Research Governance Lecture


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Research Governance Lecture

  1. 1. Introduction to Research Governance for NHS Research
  2. 2. Session Objectives <ul><li>Introduction of the Research Governance Framework. </li></ul><ul><li>Awareness of what is required by the Research Governance Framework. </li></ul><ul><li>Be informed regarding the process for obtaining Research Governance approval. </li></ul>
  3. 3. Agenda <ul><li>Definition & history of Research Governance Framework. </li></ul><ul><li>What is it? </li></ul><ul><li>What is involved? </li></ul><ul><li>Where to get further information </li></ul>
  4. 4. Research Governance Framework The Definition <ul><li>“ Research Governance improves research </li></ul><ul><li>quality and safeguards the public by: </li></ul><ul><li>Enhancing ethical and scientific quality, </li></ul><ul><li>Promoting good practice, </li></ul><ul><li>Reducing adverse incidents and ensuring lessons are learned, </li></ul><ul><li>Preventing poor performance and misconduct” </li></ul>
  5. 5. History <ul><li>Research Ethics Committees in use since 1966 – direct response to WWII atrocities. </li></ul><ul><li>Research Governance implemented in 2001 – direct response to Bristol and Alder Hey investigations into retained organs scandals. </li></ul><ul><li>Both Ethics & R&D approval need to be obtained before research commences </li></ul>
  6. 6. What is Research Governance? <ul><li>A framework in which approval from an NHS Trust (Acute or PCT) and Ethics Committee is sought to undertake research within that Institution. </li></ul>
  7. 7. What is Involved? <ul><li>Peer review. </li></ul><ul><li>Ethics Committee approval. </li></ul><ul><li>Data Protection </li></ul><ul><li>Staff Contracts. </li></ul><ul><li>Indemnity </li></ul><ul><li>Financial Probity </li></ul><ul><li>Dissemination of Results </li></ul>
  8. 8. Peer Review <ul><li>All proposals must be subjected to review by experts in the relevant fields able to offer independent advice on its quality. </li></ul><ul><li>For many student research projects the university supervisor may provide an adequate level of review.' </li></ul><ul><li>In all cases, researchers should check local requirements. </li></ul>
  9. 9. Research Ethics Committee Approval <ul><li>Create a user account with COREC </li></ul><ul><li>Complete online Ethics Committee application form – COREC website. </li></ul><ul><li>Single centre study - parts A, B & C </li></ul><ul><li>Multi centre study –parts A & B and a part C for each centre. </li></ul>
  10. 10. Research Ethics Committee Approval <ul><li>Send COREC form electronically to REC within 4 days of booking REC submission! </li></ul><ul><li>Send signed hard copy of form, research protocol and CV’s to REC. </li></ul><ul><li>You will be sent a letter of receipt of your application and invited to attend the meeting. </li></ul>
  11. 11. Research Ethics Committee Approval <ul><li>After meeting you will receive a letter stating whether you have approval / conditional approval or rejection of your project. </li></ul><ul><li>NB – Both Ethics & Trust approval are conditional upon you obtaining approval from the other party! </li></ul>
  12. 12. Data Protection <ul><li>Data Protection Act (DPA) 1998 has strengthened the rights of patients to privacy of their personal information. </li></ul><ul><li>The DPA only relates to live patients and not deceased. </li></ul><ul><li>The Act does not relate to anonymised data. </li></ul><ul><li>It applies to manually held records as well as electronic records. </li></ul>
  13. 13. Data Protection <ul><li>Patient identifiable data must be held securely. </li></ul><ul><li>Electronic data must be password protected. </li></ul><ul><li>Identifiable data must not be stored on PC hard drives/laptops. </li></ul>
  14. 14. Staff Employment Contracts <ul><li>Everyone involved in research within a Trust or PCT involving patients, tissues or samples, or identifiable patient/staff data must hold a substantive or honorary contract with NHS Organisation. </li></ul><ul><li>Health and security clearances (CRB checks) are required.  </li></ul>
  15. 15. Staff Employment Contracts <ul><li>Employees from organisations outside the Trust cannot access patients, identifiable tissues, samples or data unless they hold an honorary contract. </li></ul>
  16. 16. Indemnity <ul><li>All staff holding a contract with an NHS Trust/PCT are covered by CNST insurance for negligence. </li></ul>
  17. 17. Financial Probity <ul><li>Use of Public Funds for research demand financial probity – rules set down by H.M. Treasury. </li></ul><ul><li>Local signatures or checks may be required by R&D Dept relating to research funding – check locally. </li></ul>
  18. 18. Dissemination of Results <ul><li>All NHS research to be registered on the National Research Register – publicly accessible database. </li></ul><ul><li>Results of research MUST be published and disseminated to wider audience. </li></ul><ul><li>Research is not ethical / justifiable if results not published. </li></ul>
  19. 19. Where do I start – R&D Approval? <ul><li>Trust R&D Office will require a copy of parts A, B & C of the Ethics application form plus the national NHS R&D form.* </li></ul><ul><li>NHS R&D form is accessed via COREC web account. </li></ul><ul><li>Internal signatures/authorisations will usually be required*. </li></ul><ul><li>* Check local R&D Office requirements </li></ul>
  20. 20. The Application Process <ul><li>Apply to Trust R&D & REC in parallel. </li></ul><ul><li>Contact local R&D Dept as soon as possible to discuss local requirements for R&D approval. </li></ul><ul><li>Remember – Both Ethics & Trust approval are conditional upon you obtaining approval from the other party! </li></ul>
  21. 21. Reports <ul><li>A project report must be sent to the REC annually and/or at the end of the project whichever is soonest. </li></ul><ul><li>Trust R&D Offices monitor a random 10% sample of research projects. </li></ul><ul><li>Inform R&D Dept when project has completed. </li></ul>
  22. 22. Issues affecting Student Research <ul><li>Who is the sponsor? </li></ul><ul><ul><li>Usually will be Co-Sponsored by the University & Trust. </li></ul></ul><ul><li>Who is the Chief Investigator </li></ul><ul><ul><li>Your supervisor. </li></ul></ul>
  23. 23. The Warner Report 2005 <ul><li>The “Warner” Report published 2005 made recommendations for the re-organisation of REC’s. </li></ul><ul><li>It is proposed that Student projects will not be required to go to full REC but are reviewed by new National REC Advisors. </li></ul><ul><li>The consultation on the Implementation Plan for the recommendations of the Warner Report closed 21 st April 2006 </li></ul>
  24. 24. Conclusion <ul><li>You will need to provide evidence of peer review – your supervisor will help with this. </li></ul><ul><li>Start early! Contact R&D & Ethics ASAP – full ethics approval can take up to 60 days. </li></ul><ul><li>Use Trust R&D contacts for advice & guidance through process. </li></ul><ul><li>Keep informed re progress of REC organisational changes. </li></ul>
  25. 25. Where to get more information <ul><li>Central Office for Research Ethics Committees web site </li></ul><ul><li>Department of Health Research Governance Framework </li></ul><ul><li>Local R&D Office </li></ul><ul><li>Your Supervisor! </li></ul>