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Research ethics - 09 May 2014

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Presentation on research ethics for research awareness workshop for clinicians hosted by Anglia Ruskin University on 09 May 2014.

Presentation on research ethics for research awareness workshop for clinicians hosted by Anglia Ruskin University on 09 May 2014.

Published in: Education, Business, Technology

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Transcript

  • 1. Research Ethics Dr Leslie Gelling, Reader in Nursing, FHSCE
  • 2. 1. Why is it important for researchers to consider research ethics?
  • 3. 1800 20001850 1900 1950 Pre-WWII (1803 - 1939) Nazi Germany & WWII (1939 - 1947) Post WWII (1947 - 1964) Recent events (1964 - 2014) The future (2014 -)Uncontrolled experimentation 500BC Hippocrates 210AD Galen 1543 Andreas Vesalius 1620 Sir Frances Bacon 1628 Sir William Harvey 1721 Newgate Prison
  • 4. 2. Does all research need research ethics approval?
  • 5. 3. How many applications would I need to make?
  • 6. 4. Where should I apply for research ethics approval? Ethical approval NHS/NRES Other University Research involving NHS staff
  • 7. Integrated Research Application System (IRAS) Administration of Radioactive Substances Advisory Committee (ARSAC) Gene Therapy Advisory Committee (GTAC) Medicines and Healthcare products Regulatory Agency (MHRA) Ministry of Justice (National Offender Management Service) NHS / HSC research offices NRES/ NHS / HSC Research Ethics Committees National Information Governance Board for Health and Social Care (NIGB) Social Care Research Ethics Committee
  • 8. 5. Can I apply to any NHS REC? 12 81
  • 9. 6. Are there different types of review? Proportionate Review Full Ethical Review 13
  • 10. Proportionate review?
  • 11. 7. How long does ethical review take?
  • 12. 0 50 100 150 200 250 300 350 0 - 5 6 - 10 11 - 15 16 - 20 21 - 25 26 - 30 31 - 35 36 - 40 41 - 45 46 - 50 51 - 55 56 - 60 61 - 65 66 - 70 71 - 75 76 - 80 81 - 85 Frequency Days to Review Time taken to complete review (PR)
  • 13. 0 200 400 600 800 1000 0 - 5 6 - 10 11 - 15 16 - 20 21 - 25 26 - 30 31 - 35 36 - 40 41 - 45 46 - 50 51 - 55 56 - 60 61 - 65 66 - 70 71 - 75 76 - 80 81 - 85 86 - 90 91 - 95 96 - 100 101 - 105 106 - 110 111 - 115 Frequency Days to Review Time taken to complete review (Excluding PR)
  • 14. 1. Book an agenda slot (allocation system) 2. Approvals and submit 3. REC co-ordinator with validate application and start 60- day clock 4. Applications sent to all members of the REC/Leads 5. Meeting … with researchers in attendance 6. Informed of outcome 7. Respond to review 8. Informed of final opinion 8. How will the application be managed?
  • 15. 9. What are the possible outcomes from the review? Favourable opinion Favourable opinion with conditions Provisional opinion No opinion Unfavourable opinion
  • 16. Favourable Unfavourable Favourable with AC Provisional 0% 10% 20% 30% 40% 50% 60% 70% 80% Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Decision at first review (percent)
  • 17. 10. What do RECs look for? Risks to research participants Risks to researchers Freely given informed consent The science Ethical research
  • 18. Research Governance “Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and social Care.”
  • 19. Thank you leslie.gelling@anglia.ac.uk www.twitter.com/Leslie_Gelling