Northern X Regional Ethics Committee
Annual Report
2012
Published in May 2014
by the Ministry of Health
PO Box 5013, Wellington, New Zealand
ISBN 978-0-478-42824-7 (online)
HP 5891
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 .......................................................................................................................... 5
Applications reviewed ......................................................................................... 6
Average decision times ....................................................................................................... 6
Appendix 1: Details of applications reviewed ..................................................... 7
Applications reviewed by the full pathway .......................................................................... 7
Applications reviewed by the expedited pathway ............................................................. 16
Northern X Regional Ethics Committee – 2012 Annual Report
iii
About the Committee
The Northern X 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 Y Regional Ethics Committee, the Northern X Regional
Ethics 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 X 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 X Regional Ethics Committee is registered (number IRB00004664) 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 X Regional Ethics Committee – 2012 Annual Report
1
Membership and attendance
Membership
Lay members
Dr Brian Fergus (Chair)
Membership category:
Community representative
Date of appointment:
24 June 2010
Current term expired:
24 June 2013
Dr Brian Fergus is currently an Honorary Research Associate at the University of Auckland
(2009–present). His career included management positions in industry, and management consulting
before founding and running his own computer services company (1997–2008). Dr Fergus completed a
Diploma of Business Administration at the University of Auckland, a PhD in Chemistry at McGill University,
Montreal, Canada, a Master of Science and a Bachelor of Science at the University of Auckland. He is a
former member of the Auckland District Health Board (2007–2010) and a previous member of the
Baradene College Board of Trustees.
Ms Susan Buckland
Membership category:
Community representative
Date of appointment:
2 September 2011
Current term expired:
30 June 2012
Ms Buckland is a freelance journalist, specialising in social issues and travel writing. She was previously a
public relations manager for Air New Zealand (1979–1992). Ms Buckland is an elected member of
Auckland District Health Board (2007–present), and has previously been Chair of New Zealand Travel
(1992–2000) and a Trustee for World Wildlife Fund New Zealand (1997–1998). She completed a Bachelor
of Arts at Auckland University (1996) and a Diploma of Italian Language at Perugia University (1967).
Ms Alaina Campbell
Membership category:
Consumer representative
Date of appointment:
17 June 2010
Current term expired:
17 June 2013
Ms Alaina Campbell is currently a nurse consultant for the Midland Regional Trauma System. Prior to this
she was involved with clinical system and process review and development as Project Manager for
Waikato Hospital (2008–2009) and held Clinical Nurse Manager positions (2002–2008). Ms Campbell
completed a Bachelor of Nursing (1998) and a Diploma of Nursing (1995). She holds professional
memberships with the Nursing Council of New Zealand, the New Zealand Nurses Organisation and the
Australasian Trauma Society.
Ms Linda Kaye
Membership category:
Consumer representative
Date of appointment:
6 March 2008
Current term expired:
30 June 2012
Ms Linda Kaye has been a barrister and solicitor specialising in accident compensation and medical
misadventure law, mediation and negotiation. Prior to this, she was a consultant for Penney Patel Law
(1993–2006). Ms Kaye completed a Master of French and English at Auckland University (1969), a
Bachelor of Laws (1979) and was admitted as a Barrister and Solicitor before the High Court of New
Zealand (1979). She successfully represented victims of hepatitis C contaminated blood and blood
products and was a previous chair of the Dentists Disciplinary Tribunal (1990–1997), a member of the New
Zealand Survey Board (1988–1993), a disputes tribunal referee and a member of the Committee on
Assisted Reproductive Technology for the New Zealand Law Society.
Northern X Regional Ethics Committee – 2012 Annual Report
2
Ms Michèle Stanton
Membership category:
Lawyer
Date of appointment:
2 September 2011
Current term expired:
30 June 2012
Ms Michèle Stanton is a lawyer, consultant and director with experience in financial services, health,
education, and not for profit voluntary sector charitable organisations. She has extensive experience,
working directly with private investors, and as a manager within the financial services sector in financial
adviser and financial services provider legislation and regulation, and in relation to industry training.
Michèle was a member of the Government Taskforce in to the Regulation of Financial Intermediaries in
2004/2005. Michèle has a Diploma in Business Studies from Massey University (1998), a Bachelor of
English from the University of Canterbury (1981) and a Bachelor of Laws from the University of Canterbury
(1984). She is currently Deputy Chairman of the Physiotherapy Board, a panel member for the
JR McKenzie Trust Regional Grants Committee, and a National External Moderator for the National
Certificate in Financial Services [Financial Advice] [Level 5].
Non-lay members
Dr Marewa Glover
Membership category:
Health researcher
Date of appointment:
2 September 2011
Current term expired:
30 June 2012
Dr Marewa Glover (Ngāpuhi) is Director of the Centre for Tobacco Control Research, a Senior Lecturer,
and Research Fellow at the School of Population Health, University of Auckland (2004–present). Prior to
this she was the Health Research Council’s Post-Doctoral Fellow at the University of Auckland
(2000–2004). Dr Glover completed a PhD in Behavioural Science at the University of Auckland (2001),
and a Diploma in Psychology (Community) (1994) and a Master of Social Science (1993) at the University
of Waikato. She is currently a Board Member for End Smoking New Zealand (2009–present) and was
previously Chair of the Tobacco Control Research Strategy Group (2006–2008) and a member of the
Health Research Council’s Māori Health Committee (2001–2003), to name a few such positions. Dr Glover
has an extensive background in research, including some 40 refereed journal articles.
Ms Rosemary Langham
Membership category:
Pharmacist/pharmacologist
Date of appointment:
17 June 2010
Current term expired:
17 June 2013
Ms Rosemary Langham is currently a Research Pharmacist for Auckland Clinical Studies Limited
(2008–present) and a regular Locum Pharmacist at Mount Eden Pharmacy (2008–present). Prior to this
she was the Director of Medi-Centre Pharmacy (1993–2007). Ms Langham completed a Diploma in
Pharmacy at the Central Institute of Technology (1976). She is currently a community pharmacy
representative on the Auckland School of Pharmacy Teaching and Learning Committee (2008–present).
Dr Ieti Lima
Membership category:
Health researcher
Date of appointment:
17 June 2010
Current term expired:
17 June 2013
Dr Ieti Lima is currently a Senior Researcher with the Ministry of Pacific Island Affairs and a Senior Health
Promotion Strategist at the Health Promotion Forum of New Zealand. He completed a Health Research
Council Postdoctoral Fellowship at Massey University (2005–2009) and was a Senior Research Fellow with
the Pacific Islands Families Study, AUT in 2008. Dr Lima has had Research Fellow positions at Victoria
University and University of Auckland. Dr Lima completed a PhD in Sociology (2005), a Masters of
Development Studies (1999) and a Bachelor of Sociology and Political Studies (1997) at the University of
Auckland. He is a current member of the Heath Research Council’s Pacific Island Health Research
Committee and as been a member of the Northern X Regional Health Research Committee since June 2010.
Northern X Regional Ethics Committee – 2012 Annual Report
3
Professor Wayne Miles
Membership category:
Date of appointment:
Current term expired:
Health practitioner
7 July 2005
30 June 2012
Professor Wayne Miles is currently the Director of the Knowledge Centre for the Waitemata District Health
Board (2003–present) and a Clinical Associate Professor for the University of Auckland (2005–present).
Prior to this he was the Clinical Director for Waitemata Health and the Area Director for the Mental Health
Services (1993–2003). Professor Miles was made a Fellow (1987) and Member (1982) of the Royal
Australian and New Zealand College of Psychiatrists. He has completed a Doctor of Medicine at the
University of Otago (1982), a Diploma of Psychiatry at the University of Auckland (1981) and a Bachelor of
Medicine and Surgery at the University of Otago (1972). Professor Miles is a current member of the
Northern X Regional Ethics Committee (2005–present). He is a previous member of the Director-General’s
Strategic Workforce Group (1998–2000), the New Zealand Mental Health Commission Advisory Board
(1996–2000) and the Director-General’s Inquiry into Suicides (1995) to name a few. Professor Miles has
published over 20 articles and presented papers at over 44 conferences.
Dr Paul Tanser
Membership category:
Date of appointment:
Current term expired:
Health practitioner
3 September 2009
3 September 2012
Dr Paul Tanser is currently employed as a Cardiology Consultant at North Shore and Waitakere Hospitals
(2005–present). Prior to this he was Clinical Head of Cardiology at Palmerston North Hospital
(2004–2005). Dr Tanser received his Fellowship and Specialist Certification in the Royal College of
Physicians and Surgeons of Canada (1967) and Certification as Specialist in Cardiology Province of
Quebec (1969), Royal College of Physicians (Glasgow 2001), Royal Australasian College of Physicians
(2010), American College of Physicians, American College of Cardiology, and International College of
Angiology. He graduated with a Doctor of Medicine (Magna cum Laude) from Ottawa University (1962). He
was Governor of the American College of Cardiology for Ontario (2003) and the American College of
Physicians (2001–2003). He was Assistant Professor of Medicine, McGill University, Cardiology
Consultant, Royal Victoria Hospital, and Head of Cardiology, Queen Elizabeth Hospital, Montreal before
becoming Head of Cardiology and Cardiovascular Research and subsequently Chief of Medicine at
St Josephs Hospital, and Professor of Medicine McMaster University, Hamilton (1975–2003). Dr Tanser
has published over 100 refereed journal articles and abstracts and presented papers at numerous
conferences. He is Cardiovascular Associate Editor of Merck Manual Professional and Home editions and
the electronic Handbook edition. He is Major (retired) Canadian Army having been Brigade Surgeon LFCA,
MO Royal Hamilton Light Infantry and 3 Bn Royal Canadian Regiment.
Northern X Regional Ethics Committee – 2012 Annual Report
4
Attendance
The Northern X Regional Ethics Committee held five meetings between January and
June 2012.
Members
Meetings
Non-lay members
Lay members
Jan
Total
Feb
Mar
Apr
May
June
Cm
Dr Brian Fergus (Chair)





5/5
Cm
Ms Susan Buckland





5/5
Cn
Ms Alaina Campbell
A


A

3/5
L/Cn
Ms Linda Kaye





5/5
Cn
Ms Robyn Northey
L
Ms Michèle Stanton





5/5
HR
Ms Jocelyn Byrd
HR
Dr Marewa Glover





5/5
P
Ms Rosemary Langham

A



4/5
HR
Dr Ieti Lima



A

4/5
HP
Prof Wayne Miles




A
4/5
B
Mrs Joanna Stewart
HP
Dr Paul Tanser





5/5
Attendance
9
9
10
8
9
45/50
Applications considered
12
12
13
10
13
60*
Key: L
Lawyer
P
Pharmacist/pharmacologist

present
E
Ethicist
B
Biostatistician
A
apologies
X
absent
Cm
Community representative
HP
Health practitioner
Cn
Consumer representative
HR
Health researcher
not applicable
* This total does not include applications that were deferred and reassessed.
Northern X Regional Ethics Committee – 2012 Annual Report
5
Applications reviewed
The Northern X Regional Ethics Committee received 196 applications between January
and June 2012. Of these, 62 were reviewed by the full committee, and 123 were
reviewed between meetings at the direction of the Chair or Deputy Chair (“expedited
review”). 11 were withdrawn or did not require HDEC review.
At each of its meetings between January and June 2012, the Committee reviewed an
average of 12 applications.
Full
Approved
Declined/Deferred
0
No final decision (as at 30 June 2012)
3
Withdrawn
0
Total
Approved
Expedited
59
Declined
Ethical approval not required
No final decision (as at 30 June 2012)
Total
Total applications reviewed
62
122
1
11
0
134
196
A summary of these applications can be found in Appendix A.
Average decision times
Between January and June 2012, the average decision times were 3.6 days for
“expedited” applications and 60 days for “full” applications, including any time taken for
researchers to respond to approval conditions.
Northern X Regional Ethics Committee – 2012 Annual Report
6
Appendix 1: Details of applications reviewed
Applications reviewed by the full pathway
Project key
Full title
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
Locality
organisations
NTX/12/02/001
The use of continuous subcutaneous
Ms Jane Hannah
frusemide in decompensated heart failure:
can it achieve a diuresis?
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
NTX/12/02/002
A randomised controlled trial of the clinical Dr Owen Sinclair
benefit of oral corticosteroids versus
placebo in salbutamol responsive wheeze
in preschool children. Protocol, 12/1/12;
PIS/Cons, v#1, 25/01/12
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
NTX/12/02/003
Non-invasive measurement of Neural
Respiratory Drive (NRD) in children.
Protocol 02/12/11; PIS/Cons, 28/06/12
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
NTX/12/02/004
Human cartilage and chondrocyte controls Mr Jonathan
for tissue engineering. Protocol, v#2,
Wheeler
29/03/12; PIS/Cons v#2, 29/03/12
Approved
subject to
conditions
Full
Approved Counties
Manukau District
Health Board
Dr David
McNamara
Sponsor/funder
Consultation Days to
undertaken review
ADHB MRRC
62
A+ Trust
ADHB MRRC
50
A+ Trust
ADHB MRRC
38
CMDHB
MRRC
43
ADHB MRRC
pending
87
Kaunihera
Kaumatua o
Te Poari
Hauora a
rohe o te Tai
Tokerau
47
Gillies Hospital
University of
Auckland
NTX/12/02/005
NTX/12/02/006
A novel method for non-invasive antenatal Professor Peter
diagnosis by harvesting trophoblasts.
Stone
PIS/Cons V#2, 30/04/12
Approved
subject to
conditions
Full
Māori, Mental Illness and Health Services: Ms Maria Baker
A Māori-Centred Grounded Theory.
PIS/Cons v#1, 03/12
Deferred
Full
Approved National Women’s
Health
Auckland District
Health Board
Approved Northland DHB
Manaia Health
PHO
Te Tai Tokerau
MAPO Trust
Massey University
Northern X Regional Ethics Committee – 2012 Annual Report
7
Project key
Full title
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
Locality
organisations
NTX/12/02/007
A phase III prospective, two-cohort nonrandomised, multi-centre, multinational,
open-label study to assess the safety of
assisted-and self-administered
subcutaneous Trastuzumab as adjuvant
therapy in patients with operable HER2positive early breast cancer [SafeHer
study]. IB, version 12, 10/11; Protocol
number: MO28048 v#1, 30/11/2011;
PIS/Cons v#1.1, 21/02/12
Dr Richard North
Approved
subject to
conditions
Full
Approved Bay of Plenty
DHB
NTX/12/02/008
A comparison of an intra-vaginal pressure
device (IVPD) and intra-rectal pressure
device (IRPD) for the measurement of
intra-abdominal pressure (IAP) during
urodynamics, what do patients prefer?
PIS/Cons v#2, 7/3/12
Dr Lynsey
Hayward
Approved
subject to
conditions
Full
NTX/12/02/009
Do transient ischaemic attacks impair
balance? Protocol v#1, 24/1/12;
Prot/amend 03/12; PIS/Cons v#3, 29/3/12
Dr James
Faulkner
Approved
subject to
conditions
Full
Sponsor/funder
Roche
Consultation Days to
undertaken review
Pending
36
Approved Counties
Manukau District
Health Board
Carla Rikaheke
38
Approved Capital and Coast
District Health
Board
Kaiarahi
Maori;
Massey
University
30
Massey University
NTX/12/02/010
Perioperative Troponin I elevation,
composite cardiac outcomes and 30-day
mortality in patients undergoing surgery
for fractured neck of femur. Protocol,
v#1.2, 14/2/12; PIS/Cons v#3, 10/05/12
Dr Julian Dimech
Approved
subject to
conditions
Full
Approved Counties
Manukau District
Health Board
CMDHB
MRRC
30
NTX/12/02/011
Monitoring of human inner ear bloodlabryinthine barrier by MRI: a translational
study. PIS/Cons V#2, 03/12
Professor Peter
Thorne
Approved
subject to
conditions
Full
Approved University of
Auckland
Papaarangi
Reid
30
NTX/12/02/012
Investigating oral self-care by low-income
adults. PIS/Cons V#2, 22/02/12
Professor W
Murray Thomson
Approved
subject to
conditions
Full
Approved
Ngai Tahu
RCC has
been
consulted and
has approved
the PI’s study
22
NTX/12/03/013
To describe the lived experience of
Ms Jenny
metastatic colorectal cancer patients that Cameron
undergo more than 12 months of
continuous palliative chemotherapy in the
outpatient setting. PIS/Cons v#2, 20/03/12
Approved
subject to
conditions
Full
Approved Waikato DHB
University of
Auckland
CMDHB
MRRC
pending
55
NTX/12/03/014
CLBH589AAU03T – a phase I study of
LBH589 (panobinostat) in paediatric
patients with refractory solid and CNS
tumours
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
ADHB MRRC
36
Northern X Regional Ethics Committee – 2012 Annual Report
Dr Stephen
Laughton
ANZCHOG
8
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
Locality
organisations
Project key
Full title
Sponsor/funder
NTX/12/03/015
Exploring engagement in rehabilitation in
people with stroke. PIS/Cons v#2,
19/2/12; Cons (Waitemata) V#1, 16/04/12
Ms Nicola Kayes
Approved
subject to
conditions
Full
Approved Auckland
University of
Technology
NTX/12/03/016
Where do adolescents with diabetes
currently get their information from about
risk reduction education?
Ms Melanie
Beattie
Deferred
Full
Approved
NTX/12/03/017
A phase 2, randomised, double-blind,
Associate
placebo-controlled study to evaluate the
Professor Wayne
effect of add-on AMG 747 on
Miles
schizophrenia negative symptoms.
Protocol, 20101299. 21/10/11; IB Edn 3.1,
20/1/12; PIS/Cons v#1, 16/02/12
Approved
Full
Approved Waitemata District Amgen Inc
Health Board
NTX/12/03/018
A single blind randomised controlled study Mr Michael
to evaluate the safety and effectiveness of Hulme-Moir
EVICEL as an adjunct to gastrointestinal
anastomosis techniques. Protocol 400-11002, 26/01/12; Prot/Amend 1, 07/03/12; IB
Edn 1.0, 1/02/12; PIS/Cons V#2, 23/04/12
Approved
subject to
conditions
Full
Approved
NTX/12/03/019
MRI based computer navigation of total
hip arthroplasty
Dr Marc Hirner
Approved
subject to
conditions
Full
NTX/12/03/020
Postoperative Physical Activity: Feasibility
and Effects on Total Body Protein.
Protocol v#2, 04/04/12; PIS/Cons v#2,
04/04/12
Dr Mattias Soop
Approved
subject to
conditions
Full
Waitemata
DHB
35
120
Waitemata
DHB MRRC
14
Waitemata
DHB MRRC
70
Approved Northland DHB
Northland
DHB Te Ihi
Tito
30
Approved Waitemata District
Health Board
Waitemata
DHB MRRC
38
Omix
Biopharmaceuticals
Ltd
University of
Auckland
NTX/12/03/021
MK-7145-011: A phase I study to evaluate Dr Rod Ellisthe safety, tolerability, pharmacokinetics
Pegler
and pharmacodynamics of MK-7145 in
patients with stable heart failure
Approved
subject to
conditions
Full
Approved
Merck Sharp and
Dohme
NTX/12/03/022
GS-US-283-0106 A double-blind,
Professor Edward Approved
randomised, placebo-controlled, single
John Gane
subject to
and multiple dose ranging, adaptive study
conditions
evaluating the safety, tolerability,
pharmacokinetics, pharmacodynamics
and antiviral activity or GS-9620 in
treatment naïve subjects with chronic
hepatitis B virus infection. Protocol,
20/12/11; Prot/amend #1, 13/04/12; IB 3rd
Edn 6/10/11; PIS/Cons V#2, 26/03/12;
Substudy Biomarker PIS/Cons V#1,
20/02/12
Full
Approved Auckland Clinical
Studies Ltd
Gilead Sciences
Inc, USA
Northern X Regional Ethics Committee – 2012 Annual Report
Consultation Days to
undertaken review
79
ADHB MRRC
59
Auckland District
Health Board
9
Project key
Full title
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
Locality
organisations
NTX/12/03/023
GS-US-283-0102 A double-blind,
Professor Edward Approved
randomised, placebo-controlled, single
John Gane
subject to
and multiple-dose ranging, study
conditions
evaluating the safety, tolerability,
pharmacokinetics, pharmacodynamics,
and antiviral activity of GS-9620 in
virologically suppressed subjects with
chronic hepatitis B infection. IB 3rd Edn,
6/10/11; Protocol amendment 1, 14/12/11;
Prot/amend #2, 13/04/12; PIS/Cons V#2,
26/03/12, Substudy Biomarker PIS/Cons
V#1, 20/02/12
Full
Approved
NTX/12/03/024
An investigation into the cause of chronic
suppurative otitis media
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
NTX/12/04/025
Helicobacter pylori infection and its effect Mr Noah Sibanda
on the platelet count in patients presenting
at Manukau Superclinic and Middlemore
Hospital Gastroenterology clinic. Protocol
v#1, 17/01/12; PIS/Cons v#3, 11/05/12
Received
Full
Approved CountiesManukau District
Health Board
NTX/12/04/026
Patients First: Our People’s Voices
Dr Anita Bamford- Received
Wade
Full
Deferred
Dr Michel Neeff
Sponsor/funder
Gilead Sciences
Inc, USA
Auckland
University of
Technology
Consultation Days to
undertaken review
ADHB MRRC
59
296
CMDHB
MRRC
48
Nga Kai
Tataki MRRC
Waitemata District
Health Board
NTX/12/04/027
Examining agency within the therapeutic
processes of Cognitive Behavioural
Therapy. PIS/Cons V#4, 05/05/12
Professor Kerry
Chamberlain
Approved
Full
Approved Massey University
Jhana Gavala
20
NTX/12/04/028
Assessing automatic dysregulation in
Dr John Sollers III Approved
post-concussion syndrome by comparing
subject to
heart rate and heart rate variability in postconditions
concussion syndrome sufferers and
healthy controls
Full
Approved ABI Rehabilitation
Dr Averil
Herbert
34
NTX/12/04/029
Investigation of psychological,
physiological and psychosocial problems
in hepatitis C patients following pegylated
interferon alpha plus ribavirin treatment.
PIS/Cons V#2, 05/12
Full
Approved Auckland District
Health Board
Associate
Professor
Papaarangi
Reid;
Waitemata
DHB MRRC
56
Mr Brett Knock
Approved
subject to
conditions
Waitemata District
Health Board
Counties
Manukau District
Health Board
Northern X Regional Ethics Committee – 2012 Annual Report
10
Project key
Full title
NTX/12/04/030
An investigation into the safey and
secondarily the efficacy of the effect of
electrical simulation on the lower
oesophageal sphincter (LOS) pressure
and oesophageal acid exposure in
patients with gastro-oesophageal reflux
disease (GORD) – CS005. Protocol, CIP
CS005, amendment 2, 12/12/11;
PIS/Cons V#2.0, 05/05/12
NTX/12/04/031
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
Locality
organisations
Approved
subject to
conditions
Full
Approved
A phase I/II, multi-centre, open-label, dose Dr Michael
escalation trial of the safety and
Jameson
pharmacokinetics of intravenous PR610
given weekly in subjects with solid
tumours
Approved
subject to
conditions
Full
Approved
NTX/12/04/032
A randomised, open-label, multicenter
Phase IIIb study comparing two
trastuzumab dosing regimens, each in
combination with cisplatin/capecitabine
chemotherapy, as first-line therapy in
patients with HER2-positive metastatic
gastric or gastro-esophageal junction
adenocarcinoma who have not received
prior treatment for metastatic disease. IB
V#12, 10/11; Protocol, B027798B,
02/08/11; PIS/Cons V#1.0, 26/03/12;
PIS/Cons V#2.0, 05/05/12
Dr Dragan
Damianovich
Approved
subject to
conditions
Full
NTX/12/04/033
Prospective randomised single blind
control trial of Catheter assisted
nasotracheal intubation in children to
minimise nasopharyngeal trauma
Dr Wei Chung
Tong
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
NTX/12/04/034
An open-label study to explore the clinical
efficacy of GS7977 with ribavirin
administered pre-transplant in preventing
hepatitis C virus (HCV) recurrence posttransplant. IB Edn 3, 17/05/11; Protocol
P7977-2025, V#2, 22/03/12
Professor Edward Received
Gane
Full
Approved Auckland District
Health Board
NTX/12/04/035
AUGMENT-HF study: a randomised,
Dr Peter Ruygrok
controlled study to evaluate the safety and
cardiovascular effects of Algisyl-LVR™ as
a method of left ventricular augmentation
in patients with dilated cardiomyopathy. IB
V#5.1, 09/08/11; Protocol # LSH-10-001,
V#1.1, 20/06/11; PIS/Cons V#2, 14/05/12
Full
Approved Auckland District
Health Board
Northern X Regional Ethics Committee – 2012 Annual Report
Mr Michael Booth
Approved
subject to
conditions
Received from Ruby
Masson,
rubym@adhb.govt.nz
Approved Auckland District
Health Board
Sponsor/funder
EndoStim
Consultation Days to
undertaken review
Waitemata
DHB MRRC
52
36
F Hoffmann-La
Roche
ADHB MRRC
51
ADHB MRRC
85
Gilead Sciences
Inc, USA
ADHB MRRC
35
LoneSta HEART
CMDHB
MRRC
72
11
Primary
investigator
Locality
organisations
Vitamin D deficiency risk and respiratory/
allergy diseases in New Zealand 2–4 year
olds
Dr Pamela von
Hurst
Approved
subject to
conditions
Full
NTX/12/04/037
Evaluating the feasibility of a structured
mindful hatha yoga programme in a
forensic psychiatric setting
Ms Brigitte Sistig
Deferred
Full
Resubmission to be
reviewed by
subcommittee
Approved
Waitemata
DHB MRRC
31
NTX/12/05/038
Text messaging to improve adherence to
prehabilitation in patients undergoing
bariatric surgery: a randomised controlled
trial. PIS/Cons V#2, 28/05/12
Professor Andrew Approved
Hill
subject to
conditions
Full
Received from
daniel_lemanu@hotmail.c
om
Approved Counties
Manukau District
Health Board
CMDHB
MRRC
41
NTX/12/05/039
A pilot study to evaluate the efficacy and
safety of RepaiRx in donor site healing
Dr Amber
Moazzam
Approved
subject to
conditions
Full
Approved Counties
Manukau Police
Station
CMDHB
MRRC
148
NTX/12/05/040
Very low calorie diet (VLCD) followed by
fibre and probiotic supplementation is
superior to VLCD alone in achieving
sustained weight loss and resolution of
non-alcoholic fatty liver disease
Dr David Orr
Approved
subject to
conditions
Full
Eating and Satiety
Questionnaire (Stunkard
3-Factor Eating
Questionnaire)
Approved Auckland District
Health Board
ADHB MRRC
142
NTX/12/05/041
A phase 3, randomised, double-blind,
controlled study evaluating the efficacy
and safety of Peginterferon Lambda-1a,
with and without Daclatasvir, compared to
Peginterferon Alfa-2a, each in
combination with ribavirin, in treatment
naïve genotype 2 and 3 chronic
hepatitis C subjects. Protocol AI452-017
Professor Edward Approved
Gane
subject to
conditions
Full
Documents received
Approved Auckland District
Health Board
ADHB MRRC
136
NTX/12/05/042
A phase 3b, multicenter, open-label study
to evaluate the long-term safety and
efficacy of subcutaneous LY2127399 in
patients with systemic lupus
erythematosus (SLE) (Illuminate-X)
Dr Kristine Ng
Approved
subject to
conditions
Full
Investigator Brochure
version dated 8 August
2011
Approved Waitemata District
Health Board
Northern X Regional Ethics Committee – 2012 Annual Report
Sponsor/funder
Consultation Days to
undertaken review
NTX/12/04/036
A first-in-human, ascending-dose study to Dr David Semple
assess the safety, tolerability,
pharmacokinetics and pharmacodynamics
of Bax69 after single and multiple dose
administration in subjects with stable
proliferative lupus and persistent
proteinuria. Protocol 391001, Protocol/
amendment 2, 15/11/11
Why deferred/ declined
Status at
time of
report
Full title
NTX/12/05/043
Outcome
Review
type
Project key
Approved
51
Bristol Myers
Squibb
107
Protocol dated 6 May
2011
Approved
subject to
conditions
Full
received from Mary EllisPegler
Approved Auckland Clinical
Studies
Baxter Healthcare
Corporation
ADHB MRRC
127
Auckland District
Health Board
12
Project key
NTX/12/05/044
NTX/12/05/045
Full title
Primary
investigator
Randomised controlled trial of a
combination of Dexamethasone and
Adrenaline for Bronchiolitis (DAB Trial).
PIS/Cons V#2, 24/05/12
Dr John Beca
Cerebral blood flow variability and stroke
outcome. PIS/Cons V#2, 22/05/12
Dr Shieak Tzeng
Outcome
Review
type
Approved
subject to
conditions
Full
Approved
subject to
conditions
Full
Received from Claire
Sherring
Status at
time of
report
Locality
organisations
Sponsor/funder
Approved Auckland District
Health Board
Consultation Days to
undertaken review
ADHB MRRC
24
Ngai Tahu
Research
Consultation
Committee;
Hutt Valley
Maori Health
Unit
37
Counties
Manukau District
Health Board
NTX/12/05/046
The safety and feasibility study of the
shockwave lithoplasty system; a first in
human study. IB version, 11/04/12;
Protocol TD 0047, Rev A, 12/04/12;
PIS/Cons V#2, 30/5/12
Associate
Approved
Professor Andrew
Holden
Full
NTX/12/05/047
Ngā Waiata O Tāne Whakapiripiri: music,
mental health, and healing in a Māori
context. PIS/Cons V#2, 30/04/12
Lauren E
Sweetman
Approved
Full
Maternal sleep in pregnancy. Protocol,
v#3, 01/05/12; PIS/Cons v#2, 03/05/12
Professor Edwin
Mitchell
Approved
subject to
conditions
Full
Approved
subject to
conditions
Full
NTX/12/06/048
Why deferred/ declined
Received from Braid
MacRae
braid.macrae@otago.ac.n
z
Approved Hutt Valley
District Health
Board
From Helen Knight
hknight@adhb.govt.nz
Approved
University of
Otago
University of Otago
(Internal Funding)
Shockwave Medical ADHB MRRC
Approved Mason Clinic
Waitemata District
Health Board
20
Waitemata
DHB MRRC
21
Nga Kai
Tataki MRRC
34
Received from Lynne
Hutchinsonbl.hutchison@
auckland.ac.nz
Approved University of
Auckland
Protocol version 1
(27 April 2012)
Approved Auckland District
Health Board
ADHB MRRC
89
Auckland District
Health Board
In vivio characterisation of large bowel
pressure wave propagation in the perioperative setting and across healed colocolic anastomoses using a high resolution
manometry catheter. Protocol v#1,
27/04/12
Dr Ian Bissett
NTX/12/06/050
Identifying targets for the development of
anti-cataract therapies
Professor Paul
Donaldson
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
UoA Tumuaki
33
NTX/12/06/051
Patient-controlled versus stepwise oral
refeeding in acute pancreatitis: a
randomised controlled trial
Dr Maxim S
Petrov
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
ADHB MRRC
162
NTX/12/06/052
Observational study of frequency and
causes of impaired liver metabolism of
cyclophosphamide in breast cancer
(LIME)
Dr Nuala Helsby
Approved
subject to
conditions
Full
Approved Auckland District
Health Board
ADHB MRRC
36
NTX/12/06/049
Northern X Regional Ethics Committee – 2012 Annual Report
Questionnaire
13
Project key
Full title
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
NTX/12/06/053
Gout and its impact-improving pacific
outcomes
Professor Bruce
Arroll
Approved
subject to
conditions
Full
NTX/12/06/054
Randomised double-blind placebocontrolled trial of gastrografin in the
therapeutic management of prolonged
postoperative ileus following elective
surgery
Dr Ian Bissett
Approved
subject to
conditions
Full
Protocol version 1
(14 May 2012
Received
NTX/12/06/054
Randomised double-blind placebocontrolled trial of gastrografin in the
therapeutic management of prolonged
postoperative ileus following elective
surgery
Dr Ian Bissett
Approved
subject to
conditions
Full
Protocol version 1
(14 May 2012
NTX/12/06/055
Can a brief information session reduce the Professor Keith J
stress levels of mothers of newborns
Petrie
admitted to a high dependency unit?
Approved
subject to
conditions
NTX/12/06/056
Effect of preoperative immunonutrition on
outcome in patients undergoing partial
hepatectomy: a randomised pilot study
NTX/12/06/058
Locality
organisations
Sponsor/funder
Approved East Tamaki
Healthcare
Consultation Days to
undertaken review
Dr Tane
Arataki Taylor
78
Approved Auckland District
Health Board
ADHB MRRC
82
Full
Approved Auckland District
Health Board
Raukura
Hauora O
Tainui
32
Associate
Approved
Professor Lindsay subject to
D Plank
conditions
Full
Approved University of
Auckland
ADHB MRRC
131
A novel, non-invasive device for the
estimation of stroke volume compared
with the continuous thermodilution
technique using a pulmonary artery
catheter
Dr Alan J
Broderick
Approved
subject to
conditions
Full
NTX/12/06/059
Rapid renal sympathetic denervation for
resistant hypertension using the Maya
Medical OneShot™ Ablation System.
Protocol CIP Rev 9, 09/04/12; IB V#D,
28/02/12; PIS/Cons V#2, 21/06/12
Dr John Ormiston
Approved
subject to
conditions
Full
ADHB MRRC
31
NTX/12/06/060
A single arm, open-label, phase II,
multicentre study, to assess the safety of
Vismodegib (GDC-0449) in patient with
locally advanced or metastatic basal cell
carcinoma (BCC)
Mr Richard Martin Approved
Full
Waitemata
DHB MRRC
65
Auckland District
Health Board
Received from Helen
Farrell
Approved Auckland District
subject to Health Board
conditions
Approved Mercy
Angiography Unit
Application form
Part 4
Maya Medical Inc
Approved Waitemata District Hoffman-La Roche
Health Board
Part 5
Form B
Locality assessment
Maori consultation
SCOTT approval letter
Northern X Regional Ethics Committee – 2012 Annual Report
14
Project key
Full title
Primary
investigator
Outcome
Review
type
Why deferred/ declined
Status at
time of
report
Locality
organisations
Sponsor/funder
Consultation Days to
undertaken review
Amended application
form, page 15
Waitemata – participant
information sheet and
consent form, Version 2,
dated 20 July 2012
Waitemata – pregnant
partner data release form,
Version 1, dated 25 May
2012
MO25616 Waitemata
patient exception diary,
Version 1, dated 25 May
2012
MO25616 NZ Generic
patient participation card,
Version 1, dated 26 April
2012
SKINDEX 16 MMChren,
1997 Quality of life
questionnaire
Roche insurance
certificate, valid until end
of trial
MO25616 Protocol,
Version 2, dated
27 January 2012
Vismodegib (GDC-0449)
Investigator Brochure,
Version 6, dated
25 January 2012
NTX/12/06/061
Leg muscle strength and functional
outcomes of a previously unpublished
surgical technique for repair of complete
tears of the proximal hamstring origin
Mr Stewart Walsh
NTX/12/06/062
Experiences of HIV stigma and
discrimination in the healthcare setting.
Protocol V#1, 25/05/12; PIS/Cons V#1,
25/05/12; Q’aire, V#2, 05/06/12
Ms Susan Mundt
Northern X Regional Ethics Committee – 2012 Annual Report
Approved
Full
Approved Unisports Centre
for Sports
Medicine
Associate
Professor
Papaarangi
Reid
7
Full
Approved Auckland District
Health Board
ADHB MRRC
12
15
Applications reviewed by the expedited pathway
Project key
Full title
NTX/11/EXP/033
Management of women (DUPLICATE)
NTX/12/EXP/001
A prospective evaluation of complications in paediatric laparoscopic appendicectomy by
electrocautery division of the mesoappendix
NTX/12/EXP/002
Primary investigator
Status at time
of report
Review
type
Locality
organisations
Days to
review
Closed
EXP
Approved
EXP
Auckland District
Health Board
5
Idiopathic pulmonary arterial hypertension treated with long-term calcium channel blockers: a review Dr Arthur Coverdale
of functional and haemodynamic outcomes in adults presenting to the pulmonary hypertension clinic
Approved
EXP
Auckland District
Health Board
4
NTX/12/EXP/003
Review of clinical presentation of midgut volvulus and segmental intestinal volvulus mimicking
necrotizing enterocolitis in premature neonates: Is a preoperative diagnosis possible?
Mr Stephen Evans
Approved
EXP
Auckland District
Health Board
6
NTX/12/EXP/004
Management and outcome of pyopneumothorax in children: An audit of practice at Starship Hospital
Mr Giorgio Stefanutti
Approved
EXP
Auckland District
Health Board
6
NTX/12/EXP/005
A retrospective comparison of vitamin D levels in New Zealand and US mental health populations
Mr David Kopacz
Approved
EXP
Auckland District
Health Board
6
NTX/12/EXP/006
Predictors of mortality in patients admitted with acute exacerbations of bronchiectasis. Protocol,
4/1/12
Mr Brendon Ah Chan
Approved
EXP
Counties Manukau
District Health Board
1
NTX/12/EXP/007
Increasing productivity, reducing cost and improving quality in elective surgery in New Zealand – the Mr John Cullen
Waitemata DHB joint arthroplasty pilot
Approved
EXP
Waitemata District
Health Board
4
NTX/12/EXP/008
Additional participants for laboratory indicators of glycaemia-screening, monitoring and predicting
health outcomes
Dr Patricia Metcalf
Approved
EXP
University of Auckland
9
NTX/12/EXP/009
Private and confidential health care among adolescent patients. PIS V#1, 01/12
Mr Patrick Jia Jiunn Yap Approved
EXP
Waitemata District
Health Board
8
NTX/12/EXP/010
Triage of patients presenting with PR bleeding to Middlemore Hospital Emergency Department
Mr Vincent Chong
Approved
EXP
Counties Manukau
District Health Board
2
NTX/12/EXP/011
The use of gravity flexion measured with computer navigation intraoperatively in predicting final
range of motion after total knee arthroplasty
Mr Ali Bayan
Approved
EXP
Waitemata District
Health Board
2
NTX/12/EXP/012
Lipped tibial inserts in preventing knee hyperextension post total knee arthroplasty
Mr Ali Bayan
Approved
EXP
Waitemata District
Health Board
2
NTX/12/EXP/013
Comparing outcomes in neonates admitted to Auckland City Hospital treated with 100 mg/kg vs
200 mg/kg of curosurf
Dr Elza Cloete
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/014
A clinical audit of emboli removal by new generation oxygenators during adult cardiopulmonary
bypass
Dr Simon Mitchell
Approved
EXP
University of Auckland
1
Validation of a new chart for assessing the location and severity of post-operative pain in children.
Protocol, v#1, 20/01/12; Questionnaire, v#1, 22/1/12
Mr James Hamill
NTX/12/EXP/015
Northern X Regional Ethics Committee – 2012 Annual Report
Mr James Hamill
Auckland District
Health Board
Approved
EXP
Auckland District
Health Board
0
16
Project key
Full title
Primary investigator
Status at time
of report
Review
type
Locality
organisations
Days to
review
NTX/12/EXP/016
Predicting allograft requirement in the management of major burns. Protocol v#1, 01/12
Dr Jessica Savage
Approved
EXP
Counties Manukau
District Health Board
0
NTX/12/EXP/017
Ethnic differences in creatinine generation in South Auckland peritoneal dialysis patients
Ms Tina Sun
Approved
EXP
Counties Manukau
District Health Board
4
NTX/12/EXP/018
Development of radiological algorithms; to determine if bronchietasis can be detected on chest X-ray Dr Alys Clark
alone based on studies of chest CT scan
Approved
EXP
University of Auckland
5
NTX/12/EXP/019
Investigation of city-wide outbreak of ESBL-K pneumoniae in Auckland, New Zealand
Approved
EXP
Auckland District
Health Board
5
Dr Joshua Freeman
Counties-Manukau
District Health Board
Waitemata District
Health Board
NTX/12/EXP/020
Colorectal cancer screening perception, behaviour and willingness in general medical inpatients at
Middlemore Hospital: a study based on the health belief model
Judy Chien-Chun
Huang
Approved
EXP
Counties Manukau
District Health Board
5
NTX/12/EXP/021
Quality enhancement in residential aged care. PIS/Cons V#2, 10/2/12
Dr John Parsons
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/022
Audit of Auckland deceased donor transplant list aged greater than 65: application of co-morbidity
scoring
Dr Stephen Crofts West Closed
EXP
Auckland District
Health Board
NTX/12/EXP/023
Diabetes impact on work, income and finances in Samaon families
Associate Professor
Tim Kenealy
Approved
EXP
University of Auckland
0
NTX/12/EXP/024
Outcomes following navigated revision total knee joint arthroplasty
Dr Joshua Sevao
Approved
EXP
Counties Manukau
District Health Board
0
NTX/12/EXP/025
Normalised eating. Protocol, 01/12; PIS/Cons, 11/11
Garalynne Binford
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/026
Review of the incredible years parenting programme within a child and adolescent mental health
setting
Associate Professor
Fred Seymour
Approved
EXP
Auckland District
Health Board
5
NTX/12/EXP/027
Radiofrequency ablation of osteoid osteoma
Dr Raymond Tai
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/028
Pipeline aneurysm treatment – MRI follow-up study
Dr Ben McGuinness
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/029
A survey to assess user opinion and feedback of a pressure and oxygen monitoring device
Dr Lindsay Mildenhall
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/030
The adherence and the pattern of hepatocellular carcinoma surveillance guideline for cirrhotic
patients in Counties Manukau 2000–2010
Dr John Hsiang
Approved
EXP
Counties-Manukau
DHB
8
NTX/12/EXP/031
Observational study of Streptococcus pyogenes isolated from vaginal swabs of adult women in a
hospital and community laboratory
Dr Arlo Upton
Approved
EXP
Counties-Manukau
District Health Board
1
Northern X Regional Ethics Committee – 2012 Annual Report
17
Project key
Full title
Primary investigator
Status at time
of report
Review
type
Locality
organisations
Days to
review
NTX/12/EXP/032
Does below knee antiembolic compression stockings (TED stockings) treat orthostatic hypotension
in the elderly? PIS/Cons v#1.1, 17/2/12
Tan Aik Haw
Approved
EXP
Waitemata District
Health Board
12
NTX/12/EXP/033
Management of women following excision of vulval intraepithelial neoplasia
Dr Elizabeth Glanville
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/034
To examine the prevalence of HLA DQ2/DQ8 positivity among different ethnicities particularly asian
extracts from HLA DQ2/DQ8 tissue typing
Dr John Hsiang
Approved
EXP
Counties Manukau
District Health Board
7
NTX/12/EXP/035
Retrospective audit on management of malignant pleural effusions at Middlemore Hospital June
2010 until June 2011
Dr Elaine Yap
Approved
EXP
Counties Manukau
District Health Board
2
NTX/12/EXP/036
Incidence and risk factors for the development of postoperative lleus
Dr Ryash Vather
Approved
EXP
University of Auckland
0
NTX/12/EXP/037
An educational evaluation of the Orsim bronchoscopy simulator to differentiate between groups of
anaesthetists with different levels of bronchoscopy experience. PIS/Cons v#1, 9/2/12
Dr Paul Baker
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/038
Superficial femoral artery puncture for infrainguinal occlusive disease: the better alternative?
Ms Michelle Kweon
Completed –
report required
EXP
Auckland District
Health Board
NTX/12/EXP/039
Management of metastatic cutaneous squamous cell carcinoma to the parotid
Angus Shao
Approved
EXP
NTX/12/EXP/040
Outcomes of arthroscopic debridement of the subscapularis bursa and the ‘bare area’ of
superomedial scapular angle in patients with snapping scapula syndrome
Seung-Min Youn
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/041
Advances in distal biceps tendon repair
James Recordon
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/042
Vitamin D deficiency risk and respiratory/allergy diseases in New Zealand 1–5 year olds
Dr Pamela von Hurst
Declined
EXP
NTX/12/EXP/043
Acute VTE in pregnancy: a retrospective case control study
Ms Shannon Emmett
Approved
EXP
Auckland District
Health Board
13
NTX/12/EXP/044
Thromboprophylaxis in pregnancy and the postpartum period: a retrospective case control study
Ms Shannon Emmett
Approved
EXP
Auckland District
Health Board
13
NTX/12/EXP/045
Immunohistochemical study of colorectal polyps arising in mismatch repair deficient colorectal
cancer patients. Protocol v#1, 15/2/12
Masato Yozu
Approved
EXP
Counties-Manukau
DHB
7
NTX/12/EXP/046
Optic nerve hypoplasia in New Zealand children with severe visual impairment
Dr Shuan Dai
Approved
EXP
Auckland District
Health Board
7
NTX/12/EXP/047
What are the variations to follow-up of patients who have had treatment for primary lesion of
cutaneous squamous cell carinoma of the head and neck?
Mr Bruce Peat
Approved
EXP
Counties-Manukau
District Health Board
6
NTX/12/EXP/048
Food service delivery and patient food satisfaction
Ms Emma Miller
Ethical approval
not required
EXP
Northern X Regional Ethics Committee – 2012 Annual Report
1
18
Project key
NTX/12/EXP/049
Full title
A study to describe anatomical and physiological characteristics of healthy participants receiving
humidified air via Optiflow™ nasal cannula. PIS/Cons v#1, 24/02/12
Primary investigator
Dr Merryn Tawhai
Status at time
of report
Approved
Review
type
EXP
Locality
organisations
Auckland
Bioengineering
Institute
Days to
review
0
Fisher & Paykel
Healthcare Ltd
Counties Manukau
District Health Board
NTX/12/EXP/050
A retrospective review of elevated D-Dimer results and the corresponding clinical diagnosis
Dr James Doyle
Closed
EXP
NTX/12/EXP/051
Evaluation of the Auckland transformation project
Ms Sarah Andrews
Ethical approval
not required
EXP
NTX/12/EXP/052
Prevalence audit of delirium in wards 6, 9 and Muriwai
Dr John Scott
Approved
EXP
NTX/12/EXP/053
A retrospective observational review of staphylococcus aureus infections in children presenting to
Starship Children’s Hospital between 2007 and 2010
Dr Deborah Williamson
Approved
EXP
NTX/12/EXP/054
Audit perioperative fluid therapy audit
Dr Nigel Robertson
Approved
EXP
Auckland District
Health Board
6
NTX/12/EXP/055
Mucinous tumours of ovary – a retrospective review at a single centre. Protocol V#1, 28/2/12
Dr Komal Kumar
Approved
EXP
Counties Manukau
District Health Board
2
NTX/12/EXP/056
Paediatric ultrasound guided regional anaesthesia: an audit of practice
Dr Lena Tan
Approved
EXP
Auckland District
Health Board
2
NTX/12/EXP/057
Readmission 360 review. Protocol, 24/2/12, PIS/Cons, v#1, 15/02/12
Marc Ter Beek
Approved
EXP
Auckland District
Health Board
-5
NTX/12/EXP/058
Case series on sebecceous neoplasia and the Muir-Torre syndrome – our experience in Middlemore Masato Yozu
hospital. Protocol, v#1, 07/03/12
Approved
EXP
Counties Manukau
District Health Board
2
NTX/12/EXP/059
Bone density before and after heart or lung transplantation – a longitudinal study
Tom Wang
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/060
Long-term outcomes after the atrail switch operations for transposition of the great arteries
Dr Timothy Hornung
Approved
EXP
Starship Childrens
Hospital
-4
NTX/12/EXP/061
New Zealand peritoneal dialysis registry
Dr John Collins
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/062
Development of a balanced scorecard for measuring clinical pharmacy performance at Middlemore
Hospital
Ms Doreen Liow
Ethical approval
not required
EXP
Middlemore Hospital,
CMDHB
NTX/12/EXP/063
Assessment of ultrasound beam width in water and pork phantom
Dr Chris Nixon
Ethical approval
not required
EXP
Auckland District
Health Board
NTX/12/EXP/064
Anaesthetic modalities for total knee joint replacement at ADHB 2007–2011
Dr Gerard Willemsen
Approved
EXP
Auckland District
Health Board
Northern X Regional Ethics Committee – 2012 Annual Report
Waitemata District
Health Board
4
0
-1
19
Project key
Full title
NTX/12/EXP/065
Automated immature granulocyte count (IGC) as a diagnostic test for acute appendicitis in children:
a prospective study
Primary investigator
Mr Giorgio Stefanutti
Status at time
of report
Approved
Review
type
EXP
Locality
organisations
Starship Childrens
Hospital
Days to
review
-1
Auckland District
Health Board
NTX/12/EXP/066
Mortality outcomes of elderly patients undergoing acute abdominal surgery
Benjamin V Kumar
Closed
EXP
Waitemata District
Health Board
NTX/12/EXP/067
Evaluating the multidisciplinary operating room simulation training course
Associate Professor
Jennifer Weller
Approved
EXP
Auckland District
Health Board
17
Counties Manukau
District Health Board
NTX/12/EXP/068
Audit of treatment of young and late onset rheumatoid arthritis at Counties Manukau District Health
Board rheumatology outpatient clinic
Dr Laurence Seng
Guan Teoh
Approved
EXP
Counties Manukau
District Health Board
4
NTX/12/EXP/069
Exploring the insider’s experience of aphasia assessment in Samaon–English speakers: case study
research. PIS/Cons V#1, 24/04/12
Ms Sarah Stenning
Approved
EXP
Counties Manukau
District Health Board
36
NTX/12/EXP/070
Management of shoulder dystocia
Ms Lesley Ansell
(Irving)
Approved
EXP
Counties Manukau
District Health Board
4
NTX/12/EXP/071
Is the benefit/risk ratio for cardiac defibrillators implanted in older populations (age 75) still
favourable? Protocol, v#1, 15/3/12
Dr Warren Smith
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/072
A radiological study of the anatomy and normal variation of the tibiofibular interosseous ligament
Dr James Andrew
Campbell
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/073
Smart patient monitoring system for advanced remote health care for older adults
Dr Hamid Gholam
Hosseini
Approved
EXP
Auckland University of
Technology
30
Waitemata District
Health Board
NTX/12/EXP/074
Anaesthetic and obstetric outcomes for women with super morbid obesity – a retrospective study.
January–December 2010
Dr Fiona Gilmour
Approved
EXP
Counties Manukau
District Health Board
1
Auckland District
Health Board
NTX/12/EXP/075
Acute myocarditis: our experience at Auckland City Hospital 2003–2012
Dr Arthur Coverdale
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/076
The incidence of new-onset DKA in children with T1DM in Auckland 2000–2009
Prof Wayne Cutfield
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/077
Waitemata District Health Board integrated transition of care project
Mr Tom Robinson
Approved
EXP
Waitemata District
Health Board
3
NTX/12/EXP/078
A expedited review (retrospective study) for first episode psychosis (EPIT/CMDHB) clients over
two-year period – weight monitoring of atypical anti-psychotic medication (February 2010–February
2012) followed up in South Auckland, New Zealand. Protocol, v#1, 03/12
Ms Subrina (Sangyum)
Uitime
Approved
EXP
Counties Manukau
District Health Board
1
Northern X Regional Ethics Committee – 2012 Annual Report
20
Project key
Full title
Primary investigator
Status at time
of report
Review
type
Locality
organisations
Days to
review
NTX/12/EXP/079
Understanding the mechanisms underlying the increase in pathological anxiety and depression
during pregnancy
Professor Lesley
McCowan
Approved
EXP
University of Auckland
0
NTX/12/EXP/080
Community outcomes after a bleed (subarachnoid haemorrhage, SAH) in the brain
Dr Rita Krishnamurthi
Approved
EXP
Auckland University of
Technology
0
NTX/12/EXP/081
Anaesthetic audit of maternal satisfaction and degree of motor blocade with current labour epidural
in Middlemore Hospital
Dr Elitza Sardareva
Approved
EXP
Counties Manukau
District Health Board
1
NTX/12/EXP/082
Improving hand hygiene use on general medical wards at ACH
Dr Simon Briggs
Ethical approval
not required
EXP
NTX/12/EXP/083
To what extent do interventions by a community rehabilitation team, as documented in the medical
records, address the extended ICF core set for stroke
Ms Melissa Evans
Approved
EXP
Auckland University of
Technology
2
NTX/12/EXP/084
Palliative care, health literacy, Maori communities and health services
Dr Sue Crengle
Approved
EXP
University of Auckland
5
NTX/12/EXP/085
Spectrum of uveitis in New Zealand
Dr Jo Sims
Approved
EXP
Auckland District
Health Board
6
NTX/12/EXP/086
Evaluation of the bedside paediatric early warning system (bedside PEWS) – before and after
observational study using bedside PEWS vital sign observation charts to assess effect on patient
morbidity and mortality
Richard Matsas
Approved
EXP
Auckland District
Health Board
2
NTX/12/EXP/087
Audit of malnutrition screening tool (MST)
Ms Julie Graves
Ethical approval
not required
EXP
NTX/12/EXP/088
Nutrition therapy in adults requiring ECMO in Australia and New Zealand
Ms Kate Ormrod
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/089
An audit of acute laparoscopically inserted peritoneal dialysis catherter use in paediatric patients in
New Zealand
Dr Maria Stack
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/090
Molecular characterisation and clinical outcomes of penicillin-susceptible Staphylococcus aureus
bacteraemia in Auckland, 2004–2010
Dr Deborah Williamson
Approved
EXP
NTX/12/EXP/091
Parathyroidectomy case series
Kiarash Taghavi
Approved
EXP
NTX/12/EXP/092
Malaeola – Pacific family violence prevention – evaluation
Catherine Malama
Poutasi
Approved
EXP
NTX/12/EXP/093
Acute mastoiditis in children: the “Starship” experience
Mr Colin Brown
Approved
EXP
Auckland District
Health Board
7
NTX/12/EXP/094
Evaluation of the demographics, treatment and outcome of those diagnosed with breast cancer in
the Greater Auckland region
Dr Maria Pearse
Approved
EXP
Rainbow Youth
2
NTX/12/EXP/095
Evaluation study of the sexuality/gender diversity programme implementd by Rainbow Youth in
Auckland secondary schools. PIS/Cons V#1; 09/05/12; Questionnaire, 05/12
Mr Mathijs Lucassen
Approved
EXP
Northern X Regional Ethics Committee – 2012 Annual Report
0
Auckland District
Health Board
0
0
1
21
Primary investigator
Status at time
of report
Review
type
Locality
organisations
Days to
review
Project key
Full title
NTX/12/EXP/096
Informal bedside teaching: what needs to different grades of trainees have and are they being met?
Dr Stephen Crofts West Approved
EXP
Auckland District
Health Board
14
NTX/12/EXP/097
The referral pattern and optimal time for therapy after a distal radius fracture
Ms Angela Toemen
Approved
EXP
Hand Works, 216
Great South Road,
Epsom, Auckland
4
NTX/12/EXP/098
Youthline outcomes project: measuring change in resilience of young people who participate in
youthline’s personal development programme
Amber Davies
Approved
EXP
Youthline
4
NTX/12/EXP/099
Advance targeted transfusion in anaemic cardiac surgical patients for kidney protection (ATTACK II:
Feasibility Chart Review)
Dr Cornelis J Kruger
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/100
Patient journey data capture: patient follow up
Marc Ter Beek
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/101
Oxytocin infusion audit in association with elective caesarian section
Dr Grace Chang
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/102
Caring does matter (CDM)
Dr John Kennelly
Approved
EXP
University of Auckland
1
NTX/12/EXP/103
Evaluation of postgraduate education for graduate nurses and experienced nurses; PIS v4, 15/05/12 Dr Ann McKillop
Approved
EXP
University of Auckland
13
Lakes District Health
Board
NTX/12/EXP/104
Allograft-prosthetic composite graft in the proximal tibia: short term results. Protocol, V#1
Dr Andrew R Johnston
Approved
EXP
Auckland District
Health Board
4
NTX/12/EXP/105
Improving informed consent in anaesthesia with IT mediated risk disclosure in the preoperative
period. PIS/Cons V#1, 23/05/12
Ms Michelle Soakell-Ho
Approved
EXP
Auckland District
Health Board
4
NTX/12/EXP/106
Clinical usefulness of the fog test in the diagnosis of dystonia
Dr Mark Simpson
Approved
EXP
Auckland District
Health Board
5
NTX/12/EXP/107
The effects of organisation and governance on patient safety in New Zealand public hospitals.
PIS/Cons V#2, 24/05/12
Mr Peter James Beaver
Approved
EXP
University of Auckland
9
NTX/12/EXP/108
Development of a New Zealand health manager survey tool
Dr Nicola North
Approved
EXP
University of Auckland
4
NTX/12/EXP/109
Tracheomegaly and childhood bronchiectasis: is there a relationship? Can childhood bronchiectasis
be reversible
Mr Toby Robins
Approved
EXP
Starship Children’s
Health
4
NTX/12/EXP/110
ABO-incompatible live donor kidney transplantation – our experience to date
Enya Ho
Approved
EXP
Auckland District
Health Board
3
NTX/12/EXP/111
Supported guideline implementation in a network of peritoneal dialysis units: quality of life
assessment substudy
Associate Professor
David Mudge
Approved
EXP
NTX/12/EXP/112
New onset diabetes mellitus after transplant (NODAT) in lung transplant recipients in New Zealand
Dr Zaven Panossian
Approved
EXP
Northern X Regional Ethics Committee – 2012 Annual Report
3
Auckland District
Health Board
0
22
Review
type
Locality
organisations
Days to
review
Full title
NTX/12/EXP/113
Planned versus actual mode of delivery in women with previous caesarean. Protocol/Questionnaire,
v1, 14/05/12
Dr Michelle Wise
Approved
EXP
Auckland District
Health Board
0
NTX/12/EXP/114
What are the barriers that delay safe discharge for elderly patients deemed “medically fit for
discharge”?
Ms Vicki Fryer
Approved
EXP
Northland DHB
0
NTX/12/EXP/115
Prospective audit of intravenous (IV) iron supplementation in late pregnancy
Dr Justine Wright
Approved
EXP
Auckland District
Health Board
2
NTX/12/EXP/116
Korero Mai E Te Whanau – Whanau stories of engagement, innovation and integration. PIS/Cons
V#2, 31/05/12
Ms Moana Eruera
Approved
EXP
Te Puni Kokiri
0
NTX/12/EXP/117
Outcomes in patients with aortic stenosis undergoing anaesthesia at Auckland City Hospital during
2009–2010
Nicola Hooper
Approved
EXP
Auckland District
Health Board
7
NTX/12/EXP/118
Women’s knowledge in relation to gestational diabetes in South Auckland how it affects their health
behaviours during and after pregnancy. Protocol, v#1, 28/05/12; PIS/Cons V#1, 23/05/12
Ms Kate Smallman
Approved
EXP
Counties Manukau
District Health Board
9
NTX/12/EXP/119
Footwear in patients with gout: a feasibility study
Professor Keith Rome
Approved
EXP
Auckland University of
Technology
6
NTX/12/EXP/120
Clinical characteristics of foot ulceration in patients with chronic gout. PIS/Cons V#1, 06/06/12
Professor Keith Rome
Approved
EXP
Counties Manukau
District Health Board
5
NTX/12/EXP/121
New Zealand experience of an epicardial approach to implantable cardiac defibrillators in children
Dr Jonathan R Skinner
Approved
EXP
Auckland District
Health Board
6
NTX/12/EXP/122
Evaluation of the “Enhanced Green Prescription” programme
Dr Luis Villa
Approved
EXP
Midlands Health
Network
6
NTX/12/EXP/123
Assessing the impact of a gerontology nurse specialist role in the primary care setting: healthcare
utilisation
Dr Anna King
Approved
EXP
University of Auckland
1
NTX/12/EXP/124
Relationships between psychological variables and long-term treatment outcomes in people who
have undergone knee joint replacement. PIS/Cons V#2, 05/12
Ms Bronwyn Harman
Approved
EXP
Auckland University of
Technology
1
NTX/12/EXP/125
An audit of the incidence of palliative care needs presentations to the Emergency Department at
Waitemata District Health Board (WDHB)
Ms Su Wen Wong
Approved
EXP
University of Auckland
1
NTX/12/EXP/126
Blood glucose during cardiopulmonary bypass surgery: an audit pre and post standardisation of
cardioplegia glucose content. Protocol, V#3, 30/05/12
Dr Cornelis J Kruger
Approved
EXP
Auckland District
Health Board
1
NTX/12/EXP/127
A decade of experience with cardiac neoplasms at Auckland City Hospital
Komal Srinivasa
Approved
EXP
Auckland District
Health Board
5
NTX/12/EXP/128
Neutropenic sepsis audit
Ms Sarah Wang
Approved
EXP
Counties Manukau
District Health Board
1
NTX/12/EXP/129
An exploration of the palliative care nurses’ provision and documentation of spiritual care to patients
in their last weeks of life. PIS/Cons V#1, 05/12
Ms Hannah Walker
Approved
EXP
University of Auckland
1
Northern X Regional Ethics Committee – 2012 Annual Report
Primary investigator
Status at time
of report
Project key
Waitemata District
Health Board
23
Project key
Full title
Primary investigator
Status at time
of report
Review
type
Locality
organisations
Days to
review
NTX/12/EXP/130
Development of the gout recommendation adherence scale: an evaluation of reliability and validity
Mr Nicholas Cao
Approved
EXP
University of Auckland
1
NTX/12/EXP/131
Description of pain severity, disability and psychological factors in chronic low back pain and
complex regional pain syndrome
Ms Debbie Bean
Approved
EXP
University of Auckland
1
NTX/12/EXP/132
Analysis of New Zealand interRAI-MDS HC: 2011 data from those assessed for aged residential
care. Protocol, 06/12
Dr Michal Boyd
Approved
EXP
Waitemata District
Health Board
1
NTX/12/EXP/133
The effect of non-protocol calcium and vitamin D supplementation on health outcomes: comparison Dr Mark Bolland
of results from women’s health initiative for a randomised study design with an observational design.
Protocol, 22/02/12
Approved
EXP
Northern X Regional Ethics Committee – 2012 Annual Report
5
24