3. Commencement and termination dates by x60Wgw

VIEWS: 10 PAGES: 35

									SCHOOL OF HEALTHCARE STUDIES
Ysgol Astudiaethau Gofal Iechyd


RESEARCH ETHICS HANDBOOK



ACADEMIC YEAR 2006/7




                                  -1-
Contents                                              Page number



Introduction                                              3

The School Ethics Officer                                 4

Undergraduate Student Procedure                           5

Postgraduate Taught Students, Postgraduate Research
Students and Staff Procedure                              6

Fast Track Procedure                                      7

Application Procedures Flow Charts                        7

Monitoring Procedures                                     8

Research v Audit                                          8

The Role of NHS Trust R & D offices                       9

The Role of COREC/MREC/LREC                               9

Research Governance/Sponsorship                           10

Data Protection                                           14

Useful contacts                                           13

Appendix                                                  15




                                                                    -2-
INTRODUCTION

This Handbook details the School of Healthcare Studies ethics approval procedures for all staff and
students intending to carry out research or audit projects.

The intention is that the Handbook provides clear and straightforward guidance. However, if you require
clarification or further information please do not hesitate to contact Paul Brown, School Ethics Officer, or
Liz Harmer, Research Administrator.




Paul Brown                                                          Liz Harmer
School Ethics Officer                                               Research Administrator
Room 4.9                                                            Room GF3/C
Ty Dewi Sant                                                        Ty Dewi Sant
Ext: 4599                                                           Ext: 2907
Email: brownpn@cf.ac.uk                                             Email: harmerl@cf.ac.uk




                                                                                                        -3-
THE SCHOOL ETHICS OFFICER
At the request of the University the Head of School has appointed a School Ethics Officer responsible for
the management of ethical issues in research in the School. The responsibilities of the Officer are as
follows:


      ensuring that there are effective mechanisms to bring any policy, guidelines or procedures
       developed with or through the University Research Ethics Committee (UREC) and the School
       Research Ethics sub- Committee to the attention of staff and students for whom the School is
       responsible. These mechanisms are intended to clarify that it is a University requirement that
       these policies, guidelines and procedures are followed:

      to Chair the School Research Ethics sub-Committee;

      keeping under review School ethical issues in research;

      to advise school staff with regard to research ethics issues (students should primarily be advised
       by their supervisor/s;

      in conjunction with the Research Administrator managing and monitoring the procedures
       established within the School;

      in conjunction with the Research Administrator ensuring that appropriate records of applications,
       practices and decisions are retained within the School;

      reporting to the Head of School as appropriate;

      reporting to the School via appropriate fora;

      reporting, on an annual basis, on behalf of the School to the University Research Ethics
       Committee (UREC);

      conducting a three yearly review of School ethical procedures and reporting the outcome to
       UREC.




                                                                                                        -4-
UNDERGRADUATE STUDENT PROCEDURE
Application Process
All dissertation proposals need to be subjected to scrutiny and approval by the School. In order to manage
this process the School had agreed that each Department will establish a Departmental Undergraduate
Ethics Group. These Groups are responsible for reviewing the scientific validity and ethical requirements
of all Undergraduate dissertation proposals within a Department. All undergraduate students are
therefore required to complete a research proposal form (see appendix 1). This completed proposal form
must be submitted to the relevant Departmental Undergraduate Ethics Group, two weeks prior to the date
of the departmental meeting.

Timings of Meetings
Meeting dates will be published on the School web site and publicised to undergraduate students at the
appropriate stage during their programme of study.

Membership
Chair
Vice Chair
Representative from another department within the School
5 Representatives from within the department

Terms of Reference
   1. To review the scientific validity of the proposed research in relation to the School’s Research
      Strategy;
   2. To review the ethical requirements of the proposed research;
   3. To give written approval for research proposals in the form of minutes or to provide written
      information as to why approval has not been given;
   4. To consider revised submissions;
   5. To consider referred submissions;
   6. To report to the School Research Ethics sub-Committee on the outcome of applications;
   7. To refer to the School Research Ethics sub-Committee cases which cannot be satisfactorily
      resolved or about which there is uncertainty;
   8. Meetings will be deemed quorate if five members are present, including the Chair, or the Vice
      Chair in the Chair’s absence.


Outcomes
  1. Pass and proceed with research;
  2. Pass and inform Trust R & D;
  3. Pass and inform Trust R & D and then seek ethical approval;
  4. Proceed with amendments, to be approved by Chair and one other;
  5. Proposal rejected.

Reporting procedure
A brief report of the applications considered and the outcome is sent to the Research Administrator within
two weeks of the meeting and will be presented to the Research Ethics sub-Committee at its next meeting.




                                                                                                        -5-
POSTGRADUATE TAUGHT STUDENTS,
POSTGRADUATE RESEARCH STUDENTS AND
STAFF PROCEDURE
Application Process

Postgraduate Taught Students
All dissertation proposals need to be subjected to scrutiny and approval by the School. All postgraduate
students are required to complete the research proposal form (see appendix 1); this research proposal is
considered at a meeting of the School Research Ethics sub-Committee, which is a sub-Committee of the
Research Committee. All proposal forms are submitted to the Research Administrator no later than three
weeks prior to the date of the meeting to which the proposal form is to be submitted.

Postgraduate Research Students
Scrutinisation of the scientific validity of all postgraduate research students proposed research is an
integral part of the admissions process and is carried out by individuals both within and external to the
School. However, there is a need for the School to undertake a review of the ethical requirements of the
project. All postgraduate research students are required to complete the research proposal form (see
appendix 1). This proposal is considered by the School Research Ethics sub-Committee, which is a sub-
Committee of Research Committee. All proposal forms are submitted to the Research Administrator no
later than three weeks prior to the date of the meeting to which the proposal form is to be submitted.

Staff
There is a need for the School to scrutinise the scientific validity of, and the ethical requirements of all
research being proposed within the School. All staff proposing to undertake research projects are
required to complete the research proposal form (see appendix 1). This proposal is considered by the
School Research Ethics sub-Committee, which is a sub-Committee of Research Committee. All proposal
forms are submitted to the Research Administrator no later than three weeks prior to the date of the
meeting to which the proposal form is to be submitted.

For all applications a lead reviewer will be appointed to review the application and will be required to
submit a brief written report (Appendix ii) to the School Research Ethics sub-Committee.

Timings of Meetings
The School Research Ethics sub-Committee will meet every 2 months, the meeting dates will be
publicised on the School website.

Membership
Chair (School Ethics Officer)
Vice Chair
Director of Postgraduate Healthcare Studies and Continuing Education
Director of Research
Chairs of Departmental Undergraduate Ethics Group, or appointed nominee
Representative from another School
One lay member, who is not an employee of the University

Terms of Reference
   1. To review the scientific validity of the proposed research in relation to the School’s Research
      Strategy;
   2. To review the ethical requirements of the proposed research;


                                                                                                           -6-
   3. To give written approval for such proposals in the form of minutes or provide written information
      as to why approval has not been given;
   4. To consider revised submissions;
   5. To consider referred submissions;
   6. To refer to the University Research Ethics Committee cases which cannot be satisfactorily
      resolved or about which there is uncertainty;
   7. To advise Research Committee on the development and sustainability of school-wide awareness
      of ethical issues;
   8. Meetings will be deemed quorate if five members are present, including the Chair, or the Vice
      Chair in the Chair’s absence


Outcomes
  1 Pass and proceed with research
  2 Pass and inform trust R & D
  3 Pass and inform trust R & D and seek ethical approval from appropriate LREC
  4 Pass and inform trust R & D and seek ethical approval from MREC
  5 Proceed with amendments, to be approved by Chair and one other
  6 Proposal rejected

Reporting Procedure
The minutes of the meetings are presented to the School Research Committee




FAST TRACK PROCEDURE
If a proposal is initially deemed to be unproblematic by the, for undergraduate research proposals the
Chair of the appropriate Departmental Undergraduate Ethics Group; for all other applications the Chair of
the School Research Ethics sub-Committee, the research proposal may be considered without a meeting.
Only in the following cases can the fast track procedure be initiated;
      In the case of undergraduate proposals this may be when the student is proposing carrying out
        research on fellow students;
      In the case of staff applications this may be when an application is being submitted to a funding
        body where the deadline for the receipt of applications is imminent.

In all cases the research proposal must be vetted by the Chair of the appropriate Departmental Group or
School sub-Committee, whichever is appropriate, and one other member of the appropriate Group/sub-
Committee. In cases where a consensus can not be reached the research proposal will be considered at
the next meeting of the appropriate sub-Group/sub-Committee. Where a research proposal is approved
the matter is reported to the next meeting of the sub-Group/sub-Committee.




                                                                                                     -7-
APPLICATION PROCEDURES FLOW CHARTS

                     School of Healthcare Studies
                      Undergraduate Procedure



                  Application submitted to Department
                   two weeks prior to the date of the
                  Departmental Undergraduate Ethics
                                 Group




                         Application discussed at
                         departmental meeting

                                                           Application
                                                            rejected
 Pass proceed
 with research


                                                        Amendments
                                                         required to
                  Pass proceed        Pass proceed        proposal
                  with research       with research
                 subject to R&D        subject to
                    approval            R&D and
                                      REC approval




                       See flow diagrams
                       on pages 10 & 11




                                                                       -8-
                      School of Healthcare Studies
                    Postgraduate and Staff Procedure




                      Application submitted to Research
                    Administrator three weeks prior to the
                    date of the School Research Ethics sub
                                  Committee




                            Application discussed at
                            SREC meeting

                                                                  Application
                                                                   rejected
Pass proceed
with research


                                                               Amendments
                                                                required to
                                    Pass proceed                 proposal
                 Pass proceed
                                    with research
                 with research
                                     subject to
                subject to R&D
                                      R&D and
                   approval            LREC
                                      approval          Pass proceed
                                                        with research
                                                         subject to
                                                         R&D and
                                                       MREC approval
                          See flow diagrams
                          on pages 10 & 11




                                                                              -9-
                                         Single Site Studies

                                  Chief Investigator (C.I.) submits
                                   documentation to R&D office
                                   http://www.corecform.org.uk
                                     http://www.rdform.org.uk




                                          R&D office provides interim
                                     permission to proceed with application



R&D office finalises contracts,
  agreements and internal                             C.I. submits to REC
       arrangements



                                                       REC validates and
                                                      reviews submission




                         REC gives favourable             OR          REC asks Chief Investigator
                               opinion                                   one set of questions




              Formal Full R&D                                     Chief Investigator responds to
                 Approval                                        REC (after discussion with R&D
                                                                 where appropriate) and provides
                                                                 R&D office with updated versions
                                                                 of documentation if any changes
                                                                         have been made
              Study may start




                                                                                                    - 10 -
                                         Multi-centre Studies

    Ethics Approval                                               R&D Approval

  Chief Investigator (C.I.)

  submits documentation to

  local R&D Office at lead site

  http://www.corecform.org.uk
 http://www.rdform.org.uk
R&D office provides interim

permission to proceed with

application

C.I. submits forms A + B to
REC for single Ethics opinion                                    P.I. makes early contact with
                                                                R&D office when they expect to
                                                                  participate in a multi-centre
                                                                        study. PI submits
REC validates submission, C.I. tells       AT THE SAME           documentation to R&D office
  Principal Investigators (P.I.) to            TIME              http://www.corecform.org.uk
submit Form C and the PI’s CV for                                  http://www.rdform.org.uk
 site specific assessment (SSA)
     http://www.corec.org.uk

                                                                 R&D office finalises contracts,
                                                                   agreements and internal
                                                                        arrangements
REC informs C.I. that study has a
favourable Ethics opinion & lists
local approved sites. (Subsequent         P.I. submits REC approval
letters + annexes will be sent to C.I.    letter naming local site
as additional local sites are             with all REC
approved)                                 correspondence & final
                                          approved documentation
                                          to R&D office                     Full R & D approval
  C.I. sends REC approval
  letter & REC
  correspondence & final
  approved documentation to
  P.I. (when their local site is                                              Study may start
  approved)




                                                                                                   - 11 -
MONITORING PROCEDURES
Cardiff University requires that all applications approved by the School Research Ethics sub-Committee
are subject to annual monitoring. With regards to undergraduate research proposals the School Research
Ethics sub-Committee will require a written report from the Chair of the appropriate Departmental
Undergraduate Ethics sub-Group confirming that a project has been completed by 1 November in the
year following approval of the research proposal. In other words if a research proposal was approved in
June 2005 the dissertation submitted in April 2006 then in November 2006 the Chair of the Departmental
Undergraduate Ethics sub-Group will be required to confirm in writing that the research project has been
completed and that the details of the study have substantially followed the proposal as initially presented.

With regards to postgraduate taught students, postgraduate research students and staff, annual monitoring
will be required. An annual monitoring form will be despatched, by the Research Administrator, to the
appropriate individual until confirmation has been received that the study has been completed. The
annual monitoring form is attached as Appendix iii.




                                                                                                       - 12 -
RESEARCH V AUDIT
The distinction between research, audit and service/therapy evaluation can be nebulous. Research
projects involving patients, volunteers or health/social care staff normally requires ethical approval from a
LREC, or MREC if it involves more than one site. Audit projects and service /therapy evaluations must
comply with NHS Trust R & D arrangements.

The following table provides a useful distinction between the three activities.

          RESEARCH                                AUDIT                       SERVICE/THERAPY
                                                                                  EVALUATION
Motivated to generate new            Motivated to provide best care       Motivated to define current care
knowledge
Quantitative research: Is            Designed to answer the               Designed to answer the question:
hypothesis based                     questions: “Does this service        “What standard does this service
Qualitative research: Explores       reach a premeditated standard?”      achieve?”
themes following established
methodology
                                     Measures against a standard Measures current service without
                                                                 reference to a standard
May involve a new treatment      Doesn’t involve a new treatment Doesn’t involve a new treatment
May involve additional therapies Involves no more than           Involves no more than
or investigations                administration of questionnaire administration of questionnaire
                                 or record analysis              or record analysis
May involve allocation to        Does not involve allocation to  Does not involve allocation to
treatment groups NOT chosen by treatment groups: the HCP and     treatment groups: the HCP and
HCP or patient                   patients choose                 patients choose
May involve randomisation        Does not involve randomisation  Does not involve randomisation
ALTHOUGH ANY OF THESE THREE MAY RAISE ETHICAL PROBLEMS, UNDER CURRENT
GUIDANCE:-
REQUIRES REC REVIEW              DOES NOT REQUIRE REC            DOES NOT REQUIRE REC
                                 REVIEW                          REVIEW




THE ROLE OF NHS TRUST R & D OFFICES
Each Trust within Wales will have a NHS Office of Research and Development, in England the situation
is currently changing and you would be advised to contact the appropriate Trust to ascertain the situation
with regards to their procedures for R & D approval.

Basically, if you intend carrying out research on any NHS patient, member of staff or using any NHS
resources then you are required to submit a proposal to the relevant Trust R & D office for consideration
and approval.

Application forms can be obtained from the appropriate Trust R & D office. It is advised that, if you
require ethics approval from an LREC or MREC, you submit your research proposal to the Trust R & D
office first. The L/MREC may require proof of sponsorship from the appropriate Trust and this will only
be provided once the Trust R & D office has approved the research proposal. Normally if the lead
researcher is employed by the University then the University will act as sponsor and if the lead researcher
is employed by a Trust then the Trust will act as sponsor. In addition, the Trust R & D office may
require some changes to the proposed research so any L/MREC application that has been submitted may
no longer be relevant and a revised one L/MREC form may need to be submitted.
                                                                                                       - 13 -
Most R & D offices will have regular meetings so you are advised to contact them to establish the
timetable for the submission of applications and R & D Meetings.

One of the requirements of the Research Governance Framework for Health and Social Care (2005) is
that active studies are monitored/audited. This can happen in two ways. One way is that routine
information is requested for every study by the relevant R&D Office at registration, throughout and at the
end of the study.
The second way is that a more detailed check is made to make sure that all aspects of the Framework are
in place, including any legal obligations. The R & D offices are required to carry out this more detailed
check on at least 10% of active studies. This may involve a visit, the purpose of which is to look over the
information that is held about the study and to ask some questions about how the study is going and how
it is being managed.




THE ROLE OF COREC/MREC/LREC
Clinical research involving NHS patients, staff, information or premises is subject to local and national
level ethics review. The Central Office for Research Ethics Committees (COREC) oversees the overall
structure and operation of research ethics governance across the UK, while Local Research Ethics
Committees (LRECs) across the UK (7 in Wales) serve specific regions or Health Trusts and are
responsible for the oversight of university or health service based clinical research projects; while Multi-
Centre Research Ethics Committees (MRECs), 1 in Wales, oversee and review large scale multi-centre
clinical research projects.

The Central Office for Research Ethics Committees (COREC), working on behalf of the Department of
Health in England:

      co-ordinates the development of operational systems for local and multi-centre Research Ethics
       Committees (LRECs and MRECs), on behalf of the National Health Service in England;
      maintains an overview of the operation of the research ethics system in England, and alerts the
       Department of Health and other responsible authorities if the need arises for them to review policy
       and operational guidance relating to Research Ethics Committees (RECs);
      manages the MRECs in England;
      develops and manages a national training programme for REC members and co-ordinators in
       England;
      maintains close contact with officials in the Department of Health with policy responsibility for
       wider issues of research ethics and with colleagues from Northern Ireland, Scotland and Wales;
      with appropriate advice, develops, implements and maintains operating procedures and standards
       for RECs that will be consistent across the UK;
      establishes and manages regional Offices of Research Ethics Committees (ORECs) to oversee the
       activity of LRECs;
      provides advice to the Department of Health on the implications and practicalities of transposing
       the European Clinical Trials Directive in the UK.

COREC in England works closely with colleagues with similar responsibilities in Northern Ireland,
Scotland and Wales.




                                                                                                       - 14 -
RESEARCH GOVERNANCE/SPONSORSHIP
What is the Research Governance Framework?
The RGF was published in 2001 by the Welsh Assembly Government, Wales Office of Research and
Development for Health and Social Care (WORD). The equivalent RGF for England was published by
the Department of Health (DoH) in 2004. The RGF:

      sets out national standards in ethics, science, information, health, safety and employment, finance
       and intellectual property;
      defines mechanisms to deliver those standards;
      identifies the responsibilities of each party; and
      describes monitoring and assessment arrangements to ensure that the defined standards are met.

The main aim of the RGF is to ensure that “the dignity, rights, safety and well being of participants must
be the primary consideration in any research study” (RGF, 2.2.1).

The RGF governs all research conducted by the NHS or using NHS resources. This includes both
clinical and non-clinical research, and both commercial and non-commercial research.

NHS resources include additional NHS staff time, the use of an NHS Trust location (including
recruitment or consent in an NHS Trust clinic/ward or research participants recruited via their association
with the NHS), patient samples or data (including medical records or NHS Trust databases). All such
projects require that a Sponsor be declared.

Any research project governed by the RGF can not commence without:

      a declared Sponsor;
      independent peer review;
      ethical review by an appropriate body, e.g. an NHS Research Ethics Committee;
      monitoring systems to demonstrate adherence to the WORD/DoH RGF and Good Clinical
       Practice (GCP) (as laid down by the International Conference on Harmonisation of Good Clinical
       Practice).

What are the responsibilities of the key people involved?
The RGF defines the responsibilities of key people and organisations involved in a research project.
These should be understood by all researchers involved in the project and can be viewed at
www.word.wales.gov.uk/content/governance/governance-framework-e.pdf. The roles and responsibilities
can be summarised as detailed in Fig.1.

Chief/Principal Investigator
A senior individual must be designated as the Chief/Principal Investigator for any research undertaken
under the RGF.

A Chief/Principal Investigator is the person designated as taking overall responsibility within a team of
researchers for the design, conduct and reporting of the study. The CI/PI must have suitable experience
and expertise to enable him/her to ensure the research is carried out to the standards set out in the RGF.

If you are a Chief/Principal Investigator you must ensure that your responsibilities, as set out in the RGF,
are fully understood.




                                                                                                      - 15 -
                   Summary of Roles and Responsibilities as identfied by the RGF

                                     è Submit proposals for ethical review
               PI & other
                                     è Conduct research according to agreed protocol & in accordance
              Researchers                     with legal requirements
                                     è Ensure participant welfare
                                     è Record keeping
                                     è Report Adverse Events
                                     è Disseminate results

                                     è Assure scientific quality of proposed research
                Sponsor              è Ensure ethics approval obtained
                                     è Ensure arrangements in place for management & monitoring of
                                             research


               Employing             è Promote quality research culture
                                     è Ensure researchers understand & discharge their responsibilities
              Organisation
                                     è Ensure independent scientific review
                                     è Ensure research is properly managed & monitored


                 Care                è Authorise all research involving its patients, staff or facilities
                                     è Ensure research meets standards of RGF
              Organisation
                                     è Ensure ethics committee approval obtained
                                     è Deliver Duty of Care to participants


Fig.1


What is a Sponsor?
All research requiring the collaboration of the NHS must have an organisation willing and able to take on
the responsibilities of research Sponsor.

The Sponsor is the organisation that takes the lead in confirming there are proper arrangements for the
initiation, management and monitoring, and financing of a research project. A Sponsor is not the same as
the funding body.

Who will act as Sponsor?
Fig.2 can be used as a guide to identify who might be the Sponsor for a particular research project.
Confirmation that the University will act as Sponsor for a project can only be given in writing by the
                                                  Research and Commercial Division (RACD) on
                                                      behalf of the University.
               Will the University act as Sponsor?
                                                                                  Fig.2
                       CU not             N
                       normally                 Is the PI a Cardiff
                       Sponsor                 University employee?
                                                            Y
                                                                                  The University schools, departments or
                   Commercial             Y
                   organisation
                                                 Is this Commercial
                                                      Research?
                                                                                  individual employees shall not act as
                   as Sponsor                                                     Sponsor for any projects.
                                                            N

                                          Y      Will the funder act
                    Funder as
                                                 as Sponsor (e.g.                 In order to enable the University to consider if
                     Sponsor
                                                        DoH)?                     it will ‘declare’ it will act as Sponsor for a
                                                            N
                                                                                  research project, the principal investigator will
                                          Y
                    NHS Trust                  Will an NHS Trust act              first need to complete Spon 2 form and return it
                    as Sponsor                      as Sponsor?
                                                                                  to RACD along with other requested
                                                            N
                                                                                  information.
                    Sponsorship
                    agreements                     CU normally
                  (e.g. delegation                  as Sponsor
                     of duties)
                                                                                  What is the University Sponsor Acceptance
                Formal confirmation that Cardiff University                       process?                  Fig 3
                 will act as Sponsor can only be given by
                      RACD on the University’s behalf

                                                                                                                             - 16 -
In order to accept sponsorship of
a research project, RACD must          Procedure for Sponsor acceptance by the University
request specific information
about the research project.         Project involves CVT / Velindre    Project does not involve
                                                                            CVT/Velindre
The procedure for requesting                 Register with
                                                                        Register with RACD by
                                              R&D Office
that the University acts as                                             submitting:
                                                                                 Spon 2
Sponsor and the information           Project details sent to RACD
                                                                                 CVs
to be provided to RACD is                                                        Protocol
                                          by Trust R&D Office
                                                                                 Declaration
detailed in Fig 3
                                            RACD request
                                          declaration from PI             RACD risk assess
The University’s Spon 2                                                       project
form, declaration and this            Joint Trust University Peer
guidance note can be found           and Risk Review (JTUPeRR)           CU Sponsor approval
                                     Ä CVT R&D approval                         sent
at                                   Ä CU Sponsor approval

                                              If Sponsor required
                                               earlier in process,        Submit for relevant
                                             please contact RACD            R&D approval




http://www.cardiff.ac.uk/schoolsanddivisions/divisions/racdv/res/policy/governance/index.html.




DATA PROTECTION
All staff and students who process personal data must comply with the Data Protection Act. Section 4(4)
of the Act states that:

       ‘it shall be the duty of the data controller to comply with the data protection principles in relation
       to all personal data with respect to which he/she is the data controller’.

The University has established a Data Protection Policy the purpose of which is to ensure that the
University and the University’s staff and students comply with the requirements of the Act when
processing personal data. This Policy can be found on the University’s website at:
www.cardiff.ac.uk/schoolsanddivisions/divisions/corps/cocom/acc_inf/dataprotection/index.html.




                                                                                                         - 17 -
USEFUL CONTACTS
Cardiff University Research and Commercial Division

www.cardiff.ac.uk/schoolsanddivisions/divisions/racdv/resgovethics/index.html

Dr Kathy Pittard- Davies
Deputy Director and Head of Research Policy and Management
Telephone: 029 2087 9274
Email: davieskp2@cardiff.ac.uk

Chris Shaw
Research Governance Framework, NHS Commercial Activity, Clinical Trials
Telephone: 029 208 79130
Email: ShawC3@cardiff.ac.uk

Dr Gareth Dyer
University Ethics Fellow
Telephone: ??
Email: Dyergk@cardiff.ac.uk



Central Office for Research Ethics Committees www.corec.org.uk

COREC Manager, Wales:
Corinne Scott,

MREC for Wales
Fourth Floor, Churchill House
Churchill Way
Cardiff
CF10 2TW
Tel: 029 2037 6829
Mobile: 07766 917109.
Fax: 029 2037 6824
E-mail: corinne.scott@wales.gsi.gov.uk.



Multi-centre Research Ethics Committee for Wales.

Chair: Dr Gordon Taylor (Acting Chair)
Co-ordinator: Mrs Corinne Scott

4th Floor
Churchill House
Churchill Way
Cardiff
CF10 2TW
                                                                                - 18 -
Tel: 029 2037 6829.
Fax: 029 2037 6824
E-Mail: Mrec@bsc.wales.nhs.uk
North Central Wales Local Research Ethics Committee.

Chair: Mr C N Penfold.
Co-ordinator: Mrs Julie Whitmore.

Room 1038,
Glan Clwyd Hospital,
Sarn Lane,
Bodelwyddan,
Denbighshire,
LL18 5UJ.
Tel: 01745 534132.
Fax: 01745 583143.
E-mail: julie.whitmore@cd-tr.wales.nhs.uk.


North East Wales Local Research Ethics Committee.

Chair: Dr Peter Rutherford.
Co-ordinator: Ms Janice Lucraft

Wrexham Maelor Hospital,
Croesnewydd Road,
Wrexham,
LL13 7DT.
Tel: 01978 725368.
Fax: 01978 725368.
E-mail: janice.lucraft@new-tr.wales.nhs.uk


North West Wales Local Research Ethics Committee.

Chair: Dr Mike Jackson.
Co-ordinator: Dr Rossela Stoicescu-Jones.

Directorate of Quality and Clinical Assurance,
North West Wales NHS Trust,
Ysbyty Gwynedd,
Bangor,
Gwynedd,
LL57 2PW.
Tel: 01248 384877.
Fax: 01248 385318.
E-mail: rossela.stoicescu@nww-tr.wales.nhs.uk.


South West Wales LREC.

Chair: Mr Roy Evans.
Co-ordinator: Ms Penny Beresford.


                                                       - 19 -
Business Services Centre,
36 Orchard Street,
Swansea,
SA1 5AQ.
Tel: 01792 607416.
Fax: 01792 607533.
E-mail: penny.beresford@bsc.wales.nhs.uk.


Dyfed Powys Local Research Ethics Committee.

Chair: Dr Mark Turtle.
Co-ordinator: Mrs Sue Byng.

St David’s Park,
Jobswell Road,
Carmarthen,
SA31 3YH.
Tel: 01267 225045.
Fax: 01267 225097.
E-mail: sue.byng@bsc.wales.nhs.uk.


South East Wales Research Ethics Committee Panel B.

Chair: Mrs A Dowden.
Co-ordinator: Mr Carl Philips and Mrs Jagjit Sidhu.

Business Services Centre
4th Floor
Churchill House
Churchill Way
Cardiff
CF10 3NW
Tel: 029 2037 6822.
Tel: 029 2037 6823.
Fax: 029 2037 6835.
E-mail: carl.phillips@bsccardiff.wales.nhs.uk.


South East Wales Research Ethics Committee Panel C.

Chair: Miss S M Williams.
Co-ordinator: Mr Carl Philips and Mrs Jagjit Sidhu.

Business Services Centre
4th Floor
Churchill House
Churchill Way
Cardiff
CF10 3NW
Tel: 029 2037 6822.
Tel: 029 2037 6823.
Fax: 029 2037 6835.
E-mail: carl.phillips@bsccardiff.wales.nhs.uk.
                                                      - 20 -
South East Wales Research Ethics Committee Panel D.

Chair: Dr D E B Powell.
Co-ordinator: Mr Carl Philips and Mrs Jagjit Sidhu.

Business Services Centre
4th Floor
Churchill House
Churchill Way
Cardiff
CF10 3NW
Tel: 029 2037 6822.
Tel: 029 2037 6823.
Fax: 029 2037 6835.
E-mail: carl.phillips@bsccardiff.wales.nhs.uk.




Wales Office of Research and Development Research Governance Framework
www.word.wales.gov.uk/content/governance/governance-framework-e.pdf.



The network for R&D management in health and social care
http://www.rdforum.nhs.uk/




                                                                         - 21 -
APPENDIX
Appendix i - School Research Proposal Form

Appendix ii – Lead reviewers report

Appendix iii – School Annual Monitoring Form




                                               - 22 -
                                 School of Healthcare Studies


                                   Research Proposal Form


                                                   2006/7



 All applications must be completed in line with the guidance notes attached as Appendix I. Applications must be
 submitted no later than the deadlines stipulated at www.cardiff.ac.uk/sohcs/ethics
 Late applications will not be considered.



1, Personal Details

Name of applicant:

Please tick where appropriate;

Student:              Full time:          Part Time:

Title of Course:
Student Number:
Contact Address:

Email address:
Contact telephone number:


Staff:                             Department:

Email address:

Proposed start date of Study (m/y):

Proposed end date of study (m/y):

                                                                                                       - 23 -
2, Additional Information
(Where the project is part of an undergraduate or postgraduate course)

Full name of academic supervisor:

Address:


Full name of clinical supervisor (where appropriate):

Address:




3, Project Details

3.1    Lay Summary
(250 words maximum)




                                                                         - 24 -
3.2    Background and Objectives of Study
(one side of A4 maximum)




3.3    Principal Research Question




                                            - 25 -
3.4    Methodology
(one page of A4 maximum)




                           - 26 -
 3.5   Location of study and access arrangements




3.6    Resource Implications




                                                   - 27 -
- 28 -
3.7    Ethical Considerations

Outline the potential ethical issues of the proposed research and how you intend addressing these issues.




Is NHS R & D approval required? Yes       No

If which Trusts will be required to give approval?


Is NHS Ethics Committee approval required?       Yes    No

If so, is LREC/MREC approval requires? (Delete where appropriate)

State the name of the LREC to whom you will be applying, for multi-centred studies state the name of
the MREC.




                                                                                                   - 29 -
3.8   Project Milestones and Timescales
          Activity                    Start Date   Completion Date




                                                                 - 30 -
3.9   References




                   - 31 -
4, Signatures

Applicant:

Name:                  Date:
Signature:


Academic Supervisor:

Name:                  Date:
Signature:


Clinical Supervisor:

Name:                  Date:
Signature:




                               - 32 -
                                                               Appendix ii

                         Lead Reviewers Comments Form


                            LEAD REVIEWERS COMMENTS FORM

Application Number & Title:

Name of Lead Reviewer:
Date of Meeting at which proposal is to be considered:
1. The scientific value and validity of the proposal:
2. The welfare of the research subject:
3. Hazards, discomfort and distress to the research subject:
4. Consent of the research subject:
5. Patient information sheet:
6. Confidentiality:
7. R & D approval required? :
8. Ethics approval required – LREC or MREC? :
9. General comments:




                                                                         - 33 -
                                                                                       Appendix iii


                                  CARDIFF UNIVERSITY
              SCHOOL OF HEALTHCARE STUDIES RESEARCH ETHICS SUB-COMMITTEE

                                                  Annual monitoring form

Cardiff University requires that all applications approved by School Research Ethics Committees are
subject to annual monitoring. Please complete the attached form and return to:

Liz Harmer
Research Administrator
Ty Dewi Sant
School of Healthcare Studies
Heath Park Cardiff. CF14 4XN
harmerl@cardiff.ac.uk


1. Details of Principal Investigator / Supervisor

 Name:
 Address:



 Telephone:
 E-mail:

2. Details of study



 Full title of study:


 SOHCS reference number:
 Date of favourable ethical opinion
 from School:

3. Commencement and termination dates

 Has the study started?                                                    Yes / No
 (Note studies not started within 24 months of approval require
 reapproval from SOHCS)
 If Yes, give start date.

 If No, what are the reasons for the study not
 commencing?


 Has the study finished?                                                   Yes / No




                                                                                                  - 34 -
 If yes, on what date did the study finish.
 If no, what is the expected completion date?

 If you do not expect the study to be completed,

 give reason(s)




4. Safety of participants

 Have any concerns arisen about the safety of
 participants in this study?                                                Yes / No

 If yes, give details and say how the concerns
 have been addressed.

5. Amendments

 Have any substantial amendments been made to the
 study?
                                                                 Yes / No
 If yes please give details on a separate sheet


6. Unforseen ethical issues

 Are there any other developments in the study that you                     Yes / No
 wish to report to the Committee?

 Are there any ethical issues on which further advice is                    Yes / No
 required?
                                                           If yes to either, please attach separate
                                                           statement with details.

7. Declaration

 Signature of Principal Investigator:

 Print name:

 Date:




                                                                                                      - 35 -

								
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