AGENDA myopia

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					                              AGENDA


                     NORTHERN X ETHICS COMMITTEE

                        TUESDAY, 9 OCTOBER 2007


                               2.00 P.M.

                          KARAKA MEETING ROOM
                                   AT
                           MINISTRY OF HEALTH
                             UNISYS BUILDING
                          650 GREAT SOUTH ROAD
                           PENROSE, AUCKLAND.




PRESENT:

    Adina Halpern               (Chairperson)
    Robyn Northey               Emma Ngawhare
    Vanya Kovach                Trevor Sherwin
    Joanna Stewart              David Sinclair
    Sonya Hunt                  Stephanie Palmer
    Louisa Wall                 N. Gauld



APOLOGIES:

    Wayne Miles



ADMINISTRATOR:

     Patricia Chainey




MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 11 SEPTEMBER 2007

    Confirmed:

                                                                1
 GENERAL BUSINESS:

     2000/124
     Randomised prospective trial of the Ponseti club foot casting technique
     versus casting and surgical techniques PIS/Cons V#3 23/09/2003
     Principal Investigator:  Dr Haemish Crawford.

             Progress report received but was not received when due (4/06) and after
              repeated correspondence ethical approval was withdrawn 10/06 and file
              closed and archived.

             P.I. wishes to add an amendment to this study to investigate why patients’
              families did not wish children to enter a trial – what factors were involved in
              them selecting 2 different treatment options. Questionnaire to be designed.

     Committee to decide whether

     a)       The new study would fall under ‘Observational Study Guidelines’, or
     b)       Complete new application.
     c)       What answers to P. 2 of letter under 1. and 2.

                                                                  A. Halpern/full Committee


      APPROVALS BY CHAIR OR DEPUTY CHAIR

      Schedule attached.



END OF STUDY REPORTS RECEIVED:


      AKX/04/08/221
      Development and testing of the SACS - the substances and choices scale.
      Principal Investigator: Dr Grant Christie, Waitemata DHB


      NTX/05/09/118
      ECG electrode placement study:
      Principal Investigator:     Ms Rachael Palmer.


      NTX/05/09/119
      Myopia progression and orthokeratology lens wear:
      Principal Investigator: Dr Helen Owens.




                                                                                           2
     NTX/07/18/EXP
     Risk factors for ulceration in midfoot charcot arthropathy
     Principal Investigator:   Mr Wesley Bevan



SERIOUS ADVERSE EVENTS

   As per schedule attached for Committee Members.


                                                      D. Sinclair, T. Sherwin, N. Gauld



RESUBMIT:

     NTX/07/08/084
     A 52-week open-label extension study of the long-term safety and efficacy of
     rosiglitazone extended-release (RSG XR) in subjects with mild-to-moderate
     Alzheimer's disease (REFLECT-5): Prot. AVA102677 19/03/07: IB V#2,
     17/04/07
     Principal Investigator: Dr Phil Wood


     Amendment:
        Protocol AVA102677 #1 dated 6 August 2007.




     1. NTX/07/10/102
     A study assessing the acceptance of robots in health care
     Principal Investigator/supervisor: Dr Elizabeth Broadbent, UoA
     Co-Investigators:                  Dr Ngaire Kerse, Dr Bruce MacDonald

     Application Form
        Letter of support from Prof. Papaarangi Reid, UoA.




     2. NTX/07/10/103
     Use of Ichodextrin® Dialysate with an exchange-free period in the initial
     treatment of peritoneal dialysis associated peritonitis: a pilot study:
     Principal Investigator/supervisor: Dr Maha Yehia, Auckland City Hospital
     Co-Investigators:                  A/Prof John Collins, Prof Nicholas Topley



     3. NTX/07/10/104
     The Orelle Trial

                                                                                     3
Principal Investigator:   Ms Jill Collier, Auckland University of Technology
Co-Investigators:         Dr Peter McNair, Ms Marian Simmonds



4. NTX/07/10/105
A    randomised        clinical   trial  of    mycophenolate       mofetil  versus
cyclophosphamide for remission induction in ANCA associated vasculitis
Principal Investigator:      Dr Janak de Zoysa, ADHB
Co-Investigators:            Dr John Colins, Dr Laurie Williams, Dr Ian Dittmer, Dr
                             Helen Pilmore, Dr Maha Yehia, Prof. Ian Simpson,



5. NTX/07/10/106
A prospective, open label, controlled, multicentre trial to assess the efficacy
and safety of an induction regimen of Neoral®, myfortic® and corticosteriods,
followed by administration of Certican® together with withdrawal of Neoral®
and myfortic® or corticosteroids and myfortic® in de novo kidney transplant
recipients: Protocol CRAD001A2421 16/10/06: IB Ed. 8, 16/08/06
Principal Investigator:  Dr Helen Pilmore, ADHB
Co-Investigators:        Dr John Collins, Dr Ian Dittmer, Dr Laurie Williams, Dr
                         Maha Yehia



6. NTX/07/10/107
Determining the risk of fetal loss in women with unprovoked venous
thromboembolism (VTE) who do not have identifiable inherited thrombophilia
compared with women who have the diagnosis of VTE excluded: Protocol
V1.2, 11/07/06
Principal Investigator: Dr Sanjeev Chunilal, North Shore Hospital



7. NTX/07/10/108
A randomised parallel-group study of group education versus standard care
in subjects with type 2 diabetes mellitus
Principal Investigator:   Ms Roberta Milne, Whitiora Diabetes Service
Co-Investigators:         Ms Lynne Ferguson CMDHB



8.   NTX/07/10/109
Sorafenib long-term extension programme (STEP): Protocol V#5.2, 5/07/07: IB V#7,
12/08/05
Principal Investigator:   A/Professor Ed Gane, ADHB




                                                                                 4
OBSERVATIONAL STUDY FOR EXPEDITED REVIEW


      1. NTX/07/102/EXP
      Pregnancy outcomes following hyperemesis graavidarum at National
      Women's Health, Auckland City Hospital
      Principal Investigator: Dr Francis H. Bloomfield, Liggins Institute
      Co-Investigators:       Ms Barbara Cormack, , Mr Osama AbuSalah
                              University of Auckland, National Women’s Health.




      2. NTX/07/103/EXP
      Audit of nursing documentation within the Child Health Service, Auckland
      District Health Board
      Principal Investigator: Ms Mercy Thomas, Starship Children’s Health
      Co-Investigators:       Ms Rebecca Nicol, Ms Elaine McCall ADHB




FIVE YEAR REVIEW:

    AKT/02/00/324
    Innovative Treatment:       Autologous chondrocyte transplantation.    PIS/Cons
    V#3, 25/08/03.

             Progress Report.


AMENDMENTS:

    1.     98/055
    An open-label follow-on study of the long-term safety of aripiprazole in patients
    with chronic schizophrenia. Protocol 31-97-303 2/12/97; Prot/amend 001 (Gl)
    24/3/98; 002 (Global) 17/8/98; NZ 01 24/4/98; Prot/amend NZ 01, 24/04/98:
    Prot/amend 004 (Gl) 23/11/04: IDB V#8, Addnd #2, 4/3/05, Addnd #3, 9/05/05:
    Prot/amend #5, 13/04/05: Prot/amend #6 (Gl), 26/01/06: IB V#10, 11/08/06
    Principal Investigator: Prof Wayne Miles, Waitemata DHB

            Investigator Brochure V#11 dated 8 August 2007 + Summary of Changes.



    2.    NTX/05/08/106
    A multicentre, randomised, double blind study to evaluate the safety, efficacy
    and tolerability of L-000 899055 monotherapy in obese patients: Protocol L-
    000899055 015-00 R, V. 3.2, 3/6/05Prot/amend Appdx 7, 31/05/05: Prot/amend
    015-01, 16/08/05: Prot/amend 015-02, 25/08/05: Prot/amend 015-04 V#3, 9/06/06:
    Prot/amend 015-06, 25/01/07: PIS/Cons V#7, 19/02/07: IB Ed. 7, 28/05/07

                                                                                    5
Principal Investigator:      Dr Jocelyne Benatar, Greenlane Clinical Centre.
Co-Investigators:            Dr Ajith Dissanayake, Dr Ralph Stewart, Dr Marianne
                             Elston

          Protocol 015-10 dated 29 August 2007 + Summary of Changes.
          Participant Information Sheet/Consent Form V#8 dated 14 September 2007 for
           Dr Jocelyne Benatar, Greenlane Clinical Centre.
          Participant Information Sheet/Consent Form V#8 dated 14 September 2007 for
           Dr Ajith Dissanayake, Middlemore Hospital



3.     NTX/06/04/030
An international multi-centre study of tamoxifen vs anastrozole in
postmenopausal women with hormone sensitive ductal carcinoma in situ
(DCIS): Protocol IBIS-II (DCIS) V. 5/05: Prot/amend V. 8/06: IB Ed. 11, 12/06:
PIS/Cons V#6, 27/07/07
Principal Investigator:  Dr Michael McCrystal, North Shore Hospital
Sites:                   Waitemata DHB, Breast Associates Epsom, Waikato DHB.
                         St Anne Breastcare Hamilton.

            Protocol amendment V.6/07 (with attachment summary)
            PIS/Cons V#7 dated 12 September 2007 for:
                     Waitemata DHB
                     Waikato DHB
                     St Anne Breastcare


4.     NTX/06/10/127
A phase IIb/III randomised, placebo-controlled clinical trial to study the safety
and efficacy of MK-0364 in obsese patients and in overweight patients with
obesity-related co-morbidities: Protocol 0364 037-00 24/08/06: PIS/Cons V#3,
16/11/06: CIB MK-0364, Ed.7, 28/05/07:
Principal Investigator: Dr Jocelyne Benatar
Co-investigators:       Dr Ralph Stewart, Auckland City Hospital
                        Dr Ajith Dissanayake, Dr. Shirantha Gunatilaka, Middlemore
                        Hospital

          Protocol 037-10-10 dated 28 August 2007 + Summary of Changes.
          Participant Information Sheet/Consent Form V#4 dated 17 September 2007 for
           Dr Jocelyne Benatar, Greenlane Clinical Centre.
          Participant Information Sheet/Consent Form V#4 dated 17 September 2007 for
           Dr Ajith Dissanayake, Middlemore Hospital



5.     NTX/06/10/134
A randomised, open-label study to compare the safety and efficacy of
conversion from a calcineurin inhibitor to sirolimus versus continued use of a
calcineurin inhibitor in cardiac transplant recipients with mild to moderate renal
insufficiency: Protocol # 0468E7-408-GL, 16/06/06: IB 15/8/06: PIS/Cons V#3,
16/11/06

                                                                                    6
Principal Investigator:        Dr Cara Wasywich
Co-Investigators:              Dr. Peter Ruygrok, Dr Arthur Coverdale

          Protocol Amendment 3 dated 9 July 2007 + Summary of Changes
          Participant Information Sheet/Consent Form V#8 dated 27 August 2007.



6.     NTX/06/12/155
Stage 1): A pre-screening initiative to assess HbA1c(%) values in subjects with
type 2 diabetes mellitus and determine eligibility for a phase IIb clinical study
with SGLT-2 inhibitor GSK189075 (KG2PS101:
(Stage 2) A dose-ranging study of GSK189075 versus placebo in the treatment
of type 2 diabetes mellitus in treatment naive subjects (KG2105255):
(Substudy) Pharmacogenetic Research for the dose-ranging study of
GSK189075 versus placebo in the treatment of type 2 diabetes mellitus in
treatment naive subjects (KG2105255):
Principal Investigator:    Dr Nick Gailer
Co-investigator:           Dr Mike Williams, Dr Murray Hing, Dr Mike Watson

              Addition of Dr Gavin Lobo, Manurewa Healthcare

              Protocol KG2105255 Amendment #03 dated 31 August 2007 + Summary of
               Changes.

              Participant Information Sheets for Protocol KG2105255 and KG2PS101 V#4
               dated 6 September 2007
              Consent Forms for Protocol KG2PS101 (Stage 1) V#4 dated 6 September
               2007.
              Consent Form for Protocol KG2105255 (Stage 2) V#4 dated 6 September
               2007 for
                      Greenhithe Medical Centre, Dr Nick Gailer,
                      5 Cross Roads Medical Centre, Dr Mike Watson,
                      Bairds Road Family & Christian Health Centre, Dr Murray Hing,
                      Hinemoa House, Dr Mike Williams and
                      Manurewa Healthcare Medical Group, Dr Gavin Lobo



   7. NTX/07/02/015
   Barriers to accessing affordable housing for Mental Health Service Users?
   Principal Investigator: Mr Andy Colwell, Massey University
   Supervisor:             Dr Grant Duncan, Massey University.

   (sent to all committee)

               Substudy amendment: Self-administered survey for St Lukes Community
                Mental health Centre service users to complete.
               PIS/Cons for substudy V#1 dated 6/09/07

    Please note Marc Daglish, Chair Research Access Committee, Housing NZ’s
    email dated 20/09/07

                                                                                    7
The following were reviewed and given ethical approval by the Chairperson or the Deputy
Chairperson under ChairPerson/Deputy Chairperson’s Discretion.


APPROVALS and OBSERVATIONAL STUDY APPROVALS:

    See attached schedule (Under general Business).


PROGRESS REPORTS:


     AKL/98/271
     Acute lymphoblastic Leukaemia study VII protocol. A Phase III group wide
     study: Protocol VII V# 18/6/98; Protocol Amend #1, 1/8/00: IS/Cons V#2, 3/7/01
     Principal Investigator:    Dr Scott Macfarlane.




                                                                                      8
AKL/99/189
Menstrual cycle and surgical treatment of breast cancer: Protocol IBCSC 21-
99, Addendums 1 - 8: Protocol Addendum 9: PIS/Cons V#1, 8/10/99: PIS/Cons
V#2 6/01: Protocol Amend 10, 28/09/2001: Addendum 11, 31/12/01
Principal Investigator:  Dr Wayne Jones.


AKL/2001/187
A randomised prospective trial of fixed vs mobile bearing Sigma total knee
joint replacement: Protocol 23/5/00: Protocol 23/5/00: PIS/Cons 26/07/2002
Principal Investigator:   Dr Mark Clatworthy


AKX/02/00/214
The meaning of daily activities for people recovering from mental illness: a
phenomenological enquiry: PIS/Cons V#2, 6/9/02.
Principal Investigator:  Mr Daniel Sutton


AKX/02/00/357
Blood sampling in recurrent miscarriage to allow development of tests for
recurrent miscarriage and development of a minimally invasive test for fetal
karyotype analysis: PIS/Cons V#1, 4/11/02
Principal Investigator:   Dr Larry Chamley
Co-Investigators:         Prof P Stone, Dr M Aburnaree


AKY/04/08/208
The experience of overweight people when participating in physical activity at
their local fitness centre in South Auckland: PIS/Cons V#2, 2/09/04
Principal Investigator:       Ms Christine Cook


NTX/05/02/002
Outcome of interventions from a pelvic floor clinic for defecatory disorders:
the Auckland experience
Principal Investigator:  Dr Ian Bissett
Co-Investigators:        Dr Arend Merrie, Prof Bryan Parry, Mr Douwe Rijpsma,
                         Mr Koen Teeuwen


NTX/05/05/037
Minimising unintended clinical events using electronic health records (EHR) in
head and neck cancer care:
Principal Investigator:     Ms Pratima P. Acharya.


NTX/05/08/096
Analysis of gene expression in breast cancer: PIS/Cons V#5, 16/02/06
Principal Investigator:      Prof Michael Findlay.

                                                                             9
Co-Investigators:            Dr Kathryn Woad, Mr W. Jones, Mr Alex Ng, Dr
                             Robyn Oldfield, Dr A. Shelling, Dr Michael Black


NTX/05/08/106
A multicentre, randomised, double blind study to evaluate the safety, efficacy
and tolerability of L-000 899055 monotherapy in obese patients: Protocol L-
000899055 015-00 R, V. 3.2, 3/6/05Prot/amend Appdx 7, 31/05/05: Prot/amend
015-01, 16/08/05: Prot/amend 015-02, 25/08/05: Prot/amend 015-04 V#3, 9/06/06:
Prot/amend 015-06, 25/01/07: PIS/Cons V#7, 19/02/07: IB Ed. 7, 28/05/07
Principal Investigator:    Dr Jocelyne Benatar, Greenlane Clinical Centre.
Co-Investigators:          Dr Ajith Dissanayake, Dr Ralph Stewart, Dr Marianne
                           Elston


NTX/05/09/115
Sensorimotor integration in patients with basal ganglia dysfunction: an fMRI
and EEG investigation: PIS/Cons V#2, 16/09/05.
Principal Investigator:   Dr Vanessa Lim
Co-Investigators:         Dr Jeff Hamm, Dr Ian Kirk


NTX/05/09/116
Predictors of hand function in patients with gout: a three-dimensional CT
study: PIS/Cons V#2, 16/09/05:
Principal Investigator:   Dr Nicola Dalbeth.
Co-Investigators:         A/Prof Fiona McQueen, A/Prof Anthony Doyle, Mr David
                          Perry, Ms Julie Collis


NTX/06/08/093
Towards percutaneous necrosectomy: evaluation of chemicals and enzymes to
liquefy pancreatic necrosis: PIS/Cons V#3, 4/10/06: Substudy 20/06/07:
PIS/Cons V#7, 30/08/07
Principal Investigator: Prof John A. Windsor
Co-Investigators:       Dr Benjamin Loveday, Dr Anubhav Mittal, Dr Anthony
                        Phillips


NTX/06/08/103
Feasibility, reliability, validity and acceptability of the mini-CEX assessment
process during the anaesthesia training programme: PIS/Cons V#2, 10/08/06.
Principal Investigator:        A.Prof Jennifer Weller
Co-Investigator:               Dr Alison Jones


NTX/06/09/107
A group-wide phase II study of Sulindac and Tamoxifen in patients with
desmoid tumours that are recurrent or not amenable to standard therapy:
Protocol ARST0321 Amend #1, 25/04/05, Amend #2 & #4, 09/12/05, Amend #3,
9/09/06: PIS/Cons V#4, 24/10/06: Prot/amend #4, 14/02/07
Principal Investigator Dr Scott Macfarlane

                                                                            10
Co-Investigators:   Dr Stephen Laughton, Dr Mark Winstanley, Dr Lochie Teague,
                    Dr Ruellyn Cockroft, Dr Jane Skeen, Dr. Nyree Cole


NTX/06/09/112
Failure of cyclophosphamide therapy in lupus nephritis patients: the role of
bioactivaton phenotype and genotype: Protocol 10/08/06: Prot/amend V#2,
26/10/06: Prot/amend V#3, 27/11/06: Prot/amend V#3, 8/05/07: PIS/Cons V#3,
8/05/07
Principal Investigator:  Dr Nuala Helsby
Co-Investigators:        A/Prof Peter Gow, Dr Janak de Zoysa, Dr May Ching
                         Soh, Dr Mike Lam, Mr Michael Goldthorpe.


NTX/06/13/CPD
Comparison of assertive community treatment (ACT) model in the UK, USA,
New Zealand and Canada.
Principal Investigator:  Ms Jane Vanderpyl
Co-Investigators:        Dr Verity Humberstone, Ms Trix LeProu, Ms Maraea
                         Handley




                                                                            11

				
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