Northern A Health and Disability Ethics Committee
Annual Report2013
Published in October 2014
by the Ministry of Health PO Box 5013, Wellington, New Zealand
ISBN: 978-0-478-39332-3 (online) HP5489
This document is available on the New Zealand Health and Disability Ethics Committees’ website: http://www.ethicscommittees.health.govt.nz
Northern A Health and Disability Ethics Committee – 2013 Annual Report 2
Contents
Contents..........................................................................................................3About the Committee.....................................................................................4Chairperson’s report......................................................................................5Membership and attendance.........................................................................6
Membership..............................................................................................................6Attendance...............................................................................................................9Training and conferences.........................................................................................9Chairpersons’ meetings............................................................................................9
Applications reviewed.................................................................................11Applications processed by Secretariat...................................................................11Average review time...............................................................................................11
Post approval items reviewed.....................................................................12Reasons for declining..................................................................................12Issues and complaints.................................................................................14Action taken..................................................................................................14
Issues referred to NEAC and/or the HRC Ethics Committee.................................14Complaints received...............................................................................................14Overdue review......................................................................................................14
Appendix 1: Details of applications reviewed...........................................15Applications reviewed by full committee.................................................................15Applications reviewed by expedited review............................................................25Minimal dataset form applications..........................................................................29Overdue full applications........................................................................................52Overdue expedited applications.............................................................................53
Northern A Health and Disability Ethics Committee – 2013 Annual Report 3
About the CommitteeThe Northern A Health and Disability Ethics Committee (HDEC) 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 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 when making decisions, among other matters.
Approvals and registrations
The Northern A HDEC is approved by the Health Research Council Ethics Committee for the purposes of section 25(1)(c) of the Health Research Council Act 1990.
The Northern A HDEC is registered (number IRB00008714) 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 A Health and Disability Ethics Committee – 2013 Annual Report 4
Chairperson’s reportThe year has seen further embedding of the new system and by and large the ethical review is working quite well.
The Committee meetings have been proficiently supported by the administration staff, we now have quite detailed discussion points in our review document and generally we tend to have a high full approval record of applications.
I attribute this to improved researcher understanding of the new process as well as researcher experience (many have been submitting for a long time). The range of ethical issues is wide and the Committee members take their ethical duties seriously.
We have lost the services of Dr Wayne Miles and at times have had to second members from other committees to have quorum. The Committee is notable for its lack of clinicians and this may need to be addressed when the next appointments are made.
Furthermore, the expedited process through the online system is working well. We make every endeavour to meet the deadlines for review, and in cases where this has not happened it is due to not properly understanding the system at the time rather than tardiness on the Chairs part. It is difficult sometimes to get other reviewers to review on time, but this is due primarily to their other time commitments, but this will improve.
I have no serious concerns with the new ethical process, we are giving researchers a better service and I believe it is thorough. The new process has required a shift in workload and as our experience with the process matures, I can see the need for further resource allocation within the section of the MOH, to address the balance between straight administration support and policy advice.
We have a considerable store of information accumulating in the new system (now available online) and the challenge will be how we now use this data/knowledge to better inform researchers and committees.
Brian FergusChairpersonNorthern A Health and Disability Ethics Committee
Northern A Health and Disability Ethics Committee – 2013 Annual Report 5
Membership and attendanceNo meetings were postponed or cancelled due to inability to make quorum. One member finished their term during 2013. Two members joined the Committee in 2013.
Membership
Lay members
Dr Brian Fergus (Chair)Membership category: Community PerspectivesDate of appointment: 1 July 2012Current term expires: 1 July 2015
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. Brian is a member of ECART (Ethics Committee for Assisted Reproductive Technology). Brian was the chair of the Northern X HDEC.
Ms Susan BucklandMembership category: Consumer PerspectivesDate of appointment: 1 July 2012Current term expires: 1 July 2014
Ms Buckland is a freelance journalist and editor, specialising in the arts and travel writing. She previously managed public relations for Air New Zealand (1979 – 1992) and was an independent public relations consultant from 1992 - 2005. Ms Buckland is an elected member of Auckland District Health Board (2007 – present), a Starship Foundation Trustee (2007 – present) and is a Professional Conduct Committee member of the Medical Council of New Zealand. She has previously been Chair of New Zealand Travel Communicators (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).
Mr Kerry HiiniMembership category: Community PerspectivesDate of appointment: 1 July 2012Current term expires: 1 July 2014
Mr Kerry Hiini (Ngati Hine; Tapuika) is currently a Portfolio Manager for Waitemata and Auckland District Health Board. Prior to this he was a Planning and Funding Manager for Auckland District Health Board (2007-2013). Mr Hiini has completed 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.
Northern A Health and Disability Ethics Committee – 2013 Annual Report 6
Ms Michèle StantonMembership category: The LawDate of appointment: 1 July 2012Current term expires: 1 July 2014
Ms Michèle Stanton is a lawyer specialising in medico-legal, insurance and employment law. Michele’s background includes advocacy, research ethics, occupational regulation and quality assurance in the financial services, education and health sectors. She is a member of the Auckland District Law Society Health & Disability Law Committee, a former member of the UNITEC Research Ethics Committee, and a current Board member of the Academic Quality Agency for NZ Universities. Michele has also served on the Board of a Responsible Authority under the Health Practitioners Competence Assurance Act 2003. Michèle has a Diploma in Business Studies from Massey University (1998), a Bachelor of English from the University of Canterbury (1981) a Bachelor of Laws from the University of Canterbury (1984) and a Graduate Diploma in Law from the University of Auckland (1988).
Non-lay members
Dr Etuate SaafiMembership category: Health ResearcherDate of appointment: 1 July 2012Current term expires: 1 July 2014
Dr Etuate Saafi is a biomedical research scientist who currently works as a Senior Research Fellow at AUT University. He has a background in metabolic syndrome and diabetes research including amyloid mediated programmed cell death in pancreatic islet beta cells. Part of his more recent research interest includes the metabolic profiling of fast growing and slow growing children. He has previously held roles that include being a Senior Research Fellow & Research Manager at Massey University, Research Scientist with the Protemix Corporation, and HRC Postdoctoral Research Fellow at the University of Auckland. Dr Saafi completed a Master of Business Administration (2008) and a Master of Biochemistry and Molecular Biology with Honours (1995) at Massey University, a Doctorate in Biological Sciences at the University of Auckland (2004) and a Bachelor of Science at Victoria University (1991). He is also the current Chairman of the Health Research Council of New Zealand Pacific Health Research Committee.
Ms Shamim ChaganiMembership category: Service ProvisionDate of appointment: 1 July 2012Current term expires: 1 July 2014
Ms Shamim Chagani is working as a Charge Nurse Manager at Counties Manukau Health. She previously worked as a Nurse Educator at Mercy Ascot and Staff Nurse at Tairawhiti District Health Board. She completed Bachelor of Nursing, Post Graduate Diploma in Health Service Management at Massey University & Currently pursuing Master of Management in Health Service Management from Massey University.
Dr Christine CrooksMembership category: Service ProvisionDate of appointment: 1 July 2013Current term expires: 1 July 2016
Christine Crooks is a clinical trial coordinator and project manager at Cancer and Blood Services, Auckland City Hospital. She manages all aspects of several oncology clinical trials including collaborative group and pharmaceutical sponsored trials. Christine’s background in health research has involved managing intervention studies while completing PhD (students, athletes and older adults) and conducting an observational research project as a postdoctoral research fellow (infants and young children). She is a member of the New Zealand Association for Clinical Research, Australia New Zealand Breast Cancer Trials Group and Australia New Zealand Gynaecological Oncology Group. Christine has a PhD and MSc (Nutritional Science) from Massey University and a Science degree from Waikato University.
Dr Karen BartholomewMembership category: Service ProvisionDate of appointment: 1 July 2013Current term expires: 1 July 2016
Dr Karen Bartholomew is currently employed at Planning and Funding in Auckland Waitemata DHBs working in Child, Maternal and Youth health, and is involved in a number of research projects. Karen graduated with a Microbiology degree from Massey University in 1998. She worked from a consumer perspective in a Women’s Health Collective and Rape Crisis while in Palmerston North and then moved to Auckland graduating with her medical qualification (2004) and Masters of Public Health with honours (2011) from the University of Auckland. She has undertaken a range of clinical work, with a focus on women’s health. She holds a specialist qualification in Public
Northern A Health and Disability Ethics Committee – 2013 Annual Report 7
Health Medicine, and has an interest in women’s health, maternity, screening and public health genomics. She is also has a strong interest in public health and research ethics, and is a member of the Massey University Human Ethics Committee (Northern) and the Health and Disability Ethics Committee Northern A.
Former Members
Dr Wayne Miles (term ended July 2013)Membership category: Health Researcher (non-lay)Date of appointment: 1 July 2012
Northern A Health and Disability Ethics Committee – 2013 Annual Report 8
Attendance
The Northern A HDEC held 10 meetings in 2013.
Members MeetingsTotal
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Lay
mem
bers
Cn Dr Brian Fergus
10/10
Cn Ms Susan Buckland
A 9/10
L Ms Michele Stanton
A 9/10
Cm
Mr Kerry Hiini
10/10
Cm
Mrs Maliaga ErickCo-opted from NTB HDEC
1/1
Non
-lay
mem
bers
HP
Associate Professor Wayne Miles
A5/6
HP Ms Shamim Chagani
A 9/10
HR Dr Etuate Saafi
A 9/10
HR Dr Marewa Glover
2/2
HRDr Karen Bartholomew
4/4
HR Dr Christine Crooks
4/4
HP
Dr Paul TanserCo-opted from NTB HDEC
1/1
Key: L Lawyer P Pharmacist/pharmacologist presentE Ethicist B Biostatistician A apologies
Cm Community representative HP Health practitioner X absentCn Consumer representative HR Health researcher not applicable
Training and conferences
The Northern A HDEC did not have training during 2013.
Committee members were invited to attend the Cartwright Conference held in Auckland. Ms Michèle Stanton attended.
Chairpersons’ meetings
Dr Brian Fergus attended two Chairs’ day meetings in 2013. Both meetings were held in Wellington in the Medsafe Boardroom.
The first meeting was held on 5 April. The Chairs were updated by the Secretariat about:
appointments of new members annual reports to the Minister
Northern A Health and Disability Ethics Committee – 2013 Annual Report 9
preliminary trends and measuring quality upcoming changes to the online system.
The Chairs and Secretariat identified seven key issues that were discussed.
Bio-banking. Peer review. Restrictions on publication. Remuneration. Data safety monitoring. Examples of good practice. The possibility of a protocol template.
The Chairs spent the afternoon participating in a training session on ‘Managing Meetings’.
The second meeting was held on 23 August. The Chairs were updated by the Secretariat about:
annual reports to the Minister further improvements planned for the online system.
The Chairs and Secretariat identified four key issues that were discussed.
Peer review. Conflicts of interests. Restrictions on publication. Data safety monitoring.
Mr John Hancock, a legal adviser for the Office of the Commissioner for Children, gave a videoconference presentation to the Chairs about children’s consent in health research. The Chairs had a presentation and discussion with Associate Professor Martin Tolich on his recent academic work and practical observations of HDECs.
Northern A Health and Disability Ethics Committee – 2013 Annual Report 10
Applications reviewedThe Northern A HDEC reviewed 157 applications in 2013. From the 157 applications reviewed 102 applications were reviewed by the full committee and 55 were reviewed through the expedited pathway.
At each of its meetings in 2013 the Committee reviewed an average of 10 applications.
Full
Approved 97
Declined 2
Provisional Approval (as at 31 December 2013) 3
Total (with a decision at 31 December 2013) 102
Exp
edite
d Approved 50
Declined 1
Provisional Approval (as at 31 December 2013) 4
Total (with a decision at 31 December 2013) 55
Total applications reviewed 157
A summary of these applications can be found in Appendix A.
Applications processed by Secretariat
The Northern A HDEC received 35 applications that were screened by the HDEC Secretariat and were deemed out of scope for HDEC review.
The Northern A HDEC received 330 Minimal Dataset Forms (MDF). These forms are used to broker applications from the previous HREC Lotus Notes database to the new HDEC database.
Average review time
Average review times take into account the time taken for the Secretariat to process applications and the time taken for the Committee to review applications. The clock is stopped when a decision letter is emailed to applicants. The average time excludes time taken for researchers to respond to requests for further information.
The average review time for full applications was 23 days compared to a target timeframe of 35 calendar days.
The average review time for expedited applications was 18 days compared to a target timeframe of 15 calendar days.
Northern A Health and Disability Ethics Committee – 2013 Annual Report 11
Post approval items reviewedThe Northern A HDEC reviewed a total of 1086 post approval items. A graph of the different types reviewed is below.
Post approval items reviewed during 2013
Amendmen
t
Final
Report
Notification of C
onclusio
n of Study
Progre
ss Rep
ort
Protocol D
eviati
on or Violati
on0
100
200
300
400
500
600
478
79 74
398
57
Reasons for decliningThe Northern A HDEC is required to clearly identify the ethical standard(s) that it considers not to be met by an application. These ethical standards are contained in the Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (GFUR), Ethical Guidelines for Observational Studies (EGOS) and Ethical Guidelines for Intervention Studies (EGIS). The references in the tables below are to paragraph numbers in these documents.
Reference: 13/NTA/231Review Type: ObservationalShort title: Developing a model of care for the long term follow-up of childhood cancer survivorsCo-ordinating Investigator: Dr Rob Corbett
Reference Reason
6.11 EGOS The Committee believed that the PIS does not adequately address what is happening in the trial and this is a key component for informed consent
Reference: 13/NTA/27Review Type: InterventionShort title: A randomized, controlled study of sarilumab and methotrexate (MTX) versus etanercept and MTX in patients with rheumatoid arthritis (RA) and an inadequate response to 4 months of treatment with adalimumab and MTXCo-ordinating Investigator: Dr Alan Doube
Reference Reason
6.6 EGIS The Committee was not satisfied that the information to be provided to participants in this study would allow them to make a free and informed decision to participate. Substantial
Northern A Health and Disability Ethics Committee – 2013 Annual Report 12
revision of information sheets would be required to shorten and simplify the text.
7.17 EGIS From the information provided, the Committee was not satisfied that arrangements for publishing study results met or exceeded the relevant ethical standards
Reference: 13/NTA/88Review Type: Observational Short title: Screening for liver disease using fibroscanCo-ordinating Investigator: Dr Stephen Gerred
Reference Reason
5.8 EGOS The Guidelines indicate that an every study proposal must be based on a thorough review of relevant current literature. Scientific validity is an important component of good ethical practice in research. Investigators are advised to submit their proposals to independent peer review to help optimise scientific validity. HDECs also require evidence of adequate peer review. We request the researcher seek independent peer review from a Hepatologist. The researcher will need to adequately brief the reviewer as to the demographics of the study population as features of this population may cloud the interpretation of the scan results.
5.7 EGOS Scientific inadequacies in a study proposal have ethical implications. The scientific quality of a proposal should be such that the proposal’s objectives can reasonably be expected to be achieved.
5.9 EGOS Studies must be conducted or supervised only by investigators with the necessary skills and resources to conduct the study and deal with any contingencies that may affect participants. The Committee notes the researcher is seeking to recruit a large group and question how the costs of the research will be funded within the CMDHB budgets.
6.12 EGOS Information about the purpose of the study should be as specific as possible without compromising the validity of the study. Please adhere to the PIS/CF guidelines where the participants are fully briefed on what they are consenting to including the potential risks that they may face with this screening
Northern A Health and Disability Ethics Committee – 2013 Annual Report 13
Issues and complaintsThis section outlines issues faced by the Committee during 2013.
Issues causing difficulty in review
Online system issues Lack of appropriate peer review Provisional responses not being submitted in tracked changes format.
Action taken
New online system updates have been drafted, tested and implemented Peer review template developed and published on HDEC website Newsletter containing reminder to track changes was published on HDEC
website.
Issues referred to NEAC and/or the HRC Ethics Committee
NIL
Complaints received
None cited by the Chair.
Overdue review
During 2013 there were 10 instances where the review time was over 35 days for full applications and 24 where the review time was over 15 days for expedited applications.
See Appendix 1 for more information.
Issues causing delays in reported review times
Online system issues prevented Committee members from reviewing effectively.
The online system clock that records time taken to receive a decision includes all calendar days which results in public holidays and weekends being included in the timeframes.
The standard operating procedures state that the HDEC review should be paused over the period 25 December to 15 January the following year. This does not occur automatically and as a result, any applications awaiting review during this period have been identified and are not considered overdue.
Action taken
The online system issues have been addressed with the latest system update.
Any applications that were running over the public holidays have been identified in Appendix 1.
Northern A Health and Disability Ethics Committee – 2013 Annual Report 14
Appendix 1: Details of applications reviewedApplications reviewed by full committee
Study reference Study status Short title Co-ordinating Investigator Other Investigators Locality/ies Application type
13/NTA/100 ApproveEarly Goal Directed
Sedation vs. Standard Care Sedation
Dr Colin McArthur CCDHB Intervention
13/NTA/101 Approve
Does Targin provide effective analgesia while
reducing ileus in postoperative colorectal
and upper gastrointestinal surgery?
Mr Jeremy Rossaak Mr Scott Jones Intervention
13/NTA/102 ApproveEccentric Exercise and LLLT for the Treatment
of Achilles TendinopathyDr Steve Tumilty Professor David Baxter Stuart Horton Intervention
13/NTA/107 Approve RENABLATE-II Dr John Ormiston Margot Edwards (Mercy Angiography) Intervention
13/NTA/109 Provisionally approve
An investigation into the safety and tolerability of
Manuka Cyclopower study 2
Dr Lynne Chepulis Intervention
13/NTA/113 Approve The SPRINT Trial Associate Professor Andrew Holden Dr Andrew Hill Auckland District Health
Board Intervention
13/NTA/117 Approve
Natural History Of Elevated Newborn
Screening C14.1 In New Zealand
Dr Callum Wilson
Dr Bryony Ryder, Mr Detlef Knoll, Dr Dianne
Webster, Dr Donald Love, Dr Emma
Glamuzina,Mr Mark de Hora, Dr Peter Reed
Auckland District Health Board Observational
13/NTA/119 Approve HPV Oropharynx Dr Andrew Macann Auckland District Health Board Intervention
13/NTA/12 Approve PIF:CYP Professor Janis Paterson
Dr El-Shadan Tautolo,Dr Gerhard Sundborn
Rishard Bedford - PVC Research Observational
13/NTA/121 Approve
ADMYRE: Aplidin-Dexamethasone in
RElapsed/Refractory MYeloma (APL-C-001-
09)
Dr David Simpson Dr Peter Ganly Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 15
13/NTA/122 ApproveHot Avulsion Versus
Argon Plasma Coagulation
Dr Ravinder Ogra CMDHB Research Office Intervention
13/NTA/124 Approve
Quetiapine 1 x 200 mg bioequivalence study conducted under fed
conditions
Dr Noelyn Hung Intervention
13/NTA/125 Approve
Metoprolol 1 x 200 mg bioequivalence study
conducted under fasting conditions
Dr Noelyn Hung
Zenith Technology Corporation Limited, Zenith Technology Corporation Limited
Intervention
13/NTA/126 Approve
A comparison of BI 695500 and rituximab
metabolism and processing in the body in follicular lymphoma
patients with low tumour burden
Dr William Nigel Patton Auckland Clinical Studies Intervention
13/NTA/127 Approve
Tibolone 1 x 2.5 mg pilot bioequivalence study
conducted under fasting conditions
Dr Noelyn Hung Intervention
13/NTA/13 Approve SPARTAN Associate Professor Peter Gilling
Mr Nicholas Buchan, Mr Anthony Nixon, Mr
Patrick Bary, Doctor Patrick Meffan, Mr Tony
Beaven
Canterbury Urology Research Trust, Cardinal
Points Research Ltd,Michael Holmes, Peter
Gilling, Roundhay Medical ,Waitemata DHB
Intervention
13/NTA/14 Approve
Vemurafenib with Acenocoumarol in
patients with BRAFV600 mutation positive
metastatic malignancy.
Dr Chris Wynne Auckland District Health Board,Chris Taylor, CCST Intervention
13/NTA/143 Approve CheckMate067 Dr Mike McCrystal Auckland District Health Board Intervention
13/NTA/144 Approve the CKD-FIX trial Dr Janak de Zoysa
Dr Walaa Saweirs,Clinical A/Prof
John Collins,Dr Kannaiyan
Rabindranath,Dr Suetonia Palmer
Dr Michael Roberts, Chief Medical Officer,Jan
Adams, COO,Waitemata DHB
Intervention
13/NTA/145 Approve PQ Bypass Associate Professor Dr Andrew Hill Auckland District Health Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 16
Andrew Holden Board
13/NTA/146 Approve "Our Child has Died - Hear our Story" Dr Jane Skeen Auckland District Health
Board Observational
13/NTA/147 Approve TEST PROJECT - DO NOT USE Mr Nic Aagaard Observational
13/NTA/148 Approve
A Study to Evaluate GS-4774 for the treatment of
Virally Suppressed, Chronic Hep B Subjects
Prof Edward Gane Auckland Clinical Studies Limited Intervention
13/NTA/149 Approve
A study look at VS-6063 versus placebo in
patients with malignant pleural mesothelioma.
Dr. Richard Sullivan Auckland District Health Board Intervention
13/NTA/15 Approve
Vemurafenib extension study in patients with
BRAFV600 mutation−positive
malignancies.
Dr. Chris Wynne Auckland District Health Board,Chris Taylor, CCST Intervention
13/NTA/150 Approve Study of nasal delivery of warmed air Doctor Janine Pilcher Intervention
13/NTA/151 Approve
Drospirenone 3 mg/ethinyloestradiol
0.02 mg tablet bioequivalence study
conducted under fasting conditions
Dr Noelyn Hung
Zenith Technology Corporation Limited,Zenith
Technology Corporation Limited
Intervention
13/NTA/152 Approve
Drospirenone 3 mg/ethinyloestradiol
0.03 mg tablet bioequivalence study
conducted under fasting conditions
Dr Noelyn Hung
Zenith Technology Corporation Limited,Zenith
Technology Corporation Limited
Intervention
13/NTA/153 Approve
Which school model for group A streptococci and acute rheumatic
fever reduction?
Professor Diana Lennon Intervention
13/NTA/16 Approve
Improving patient screening for risk of malnutrition in the
hospital setting. (V-1.0)
Mrs Tracey EcclesAssociate Professor
Welma Stonehouse,Dr Russell Walmsley
Intervention
13/NTA/160 Approve ADVANCE Associate Professor Andrew Holden Dr Andrew Hill Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 17
13/NTA/161 Approve 1237.26 OTEMTO™ 2 Dr Andrew G Veale Carol Veale,Dr Andrew Veale Intervention
13/NTA/162 Approve
A study of Sofosbuvir and Ribavirin in patients
with Genotype 1 or 3 Chronic Hepatitis C and
Renal Insufficiency.
Prof Edward Gane Dr Richard RobsonAuckland Clinical Studies
Limited ,Chris Taylor, CCST Ltd
Intervention
13/NTA/165 Approve
A study to investigate a new drug Sofosbuvir
when used with Ribavirin for 16 or 24 weeks or when used
with Ribavirin and pegylated interferon for 12 weeks in Patients with chronic Hepatitis
infection
Professor Ed Gane
Auckland District Health Board,CCDHB,cdhb,Healt
h Research South,Jan Adams, COO
Intervention
13/NTA/166 Approve PI 13-05 Associate Professor Andrew Holden Dr Andrew Hill Auckland District Health
Board Intervention
13/NTA/167 ApprovePT003008 - A 28-week safety extension study
from PT003006Dr Dean Quinn
Carol Veale,Dr Samantha Everitt (CMDHB),Jan
Adams, COO,Jim Reid,Prof Richard Stubbs,
P3 Research
Intervention
13/NTA/168 Approve WHiP Mr Lindsay McTavish CCDHB Intervention
13/NTA/170 Approve Cervical Screening with HPV Dr Mee Ling Yeong Intervention
13/NTA/171 Approve
An Efficacy and Safety Trial of MK-8931 in
subjects with amnestic Mild Cognitive
Impairment due to Alzheimer’s Disease
(Prodromal AD)
Dr Nigel Gilchrist Dr Jane WaltonAuckland Clinical Studies Limited,CGM Research
TrustIntervention
13/NTA/172 ApprovePhase I study of
selenium in cancer patients
Dr Michael Jameson Intervention
13/NTA/173 Approve
A study of intravenous Alpha1-Proteinase
inhibitor to assess the safety and effectiveness
in participants with Pulmonary Emphysema
Dr Jeffrey Garrett Dr Michael EptonCarol Veale,Jan Adams, COO,NZ Respiratory &
Sleep InstituteIntervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 18
13/NTA/19 ApprovePOINT: Platlet Oriented
Inhibition in TIA and minor stroke.
Professor Alan Barber Auckland District Health Board Intervention
13/NTA/212 Approve Probenecid boosting of cephalexin Dr Richard Everts Bruce King Intervention
13/NTA/215 ApproveThe link between impulsivity and
dopamine
Professor Winston D Byblow Ms Hayley MacDonald Intervention
13/NTA/216 Approveintra-coronary
hypothermia and ischaemia
Dr Mark WI Webster Intervention
13/NTA/217 Provisionally approve CANVAS-R Professor Russell Scott
Dr Calum Young,Dr Dean Quinn,Dr Michael
Williams,Dr Simon Carson,Dr Jeremy
Krebs,Dr John Baker
Dr Jinny Willis,Dr Kenneth Clark,Lakeland Clinical Trials,Southern Clinical Trials - Waitemata Ltd
Intervention
13/NTA/218 Provisionally approve PRESERVE Prof Ralph Stewart Dr Scott Harding Intervention
13/NTA/219 Approve
A study of how effective the experimental flu drug favipiravir is, in
adults with flu.
Dr Chris Wynne Chris Taylor, CCST Intervention
13/NTA/22 ApproveAustralasian Paediatric Head Injury Rules Study
(APHIRST)Dr Jocelyn Neutze Dr Stuart Dalziel
Auckland District Health Board,Dr Samantha
Everitt (CMDHB)Observational
13/NTA/221 Approve
A study comparing MPDL3280A to
Docetaxel in Patients with Non-Small Cell Lung Cancer - OAK
Dr. Richard SullivanDr Archana
Srivastava,DR Blair McLaren
Intervention
13/NTA/222 Approve
A study assessing the similarity of Humira and a new anti-inflammation
drug, BI 695501.
Dr Chris Wynne Chris Taylor, CCST Intervention
13/NTA/223 Approve Optimising Hypertension Management
Professor Robert Doughty
National Institute for Health Innovation,Richard
TroughtonIntervention
13/NTA/225 ApprovePlant-origin berry
extracts and appetite control
Prof Sally D Poppitt Mr Wilson Yip Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 19
13/NTA/230 ApproveGenome screens for
disease causing genes in neurogenetics
Dr Richard Roxburgh Observational
13/NTA/231 Decline
Developing a model of care for the long term follow-up of childhood
cancer survivors
Dr Rob Corbett CCDHB Observational
13/NTA/26 Approve EnligHTN III Dr Mark Webster
Dr G T Wilkins,Health Research South (Ruth
Sharpe),Southern District Health Board, Dunedin
Hospital
Intervention
13/NTA/27 Decline
A study to assess the efficacy and safety of
sarilumab and methotrexate (MTX)
compared to etanercept and MTX in patients with
Rheumatoid Arthritis after an inadequate
response to adalimumab and MTX.
Dr Alan Doube Intervention
13/NTA/28 Approve Nicotinamide and innate immunity Dr Conroy Wong Dr Samantha Everitt
(CMDHB) Intervention
13/NTA/29 Approve RESTORE II Trial Dr John Ormiston ADHB,Elina Vaisanen,Waitemata DHB Intervention
13/NTA/30 Approve PHASE II CLINICAL STUDY MODEL XRA03 Dr Dean Corbett doctor neil murray auckland eye,Lakes
District Health Board Intervention
13/NTA/31 Approve Equipment use after stroke Ms Pauline Boland
CDHB Research Office,Health Research
South (Ruth Sharpe),Helen White,Hutt Valley DHB,Jan Adams
(COO)
Observational
13/NTA/32 Approve
Phase III, Safety and Tolerability; 4-17 years of age; Flu Cell Culture vs Egg derived vaccine.
Dr Simon CarsonSouthern Clinical trials - Waitemata Ltd,Southern
Clinical Trials LtdIntervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 20
13/NTA/33 Approve EVOLVE II QCA Dr Seif El-JackMedical Director John Ormiston,Dr Warwick Jaffe,Dr Mark Webster
ADHB,Ascot Angiography Ltd,CDHB Research
Office,CMDHB Research Office,Elina
Vaisanen,Waitemata District Health Board
Intervention
13/NTA/37 ApproveAssessing the benefits
of prescribed exercise in clinical populations
Dr James Stinear Auckland District Health Board Intervention
13/NTA/38 ApproveFuture care preferences
in patients with advanced liver cirrhosis
Dr Alex Lampen-Smith
Auckland District Health Board,Dr Samantha
Everitt,Waitemata District Health Board
Observational
13/NTA/39 Approve CHISEL Dr Christine ElderDr Douglas Iupati,Dr
Nikolay Nedev,Doctor Scott Babington
Auckland District Health Board,CDHB Research
Office,Dr Kenneth Clark,Helen White for
Marina Dzhelali
Intervention
13/NTA/40 Approve PEME for the Treatment of Low Back Pain Dr Steve Tumilty Karen Keith Intervention
13/NTA/41 Approve
Correlation of functional and morphological
change in the ageing lung.
Dr Clair King
Dr David Milne,Dr Kenneth Whyte,Dr Kevin
Ellyett,Dr Margaret Wilsher,Associate Professor Merryn
Tawhai
Observational
13/NTA/42 Approve
A trial assessing Sovaprevir and ACH-0143102 in treatment
naive patients with Chronic HCV.
Professor Edward/EJG Gane
Auckland Clinical Studies Ltd,Chris Taylor,
Christchurch Clinical Studies Trust
Intervention
13/NTA/43 Approve
Desvenlafaxine 1 x 100 mg bioequivalence
study conducted under fasting conditions and at
steady state
Dr Noelyn Hung Intervention
13/NTA/44 Approve
Desvenlafaxine 1 x 50 mg bioequivalence
study conducted under fasting conditions
Dr Noelyn Hung Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 21
13/NTA/45 Approve
Desvenlafaxine 1 x 100 mg bioequivalence
study conducted under fed conditions
Dr Noelyn Hung Intervention
13/NTA/46 Approve
Desvenlafaxine 1 x 100 mg bioequivalence
study conducted under fasting conditions
Dr Noelyn Hung Intervention
13/NTA/51 Approve
Violence, Substance Abuse, Reports of Concern and Non-
Accidental Head Injury.
Dr Patrick Kelly Dr Santuri Rungan Auckland District Health Board Observational
13/NTA/52 Approve Supplemental PN Dr Shay McGuinness dr paul young CCDHB,Research Office Auckland DHB Intervention
13/NTA/53 Approve
Identification of risks and protective factors
for long term outcomes following pediatric liver
transplantation
Dr Rachael Harry Auckland District Health Board Observational
13/NTA/54 Approve The CCC trial Dr Shay McGuinness Intervention
13/NTA/57 ApproveStudy of MK-5172 and MK-8742 +/- RBV in
HepC patientsProf Edward Gane Auckland Clinical Studies
Ltd Intervention
13/NTA/58 Approve
Intravenous magnesium sulphate as an adjuvant
therapy in acute exacerbations of chronic obstructive pulmonary
disease.
Dr saptarshi mukerjiDr Berinder Singh
Shahpuri,Mr Bevan Clayton-Smith
Intervention
13/NTA/59 Approve CVI Pharmacokinetic Trial
Associate Professor Andrew Holden Dr Andrew Hill ADHB,Jan Adams, COO Intervention
13/NTA/61 Approve GBM Immune Suppression Study Dr. Martin Hunn
CCDHB,Malaghan Institute of Medical
ResearchObservational
13/NTA/62 Approve CHINA Study Dr James Hamill Mr Stephen Adams Auckland District Health Board Intervention
13/NTA/63 Approve Is analgesia required for grommet insertion? Dr Ben McHale Dr Ben McHale Lakes DHB Ethics
committee Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 22
13/NTA/70 Approve MAJESTIC Associate Professor Andrew Holden
Dr Andrew Hill,Dr Stewart Hawkins,Dr Thodur Vasudevan
Auckland District Health Board,CMDHB Research Office,CMDHB Research
Office,Jan Adams, COO,kath phillips
Intervention
13/NTA/72 Approve
PSA-EPO in People with CKD Not on Dialysis or
Receiving Erythropoiesis
Stimulating Agents
Dr Janak De Zoysa Auckland Clinical Studies Ltd,Chris Taylor, CCST Intervention
13/NTA/73 ApproveRM08-3002 - NTZ +/-
OST in the Treatment of Influenza
Professor Murray Barclay
Clinical Horizons NZ,Dr Sheelagh james ,Kylie
Haaima,Lakeland Clinical Trials,Matt Kepple,Optimal
Clinical Trials,Southern Clinical trials - Waitemata
Ltd
Intervention
13/NTA/74 Approve
Music therapy to support the well-being of young people with intellectual
disability
Dr Daphne J. Rickson Intervention
13/NTA/75 ApproveUterine sepsis - a
clinicopathological case series
Dr Susan Bigby Counties Manukau DHB (Dr Samantha Everitt) Observational
13/NTA/76 Approve Infant Genetics Study Dr Kelly JonesDr Alice
Theadom,Professor Valery Feigin
Observational
13/NTA/78 Approve
Open-Label Study of Sofosbuvir + GS-5816 in
Subjects with Chronic HCV Infection
Professor Edward GaneAuckland Clinical Studies
Limited,Chris Taylor, CCST
Intervention
13/NTA/79 Approve Youth New Directions Study Dr Theresa Fleming
Dr Matthew Shepherd,Dr Chris
Frampton,Dr Karolina Stasiak,Associate
Professor Sally Merry
Intervention
13/NTA/8 ApprovehPOD – Hypoglycaemia
Prevention with Oral Dextrose
Dr Jo Hegarty Professor Jane Harding Auckland District Health Board Intervention
13/NTA/80 ApproveART-123 in severe
sepsis and coagulopathy
Dr Paul YoungAuckland District Health Board,CCDHB,cdhb,Jan
Adams, COOIntervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 23
13/NTA/81 Approve
Comparison of three methods of sputum
clearance in patients with an acute
exacerbation of COPD. A randomised controlled
trial.
Miss Brigitte Eastwood Ms Irene SL Zeng,Mrs Katie Coulter CMDHB Research Office Intervention
13/NTA/84 Approve ILLUMINATE Global Associate Professor Andrew Holden
Dr Andrew Hill,Dr Stewart Hawkins,Dr Thodur Vasudevan
Auckland District Health Board,Dr Samantha Everitt,Jan Adams, COO,Kath Phillips
Intervention
13/NTA/90 ApproveCorrelation Between
Alcohol Concentration and BIS
Associate Professor Simon Mitchell Alan Merry Intervention
13/NTA/92 Approve Implementation trial of e-monitoring for SPARX
Associate Professor Sally N. Merry
Mrs Raechel Osborne,Dr Robyn Whittaker,Dr Susan
Jane Hawken,Dr Matthew Shepherd
Intervention
13/NTA/94 Approve Kona - WAVE III Dr John Ormiston Elina Vaisanen Intervention
13/NTA/95 Approve Post-prandial effects of dairy products
Prof David Cameron-Smith
Dr Robin McGregor,Prof Sally Poppitt
HOD Biological Sciences, UoA Intervention
13/NTA/96 Approve
Dose finding study of linagliptin in children 10 to 17 years with Type 2
diabetes.
Dr Andrew G Veale Carol Veale,CCDHB,Dr Andrew G Veale Intervention
13/NTA/97 Approve Mental Health Review Tribunals Dr Lillian Ng Waitemata DHB Observational
13/NTA/99 ApproveSupporting people
getting back into life after TBI
Associate Professor Paula Kersten Allison Foster Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 24
Applications reviewed by expedited review
Study reference Study status Short title Co-ordinating Investigator Other Investigators Locality/ies Application type
13/NTA/103 Approve A Survey of Infant Care Practices among Auckland Mothers Dr Lynne Hutchison Auckland District Health
Board Observational
13/NTA/105 ApproveImmediate effects of mindfulness body scan meditation on the nociceptive and
autonomic nervous systemsDr Neil Bossenger Dr Gwyn Lewis,Dr
Alice Theadom Intervention
13/NTA/111 ApproveCan a clinical care protocol reduce
pneumonia rates in patients with acute stroke?
Ms Sarah Davies CDHB Observational
13/NTA/114 Approve Retail Access to Tobacco limited (RAtTle) Dr Janine Paynter Observational
13/NTA/115 Approve HE 4 as a tumour marker for the prediction of ovarian carcinoma Dr Fiona Keogh DR Ai Ling Tan
Auckland District Health Board,Dr Samantha Everitt
(CMDHB)Intervention
13/NTA/123 Approve Waitemata District Health Board Cancer Patient Experience Survey Dr Peter Sandiford Waitemata District Health
Board Observational
13/NTA/130 Approve NZ Cerebral Palsy Register Prof N.Susan Stott
Auckland District Health Board,CCDHB,Research
Office, HBDHB,Waitemata DHB
Observational
13/NTA/131 Approve Review of Secondary Prevention of Fractures in People over 50 Years Old Dr Roger Harris Auckland District Health
Board Observational
13/NTA/138 Approve New PAP In-Lab Assessment Dr Rachel Vicars Intervention
13/NTA/139 Approve MRI in Meniere's Disease Professor Peter Thorne Observational
13/NTA/141 Approve Upper Cervical Spine Instability in Patients with Skeletal Dysplasia
MR Haemish Crawford
Auckland District Health Board Observational
13/NTA/142 Approve Population specific validation of body composition assessment Prof Sally D Poppitt
Dr Robin McGregor,Associate Professor Lindsay
Plank,Mr Wilson Yip
Observational
Northern A Health and Disability Ethics Committee – 2013 Annual Report 25
13/NTA/155 Approve Milk 2 Dr Clare Wall Robyn Whittaker Observational
13/NTA/158 Provisionally approve
Outcomes up to 90 days after PD related peritonitis Dr John Collins Observational
13/NTA/159 Approve Ambulatory coronary angiography Dr Peter Ruygrok Auckland District Health Board Observational
13/NTA/164 Approve Different approaches to communicating fracture risk Dr Rama Kalluru Observational
13/NTA/17 Approve Primary Prevention of Stroke in the Community
Dr Rita Krishnamurthi
Dr Amy Jones,Professor
Valery FeiginIntervention
13/NTA/179 Approve A Postpartum Intervention for Women with a History of Gestational Diabetes Mellitus Miss Heidi Baxter Intervention
13/NTA/18 Approve Peak Heart Rate Associate Professor Alistair Young Dr Jocelyne Benatar Auckland District Health
Board Intervention
13/NTA/182 Approve New outcome form for CAMHS Associate Professor Sally N Merry
Dr Chris Frampton,Dr Mathijs Lucassen,Dr Karolina Stasiak,Dr
Sue Crengle
Observational
13/NTA/185 Approve Innate Immune Defects in Maori and Pacifica Children with Bronchiectasis
Dr Annaliesse Blincoe Intervention
13/NTA/186 Approve POSA Dr Melanie Speer Observational
13/NTA/190 Approve BIO-STORM Professor Ed Gane ADHB Observational
13/NTA/191 Approve ARES Collaborative Dr Laura Young Observational
13/NTA/192 Approve The Quit Booth Pilot Dr Marewa Glover Dr Anette Kira,Mr Dudley Gentles Intervention
13/NTA/193 Approve iPhone Atrial Fibrillation Study Dr Natalie Walker
Mrs Marie Bennett,Dr Jeff
Harrison,Professor Rob Doughty,Ms
Varsha Parag
All Seasons Pharmacy Intervention
13/NTA/207 Approve Ileal brake activation – a pilot study in ileostomy patients Dr Hyun Sang Shin Dr John Ingram,Prof
Sally Poppitt Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 26
13/NTA/208 Approve MarfaNZ Study Dr Timothy HornungDr Samantha
Everitt,Waitemata District Health Board
Observational
13/NTA/209 Approve Living Well Toolkit Dr. Suzie Mudge Observational
13/NTA/211 Approve Protein-bound uremic toxins in Dialysis Patients
ClinA/Prof John Collins Observational
13/NTA/227 Approve Autobiographical Memory Function in Patients with Cerebellum Dysfunction Ms Eleanor Moloney Observational
13/NTA/228 Provisionally approve
Perceptions that mothers of chronically ill children have of their community
pharmacistMiss Mehak Gill Observational
13/NTA/23 Approve DLEQSS Dr Aravind Chandran Dr Paul Jarrett CMDHB Research Office Observational
13/NTA/232 Approve Using Text Messages to Enhance Adherence with Discharge Instructions
Professor Gregory Luke Larkin Intervention
13/NTA/233 Provisionally approve The CANE Study Professor Cindy
Farquhar Observational
13/NTA/234 Approve Game for Health Dr Hiran ThabrewDr Karolina
Stasiak,Associate Professor Sally Merry
Observational
13/NTA/238 Provisionally approve CoB: Costs of Bronchiectasis Study Dr Catherine Byrnes Observational
13/NTA/24 Approve Pregnancy Outcomes CMDHB 2001-2010 Dr David Bailey CMDHB Research Office Observational
13/NTA/240 Approve The effect of selective laser trabeculoplasty on intraocular pressure diurnal variation Dr Hussain Patel Observational
13/NTA/241 Approve The Man Plan programme for prostate cancer survivors Dr Asmita Patel Intervention
13/NTA/3 ApproveLaryngeal Squamous Cell Carcinoma Outcomes at ADHB: The 2002-2012
CohortDr Kevin Smith Observational
13/NTA/35 Approve Are our babies getting bigger? Professor Alistair Woodward
Mr Kaharmuzri Razman
Auckland District Health Board Observational
13/NTA/47 Approve Predicting Serious Drug Side Effects in Gastroentorology - PRED4
Assoc Prof Michael Schultz
Health Research South (Ruth Sharpe) Observational
Northern A Health and Disability Ethics Committee – 2013 Annual Report 27
13/NTA/55 Approve SMS4BG Dr Robyn Whittaker Dr Catherine McNamara
Aroha Hudson,Dr Richard Hulme,karen
carter,Kelston Medical Centre,Waitemata District
Health Board
Intervention
13/NTA/6 Approve Text4Heart Ms Leila Pfaeffli Auckland District Health Board,Waitemata DHB Intervention
13/NTA/65 ApproveCollection of computed tomography (CT) and magnetic resonance imaging (MRI)
from human infants
Professor Poul Nielsen
Dr Jennifer Kruger,Professor
Martyn Nash,Mr Nikini Puhulwelle
Gamage,Dr Russell Metcalfe,Mr Thomas
Lintern
Auckland District Health Board Observational
13/NTA/68 Approve Bariatric surgery and diabetic retinopathy progression Dr Rinki Murphy
Auckland District Health Board,Dr Samantha Everitt (CMDHB),Waitemata DHB
Observational
13/NTA/69 Approve Understanding NETs through genomics Dr B Lawrence Professor Michael Findlay
Auckland District Health Board Observational
13/NTA/7 ApproveEnvironmental factors that are likely to influence pregnancy – in particular fetal
growth restriction
Professor Philip Baker
Auckland District Health Board Observational
13/NTA/71 Approve Outcomes in hepatitis B positive renal transplant patients. Dr Ian Dittmer Auckland District Health
Board Observational
13/NTA/77 Approve Use of V1STA NPWT for oro- and pharyngocutaneous fistula Dr Kit Chung Wong Auckland District Health
Board Observational
13/NTA/86 Approve Is Self-Compassion Protective Against Depression in Diabetes Patients? Ms Anna Friis Waitemata District Health
Board Observational
13/NTA/88 Decline Screening for liver disease using fibroscan Dr Stephen Gerred Dr Geogry Peter Kini Observational
13/NTA/89 Approve Reflux-Hyperventilation study Dr Geogry Peter Kini Dr Paul Casey Observational
13/NTA/9 Approve Oral Refeeding Intolerance after Nasogastric tube feeding (ORION) Dr. Max Petrov Ms Lorraine Grayson Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 28
Minimal dataset form applications
Study reference Study status Short title Co-ordinating Investigator Other Investigators Locality/ies Application type
4529 Invalid Application
Task One: Exploring the Voices of Parents and Whanau Ms. Erin Gaab Intervention
4530 Invalid Application
Task Two: The Voices of Patients and Siblings Ms. Erin Gaab Intervention
4531 Invalid Application
Task Four: Understanding the views of siblings of paediatric
palliative care patientsMs. Erin Gaab Intervention
96/080 Invalid Application Asthma in Niue Dr. William Abbott Intervention
99/146 Invalid Application IBCSG Trial 20-98/BIG 2-89 Prof Vernon Harvey Intervention
AKL/1999/152 Invalid Application IBCSG 16-98 Exemestane Prof Vernon Harvey Intervention
AKL/2000/009 Approve IBCSG 19-98/BIG 1-98 Prof Vernon Harvey Intervention
AKL/2000/155 Approve IRIS Study Professor Peter John Browett Intervention
AKL/2000/176 ApproveCCG 4941/9440 National
Wilms Tumour Study Group Study 5
Dr Ruellyn Cockcroft Intervention
AKL/2000/176 Invalid Application
CCG 4941/9440 National Wilms Tumour Study Group
Study 5Dr Jane Skeen Intervention
AKL/2000/184 Approve In vitro radiation/anticancer drug sensitivity testing Professor Bruce Baguley Intervention
AKL/88/025 Approve Neurochemistry and Molecular Biology of the Human Brain Prof Richard Faull Intervention
AKL/94/207 Approve Bone cell activity in Paget's disease of bone Professor Tim Cundy Intervention
AKL/96/080 Approve Asthma in Niue Dr. William Abbott Intervention
AKL/97/179 Approve Australasian colorectal cancer family study Associate Professo Susan Parry Auckland District
Health Board Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 29
AKL/97/256 Approve Clinical Investigations of HD Dr Lynette Tippett Intervention
AKL/98/040 Approve Drug Metabolism by Human Liver Dr Malcolm Tingle Intervention
AKL/99/152 Invalid Application
Exemestane compared to Tamoxifen for breast cancer A/Prof Ian Campbell Intervention
AKL/99/152 Approve IBCSG 16-98 Exemestane Prof Vernon Harvey Auckland District Health Board Intervention
AKX/02/00/107 Approve Cardiac Inherited Disease Registries Dr Jonathan Skinner Intervention
AKX/02/00/364 Approve Screening for pregnancy endpoints (SCOPE Study) Professor Lesley McCowan Intervention
AKX/04/03/069 Approve Inheritance of Paget’s Disease Dr Mark Bolland Intervention
AKX/04/04/099 Approve Genes and Hepatitis B Dr. William Abbott Intervention
AKX/04/08/224 Approve Genetic Analysis of Glaucoma Dr Andrea Vincent Intervention
AKX/04/10/298 Approve Maxianalgesic study Prof. AF Merry Intervention
AKY/02/00/093 Approve TROG 99.05 Dr Hedley Krawitz Intervention
AKY/03/02/029 ApproveLong-Term Evaluation of the
Medtronic MOSAIC Bioprosthesis
Dr Malcolm Legget Intervention
AKY/04/08/212 Approve Breast Cosmesis study Dr Gillian Campbell Auckland District Health Board Intervention
AKY/04/10/284 ApproveThe development of infants
exposed prenatally to methamphetamines
Dr Trecia Wouldes Intervention
AKY/04/12/339 Approve WA18230 Dr Joe Singh Intervention
CEN/09/04/017 ApproveTenofovir plus Pegylated
Interferon in Chronic Hepatitis B
Professor Edward Gane Intervention
CEN/09/09/EXP ApproveTracking breast cancer across
different imaging modalities using biomechanical models
Mr Duane Malcolm Auckland District Health Board Intervention
CEN/09/09/EXP Invalid Application
Tracking breast cancer across different imaging modalities using biomechanical models
Prof Martyn Nash Intervention
CEN/09/09/EXP Invalid Does 6 Minute Walk Distance Dr Melanie Speer Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 30
Application Predict Outcome after Liver Transplantaion
CEN/11/02/03 Approve Antibiotic Dosing Calculator for Neonates and Children Trial Professor Nick Holford Intervention
CEN/11/03/010 ApproveWill mobile phone technology
help young drinkers avoid harm? Spill IT.
Mrs Karen Renner Intervention
CEN/11/12/071 ApproveUnderstandings and
experiences of embryo donation
Mrs Sonja Goedeke Intervention
CEN/12/06/017 Approve Analysis of Antibodies in Rheumatic Fever Dr Nicole Moreland cambridge medical
centre Intervention
CEN/12/06/028 Approve STRIDER NZAus Dr Katie Groom CCDHB Intervention
LRS/11/02/001 ApproveDuplex
orthokeratology(DOK)and myopia progression in children
Mr Martin Loertscher Intervention
LRS/11/09/031 Invalid Application
16th International Histocompatibility Workshop:
"One HLA antibody test predicts future graft survival"
Mr Jonathan Downing Mr Jonathan Downing Intervention
LRS/11/09031 Invalid Application
16th International Histocompatibility Workshop:
"One HLA antibody test predicts future graft survival"
Dr Paul Dunn Intervention
LRS/11/12/058 Approve Predictors of pain after abdominal surgery Dr Michal Kluger Intervention
LRS/11/12/059 Approve Maori Child Maltreatment Helen Harte Intervention
LRS/12/06/020 Approve ASAP-ECMO Dr Shay McGuinness Intervention
MEC/04/12/004 Approve MRI cartilage extension study Professor Fiona McQueen Intervention
MEC/04/12/011 Approve Diet/gene linkage in Inflammatory Bowel Disease Professor Lynnette R. Ferguson Auckland District
Health Board Intervention
MEC/05/08/095 Approve Suppression of Ovarian Function Trial (SOFT) A/Prof Ian Campbell
christchurch Hospital,Christine
CrooksIntervention
MEC/05/09/108 Approve PPROMT Dr. Graham Parry Intervention
MEC/05/11/157 Approve Posurdex Diabetic macular oedema study MR Mark /MD Donaldson Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 31
MEC/05/12/171 Approve POST Dr Andrew Macann Intervention
MEC/05/12/175 ApproveSafety of Tysabri (Natalizumab)
Re-Dosing and Treatment (STRATA) in Multiple Sclerosis.
DR Ernest Willoughby Intervention
MEC/05/12/176 Approve TITAN Dr. Richard Sullivan Intervention
MEC/06/08/083 Approve Extend TRA105325 Dr David Simpson Intervention
MEC/06/10/132 Approve QUASAR 2 Dr Paul Thompson Auckland District Health Board Intervention
MEC/06/10/134 Approve Hypogammaglobulinemia/ CVID study in NZ Assoc Prof Rohan Ameratunga Intervention
MEC/07/02/027 Approve Watch and Wait Dr Leanne Berkahn Auckland District Health Board Intervention
MEC/07/06/086 Approve Taxus Perseus Dr John Ormiston Auckland District Health Board Intervention
MEC/07/10/132 ApproveThe ALLG (Australasian Leukaemia & Lymphoma
Group) CML9/TIDEL II StudyProfessor Peter John Browett Intervention
MEC/07/19/EXP Approve VIEW-primary and secondary care PREDICT CVD cohort Ms T Riddell Intervention
MEC/07/76/EXP Approve BCCA Associate Professor Ian Bissett Intervention
MEC/07/76/EXP Invalid Application BCCA Dr Andrew Hunter Intervention
MEC/08/01/008 Approve ICISS Dr Melinda Nolan Intervention
MEC/08/03/028 ApproveProtocol No. 3133K1-3000-WW or Protocol No. 3133K1-3001-
WWDr Philip Wood Intervention
MEC/08/05/055 Approve STORM Professor Edward Gane Mary-Anne Woodnorth Intervention
MEC/08/06/072 Approve
ANBL0531 Response and Biology-Based Therapy for
Intermediate Risk Neuroblastoma.
Dr Lochie Teague Auckland District Health Board Intervention
MEC/08/07/081 Approve SUCCEED Dr David Porter Intervention
MEC/08/09/110 Approve OSA Interfaces Ms Irene Cheung Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 32
MEC/08/10/123 ApproveFirst Study Protocol Number: CC-5013-MM-020/IFM 07-01
(Celgene)Professor Peter John Browett Auckland District
Health Board Intervention
MEC/08/10/133 Approve
A clinical trial to test the benefit of recMAGE-A3 + AS15ASCI in
patients with malignant melanoma
Dr Mike McCrystal Intervention
MEC/08/10/133 Invalid Application
A clinical trial to test the benefit of recMAGE-A3 + AS15ASCI in
patients with malignant melanoma
Ms Sherry Nisbet Intervention
MEC/09/01/004 Approve
A Phase IIa, Randomized, Iternational, Double-Blinded
(With In-House Blinding), Controlled With Gardasil,
Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human
Papillom
Dr. Helen Roberts Intervention
MEC/09/05/047 Approve M10-440 Dr George Laking Intervention
MEC/09/06/059 Approve
A study comparing two different types of treatment regimes in patients with hepatocellular
(liver) cancer.
Professor Edward Gane Auckland District Health Board Intervention
MEC/09/06/060 Approve Improved Prognostic Tests for New Zealand Breast Cancer Dr Cristin Print Intervention
MEC/09/06/066 Approve
A study of the safety and efficacy of ritonivir boosting of protease inhibitor in chronic
Hepatitis C.
Professor Edward Gane Intervention
MEC/09/07/077 Approve The Dukes B Prognostic Study Dr Ravinder Ogra CMDHB Research Office Intervention
MEC/09/08/086 Approve Cardiac MRI During Exercise Associate Professor Alistair Young Waitemata DHB Intervention
MEC/09/10/11 Invalid Application
Genetic analysis of ovarian granulosa cell tumours Dr Andrew N Shelling Intervention
MEC/09/10/111 Approve Genetic analysis of ovarian granulosa cell tumours Dr Andrew N Shelling Intervention
MEC/09/11/119 Approve SAVE Cardiac MRI Sub-Study A/Professor Brett Cowan Intervention
MEC/09/11/124 Approve The People study Professor Robert Doughty Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 33
MEC/09/11/130 Approve
A Study to Evaluate the Long Term Effects of Repeated
Administration of Adalimumab in Participants with Ulcerative
Colitis
Dr Ian Wallace Intervention
MEC/09/17/EXP Approve The ANZTADC Project Professor Alan Merry Intervention
MEC/10/03/022 Approve PEXIVAS Dr Janak de Zoysa Intervention
MEC/10/03/026 Approve
The purpose of this research study is to evaluate the safety,
tolerability and pharmacokinetics of single
doses of AMG 139 in healthy subjects and in subjects with
moderate to severe Psoriasis.
Dr John Wishart Intervention
MEC/10/04/037 Invalid Application CICL670A2303 Mrs Fay Sommerville Intervention
MEC/10/06/059 Approve
An evaluation of the relationship between intestinal
Crohn’s Disease and Oral Crohn’s Disease.
Professor Anita Nolan Kate O'Connor Intervention
MEC/10/06/059 Invalid Application
An evaluation of the relationship between intestinal
Crohn’s disease and oral Crohn’s disease
Professor Anita Nolan Intervention
MEC/10/068/EXP Approve
Prevalence of sleep symptoms within high school and
university students in New Zealand
Dr Antonio Fernando Intervention
MEC/10/090/EXP Approve
Have special authority requirements been associated
with differential access to atorvastatin and clopidogrel by
socio-demographic status?
Dr Suneela Mehta Intervention
MEC/10/10/099 Approve ANZ NMO Collaboration Dr Jennifer Pereira Intervention
MEC/10/12/130 Approve QUEST Professor Edward Gane
ADHB Research Office - Dr Mary-
Anne Woodnorth,CDHB Research Office
Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 34
MEC/10/12/131 Approve TMC435HPC3007 – PROMISE STUDY Professor Ed Gane
ADHB Research Office - Dr Mary-
Anne Woodnorth,CDHB Research Office
Intervention
MEC/11/03/032/AM02
Invalid Application
A 52 weeks extension to: A Phase 11b Study of MK-4618
in patients with OABDr. Helen Roberts Intervention
MEC/11/04/034 Invalid Application TWISTER Dr Eileen Merriman Intervention
MEC/11/04/034 Approve TWISTER Dr Eileen Merriman Waitemata District Health Board Intervention
MEC/11/04/036 Invalid Application The Genetics of Renal Disease Intervention
MEC/11/06/063 Approve USL P09-004 Dr Elizabeth Walker Intervention
MEC/11/06/064 Invalid Application USL P09-005 Ms Lynair Roberts Intervention
MEC/11/08/069 Invalid Application
Brinz/Brim BID FC vs Brinzolamide BID and
Brimonidine BID in Patients with OAG
Dr Sasi Suda Intervention
MEC/11/08/069 Approve
Brinz/Brim BID FC vs Brinzolamide BID and
Brimonidine BID in Patients with OAG
Prof. Helen Danesh Meyer Intervention
MEC/11/08/070 ApproveBrinz/Brim BID versus
Brinzolamide + Brimonidine BID in OAG or OHT
Prof. Helen Danesh Meyer Intervention
MEC/11/08/070 Invalid Application
Brinz/Brim BID versus Brinzolamide + Brimonidine
BID in OAG or OHTDr Sasi Suda Intervention
MEC/11/09/081/AM03
Invalid Application
The SOdium Lowering In Dialysate (SOLID) trial Dr David Semple Intervention
MEC/11/11/089 Approve The ACTIV Trial Dr D Taylor Intervention
MEC/11/EXP/019 Approve Implementation of the immunisation health target Ms Esther Willing Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 35
MEC/11/EXP/052 ApproveFirst Outcome Analysis of the
New Zealand Children's Cancer Registry (NZCCR)
Dr Scott Macfarlane Intervention
MEC/11/EXP/067 Approve Pertussis VE Dr Helen Petousis-Harris Intervention
MEC/11/EXP/131 Invalid Application
Evaluation of the Safety of New Zealand’s Maternity System Mrs Ellie Moon Intervention
MEC/12/01/006 Approve
SNAP trial: Sonographically guided Nerve block for
Abdominal port in Paediatric laparoscopic appendicectomy.
Dr James Hamill Intervention
MEC/12/03/027 Approve Merck 3034 Professor Edward/EJG Gane ADHB Intervention
MEC/12/03/028 Approve The MENDIT Trial: Multicentre endometrial injury trial. Dr Phill McChesney Intervention
MEC/12/04/036 Approve Lumiere (C14012) Professor Peter John Browett Intervention
MEC/12/06/062 Approve Evaluation of Nucleus® 6 in children with cochlear implants Ms Leigh Martelli Intervention
MEC/12/EXP/013 Approve New Zealand Survey of Glomerulonephritis
Associate Professor Helen Pilmore
Auckland District Health Board Intervention
MEC/12/EXP/022 Approve The PIPER Project Prof Michael Findlay
Auckland District Health Board,Dr Samantha Everitt
(CMDHB),Waitemata DHB
Intervention
MEC/12/EXP/024 Approve
Post Injection Syndrome in Patients with Schizophrenia receiving Olanzapine Long
Acting Injection
Dr Sara Weeks Intervention
MEC/12/EXP/025 Approve Autonomous Paramedic Pre-Hospital Thrombolysis Mr Paul Davis Intervention
MEC/12/EXP/027 Approve Osteosarcoma and hearing loss Dr Mandy de Silva Auckland District
Health Board Intervention
MEC/12/EXP/033 Approve 5-Pt Star Research Project Ms Marion Gordon-Flower Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 36
MEC/12/EXP/043 Approve
Aged Residential Care Hospital Utilisation Study
(ARCHUS)Waitemata Medicines Reviews Audit
Ms Tanya Bish Intervention
MEC/12/EXP/062 Approve Fluid therapy after cardiac surgery Mrs Rachael Parke Auckland District
Health Board Intervention
MEC-10-03-026 Invalid Application
The purpose of this research study is to evaluate the safety,
tolerability and pharmacokinetics of single
doses of AMG 139 in healthy subjects and in subjects with
moderate to severe Psoriasis.
Dr John Wishart Intervention
MED/11/EXP/052 Invalid Application
First Outcome Analysis of the New Zealand Children's
Cancer Registry (NZCCR)Dr Scott Macfarlane Intervention
NTX 1106044 Invalid Application
Can antidepressants and patching improve vision in
adults with lazy eye?Dr. Benjamin Thompson Intervention
NTX/04/12/007 Approve Clinical and Neural changes in H.D. Dr Lynette Tippett Intervention
NTX/04/12/011 Approve ReBICS: Reducing ischaemic brain injury in cardiac surgery Professor Alan Barber Intervention
NTX/05/06/058 Approve Bone erosion in gout Assoc Prof Nicola Dalbeth Intervention
NTX/05/08/108 Approve Analysis of keratoconus Prof Charles McGhee Intervention
NTX/05/08/108 Invalid Application Analysis of keratoconus Associate Professor Trevor
Sherwin Intervention
NTX/05/12/160 Approve Viral mutations and chronic hepatitis B. Dr. William Abbott Intervention
NTX/06/04/030 Approve IBIS-11 DCIS Dr Mike McCrystal Intervention
NTX/06/07/085 Approve Depression Study Dr. Nikolaos Kazantzis Intervention
NTX/06/09/112 ApproveFailure of cylophosphamide
therapy in lupus nephritis patients
Dr Nuala Helsby Intervention
NTX/06/11/145 ApproveIBCSG 34-05/SWOG
S0230/POEMS - Prevention of early menopause study
Dr David Porter ADHB Research Office Intervention
NTX/06/12/159 Approve COPD and defective tissue Dr. Lian Wu Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 37
repair
NTX/06/12/161 Approve Genetic Analysis of Corneal and Anterior Segment Disease Dr Andrea Vincent Intervention
NTX/07/02/003 Approve Stem cells from fat tissue Professor Rod Dunbar Ronald Goedeke Intervention
NTX/07/03/023 Approve Vitamin D and Bone Density in Sarcoidosis Dr Mark Bolland Intervention
NTX/07/08/080 Approve Corneal stem cell implants for tissue repair
Associate Professor Trevor Sherwin Intervention
NTX/08/02/003 Approve REstriction for REorganising Sleep Habits (REFRESH) Professor Bruce Arroll Intervention
NTX/08/03/013 Approve Genetics of Serrated Neoplasia Study Associate Professo Susan Parry Auckland District
Health Board Intervention
NTX/08/08/070 Approve
The effect of collagen cross-linking in patients with
progressive keratoconic corneas (thinning and bowing
of the cornea).
Dr Charlotte Jordan Intervention
NTX/08/08/EXP ApproveFamily studies in idiopathic osteoporosis and other rare
bone diseasesProfessor Tim Cundy Intervention
NTX/08/09/086 Approve Immunity in skin and skin cancer Professor Rod Dunbar Intervention
NTX/08/12/120 Approve CARES Mr Warwick Pudney Intervention
NTX/08/12/123 Approve Database of Inherited Retinal and Optic Nerve Disorders Dr Andrea Vincent Intervention
NTX/08/12/126 Approve An investigation into the cause of sinusitis Dr. Richard Douglas Auckland District
Health Board Intervention
NTX/09/02/006 Approve Treatment of amblyopia Dr. Benjamin Thompson Intervention
NTX/09/03/017 ApproveIs cyclophosphamide
bioactivation compromised in multiple myeloma?
Dr Nuala Helsby Intervention
NTX/09/03/022 ApproveThe Effect of Nilotinib on Bone Metabolism in Chronic Myeloid
LeukemiaDr Susannah O'Sullivan Auckland District
Health Board Intervention
NTX/09/04/032 Approve Whooping cough in infants: does it cause bleeding in the
Dr Patrick Kelly Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 38
eye?
NTX/09/05/037 Approve GS-US-174-0121 Professor Ed Gane Auckland District Health Board Intervention
NTX/09/05/042 Approve Biomarkers of Treatment Resistant Schizophrenia Dr Bruce Russell Dr Valerie Anderson Waitemata District
Health Board Intervention
NTX/09/06/050 Approve The Engage study Mr Andrew Hill Intervention
NTX/09/06/054 Invalid Application
Efficacy of zoledronate in fracture prevention in
osteopenic postmenopausal women
Dr Anne Horne Intervention
NTX/09/06/054 Approve
Efficacy of zoledronate in fracture prevention in
osteopenic postmenopausal women
Professor Ian Reid Intervention
NTX/09/06/50 Invalid Application The Engage study Mr Andrew Hill Intervention
NTX/09/07/058 Approve
Evaluation of the physiological and cognitive effect of repeated low level blast exposure during
specialised military training using neurocognitive
assessment, serum biomarkers and brain imaging.
Dr Charmaine Tate Intervention
NTX/09/07/060 Approve
The EPPI Trial – Enoxaparin for the Prevention of
Preeclampsia and Intrauterine growth restriction.
Dr Katie Groom Intervention
NTX/09/07/061 Approve Burns and Silver in Children Dr Matthew Brown Auckland District Health Board Intervention
NTX/09/08/073 ApproveGenetic biomarkers in the
blood to diagnose and manage inflammatory diseases
A/Professor Geoffrey Krissansen
Auckland District Health Board Intervention
NTX/09/10/091 Approve Children on nasal high flow Dr John Beca Intervention
NTX/09/11/101 Approve Vitamin D during pregnancy and infancy
Associate Professor Cameron Grant
Auckland District Health Board,Kate
O'ConnorIntervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 39
NTX/09/12/114 Approve
Suction dressings and mobility compared to conventional dressings and bed rest for
healing of split skin grafts of the lower leg
Mr Richard MartinAwhina Research &
Knowledge, Waitemata DHB
Intervention
NTX/09/12/122 Approve Corneal nerve microstructure in Diabetes Mellitus Ms Stuti Misra Intervention
NTX/09/15/EXP ApproveOutcomes following
Psychotropic Use During Pregnancy and Breastfeeding
Mrs Emma McPhee Intervention
NTX/09/184/EXP Approve The Cardiac Study Dr John Beca Intervention
NTX/09/54/EXP Approve
PACT in NSCLC - Preferences for adjuvant chemotherapy in non small cell lung cancer:
What makes it worthwhile to patients and their doctors?
Dr Timothy Christmas Intervention
NTX/09/90/EXP Approve Centre for Brain Research Volunteer Register Prof Richard Faull Intervention
NTX/10/02/009 Approve M10-757 Ovarian Study Dr Peter C Fong Intervention
NTX/10/03/011 Approve CASS Professor Alan Barber Intervention
NTX/10/05/038 ApproveTRUST Trial: Timing of
Removal for Ureteric Stents post-Transplant
Dr. Adam Bartlett Auckland Districy Health Board Intervention
NTX/10/07/061 Approve Predictors of heart disease and stroke Dr Patricia Metcalf Intervention
NTX/10/07/067 Approve
Identifying factors that influence psychological health and therapy uptake in children who have experienced child
abuse.
Ms Sarah Wolstenholme Intervention
NTX/10/08/081 Invalid Application Xpert Stent Study Mr Shaun Gilder Intervention
NTX/10/081 Invalid Application Xpert Stent Study Mr Shaun Gilder Intervention
NTX/10/09/090 Approve ARCOS IV: Incidence and Outcomes Professor Valery L. Feigin
ADHB Research Office,Waitemata
DHBIntervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 40
NTX/10/09/091 Approve Motivational Interviweing in Stroke Trial Dr Rita Krishnamurthi ADHB Research
Office Intervention
NTX/10/09/094 Approve Healthy Lungs Dr Adrian Trenholme Intervention
NTX/10/09/096 ApprovePortable airway support in stable Chronic Obstructive
Pulmonary DiseaseProf Kathryn McPherson Intervention
NTX/10/12/124 ApproveSuicidal behaviours and
ideation amongst Samoan people
Dr Jemaima Tiatia Intervention
NTX/10/12/129 Approve The Secret to Happiness Mrs Marama Mcdonald Intervention
NTX/10/12/130 Approve
Evaluation of clinic-based measures of walking ability and
the usual level of community walking activity in children with
cerebral palsy.
Prof N.Susan Stott Auckland District Health Board Intervention
NTX/10/12/132 ApproveManaging re-feeding syndrome in critical illness: A randomised
control trialDr Tony Williams Intervention
NTX/10/EXP/003 Approve Vaginal birth after Caesarean section at Middlemore Hospital Dr Anna-Marie Van der Merwe Intervention
NTX/10/EXP/244 Invalid Application VHIU Study Associate Professor Timothy
Kenealy Intervention
NTX/11/02/002 Approve EPOCH Dr John Beca Intervention
NTX/11/02/003 ApproveThe New Zealand
Neuromuscular Disease Registry
Dr Richard Roxburgh Intervention
NTX/11/02/009 Approve C21005 Dr Peter C Fong Auckland District Health Board Intervention
NTX/11/03/020 Approve Light exposure patterns in children: pilot study Dr Simon Backhouse Intervention
NTX/11/04/021 Approve COOEE Study Dr Joshua Freeman Auckland District Health Board Intervention
NTX/11/04/026 Approve The ABSORB BTK Clinical Investigation
Associate Professor Andrew Holden Intervention
NTX/11/05/034 Approve A study of Maori positive ageing Mr Kerry Hiini Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 41
NTX/11/05/037 Approve Measuring Tear Flow after Tear Duct Repair Dr Jennifer Craig Intervention
NTX/11/05/31 Invalid Application
Pilot inter-skeletal implant system for lower extremity
amputees.Professor Rocco Pitto Intervention
NTX/11/06/044 ApproveCan antidepressants and patching improve vision in
adults with lazy eye?Dr. Benjamin Thompson Intervention
NTX/11/06/051 ApproveProspectively investigating
chemotherapy neurotoxicity: The PICNic Study
A/Prof. Mark McKeage Intervention
NTX/11/07/058 Approve ARCOS IV Part 3 Prof Kathryn McPherson Intervention
NTX/11/07/063 Approve
In patients with psoriasis vulgaris, can supplementation
with vitamin D3improve psoriasis as measured by psoriasis area and severity
index score?
Ms Michelle Ingram Intervention
NTX/11/07/066 Approve Diagnosis of Hip Joint Pathology Mr Steven White Intervention
NTX/11/09/088 Invalid Application
START project: Evaluating the impact of a Supported
Discharge Team in the Waikato region.
Professor Matthew Parsons Intervention
NTX/11/11/096 ApproveEnd of life choices and needs
of long-term haemodialysis patients
Dr Elizabeth Stallworthy Intervention
NTX/11/11/098 ApproveThe Auckland Birthweight
Collaborative (ABC) Study: 16 year old follow-up.
Dr John Thompson Auckland District Health Board Intervention
NTX/11/12/109 ApproveAntenatal intervention for
women with previous caesarean birth
Dr Michelle Wise Intervention
NTX/11/12/110 Approve TMC435-C213 Prof Edward Gane
ADHB Research Office - Dr Mary-
Anne Woodnorth,CDHB Research Office
Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 42
NTX/11/12/111 Approve
A Trial of Intravenous GC33 in Previously Treated Patients
with Metastatic Hepatocellular Carcinoma (HCC) as a
Second-line treatment for adult patients with unresectable
advanced or metastatic HCC
Professor Ed Gane Auckland District Health Board Intervention
NTX/11/12/112 Invalid Application
Metformin safety study in patients with type 2 diabetes and chronic kidney disease.
Mrs Catherine Howie Intervention
NTX/11/12/112 ApproveMetformin safety study in
patients with type 2 diabetes and chronic kidney disease.
Dr Ajith Dissanayake Intervention
NTX/11/12/114 ApproveFoot and ankle characteristics
associated with falls in rheumatoid arthritis
Professor Rome Keith Auckland District Health Board Intervention
NTX/11/EXP/027 Approve Glue ear in children Ms Rebecca Walker Intervention
NTX/11/EXP/042 Approve The Check WHO Study Professor Alan Merry Auckland District Health Board Intervention
NTX/11/Exp/059 Approve93/107: Catch-up growth in
small for gestational age(SGA) babies
Professor Lesley McCowan Intervention
NTX/11/EXP/062 Approve Stroke family/whānau project 2 Dr Dianne Roy Intervention
NTX/11/EXP/069 Approve Nellix Long Term Study Associate Professor Andrew Holden Dr Andrew Hill Auckland District
Health Board Intervention
NTX/11/EXP/092 Approve Type 1 diabetes DR Shiva Reddy Intervention
NTX/11/EXP/106 ApproveProgression of muscle
weakness over time in patients with Inclusion Body Myositis
Dr Laurence Teoh Auckland District Health Board Intervention
NTX/11/exp/106 Invalid Application
Progression of muscle weakness over time in patients
with Inclusion Body MyositisDr Laurence Teoh Intervention
NTX/11/EXP/115 Approve
Differentiating Acute Cellular Rejection from Recurrent
Hepatitis C in Liver Transplant Recipients using Multicolour
Immunophenotyping
Dr. Adam Bartlett Auckland District Health Board Intervention
NTX/11/EXP/135 Approve Cervical screening in women with HIV infection
Dr Simon Briggs Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 43
NTX/11/EXP/139 Approve
Patient and donor information sheet and consent forms for
data submission to international Bone Marrow
Transplant Registries
Dr William Nigel Patton Auckland District Health Board Intervention
NTX/11/EXP/218 Invalid Application IPNA Mrs Sue Larsen Intervention
NTX/11/EXP/228 Approve
A retrospective review of management and outcomes for
pregnancies complicated by preterm prelabour rupture of
membranes (PPROM) at 34-36 weeks gestation at National
Women's Health, ACH 2006-2010
Dr Charlotte Oyston Intervention
NTX/11/EXP/255 Approve B4 school screening Mrs Miriam Langeslag-Smith Intervention
NTX/11/EXP/265 Invalid Application
Ahoulder subluxation in stroke patients clinical audit Ms Catherine Holdsworth Auckland District
Health Board Intervention
NTX/11/Exp/268 Approve Markers in blood to predict risk for VTE in pregnancy Professor Lesley McCowan Intervention
NTX/11/EXP/284 Approve Place of Birth Maternal and Newborn outcomes Dr Judith McAra-Couper Intervention
NTX/11/EXP/295 Approve Effortless S-ICD Registry Dr Margaret Hood Intervention
NTX/11/EXP/313 Invalid Application Burns Nutrition Support Audit Mrs Rochelle Kurmis Intervention
NTX/11/EXP/313 Approve Burns Nutrition Support Audit Ms Vicki Young Intervention
NTX/11/EXP/320 ApproveProspective audit of outcomes of elective hand and upper limb
surgeryMrs Shirley Collocott Intervention
NTX/12/02/006 ApproveWhat is occurring with Maori,
mental illness and health services?
Ms Maria Baker Intervention
NTX/12/03/015 Approve Involvement and participation in rehabilitation following stroke Dr Nicola Kayes Intervention
NTX/12/03/017 Approve
Evaluation of the effect of addition of AMG 747 on Schizophrenia Negative
Symptoms
Assoc Prof Wayne Miles Waitemata DHB Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 44
NTX/12/03/021 ApproveA study evaluating safety and
tolerability of MK-7145 in stable heart failure patients
Dr Roderick Ellis-Pegler Intervention
NTX/12/03/024 ApproveA study exploring possible reasons why some patients suffer chronic ear discharge
Mr Michel Neeff Intervention
NTX/12/04/025 (CMDHB#1227) Approve
Helicobacter pylori infection and its effect on the platelet
count.Mr Noah Sibanda Intervention
NTX/12/04/030 Approve Endostim Mr Michael WC Booth Intervention
NTX/12/04/031 Approve PR610-1001 Dr Michael Jameson Auckland District Health Board Intervention
NTX/12/04/032 Approve The Heloise Study Dr Dragan Damianovich Intervention
NTX/12/04/033 Approve Catheter assisted nasal intubation in children Dr Wei Chung Tong Auckland District
Health Board Intervention
NTX/12/04/037 (WDHB RM12192) Approve Mindful yoga in forensic mental
health Ms Brigitte Sistig Intervention
NTX/12/05/038 ApproveDo text message reminders
increase preoperative exercise in obesity surgery candidates?
Professor Andrew Hill Intervention
NTX/12/05/039 Approve RepaiRx Study Dr Amber Moazzam Intervention
NTX/12/05/041 Approve A1452-017 Professor Ed Gane Auckland District Health Board Intervention
NTX/12/05/044 Approve DAB Trial Dr John Beca Intervention
NTX/12/05/047 Approve Music and Healing in Tāne Whakapiripiri Ms Lauren E Sweetman Intervention
NTX/12/06/049 ApproveLarge bowel pressure wave
movement after surgery and at sites of healing
Associate Professor Ian Bissett Auckland District Health Board Intervention
NTX/12/06/050 Approve Strategies to prevent or delay cataract Professor Paul Donaldson Auckland District
Health Board Intervention
NTX/12/06/052 ApproveObservational study of
frequency and causes of impaired liver metabolism of
Dr Nuala Helsby Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 45
cyclophosphamide in breast cancer (LIME)
NTX/12/06/053 Approve Gout Study Professor Bruce Arroll Dr Richard Hulme Intervention
NTX/12/06/057 Approve Understanding the placenta Associate Professor Larry Chamley
Auckland District Health Board Intervention
NTX/12/06/061 Approve
Leg muscle strength and functional outcomes of a previously unpublished technique for repair of
complete tears of the proximal hamstring origin
Mr Stewart Walsh Intervention
NTX/12/06/062 ApproveExperiences of HIV stigma and discrimination in the healthcare
settingMs Susan Mundt Auckland District
Health Board Intervention
NTX/12/EXP/008 ApproveAdditional participants for
predicting glycaemic health outcomes
Dr Patricia Metcalf Intervention
NTX/12/EXP/009 Approve Private and Confidential Health Care Among Adolescents Dr Patrick Yap Intervention
NTX/12/EXP/019 Approve City-Wide outbreak of ESBL-K. pneumoniae Dr Joshua Freeman Intervention
NTX/12/EXP/061 Approve New Zealand Peritoneal Dialysis Registry ClinA/Prof John Collins Intervention
NTX/12/EXP/068 Approve Late Onset Rheumatoid Arthritis Audit Dr Laurence Teoh Intervention
NTX/12/EXP/073 Approve Smart Patient Monitoring System Dr Hamid GholamHosseini Intervention
NTX/12/EXP/077 ApproveWaitemata District Health
Board Integrated Transition of Care Project
Dr. Tom Robinson Intervention
NTX/12/Exp/079 Approve Mechanisms of anxiety and depression during pregnancy Professor Lesley McCowan Intervention
NTX/12/EXP/080 Approve Community outcomes after a bleed in the brain Dr Rita Krishnamurthi Intervention
NTX/12/EXP/085 Approve Spectrum of uveitis in New Zealand Dr Joanne Sims Auckland District
Health Board Intervention
NTX/12/EXP/094 Approve Evaluation of the demographics, treatment and
Dr Maria Pearse Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 46
outcome of those diagnosed with breast cancer in the greater Auckland region
NTX/12/EXP/102 Approve Caring Does Matter (CDM) Dr John Kennelly Intervention
NTX/12/EXP/106 ApproveClinical usefulness of the Fog
Test for the diagnosis of dystonia
Dr Mark Simpson Auckland District Health Board Intervention
NTX/12/EXP/110 ApproveABO-incompatible live donor kidney transplantation- our
experience to dateDr Enya Ho ADHB Research
Office Intervention
NTX/12/EXP/114 Approve Barriers that prevent discharge from acute wards MS VICKI FRYER Intervention
NTX/12/EXP/115 Approve
Prospective audit of intravenous (IV) iron
supplementation in late pregnancy
Dr Justine Wright Intervention
NTX/12/EXP/124 Approve
Relationships between psychological variables and
long term treatment outcomes in people who have undergone
knee joint replacement
Mrs Bronwyn Harman Intervention
NTX/12/EXP/125 Approve
An audit of the incidence of palliative care needs presentations to the
Emergency Department at Waitemata District Health
Board (WDHB).
Miss Su Wen (Joanne) Wong Intervention
NTX/12/EXP/131 Approve
Pain severity, disability & psychological factors in chronic
low back pain and complex regional pain syndrome
Miss Debbie Bean Intervention
NTX/9/08/074 Invalid Application
Predicting pulmonary hypertension Dr Margaret Wilsher Intervention
NTX06/09/112 Invalid Application
Failure of cylophosphamide therapy in lupus nephritis
patientsDr Nuala Helsby Intervention
NTX109/15/EXP Invalid Application
Outcomes following Psychotropic Use During
Pregnancy and BreastfeedingMrs Emma McPhee Intervention
NTY 05/12/106 Invalid Application PILLAR II Study Professor Peter John Browett Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 47
NTY/04/12/011 Invalid Application
ReBICS: Reducing ischaemic brain injury in cardiac surgery Professor Alan Barber Intervention
NTY/05/08/050 Approve Structure and Function in Failing Heart Dr David Crossman Intervention
NTY/06/12/136 Approve The Experience of gout in South Auckland. Dr Karen Lindsay Intervention
NTY/07/08/094 Approve AVERT: A Very Early Rehabilitation Trial Miss Anna McRae
Research Office Auckland District
Health BoardIntervention
NTY/08/02/EXP Approve Imatinib in CML Mrs Jane WylieCMDHB Research Office,Waitemata
DHBIntervention
NTY/08/10/101 Invalid Application OSA CPAP Dr Rachel Vicars Intervention
NTY/08/10/101 Approve OSA CPAP Dr Rachel Vicars Intervention
NTY/08/11/109 Approve OFOCIR / CLL5 Dr Leanne Berkahn Auckland District Health Board Intervention
NTY/08/11/110 Approve Panobinostat Study Professor Peter John Browett Intervention
NTY/09/06/051 Invalid Application PILLAR II Study Mrs Fay Sommerville Intervention
NTY/09/07/059 Approve Non-technical skills of the general surgical nurse. Ms Dianne Marshall Intervention
NTY/09/08/077 Approve Advanced Imaging in gout Professor Fiona McQueen Intervention
NTY/09/09/092 Approve Studies of the human immune system Professor Rod Dunbar Intervention
NTY/09/09/095 Approve Brain Injury Outcomes in the Community (BIONIC) Professor Valery Feigin Intervention
NTY/09/12/117 ApproveBioenergetic and
immunological profile in normal and diseased liver
Dr. Adam Bartlett Auckland District Health Board Intervention
NTY/09/12/118 Approve RATHL (HD8) Dr Leanne Berkahn Auckland District Health Board Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 48
NTY/10/03/021 Approve CHYLD Professor Jane Harding Intervention
NTY/10/08/060 Approve Investigating Gender Differences in Psychosis Miss Jennifer O'Callaghan Intervention
NTY/10/08/061 ApproveExperiences of recovery and
adaptation after traumatic brain injury
Prof Kathryn McPherson Intervention
NTY/10/08/062 Approve Genes and Brain Injury Professor Robert Kydd Intervention
NTY/10/09/062 Invalid Application Genes and Brain Injury Professor Robert Kydd Intervention
NTY/10/10/084 Approve New Fathers Mr Warwick Pudney Intervention
NTY/10/11/090 Invalid Application ARCHUS Project Manager Susan Foster Intervention
NTY/10/12/100 Approve CML 10, The Australasian RESIST Study Professor Peter John Browett Intervention
NTY/10/EXP/002 Approve
Physiological and drug data from anaesthetics:
Observational study for pharmacological modelling and
simulation.
Miss Jacqueline Hannam Auckland District Health Board Intervention
NTY/10/EXP/035 Approve Exploring experienced doctors’ and nurses’ perceptions
Associate Professor Mark Barrow Intervention
NTY/10/EXP/064 ApproveAn exploratory study into
measuring medication safety in New Zealand
Mr Jerome Ng Intervention
NTY/10/EXP064 Invalid Application
An exploratory study into measuring medication safety in
New ZealandMr Jerome Ng Intervention
NTY/11/01/002 Approve Patient experience in diagnosis of genetic disease. Dr Richard Roxburgh Intervention
NTY/11/01/005 Approve
Calicum and Magnesium Preventing Oxaliplatin
Neurotoxicity: The ChAMPION study
Dr Catherine Han Intervention
NTY/11/01/006 ApproveMobile computing for people with face naming difficulties
after brain injury.Mr Philip Howard Intervention
NTY/11/01/012 Approve
25 year follow up of Hepatitis B carriers from the Kawerau
Cohort: A case-control study- Can we identify predictors of
outcome.
Professor Ed Gane Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 49
NTY/11/01/012 Invalid Application Kawerau study Professor Edward Gane Auckland District
Health Board Intervention
NTY/11/04/038 Approve Validating cough reflex testing against penetration/ aspiration Ms Anna Miles Intervention
NTY/11/04/039 Approve CLCQ908A2214 Prof Edward Gane Intervention
NTY/11/04/040 Invalid Application
The National Gambling Study and Longitudinal Follow-up
(NGS)Professor Max Abbott Intervention
NTY/11/04/040 Approve The National Gambling Study and Longitudinal Follow-up Professor Max Abbott Intervention
NTY/11/05/056 Approve
H9H-MC-JBAK: Randomized Phase 2 Study of LY2157299 in Patients with Hepatocellular
Carcinoma
Professor Ed Gane Auckland District Health Board Intervention
NTY/11/07/072 ApproveThe Effect of Dasatinib on
Bone Metabolism in Chronic Myeloid Leukemia
Dr Susannah O'Sullivan Auckland District Health Board Intervention
NTY/11/07/075 ApproveYoung people talk about their experiences of psychological assessment and counselling.
Dr Kerry Gibson Intervention
NTY/11/10/095 Approve Dementia Caregiver Grief Rev Susan Jacobi Intervention
NTY/11/10/098 ApproveMeasuring Stomach and
Intestine Electrical Activity During Surgery
Mr Timothy R Angeli Auckland District Health Board Intervention
NTY/11/EXP/034 Approve
Exercise for Men: Exploring the exercise preferences and
experiences of men who have had a diagnosis of cancer.
Mrs Colleen Kendrick Intervention
NTY/12/04/028 Invalid Application
Supporting our Children Through Early Assessment Intervention
NTY/12/04/028 Invalid Application
Supporting our Children Through Early Assessment Intervention
NTY/12/04/028 Invalid Application
Supporting our Children Through Early Assessment Intervention
NTY/12/04/028 Approve Supporting our Children Through Early Assessment
Associate Professor Paula Kersten Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 50
NTY/12/05/042 ApproveEstablishing a reference set for
cardiovascular autonomic responses in a local population.
Miss Brooke Cantley Intervention
NTY/12/06/045 Invalid Application
Previously cannulated radial grafts as conduits for CABG Dr Timothy Watson Intervention
NTY/12/06/045 Approve Previously cannulated radial grafts as conduits for CABG Dr Peter Ruygrok Intervention
NTY/12/EXP/011 Approve Audit of RIF pain Mr Andrew MacCormick Intervention
NTY/12?EXP/011 Invalid Application Audit of RIF pain Mr Andrew MacCormick Intervention
NTY/12EXP/014 ApproveThe competency review
process for registered nurses- a case study
Mrs Dianne Barnhill Intervention
NZ/13/IEB0019 Invalid Application MiG TOFU Dr Janet Rowan Intervention
URA/11/06/027 Invalid Application POISE 2 trial Dr Stuart Walker Intervention
URA/11/07/028 Approve Randomised TRIAL OF heated humidification Mrs Diana Hart Intervention
URA/11/10/062 ApproveA La CaRT (Australasian
Laparoscopic Cancer of the Rectum Trial
Dr Julian Hayes Intervention
URA/11/11/070 ApproveTrabectedin or dacarbazine for
advanced liposarcoma/leiomyosarcoma
Dr David Porter Auckland District Health Board Intervention
URA/12/06/023 Approve BLING II Dr Tony Williams Dr Robert Frengley Intervention
URB/11/07/023 Approve Improving Medication Practice Ms Elaine McCall Intervention
ZPS/BDCF Invalid Application
Zenith Technology Blood Donation Consent Form Dr Noelyn Hung Mrs Linda Folland Intervention
Northern A Health and Disability Ethics Committee – 2013 Annual Report 51
Overdue full applications
Reference Short Title Days overdue Reason
13/NTA/101 Does Targin provide effective analgesia while reducing ileus in postoperative colorectal and upper gastrointestinal surgery? 3 Committee Response Overdue
13/NTA/117 Natural History Of Elevated Newborn Screening C14.1 In New Zealand 2 Committee Response Overdue
13/NTA/167 PT003008 - A 28-week safety extension study from PT003006 1 Committee Response Overdue
13/NTA/171 An Efficacy and Safety Trial of MK-8931 in subjects with amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (Prodromal AD) 1 Committee Response Overdue
13/NTA/173 A study of intravenous Alpha1-Proteinase inhibitor to assess the safety and effectiveness in participants with Pulmonary Emphysema 27 Committee Response Overdue
13/NTA/40 PEME for the Treatment of Low Back Pain 1 Committee Response Overdue
13/NTA/51 Violence, Substance Abuse, Reports of Concern and Non-Accidental Head Injury. 1 Committee Response Overdue
13/NTA/62 CHINA Study 14 Committee Response Overdue
13/NTA/80 ART-123 in severe sepsis and coagulopathy 7 Committee Response Overdue
13/NTA/96 Dose finding study of linagliptin in children 10 to 17 years with Type 2 diabetes. 5 Committee Response Overdue
Northern A Health and Disability Ethics Committee – 2013 Annual Report 52
Overdue expedited applications
Study reference Short title Days Overdue Reason
13/NTA/103 A Survey of Infant Care Practices among Auckland Mothers 2 Committee Response Overdue
13/NTA/105 Immediate effects of mindfulness body scan meditation on the nociceptive and autonomic nervous systems 17 Committee Response Overdue
13/NTA/111 Can a clinical care protocol reduce pneumonia rates in patients with acute stroke? 11 Committee Response Overdue
13/NTA/114 Retail Access to Tobacco limited (RAtTle) 1 Committee Response Overdue
13/NTA/123 Waitemata District Health Board Cancer Patient Experience Survey 6 Committee Response Overdue
13/NTA/131 Review of Secondary Prevention of Fractures in People over 50 Years Old 12 Committee Response Overdue
13/NTA/138 New PAP In-Lab Assessment 8 Committee Response Overdue
13/NTA/155 Milk 2 7 Committee Response Overdue
13/NTA/159 Ambulatory coronary angiography 2 Committee Response Overdue
13/NTA/17 Primary Prevention of Stroke in the Community 6 Committee Response Overdue
13/NTA/179 A Postpartum Intervention for Women with a History of Gestational Diabetes Mellitus 13 Committee Response Overdue
13/NTA/182 New outcome form for CAMHS 16 Committee Response Overdue
13/NTA/209 Living Well Toolkit 33 Public Holidays
13/NTA/227 Autobiographical Memory Function in Patients with Cerebellum Dysfunction 30 Public Holidays
13/NTA/234 Game for Health 30 Public Holidays
13/NTA/240 The effect of selective laser trabeculoplasty on intraocular pressure diurnal variation 12 Public Holidays
13/NTA/241 The Man Plan programme for prostate cancer survivors 8 Public Holidays
13/NTA/35 Are our babies getting bigger? 3 Committee Response Overdue
13/NTA/47 Predicting Serious Drug Side Effects in Gastroentorology - PRED4 3 Committee Response Overdue
13/NTA/6 Text4Heart 1 Committee Response Overdue
13/NTA/68 Bariatric surgery and diabetic retinopathy progression 5 Committee Response Overdue
13/NTA/71 Outcomes in hepatitis B positive renal transplant patients. 2 Committee Response Overdue
13/NTA/86 Is Self-Compassion Protective Against Depression in Diabetes Patients? 3 Committee Response Overdue
13/NTA/9 Oral Refeeding Intolerance after Nasogastric tube feeding (ORION) 9 Committee Response Overdue
Northern A Health and Disability Ethics Committee – 2013 Annual Report 53