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The Research Ethics Process

The Research Ethics Process. RPT Conference 28 th April 2006. Presentation Aims. To explain how to use the process in order to apply for ethical approval Clarify use of the online form Clarify FAQs. What do you mean I have to complete the COREC form…. This is only:

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The Research Ethics Process

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  1. The Research Ethics Process RPT Conference 28th April 2006

  2. Presentation Aims • To explain how to use the process in order to apply for ethical approval • Clarify use of the online form • Clarify FAQs

  3. What do you mean I have to complete the COREC form….. This is only: • A ‘little’ piece of research!! • A simple study!! • A questionnaire study!! • A staff study!! • An observational study!!

  4. What is a Research Ethics Committee (REC)? • Lay, expert clinical and non-clinical members (Max 18 members, Hull currently have 16 inc. 5 lay members) • Provide independent advice to participants, researchers, funding bodies, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards • The purpose of a REC in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants

  5. EU Directive2001/20/EC • Requirements the directive sets for ethical review are: • deliver a decision on a valid application within 60days (valid application received the clock starts) • one decision to be valid for the whole of the UK • one written request for clarification or further information to applicants(clock stops whilst waiting for response)

  6. The Ethical Review process • All RECs meet on a monthly basis to ensure that decisions can be made within the 60 day time frame. • Applicants will be invited to attend the meeting in support of their applications (attendance is not compulsory)

  7. The Ethics Review Process • Contact appropriate R&D dept • Write Research Protocol / Proposal • Complete COREC On-line form & R&D On-line form • Submit to REC with Supporting Documents • Ethical Review Carried out by Committee -- after Favourable Opinion • Trust Approval gained

  8. The COREC On-Line Form • www.corec.org.uk • Print off Guidance for Applicants document as reference tool • Use link to create a tailor made application form • Input user name and a pass word to create your own secure account

  9. The Filter Page • 6 Questions • IMPORTANT! Answer carefully as these questions determine the pages of the form •  -- The information icon allows applicant to clarify each question

  10. The COREC On-Line Form • REC Reference number & Submission date – complete form and enter this information later • Answer all Questions in Full • Section A59 – Sponsor details Application not valid without this information

  11. The COREC On-Line Form • Section A35 – 36 Indemnity Application not valid without this information • Signatures in Ink – Application not valid without the signatures • Separate Research Protocol / Proposal document

  12. Supporting Documents • REC must review all documents to be used in the study • Version number and date on supporting documents– document not valid without this information • CV for Chief Investigator (& Ed. Supervisor if student application)

  13. Ready for Submission? • When documents are complete a REC Reference number can be allocated • If CTIMP study application must be booked through Central Allocations System (0845 270 4400) • If “other” study book direct with LREC (Hull 01482 389246)

  14. Deadline Date • LREC Must receive application documents before the deadline date (submission date) in order to process the documents and prepare them for review by committee members • Deadline date is the VERY LAST date documents can be submitted

  15. Validation Process • LREC Coordinator carries out validation process • If application not valid then documents will be returned to investigator with letter • If application valid – put forward to the next meeting and information sent out to all members for reading

  16. THE LREC Meeting • All members review all studies • Lead 1 and Lead 2 reviewers allocated to look at each study in detail • Investigator in attendance – answer questions – saves time • No decision given at meeting

  17. Decisions • Favourable Opinion • Provisional Opinion • Unfavourable Opinion • No decision – Expert Referee Opinion Sought

  18. Conditions of Approval • Adverse Events Reports • Protocol Amendments • Annual Progress Report • Declaration of End of Study • Final Report

  19. Don’t Panic!! • LREC Office is open 9am – 4.30pm • Room SC39 Coniston House Willerby (HMHT NHS Trust HQ) • Happy to help

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