Research governance, ethical review and the new health research strategy

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Research governance, ethical review andthe new
health research strategy

• C Marc Taylor
• Department of Health
• marc.taylor_at_dh.gsi.gov.uk

Research and Development Knowledge for
Health and Social Care
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Todays agenda

• Best Research for Best Health
• UK Clinical Research Collaboration
• National Institute for Health Research
• Faculty
• Programmes
• Infrastructure
• NIHR Systems
• RD management through networks
• Advice service
• Research ethics
• Information systems

Research and Development Knowledge for
Health and Social Care
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New health research strategy

• Vision to improve the health and wealth of the
  nation through research
• To create a health research system in which the
  NHS supports outstanding individuals, working in
  world-class facilities, conducting leading-edge
  research, focused on the needs of patients and
  the public.

Research and Development Knowledge for
Health and Social Care
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UK Clinical Research Collaboration
Funding
New networks
Training, career pathways
Clinical research facilities
Regulation
Research and Development Knowledge for
Health and Social Care
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National Institute for Health Research
Faculty
Trainees
Investigators
Senior Investigators
Programmes
Infrastructure
Universities
Research Projects
Research Networks
NHS Trusts
Networks
Research Programmes
Experimental Medicine Facilities
PatientsPublic
Research Units
Technology Platforms
National Schools for Research
Research Centres
Advice Service
Governance Network
ResearchEthics
Information Systems
Systems
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National Institute for Health Research
Faculty
Trainees
Investigators
Senior Investigators
Programmes
Infrastructure
Universities
Research Projects
Research Networks
NHS Trusts
Networks
Research Programmes
Experimental Medicine Facilities
PatientsPublic
Research Units
Technology Platforms
National Schools for Research
Research Centres
Advice Service
Governance Network
ResearchEthics
Information Systems
Systems
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National Institute for Health Research
Faculty
Trainees
Investigators
Senior Investigators

• Aim
• To provide world-class support to those who
  conduct and participate in health research for
  the benefit of patients in the NHS and the wider
  public
• To increase professionalism in research through
  developing an esprit de corps of research
  effort
• To help ensure that we attract and retain the
  outstanding clinical, health service and public
  health researchers needed to tackle the health
  challenges of the future
• To focus the talents of this cohort of clinical
  academics on applied health research responding
  to the needs of the NHS and its current and
  potential patients

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National Institute for Health Research
Faculty
Trainees
Investigators
Senior Investigators
Programmes
Infrastructure
Universities
Research Projects
Research Networks
NHS Trusts
Networks
Research Programmes
Experimental Medicine Facilities
PatientsPublic
Research Units
Technology Platforms
National Schools for Research
Research Centres
Advice Service
Governance Network
ResearchEthics
Information Systems
Systems
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National Institute for Health Research
Faculty
Trainees
Investigators
Senior Investigators
Programmes
Infrastructure
Universities
Research Projects
Research Networks
NHS Trusts
Networks
Research Programmes
Experimental Medicine Facilities
PatientsPublic
Research Units
Technology Platforms
National Schools for Research
Research Centres
Advice Service
Governance Network
ResearchEthics
Information Systems
Systems
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National Institute for Health Research
Faculty
Trainees
Investigators
Senior Investigators
Programmes
Infrastructure
Universities
Research Projects
Research Networks
NHS Trusts
Networks
Research Programmes
Experimental Medicine Facilities
PatientsPublic
Research Units
Technology Platforms
National Schools for Research
Research Centres
Advice Service
Governance Network
ResearchEthics
Information Systems
Systems
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National Institute for Health Research

• Aim
• To promote a regulatory and governance
  environment that both facilitates high-quality
  research and protects the rights, dignity and
  safety of those who agree to take part.
• To promote research governance processes that are
  proportionate to risk.
• To unify and streamline administrative procedures
  associated with regulation, governance,
  reporting, research administration and approvals,
  and ensure that procedures and decisions are
  rationalised.

Governance Network
Advice Service
Research Ethics
Information Systems
Systems
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National Institute for Health Research

• Action
• Establish research management and governance as
  an integral part of the new Comprehensive
  Research Network.
• Research-active centres in the network will work
  together, locally and nationally, to establish
  research management approaches which minimise
  bureaucracy and maximise effectiveness.
• Networks will share common procedures and be and
  supported by integrated national RD information
  systems, research passports and a national expert
  advice service.

Governance Network
Advice Service
ResearchEthics
Information Systems
Systems
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National Institute for Health Research

• Action
• Develop a single IT system for researchers and
  NHS research management
• To underpin this, we will unify and simplify the
  administrative procedures associated with
  regulation, governance, reporting and NHS
  research administration, ensuring that procedures
  and data input are, wherever possible, undertaken
  once for multiple uses.
• This will enable the information systems to be
  populated with data needed by different users
  interested in health and social care research,
  and will make information supporting regulatory
  approvals and permissions available to those who
  need it.

Information Systems
Advice Service
Governance Network
ResearchEthics
Systems
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National Institute for Health Research

• Action
• Create a national advice service to help
  researchers navigate regulatory processes,
  approvals and permissions, particularly for
  clinical trials and other types of research when
  they need to interpret the law for research in
  practice.
• The service will operate through e-mail and
  telephone helpline based within the Comprehensive
  Research Network, backed up by an electronic
  interface that links the advice service to
  regulatory experts.

Advice Service
Governance Network
ResearchEthics
Information Systems
Systems
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National Institute for Health Research

• Action
• 2005 review proposed a package of measures to
  strengthen expert support for the ethics
  committee service, speed up the review of
  low-risk studies, and help committees improve
  consistency
• National Patient Safety Agency (NPSA), as host of
  the Central Office for Research Ethics Committees
  (COREC), has consulted on an implementation plan
  based on the review.
• We will work closely with the NPSA to harmonise
  and simplify the exchange of information between
  the research ethics committee service, the NHS,
  and others, while protecting the independence of
  ethical review.

Research Ethics
Advice Service
Governance Network
Information Systems
Systems
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National Institute for Health Research

• Issues to be managed
• Complexity
• Scale
• Need to gain agreement on common systems
• Balancing local autonomy with collective
  responsibility
• Keeping people on board during transition

Governance Network
Advice Service
Research Ethics
Information Systems
Systems
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DH research governance

• Department of Health Research Governance
  Framework for Health and Social Care
• 1st edition 2001 guidance
• 2nd edition 2005 a quality standard for health
  care
• Covers RD in health and social care settings
• Includes studies when access to research
  populations is via NHS or CSSR or agencies
  contracted to them

Research and Development Knowledge for
Health and Social Care
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Research governancegood management in
partnership
Ethics committee
PIAG
Healthcare Commission
MHRA
Research and Development Knowledge for
Health and Social Care
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NHS permission for RD

• Manage risk
• Minimise bureaucracy
• Facilitate research
• NHS scrutiny should be
• proportionate
• timely
• focussed on the NHS bodys own responsibilities
• Rely on assurances from others

Research and Development Knowledge for
Health and Social Care
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Networked RDmanagement expertise

• Best Research for Best Health
• We aim to promote a regulatory and governance
  environment that both facilitates high-quality
  research and protects the rights, dignity and
  safety of those who agree to take part. We will
  promote research governance processes that are
  proportionate to risk. We will unify and
  streamline administrative procedures associated
  with regulation, governance, reporting, research
  administration and approvals, and ensure that
  procedures and decisions are rationalised. To
  achieve this, we will set up centres of expertise
  in RD management, closely linked to the
  comprehensive NHS research networks. Each centre
  will coordinate the research management and
  governance resources in its health economy.
  Together the centres will operate as a network,
  sharing common procedures, and supported by
  integrated national RD information systems.
  Other key elements of this system will be
  research passports and a national expert advice
  system.

Research and Development Knowledge for
Health and Social Care
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Comprehensive Research Network

• Local research networks will make up CRN for
  England
• CLRNs to deliver expert RD management, good
  governance
• UKCRN, SHAs DH will lead implementation
  planning
• Define RD health economies for local networks
• Plan how to provide RD management functions
• RD management functions distributed through
  networks
• Research active centres will work together
  locally and nationally
• Care organisations functions including proper
  governance
• One-stop shop to serve each research-active site
• Planning in 2006-07 implementation from 2007-08

Research and Development Knowledge for
Health and Social Care
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Research ethics -the Ad Hoc review

• Ad hoc review commissioned by Lord Warner
• Panel of five
• Announced 3 November 2004
• Took evidence November - January
• Reported 6 April 2005
• Published 6 June 2005
• Consulted on implementation Jan to April 2006
• Aim for UK-wide systems

Research and Development Knowledge for
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9 recommendations

• Remit should not include surveys or non-research
  activity if no material ethical issues for
  humans.
• Clarify definitions, simple review if minimal
  risk
• RECs should not do scientific review. Should be
  able to refer applications for scientific
  guidance.
• Screening and better preparation before ethics
  committee
• Further efficiency and quality improvements in
  managed operating system. SSAs to go to NHS.
• Improve application form and process. More
  account of types of research, more space for
  ethical issues.
• Common national systems to improve local RD
  procedures and interaction with ethical review.

Research and Development Knowledge for
Health and Social Care
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9 recommendations

• Fewer RECs, working more intensely
• Better support, clustering, match workload with
  committees
• Membership from wider mix of society, better
  training, paid for time.
• Gather evidence, keep under review
• Reduce excessive inconsistency by training,
  sharing good practice, quality assurance by peer
  review.
• Scientific Officers in COREC to do preliminary
  assessment and review reports.
• Research Ethics Advisers, national research
  ethics service

Research and Development Knowledge for
Health and Social Care
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Priorities for NHS RD ICT systems

• Short term
• Workshops to share views of priorities and
  opportunities
• Unify/simplify/speed up DH/NHS approvals
  permissions
• Medium term
• Standardise/simplify minimum data set for health
  RD
• Main funders and regulators systems exchange
  data
• Long term
• Unify/simplify reporting
• Integrate web-based systems
• Single data set through whole cycle of a study

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Health and Social Care
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Joined-up systems,shared standards
WWW
WWW
WWW
WWW. J-eS
Ethics NHS RD
Research Councils
XML
NHS RD
ethics
Funders
reports
ethics
NHS RD
university
RD office
GTAC
PIAG
MHRA
NRR
Trials register
Pubmed
Repository
Research and Development Knowledge for
Health and Social Care
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Aims for RD management

• Best Research for Best Health
• A vibrant efficient research environment that
  commands public confidence and protects research
  participants, through
• World-class networks for RD 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

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Issues for discussion

• PCTs and SHAs
• Reconfiguration, timing, future role
• Health economy RD networks
• Economies of scale vs visibility
• Matching expertise and resources to workload
• Delegated authority vs NHS ownership
• Pace of change to integrated IT systems
• NHS and university priorities and working
  practices
• Can we adopt solutions that work well?
• Integration with partners

Research and Development Knowledge for
Health and Social Care
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www.dh.gov.ukwww.nihr.ac.uk

• C Marc Taylor
• Department of Health
• marc.taylor_at_dh.gsi.gov.uk

Research and Development Knowledge for
Health and Social Care