics Committees (COREC)
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Aim of Presentation

• Reflect on (recent) journey for Research Ethics
  Committees
• Consider drivers for change
• COREC business plans
• History of the development of the COREC form
• Creating integrated systems for approvals

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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

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Drivers for Change

• Research community
• PICTF
• Clinical Trials Directive
• Ad Hoc Review

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Business Plans

• Building on Improvement published August 2006
• Updated Business Plans 2006/2007 and
  pre-planning statement 2007/2008 on COREC
  website

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Business plans - principles

• Protecting rights, safety, dignity and wellbeing
  of research participants and promoting ethical
  research
• Provision of a service
• Timely, efficient, proportional, robust
• Quality Assurance
• Training
• Communication

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Wider Regulatory Environment

• Recognition of requirement for independent
  decision making
• but strengthening administrative links

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History to the development of the COREC form (1)

• First common form developed for use by MRECs
• MREC approval
• Locality assessment

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History to the development of the COREC form (2)

• COREC role for LRECs
• EU Clinical Trials Directive
• One decision for the UK
• Management of applications
• Time lines
• Central Allocation system

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History to the development of the COREC form (3)

• COREC Electronic form
• Required downloadable software
• Piloted with MRECs, February 2003
• Compatibility problems
• IT policies regarding downloading of software
• (lots of bad press----)

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History to the development of the COREC form (4)

• Development of web based version of form
• Expansion to all RECs
• Implementation
• Communications
• Marketing
• Strategy (decision to stay faithful to page
  numbering)
• (lots more bad press--- plus issues with RECs
  regarding adoption)

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History to the development of the COREC form (5)

• Redesign to make minimal by default, using filter
  to enable rather than disable sections
• Navigation to manage change in page number for
  particular questions
• Question specific advice
• (acceptance, benefits beginning to be realised,
  some positive feedback!)

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History to the development of the COREC form (6)

• Ad hoc review (published 2006)
• Notes and applauds improvements to REC system and
  references the common application form
• Calls for further improvement and development of
  the application form and application systems

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Development of integrated form systems

• Form development using COREC platform and
  therefore this element being taken forward by
  COREC, this is only one part of an overall IT
  agenda within Best Research for Best Health
• One dataset to generate forms for ethics, RD,
  GTAC, PIAG, ARSAC
• One study dataset with linked site dataset

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Site Specific Information Form

• Launched for use and consultation January 2007
• SSA
• NHS sites
• Non NHS sites
• RD management approval

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Study Information Form (1)

• Tendering complete and contract awarded to
  Infonetica
• First development meeting February 15th
• Estimated delivery for use and consultation
  September 2007

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Study Information Form (2)

• One study information form Ethics, RD, GTAC,
  PIAG, ARSAC
• Dataset managed by researcher and appropriate
  snapshot taken for particular submission
• Functionality to support management of dataset
• No dominant approval or dictated order for
  generation of new datasets
• Data transfer from existing ethics form and
  exploring import from other systems

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Establishing a National Research Ethics Service

• COREC (NRES) and RECs in England
• Continued collaboration to maintain UK wide
  system for ethical review
• National Research Ethics Service will be formally
  launched at end of March 2007
• --Volunteer based and professional--

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Thank you. Questions?