1 / 26

New system for Research Ethics Committees Sure Start - April 2004

This system introduces a new approach for Research Ethics Committees (RECs) to expedite the approval process for clinical trials, in compliance with the EU Directive on Good Clinical Practice. It aims to provide a single ethical opinion within 60 days, ensuring efficient decision making and promoting ethical research practices. The system also addresses ethical approval requirements for various research studies involving patients, users of the NHS, and access to data and NHS premises.

hal
Download Presentation

New system for Research Ethics Committees Sure Start - April 2004

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. New system for Research Ethics CommitteesSure Start - April 2004 Maureen Thrupp OREC Manager for West Midlands 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. Evaluation and how it fits in: • Socially sensitive areas (education, health and social issues) • Post natal depression • Breastfeeding • Health related work • Targets and how that impacts on research

  11. Evaluation and how it fits in: • Who is doing the work • Who is the sample size and where are you finding them (parents, children and evaluators) • Use of contact details • Confidentiality • R&D and ethics

  12. 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:

  13. 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

  14. 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

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

  16. 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

  17. 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

  18. 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

  19. 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

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

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

  22. 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

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

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

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

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

More Related