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Central Office for Research Ethics Committees (COREC)
New system for Research Ethics Committees
Sure Start – April 2004Joan KirkbrideJoan Kirkbride
OREC Manager for North East/North WestOREC Manager for North East/North West
Central Office for Research Ethics Central Office for Research Ethics CommitteesCommittees
Central Office for Research Ethics Committees (COREC)
Driver for change:
EU Directive on Good Clinical EU Directive on Good Clinical Practice in Clinical Trials - Practice in Clinical Trials - 2001/20/EC2001/20/EC
National Standards/SystemsNational Standards/Systems
National Application FormNational Application Form
Standard Operating ProceduresStandard Operating Procedures
Standard LettersStandard Letters
Central Office for Research Ethics Committees (COREC)
EU Directive requires: Before a clinical trial of IMP Before a clinical trial of IMP
commences all studies must be commences all studies must be approved by a research ethics approved by a research ethics committee (REC)committee (REC)
One single ethical opinion for UKOne single ethical opinion for UK RECs must reach a decision within RECs must reach a decision within
60 days60 days RECs permitted only one set of RECs permitted only one set of
questionsquestions
Central Office for Research Ethics Committees (COREC)
GAfRECEthical approval is required for research Ethical approval is required for research
studies which include:studies which include: Patients & users of the NHSPatients & users of the NHS Relatives/carers of NHS patientsRelatives/carers of NHS patients Access to data, organs, and other bodily Access to data, organs, and other bodily
material past & presentmaterial past & present Fetal materialFetal material Recently dead in NHS premisesRecently dead in NHS premises Use or access to NHS premises, andUse or access to NHS premises, and NHS staff as subjectsNHS staff as subjects
Central Office for Research Ethics Committees (COREC)
Research: Ethical Approval - YES
Key Question:Key Question: About generalisable new knowledge - About generalisable new knowledge -
“what is the best thing to do”“what is the best thing to do” Method:Method: Experiments involving drugs, new Experiments involving drugs, new
technology trials or new service deliverytechnology trials or new service delivery Qualitative investigations such as Qualitative investigations such as
interviews, focus groups or observationinterviews, focus groups or observation Novel analysis of routine dataNovel analysis of routine data
Central Office for Research Ethics Committees (COREC)
Research:
Staff involved might include:Staff involved might include: Local researchers.Local researchers. External researchers/organisationsExternal researchers/organisations
Subjects might be:Subjects might be: Patients (or their rcords), carers, Patients (or their rcords), carers,
staff, healthy volunteersstaff, healthy volunteers
Central Office for Research Ethics Committees (COREC)
Quality improvement/Service evaluation: Ethical Approval - MAYBE
Key Question:Key Question: Less generalisable – more developmental Less generalisable – more developmental
issues specific to locality/area of workissues specific to locality/area of work Method:Method: Introduction of new service with formal Introduction of new service with formal
reviewreview Needs assessmentNeeds assessment Market researchMarket research
Central Office for Research Ethics Committees (COREC)
Research:
Staff involved might include:Staff involved might include: Local staffLocal staff External organisationsExternal organisations
Subjects might be:Subjects might be: Patients, users, carers, staff, Patients, users, carers, staff,
general public, external general public, external organisationsorganisations
Central Office for Research Ethics Committees (COREC)
MAYBE:
Contact the REC Contact the REC
Make a phone callMake a phone call Send an emailSend an email Write a letterWrite a letter
Central Office for Research Ethics Committees (COREC)
Audit - No
www.arec.org.ukwww.arec.org.uk
Archive – Newsletter – December Archive – Newsletter – December 20002000
Central Office for Research Ethics Committees (COREC)
Changes in terminology:
Definitions:Definitions: SiteSite DomainDomain Chief InvestigatorChief Investigator Principal InvestigatorPrincipal Investigator TerminologyTerminology Ethical review by a Main RECEthical review by a Main REC Site Specific AssessmentSite Specific Assessment Host R&D Management permissionHost R&D Management permission
Central Office for Research Ethics Committees (COREC)
Electronic application form:
New form is web-based – go to New form is web-based – go to www.corecform.org.ukwww.corecform.org.uk
No need to down-load form, No need to down-load form, complete onlinecomplete online
Facility to print out and email form Facility to print out and email form to others before submissionto others before submission
Section D for R&D will still exist for Section D for R&D will still exist for those Trusts who wish to use itthose Trusts who wish to use it
Central Office for Research Ethics Committees (COREC)
Electronic application form
Those who do not have good web Those who do not have good web access can down-load stand-alone access can down-load stand-alone form with form-filler software from form with form-filler software from COREC site now COREC site now
Stand-alone form will also be Stand-alone form will also be available on disc from available on disc from administratorsadministrators
Central Office for Research Ethics Committees (COREC)
Electronic Form - structure
• Sections A&B – ethical review• Section C – site specific
assessment
• Section D – R&D management approval (optional)
Central Office for Research Ethics Committees (COREC)
How to apply: All studies must be booked in All studies must be booked in
advance by telephone when an advance by telephone when an agenda slot will be allocated and a agenda slot will be allocated and a reference number will be givenreference number will be given
All applications must be made All applications must be made using the new COREC form, this using the new COREC form, this will be compulsorywill be compulsory
Central Office for Research Ethics Committees (COREC)
Clinical trial of a medicinal product
Study taking place in more than one domain
Multisite within one single domain
Single site study
Central allocation system
Central allocation system
Local REC
Local REC
YES
NO
NO
NO
YES
YES
YES
Central Office for Research Ethics Committees (COREC)
Where to apply after 1st March 2004?
All All clinical trials with medicinal clinical trials with medicinal productsproducts have to go to a have to go to a ‘‘recognisedrecognised’’ REC REC - even single site studies- even single site studies
All All clinical trials with medicinal clinical trials with medicinal productsproducts have to be booked in have to be booked in through our central booking through our central booking system in Londonsystem in London
Central Office for Research Ethics Committees (COREC)
Where to apply: All other multisite studies which take All other multisite studies which take
place in more than one domain also place in more than one domain also have to go to a ‘have to go to a ‘recognisedrecognised’ REC via ’ REC via our central booking systemour central booking system
Multisite studies within one single Multisite studies within one single domain can go to any LREC in that domain can go to any LREC in that areaarea
Single site studies excluding all Single site studies excluding all clinical trials of medicinal products clinical trials of medicinal products can go to their nearest RECcan go to their nearest REC
Central Office for Research Ethics Committees (COREC)
After March 2004: Multicentre Research Ethics Multicentre Research Ethics
Committees (MRECs)Committees (MRECs)
‘‘Recognised’Recognised’ RECs RECs
‘‘AuthorisedAuthorised’ RECs’ RECs
Central Office for Research Ethics Committees (COREC)
Validation criteria:
Official current application formOfficial current application form Plus supporting documentationPlus supporting documentation Application completeApplication complete Funding where applicableFunding where applicable Dates and version numbersDates and version numbers signaturessignatures
Central Office for Research Ethics Committees (COREC)
Interface between R&D and Ethics
Peer Rev ieworganised by T rust
T rust Indem nity
F inal approval from R&D underResearch Governance
Approval from REC
Subm ission to Research E thics Com m ittee
Registration with R&D O fficeInitial approval from R&D
Initial registration with R&D
Peer review
Submission to REC
Indemnity
Approval from REC
Final approval from R&D
Central Office for Research Ethics Committees (COREC)
New system – in parallel
2+ sites
MREC LREC LREC
60 day limit
30 day limit
Central Office for Research Ethics Committees (COREC)
LRECs - Site specific assessment
• Suitability of the local researcher• Appropriateness of the local
research environment and facilities• Specific issues relating to the local
community
Central Office for Research Ethics Committees (COREC)
Decision Making Process
Favourable OpinionFavourable Opinion
Unfavourable OpinionUnfavourable Opinion
Provisional DecisionProvisional Decision