Central Office for Research Ethics Committees (COREC) 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

Central Office for Research Ethics Committees (COREC) Driver for change: EU Directive on Good Clinical Practice in Clinical Trials /20/EC EU Directive on Good Clinical Practice in Clinical Trials /20/EC National Standards/Systems National Standards/Systems National Application Form National Application Form Standard Operating Procedures Standard Operating Procedures Standard Letters Standard Letters

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

Central Office for Research Ethics Committees (COREC) GAfREC Ethical approval is required for research studies which include: Patients & users of the NHS Patients & users of the NHS Relatives/carers of NHS patients Relatives/carers of NHS patients Access to data, organs, and other bodily material past & present Access to data, organs, and other bodily material past & present Fetal material Fetal material Recently dead in NHS premises Recently dead in NHS premises Use or access to NHS premises, and Use or access to NHS premises, and NHS staff as subjects NHS staff as subjects

Central Office for Research Ethics Committees (COREC) Research: Ethical Approval - YES Key Question: Key Question: About generalisable new knowledge - “what is the best thing to do” About generalisable new knowledge - “what is the best thing to do” Method: Method: Experiments involving drugs, new technology trials or new service delivery Experiments involving drugs, new technology trials or new service delivery Qualitative investigations such as interviews, focus groups or observation Qualitative investigations such as interviews, focus groups or observation Novel analysis of routine data Novel 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/organisations External researchers/organisations Subjects might be: Subjects might be: Patients (or their rcords), carers, staff, healthy volunteers Patients (or their rcords), carers, staff, healthy volunteers

Central Office for Research Ethics Committees (COREC) Quality improvement/Service evaluation: Ethical Approval - MAYBE Key Question: Key Question: Less generalisable – more developmental issues specific to locality/area of work Less generalisable – more developmental issues specific to locality/area of work Method: Method: Introduction of new service with formal review Introduction of new service with formal review Needs assessment Needs assessment Market research Market research

Central Office for Research Ethics Committees (COREC) Research: Staff involved might include: Staff involved might include: Local staff Local staff External organisations External organisations Subjects might be: Subjects might be: Patients, users, carers, staff, general public, external organisations Patients, users, carers, staff, general public, external organisations

Central Office for Research Ethics Committees (COREC) MAYBE: Contact the REC Contact the REC Make a phone call Make a phone call Send an Send an Write a letter Write a letter

Central Office for Research Ethics Committees (COREC) Audit - No Archive – Newsletter – December 2000 Archive – Newsletter – December 2000

Central Office for Research Ethics Committees (COREC) Changes in terminology: Definitions: Site Domain Chief Investigator Principal Investigator Terminology Ethical review by a Main REC Site Specific Assessment Host 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 No need to down-load form, complete online No need to down-load form, complete online Facility to print out and form to others before submission Facility to print out and form to others before submission Section D for R&D will still exist for those Trusts who wish to use it Section D for R&D will still exist for those Trusts who wish to use it

Central Office for Research Ethics Committees (COREC) 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 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 Stand-alone form will also be available on disc from administrators

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 advance by telephone when an agenda slot will be allocated and a reference number will be given 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 All applications must be made using the new COREC form, this will 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 Local REC YES NO YES

Central Office for Research Ethics Committees (COREC) Where to apply after 1 st 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 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 All clinical trials with medicinal products have to be booked in through our central booking system in London

Central Office for Research Ethics Committees (COREC) 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 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 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 Single site studies excluding all clinical trials of medicinal products can go to their nearest REC

Central Office for Research Ethics Committees (COREC) After March 2004: Multicentre Research Ethics Committees (MRECs) Multicentre Research Ethics Committees (MRECs) ‘Recognised’ RECs ‘Recognised’ RECs ‘Authorised’ RECs ‘Authorised’ RECs

Central Office for Research Ethics Committees (COREC) Validation criteria: Official current application form Official current application form Plus supporting documentation Plus supporting documentation Application complete Application complete Funding where applicable Funding where applicable Dates and version numbers Dates and version numbers signatures signatures

Central Office for Research Ethics Committees (COREC) 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

Central Office for Research Ethics Committees (COREC) New system – in parallel 2+ sites MREC 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 Opinion Favourable Opinion Unfavourable Opinion Unfavourable Opinion Provisional Decision Provisional Decision

Central Office for Research Ethics Committees (COREC) Any questions? Central Allocation system tel: See website for uptdate information Joan Kirkbride