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The Health Research Authority and the National Research Ethics Service

The Health Research Authority and the National Research Ethics Service. Jonathan Fennelly-Barnwell NRES Manager – South of England. Objective. To provide prospective applicants for NHS ethical review with a brief overview of the HRA, the NRES and REC work.

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The Health Research Authority and the National Research Ethics Service

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  1. The Health Research Authority and the National Research Ethics Service Jonathan Fennelly-Barnwell NRES Manager – South of England

  2. Objective • To provide prospective applicants for NHS ethical review with a brief overview of the HRA, the NRES and REC work

  3. The Health Research Authority (HRA)

  4. The Health Research Authority • Established as a Special Health Authority – 1 December 2011 • Budget - £9.7m • Headcount – 134 wte (154 staff)

  5. The Health Research Authority • Chairman – Professor Jonathan Montgomery • Chief Executive – Dr Janet Wisely • Three Divisions – Corporate, NRES and Improvement

  6. HRA Remit • NRES • IRAS • Advice, guidance, training • Section 251 • Communications and engagement • Collaboration and development steering group - A UK wide steering groupspecifically where implementation will be required not just by the HRA but by others as well to improve the research journey in the UK

  7. National Research Ethics Service (NRES)

  8. NRES • the National Research Ethics Service has transformed the operation of NHS research ethics committees in the UK • NRES focusses on REC operation , the independent Research Ethics Committee review as described in Governance Arrangements for RECs • the HRA will continue to work with colleagues in the Devolved Administrations to provide a UK wide National Research Ethics Service

  9. Stepping back--- Our journey in the UK • 1982, Institute of Medical Ethics Findings. 254 RECs contacted, 174 (69%) response (Long, T and Johnson, M, Research Ethics in the Real World, Churchill Livingstone, November 2006) • RECs unclear about their task • 153 stated that they expected to review all proposals • 21 replied that it was not compulsory for proposals to be submitted • Only seven provided guidelines • Membership varied from 1 to 73 • 14 had only doctors and nurses on the committee • Nine of these had no nurse currently • 93 had only one lay member

  10. COREC - NRES – HRA history • 2000- Central Office for Research Ethics Committees (MREC and LREC) • 2002 – start work to implement EU Directive (required one decision for UK) • 2004– national systems (standards) • 2007 – NRES launched (protecting and facilitating) • 2008 – IRAS launched (coordination and integration) • 2011– HRA establishment – NRES core division

  11. NHS Research Ethics Committees

  12. Why Research Ethics Committees? • Their purpose: • To protect research participants • To facilitate and promote good quality research • To protect researchers

  13. Research Ethics Committees • Appointed by an “Appointing Authority” (in England HRA) • Recognised by United Kingdom Ethics Committee Authority

  14. The Law, Guidance and RECs RECs deliver an ethical opinion within a legal and Health Departments policy framework. • Policy/guidance: Research Governance Framework ;Governance Arrangements for Research Ethics Committees; NRES SOPs (standard operating procedures) • Law: Handling personal data – the Data Protection Act and common law duty of confidentiality Working with tissue – The Human Tissue Act 2004 European Clinical Trials Regulations – the UK Clinical Trials Regulations 2004 and amended 2006 Research involving those who lack capacity – the Mental Capacity Act 2005 (the Adult with Incapacity Act in Scotland 2001)

  15. What does NHS ethical review involve? • The validity of the research • The welfare of the research subjects • Dignity of the research subject

  16. Decisions by RECs • 5439 applications • 13% favourable • 17% favourable with additional conditions (enables researcher to proceed without a further opinion from the REC) • 64% provisional • 6% unfavourable

  17. NRES REC timelines ( full committee)

  18. NRES proportionate review service • PRS is the sub-committee review of low risk studies • The framework for studies suitable for PRS is reviewed and agreed by the National Research Ethics Advisors Panel • A proportionate approach for low risk studies ( aim 10 working days) • Enables the appropriate focus of full committee resource

  19. Thank you j.fennelly-barnwell@nhs.net 07825 928 414

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