Child Health

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Research for Health Wellbeing
A Strategy for Research and Development to lead
Northern Ireland into the 21st Century
Northern Ireland Forum for Health Social
Care Research 5 November 2003 Rosspark Hotel
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Research Governance
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Topics

• General aspects
• Pathfinder Project
• Medicines for Human Use (Clinical Trials)
  Regulations 2003
• Ethics

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Research Governance - Purpose

• to ensure the dignity, rights, safety and
  well-being of the public
• to improve research quality
• to prevent poor performance and adverse events
• to help prevent misconduct and fraud

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MRC led Impact Assessment

• The single sponsor model
• Excessive monitoring and pharmacovigilance
• Onerous trial and manufacturing authorisation and
  registration
• Transitional arrangements
• Trials in incapacitated adults
• Uncertainty about precise requirements and legal
  liability

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DoH/MRC Project TOR

• 1. to consider the concerns expressed in
  relation to publicly-funded trials particularly
  those identified in the impact assessment the MRC
  and other stakeholders prepared in response to
  the MHRAs consultation on the draft Statutory
  Instrument, the Medicines for Human Use (Clinical
  Trials) Regulations 2003
• 2. to formulate practical advice on
  publicly-funded clinical trials involving
  medicines so that such trials
• comply with the law by making best use of
  existing good practice,
• Minimise additional bureaucracy, and
• Make maximum use of public resources to avoid
  unnecessary expense.
• 3. to identify issues that may be taken up in
  redrafting guidance, such as MHRA guidance notes,
  the DH Research Governance Framework for Health
  and Social Care and MRC Good Clinical Practice in
  Clinical Trials guidelines.

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Timelines for Research Governance Framework

• Nov 02 Publication of Research Governance
  Framework for consultation
• Jan 03 Close of Consultation Stage
• Summer 03 Final Research Governance Framework
  published
• Sept 03 Pathfinder Project
• Nov 03 Controls Assurance Standard
• May 04 Full compliance

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Work in Progress

• Framework Document
• Pathfinder Project
• Ethics Committees review and reorganisation
• IP
• Generic agreements
• Honorary Contracts
• Indemnity

• Data Protection
• Informed Consent
• Controls Assurance Standards
• Primary Care
• Student Research
• Misconduct Fraud

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Stages of Pathfinder Project

• Phase 1 - Research Management System in RGHT
• Phase 2 - Adaptation to other HSS bodies
• Phase 3 - Generic application/monitoring forms
  for NI

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Research for Health Wellbeing
A Strategy for Research and Development to lead
Northern Ireland into the 21st Century
Northern Ireland Forum for Health Social
Care Research 5 November 2003 Rosspark Hotel