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New system for Research Ethics Committees Sure Start – April 2004

New system for Research Ethics Committees Sure Start – April 2004. Joan Kirkbride OREC Manager for North East/North West Central Office for Research Ethics Committees. Driver for change:. EU Directive on Good Clinical Practice in Clinical Trials - 2001/20/EC National Standards/Systems

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New system for Research Ethics Committees Sure Start – April 2004

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  1. New system for Research Ethics CommitteesSure Start – April 2004 Joan Kirkbride OREC Manager for North East/North West Central Office for Research Ethics Committees

  2. Driver for change: • EU Directive on Good Clinical Practice in Clinical Trials - 2001/20/EC • National Standards/Systems National Application Form Standard Operating Procedures Standard Letters

  3. EU Directive requires: • Before a clinical trial of IMP commences all studies must be approved by a research ethics committee (REC) • One single ethical opinion for UK • RECs must reach a decision within 60 days • RECs permitted only one set of questions

  4. GAfREC Ethical approval is required for research studies which include: • Patients & users of the NHS • Relatives/carers of NHS patients • Access to data, organs, and other bodily material past & present • Fetal material • Recently dead in NHS premises • Use or access to NHS premises, and • NHS staff as subjects

  5. Research: Ethical Approval - YES • Key Question: • About generalisable new knowledge - “what is the best thing to do” • Method: • Experiments involving drugs, new technology trials or new service delivery • Qualitative investigations such as interviews, focus groups or observation • Novel analysis of routine data

  6. Research: • Staff involved might include: • Local researchers. • External researchers/organisations • Subjects might be: • Patients (or their rcords), carers, staff, healthy volunteers

  7. Quality improvement/Service evaluation: Ethical Approval - MAYBE • Key Question: • Less generalisable – more developmental issues specific to locality/area of work • Method: • Introduction of new service with formal review • Needs assessment • Market research

  8. Research: • Staff involved might include: • Local staff • External organisations • Subjects might be: • Patients, users, carers, staff, general public, external organisations

  9. MAYBE: • Contact the REC • Make a phone call • Send an email • Write a letter

  10. Audit - No • www.arec.org.uk • Archive – Newsletter – December 2000

  11. Definitions: Site Domain Chief Investigator Principal Investigator Terminology Ethical review by a Main REC Site Specific Assessment Host R&D Management permission Changes in terminology:

  12. Electronic application form: • New form is web-based – go to www.corecform.org.uk • No need to down-load form, complete online • Facility to print out and email form to others before submission • Section D for R&D will still exist for those Trusts who wish to use it

  13. Electronic application form • Those who do not have good web access can down-load stand-alone form with form-filler software from COREC site now • Stand-alone form will also be available on disc from administrators

  14. Electronic Form - structure • Sections A&B – ethical review • Section C – site specific assessment • Section D – R&D management approval (optional)

  15. How to apply: • All studies must be booked in advance by telephone when an agenda slot will be allocated and a reference number will be given • All applications must be made using the new COREC form, this will be compulsory

  16. Clinical trial of a medicinal product YES Central allocation system NO YES Study taking place in more than one domain Central allocation system NO YES Multisite within one single domain Local REC NO YES Single site study Local REC

  17. Where to apply after 1st March 2004? • All clinical trials with medicinal products have to go to a ‘recognised’ REC - even single site studies • All clinical trials with medicinal products have to be booked in through our central booking system in London

  18. Where to apply: • All other multisite studies which take place in more than one domain also have to go to a ‘recognised’ REC via our central booking system • Multisite studies within one single domain can go to any LREC in that area • Single site studies excluding all clinical trials of medicinal products can go to their nearest REC

  19. After March 2004: • Multicentre Research Ethics Committees (MRECs) • ‘Recognised’ RECs • ‘Authorised’ RECs

  20. Validation criteria: • Official current application form • Plus supporting documentation • Application complete • Funding where applicable • Dates and version numbers • signatures

  21. Interface between R&D and Ethics Initial registration with R&D Peer review Submission to REC Indemnity Approval from REC Final approval from R&D

  22. New system – in parallel 2+ sites LREC LREC MREC 30 day limit 60 day limit

  23. LRECs - Site specific assessment • Suitability of the local researcher • Appropriateness of the local research environment and facilities • Specific issues relating to the local community

  24. Decision Making Process • Favourable Opinion • Unfavourable Opinion • Provisional Decision

  25. Any questions? Central Allocation system tel: 0845 270 4400 See website for uptdate information www.corec.org.uk Joan Kirkbride - 07979806425

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