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MEETING AGENDA

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									            Agenda for the meeting of the Multi-region Ethics Committee 24/1/06




        MEETING AGENDA
      Multi – region Ethics Committee




                      24 January 2006




VENUE:
Royal New Zealand
Foundation of the Blind,
121 Adelaide Road
Newtown
Ph 04 380 2160
Wellington


Members of the public may attend the open
section of the meeting, which commences at 9.30
am.




                                                                   Page 1 of 11
               Agenda for the meeting of the Multi-region Ethics Committee 24/1/06




Meeting of the Multi-Region Ethics Committee open to the public to be held on
Tuesday
13th December 2005 at the Royal NZ Foundation of the Blind, Newtown,
Wellington at 9.30am.


PRESENT:                    Dr. Martin Tolich (Chairperson)

                            Assoc Prof. Cynthia Darlington (Deputy Chairperson)
                            Mrs. Maliaga Erick
                            Ms. Carolyn Weston
                            Mrs Georgina Johnson
                            Assoc Prof Sheila Williams
                            Assoc Prof. Jane Koziol-McLain
                            Dr. Fiona McCrimmon
                            Dr. Chris Wynne
                            Dr. Simon Jones
                            Dr Barry Smith

ADMINISTRATORS:             Sue Fish, Michelle Judge



APOLOGIES:                  Prof. Graham Mellsop



                  MINUTES OF THE PREVIOUS MEETING

Minutes of the meetings held on 1st November and 15th November 2005 to be
confirmed.

Minutes of the meeting held on the 13th December 2005 to be confirmed.
Decisions made at the meeting on the 13th December to be ratified.
Assoc Prof Cynthia Darlington in the Chair.


                              NEW PROTOCOLS


          1. A multicenter, Randomised, Double-blind, Placebo-controlled Trial
          of golimumab, a Fully Human Anti-TNF monoclonal Antibody,
          Administered Subcuaneously, in Subjects with Active Rheumatoid
          Arthritis Despite Methotrexate therapy
          Lead Investigator:   Dr Daniel Ching
          Main Site:           Timaru Hospital


                                                                         Page 2 of 11
    Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


MEC Ref:             MEC/06/01/001
Primary Presenter:   Assoc. Prof Cynthia Darlington
Secondary Presenter: Dr Martin Tolich

Form B
Protocol CO524T06 dd 25 August 2005
Information sheet/consent form v 1.2 dd 7 November 2005
Site                Locality               M/C               Pt 4
Auckland
DHB
Lakes DHB
South                  Y                    Y                 Y
Canterbury
DHB
(Timaru
Hospital)


2. A Multicenter, Randomized, Double-blind, Placebo-controlled
Trial of Golimumab, a Fully Human Anti-TNF Monoclonal Antibody,
Administered Subcutaneously, in Methotrexate-naive Subjects with
Active Rheumatoid Arthritis
Lead Investigator:   Dr Daniel Ching
Main Site:           Timaru Hospital
MEC Ref:             MEC/06/01/003
Primary Presenter:   Assoc Prof Cynthia Darlington
Secondary Presenter: Dr Martin Tolich

Form B
Protocol CO524T05 dd 25 August 2005
Investigator Brochure CNTO 148 ed 6 dd 6 September 2005
Information sheet/consent form v 1.2 dd 7 November 2005
Consent for Carotid Ultrasound v 1.2 dd 7 November 2005
Consent for Magnetic Resonance Imaging v 1.2 dd 7 November 2005
Site                Locality               M/C             Pt 4
Timaru                 Y                    Y
Hospital
Middlemore
Hospital
North Shore
Hospital


3. A Long-Term, Open-Label Extension study to Investigate the
Long-Term Safety of SYR110322 (SYR-322) in Participants with Type
2 Diabetes
Lead Investigator: Prof Russell Scott
Main Site:         Christchurch Hospital
MEC Ref:           MEC/06/01/002


                                                           Page 3 of 11
    Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


Primary Presenter:   Dr Simon Jones
Secondary Presenter: Mrs Carolyn Weston


No form
Protocol SYR-322-OLE-012 dd 31 August 2005
Information sheet/consent form v 1.0 dd 21 November 2005
Site                Locality               M/C               Pt 4
Waitemata
DHB
Capital &
Coast DHB
Auckland
DHB
Canterbury
DHB
Counties
Manukau
DHB


4. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
Multicentre Study to evaluate the Efficacy and Safety of Once-Daily
Intranasal Administration of GW685698X Aqueous Nasal Spray
100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age
and Older with Perennial Allergic Rhinitis (PAR).
Lead Investigator:   Dr Peter Black
Main Site:           University of Auckland
MEC Ref:             MEC/06/01/004
Primary Presenter:   Dr Simon Jones
Secondary Presenter: Georgina Johnson

No form
Protocol FFR 106080 dd 7 November 2005
CIB GW685698X dd 10 May 2005
Information sheet/consent form v 1 dd 17 November 2005
Site                Locality              M/C                Pt 4
University of          Y                                      Y
Auckland
Greenhithe             Y                                      Y
Medical
Centre
Bairds Road            Y                                      Y
Family and
Christian
Church
Health
Centre



                                                           Page 4 of 11
    Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


5. Evaluation of Vocational Rehabilitation under the Injury
Prevention Rehabilitation and Compensation (IPRC) Act 2001
Lead Investigator:   Prof Kathryn McPherson
Main Site:           AUT
MEC Ref:             MEC/06/01/005
Primary Presenter:   Dr Barry Smith
Secondary Presenter: Mrs Mali Erick

No Form
Participant Information sheet/consent form v XX dd February 2006
Stakeholder Information sheet/consent form v XX dd February 2006
Site                 Locality               M/C               Pt 4
AUT                                          Y                 Y


6. A Phase III, randomised, double blind, parallel-group study of the
efficacy and safety of oral dabigatran etexilate (150 mg bid) compared
to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic
venous thromboembolism, following initial treatment (5-10 days) with
a parental anticoagulant approved for this indication
Lead Investigator:    Dr Sanjeev Chunilal
Main Site:            North Shore Hospital
MEC Ref:              MEC/06/01/006
Primary Presenter:    Dr Chris Wynne
Secondary Presenter: Dr Sheila Williams

Form B
Protocol 1160.53 dd 18 November 2005
IB 1160.P1 and 1160.P2 dd 2 September 2005
Information sheet/consent form v 5 dd 19 December 2005
Site                Locality              M/C                  Pt 4
North Shore                                                     Y
Hospital
Auckland                                                        Y
City Hospital
Middlemore                                                      Y
Hospital
Christchurch                                                    Y
Hospital


7. Detrerminants of inequalities in breast cancer survival
Lead Investigator:   Dr Mona Jeffreys
Main Site:           Massey University
MEC Ref:             MEC/06/01/007
Primary Presenter:   Mrs Carolyn Weston
Secondary Presenter: Dr Fiona McCrimmon




                                                             Page 5 of 11
    Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


No Form
Information sheet/consent form v 1 dd 12/12/05
Site                Locality               M/C               Pt 4
Massey                                       Y                Y
university


8. Maori Womens access to the National Cervical Screening
Pathway and Breastscreen Aotearoa Screening Pathways
Lead Investigator:   Ms Nicola Coupe
Main Site:           Waiatarua
MEC Ref:             MEC/06/01/008
Primary Presenter:   Georgina Johnson
Secondary Presenter: Dr Jane Koziol-McLain

No Form
Information sheet v 1 dd 13/12/05
Consent form v 001 dd 24/10/05
Site                Locality             M/C                 Pt 4
                                                              Y


9. A Pivotal, Multicenter, Multinational, Randomized, Double-Blind,
Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-
242 in Adults with Severe Sepsis
Lead Investigator:   Dr Colin McArthur
Main Site:           Auckland DHB
MEC Ref:             MEC/06/01/009
Primary Presenter:   Assoc Prof Cynthia Darlington
Secondary Presenter: Dr Sheila Williams

Form B
Protocol 01-04-TL-242-011 dd 22/07/2005
IB TAK 242 ed 3 dd 10/5/05
Information sheet/consent form v 1 dd 29/12/05
Site                Locality               M/C               Pt 4
Auckland              Y                                       Y
DHB
Canterbury                                                    Y
DHB
Waikato                                                       Y
DHB
Counties                                                      Y
Manukau
DHB
BOP DHB                                                       Y




                                                           Page 6 of 11
    Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


10. A Phase 2, Randomised, Double-blind Study to Evaluate the
safety, tolerability and Immunogenicity of Motavizumab ( MEDI-524),
a Humanised Enhanced Potency Monoclonal Antibody gainst
Respiratory Syncitial Virus (RSV), and Palivizumab when
Administered in the Same Season
Lead Investigator:     Dr Adrian Trenholme
Main Site:             Middlemore Hospital
MEC Ref:               MEC/06/01/011
Primary Presenter:     Dr Chris Wynne
Secondary Presenter: Dr Fiona McCrimmon

Form B
Protocol MI-CP127 dd 19/12/2005
Information sheet/consent form v 1.0 dd 16/12/05
Site                       Locality          M/C             Pt 4
Christchurch                                                  Y
Women’s Hospital
Middlemore Hospital                                           Y
Waikato Hospital                                              Y
Palmerston North                                              Y
Hospital
Starship Children’s                                           Y
Hospital
Dunedin Hospital                                              Y


11. An Open Label Multi-Center study to Assess the Eficacy and
Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,
ReFacto AF) in Patients with Hemophilia A Undergoing Elective
Major Surgery
Lead Investigator:   Dr Mark Smith
Main Site:           CDHB Haemostasis Service
MEC Ref:             MEC/06/01/012
Primary Presenter:   Dr Simon Jones
Secondary Presenter: Dr Jane Koziol-McLain

Form B
Protocol 3082B2-311-WW dd 16/06/2005
IB ed 8 dd December 2003
Information sheet/consent form v dd
Site                      Locality           M/C               Pt 4
CDHB Haemostasis             Y                                  Y
Service
Auckland City                                                     Y
Hospital
Haemophilia Centre




                                                           Page 7 of 11
      Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


12.   Evaluation of South Canterbury District Health Board and Mid
        Central District Health Board Mental Health Services
                         (RESUBMISSION)
Lead Investigator:   Mr Jim Hales
Main Site:
MEC Ref:             MEC/05/11/155
Primary Presenter:   Dr Barry Smith
Secondary Presenter: Mrs Carolyn Weston

No Form
Information sheet/consent form v dd
Site                Locality                M/C                Pt 4
South                                                           Y
Canterbury
DHB
Mid-Central                                                     Y
DHB


13. Validation of urine tests for cancer
Lead Investigator:   Parry Guilford
Main Site:           Canterbury DHB
MEC Ref:             MEC/06/01/014
Primary Presenter:   Dr Chris Wynne
Secondary Presenter: Dr Barry Smith

No Form
Information sheet/consent form dd 1/12/05
Site                      Locality           M/C               Pt 4
Canterbury DHB                                                  Y
Promed Urology                                                  Y


14. Reception screening for mental illness in New Zealand Prisons: a
prospective study
Lead Investigator:   Dr Ceri Evans
Main Site:           Hillmorton Hospital
MEC Ref:             MEC/06/01/015
Primary Presenter:   Dr Jane Koziol-McLain
Secondary Presenter: Dr Sheila Williams

No Form
Information Sheet/Consent form v 1 dd 2005
Site                    Locality           M/C                 Pt 4
Hillmorton                  Y               Y                   Y
Hospital (Chch)
Mason Clinic                                Y                   Y
(Acklnd)



                                                             Page 8 of 11
               Agenda for the meeting of the Multi-region Ethics Committee 24/1/06




          15. The effect of pre-hospital antibiotics on mortality in
          meningococcal disease. (Retrospective review of patient/client notes
          or data)
          Lead Investigator:   Dr Amanda Kvalsvig
          Main Site:           Wellington School of Med & Health Sciences
          MEC Ref:             MEC/06/01/016
          Primary Presenter:   Dr Sheila Williams
          Secondary Presenter: Dr Barry Smith




                               MATTERS ARISING

Resubmission


1. The impact of collaborative prescribing by pharmacists for heart failure
patients.

Lead Investigator:     Mr John A Dunlop
Main site:             University of Auckland
MEC Ref:               MEC/05/04/051
Primary Presenter:     Dr Fiona McCrimmon
Secondary Presenter:   Dr Sheila Williams

No Form
Appendix 9: GP Information Sheet
Appendix 10: Patient Information Sheet
Appendix 11: Informed Consent form
Site                 Locality              M/C                Part 4
AUT                                        Y                            Y
Wellington                                 Y


               EXTENSIONS/MODIFICATIONS/AMENDMENTS

Amendments:

1. A Randomized multicentre double-blind placebo-controlled 18 month study
of the efficacy of Xaliproden in patients with mild-to-moderate Alzheimer’s
disease, Protocol EFC 2724. Version date: 31 July 2003

Lead Investigator: Dr Nigel Gilchrist
Main site:         Christchurch
MRC Ref:           AKY/04/02/007



                                                                       Page 9 of 11
                Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


Primary presenter: Dr Martin Tolich
Secondary presenter:

Request to add an extension phase, with interim visits every 3 months.

No form
Participants’ information sheets and consent forms for Christchurch and Auckland
Caregivers’ information sheets and consent forms for Christchurch and Auckland
Site                   Locality              M/C                  Part 4
Princess Margaret
Hospital
North Shore
Hospital


2. M/C (Auck lead): A multicentre, randomised, double-blind, parallel-group,
placebo-controlled study of pexelizumab in patients with acute myocardial
infarction undergoing primary percutaneous coronary intervention

Lead Investigator:     Prof. Harvey D White
Main Site:             Auckland City Hospital
MEC Ref:               AKX/04/06/153
Primary Presenter:     G Mellsop
Secondary Presenter:   B Smith

Request to include participants who are unable to consent themselves at
Christchurch Hospital site

Part 7
Unconscious Patients’ Consent Form v 1 dated 30/9/05, Christchurch Hospital

Site                                   Locality           M/C                 Pt 4
Auckland DHB                              Y                Y                   Y
Auckland City Hospital                    Y                Y                   Y
Wellington Hospital                       Y                Y                   Y


3. A randomized controlled trial of probiotics on the development of atopy and
allergic disease in early childhood.

Lead Investigator: Prof Julian Crane
Main site:         Wellington
MRC Ref:           WGT/01/08/095
Primary presenter: Dr Martin Tolich
Secondary presenter:

Request to add additional blood test at age two years, and atopy patch test.

Original application and previous amendments, correspondence from the file,


                                                                       Page 10 of 11
               Agenda for the meeting of the Multi-region Ethics Committee 24/1/06


included for your information.


                         SERIOUS ADVERSE EVENTS


                                 GENERAL BUSINESS

          Discussion Document: Guidelines on Using Cells from Established
           Human Embryonic Stem Cell Lines for Research

          Amendment to Child Cancer Heart Study MEC/05/02/028


                           CHAIRPERSON’S REPORT


                                 ADMINISTRATION

Claim forms




                                                                    Page 11 of 11

								
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