Northern A Health and Disability Ethics Committee Annual ...€¦ · Web viewBrian was the chair of the Northern X HDEC ... (1992 – 2000) and a Trustee for World Wildlife Fund

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

http://www.ethicscommittees.health.govt.nz/

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


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.


http://legislation.govt.nz/act/public/1990/0068/latest/DLM213017.html

http://legislation.govt.nz/act/public/1990/0068/latest/DLM213017.html

http://www.ethicscommittees.health.govt.nz/moh.nsf/indexcm/ethics-about-central#tor

http://www.legislation.govt.nz/act/public/2000/0091/latest/DLM80051.html

http://www.legislation.govt.nz/act/public/2000/0091/latest/DLM80051.html

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


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.


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


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


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


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.


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.


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


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


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.


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


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



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


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


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


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


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


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


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


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


13/NTA/44 Approve


study conducted under fasting conditions



13/NTA/45 Approve


study conducted under fed conditions


13/NTA/46 Approve


study conducted under fasting conditions


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


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


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


Applications reviewed by expedited review


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


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


13/NTA/155 Approve Milk 2 Dr Clare Wall Robyn Whittaker Observational


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


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


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


13/NTA/47 Approve Predicting Serious Drug Side Effects in Gastroentorology - PRED4

Assoc Prof Michael Schultz

Health Research South (Ruth Sharpe) Observational


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


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


13/NTA/7 ApproveEnvironmental factors that are likely to influence pregnancy – in particular fetal

growth restriction

Professor Philip Baker


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


Minimal dataset form applications


4529 Invalid Application

Task One: Exploring the Voices of Parents and Whanau Ms. Erin Gaab Intervention


Task Two: The Voices of Patients and Siblings Ms. Erin Gaab Intervention


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


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


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


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


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


MEC/08/10/123 ApproveFirst Study Protocol Number: CC-5013-MM-020/IFM 07-01

(Celgene)Professor Peter John Browett Auckland District



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


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


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


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


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



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


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


An evaluation of the relationship between intestinal

Crohn’s Disease and Oral Crohn’s Disease.

Professor Anita Nolan Kate O'Connor Intervention


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


MEC/10/12/131 Approve TMC435HPC3007 – PROMISE STUDY Professor Ed Gane



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


Brinz/Brim BID FC vs Brinzolamide BID and

Brimonidine BID in Patients with OAG

Dr Sasi Suda Intervention


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


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


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


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


MEC/12/EXP/033 Approve 5-Pt Star Research Project Ms Marion Gordon-Flower Intervention


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


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


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


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


NTX/09/02/006 Approve Treatment of amblyopia Dr. Benjamin Thompson Intervention

NTX/09/03/017 ApproveIs cyclophosphamide

bioactivation compromised in multiple myeloma?


NTX/09/03/022 ApproveThe Effect of Nilotinib on Bone Metabolism in Chronic Myeloid

LeukemiaDr Susannah O'Sullivan Auckland District


NTX/09/04/032 Approve Whooping cough in infants: does it cause bleeding in the

Dr Patrick Kelly Intervention


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


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


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


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


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


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



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


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


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


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


NTX/11/05/037 Approve Measuring Tear Flow after Tear Duct Repair Dr Jennifer Craig Intervention


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


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


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



Intervention



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


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


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



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


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


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


Evaluation of the effect of addition of AMG 747 on Schizophrenia Negative

Symptoms

Assoc Prof Wayne Miles Waitemata DHB Intervention


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


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


NTX/12/06/052 ApproveObservational study of

frequency and causes of impaired liver metabolism of



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



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


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


NTX/12/EXP/094 Approve Evaluation of the demographics, treatment and

Dr Maria Pearse Intervention


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


Prospective audit of intravenous (IV) iron

supplementation in late pregnancy

Dr Justine Wright Intervention


Relationships between psychological variables and

long term treatment outcomes in people who have undergone

knee joint replacement

Mrs Bronwyn Harman Intervention


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


Pain severity, disability & psychological factors in chronic

low back pain and complex regional pain syndrome

Miss Debbie Bean Intervention


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


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


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


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


NTY/11/01/012 Invalid Application Kawerau study Professor Edward Gane Auckland District


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


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


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


Supporting our Children Through Early Assessment Intervention





NTY/12/04/028 Approve Supporting our Children Through Early Assessment

Associate Professor Paula Kersten Intervention


NTY/12/05/042 ApproveEstablishing a reference set for

cardiovascular autonomic responses in a local population.

Miss Brooke Cantley Intervention


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


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


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


Documents

Northern A Health and Disability Ethics Committee Annual ...€¦ · Web viewBrian was the chair of the Northern X HDEC ... (1992 – 2000) and a Trustee for World Wildlife Fund