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					                     MEETING AGENDA

              Multi – region Ethics Committee

                                16 June 2009

Ministry of Health
133 Molesworth St

Emalene’s DDI: 470 0655

Members of the public may attend the meeting, which commences at 9.00 am.
Meeting of the Multi-Region Ethics Committee open to the public to be held on
                             Tuesday 16 June 2009
         at the Ministry of Health, 133 Molesworth Street, Wellington
                                     at 9.00am

PRESENT:                Dr Barry Smith (Acting Chairperson)
                        Mrs Mali Erick
                        Dr Russell Franklin
                        Mrs Georgina Johnson
                        Mr Richman Wee
                        Mrs Carolyn Weston
                        Dr Helen Moriarty
                        Dr Margaret Horsborugh
                        Dr Chris Wynne – via teleconference
                        Dr Paul Copland
                        Assoc Prof Sheila Williams


ADMINISTRATORS:         Emalene Pearson
                        Rebecca Stewart
                          MINUTES OF THE PREVIOUS MEETING

Confirmation of the Minutes of the Meeting on 19 May 2009


1. Gender and medicine: identities and bodies beyond the male/female binary code
Lead Investigator:   Geraldine Christmas
Main Site:           Victoria University
MEC Ref:             MEC/08/12/153
Primary Presenter:   Margaret
Secondary Presenter: Paul

       Letters to clinicians
       Interview guidelines
       PIS & CF
       Letters of support
                      Site                       L/A            M/C            Part 4
Victoria University                               Y              Y               Y

                                  NEW PROTOCOLS

1. A phase III randomized, placebo controlled, double blind trial of Sofafenib plus
Erlotinib vs. Sorafenib plus placebo as First Line systemic treatment for Hepatocelluar
Carcinoma (HCC)
Lead Investigator:   Dr Ed Gane
Main Site:            Auckland City Hospital
MEC Ref:               MEC/09/06/059
Primary Presenter:      Russell
Secondary Presenter: Georgina
    Form B
    Registered drug form
    Parts 5 &6
    PISCF
    Pharma PIS CF
    EQ-5D Health Questionnaire
    Insurance cert
    Study contact card
    Protocol
    IBs for erlotinib and sorafenib
                    Site                         L/A          M/C           Part 4
Auckland City Hospital                            Y                           Y
Wellington Hospital
Christchurch Hospital

2. Improved Prognostic Tests For New Zealand Breast Cancer
Lead Investigator: Dr Cristin Print
Main Site:             University of Auckland
MEC Ref:                MEC/09/06/060
Primary Presenter:      Helen
Secondary Presenter: Richman
     PISCF
     No Form
                   Site                       L/A             M/C           Part 4
Auckland DHB                                                                  Y
Counties Manukau DHB
Cancer Society Tissue Bank CHCH

3. The implications of aging with a physical disability
Lead Investigator: Richard Smaill
Main Site:          Christchurch
MEC Ref:                MEC/09/06/061
Primary Presenter:      Margaret
Secondary Presenter: Carolyn
     No form
     Bibliography
     Paper on info sources
     Preliminary results of qualitative analysis
     Letters of support – not MC
                    Site                          L/A         M/C           Part 4
NZ Spinal Trust Christchurch                                                  Y
Association of Spinal Concern (TASC),
Auckland Spinal Rehabilitation Unit
2 spinal Injury rehab units Christchurch
and Auckland

4. Enabling occupation in action: Developing a community of practice scholars
Lead Investigator: Dr Claire Hocking
Main Site:           AUT
MEC Ref:            MEC/09/06/062
Primary Presenter:    Margaret
Secondary Presenter: Russell
    Advertisement
    Teleconference Discussion Guide
    PISCF
    No Form
                   Site                        L/A            M/C           Part 4
Auckland University of Technology                              Y              Y
5. An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride
    and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and
    Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced
    Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)
Lead Investigator:    Dr Peter Ganly
Main Site:      Canterbury DHB
MEC Ref:        MEC/09/06/063
Primary Presenter:     Helen
Secondary Presenter: Paul
    Unregistered Drug Form
    Form B
    Indemnity Form from sponsor
    Insurance cert (EXPIRED)
    Statistical report
    PISCF
    Protocol
    IB
                    Site                       L/A             M/C          Part 4
Canterbury District Health Board                Y                             Y
Waitemata District Health Board                 Y                             Y
Auckland District Health Board                                                Y
Counties Manukau District Health Board
MidCentral District Health Board
Capital & Coast District Health Board

6. A 52-week treatment, randomized, double-blind, placebo controlled, with open label
    tiotropium, parallel-group study to assess the efficacy, safety and tolerability of
    NVA237 in patients with chronic obstructive pulmonary disease. Study Number
Lead Investigator: Dr Ted Walford
Main Site:         P3 Research Tauranga
MEC Ref:           MEC/09/06/064
Primary Presenter:    Chris
Secondary Presenter: Richman

     Part 5 & 6
     Form B
     PISCF
     Pharma PISCF
     User Manual for The AM3
     Patient Card
     Advertisement
     Radio Script
     Letter from Novartis
     Protocol
     Protocol Amendment 1
     IB
     NZ Data Sheets for Spiriva & Ventolin
                  Site                          L/A             M/C            Part 4
P3 Research Tauranga                           Ethics                            Y
Waikato Hospital
Greenlane Clinical Centre, Auckland
Tauranga Hospital
Hinemoa House Family Health Care,
Medical Research Institute of New
Zealand/P3 Research, Wellington
Christchurch Hospital
Caversham Medical Centre, Dunedin
Southern Clinical trials Ltd., Christchurch     Ethics                             Y
Centre for Clinical Resarch & Effective
Practice (CCRep), Middlemore Hospital

7. A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study
    to Evaluate the Efficacy and Safety of PEGylated Interferon Beta 1-a (BIIB017) in
    Subjects with Relapsing Multiple Sclerosis
Lead Investigator: Dr Deborah Mason
Main Site:           Christchurch Hospital
MEC Ref:             MEC/09/06/065
Primary Presenter:     Graham
Secondary Presenter: Paul
        Form B
        Parts 5 & 6
        Main PISCF
        MRI PISCF
        Supplemental PISCF
        Genetic PISCF
        Patient ID Card
        Insurance cert
        Patient Assessment Tools: Visual Analog Scale, Subject Injection Pain
           Assessment, SF-36, Symbol Digit Modalities Test, MSIS-29, EQ-5D. BDI-II, Letter
           Chart testing, MS Function Composite, Information for the Patient Guide
        Subject Diaries (2 Copies)
        IB
        Protocol
        CV Deborah Mason
                    Site                          L/A               M/C            Part 4

Christchurch Hospital                             Y                                Y
Auckland Hospital
CNSL Hamilton
8. A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Viral
    Kinetics of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-
    2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Lead Investigator: Dr Ed Gane
Main Site:          Auckland Clinical Studies
MEC Ref:           MEC/09/06/066
Primary Presenter:      Chris
Secondary Presenter: Mali
        Form B
        Parts 5& 6
        PISCF
        Protocol
        IB
        Data Sheet for Ritonavir
        Indemnification Document
        Insurance certificate
        Participation card
                   Site                         L/A             M/C          Part 4

Auckland Clinical Studies                       Y                              Y
Auckland City Hospital
9. Te Ira Tangata: Cultural Assessment for Suicide Prevention with Māori (A Zelan
    randomized controlled trial of integrated self harm
Lead Investigator: Dr Simon Hatcher
Main Site:          Auckland University
MEC Ref:           MEC/09/06/067
Primary Presenter:   Georgina
Secondary Presenter: Graham
        Māori consultation will have hardcopies for meeting
        Cultural Identity profile
        Survey
        Cultural Assessment for Suicide Prevention PIS
        Cultural Assessment for Suicide Prevention with Maori PIS
        HADS
        Beck’s Hopelessness Scale
        SF-36 Health Survey
        Patient Check up card?
        Beck suicidal Intent Scale
        EQ-5D Health Questionnaire
        12 Month telephone interview
        12 Month self report questionnaire
        3 Month telephone interview
        3 Month self report questionnaire

                 Site                             L/A              M/C              Part 4
Waitemata DHB                                                                         Y
Counties Manukau DHB
Northland DHB

As per schedule

                   GENERAL BUSINESS

1.   Schedules
2.   Claim Forms

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