Multi-region Ethics Committee
Annual Report
2012
Published in May 2014
by the Ministry of Health
PO Box 5013, Wellington, New Zealand
ISBN 978-0-478-42828-5 (online)
HP 5895
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 .......................................................................................................................... 6
Applications reviewed ......................................................................................... 7
Average decision times ....................................................................................................... 7
Appendix 1: Details of applications reviewed ..................................................... 8
Applications reviewed by the full pathway .......................................................................... 8
Applications reviewed by the expedited pathway ............................................................. 18
Multi-region Ethics Committee – 2012 Annual Report
iii
About the Committee
The Multi-region 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.
The Committee has primary responsibility for ethics committee review of national and
multi-region health and disability research and innovative practice occurring in New
Zealand. Multi-region or national research is defined as research conducted by the
investigator(s) in more than one Regional Ethics Committee region or nationally, with
identical methods and following the same protocol.
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 Multi-region 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 Multi-region Ethics Committee is registered (number IRB00004663) 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.
Multi-region Ethics Committee – 2012 Annual Report
1
Membership and attendance
Membership
Lay members
Mr Hector Matthews (Chair)
Membership category:
Community representative
Date of appointment:
27 August 2009
Current term expired:
27 August 2012
Mr Hector Matthews (Te Rarawa) is currently Executive Director of Māori and Pacific Health at Canterbury
District Health Board (2004–present). Prior to this he was Business Development Manager at Community
& Public Health (1997–2004). Mr Matthews completed a Postgraduate Diploma in Telecommunications
Systems Management at the Swinburne Institute of Technology, Melbourne (1987) and received a
Queen’s Commission and Certificate in Military Studies with the New Zealand Army (1984). He was Chair
of the Christchurch Polytechnic Institute of Technology Council (2001–2010) and chaired the school board
of trustees at Te Kura Kaupapa Māori o Te Whānau Tahi from 1998 to 2010. Mr Matthews is also a trustee
at Christchurch Boys’ High School and Villa Maria College. Mr Matthews holds a professional membership
with the New Zealand Institute of Management.
Mr Doug Bailey
Membership category:
Lawyer
Date of appointment:
2 September 2011
Current term expired:
30 June 2012
Mr Doug Bailey is a consultant in Russell McVeagh Law’s Corporate Advisory Group (2005–present). Prior
to this he was a public law and policy consultant at Kensington Swan (2001–2005). Mr Bailey completed a
Master of Laws in Health Law and Medical Ethics at Northwestern University, Chicago (1991). He is
currently a Director of Lazar Associates, the New Zealand Law Society’s Rule of Law Committee, and the
Johnson Group’s Advisory Board.
Dr Paul Copland
Membership category:
Ethicist
Date of appointment:
11 September 2008
Current term expired:
30 June 2012
Dr Paul Copland is currently trustee of the Hedgehope Trust and Director of DRS Copland Ltd. Prior to this
he was a Briefing Paper Writer for the Ministry of Environment (2003) and a Researcher for the Marsden
Fund Project (2002). Dr Copland has completed a Doctor in Philosophy (2007) and Post Graduate
Diploma in Philosophy (2000) and a Bachelor of Science at the University of Otago (1998). He is a
founding member of the New Zealand Speed Gliding Team.
Mrs Maliaga Erick
Membership category:
Consumer representative
Date of appointment:
9 December 2004
Current term expired:
30 June 2012
Mrs Maliaga Erick is currently a Senior Community Support Worker for Lotofale Pacific Mental Health
Service (2001–present). Prior to this she was a Clinical Social Worker at Manaaki House Community
Mental Health Centre (1996–2001). Mrs Erick completed a Certificate in Governance and Management of
Not For Profit Organisations at Unitech (2007), a Bachelor of Social Work (2006), a Certificate of
Management and Professional Development (2006) and a Diploma of Youth Work (2006) at Auckland
University. She has also completed a Graduate Certificate in Mental Health at Unitech (2000), a Certificate
in Clinical Supervision at the Central Institute of Technology (2000), and a Certificate of Qualification of
Social Work through the Council for Education and Training in the Social Service (1994). Mrs Erick is a
member of the Mental Health Advocacy Coalition, the Mental Health Commission and the Chair of Niu
Development Incorporated.
Multi-region Ethics Committee – 2012 Annual Report
2
Mr Kerry Hiini
Membership category:
Community representative
Date of appointment:
2 September 2011; appointed to Northern Y Regional Ethics Committee
3 June 2011
Current term expired:
30 June 2012
Mr Kerry Hiini (Ngati Hine; Tapuika) is currently a Planning and Funding Manager for Auckland District
Health Board (2007–present). Prior to this he was a Programme Manager of Funding and Planning for
Counties Manukau District Health Board (2002–2007). Mr Hiini is currently completing a Postgraduate
Diploma in Public Health at Massey University and completed a Diploma of Health Management at the
University of Auckland (1996). He is a current member of the Kowhai Intermediate Board of Trustees
(2007–present) and a previous member of the Te Whao Urutaki Board of Trustees (2005–2006), the
Newton Central Primary School Board of Trustees (2005–2006) and the Counties Manukau District Health
Board Ethical Issues Review Committee (2006) to name a few such positions.
Mrs Carolyn Weston
Membership category:
Consumer representative
Date of appointment:
9 December 2004
Current term expired:
30 June 2012
Mrs Carolyn Weston is a member of the Royal New Zealand Foundation of the Blind’s (RNZFB) Client
Services Committee and she represents the Association of Blind Citizens of New Zealand (ABC) on the
Ministry of Health Disability Services’ Consumer Consortium. Mrs Weston was a member of the Southland
District Health Board Disability Support Advisory Committee (2005–2008). She was also a member of the
Office for Disability Issues’ Disability Advisory Council (2005–2006). Mrs Weston was a member of the
Medical Council of New Zealand’s Complaints Assessment Committee (1999–2002). She has been a
National Executive Committee member (1991–1997) and National President (2000–2001) of DPANZ
(Disabled Persons Assembly). Mrs Weston was a Board member for the Association of Blind Citizens of
New Zealand (1992–2004) and National President (2004-2007). She represented New Zealand at the
Disabled Persons International World Assembly (1994) and also at the Commonwealth Foundation NGOs
Forum (1995). She presented a paper on the Role of Women with Disabilities in Society at the
Rehabilitation International – World Congress (1996). Mrs Weston received the Queen’s Service Medal for
services to the community (1995), the New Zealand Institute of Travel and Tourism’s Research Award
(1998) and the Association of Blind Citizens of New Zealand’s Beamish Memorial Medal (2010). Mrs
Weston has served on several Boards and Committees in Invercargill such as the Southland Community
Radio Board (2009–present), RNZFB’s Invercargill Community committee (1986–present, Mt Anglem
College Establishment Board (1998–2000) and the Disability Resource Centre Southland first Chair
(1992–1995) and Board member (1995–2003).
Non-lay members
Dr John Baker
Membership category:
Health researcher
Date of appointment:
11 September 2008
Current term expired:
30 June 2012
Dr John Baker is currently Clinical Director at the Centre for Clinical Research and Effective Practice and is
also an Endocrinologist at Middlemore Hospital (2005–present). Prior to this he was a Chief Medical
Officer for Protemix Limited (2003–2005). Dr Baker was made a Fellow of the Royal College of
Pathologists of Australia (1984) and the Royal College of Physicians (1983). He has completed a Doctor of
Medicine (2007), a Bachelor of Medicine and Surgery (1975) and a Bachelor of Science (1971) at the
University of Otago. Dr Baker is a current member of the Diabetes Project Trust (1998–present) and is a
previous member of the Protemix Corporation (1999–2005).
Multi-region Ethics Committee – 2012 Annual Report
3
Dr Russell Franklin
Membership category:
Health practitioner
Date of appointment:
14 June 2007
Current term expired:
30 June 2012
Dr Russell Franklin has recently retired a Managing Director of Corporate HealthCare, a private health
services company. Prior to this he was a Health Advisor to the Department of the Prime Minister and
Cabinet and the Office of the Hon Jim Anderton (2000–2002), Medical Advisor for the Central Regional
Health Authority (RHA) Secondary and Tertiary Services (1994–1996). He was also employed by the
Central RHA as a Specialist Projects Analyst (1993–1994). His role as a consultant for Northern RHA was
to review paediatric and child health services (1992–1993). Dr Franklin completed his Bachelor of
Medicine and Bachelor of Surgery at the University of Otago (1967). He became a member (1972) and
then a fellow (1975) of the Royal Australasian College of Physicians. He received a Post Graduate Medical
Scholarship from the National Health and Medical Research Council of Australia (1974–1976), and went
on to complete his Doctor of Philosophy in Endocrinology and Research at Monash University (Melbourne,
1978). Dr Franklin also completed a Diploma in Management at the New Zealand Institute of Management
(1990). Dr Franklin is a current member of the Child and Youth Mortality Review Committee
(2004–present).
Dr Margaret Horsburgh
Membership category:
Health researcher
Date of appointment:
21 December 2006
Current term expired:
30 June 2012
Dr Margaret Horsburgh is an Associate Professor of nursing at the University of Auckland (2005–2009).
Prior to this she was the Associate Dean (education) of the Faculty of Medical and Health Sciences
(2002–2005) and the Assistant Dean and Director of Nursing (1999-2002), both at the University of
Auckland. Dr Horsburgh was the Director of the academic development at the Auckland Institute of
Technology (1992–1999). She qualified as a nurse at the Auckland Hospital Board School of Nursing
(1964) and went on to qualify as a midwife at Paddington General Hospital, London (1966). Dr Horsburgh
graduated from the University of Auckland with a Bachelor of Arts (1978), a Diploma in Education (1983),
and a Master of Arts (1987). She later completed a Doctor of Education at Charles Sturt University (1998).
She holds professional memberships with the College of Nurses Aotearoa, the Institute of Directors, and
the Rotary Club of Ellerslie Sunrise. She is Deputy Chair of Spectrum Care Trust (2004-present) and a
Trustee of Auckland Museum (2010–present). Dr Horsburgh was Deputy Chair of the performance based
research fund health panel for the Tertiary Education Commission in 2003 and 2006. She was Chair of the
New Prescribers Advisory Committee (2001–2006), and a member (2000–2004) and deputy chair
(2001–2004) of Auckland District Health Board. She was chair of its Quality Committee (2002–2004) and a
member of its Audit Committee (2001–2004). Dr Horsburgh has published numerous articles, technical
reports, books and presented papers on various health and education topics.
Dr Dean Quinn
Membership category:
Health researcher
Date of appointment:
2 September 2011; appointed to Central Regional Ethics Committee 23 July
2009
Current term expired:
30 June 2012
Dr Dean Quinn is currently Unit Director at Bowen P3 Research Hospital (2004–present). Prior to this he
was a Clinical Research Associate at the Medical Research Institute of New Zealand (2004). Dr Quinn
completed a Bachelor of Science with Honours at Victoria University, Wellington (1998) and a Bachelor of
Medicine and Bachelor of Surgery at the University of Otago (1993). He is a member of the Bowen Child
Care Management Committee (2007–2010).
Multi-region Ethics Committee – 2012 Annual Report
4
Dr Sheila Williams
Membership category:
Biostatistician
Date of appointment:
9 December 2004
Current term expired:
30 June 2012
Dr Sheila Williams is currently an Associate Professor for the Department of Preventive and Social
Medicine (1986–present). Prior to this she was a Biostatistician at the Dunedin Multidisciplinary Health and
Development Unit, Department of Paediatrics at the University of Otago Medical School (1977–1986).
Dr Williams completed a Doctor of Science (2004) and a Postgraduate Diploma of Science (1979) at the
University of Otago and a Bachelor of Science (Honours) at the University of Hull, England (1962). She is
a previous member of the Public Health Research Assessing Committee (2001), the Public Health Project
Assessing Committee (1997) and the Public Health Research Limited Budget Assessing Committee
(1996) to name a few. Dr Williams has published over 300 book chapters and refereed journal articles.
She is a fellow of the Royal Statistical Society and a member of the New Zealand Statistical Association
and the New Zealand Federation of Graduate Women.
Dr Chris Wynne
Membership category:
Health practitioner
Date of appointment:
9 December 2004
Current term expired:
30 June 2012
Dr Chris Wynne is a Radiation Oncologist at St George’s Hospital Cancer Care Centre, Christchurch, and
a Director and Principal Investigator at Christchurch Clinical Studies Trust. He has worked as a Radiation
Oncologist at Canterbury District Health Board (Christchurch Hospital) (2003–2010) and as the head of the
Radiation Oncology Department at National University Hospital, Singapore (2001–2003). Dr Wynne
completed a Bachelor of Medicine and Surgery at the University of Otago (1980). He is a Fellow of the
Royal Australia and New Zealand College of Radiologists (1987) and the Chapter of Palliative Medicine for
the Royal Australasian College of Physicians (2000). Dr Wynne has published over 30 journal articles, and
50 letters and conference proceedings. He holds professional memberships with the Royal Australasian
College of Radiologists, the New Zealand Society for Oncology, the Clinical Oncology Group of New
Zealand, the Trans Tasman Radiation Oncology Group, and the Canterbury Medical Research Society.
Multi-region Ethics Committee – 2012 Annual Report
5
Attendance
The Multi-region Ethics Committee held six meetings between January and June 2012.
Non-lay members
Lay members
Members
Key:
Meetings
Jan
Feb
Mar
Apr
May
Jun
Total
Cm
Mr Hector Matthews (Chair)






6/6
L
Mr Doug Bailey






6/6
E
Dr Paul Copland






6/6
Cn
Mrs Maliaga Erick






6/6
Cm
Mr Kerry Hiini






6/6
Cm
Ms Georgina Johnson
L
Mr Richman Wee
Cn
Ms Carolyn Weston






6/6
HR
Dr John Baker

A

A

A
3/6
HP
Dr Russell Franklin






6/6
HR
Dr Margaret Horsburgh

A


A

4/6
HR
Dr Dean Quinn






6/6
B
Dr Sheila Williams
A



A
A
3/6
HR
Dr Chris Wynne



A
A
A
3/6
Attendance
11
10
12
10
9
9
61/72
Applications considered
9
12
14
11
14
15
75*
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
* Includes second opinions and resubmissions for full applications.
Multi-region Ethics Committee – 2012 Annual Report
6
Applications reviewed
The Multi-region Ethics Committee received 150 applications between January and
June 2012. Of these, 68 were reviewed by the full committee, and 76 were reviewed
between meetings at the direction of the Chair (“expedited review”). 6 applications were
either withdrawn or did not require review.
Expedited
Full
At each of its meetings between January and June 2012, the Committee reviewed an
average of 11 new applications.
Approved
64
Declined
1
No final decision (as at 30 June 2012)
3
Withdrawn / ethical approval not required
3
Total
71
Approved
75
Declined
0
No final decision (as at 30 June 2012)
1
Withdrawn / ethical approval not required
3
Total
Total applications reviewed
79
150
A summary of these applications can be found in Appendix A.
Average decision times
Between January and June 2012, the average decision times were eight days for
“expedited” applications and 94 days for “full” applications, including any time taken for
researchers to respond to approval conditions.
Multi-region Ethics Committee – 2012 Annual Report
7
Appendix 1: Details of applications reviewed
Applications reviewed by the full pathway
Review
type
Status at time
of report
Dr Ian
MEC/12/01/001 VP 20621-200 – a phase 2, randomised, double-blind,
placebo-controlled dose-ranging study to assess the
Wallace
safety and efficacy of VP 20621 for prevention of
recurrence of clostridium difficile infection (CDI) in adults
previously treated for CDI
Full
Withdrawn
Shakespeare Specialist Group
Viropharma
Incorporated
Pending as of
11 January 2012
MEC/12/01/002 Prospective study – detecting incidence and recovery of
impaired inner ear function with gentamicin use
Full
Approved
Capital Coast District Health Board
Hutt Valley DHB
Southern DHB
Health Excellence
Research Centre
and the
Wellington
Hospital
Research Funds
RAG-M; Hutt
Valley DHB Maori
Health Unit – still
pending SDHB
124
Dr Paul
MEC/12/01/003 A multi-centred phase 2b randomised, parallel groups,
single blind, clinical trial investigating the safety, efficacy Young
and feasibility of standard high concentration oxygen
compared to a strategy of administration of titrated
oxygen in patients resuscitated from out-of-hospital VF
and VT cardiac arrest
Full
Approved
Capital and Coast District Health Board
Hutt Valley Hospital
Auckland City Hospital
North Shore Hospital
Middlemore Hospital
Christchurch Hospital
Dunedin Hospital
Hawkes Bay Hospital
HRC
Maori consultation
from Matire
Harwood –
Te Hononga O
Tamaki Me
Hoturoa
19
MEC/12/01/004 Researching and evaluating the evidence base for peer
support mental health services delivered by nongovernment organisations (NGOs)
Marge
Jackson
Full
Approved
Balance Whanganui
Connect Supporting Recovery, Auckland
Journeys to Wellbeing, Palmerston North
Mental Illness Survivors Team
Incorporated Society, Whanganui
Oasis Network Inc, Lower Hutt
Otago Mental Health Support Trust,
Dunedin
Turning Point Trust, Tauranga
Walsh Trust, Henderson, Auckland
Wellink Trust, Wellington
MEC/12/01/005 Occupational and environmental risk factors for motor
neurone disease HRC reference 11/1041
Dr David
McLean
Full
Approved
MEC/12/01/006 SNAP trial: in paediatric laparoscopic appendicectomy
does sonographically guided rectus sheath nerve block
compared to standard port-site local anaesthetic
infiltration reduce post-operative pain at the umbilical
port site?
Mr James
Hamill
Full
Approved
Project key
Full title
Multi-region Ethics Committee – 2012 Annual Report
Primary
investigator
Dr Stuart
Mossman
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
230
42
Auckland District Health Board
Auckland District
Health Board
79
8
Primary
investigator
Review
type
Status at time
of report
MEC/12/01/007 A multicentre, randomised, double-blind, activecontrolled, phase 3 study to evaluate the efficacy and
safety of TAK-875 25 mg and 50 mg compared to
glimepiride when used in combination with metformin in
subjects with type 2 diabetes
Dr Ian Rosen
Full
Approved
Middlemore Hospital
Lakeland Clinical Trials
P3 Research Wellington
P3 Research Tauranga
North Shore Hospital
Takeda Global
Research &
Development
Centre Inc
Pending for all
sites as of
11 January 2012
48
MEC/12/01/008 A randomised, double-blind, five treatment arms, fourperiod, incomplete crossover study to determine the
effect of six weeks treatment of orally inhaled tiotropium
+ olodaterol fixed dose combination (FDC) (2.5 / 5 µ;
and 5 / 5 µg) (delivered by the Respimat ® Inhaler)
compared with tiotropium (5 µg), olodaterol (5 µg) and
placebo (delivered by the Respimat ® Inhaler) on lung
hyperinflation and exercise endurance time during
constant work rate cycle ergometry in patients with
chronic obstructive pulmonary disease (COPD)
[MORACTO™1]. BI 1237.13
Dr Andrew G
Veale
Full
Approved
NZ Respiratory and Sleep Institute
Canterbury Respiratory Research Group
Boehringer
Ingelheim
Maori approval
letter dated
7 March 2012 by
Mata Forbes –
ADHB;Maori
approval letter
dated 9 March
2012 by Eru Waiti
– CDHB
79
MEC/12/02/009 A multicentre, randomised, double-blind, placebocontrolled, parallel-group study of oral CP-690,550 as a
maintenance therapy in subjects with ulcerative colitis
Dr Richard
Gearry
Full
Approved
Tauranga Hospital
Southern District Health Board
Shakespeare Specialist Group
Canterbury District Health Board
Waikato District Health Board
Auckland District Health Board
P3 Research Wellington
Pfizer
Pending as of
08/02/2012
138
MEC/12/02/010 Occupational exposures and possible health effects in
workers exposed to fumigants
Dr Andrea
‘t Mannetje
Full
Approved
Centre for Public Health Research,
Massey University, Wellington
Submitted
18 April 2012
70
MEC/12/02/011 A multicentre, open label study of CP-690,550 in
subjects with moderate to severe ulcerative colitis
Dr Richard
Gearry
Full
Approved
Tauranga Hospital
Christchurch Hospital
Shakespeare Specialist Group
Dunedin Hospital
Waikato Hospital
Auckland City Hospital
P3 Research Wellington
Pfizer
Pending Maori
consultation as of
08/02/2012
78
Dr Richard
MEC/12/02/012 A multicentre, randomised, double-blind, placebocontrolled, parallel-group study of oral CP-690,550 as an Gearry
induction therapy in subjects with moderate to severe
ulcerative colitis
Full
Approved
Christchurch Hospital
Waikato Hospital
Auckland City Hospital
P3 Research Wellington
Pfizer
Project key
Full title
Multi-region Ethics Committee – 2012 Annual Report
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
76
9
Project key
Full title
MEC/12/02/013 Study title: a phase 3 randomised, double-blind,
multicentre, placebo-controlled, combination study to
evaluate the efficacy and safety of Lesinurad and
Febuxostat compared to Febuxostat alone at lowering
serum uric acid and resolving tophi in subjects with
tophaceous gout (CRYSTAL) Protocol Number:
RDEA594-304, Version 2, Protocol Date 09 December
2011
Primary
investigator
Review
type
Status at time
of report
Associate
Professor
Nicola
Dalbeth
Full
Approved
Waikato District Health Board
Auckland City Hospital
Bay of Plenty Clinical School
Ardea
Biosciences, Inc
Dr Nigel
Gilchrist
Full
Approved
CGM Research Trust
Department of Medicine – University of
Auckland
Amgen Inc
Full
Approved
Tauranga Hospital
Dunedin Hospital
Shakespeare Specialist Group
Pfizer
90
Full
Approved
Northland DHB
Waitemata District Health Board
Auckland District Health Board
Counties-Manukau District Health Board
Waikato District Health Board
Bay of Plenty District Health Board
Lakes District Health Board
Tairawhiti District Health Board
Taranaki District Health Board
Hawkes Bay District Health Board
MS Society –
full-time salary
110
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
49
Approved sites: Associate Professor Peter Jones –
Waikato Hospital, WDHB, Associate Professor Nicola
Dalbeth
Auckland University, ADHB, Dr Tracey Kain, Bay of
Plenty Clinical School, BOPDHB
MEC/12/02/014 A multicentre, international, randomised, double-blind,
placebo-controlled, parallel-group study to assess the
efficacy and safety of AMG785 treatment in
postmenopausal women with osteoporosis
Dr Adrian
MEC/12/02/015 A multicentre, randomised, double-blind, placebocontrolled, parallel-group study of oral CP-690,550 as an Claydon
induction therapy in subjects with moderate to severe
ulcerative colitis
Pending as of
8 February 2012
75
Investigators: Dr Adrian Claydon, Dr Michael Schultz,
Dr Ian Wallace
Approved sites: Tauranga Hospital, Dunedin Hospital,
Shakespeare Specialist Group
MEC/12/02/016 A national incidence study of multiple sclerosis in
New Zealand
Multi-region Ethics Committee – 2012 Annual Report
Dr Deborah
Mason
The Neurology
Trust and The
New Zealand
Brain Research
Institute – other
costs
10
Review
type
Status at time
of report
Associate
Professor
Nicola
Dalbeth
Full
Approved
Auckland City Hospital
Waikato Hospital
Bay of Plenty Clinical School
MEC/12/02/018 A programme of development for older patients with
acute myeloid leukaemia and high risk myelodysplastic
syndrome
Dr Lucy
Pemberton
Full
Approved
Canterbury District Health Board
Auckland City Hospital
MEC/12/02/019 *** Double entry *** please ignore
Dr Lucy
Pemberton
Full
Received
Department of Paediatrics, Christchurch
Hospital
MEC/12/02/019 Crohns and colitis in children in the South Island
Professor
Andrew Day
Full
Approved
Department of Paediatrics, Christchurch
Hospital
MEC/12/02/020 Spinal cord injury and physical activity (SPICA):
intensive exercise from acute care to the community.
Part 3 of 4: Switch-on: electrical stimulation: acute care
Mr Raj
Singhal
Full
Approved
Burwood Spinal Unit
Project key
Full title
MEC/12/02/017 Study title: a phase 3 randomised, double-blind,
multicentre, placebo-controlled study to assess the
efficacy and safety of Lesinurad monotherapy compared
to placebo in subjects with gout and an intolerance or
contraindication to a xanthine oxidase inhibitor (LIGHT).
Protocol number: RDEA594-303, Version 1, Protocol
Date 31 October 2011
Primary
investigator
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
Pending as of
8 February 2012
49
Connections
Nga Kete E Rua –
Pete Mason; letter
dated 8 March
2012
112
Approved sites: Associate Professor Peter Jones,
Waikato Hospital, WDHB, Associate Professor Nicola
Dalbeth, Auckland University, ADHB, Dr Tracey Kain,
Bay of Plenty Clinical School, BOPDHB
Cardiff University
will be providing
the courier cost
from drug and
sample shipping
146
Transport
Accident
Commission
(Australia)
Perry Foundation
Apparently they
have approval
from their Part 1
of this study. This
is Part 3 of the
study. Need to
check.
99
MEC/12/03/021 MOBI-KIDS New Zealand: Risk factors for brain cancer
in children and adolescents
Dr Andrea
‘t Mannetje
Full
Approved
Massey University – Centre for Public
Health Research
MEC/12/03/022 KH02: a pilot study of topical honey for the treatment of
psoriasis
Dr James
Fingleton
Full
Approved
Medical Research Institute of New
Zealand (MRINZ)
Clinical Horizons NZ
Papamoa Pines Medical Centre
HoneyLab
58
MEC/12/03/023 KH03: a pilot study of topical honey for the treatment of
nappy rash
Dr James
Fingleton
Full
Approved
Medical Research Institute of New Zealand HoneyLab
Clinical Horizons NZ
Papamoa Pines Medical Centre
54
MEC/12/03/024 KH04: a pilot study of topical honey for the treatment of
cold sores
Dr James
Fingleton
Full
Approved
Medical Research Institute of New Zealand HoneyLab
Clinical Horizons NZ
Papamoa Pines Medical Centre
54
MEC/12/03/025 KH05: a pilot study of topical honey for the treatment of
rosacea
Dr James
Fingleton
Full
Approved
Medical Research Institute of New Zealand HoneyLab
Clinical Horizons Ltd
Papamoa Pines Medical Centre
54
Multi-region Ethics Committee – 2012 Annual Report
471
11
Primary
investigator
Review
type
Status at time
of report
Professor
Edward John
Gane
Full
Approved
Auckland Clinical Studies Unit
Canterbury DHB
Auckland District Health Board
Gilead Sciences
Inc, USA
43
Professor
MEC/12/03/027 A phase 3, safety and efficacy study of boceprevir/
peginterferon alfa-2a/ribavirin in chronic HCV genotype Edward J
1 IL28B CC subjects (Protocol No. P07755) (also known Gane
as MK-3034-040-00)
Full
Approved
Auckland City Hospital, ADHB
Waikato Hospital, WDHB
Wellington Hospital, CCDHB
Christchurch Hospital, CDHB
Merck Sharp &
Dohme
Corporation
144
MEC/12/03/028 A randomised, single blind controlled study assessing
the effect of endometrial injury on live birth rate in
women who are undergoing an IVF/ICSI cycle
Full
Approved
Fertility Associates, Auckland
Fertility Associates, Hamilton
Fertility Associates, Wellington
Fertility Associates, Christchurch
RANZCOG
Research
Foundation
152
Project key
Full title
MEC/12/03/026 GS-US-334-0107: a phase 3, multicentre, randomised,
double-blind, placebo-controlled study to investigate the
efficacy and safety of GS-7977 + ribavirin for 12 weeks
in subjects with chronic genotype 2 or 3 HCV infection
who are interferon intolerant, interferon ineligible or
unwilling to take interferon
Dr Phillip
McChesney
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
Mercia Barnes
Trust
Merck Serono
(providing
Crinone for
standardised
luteal support)
MEC/12/03/029 Nursing the long-term, complex surgical patient – a
discursive study
Ms Claire
Notman
Full
Approved
Waikato Hospital
MEC/12/03/030 A randomised controlled trial of permissive hypercapnia, Dr Shay
alveolar recruitment and low airway pressure
McGuiness
Full
Approved
Auckland District Health Board
Capital and Coast District Health Board
Canterbury District Health Board
Counties-Manukau District Health Board
Hawkes Bay District Health Board
MEC/12/03/031 Mouri Whakapapa: Repositioning Maori resistance and
wellbeing in sexual and reproductive health policy and
service provision
Ms Mera
Penehira
Full
Approved
University of Waikato
147
Professor
MEC/12/03/032 Protocol GB27980: A phase IIB, randomised, doubleblind, placebo controlled study to evaluate the efficacy,
Richard
safety and dosing regimens of MEMP1972A in adults
Beasley
with allergic asthma who are inadequately controlled on
inhaled corticosteroids and a second controller (COSTA)
Full
Approved
Medical Research Institute of New Zealand Genentech, Inc
Auckland District Health Board
Waikato District Health Board
University of Otago – Christchurch School
of Medicine
University of Otago – Dunedin School of
Medicine
CCRep, Middlemore Hospital
86
Multi-region Ethics Committee – 2012 Annual Report
51
The Alfred
Research Trust,
NHMRC Australia
180
12
Review
type
Status at time
of report
Dr Mark
Jeffery
Full
Approved
MEC/12/03/034 2012 study into older people’s oral health
Dr Barry
Gribben
Full
Approved
MEC/12/04/035 A randomised, open-label study to evaluate the efficacy
and safety of obatoclax mesylate in combination with
carboplatin and etoposide compared with carboplatin
and etoposide alone in chemotherapy-naïve patients
with extensive-stage small cell lung cancer
Dr Richard
North
Full
Withdrawn
Bay of Plenty District Health Board
MEC/12/04/036 A phase 3, randomised, two-arm, open-label,
multicentre, international trial of alisertib (MLN8237) or
investigator’s choice (selected single agent) in patients
with relapsed or refractory peripheral T-cell lymphoma
Dr Peter
Browett
Full
Approved
Auckland City Hospital – Professor Peter Millennium
Browett
Pharmaceuticals
North Shore Hospital – Dr David Gibbs
Inc
Christchurch Hospital – Dr David Simpson
77
MEC/12/04/037 The role of serotonin in older adults’ emotion recognition Professor Ted
and social understanding
Ruffman
Full
Approved
University of Otago
University of
Otago Research
Grant
111
MEC/12/04/038 A phase 3 study to evaluate the efficacy and safety of
dinaciclib or ofatumumab in subjects with refractory
chronic lymphocytic leukaemia
Full
Approved
Canterbury DHB
Auckland City Hospital
Capital & Coast DHB
Merck and Co Inc
88
Dr Jocelyne
MEC/12/04/039 A phase III, multicentre, international, randomised,
parallel group, double blind cardiovascular safety study Benatar
of BI 10773 (10 mg and 25 mg administered orally once
daily) compared to usual care in type 2 diabetes mellitus
patients with increased cardiovascular risk. Protocol
1245.25.
Full
Approved
Waitemata DHB
Capital Coast DHB
Canterbury DHB
Boehringer
Ingelheim
60
MEC/12/04/040 Quality and outcomes of care for patients with breast
and colorectal cancer receiving chemotherapy
Full
Approved
Christchurch Oncology Centre –
Christchurch Hospital
Southern Blood and Cancer Service –
Dunedin Hospital
MEC/12/04/041 Better prediction of anthracyclene induced cardiotoxicity: Dr Dean
a role for cardiac MRI spectroscopy and serum markers Harris
– a pilot study
Full
Approved
Canterbury District Health Board
Cancer Society
Elizabeth
Cunningham
55
MEC/12/04/042 Making a decision about upper limb reconstructive
surgery after more than ten years following spinal cord
injury
Full
Approved
Canterbury District Health Board
University of
Otago
Elizabeth
Cunningham
46
Project key
Full title
MEC/12/03/033 SSCOT – Short course oncology therapy. a study of
adjuvant chemotherapy in colorectal cancer.
Primary
investigator
Investigators: Dr Mark Jeffery, Dr Anne O’Donnell,
Dr George Laking, Dr Garry Forgeson, Dr Christopher
Jackson
Locality organisations
Christchurch Hospital
Auckland City Hospital
Palmerston North Hospital
Wellington Hospital
Dunedin Hospital
Sponsor/funder
Consultation
undertaken
Cancer Australia
Days to
review
63
Approved sites: Wellington Hospital – CCDHB,
Christchurch Hospital
Multi-region Ethics Committee – 2012 Annual Report
Dr Andrew
Butler
Dr Lisa
Whitehead
Ms Jennifer
Dunn
20
Cephalon Inc
90
13
Project key
Full title
Primary
investigator
Review
type
Status at time
of report
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
MEC/12/04/043 Are viruses involved in meniscal degeneration? A pilot
study
Dr Angus
Jennings
Full
Approved
subject to
conditions
Canterbury District Health Board
Wishbone Trust
MEC/12/04/044 An ascending single dose study to evaluate the safety,
tolerability and pharmacokinetics / pharmacodynamics
of PF-05280602, a recombinant factor VIIA variant
(813D) in adult haemophilia A and B subjects with or
without inhibitors
Dr Mark
Smith
Full
Approved
Christchurch Clinical Studies Trust
(CCST)
Pfizer
56
MEC/12/04/045 A randomised, double-blinded, active-controlled study of Dr Timothy
CB-183,315 in patients with clostridium difficile
Blackmore
associated diarrhoea.
Protocol number: LCD-CDAD-11-06.
Full
Approved
Wellington Hospital
North Shore Hospital
Middlemore Hospital
Christchurch Hospital
Palmerston North Hospital
Tauranga Hospital
Waikato Hospital
Taranaki District Health Board
Dunedin
Cubist
Pharmaceuticals
57
MEC/12/05/046 Health outcomes for mental health service users –
exploring the case of cancer
Full
Approved
Capital and Coast District Health Board
Dr Hamish
MEC/12/05/047 A multicentre, prospective, randomised, double-blind,
placebo-controlled, parallel-group study to evaluate the Hart
effect of AMR101 on cardiovascular health and mortality
in hypertriglyceridemic patients with cardiovascular
disease or at high risk for cardiovascular disease
Full
Approved
Waitemata District Health Board
Hawkes Bay District Health Board
Nelson Hospital
Lipid and Diabetes Research Group
Waikato Hospital
Dunedin Hospital
Whangarei Hospital
Bay of Plenty DHB
Taranaki Base Hospital
Professor Tim
MEC/12/05/048 A randomised, double-blind, multicentre, multinational,
phase II, dose-parallel study to determine the safety and Anderson
efficacy of MT10109 (clostridium botulinum toxin type A)
in subjects with cervical dystonia in comparison to botox
Full
Approved
New Zealand Brain Research Institute
Auckland City Hospital
Waikato Hospital
53
MEC/12/05/049 Evaluating the utility of a patient decision aid for
prospective participants in the TROG 08.03 RAVES
prostate cancer trial
Dr Maria
Pearse
Full
Approved
Auckland City Hospital
Waikato Hospital
Palmerston North Hospital
Wellington Hospital
Dunedin Hospital
80
MEC/12/05/050 A randomised blinded placebo controlled trial of
hydrocortisone in critically ill patients with septic shock.
Protocol Number: GI-CCT372273.
Dr Colin
McArthur
Full
Approved
Auckland District Health Board
Waitemata District Health Board
Counties Manukau District Health Board
Capital and Coast District Health Board
Canterbury District Health Board
154
Multi-region Ethics Committee – 2012 Annual Report
Ms Ruth
Cunningham
Amarin Pharma
Inc.
Elizabeth
Cunningham
Ngai Tahu
Research
Consultation
Committee
29
North Shore
Hospital
85
14
Project key
Full title
Primary
investigator
Review
type
Status at time
of report
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
MEC/12/05/051 AALL1131: a phase III randomised trial for newly
diagnosed high risk B-precursor acute lymphoblastic
leukaemia (ALL) testing Clorafabine (IND#673789,
NSC#606869) in the very high risk stratum
Dr Lochie
Teague
Full
Declined
Starship Children’s Health
Christchurch Hospital
MEC/12/05/052 Study C38072/3085
Dr Conroy
Wong
Full
Approved
Middlemore Hospital
Tauranga Hospital
Medical Research Institute of New Zealand
RMC Medical Research Ltd
Waikato Hospital
MEC/12/05/053 A phase II, randomised, placebo controlled, double-blind
study of the safety and efficacy of MPSK3169A in
patients with coronary heart disease or high risk of
coronary heart disease
Associate
Professor
Richard
Troughton
Full
Approved
University of Otago
Middlemore Hospital
Nelson Hospital
University of Auckland
P3 Research Tauranga
MEC/12/05/054 NP28266: a randomised, open-label, multicentre study
of the safety, efficacy and tolerability of combination
treatment of Setrobuvir, Danoprevir, Ritonavir, and
Copegus with or without Mericitabine in HCV Genotype
1-infected patients who are either treatment naive or
have previously experienced a null response to
Interferon-based treatment
Professor
Edward Gane
Full
Approved
Auckland Clinical Studies Ltd
Auckland City Hospital
Christchurch Clincal Studies Trust
Waikato Hospital
Southern District Health Board
72
MEC/12/05/055 A multicentre, randomised, phase 3 study of sequential Dr Andrew
Pralatrexate versus observation in patients with
Butler
previously undiagnosed peripheral T-cell lymphoma who
have achieved an objective response following initial
treatment with CHOP-based chemotherapy
Full
Approved
Canterbury District Health Board
Auckland City Hospital
Middlemore Hospital
North Shore Hospital
71
MEC/12/05/056 A randomised, open-label, phase 3 study of Carfilzomib
plus Dexamethasone vs Bortezomib plus
Dexamethasone in patients with relapsed multiple
myeloma
Dr Peter
Ganly
Full
Approved
Canterbury District Health Board
Counties-Manukau District Health Board
Auckland District Health Board
Waitemata District Health Board
80
MEC/12/05/057 A multicentre, randomised, double-blinded, placebocontrolled, parallel group, multiple dose, study of the
efficacy of 8.75 mg Flurbiprofen spray in the relief of
sore throat due to upper respiratory tract infection
Dr Jason
Russell Pryke
Full
Approved
Southern Clinical Trials Ltd – Christchurch
Southern Clinical Trials Ltd – Auckland
84
An open-label extension study to evaluate the long-term
safety and efficacy of Reslizumab (3.0 mg/kg) as
treatment for patients with eosinophilic asthma who
completed a prior Cephalon-sponsored study in
eosinophilic asthma
Multi-region Ethics Committee – 2012 Annual Report
72
University of
Otago
52
15
Primary
investigator
Review
type
Status at time
of report
Locality organisations
Dr Ian Rosen
Full
Approved
Middlemore Hospital, CMDHB
P3 Research Tauranga
P3 Research Wellington
Diabetes Research Institute, Christchurch
Hospital
RMC Medical Research Ltd
Wellington Hospital
Auckland City Hospital
North Shore Hospital
98
Dr Jan
Schmid
Full
Approved
Auckland City Hospital
Dunedin Hospital
261
Professor
MEC/12/06/060 NV22877 parachute: a phase II, double-blind study to
evaluate the sustained virologic response of
Edward John
RO5024048 (Mericitabine) at two doses in combination Gane
with RO5190591 (Danoprevir) boosted with low-dose
Ritonavir (DNV/R) and Pegasys®/ Copegus® with or
without two weeks of RO5024048/ Pegasys®/Copegus®
lead-in, in patients with chronic hepatitis C genotype 1
virus infection who have failed prior treatment with a
protease inhibitor
Full
Closed
Auckland Clinical Studies Ltd
Auckland City Hospital
MEC/12/06/061 GS-US-283-0110: a long term follow-up registry study of Professor
subjects who did not acheive loss of S antigen (HBsAg) Edward John
and sustained HBV viral load reduction below the limit of Gane
quantitation (BLQ) in Gilead-sponsored trials of
GS-9620 in subjects with chronic hepatitis B infection
Full
Approved
Auckland City Hospital
Auckland Clinical Studies Ltd
161
MEC/12/06/062 Evaluation of performance and usability of Nucleus® 6
in the paediatric population
Full
Approved
The Hearing House
The Southern Cochlear Implant
Programme
70
Project key
Full title
MEC/12/06/058 A multicentre, randomised, double-blind, placebocontrolled, phase 3 study to evaluate cardiovascular
outcomes of TAK-875, 50 mg in addition to standard of
care in subjects with type 2 diabetes and with
cardiovascular disease or multiple risk factors for
cardiovascular events. “TAK-875,50MG CV Outcomes
Study”. Protocol: TAK-875_306
Sites: Dr Ian Rosen, CCRep, Middlemore Hospital,
CMDHB – Lead Site
Sponsor/funder
Consultation
undertaken
Days to
review
Dr Dean Quinn, P3 Research Ltd, Wellington
Dr Edmond Walford, P3 Research Ltd, Tauranga
Dr Dean Millar-Coote, RMC Medical Research Ltd,
Dunedin
Professor Russell Scott, Diabetes Research Institute,
Christchurch
Dr Jeremy Krebs, Wellington Hospital, Wellington
Dr Simon Young, North Shore Hospital, Auckland
Dr Jocelyne Benatar, Auckland City Hospital, Auckland
MEC/12/06/059 Candida albicans hypermutable genes: basic biology
and potential use in risk stratification for candidemia
patients
Multi-region Ethics Committee – 2012 Annual Report
Dr Leigh
Martelli
Roche
Pharmaceuticals
16
Project key
Full title
Primary
investigator
Review
type
Status at time
of report
Locality organisations
Sponsor/funder
Consultation
undertaken
Days to
review
MEC/12/06/063 A multicentre randomised double blinded phase III trial
of the effect of standard issue red blood cell blood units
on mortality compared to freshest available red blood
cell units
Dr Colin
McArthur
Full
Approved
Auckland District Health Board
Counties-Manukau District Health Board
Capital and Coast District Health Board
Canterbury District Health Board
Hawkes Bay District Health Board
Waitemata District Health Board
Nelson Marlborough District Health Board
MidCentral District Health Board
NHMRC
125
MEC/12/06/064 Millennium C16010 – a phase 3, randomised, doubleblind, multicentre study comparing oral MLN9708 plus
Lenalidomide and Dexamethasone versus placebo plus
Lenalidomide and Dexamethasone in adult patients with
relapsed and/or refractory multiple myeloma
Dr Peter
Ganly
Full
Approved
Canterbury Health Laboratories
North Shore Hospital
Palmerston North Hospital
Auckland City Hospital
Wellington Hospital
Waikato Hospital
Middlemore Hospital
Millennium
Pharmaceuticals
Inc
80
MEC/12/06/065 A randomised, double-blind, multicentre study of
denosumab compared with zoledronic acid (Zometa) in
the treatment of bone disease in subjects with newly
diagnosed multiple myeloma
Dr Peter
Ganly
Full
Approved
Canterbury District Health Board
Auckland City Hospital
Capital and Coast District Health Board
Amgen Inc
56
MEC/12/06/066 A phase IV, open-label, multicentre study to assess the
immunogenicity and safety of GSK Biologicals’ hepatitis
B vaccine, Engerix™-B administered at 0, 1 and 6
months in adults with or without type 2 diabetes mellitus
Dr Simon
Carson
Full
Approved
Southern Clinical Trials Ltd
Medical Research Institute of New
Zealand
Waikato Regional Diabetes Service
Lakeland Clinical Trials Ltd
GlaxoSmith Kline
Biologicals
79
Dr Richard
MEC/12/06/067 A phase II, multicentre, open-label, randomised study
evaluating the efficacy and safety of FOLFIRI +
North
MEHD7945A versus FOLFIRI+Cetuximab in second line
in patients with kras wild-type metastatic colorectal cancer
Full
Approved
Bay of Plenty District Health Board
Southern District Health Board
Canterbury District Health Board
Genentech, Inc
136
MEC/12/06/068 Children’s Oncology Group (COG) ACNS0821:
Temozolomide with Irinotecan versus Temozolomide,
Irinotecan plus Bevacizumab (NSC#704865,BBIND#7921) for recurrent/ refractory
medulloblastoma/CNS PNET (primitive neuroectodermal tumour) of childhood, a COG randomised
phase II screening trial
Dr Stephen
Laughton
Full
Approved
subject to
conditions
Starship Children’s Health, ADHB
Children’s
Oncology Group
MEC/12/06/069 GS-US-334-0109: an open-label study of GS-7977 +
ribavirin for 12 weeks in subjects with chronic HCV
infection (GT 2 or GT3) who participated in prior studies
evaluating GS-7977
Dr Catherine
Stedman
Full
Approved
Auckland DHB
Canterbury DHB
Southern DHB
Bay of Plenty DHB
Waikato DHB
Capital Coast DHB
OTA/03/11/116b An extension study to SHARP OTA/03/11/116. SHARPER study of heart and renal
Professor
Rob Walker
72
Approved
Protection – extended review
Multi-region Ethics Committee – 2012 Annual Report
17
Applications reviewed by the expedited pathway
Project key
Full title
Primary
investigator
Date
received
Review
type
Status at time
of report
Date of
approval
Days to
review
MEC/12/EXP/001
New Zealand midwives management of perineal trauma during childbirth: a survey of practice
Robin Cronin
5/01/2012
EXP
Approved
16/01/2012
11
MEC/12/EXP/002
The Empathy project, postgraduate follow-up on brief intervention and motivational interviewing skills
(Phase 3 of the project)
Dr Helen Moriarty
6/01/2012
EXP
Approved
16/01/2012
10
MEC/12/EXP/003
Examination of the experiences of older people with dementia and their family/whanau/caregivers and
staff during admission to an acute hospital unit
Dr Kay de Vries
6/01/2012
EXP
Approved
16/01/2012
10
MEC/12/EXP/004
An analysis of reverse total shoulder arthroplasties and the management of secondary acromion
stress fractures
Andre Poon
6/01/2012
EXP
Approved
16/01/2012
10
MEC/12/EXP/007
Risk factor analysis of multi-drug resistant Escherichia coli urinary tract infections in South Canterbury, Dr Rosemary Ikram
New Zealand
20/01/2012
EXP
Approved
22/01/2012
2
MEC/12/EXP/008
ASPIRE: a multicentre, randomised, double-blind, placebo-controlled clinical trial examining the
efficacy and safety of low-dose aspirin after initial oral anticoagulation to prevent recurrent venous
thromboembolism
Dr Paul Ockelford
20/01/2012
EXP
Approved
1/02/2012
12
MEC/12/EXP/009
Audit of HIV testing results in treatment naive patients with HIV infection in New Zealand
Dr Simon Briggs
20/01/2012
EXP
Approved
22/01/2012
2
MEC/12/EXP/010
Anti-N-methyl-aspartate receptor antibody encephalitis: a case series
Dr Paul Young
30/01/2012
EXP
Approved
7/02/2012
8
MEC/12/EXP/011
New to New Zealand; making migrant nurses welcome in NZNO
Dr Leonie Walker
30/01/2012
EXP
Approved
7/02/2012
8
MEC/12/EXP/012
Comparison of core and peripheral temperature measurement in adult critically ill patients with brain
injury and sepsis
Dr Paul Young
30/01/2012
EXP
Approved
7/02/2012
8
MEC/12/EXP/013
New Zealand survey of glomerulonephritis
Associate Professor
Helen Pilmore
30/01/2012
EXP
Approved
7/02/2012
8
MEC/12/EXP/014
The outcome of a national roll out of Maudsley family-based therapy for the treatment of anorexia
nervosa
Ms Rachel Lawson
30/01/2012
EXP
Approved
7/02/2012
8
MEC/12/EXP/015
A quantitative investigation into third-party disability in family members of people with aphasia: the
second phase of a mixed methods study
Ms Meghann
Grawburg
10/02/2012
EXP
Approved
17/02/2012
7
MEC/12/EXP/016
Australian and New Zealand Cardiac Society acute coronary syndrome audit: ANZ snapshot 2012
Dr Chris Ellis
7/02/2012
EXP
Approved
17/02/2012
10
MEC/12/EXP/017
Late career nurses in New Zealand
Dr Jill Clendon
10/02/2012
EXP
Approved
17/02/2012
7
MEC/12/EXP/018
Health and lifestyles survey
Dr Barry Gribben
10/02/2012
EXP
Approved
17/02/2012
7
MEC/12/EXP/019
Depression and social support among community-dwelling older adults
Ms Louise
Cowpertwait
14/02/2012
EXP
Approved
24/02/2012
10
MEC/12/EXP/020
Consumer testing of terminology and key messages for smoking cessation
Professor Janet
Hoek
31/01/2012
EXP
Approved
16/02/2012
16
MEC/12/EXP/021
Ototoxicity as a predictor of outcome in osteosarcoma patients treated with cisplatin
Dr Mandy de Silva
16/02/2012
EXP
Approved
24/02/2012
8
Multi-region Ethics Committee – 2012 Annual Report
18
Project key
Full title
Primary
investigator
Date
received
Review
type
Status at time
of report
Date of
approval
Days to
review
MEC/12/EXP/022
An internal examination of colorectal cancer management in New Zealand
Professor Michael
Findlay
16/02/2012
EXP
Approved
24/02/2012
8
MEC/12/EXP/023
International collaborative study of Susac’s syndrome
Professor Robert
Rennebohm
17/02/2012
EXP
Approved
24/02/2012
7
MEC/12/EXP/024
Post-injection syndrome in patients with schizophrenia receiving olanzapine long-acting injection
Dr Sara Weeks
20/02/2012
EXP
Approved
24/02/2012
4
MEC/12/EXP/025
The accuracy of New Zealand intensive care paramedics’ clinical decision-making applied to
autonomous pre-hospital thrombolysis
Mr Paul Davis
20/02/2012
EXP
Approved
24/02/2012
4
MEC/12/EXP/026
Strengthening health literacy among indigenous people living with cardiovascular disease, their
families, and health care providers – graduate student segment two
Ms Bernice Downey
20/02/2012
EXP
Approved
24/02/2012
4
MEC/12/EXP/027
Ototoxicity as a predictor of outcome in osteosarcoma patients treated with Cisplatin
Dr Mandy de Silva
23/02/2012
EXP
Approved
5/03/2012
11
MEC/12/EXP/028
A survey of formal infectious disease consultations in Australia, New Zealand and Singapore
Dr Tony Walls
23/02/2012
EXP
Approved
2/03/2012
8
MEC/12/EXP/029
The use of regression and Bayesian spatial and temporal mapping techniques to overcome data gaps
in the reporting of enteric notifiable disease
Dr Rob Lake
24/02/2012
EXP
Approved
2/03/2012
7
MEC/12/EXP/030
Research to improve oral health self-care outcomes for at-risk adults
Ms Carolyn Watts
20/02/2012
EXP
Approved
17/02/2012
-3
MEC/12/EXP/031
Refugee household-based health and wellbeing programme – baseline knowledge, attitude and
practice survey
Dr Demissie
Tadesse Diressie
5/03/2012
EXP
Approved
20/03/2012
15
MEC/12/EXP/033
5-Pt star research project
Ms Marion GordonFlower
27/02/2012
EXP
Approved
12/03/2012
14
MEC/12/EXP/034
Patient-derived weighting for component of composite response criteria for chronic gout clinical trials
Associate Professor
William Taylor
27/02/2012
EXP
Approved
12/03/2012
14
MEC/12/EXP/035
Venepuncture related nerve injury
Ms Abigail Moore
5/03/2012
EXP
Approved
12/03/2012
7
MEC/12/EXP/036
Leptospirosis in Hawkes Bay, New Zealand: the presenting features and outcomes
Dr Paul Sellors
8/03/2012
EXP
Approved
20/03/2012
12
MEC/12/EXP/037
An investigation of best ways for GPs to support and inform those affected by cancer under their care
Mr Paul Kane
8/03/2012
EXP
Approved
2/04/2012
25
MEC/12/EXP/038
Health literacy: and the prevention and early detection of gout; prevention and treatment of skin
infections in Maori children, and the screening and management of gestational diabetes
Ms Susan Reid
8/03/2012
EXP
Approved
23/03/2012
15
MEC/12/EXP/039
Audit of blood sample collecting and labelling
Dr Richard
Charlewood
12/03/2012
EXP
Approved
20/03/2012
8
MEC/12/EXP/040
Diabetes nurse specialist prescribing six months on – what’s working and what’s not?
Hazel Phillips
12/03/2012
EXP
Approved
20/03/2012
8
MEC/12/EXP/041
How do the attitudes, and beliefs of health professionals in general practice regarding obesity affect
the care provided to, and the experiences of New Zealand men who are significantly overweight?
Fiona Doolan-Noble
12/03/2012
EXP
Approved
20/03/2012
8
MEC/12/EXP/042
District Health Board staff safety culture survey
Dr Nick Fisher
15/03/2012
EXP
Approved
16/03/2012
1
MEC/12/EXP/043
Aged residential care hospital utilisation study (ARCHUS) Waitemata medicines review audit
Ms Tanya Bish
16/03/2012
EXP
Approved
23/03/2012
7
Multi-region Ethics Committee – 2012 Annual Report
19
Project key
Full title
Primary
investigator
Date
received
Review
type
Status at time
of report
Date of
approval
Days to
review
MEC/12/EXP/044
Dental laboratory services offered in New Zealand and industry trends
Mr Saaed Salem
Alameri
23/03/2012
EXP
Approved
2/04/2012
10
MEC/12/EXP/045
New Zealand adolescent and young adult cancer incidence and survival 2000–2009
Dr Michael Sullivan
23/03/2012
EXP
Approved
2/04/2012
10
MEC/12/EXP/046
National retrospective audit of perinatal outcomes including Caesarian section, NICU admission,
readmission and mortality in relation to ethnicity, rural, urban and provider factors
Dr Beverley Lawton
23/03/2012
EXP
Approved
2/04/2012
10
MEC/12/EXP/047
Family carers doing technical health procedures at home – their learning and experiences
Ms Janet McDonald
23/03/2012
EXP
Approved
2/04/2012
10
MEC/12/EXP/048
CT morphometry of thoracic intervertebral discs and changes associated with aging
Mr Justin GR
Fletcher
26/03/2012
EXP
Approved
2/04/2012
7
MEC/12/EXP/049
Wellbeing in educational settings
Dr Pauline
Dickinson
29/03/2012
EXP
Approved
10/04/2012
12
MEC/12/EXP/050
Palliative care, health literacy, Maori communities, and health services
Dr Jacquie Kidd
30/03/2012
EXP
Approved
13/04/2012
14
MEC/12/EXP/051
An audit of temperature regulation in intensive care patients with traumatic brain injury and stroke in
Australia and New Zealand (CLARITY)
Dr Paul Young
5/04/2012
EXP
Approved
13/04/2012
8
MEC/12/EXP/052
Early activity and mobility in the intensive care unit
Dr Paul Young
5/04/2012
EXP
Approved
13/04/2012
8
MEC/12/EXP/053
A study of the use of business models in the New Zealand health care sector
Professor David
Crick
13/04/2012
EXP
Approved
18/04/2012
5
MEC/12/EXP/054
Leg swelling after caesarean section
Dr Daniel Mattingley 13/04/2012
EXP
Approved
18/04/2012
5
MEC/12/EXP/055
Early oral intake following free flap reconstruction for oral cavity cancer
Dr Alice Guidera
18/04/2012
EXP
Approved
9/05/2012
21
MEC/12/EXP/057
Mortality and non-fatal suicidal behaviour in the 20 years after a medically serious suicide attempt
Dr Annette L
Beautrais
19/04/2012
EXP
Approved
9/05/2012
20
MEC/12/EXP/058
What are non-prescribing diabetes nurse specialists' views of nurse prescribing in diabetes?
Hazel Phillips
20/04/2012
EXP
Approved
27/04/2012
7
MEC/12/EXP/059
Dementia in primary care: New Zealand general practitioners’ perspectives
Dr Katherine
Bloomfield
20/04/2012
EXP
Approved
27/04/2012
7
MEC/12/EXP/060
Intensive care over nations (ICON) prospective audit
Dr Anthony Williams 24/04/2012
EXP
Approved
8/05/2012
14
MEC/12/EXP/061
Clinical and molecular epidemiology of methicillin-resistant staphylococcus aureus (MRSA) in New
Zealand, 2005–2012
Dr Deborah
Williamson
4/05/2012
EXP
Approved
9/05/2012
5
MEC/12/EXP/062
Fluid therapy after cardiac surgery
Ms Rachael Parke
7/05/2012
EXP
Approved
9/05/2012
2
MEC/12/EXP/063
Blood alcohol levels in New Zealand suicides
Dr Annette L
Beautrais
9/05/2012
EXP
Approved
17/05/2012
8
MEC/12/EXP/064
A review of the accuracy of a high risk obstetrical ultrasound department in determining estimated fetal Ms Laura Neuss
weights
14/05/2012
EXP
Approved
16/05/2012
2
MEC/12/EXP/065
Testicular cancer and cryptorchidism: could incidence trends in the New Zealand context reveal the
strength of this critical aetiological link?
17/05/2012
EXP
Approved
24/05/2012
7
Multi-region Ethics Committee – 2012 Annual Report
Dr Jason Gurney
20
Date
received
Review
type
Status at time
of report
Date of
approval
Days to
review
Dr Sally Abel
17/05/2012
EXP
Approved
24/05/2012
7
Development and validation of a measure of eating compulsivity
Dr Ria Schroder
18/05/2012
EXP
Approved
24/05/2012
6
MEC/12/EXP/068
Does standard dietetic education delivered by Waitemata DHB dieticians to hospital inpatients
translate to self-reported behaviour change once the patient has returned to the patient’s or the
patient’s family’s own home?
Ms Hazel Ingrid
Oxford
21/05/2012
EXP
Approved
24/05/2012
3
MEC/12/EXP/069
Asbestos exposure and health outcomes
Associate Professor
Barry Borman
21/05/2012
EXP
Approved
31/05/2012
10
MEC/12/EXP/070
Follow-up after Jadelle insertion
Dr Christine Roke
24/05/2012
EXP
Approved
31/05/2012
7
MEC/12/EXP/071
Retailers who stop selling tobacco products: motivations and experiences
Dr Natalie Walker
29/05/2012
EXP
Approved
1/06/2012
3
MEC/12/EXP/072
The health of people with Coeliac disease in New Zealand and the impact of a gluten free diet
Ms Kiri Sharp
28/05/2012
EXP
Approved
6/06/2012
9
MEC/12/EXP/073
Adaptive support ventilation (ASV) management as a default mode in a tertiary ICU
Mr Mark
Henderwood
11/06/2012
EXP
Approved
18/06/2012
7
MEC/12/EXP/074
Consumers’ priorities for mental health research: a New Zealand perspective
Dr Sarah Gordon
11/06/2012
EXP
Approved
15/06/2012
4
MEC/12/EXP/075
New information systems implemented into health services: impacts for clinicians and health service
managers
Ms Joanne Smith
11/06/2012
EXP
Approved
15/06/2012
4
MEC/12/EXP/076
Indeterminate breast screen lesions: comparison of core biopsy to final histology
Dr Nicola Davis
11/06/2012
EXP
Approved
15/06/2012
4
MEC/12/EXP/077
Epidemiology of important congenital heart disease in New Zealand: perinatal diagnosis and
outcomes
Dr Luke Eckersley
13/06/2012
EXP
Approved
25/06/2012
12
MEC/12/EXP/078
What are the barriers and enablers to emergency department nurses’ management of patients’ pain?
Ms Annatjie
Pretorius
14/06/2012
EXP
Approved
22/06/2012
8
MEC/12EXP/072
Supporting traditional rongoa practice in contemporary health care settings
Dr Amohia Boulton
1/06/2012
EXP
Approved
18/06/2012
17
Project key
Full title
MEC/12/EXP/066
The Wahakura: A qualitative study of the flax bassinet as a safe infant sleeping environment for Maori
MEC/12/EXP/067
Multi-region Ethics Committee – 2012 Annual Report
Primary
investigator
21