Central Office for Research Ethics Committees (COREC) New system for Research Ethics Committees Sure Start – April 2004 Joan Kirkbride OREC Manager for.

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

Central Office for Research Ethics Committees (COREC)

Any questions?

Central Allocation system tel: 0845 270 4400

See website for uptdate information

www.corec.org.uk

Joan Kirkbride - 07979806425