NORTHERN X ETHICS COMMITTEE
WEDNESDAY, 3 MAY 2006
KARAKA MEETING ROOM
MINISTRY OF HEALTH
650 GREAT SOUTH ROAD
Adina Halpern (Chairperson)
John France (Deputy Chairperson)
Jeffrey Harrison Scott Macfarlane
Emma Ngawhare Robyn Northey
Stephanie Palmer Louisa Wall
Patricia Hanlen Wayne Miles
Joanna Stewart Vanya Kovach
MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 1 March 2006.
A phenomenological investigation of disturbances in self-experience prior to
psychosis among clients of Auckland mental health services receiving
treatment for a first episode of psychosis:
Committee needs to assure itself that there has been satisfactory consultation
with Maori in relation to WDHB and make a decision as to whether this
research can ethically take place at WDHB. Members to note that currently
study has support from ADHB MRRC and has been approved by this
Committee for Auckland Hospital site.
Randomised trial of high-dose epirubicin and cyclophosphamide x 3 supported
by peripheral blood progenitor cells versus anthracycline and
cyclophosphamide x 4 followed by cyclophosphamide methotrexate and 5-
fluoracil x 3 adjuvant treatment for high risk operable stage II and stage III
breast cancer in premenopausal and young post-menopausal (<65 years)
patients. International Breast Cancer Study Trial 15-95
Study closed to accrual but continuing in the follow-up phase.
Letter from Gayl Humphrey, Research Manager, ADHB dated 15 March 2006.
END OF STUDY REPORTS:
Elastin synthesis in human arteries:
International SDH consortium study.
Medication beliefs and adherence to medication in depression:
What is it that affects a client's adherence to a graduated return to work
Different ways of expressing cardiovascular benefit from effective new
Young adults' experience of day-stay surgery: a qualitative descriptive pilot
The persistence and recovery of DNA from skin contact and saliva deposits on
post-mortem skin using hydosoluble tape:
SERIOUS ADVERSE EVENTS
As per schedule attached.
An evaluation of the factors that determine success and difficulty within 4
community service organisations in Tai Tokerau (Northland) New Zealand
Principal Investigator: Ms Christine Darkins
Supervisor: Dr Deb Spence.
Ultrasound measurement of the internal jugular vein as an indication of
central venous pressure.
Principal Investigator: Dr James Lai, Specialist Anaesthetist, Auckland City
Co-investigators: Dr Chris Nixon Dr Neil Maclennan
Dr Andrew Cameron Dr James King
A multicentre, randomised, double-blind, placebo controlled study to evaluate
the safety of SCH 530348 in subjects undergoing non-emergent percutaneous
coronary intervention/thrombin receptor antagonist in PCI (TRAsm-PCI):
Protocol SCH 530348Amend #1, 21/02/06; IB 12/05
Principal Investigator: Professor Harvey White, Director of Coronary Care and
Cardiovascular Research Unit, Auckland City Hospital.
Co-investigators: Dr Ralph Stewart.
The use of intravenous aminophylline to improve respiratory function in
infants with severe bronchiolitis in intensive care.
Principal Investigator: Dr John Beca, Starship
Co-investigators: Dr Fiona Miles, Dr David Buckley, Dr Brian Anderson
Recovery of illness and treatment in coronary artery bypass graft (CABG) and
cardiac valve surgery (CVS) patients: predicting functional recovery after
Principal Investigator: Mr Unique Weber
Co-investigators: Prof Keith Petrie, Dr Chris Ellis, Prof. Alan Merry, Dr
Paget Milsom, Mr Greg Gamble
Assessment of predictors for the development of diabetes mellitus following
Principal Investigator: Dr Paul Manley, Dept Renal Medicine, Auckland City
Co-investigators: Dr Helen Pilmore, Dr Ian Dittmer.
How do patients' perceptions of the aniography procedure affect
Principal Investigator: Mr Daniel A. Devcich, University of Auckland
Co-investigators: Prof. Keith Petrie, Dr Chris Ellis
Supervisor: Prof. Keith Petrie.
Can the use of electronic reminder alarms in metered dose inhalers lead to
better control of asthma?
Principal Investigator: A/Prof Peter Black, University of Auckland
Co-investigators: Ms Claire Arandjus, University of Auckland
Dr Berrnadette Salmon, C-M DHB
Mr Garth Sutherland, Nexus6
Mindfulness-based cognitive behavioural therapy and type II diabetes
mellitus: a pilot programme for developing self efficacy and self compassion
Principal Investigator: Ms Melanie Lindsay, MCs student, University of
Co-investigators: Dr Roger Booth, Dr Linda Cameron
Dr Bruno Cayoun (Australia)
Supervisor: A/Prof Roger Booth.
A pilot study investigating hyypothermia in traumatic brain injury in children .
Principal Investigator: Dr John Beca
Co-investigators: 6 Australian co-investigators)
Determinants of late fetal death in Auckland 2006-9: the exploration of
modifiable risk factors for late fetal death.
Principal Investigator: Ms Tomasina Stacey
Co-investigators: A/Prof Lesley McCowan, Prof. Ed Mitchel, Dr John
Sites: Waitemata DHB, Auckland DHB, Counties Manukau
An observational study of the effect of knowing the CYP 450 metaboliser
status on clinician prescribing behaviour when treating psychosis with
Principal Investigator: A/Prof Wayne Miles
Co-investigators: Ms Amanda Wheeler, Dr Janie Sheridan
Sites: Waitemata DHB, Auckland DHB, Counties Manukau
Dialectical behaviour therapy (DBT) based psychosocial skills training for
outpatients in a community mental health setting: a pilot study
Principal Investigator: Yunfei Zhao, Bachelor of Science, Psychology Dept,
University of Auckland.
Co-investigators: Ms Trish Du Villier, The Taylor Centre.
Supervisor: Ms Heather McDowell, The University of Auckland
TAXUS II: a randomised, double-blind, controlled, study of the safety and
performance of the NIRx ™ paclitaxel-coated conformer coronary stent:
Protocol # SC E 0102, 21/05/2001 V#2: IB 24/05/2001: : Cons V#2, 24/07/2001:
Prot Amend #1 (A) 13/05/03, Prot Amend #1 (B) 23/05/03, IB V#3, 06/12/02:
PIS/Cons V#9, 4/08/03 IB V#4,20/01/04.
Principal Investigator: Dr John Ormiston
Investigator Brochure V#5, 15 November 2005.
A multicentre, double-blind, randomised, placebo-controlled study to evaluate
the safety and efficacy of zoledronic acid in the treatment of osteoporosis in
post-menopausal women taking calcium and vitamin D: Prot. CZOL446H2301,
22/10/2001: Prot/amend #1, 25/03/2002. Prot/amend #2, 26/11/02: Ext. Study
Prot, 6/04/05: PIS/Cons Amend 5, 23/09/05: IB Ed 10, 12/08/05:
Prot/amend(corrected V#5 17/6/05)
Principal Investigator: Prof. Ian Reid.
Protocol Amendment #6, 28 February 2006.
Screening of human sera derived from patients with malignant and benign
hyper-gammaglobulinaemias for the presence of glutamate receptor
modulating antibodies: : Prot/amend V#03, 05/06/04, Substudy (stroke)
PIS/Cons V#4, 27/01/05: Substudy (Rheumatology patients): PIS/Cons V#4,
7/4/05: Prot/amend: SLEDAI Protocol.
Principal Investigator: Dr Maggie Kalev, Auckland City Hospital
Co-investigator: Dr Fiona McQueen
Extend recruiting age and steroid dose-matched rheumatoid arthritis controls
by including another rheumatological disease group.
1. A Rheumatology assessment
2. A functional MRI brain scan.
3. Repeating antibody tests looking for antibodies in sera reactive to the
PIS/Cons V#5, 13/04/06
Evaluation of the VentrAssist ™ left ventricular assist system as a bridge to
cardiac transplantation (trial No. CP023001): Protocol 27/04/04: IB 06/04,
Addendum #1, 18/5/04 Addendum #2, 18/05/04: Patient Handbook, 4/05/04: PIS
V#1, 11/08/04. IS/Cons V#2, 08/04 Prot/amend 31/08/04
Protocol Amendment 2, Version 4.0 dated February 2006
PIS/Cons V#4 dated 24 March 2006.
Early prediction of brain damage after heart surgery in infants: PIS/Cons V#4,
Principal Investigator: Dr John Beca ADHB
Co-investigators: A/Prof Chris Williams, Liggins Institute
Dr Malcolm Battin, Newborn Services, Auckland City
Dr Tom Gentles, Dr David Buckley, Dr Kirsten Finucane
(Starship Children’s Health)
Dr Ayton Hope, Auckland City Hospital.
Addition of Cardiac scan trial: researcher Dr Tom Gentles
A andomized placebo-controlled, multicentre, blinded phase I/II study of the
safety of escalating single, intravenous doses of rhuMab 2H7 (Ro 496-4913,
PRO70769) in patients with moderate to severe rheumatoid arthritis receiving
stable doses of concomitant methotrexate but with unsatisfactory clinical
response: Protocol # WA18230, RO 496-4913, 19/10/04: Prot/amend C
12/01/05: Proced/Admin Manual V#2, Prot/amend WA18230D, 13/6/05:
Prot/amend WA18230D-1, 13/06/05: Proced/Admin Manual V#3, 15/08/05:
PIS/Cons V#4, 30/08/05
Principal Investigators Dr G.P. Singh and Dr H. Hart, North Shore Hospital
Co-investigator: Dr Peter Gow, Middlemore Hospital
Protocol WA18230 RO 496-4913 (rhuMab 2H7, PR070769) Amendment E
dated 21 March 2006.
Amendment history for Protocol WA18230E
Participant Information Sheet/Consent Form for Dr Singh and Dr Hart, V#5, 7
Participant Information Sheet/Consent Form for Dr Peter Gow, Middlemore
Hospital V#5, 7 April 2006.il 2006
A double blind randomised placebo controlled multi centre phase II parallel
dose ranging study to assess the activity of GI262570.
Protocol Amendment # 2, 24/03/06
PIS/Cons V#4, 6/04/06
The following were reviewed and given ethical approval by the Chairperson under
APPLICATIONS FOR THE RETROSPECTIVE REVIEW OF PATIENT NOTES/DATA
Title: Incidence of missed traumatic brain injury (TBI)
diagnosis in patients admitted for inpatient rehabilitation
following accidents/multitrauma injuries – impact on the
Principal Investigator: Dr Boris Mak, Rehab Plus
Supervisor: Dr Samir Anwar
Title: An investigation into electronic discharge summary (EDS)
errors at Auckland City Hospital.
Principal Investigator: Nirasha Parsotam, Auckland City Hospital
Co-investigator: Anne-Maree Callaghan.
AMENDMENTS: - (Approved by Chairperson/Deputy Chairperson under CPD)
International breast cancer study VIII: adjuvant therapy in pre and
perimenopausal patients with node negative breast cancer: PIS/Cons V#3,
Principal Investigator: V. Harvey.
Co-Investigator: P. Thompson, B. Evans
International breast cancer study IX: adjuvant therapy post menopausal
patients with node negative operable breast cancer
Principal Investigator: Dr V. Harvey.
Co-Investigator: Dr P. Thompson, Dr B. Evans.
Workforce diabetes follow-up survey
Principal Investigator: Dr Patricia Metcalf
Pilot investigation of airway size and respiration of premature/full term babies
before discharge from the neonatal unit when placed in standard car seats
and the effect of modification of those car seats by way of an insert to
maintain a physiologically correct head position: PIS/Cons V#2, 18/10/2001.
Principal Investigator: Dr S. Tonkin
Co-Investigator: Dr W. Haddon, Dr A. Gunn, Dr S. Rowley
Promoting independent living study (PILS): a controlled investigation of a
client centred repetitive activities of daily living (ADL) programme in
residential care: PIS/Cons V#7, 10/2/03.
Principal Investigator: Dr N. Kerse
Co-Investigator: Mr M. Parsons, Ms K. Peri, Ms N. Latham, Mr R.N.
SPRASA, a novel sperm protein: is it important in fertility?Cons V#1 05/11/03,
PIS V#2 06/01/04.
Principal Investigator: Dr L. Chamley
Co-Investigator: Dr A. Shelling
An Open Label Study of the Efficacy and Safety of Re-Treatments with
Rituximab (Mabthera®) in Patients with Active Rheumatoid Arthritis. PIS/Cons
(Waitemata DHB/CMDHB) V#2 10/3/0: Prot. WA16855/U2653g V#B 21 Aug
2003. Cons Frm (Female Partners) V#1 5/12/03 (WDHB CMDHB).IB V#3, 03/04:
PIS/Cons V#3, 19/01/05: Adden 1, Amend C V. 1, 25/07/05: PIS/Cons Amend C.
Principal Investigator: Dr G.P. Singh, Dr H. Hart.
Co-Investigator: Dr P. Gow.
Effective goal setting and its relationship to other outcome measures for
people participating in pain management programmes: PIS V#1 15/12/2003
Cons V#2 05/02/04.
Principal Investigator: Ms D. Henare.
Co-Investigator: Mr M. Johnson.
A randomised trial of 2 CT scans versus 5 CT scans in the surveillance of
patients with stage I teratoma of the testis: Protocol TE08 V. April 2001:
PIS/Cons V#2, 4/4/02.
Principal Investigator: A/Prof V. Harvey
Co-Investigator: Dr M. McCrystal, Dr D. Porter, Dr P. Thompson.
Constructing a three-dimensional anatomically based mathematical model to
investigate the effect of microstructure on the function of the gastro-
oesophageal junction: IS/Cons V#2, 22/03/05
Principal Investigator: Ms R. Yassi.
Co-Investigator: Prof J. Windsor, A/Prof A. Pullan, Dr L. Cheng, Dr I. LeGrice.
Early inpatient-outpatient hospital-based pulmonary rehabilitation following
hospitalisation for acute exacerbations of COPD: a randomised controlled
study: IS/Cons V#1.2, 15/04/05
Principal Investigator: Dr T. Eaton
Co-Investigator: A/Prof P. Poole, Ms P. Young.
Do beta-blockers affect the use of beta-agonist inhalers in chronic
obstructive pulmonary disease? PIS/Cons V#1, 9/3/05: Prot/amend V#5,
6/05/05: PIS/Cons V#3, 10/05/05
Principal Investigator: Dr C. Chang.
Co-Investigator: Dr G. Mills, Dr R. Hancox, Dr N. Karalus, Dr J. McLachlan.
Family analysis of a unique chromosomal market identified at a sex
specific locus: PIS/Cons V#2, 10/05/05.
Principal Investigator: Patricia Stapleton.
Co-Investigator: Eileen Wu, Malou Andres.
Dual focus contact lens intervention in children with progressing myopia:
PIS/Cons V#5, 26/10/06
Principal Investigator: Ms. N. Anstice.