Northern Y Regional Ethics Committee
Annual Report
2012
Published in May 2014
by the Ministry of Health
PO Box 5013, Wellington, New Zealand
ISBN 978-0-478-42825-4 (online)
HP 5892
This document is available on the New Zealand Health and Disability Ethics Committees’
website: http://www.ethicscommittees.health.govt.nz
Contents
About the Committee .......................................................................................... 1
Membership and attendance .............................................................................. 2
Membership ........................................................................................................................ 2
Attendance .......................................................................................................................... 4
Applications reviewed ......................................................................................... 5
Average decision times ....................................................................................................... 5
Appendix 1: Details of applications reviewed ..................................................... 6
Applications reviewed by the full pathway .......................................................................... 6
Applications reviewed by the expedited pathway ............................................................. 14
Northern Y Regional Ethics Committee – 2012 Annual Report
iii
About the Committee
The Northern Y Regional Ethics Committee is a Ministerial committee established
under section 11 of the New Zealand Public Health and Disability Act 2000. Its
members are appointed by the Minister of Health through the public appointments
process.
The primary function of the Committee is to provide independent ethical review of
health research and innovative practice in order to safeguard the rights, health and
wellbeing of consumers and research participants and, in particular, those persons with
diminished autonomy.
In conjunction with the Northern X Regional Ethics Committee, the Committee has
primary responsibility for ethics committee review of health and disability research and
innovative practice occurring in the following District Health Board regions:
 Northland
 Waitemata
 Auckland
 Counties Manukau
 Waikato
 Tairawhiti
 Lakes
 Bay of Plenty.
The Committee is required by its Terms of Reference to submit an Annual Report to
the Minister of Health. The Annual Report must include information on the membership
of the Committee, a summary of the applications reviewed during the year, details of
any complaints received (and how they were resolved), and areas of review that
caused difficulty in making decisions, among other matters.
Approvals and registrations
The Northern Y Regional Ethics Committee is approved by the Health Research
Council’s Ethics Committee for the purposes of section 25(1)(c) of the Health Research
Council Act 1990.
The Northern Y Regional Ethics Committee is registered (number IRB00004665) with
the United States’ Office for Human Research Protections. This registration enables
the committee to review research conducted or supported by the US Department of
Health and Human Services.
Northern Y Regional Ethics Committee – 2012 Annual Report
1
Membership and attendance
Membership
Lay members
Ms Raewyn Sporle (Chair)
Membership category:
Lawyer
Date of appointment:
11 September 2008
Current term expired:
30 June 2012
Ms Raewyn Sporle was appointed Chairperson in June 2010. Ms Sporle is currently a self-employed
barrister and solicitor specialising in Family Law, Criminal Law and Employment Law. Ms Sporle is a
current Trustee of the Waikato Breast Cancer Trust (2006–present), and Trustee of Trust Waikato
(2010–present). Ms Sporle is a previous Chairperson of St Joseph’s Board of Trustees, Fairfield, Hamilton,
and holds professional memberships with the New Zealand Law Society, the Waikato / Bay of Plenty Law
Society, New Zealand Family Law Society. She is also a trained Mediator (LEADR).
Mrs Mary Anne Gill
Membership category:
Community representative
Date of appointment:
3 September 2009
Current term expired:
3 September 2012
Mrs Mary Anne Gill is currently Media and Communications Director at Waikato District Health Board
(2007–present). Prior to this she was a journalist at the Waikato Times (1994–2007), managing editor at
the Ruapehu Press in Taumarunui (1989–1994) and a journalist at Taranaki Daily News and Wanganui
Chronicle (1984–1989). During her overseas experience in the UK, she was the South East England
advertising executive of the year (1980). Mrs Gill completed a National Certificate in Retailing at Wellington
Polytechnic (1975) and graduated as a management trainee at Woolworths NZ Ltd (1977). She is currently
a member of the Northern Y Regional Ethics Committee (2011–present) and was previously an elected
trustee for the Fairfax New Zealand Superannuation Fund (2003–2007), a Board Trustee for St John’s
College, Hamilton (1998–2002), a Board Trustee for St Patrick’s Catholic School, Taumarunui
(1989–1992), and the first woman to be elected president at the Narrows Golf Club in Hamilton.
Mrs Phyllis Huitema
Membership category:
Consumer representative
Date of appointment:
2 September 2011
Current term expired:
30 June 2012
Ms Huitema is a self-employed consultant (1994–present) and a consumer representative, currently
holding lay positions on the Veterinary Council Complaints Assessment Committee (2009–present), the
Medical Council Professional Conduct Committees (1996–present), and the New Zealand Committee of
RANZCOG (2007–present). She is also a Trustee of the Dr Marcia Barns Trust (2002–present), and was
previously a member of the Waikato Health Ethics Committee (2000–2002) and the Dental Technicians
Board (2004–2010). Ms Huitema is a Justice of the Peace.
Mrs Lyn Murphy
Membership category:
Community representative
Date of appointment:
2 September 2011
Current term expired:
30 June 2012
Mrs Lyn Murphy is currently a senior lecturer at Manukau Institute of Technology (1990–present). Prior to
this she was an occupational therapist. Mrs Murphy is an elected member of Counties Manukau District
Health Board (2010–present), and has previously been a member of the Howick Community Board
(2007–2010) and Chair of St Marks Catholic School Board of Trustees (1992–2001). She completed a
Master of Business Studies (Management) at Massey University (1998) and is currently a PhD candidate
at the University of Tasmania.
Northern Y Regional Ethics Committee – 2012 Annual Report
2
Non-lay members
Dr Willem Fourie (Deputy Chair)
Membership category:
Health practitioner
Date of appointment:
6 March 2008
Current term expired:
30 June 2012
Dr Willem Fourie is currently the Dean of the Faculty of Nursing and Health Studies. Until August 2010 he
was Research Leader and Deputy Head of the Health Studies Department at the Manukau Institute of
Technology (2006–present). Prior to this he was the Programme Leader and Deputy Head of the Health
Studies Department at the Manukau Institute of Technology (2001–2006). Dr Fourie completed a
Doctorate in Mental Health Nursing at the University of the Free State, South Africa (1995), a Master of
Nursing at the University of Fort Hare, South Africa (1987), a Diploma in Nursing Education (1990) and a
Bachelor of Nursing (1982) at the University of Port Elizabeth, South Africa. He is currently an Ethics
Advisor for the Manukau Institute of Technology’s Ethics Committee (2004–present), the Chair of the
Auckland Region College of Nurses Aotearoa (2004-present) and a Fellow of the College of Nurses
Aotearoa (2003–present). Dr Fourie is also a member of the Nurse Educators in the Tertiary Sector
(2001–present) and an International Advisor for the Journal of Health South Africa Gasondheid (2000–
present). He has ublished several articles and presented papers at the International Health Conference
(2005), the ITPNZ Research Conference (2004) and the APNZ e-Fest (2003) to name a few.
Ms Sanya Ram
Membership category:
Pharmacist/pharmacologist
Date of appointment:
6 March 2008
Current term expired:
30 June 2012
Ms Sanya Ram is currently a Senior Tutor in Pharmacy Law at the University of Auckland (2005–present).
Prior to this she was the Acting Medical Services Manager (2003) at Boots Healthcare Australia and
Senior Regulatory and Medical Affairs Associate (2001–2003) at Boots Healthcare New Zealand. Ms Ram
completed a Bachelor of Law at the University of Auckland (2006) and a Bachelor of Pharmacy at the
University of Otago (1997). Ms Ram has also completed a Project Management Course from the
Australian Institute of Management (2003) and is a member of the Medicines Review Committee (2010).
Dr Etuate Saafi
Membership category:
Health researcher
Date of appointment:
3 September 2009
Current term expired:
3 September 2012
Dr Etuate Saafi is currently a Senior Research Fellow & Research Manager at Massey University. Prior to
this he was a Health Research Council of New Zealand Postdoctoral Research Fellow at the University of
Auckland (2004–2007). Dr Saafi completed a Master of Business Administration (2008) and a Master of
Biochemistry and Molecular Biology with Honours (1995) at Massey University, a Doctorate in Biological
Sciences at the University of Auckland (2004) and a Bachelor of Science at Victoria University (1991). He
is currently a member of the Health Research Council of New Zealand Pacific Health Research Committee
and the Counties Manukau District Health Board Pacific Health Advisory Committee. Dr Saafi’s research
interests have been in the area of type 2 diabetes and he has published and presented at a range of
conferences.
Mr Alistair Stewart
Membership category:
Biostatistician
Date of appointment:
6 March 2008
Current term expired:
30 June 2012
Mr Alistair Stewart is currently a Senior Research Fellow at the University of Auckland (1998–present).
Prior to this he was a Research Fellow at the University of Auckland (1991–1998). Mr Stewart completed a
Diploma of Statistics (1972) and a Bachelor of Mathematics (1971) at the University of Otago. He is a
previous member of the Health Research Council Funding Assessing Committee (1998-2002) and holds
professional memberships with the New Zealand Statistical Association, the Royal Statistical Society, the
American Statistical Association and the Biometrics Society. Mr Stewart has published over 190 peer
reviewed journal articles on topics such as the decline in SIDS mortality (2007) and the epidemiology of
plagiocephaly (2010).
Northern Y Regional Ethics Committee – 2012 Annual Report
3
Dr Tessa Turnbull (Deputy Chair)
Membership category:
Health practitioner
Date of appointment:
21 December 2006
Current term expired:
3 June 2013
Dr Tessa Turnbull is a General Practitioner and previously Senior Partner at Katikati Medical Centre. She
completed a Fellowship with the Royal New Zealand College of General Practitioners (1987), a Diploma of
Obstetrics at Auckland University (1977), and a Bachelor of Medicine and Bachelor of Surgery at the
University of Otago (1969). Dr Turnbull was a Director of PHARMAC Seminar Series (2006–2007), a
member of the Board for Osteoporosis New Zealand (1996–2006), and President of the Royal New
Zealand College of General Practitioners (1997–1998), to name a few such positions. She holds
professional memberships with the Royal New Zealand College of General Practitioners and the Royal
Australasian College of General Practitioners. Dr Turnbull is currently doing some sessional work and is
also a Fellowship Assessor for the RNZCGP.
Attendance
The Northern Y Regional Ethics Committee held five meetings between January and
June in 2012.
Non-lay members
Lay members
Members
Key:
Meetings
Jan
Feb

Mar
Total
Apr
May
Jun


X

4/5
L
Ms Raewyn Sporle (Chair)
E
Ms Christina Bryant
Cn
Dr Adelaide Collins
Cm
Mr Kerry Hiini
Cn
Mrs Phyllis Huitema





5/5
Cm
Ms Mary-Anne Gill





5/5
Cm
Ms Lyn Murphy

X
X

A
2/5
Cn
Mr Mike Vale
HR
Dr John Fitzgerald
HP
Dr Willem Fourie


X


4/5
P
Ms Sanya Ram





5/5
HR
Dr Etuate Saafi





5/5
B
Mr Alistair Stewart





5/5
HP
Dr Tessa Turnbull





5/5
Attendance
9
8
7
8
8
41/45
Applications considered
11
8
12
12
12
56*
L
Lawyer
P
Pharmacist/pharmacologist

present
E
Ethicist
B
Biostatistician
A
apologies
Cm
Community representative
HP
Health practitioner
X
absent
Cn
Consumer representative
HR
Health researcher
not applicable
* Note two applications went to full meetings but did not require ethics approval.
Northern Y Regional Ethics Committee – 2012 Annual Report
4
Applications reviewed
The Northern Y Regional Ethics Committee received 85 applications between January
and June 2012. Of these, 52 were reviewed by the full committee, and 25 were
reviewed between meetings at the direction of the Chair (“expedited review”). 8 were
withdrawn or did not require HDEC review.
Expedited
Full
At each of its meetings between January and June 2012, the Committee reviewed an
average of 11 applications.
Approved
47
Declined
0
No final decision (as at 30 June 2012)
5
Withdrawn / ethical approval not required
2
Total
54
Approved
24
Declined
0
No final decision (as at 30 June 2012)
1
Withdrawn / ethical approval not required
6
Total
Total applications reviewed
31
85
Average decision times
In 2012, the average decision times were 24 days for “expedited” applications and
80 days for “full” applications, including any time taken for researchers to respond to
approval conditions.
Northern Y Regional Ethics Committee – 2012 Annual Report
5
Appendix 1: Details of applications reviewed
Applications reviewed by the full pathway
Project key
Full title
Primary
investigator
An ethnography to explore the social
context – political economy and ecology of
the sick poor
Dr Leo Revell
NTY/12/01/003
Tramadol vs morphine for refractory
postoperative pain in the recovery room
Dr Kelly Byrne
NTY/12/01/004
An exploration of patients’ engagement with Dr Kate Perry
and response to blood clot (venous
thromboembolism; VTE) information and
risk self-assessment tool provided to
patients prior to surgery
NTY/12/01/005
Acupuncture to improve live birth rates for
women undergoing IVF: a randomised
controlled trial
NTY/12/01/002
Outcome
Deferred
Why deferred /
declined
Status at
time of
report
Review
type
Deferred the study
due to validity of
research proposal
and lack of
information to make a
decision (OSEC 2.4)
Approved
Full
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
Radius Davies
Corner, Hamilton
Kaute Pasifika
Approved
subject to
conditions
Approved
Full
Waikato Hospital
Approved
subject to
conditions
Approved
Full
Southern Cross
North Harbour
Hospital
Dr Caroline Smith Approved
subject to
conditions
Approved
Full
Auckland District
Health Board
Waikato hospital
anaesthetic
department
Ngai Tahu
research
consultation
committee
178
Kaumatua
Kaunihera at
WDHB
70
Taniwha
Blackburn –
cultural
advisor
59
94
188 Specialist
Centre, St Heliers
Fertility Associates
NTY/12/01/006
Children’s Oncology Group (COG)
AREN0534: Treatment for patients with
bilateral, multicentric, or bilaterallypredisposed unilateral wilms tumour
Approved
subject to
conditions
Approved
Full
Starship Childrens
Hospital
NTY/12/01/007
Healthy ageing protein supplementation trial Ms Karen Munday Approved
subject to
conditions
Approved
Full
Auckland
Fonterra
Co-operative
Group Ltd
68
NTY/12/01/008
Randomised cross-over study to investigate Professor Richard Approved
the effects of airvo on arterial carbon
Bealsey
subject to
dioxide pressure and ventilation in patients
conditions
with chronic obstructive pulmonary disease
Approved
Full
Medical Research
Institute of New
Zealand
Fisher and Paykel MRRC
Healthcare
71
Northern Y Regional Ethics Committee – 2012 Annual Report
Dr Jane Skeen
MRRC at
ADHB
65
Capital and Coast
District Health
Board
6
Project key
Full title
Primary
investigator
NTY/12/01/009
Randomised cross-over study to investigate Janine Pilcher
the effects of varying concentrations of
oxygen on arterial carbon dioxide pressure
and ventilation in patients with chronic
obstructive pulmonary disease
NTY/12/01/010
MK5172-034: a phase II randomised,
partially blinded, pilot study to evaluate the
efficacy and safety of MK-5172 in
combination with ribavirin (RBV) in
treatment-naïve (TN) patients with chronic
genotype (GT-1) hepatitis C virus infection
PI: Associate Professor Ed Gane
Outcome
Professor Edward Approved
John Gane
subject to
conditions
Why deferred /
declined
Status at
time of
report
Review
type
Approved
Full
Terminated
Full
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
Medical Research MRRC
Institute of New
Zealand
Auckland Clinical
Studies
Merck Sharp and
Dohme
59
MRRC
Auckland DHB
Christchurch
Clinical Studies
Trust
Waikato Hospital
NTY/12/01/011
A phase 4, randomised, double-blind, active Dr Mike Williams
and placebo-controlled, multicentre study
evaluating the neuropsychiatric safety and
efficacy of 12 weeks varenicline tartrate
1 mg BID and bupropion hydrochloride
150 mg BID for smoking cessation in
subjects with and without a history of
psychiatric disorders; Protocol Number:
A3051123
Approved
subject to
conditions
Approved
Full
NTY/12/02/012
Exploring the association between anxiety,
depression and visual impairment: the role
of preliminary screening using the PHQ-4
Dr John
Fitzgerald
Approved
Approved
Full
NTY/12/02/013
The effect of 12 months of cholecalciferol
supplementation on muscle strength, bone
mineral density and respiratory infection in
female adolescent dancers
Dr Pamela von
Hurst
Approved
subject to
conditions
Approved
Full
Massey University
Massey University Dr Lily
George –
Massey
University
36
NTY/12/02/014
Predictors of persistent postoperative pain
after total knee joint arthroplasty
Dr Michal Kluger
Approved
subject to
conditions
Approved
Full
North Shore
Hospital
AUT University,
ANZCA
Nga Kai
Tataki –
WDHB
65
NTY/12/02/015
Adherence and outcomes of patients
prescribed Dabigatran (Pradaxa):
observational case series
Dr Katie Thorne
Approved
subject to
conditions
Approved
Full
Hutt Valley District
Health Board
Maraea
Cookson –
Hutt Valley
DHB
43
AAML1031: a phase III randomised trial for
patients with de novo AML using
Bortezomib (IND #58443) and Sorafenib
(IND #69896) for patients with high allelic
ratio FLT3/ITD
Dr Nyree Cole
Approved
subject to
conditions
Approved
MRRC at
ADHB and
CDHB
108
NTY/12/02/016
Northern Y Regional Ethics Committee – 2012 Annual Report
Lakeland Clinical
Trials Ltd
67
The Psychology
Centre and
RNZFB
Ropata Med Centre
Full
Auckland District
Health Board
Canterbury District
Health Board
COG
Mana Kapo –
RNZFB
14
7
Project key
NTY/12/02/017
Full title
The management of metastatic prostate
cancer in high health needs ethnic groups
Primary
investigator
Professor Ross
Lawrenson
Outcome
Approved
subject to
conditions
Why deferred /
declined
Status at
time of
report
Review
type
Approved
Full
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
Midland Cancer
Network
MRRC at all
DHBs
80
Health Waikato
Bay of Plenty
District Health
Board
Lakes District
Health Board
Auckland District
Health Board
Cancer societies
General practice
NTY/12/02/018
Utility of circulating microRNAs as a
biomarker for differentiated thyroid cancer
Dr Goswin
Meyer-Rochow
Approved
subject to
conditions
Approved
subject to
conditions
Full
Waikato District
Health Board
NTY/12/02/019
Incidence of iodine-induced throtoxicosis
Dr Kim Simcox
following computed tomography of the chest
or neck with intravenous contrast
Approved
subject to
conditions
Approved
Full
Waikato Hospital
Waikato Medical
Research
Foundation
Te Puna
Oranga –
WDHB
133
NTY/12/02/020
A phase II, single arm, non-randomised,
Dr Peter Fong
multi-centre study to evaluate the efficacy of
oral TK1258 as second line therapy in
patients with either FGFR2 mutated or wildtype advanced and or metastatic
endometrial cancer
Approved
subject to
conditions
Approved
Full
Auckland District
Health Board
Novartis
Pharmaceuticals
MRRC at
ADHB
86
NTY/12/04/021
Oranga Niho Nga Tangata Whaiora
Associate
Professor John
Broughton
Approved
Full
Te Manu Toroa
HRC NZ
Te Manu
Toroa
78
MRRC at
ADHB
58
MRRC at
ADHB
133
RAGM at
CCDHB
83
Bay of Plenty
District Health
Board
NTY/12/04/022
What are the perceptions of parents and
caregivers of paediatric palliative care
patients regarding place of end-of-life care
and death?
Dr Emily Chang
Approved
Full
Auckland District
Health Board
NTY/12/04/023
EXTEND-IA: Extending the time for
thrombolysis in emergency neurological
deficits – intra-arterial
Professor Alan
Barber
Approved
Full
Auckland City
Hospital
NTY/12/04/024
The effect of alcohol withdrawal on bone
Elaine Dennison
turnover in women with alcohol dependence
Approved
Full
Northern Y Regional Ethics Committee – 2012 Annual Report
Te Puna
Oranga at
WDHB
RACP, CSIRO,
Covidien
8
Project key
Full title
Primary
investigator
Outcome
Why deferred /
declined
Status at
time of
report
Review
type
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
NTY/12/04/025
Identification and functional characterisation Dr Marjan
of non-protein-coding genes (ncRNA) in
Askarian -Amiri
cancer
Deferred
Full
University of
Auckland
Dr Papaarangi
Reid –
University of
Auckland
NTY/12/04/026
The effect of mandatory fortification of bread Dr Sheila Skeaff
with iodised salt on the iodine status of
pregnant women in New Zealand
Approved
Full
Dunedin
Ngai Tahu
Research
Consultation
Committee
77
None
31
Ministry of Health
Huhana
Hickey
73
Gilead Sciences
Inc, USA
MRRC at
ADHB and
CDHB
59
MRRC at
Waitemata
DHB
97
Department of
Pscyhological
Medicine,
University of Otago
Ngai Tahu
Research
Consultation
Committee
253
Seed funding
from University of
Auckland
MRRC at
CMDHB
Wellington
Hamilton
NTY/12/04/027
The Hua Oranga: A Maori measure of
mental health outcome service application
Ms Kahu
McClintock
Approved
Full
NTY/12/04/028
A validation and norming study of the
strengths and difficulties questionnaire
(SDQ) in the New Zealand context
Associate
Professor Paula
Kersten
Approved
Full
NTY/12/04/029
GS-US-334-0108: a phase 3, multicentre,
Professor Edward
randomised, double-blind study to
John Gane
investigate the efficacy and safety of
GS-7977 + Ribavirin for 12 or 16 weeks in
treatment experienced subjects with chronic
genotype 2 or 3 HCV infection
Approved
Full
Describing the feeding experiences of
first-time mothers
Associate
Professor
Suzanne C Purdy
Approved
Professor Paul
Glue
Approved
Full
Approved
subject to
conditions
Full
NTY/12/04/030
Waitemata District
Health Board
Auckland District
Health Board
Auckland Clinical
Studies
Canterbury District
Health Board
Full
Waitemata District
Health Board
Waitakere Hospital
NTY/12/04/031
The role of CYP2D6 in the
pharmacokinetics of ibogaine and
noribogaine
NTY/12/04/032
A randomised placebo-controlled trial of an Dr Gregory Luke
N-Methyl-D-Aspartate antagonist as a rapid- Larkin
acting anti-depressant in depressed
emergency department patients
NTY/12/05/033
HRC 11/793 He Kokonga Whare: Maori
integenerational trauma and healing
Dr Paul Reynolds
Approved
subject to
conditions
Approved
Full
115
NTY/12/05/034
A prospective, double blind, randomised,
placebo-controlled clinical trial of
intracoronary infusion of immunoselected,
bone marrow-derived Stro3 mesenchymal
precursor cells (MPC) in the treatment of
patients with ST-elevation myocardial
infarction
Dr Gerard Devlin
Approved
subject to
conditions
Approved
Full
86
Northern Y Regional Ethics Committee – 2012 Annual Report
Counties Manukau
District Health
Board
9
Project key
NTY/12/05/035
Full title
Long-term neurodevelopmental and
metabolic consequences of neonatal
hyperglycaemia and protein intake
Primary
investigator
Dr Anna Tottman
Outcome
Approved
subject to
conditions
Why deferred /
declined
National application
form
Status at
time of
report
Review
type
Approved
Full
Approved
Full
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
125
Form A
Part 4 Declaration –
Dr Anna Tottman
Part 5
Part 8
Locality assessment –
The Liggins Institute
Parent/guardian
information sheet,
Version 1, dated
1 May 2012
Consent form,
Version 1, dated
1 May 2012
MRI information
sheet, Version 1,
dated 1 May 2012
MRI consent form,
Version 1, dated
1 May 2012
Study protocol,
Version 1, dated
1 May 2012
NTY/12/05/036
MEK116513 – a phase III, randomised,
Dr Catherine
open-label study comparing the combination Barrow
of the BRAF inhibitor, dabrafenib and the
MEK inhibitor, tramtinib to the BRAF
inhibitor vemurafenib in subjects with
unresectable (stage IIIc) or metastatic
(stage IV) BRAF V600E/K mutation positive
cutaneous melanoma
Northern Y Regional Ethics Committee – 2012 Annual Report
Approved
subject to
conditions
Christchurch
Hospital
48
10
Project key
Full title
NTY/12/05/037
A randomised, open-label, phase 3 study of
Carfilzomib vs Best supportive care in
subjects with relapsed and refractory
multiple myeloma
Primary
investigator
Dr Peter Ganly
Outcome
Approved
subject to
conditions
Why deferred /
declined
Protocol PX-171-011
amendment 2 dated
8 March 2012
Status at
time of
report
Review
type
Approved
Full
Approved
Full
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
120
Carfilzomib
investigator brochure:
10th edition dated
15 March 2012
NAF
Including Part 4 –
Christchurch Hospital
North Shore Hospital
– pending
Form B (pending)
Locality assessment –
pending all sites
Maori consultation –
pending all sites
Participant
information and
consent form,
version 1, dated
16 April 2012
Certificate of
insurance
PX-171-011_Patient
Card Template_AUS
Version 1, 4 Nov 2011
NTY/12/05/038
A randomised, double-blind, placeboProfessor Tim
controlled study of the safety and efficacy of Anderson
intranasal midazolam (USL 261) in the
outpatient treatment of subjects with seizure
clusters. Protocol number P261-401
Approved
subject to
conditions
New Zealand Brain
Research Institute
Christchurch
69
Auckland City
Hospital
Waikato Hospital
NTY/12/05/039
A phase 4, non-treatment follow-up for
cardiac assessments following use of
smoking cessation treatments in subjects
with and without a history of psychiatric
disorders
Dr Mike Williams
Approved
Approved
Full
NTY/12/05/040
Bronchiectasis exacerbations study (BEST)
in Australia and New Zealand
Dr Catherine A
Brynes
Approved
subject to
conditions
Approved
Full
Northern Y Regional Ethics Committee – 2012 Annual Report
Pfizer
30
122
11
Project key
Full title
Primary
investigator
Outcome
Why deferred /
declined
Status at
time of
report
Review
type
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
NTY/12/05/041
Evaluation of three singlepex PCR assays
for enteroviruses, meniingococcus, and
leptospira: blood versus cerebrospinal fluid
(CSF) samples
Professor Mary
Nulsen
Approved
Approved
Full
30
NTY/12/05/042
Establishing a reference set for
cardiovascular autonomic responses in a
local population
Dr Brooke
Cantley
Approved
subject to
conditions
Approved
Full
49
NTY/12/05/043
ACIST diagnosis of coronary arterial
disease with a rapid exchange monorail
pressure sensor (MPS) for the
measurement of fractional flow reserve
(FFR). Protocol No: NZ100
Dr Madhav
Menon
Approved
subject to
conditions
Approved
Full
49
NTY/12/05/044
A randomised, double-blind, escalating,
single dose study to assess the safety and
tolerability of manuka health cyclopower
capsules in healthy volunteers
Ms Evelyn
Francis
Deferred
Approved
Full
80
NTY/12/06/045
Effectiveness of previously cannulated
radial arteries as conduits for coronary
artery bypass surgery
Dr Peter Ruygrok
Approved
subject to
conditions
Approved
Full
NTY/12/06/046
Randomised, placebo-controlled phase II
trial of simvastatin as prophylaxis against
radiation-induced skin toxicity in breast
cancer patients
Dr Shibu Joseph
Approved
Full
Waikato District
Health Board
NTY/12/06/047
REDUCE-HTN: treatment of resistant
hypertension using a radiofrequency
percutaneous transluminal angioplasty
catheter
Dr Mark Webster
Approved
Full
Auckland City
Hospital
NTY/12/06/048
BV28333: An exploratory evaluation of
Professor Edward
interleukin 28B (IL28B) genotype, protein
J Gane
and RNA biomarkers in serum samples
(stored, already obtained from completed
studies) from subjects with HBe-antigen
positive or negative chronic hepatitis B, who
have completed therapy for hepatitis B with
Pegasys ± lamivudine
Deferred
Full
Auckland City
Hospital
Northern Y Regional Ethics Committee – 2012 Annual Report
The committee
deferred the study
due to validity of
research proposal
and lack of
information to make a
decision (OSEC 2.4)
Auckland City
Hospital
None
MRRC at
ADHB
17
Waikato Medical
Research
Foundation
Kaumatua
Kaunihera at
WDHB
71
MRRC at
ADHB
85
Mercy Hospital
Hoffman la Roche
12
Project key
NTY/12/06/050
Full title
Incredible years specialist service – an
evaluation of the efficacy of adding a
manualised enhancement service to
improve outcomes for high-risk families/
whanau attending the incredible years
parent programme
Primary
investigator
Outcome
Ms Dianne Lees
Why deferred /
declined
Status at
time of
report
Review
type
Approved
Full
Locality
organisations
Sponsor / funder Consultation Days to
undertaken review
Bay of Plenty District Ministry of Health
Health Board
MRRC at
BOPDHB
86
Ministry of Education
Positive Families
NGO
St Peters Care and
Counselling
Charitable Trust
NTY/12/06/051
A trial of tetrahydrobiopterin-responsiveness Dr Callum Wilson
in a subgroup of the New Zealand PKU
population, preselected on phenotype and
genotype
Approved
Full
LabPlus
Auckland City
Hospital
National
Mata Forbes
Metabolic Service
and Merck
Serano
112
Starship Children’s
Hospital
NTY/12/06/052
Maori experiences of bipolar affective
disorder and pathways to care
Associate
Professor Linda
Nikora
Approved
Full
Te Runanga O
Kirikiriroa Inc
99
Waikato District
Health Board
Raukura Hauora O
Tainui
Hauora Waikato
Birthcare Huntly
Waahi Whaanui
Health Services
Approved
subject to
conditions
Full
Closed
Full
Dr Warren Tate
Approved
Full
University of Otago
Ms Heather Clark
Approved
Full
Carrington Road
Physio
NTY/12/06/053
Genetic basis of epilepsy
Dr Lynette Sadleir Received
NTY/12/06/054
Aunty Whakahaere Hapunga Initiative
Dr Marewa Glover
(AWHI): Could local ‘aunties’ facilitate better
Maori pregnancy outcomes?
NTY/12/06/055
Development of a simple biomarker-based
diagnostic blood test for myalgic
encephalomyelitis (ME)
NTY/12/06/056
The effect of a computer-based patient
education programme on rehabilitation
adherence and shoulder function when
used as an adjunct to physiotherapy in
patients with shoulder injuries
Capital and Coast
District Health
Board
MRRC at
CCDHB
Lotteries Health
Grant
59
Award fund
Leah Pearsall
64
Birkenhead
Physiotherapy
Centre
Golf Works Ltd
Northern Y Regional Ethics Committee – 2012 Annual Report
13
Applications reviewed by the expedited pathway
Project key
Full title
Primary investigator
Status at time
of report
Review
type
NTY/12/EXP/001 Incidental adrenal nodules – assessment of follow up investigations
Dr Marianne Elston
Ethical approval
not required
EXP
NTY/12/EXP/002 Ethnic differences in creatinine generation in South Auckland peritoneal dialysis patients
Ms Tina Sun
Withdrawn
EXP
NTY/12/EXP/003 Triage of patients presenting with PR bleeding to Middlemore Hospital Emergency
Department
Mr Vincent Chong
Ethical approval
not required
EXP
NTY/12/EXP/004 Introducing a fibreoptic endoscopic evaluation of swallowing (FEES) service to acute
wards: staff perceptions and functional outcomes for stroke patients
Ms Anna Miles
Approved
EXP
NTY/12/EXP/005 A retrospective observational study on growth discordancy in dichorionic twins stratified by
ethnicity
Dr Unmandani
Devashana Gupta
Ethical approval
not required
EXP
NTY/12/EXP/006 Patient hospital acquired venous thromboembolism study (phase study)
Mr Martyn James
Ethical approval
not required
EXP
NTY/12/EXP/007 Change in patient scores following arthroplasty surgery: are there any differences between
Maori and non-Maori? A registry-based cohort study.
Neal Singleton
Approved
EXP
NTY/12/EXP/008 Confidence levels of ANZCA trainees in obstetric anaesthesia
Dr Timothy G Short
Approved
EXP
Locality organisations
Days to
review
27
Counties Manukau District
Health Board
7
Auckland District Health Board
3
Royal Brisbane and Women’s
Hospital
NTY/12/EXP/009 The perceived barriers to following dietary advice in Pacific Island women with diabetes in
pregnancy, in the Waikato District Health Board region
Dr Alexandra Chisholm
Approved
EXP
NTY/12/EXP/010 The effect of introduction of a national standardised medication chart on the incidence of
prescription erors in an intensive care unit
Dr Tom Burrows
Received
EXP
NTY/12/EXP/011 Retrospective review of current right iliac fossa (RIF) pain management within the
department of general surgery at Middlemore Hospital, Auckland, New Zealand
Mr Andrew MacCormick Approved
EXP
2
NTY/12/EXP/012 Teddy Bear Hospital: effective at reducing both children’s and medical students’s anxiety?
Ms Lindsey Harbour
Approved
EXP
41
NTY/12/EXP/013 A clinical outcomes study of the trimed ulnar osteotomy compression plate
Dr Mike Foster
Approved
EXP
19
NTY/12/EXP/014 The competency review process for registered nurses – a case study
Ms Dianne Barnhill
Approved
EXP
20
NTY/12/EXP/015 Barriers to renal transplantation in the Auckland dialysis population
Ms Gillian Balbir Singh
Approved
EXP
20
NTY/12/EXP/016 A retrospective review the bacteriology of patients diagnosed with a necrotising soft tissue
infection in South Auckland between 1997 and 2010
Dr Benjamin Cribb
Approved
EXP
11
NTY/12/EXP/017 A case control study comparing patients with a diagnosis of a necrotising soft tissue
infection compared to patients with severe cellulitis in South Auckland between 1997 and
2010
Dr Benjamin Cribb
Approved
EXP
11
NTY/12/EXP/018 Psoriasis and lichen sclerosus: an observational study
Dr Harriet Cheng
Approved
EXP
39
Northern Y Regional Ethics Committee – 2012 Annual Report
44
14
Project key
Full title
Primary investigator
Status at time
of report
Review
type
Locality organisations
Days to
review
NTY/12/EXP/019 The epidemiology of gastric and oesophageal cancer in New Zealand from 1998 to 2011
Mr Andrew MacCormick Approved
EXP
35
NTY/12/EXP/020 The proposal is to conduct baseline secondary data analysis of databases which house
data pertaining to patients presenting to the Lakes District Health Board Emergency
Department
Dr Graham Hukins
Approved
EXP
16
NTY/12/EXP/021 Assessment of ventialtion pressures of mannequin infants using a self-inflating ventialtion
bag vs Neopuff device
Dr Boon Ong
Approved
EXP
30
NTY/12/EXP/022 How can the costs of providing care for family and whanau within a palliative care context
be appropriately captured for research purposes?
Professor Merryn Gott
Ethical approval
not required
EXP
NTY/12/EXP/023 Multivariable analysis of risk factors for protein loss after major abdominal surgery
Dr Mattias Soop
Approved
EXP
23
NTY/12/EXP/024 Model of care development in the older person rehabilitation service (OPRS), Waikato DHB Dr Ann McKillop
Approved
EXP
23
NTY/12/EXP/025 Transfer of paediatric clinic patients at Tauranga Hospital from paediatrician to GP: a pilot
study
Dr Victoria Gates
Approved
EXP
17
NTY/12/EXP/026 Real life correlates of medication choice and effectiveness in patients with schizophrenia
Ms Sangeeta Dey
Approved
EXP
51
NTY/12/EXP/027 Functional outcomes following cruciate retaining versus posterior stabilised total knee
arthroplasty: are there any differences? A registry-based cohort study
Neal Singleton
Approved
EXP
19
NTY/12/EXP/028 ADHB surgical VTE prohylaxis: second snapshot audit
Mr Eddie Kim
Approved
EXP
27
NTY/12/EXP/029 Moral distress and resilience as experienced in aged residential care – a New Zealand
perspective
Ms Cornelia Bronkhorst
Approved
EXP
87
NTY/12/EXP/030 Phase 1: An evaluation of the fidelity and short term outcomes of a Wraparound Initative in
New Zealand
Ms Jacinda Shailer
Approved
EXP
24
NTY/12/EXP/031 To evaluate use of patient web portals (PWPs) and diabetes outcomes in primary care
Dr Poornima Nair
Approved
EXP
32
Northern Y Regional Ethics Committee – 2012 Annual Report
15