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Northern X Regional Ethics Committee

Annual ReportJanuary 2006 to December 2006

Northern X Regional Ethics Committee

Annual Report

January 2006 to December 2006

Published in October 2007 by the Ministry of Health

PO Box 5013, Wellington, New Zealand

ISBN 978-0-478-31202-7 (print) ISBN 978-0-478-31205-8 (online)

HP 4467

This document is available on the New Zealand Health and Disability Ethics Committees’ website: http://www.newhealth.govt.nz/ethicscommittees/

Northern X Regional Ethics Committee Annual Report 2006 iii

Contents

Chairperson’s Report 1

Committee Membership 2 Appointments 2 Changes to membership 5 Members’ attendance in 2006 7 Training 7 Approval by the Health Research Council 9 United States Department of Health and Human Services Registration 10

Response to Cultural Issues 11

Applications 12 Northern X Regional Ethics Committee statistics for January–December 2006 12 Other committee statistics 12 Audit or matters not requiring ethical approval 12 Innovative practice 12 Complaints 13 Second opinions 13

Issues for the Committee 14

Guidelines for the Chairperson’s and Deputy Chairperson’s Delegation 15

Appendices Appendix 1: Applications Received January to December 2006 16 Appendix 2: Northern X Regional Ethics Committee Terms of Reference 40

Northern X Regional Ethics Committee Annual Report 2006 1

This report provides an overview of the work of the Northern X Regional Ethics Committee from January 2006 to December 2006. The report was presented to the Northern X Regional Ethics Committee at its meeting on 13 March 2007. The report details applications received for ethical review and approval, the review of those applications and other work undertaken by the committee.

Chairperson’s Report

The Northern X Regional Ethics Committee continues to enjoy a very high applicant attendance. The majority of researchers submitting applications were Auckland based and preferred to submit their application to their local committee in Auckland rather than have the matter heard by the Northern Y Regional Ethics Committee in Hamilton. The volume of serious adverse events received for ongoing studies continues to be onerous. The load falls particularly on medical members of the committee but, more generally, this area takes up valuable meeting time. It is important to note that there has been significant disquiet among the committee throughout this year in relation to compensation for participants in clinical trials, the inadequacy of the Researched Medicines Industry guidelines and Sections C and F of the National Application Form for Ethical Approval of a Research Project. Issues for the committee are discussed further in this report. Losing four experienced members (three of them medical members) – a third of the committee – at the end of the year has also been a blow to the committee. Pat Chainey continued as administrator for the committee, who greatly appreciated her eight years of experience. Pat is now assisted by Laura Neal.

Adina Halpern Solicitor, MA Law (Hons), LicSpec, DrEu Chairperson Northern X Regional Ethics Committee

2 Northern X Regional Ethics Committee Annual Report 2006

Committee Membership

Appointments

The following members were appointed in November 2004 by the Minister of Health, pursuant to section 11 of the New Zealand Public Health and Disability Act 2000.

Chairperson (to March 2006)

Tim Dare BA, LLB, MJurPhD Representation Lay member Gender Male Date of appointment November 2004 Term of appointment 1 year Six-year maximum term December 2005 Professional affiliations Lecturer, Ethics, University of Auckland

Chairperson (from April 2006)

Adina Halpern MA Law (Hons), LicSpec, DrEu Representation Lay member Member category Lawyer Gender Female Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2007 Professional affiliation Auckland Law Society Iwi affiliation None

Deputy Chairperson

John France PhD (Biochemistry), DSc, FAACB Representation Non-lay member Member category Health researcher Gender Male Date of appointment November 2004 Term of appointment 2 years Six-year maximum term April 2009 Professional affiliation Reproductive scientist (retired), A Prof (Honorary)

Obstetrics and Gynaecology, University of Auckland Iwi affiliation None Retired 18 December 2006


Members

Jeffrey Harrison PhD, DipClin Pharm Representation Non-lay member Member category Pharmacist/pharmacologist Gender Male Date of appointment November 2004 Term of appointment 2 years Six-year maximum term November 2010 Professional affiliation University of Auckland Iwi affiliation None Retired 18 December 2006 Scott Macfarlane MBChB, FRACP, BSc Representation Non-lay member Member category Health practitioner Gender Male Date of appointment November 2004 Term of appointment 2 years Six-year maximum term November 2010 Professional affiliation Royal Australasian College of Physicians, Starship

Children’s Health Iwi affiliation None Retired 18 December 2006 Emma Ngawhare Representation Lay member Member category Consumer representative Gender Female Date of appointment November 2004 Term of appointment 2 years Six-year maximum term November 2010 Iwi/hapū affiliation Ngātihine, Ngāti Porou Robyn Northey MA (Hons) Social Welfare and Development Representation Lay member Member category Consumer representative Gender Female Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2010 Iwi affiliation None


Stephanie Palmer PhD Psychology, BSc (Hons) Representation Non-lay member Member category Health researcher Gender Female Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2010 Iwi/hapū affiliation Ngāti Porou, Ngaiterangi, Marutuahu, Ngā Puhi,

Cook Islands Māori Louisa Wall MPhil (Social Policy) Representation Lay member Member category Community representative Gender Female Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2010 Iwi/hapū affiliation Ko Ngāti Tūwharetoa me Waikato Patricia Hanlen Representation Lay member Member category Community representative Gender Female Date of appointment November 2004 Term of appointment 2 years Six-year maximum term November 2010 Iwi affiliation None Retired 18 December 2006 Wayne Miles MBChB, MD, Dip Psychiat, FRANZCP Representation Non-lay member Member category Health practitioner Gender Male Date of appointment June 2005 Term of appointment 3 years Six-year maximum term June 2011 Professional affiliation Waitemata District Health Board, University of Auckland

School of Medicine Iwi affiliation None Joanna Stewart MSc (Mathematics and Statistics) Representation Lay member Member category Biostatistician Gender Female Date of appointment June 2005 Term of appointment 3 years Six-year maximum term June 2011 Professional affiliation University of Auckland Iwi affiliation None


Vanya Kovach Ethicist Representation Lay member Member category Ethicist Gender Female Date of appointment 1 March 2006 Term of appointment 3 years Six-year maximum term March 2012 Professional affiliation University of Auckland Iwi affiliation None John France was re-elected Deputy Chairperson by the committee at its February 2006 meeting.

Changes to membership

Tim Dare completed his term as Chairperson at the end of March 2006. Adina Halpern was appointed Chairperson by the Minister of Health from April 2006. John France, Scott MacFarlane, Jeffery Harrison, Patricia Hanlen retired in December 2006 as each had reached their relevant terms of office. These members were thanked by the committee for the effort each had put into the committee. The following appointments were made by the Minister of Health on 18 December 2006. David Sinclair MBChB, FAFPHM Representation Health practitioner Member category Non-lay member Gender Male Date of appointment 18 December 2006 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliation Auckland Regional Public Health Service Environmental Health Unit Iwi affiliation None Trevor Sherwin BSc (Hons) Representation Non-lay member Member category Health researcher Gender Male Date of appointment 18 December 2006 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliation Senior lecturer, Department of Ophthalmology,

University of Auckland Iwi affiliation None


Natalie Gauld MPharm, RegPharmNZ, MPS Representation Non-lay member Member category Pharmacist Gender Female Date of appointment 18 December 2006 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliation Consultant pharmacist Iwi affiliation None Sonya Hunt MSW (Hons), MANZASW Representation Lay member Member category Social worker Gender Female Date of appointment 18 December 2006 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliation Consultant: Social Work & Health Management Iwi affiliation None


Members’ attendance in 2006

There was no meeting in January 2006. Member M/F Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total

T Dare Ethicist Chairperson to 3/06

M Y Y Retired March 2/2

A Halpern Lawyer Chairperson from 4/06

F Y Y Y Y Y Y Y Y A(2) Y Y 10/11

John France Health researcher

M Y Y Y Y Y Y Y A(2) Y Y Y 10/11

J Harrison Pharmacist/ pharmacologist

M A(2) Y Y Y Y Y Y A(1) Y Y Y 9/11

S Macfarlane Health practitioner

M Y Y Y Y A(2) Y Y Y Y Y Y 10/11

E Ngawhare* Consumer rep

F Y Y Y Y Y A(2) A(2) Y Y Y Y 9/11

R Northey Consumer rep

F Y Y Y Y Y A(2) Y Y Y Y Y 10/11

S Palmer Researcher

F Y Y Y Y Y Y Y A(1) A(1) Y Y 9/11

P Hanlen Community rep

F Y Y Y Y Y Y Y A(2) A(2) A(2) Y 8/11

L Wall Community rep

F Y Y A(1) Y A(2) A(2) Y Y Y Y Y 8/11

W Miles Psychiatrist

M Y Y Y Y Y Y Y Y Y Y Y 11/11

J Stewart Biostatistician

F Y A(1) Y Y Y (A2) Y Y Y Y Y 9/11

V Kovach Ethicist

F Joined 06/04 Y Y Y Y Y Y Y Y A(1) 8/9

Committee members present

11 11 11 12 10 8 11 8 9 11 11

No. of new applications considered

13 14 16 13 16 16 17 15 15 15 15 165

Y = Present A = Apology: Reasons for absences: (1) Personal (2) On leave

Training

New member training

The following members attended training for new members held in Wellington on 1 April 2006.

Wayne Miles Joanna Stewart Vanya Kovach


Ongoing training

Ongoing training for all members was held in June 2006. For convenience, the one-day programme was run in three centres: Christchurch on 20 June, Auckland on 27 June and Wellington on 29 June. The programme covered research with children, committee relationships, qualitative research and a discussion led by the National Ethics Advisory Committee on observational studies and intervention studies. The following members attended the one-day training programme.

Adina Halpern Joanna Stewart Vanya Kovach Scott Macfarlane Emma Ngawhare Louisa Wall Patricia Hanlen Wayne Miles

Training regarding using cells from established human embryonic stem cell lines for research was held on 15 August 2006. The following members attended the half-day training programme.

Adina Halpern John France

Chairpersons’ meetings

Tim Dare and Wayne Miles attended the chairpersons’ meeting on 9 February 2006. Adina Halpern attended the chairpersons’ meetings on 15–16 August and 5–6 September.

Meeting of the Māori members

A hui for Māori members of all health and disability ethics committees (Pū Tai Ora) was held on 18 October 2006. It was attended by the following Northern X Regional Ethics Committee members: Adina Halpern (representing the chairpersons of the ethics committees), Louisa Wall and Stephanie Palmer. Pū Tai Ora expressed concerns about a range of ethical issues, including the:

• kaitiakitanga role of Māori ethics committee members and collective obligation to ensure protection and guardianship of Māori cultural and intellectual capital

• need to improve accountability back to whānau/hapū/iwi and Māori communities

• quality of consultation with Māori

• need to agree on and implement a consistent approach to participant information sheets, consent forms and the implementation of Māori safety/monitoring techniques such as the wording of Māori risk statements, requesting certification or notification of tissue destruction at the end of studies

• inadequacy of national data collection techniques for tracking and monitoring Māori participation in clinical trials as donors of information, tissues and genetic material

• need for more training on a range of issues including the structure of the New Zealand ethics system, accreditation process for good clinical practice in laboratories, international context, Health Research Council role and mechanisms for auditing research practice.


Māori ethics committee members were unanimous in their concerns about an unacceptable lack of progress on the Māori ethics framework and inadequate level of representation on the National Ethics Advisory Committee working party. Since 1993 Māori have been highlighting the importance of a Māori ethics framework to guide thinking and decision-making about Māori ethical issues. Five people were nominated to the working party, including Stephanie Palmer and Louisa Wall from the Northern X Regional Ethics Committee. Louisa Wall facilitated the redrafting of Section F amendments on behalf of Pū Tai Ora. Stephanie Palmer’s presentation can be obtained by emailing her at [email protected]

Bioethics Conference

The New Zealand Bioethics Conference, held in Dunedin on 10–12 February 2006, was attended by Wayne Miles, Stephanie Palmer and the administrator, Pat Chainey.

Non-therapeutic Standard Advisory Committee

Louisa Wall was requested to attend the meeting of the Non-therapeutic Standard Advisory Committee held on 5 September in Wellington. She considered that a chairperson of one of the regional ethics committees should be represented on this committee and suggested that ideally its chairperson should be a lawyer.

Counties Manukau Workshop for Researchers

The Counties Manukau Workshop for Researchers, held on 31 October 2006, was attended by the Deputy Chairperson, John France, and the administrator, Pat Chainey. They gave an interactive presentation on ethical research and the administrative requirements for applications. The presentation was well received.

Supervised student research applications

The Deputy Chairperson, John France, made contact with tertiary institutions regarding the importance of supervisors attending the ethics committee meetings with their student. He stressed the committee’s concerns about the quality of the student research applications that it was receiving and the frequent apparent lack of appropriate supervisor involvement. Contact was made with The University of Auckland (Associate Dean of Research), Massey University (Dean of Research) and Auckland University of Technology.

Approval by the Health Research Council

The committee is approved by the Health Research Council until December 2007.


United States Department of Health and Human Services Registration

The Northern X Regional Ethics Committee is registered with the United States Department of Health and Human Services. The registration number is: IRB00004664 – Northern X Regional Ethics Committee.


Response to Cultural Issues

Number of applications deferred because Māori guidelines were not read

0

Number of applications for which consultation with Māori was considered appropriate

162

Number of applications returned through insufficient consultation on cultural issues

4 (Evidence of consultation was required and was carried out concurrently)

Process the committee has for following through on consultation

Written evidence of consultation and support for the study from the appropriate Māori review committee or appointed institutional representative/s.

Cases of unsatisfactory reasons for not including Māori

0

Mechanisms in place to facilitate consultation with Māori by researchers

District Health Board, university or institution Māori research committee review committees/representatives are available to researchers

Examples of Māori not being included in research

2 studies recruiting only Asian speaking participants. 1 extension study where participants in the original transplant study did not identify as Māori.

Number of applications stalled because of lack of support from a Māori Research Review Committee

One study involving audio-taping could not obtain a letter of support from one of the two District Health Board Māori Research Review Committees. After a six-month period, permission was granted for the study to go ahead without Māori participants.


Applications

The committee held 11 scheduled meetings from February 2006 to December 2006.

Northern X Regional Ethics Committee statistics for January–December 2006

Status at time of report Applications approved 165 Applications deferred 4 Applications deferred but later approved 9 Applications declined 2 Applications carried forward (approved subject to conditions) 7 Withdrawn prior to meeting 2 Withdrawn after meeting review 5 Application terminated by sponsor 4 Approval not required (prospective audit) 48

Total 246

Applications for which approval was not required (audit) 48 Applications considered/approved under delegated authority (CPD) 34 Withdrawn prior to meeting 2 Total number of applications considered by the committee 162

Total number of applications received 246

Other committee statistics

Number of matters arising considered 16 Number of general business items reviewed 49 Number of amendments reviewed by committee 80 Number of amendments approved under delegated authority 93

Audit or matters not requiring ethical approval

Forty-eight projects were confirmed as audits or surveys not requiring ethical approval.

Innovative practice

There were no innovative practice applications.


Complaints

There were no complaints regarding studies.

Second opinions

There were no requests for second opinions.


Issues for the Committee

The following issues were noted by Northern X Regional Ethics Committee members throughout the year.

• Some disciplines are presenting a very high number of applications for clinical trials such that patients, in these units, may be facing an undue burden of participation. In such cases, participation in another clinical trial may need to be an exclusion criterion.

• In the vast majority of applications, the principal investigator and members of the research team are making the initial approach to potential participants. This recruitment technique is generally unacceptable and should be the exception rather than the rule. Applicants are encouraged to find alternative approaches. If an alternative approach is not possible, the reasons need to be fully explained in writing.

• The purpose/rationale for the Interpreters Box in the Consent Form needs to be clarified. In most cases, the ability to communicate in English is a criterion for participation and the applicants have said an interpreter will not be available during the study.

• Responses to the cultural section of the application form (Section F) are often inadequate, with applicants failing to provide basic information about the relevance of studies for Maori.


Guidelines for the Chairperson’s and Deputy Chairperson’s Delegation

At its meeting on 1 February 2006, the committee agreed to delegate the following authority to the Chairperson and the Deputy Chairperson. The Chairperson and Deputy Chairperson may approve the following under their respective delegated authority:

• advertisements, letters or minor information sheet changes

• reviewing and receiving serious adverse events (Deputy Chairperson only)

• enquiries as to whether audit or research and retrospective audit

• progress reports: confirmation of approval of ongoing applications after receipt of the researcher’s annual report

• applications provisionally approved by the committee subject to final approval by the Chairperson/Deputy Chairperson, usually after review by nominated committee members.

The following applications are also required to be reviewed by a subcommittee, whose membership must include one health professional:

• student applications, especially where there is a time constraint for the course and where there is minimal potential for harm to participants, for example, questionnaires or interviews

• applications where the consequences of delaying approval would be significant. All applications, amendments and progress reports approved under delegated authority are to be listed on the agenda for the next meeting for ratification.


Appendix 1: Applications Received January to December 2006

Appendix 1 details the applications considered by the committee from January to December 2006. Four applications were held in ‘closed’ meetings. Project key Full title Primary

investigator Date

received Meeting reviewed

Outcome Why deferred/ declined

Status at time of report

Date of approval

Locality organisations

Form Sponsor/ funder Consultation undertaken

NTX/06/02/001 A study to determine the pharmacokinetics of intravenously administered Flucloxacillin in cerebrospinal fluid of patients treated for presumptive or proven meningitis PIS/Cons V#2, 09/03/06.

Assoc Prof Mark Thomas

1/01/2006 2/01/2006 Approved subject to conditions

Approved 30/03/2006 Auckland DHB A N/A ADHB MRRC

NTX/06/02/002 Hypothermia in traumatic brain injury in children.

Dr John Beca 1/01/2006 2/01/2006 Deferred Until Canadian results/ redesign required

Closed Auckland DHB A Nil ADHB MRRC

NTX/06/02/003 A randomised double-blind placebo controlled multi-centre study of the efficacy and safety of up to 100 days of Valgancyclovir vs up to 200 days of Valgancyclovir for prevention of cytomegalovirus disease in high-risk kidney allograft recipients: Protocol V# NT18435/A, 25/08/05: IB RO107-9070, 8th V, 8/05. PIS/Cons V#2, 9/02/06.

Dr Ian Dittmer 12/01/2006 2/01/2006 Deferred Relative to Standard ‘A validity of research’ (Pt 2 Ethical principles) and Pt 5 Use of human tissue

Approved 6/03/2006 Auckland DHB B Hoffmann la Roche ADHB MRRC

NTX/06/02/004 A long-term follow-up study to evaluate the safety and efficacy in transplant recipients treated with modified release tacrolimus FK506E (MR4) based immunosuppression regimen: Protocol FK506E (MR4), 5/06/02 and Amend 3, 19/08/05: IB Ed 2, 1/04: PIS/Cons V#2, 9/2/06.

Prof Stephen Munn


Approved 24/04/2006 Auckland DHB B Astellas Pharma GmbH, Germany

No M ori in original trial

NTX/06/02/005 Pharmacokinetics and pharmacodynamics of alph2-adrenoceptor agonists in children undergoing cardiac surgery: Prot/amend 10/10/06: PIS/Cons V#3, 10/10/06.

Assoc Prof Brian Anderson


Approved 23/02/2006 Auckland DHB University of Auckland

A Greenlane Research and Education Fund (sought)

ADHB MRRC

NTX/06/02/006 Comparison of methicillin resistant staphylococcus aureus (MRSA) carriers in the general population and hospital staff: PIS/Cons V#3, 06/03/06.

Ms Zeena Fadheel


Closed 24/03/2006 Auckland University of Technology Waitemata DHB

A Lab budget Waitemata DHB

Waitemata DHB MRRC

NTX/06/02/007 Clinical study to determine the efficacy of a therapeutic blue shirt for the treatment of body acne.

Dr Mark H Gray

16/01/2006 2/01/2006 Declined Considered a marketing exercise

Declined Skin Institute A – N/A

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Project key Full title Primary investigator

Date received

Meeting reviewed



Date of approval



NTX/06/02/008 Human salivary total IgA and IgA subclasses: evaluation of a nephelometric method and establishment of an adult reference interval: PIS/Cons V#3, 15/02/06.

Ms Andrea Lun


Approved 29/03/2006 Counties Manukau DHB

A Various Solely laboratory-based. Letter sent to Group Manager, M ori Health CMDHB

NTX/06/02/009 Introduction and pilot testing of a new patient derived self-assessment questionnaire to provide a measure of the impact on life (IOL) of visual disability resulting from the presence of a cataract or cataracts: PIS/Cons V#3, 14/02/06.

Dr Peter Haddad


Approved 16/03/2006 Bay of Plenty DHB Counties Manukau DHB

A MoH BOP and C-M DHB MRRC

NTX/06/02/010 Health related quality of life in patients with dystonia and their caregivers. PIS/Cons V#2, 9/2/06

Dr Vanessa Lim


Approved 20/02/2006 University of Auckland

A Existing project funds

Dr Jason Turuwhenua; lecturer; UoA.

NTX/06/02/011 The ‘crush’ technique for coronary bifurcations using drug-eluting stents: clinical and angiographic follow-up: Protocol V#5, 20/11/05

Dr John Ormiston


Approved 31/03/2006 A Auckland Heart Group Charitable Trust

ADHB MRRC

NTX/06/02/012 Pimecrolimus-eluting Duraflex stent safety evaluation: a non-randomised, consecutive enrollment evaluation of the Avantec pimecrolimus-eluting Duraflex stent in the treatment of patients with de novo native coronary artery lesions: Protocol DVP 0247, 27/12/05: IB DVP 0247 Rev A, 1/12/05: PIS/Cons V#3, 20/02/06: Prot/amend Rev C, 14/02/06.

Dr John Ormiston


Approved 24/02/2006 Auckland DHB B Avantec Vascular Corporation

ADHB MRRC

NTX/06/03/014 Testing new compounds with polyamine-like backbone for tumour necrosis factor-alpha (TNF-alpha) inhibition in human white blood cells.

Dr Jun Lu 19/01/2006 3/01/2006 Approved subject to conditions

Terminated University of Auckland

B Protemix Corporation

NTX/06/03/016 Investigation of pacifier (dummy) use and mandibular position on the skull in small babies – a pilot study.

Dr Shirley Tonkin


Approved 6/09/2006 Auckland DHB A Nil ADHB MRRC

NTX/06/03/017 Validation of the six-minute walk test in patients with scleroderma lung disease: PIS/Cons V#2, 10/03/06.

Dr Margaret Wilsher


Approved 29/03/2006 Auckland DHB A Greenlane Research/ Educational Fund

Auckland DHB MRRC

NTX/06/03/018 Laparoscopic vs open inguinal hernia mesh repair for younger patients – a randomised controlled trial: PIS/Cons V#2, 28/03/06.

Dr Michael Rodgers


Approved 30/03/2006 Auckland DHB A N/A Waitemata DHB MRRC

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Date received

Meeting reviewed



Date of approval



NTX/06/03/019 International, multicentre, randomised, parallel group, double-blind study in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at steady state of equimolar doses of SSR126517E (3.0 mg) once a week and SR34006 (2.5 mg) once a week, documenting the safety and efficacy of both compounds during a 6-month treatment and demonstrating the neutralising effect of SSR29261 on the SSR126517E-induced anti-Xa activity: Protocol CPR-EFC5945 -EN-E01 V 1/12/05: Prot/amend #1 30/06/06: Prot/amend #3 30/11/06: PIS/Cons V#1. 27/02/07.

Dr Paul Ockelford


Approved 23/05/2006 Auckland DHB Waitemata DHB

B Sanofi-Aventis Australia Pty Ltd

ADHB MRRC/ Waitemata DHB MRRC

NTX/06/03/020 Is neuropsycholigical function modified by acute and chronic pain? Is this dependent on pain intensity, duration or emotional status? PIS/Cons V#4, 11/05/06: Questionnaire V#3, 12/04/06.

Ms Catherine Mary Howie



A Department funds ADHB MRRC

NTX/06/03/021 Dimensions of the nasolacrimal duct by computed tomography in European and Polynesian peoples: PIS/Cons.

Dr Austin McCormick


Approved 13/07/2006 University of Auckland Auckland DHB

A N/A ADHB MRRC

NTX/06/03/022 A randomised controlled trial: should aspirin be stopped prior to dacryocystorhinostomy? PIS/Cons V#2, 06/06.

Dr Austin McCormick



A N/A ADHB MRRC

NTX/06/03/023 A phenomenological investigation of disturbances in self-experience prior to psychosis among clients of Auckland mental health services receiving treatment for a first episode of psychosis: PIS/Cons V#2, 10/03/06.

Mr Angus Maxwell


Approved 24/03/2006 University of Auckland Waitemata DHB Auckland DHB

A Department Psychology PhD funding

Waitemata DHB MRRC – ADHB MRRC

NTX/06/03/024 The cost of disability: PIS/Cons V 30/03/06.

Dr Paul Brown 13/02/2006 3/01/2006 Approved subject to conditions


A Ministry Social Development/ HRC

Ronelle Baker/ Tania Kingi/ Te Roopu Waiora Trust

NTX/06/03/025 Overcoming depression: the acceptabiity and effectiveness of a computer-based cognitive vehavioural self-help programme as an adjunt to treatment for depression and anxiety.

Ms Rebecca Scheibmair

13/02/2006 3/01/2006 Withdrawn Changes to be inserted after PI consulted with university

Withdrawn Massey University Nil Leainne Nathan (private consultant) letter of support

NTX/06/03/026 A right to a risk-filled life? Understandings and analysis of the risk discourse for consumers within mental health.

Mr Ross Phillips


Approved 31/03/2006 Massey University Nil Massey University Graduate Research Fund/ researcher

Tuhakia Keeper; Maori Health Te Arawhiriwhiri; C-M DHB

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Date received

Meeting reviewed



Date of approval



NTX/06/04/034 Validation of bio-impedance analyser in Auckland youth: PIS/Cons V#2, 21/07/06.

Dr David Schaaf



A Working expenses covered by main OPIC budget

Consulted with tangata whenua within Mangere area

NTX/06/04/036 Mutations in the protein Z dependent protease inhibitor gene and small for gestational age pregnancies.

Dr Laura Young



A LBF grant – materials from Roche Diagnostics, DNA will be funded from grant from Leukaemia/ Blood Foundation

European/M ori participants already recruited in original study; reviewed by Harataki Jahnke; Mauri Oranga Team

NTX/06/04/037 A pilot study to validate the use of high flow humidified nasal oxygen therapy in a cardiothoracic and vascular intensive care unit (CVICU): Protocol V#2, 3/3/06: Prot/amend V#3, 12/09/06: PIS/Cons V#4, 12/09/06.

Dr Shay McGuiness



B F&P Healthcare ADHB MRRC

NTX/06/04/038 A phase 2, double-blind, multicentre, randomised study comparing Tenofovir Disproxil Fumarate, Emtricitabine plus Tenofovir Disproxil Fumarate and Entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease and in the prevention of hepatitis B recurrence post-transplantation: Protocol GS-US-174-0108, 6/12/05: IB on Entecavir: IB on Emtricitabine/ Tenofovir, Ed 1, 2/09/05.

Assoc Prof Edward J Gane


Withdrawn Auckland DHB B Gilead Sciences Inc, USA

ADHB MRRC

NTX/06/04/039 Evaluation of the Counties Manukau District Health Board’s Let’s Beat Diabetes initiative.

Dr Janet Clinton


Approved 14/05/2006 Counties Manukau DHB University of Auckland

A Uniservices University of Auckland/ Riripeti Haretuku (CMDHB); Dr Lorna Dyall

NTX/06/04/040 Accuracy, precision and reliability of the 1-STAT point-of-care device in assessment of haematocrit in patients undergoing massive blood loss and transfusion and with consequent instability of plasma albumin levels.

Dr Wai Leap Ng


Approved 2/05/2006 Auckland DHB A None ADHB MRRC

NTX/06/04/041 The use of response surface modelling to define the interaction between sevoflurane and remifentanil.

Dr Doug Campbell


Approved 11/05/2006 A ADHB Department Anaesthesia grant

ADHB MRRC

NTX/06/04/042 Evaluation of cadsonline counselling service: PIS/Cons V#3, 3/5/06.

Ms Kim Conway


Approved 29/06/2006 Nil ADHB ADHB MRRC

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Date received

Meeting reviewed



Date of approval



NTX/06/04/034 Validation of bio-impedance analyser in Auckland youth: PIS/Cons V#2, 21/07/06.

Dr David Schaaf



A Working expenses covered by main OPIC budget

Consulted with tangata whenua within Mangere area

NTX/06/04/036 Mutations in the protein Z dependent protease inhibitor gene and small for gestational age pregnancies.

Dr Laura Young



A LBF grant – materials from Roche Diagnostics, DNA will be funded from grant from Leukaemia/ Blood Foundation

European/M ori participants already recruited in original study; reviewed by Harataki Jahnke; Mauri Oranga Team

NTX/06/04/037 A pilot study to validate the use of high flow humidified nasal oxygen therapy in a cardiothoracic and vascular intensive care unit (CVICU): Protocol V#2, 3/3/06: Prot/amend V#3, 12/09/06: PIS/Cons V#4, 12/09/06.

Dr Shay McGuiness



B F&P Healthcare ADHB MRRC

NTX/06/04/038 A phase 2, double-blind, multicentre, randomised study comparing Tenofovir Disproxil Fumarate, Emtricitabine plus Tenofovir Disproxil Fumarate and Entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease and in the prevention of hepatitis B recurrence post-transplantation: Protocol GS-US-174-0108, 6/12/05: IB on Entecavir: IB on Emtricitabine/ Tenofovir, Ed 1, 2/09/05.



Withdrawn Auckland DHB B Gilead Sciences Inc, USA

ADHB MRRC

NTX/06/04/039 Evaluation of the Counties Manukau District Health Board’s Let’s Beat Diabetes initiative.

Dr Janet Clinton


Approved 14/05/2006 Counties Manukau DHB University of Auckland

A Uniservices University of Auckland/ Riripeti Haretuku (CMDHB); Dr Lorna Dyall

NTX/06/04/040 Accuracy, precision and reliability of the 1-STAT point-of-care device in assessment of haematocrit in patients undergoing massive blood loss and transfusion and with consequent instability of plasma albumin levels.

Dr Wai Leap Ng


Approved 2/05/2006 Auckland DHB A None ADHB MRRC

NTX/06/04/041 The use of response surface modelling to define the interaction between sevoflurane and remifentanil.

Dr Doug Campbell


Approved 11/05/2006 A ADHB Department Anaesthesia grant

ADHB MRRC

NTX/06/04/042 Evaluation of cadsonline counselling service: PIS/Cons V#3, 3/5/06.

Ms Kim Conway


Approved 29/06/2006 Nil ADHB ADHB MRRC

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NTX/06/04/043 Effectiveness of surface electromyography (SEMG) biofeedback in dysphagia rehabilitation versus conventional rehabilitation techniques that do not include biofeedback.

Dr Clare McCann


Withdrawn University of Auckland Counties Manukau DHB

A No funding required

NTX/06/05/044 An evaluation of the factors that determine success and difficulty within four community service organisations in Tai Tokerau (Northland) New Zealand: PIS/Cons V#2, 11/05/06.

Ms Tina Darkins


Approved 28/06/2006 Auckland University of Technology

A Self-funded. Support from Ministry of Social Development SPEAR Fund, NZNO

CYFS; Te Puni K kiri; Ministry of Social Development; kaumatua and kuia

NTX/06/05/045 Ultrasound measurement of the internal jugular vein as an indication of central venous pressure: PIS/Cons V#2, 06/06.

Dr James Lai 10/04/2006 5/03/2006 Approved subject to conditions

Approved 26/07/2006 Auckland DHB A No funding required

ADHB MRRC

NTX/06/05/046 A multicentre, randomised, double-blind, placebo controlled study to evaluate the safety of SCH 530348 in subjects undergoing non-emergent percutaneous coronary intervention/ thrombin receptor antagonist in PCI (TRAsm-PCI): Protocol SCH 530348 Amend #1, 21/02/06; IB 12/05.

Professor Harvey D White


Withdrawn 23/08/2006 Auckland DHB Auckland City Hospital

B Schering-Plough P/L

ADHB MRRC

NTX/06/05/047 The use of intravenous aminophylline to improve respiratory function in infants with severe bronchiolitis in intensive care: PIS/Cons V#2, 4/09/06.

Dr John Beca 11/04/2006 5/03/2006 Approved subject to conditions

Approved 11/09/2006 Auckland DHB A New Zealand College of Massage Research budget

ADHB MRRC

NTX/06/05/048 Recovery of illness and treatment in coronary artery bypass graft (CABG) and cardiac valve surgery (CVS) patients: predicting functional recovery after surgery: PIS/Cons V#2, 11/05/06.

Ms Unique Weber



A Masters Project – no external funding

ADHB MRRC

NTX/06/05/049 Assessment of predictors for the development of diabetes mellitus following renal transplantation: PIS/Cons V#3, 1/08/06.

Dr Paul Manley


Approved 2/08/2006 Auckland DHB A Renal Trust Fund ADHB MRRC

NTX/06/05/050 How do patients’ perceptions of the aniography procedure affect reassurance?

Mr Daniel A Devcich



A N/A ADHB MRRC

NTX/06/05/051 Can the use of electronic reminder alarms in metered dose inhalers lead to better control of asthma? Prot/amend 20/11/06: PIS/Cons V#4, 19/10/06.

Assoc Prof Peter Black



A Grant – Child Health Research Foundation

ADHB MRRC

NTX/06/05/052 Mindfulness-based cognitive behavioural therapy and type II diabetes mellitus: a pilot programme for developing self efficacy and self compassion: PIS/Cons V#2, 11/05/06.

Ms Melanie Lindsay



A Supervisor’s research funds

Papaarangi Reid

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NTX/06/05/053 A pilot study investigating hyypothermia in traumatic brain injury in children.: PIS/Cons V#2, 12/04/06.


Approved 25/09/2006 Auckland DHB Starship Children’s Health

A Application lodged with HRC

ADHB MRRC

NTX/06/05/054 Determinants of late fetal death in Auckland 2006–9: the exploration of modifiable risk factors for late fetal death: PIS/Cons V#4, 5/06: Prot/amend 7/11/06: Questionnaire Draft 10/06/06.

Ms Tomasina Stacey


Approved 29/06/2006 Auckland DHB Waitemata DHB Counties Manukau DHB

A Child Health Research Foundation for 18 months

ADHB MRRC; C-M MRRC; Waitemata MRRC

NTX/06/05/055 An observational study of the effect of knowing the CYP 450 metaboliser status on clinician prescribing behaviour when treating psychosis with risperidone: Protocol 14/03/06.

Assoc Prof Wayne Miles


Approved 30/08/2006 Waitemata DHB A Grant from Roche Diagnostics

Nga Kai Taataki; Waitemata DHB MRRC

NTX/06/05/056 Dialectical behaviour therapy (DBT) based psychosocial skills training for outpatients in a community mental health setting: a pilot study: PIS/Cons V#4, 24/08/06.

Yunfei Zhao 18/04/2006 5/03/2006 Approved subject to conditions

Approved 26/05/2006 University of Auckland Taylor Centre

Nil No funding None

NTX/06/06/057 Relationship of the StepWatch (tm) Activity Monitor output to clinical measures of walking: Prot/amend 31/10/06: PIS/Cons V#4, 26/10/06.

Ms Suzie Mudge



A N/A ADHB MRRC

NTX/06/06/058 A phonation therapy approach for Mandarin–English bilingual clients with dysarthria – will it improve their speech intelligibility in Mandarin more than English? PIS/Cons V#2, 12/07/06.

Dr Clare McCann


Closed 2/10/2006 University of Auckland

A University of Auckland

Mandarin only but consultation suggested

NTX/06/06/059 A Phenomenoligical study: what is the experience of breastfeeding for women who have had previous breast surgery?

Ms Marlene Scobbie

9/05/2006 6/07/2006 Deferred Op Stand para 57 Terminated Auckland University of Technology

Nil

NTX/06/06/060 A phase 2/3 multicentre, randomised, double-blind, dose-finding and dose-confirmation study to evaluate the safety and efficacy of a single epidural dose of SKY0401 (morphine sulfate extended-release liposome injection) in the management of post-operative pain in pediatric subjects undergoing lower abdominal (below the umbilicus), genitourinary or lower extremity orthopedic surgery: Protocol SKY0401-C2-021, 04/02/06: IB Ed 11, 18/05/05.

Dr Jane Thomas

16/05/2006 6/07/2006 Deferred Op Stand: various, para 57

Terminated Auckland DHB B SkyPharma Inc, USA

ADHB MRRC

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NTX/06/06/061 A randomised controlled trial of bispectral index monitoring to prevent awareness during anaesthesia (Ethics 2000/195). Substudy: to compare the long-term mortality and morbidity of patients enrolled in the B-Aware trial who were randomised to Bispectral Index (BIS) monitoring or routine care (randomised controlled trial).

Dr Timothy G Short

16/05/2006 6/07/2006 Approved Approved 7/06/2006 Auckland DHB A ANZCA Project grant

ADHB MRRC

NTX/06/06/062 Exercise testing and natriuretic peptides in valvular heart disease: Protocol V#2, 27/06/06: PIS/Cons V#3, 24/07/06.

Dr Ralph Stewart

16/05/2006 6/07/2006 Deferred Op Stand para 57 Approved 15/08/2006 Auckland DHB Counties Manukau DHB

A Initial funds from National Heart Foundation/HRC

ADHB MRRC

NTX/06/06/063 Dietary behaviour in people undergoing bariatric surgery: PIS/Cons V#3.

Ms Irene Kvame Pedersen

16/05/2006 6/07/2006 Deferred Op Stand paras 57/71


A Undertaken in fulfilment of an MSc in Health Psychology

University of Auckland MRRC

NTX/06/06/065 Pilot study of the residual effectiveness of chlorhexidine gluconate 0.5% on public health nurses hand flora during student mass vaccination programmes: PIS/Cons V#3, 19/06/06.

Ms Robyn Duffy


Approved 29/06/2006 Massey University Auckland DHB

A Researcher ADHB MRRC

NTX/06/06/066 Identifying facilitators and barriers to physical activity in people with multiple sclerosis (MS): Proto/amend 17/07/06: 19/06/06: Substudy PIS/Cons V#4, 22/09/06.

Ms Nicola Kayes


Approved 16/08/2006 Auckland University of Technology Auckland DHB

Nil AUT grant/HRC Waitemata MRRC; ADHB MRRC; AUT MRRC

NTX/06/06/067 A cross-sectional observational study of enamel defects and dental caries in the permanent teeth of nine-year-old children in relation to water fluoridation and toothpaste use in infancy: PIS/Cons V#2, 5/07/06.

Dr Sathananthan Kanagaratnam


Approved 17/07/2006 Waitemata DHB Counties Manukau DHB

Nil Waitemata M ori Research Advisor (WDHB); South Kaipara Takiwa

NTX/06/06/068 Sleep and arousal in infants exposed to methamphetamine in utero: PIS/Cons V#2, 26/06/06.

Prof Ed Mitchell



A N/A Waitemata DHB MRRC letter of support for original study as participants all recruited

NTX/06/06/069 A randomised, open-label study to compare the rate of new non-melanoma skin cancer in maintenance renal allograft recipients converted to a Sirolimus-based regim versus continuation of a calcineurin inhibitor-based regimen: Protocol 0468H1-407-AUS, 15/06/05: IB Ed. 15, 08/05: PIS/Cons V#2, 21/06/06: Prot/amend 1 046H1-407-WW, 11/05/06: PIS/Cons V#3, 07/08/06.

Dr Helen Pilmore


Approved 26/07/2006 Auckland DHB B Wyeth Parmaceuticals

ADHB MRRC

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NTX/06/06/070 An evaluation of being there: a peer support service for older people with mental illness.

Ms Jane Vanderpyl



A C-M DHB provider arm budget

C-M DHB MRRC

NTX/06/06/072 Does a polypill improve cardiovascular guideline implementation in primary care? A randomised controlled trial of fixed dose combination medication compared to usual care in those at high risk of cardiovascular disease: Prot V#1, 16/05/06: Prot/amend V#2, 26/10/06: PIS/Cons V#2, 26/10/06.

Dr Anthony Rodgers



A HRC/National Heart Foundation

M ori PHOs; Raukura Hauora O Tainui; Tamaki Healthcare PHO and many more

NTX/06/07/073 An open label, single dose, prospective study of the acute effects of GC811007 (triethylenetetramine dihydrochloride) on urinary copper output in patients with hypertension and left ventricular hypertrophy, heart failure, type 2 diabetes mellitus and healthy controls.

Dr Anne Thea McGill


Withdrawn University of Auckland

B Protemix Corporation

NTX/06/07/074 Iconic memory in normal subjects and in patients with mild cognitive impairment: PIS/Cons.

Dr Mary Tucker


Approved 16/08/2006 Waitemata DHB University of Auckland

A Department of Optometry, University of Auckland; Charitable Trust of the Royal New Zealand College of General Practitioners

Jane Sherard; Waitemata DHB

NTX/06/07/075 Swelling of the knee joint: the effect of cryotherapy on arthrogenic muscle inhibition of the quadriceps: PIS/Cons V#2, 29/07/06.

Dr Peter McNair



Nil Physical Rehabilitation Research Centre

M ori Research Advisory Group/ Deputy Vice Chancellor; M ori Advancement; AUT

NTX/06/07/076 Peri-aceabular osteotomy for the treatment of developmental dysplasia of the hip in adults: PIS/Cons V#2, 2/08/06.

Dr Brendan Coleman


Closed 2/10/2006 Auckland City Hospital

A Orthopaedic Department, Auckland City Hospital

ADHB MRRC

NTX/06/07/077 Clinical utility of expired nitric oxide in the diagnosis of asthma in elite athletes: PIS/Cons V#2, 3/8/06.

Dr John Kolbe 16/06/2006 7/05/2006 Approved subject to conditions

Approved 15/08/2006 Auckland DHB A

NTX/06/07/078 Validity of clinical signs for assessment of dehydration in endurance athletes: PIS/Cons V#1, 3/8/06.

Dr James McGarvey



A Privately Tamaki Healthcare primary health organisation; Te Puni K kiri and Ngati Whatua; contact Martin Mariassouce

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NTX/06/07/079 Long-term follow-up study of women with PCOS and clomiphene resistance randomised to laparoscopic ovarian diathermy or gonadotropin therapy (Trial No 95/222): PIS/Cons V# 3/09/06.

Prof Cindy Farquhar


Approved 14/09/2006 A Funding not required

ADHB MRRC

NTX/06/07/080 A study of the pharmacokinetics of Benzylpiperazine (BZP) and Trifluoromethylphenylpiperazine (TFMPP) in human subjects: PIS/Cons V#2, 29/07/06.

Dr Bruce Russell



A University of Auckland

Assoc Prof Papaarangi Reid from the Office of the Tumuaki; The University of Auckland

NTX/06/07/081 The correlation between perceived control over cardiac condition and lifestyle modifications in patients who have undergone coronary artery bypass graft surgery or angioplasty: a pilot study.

Ms Leah Borthwick


Subcommittee review of amended documents and responses

Approved 30/08/2006 A The University of Auckland

Consultation occurred with the original project; this is a follow-up study

NTX/06/07/082 Knowledge of the use, storage and when to seek medical attention in patients using sublingual glyceryl-trinitrate spray: PIS/Cons V 1/08/06.

Ms Beverley Wemekamp

16/06/2006 7/05/2006 Deferred Op Stand para 52: guidelines not followed

Approved 13/09/2006 A Middlemore Hospital, Emergency Care Department.

Henare Mason from the M ori Health Unit; Kerry Hiini; the Chairperson of M ori Research Review Committee

NTX/06/07/083 A survey-based study of the incidence of depression in adolescent girls with polycystic ovary syndrome (n= approximately 100) compared with normal, healthy adolescent girls in Auckland, New Zealand.

Dr Stella Ruth Milsom



A ANZAME/fertility+ pending

Mata Forbes; M ori Health Service Consultant

NTX/06/07/084 The effect of botulinum toxin A and dermal filler treatment on mood.

Dr Karl LR Jansen

19/06/2006 7/05/2006 Declined Op Stand para 57 2.4 Declined Nil

NTX/06/07/085 The relationship between therapist competence in using homework assignments, patient homework adherence, and treatment outcome in cognitive behaviour therapy for depression.

Mr Nikolaos Kazantzis


Review by subcommittee of amended documents

Approved 11/10/2006 A Kaumatua koro turoa and a letter of support

NTX/06/07/086 Molecular genetic markers in predicting the prognosis of childhood medulloblastoma: a retrospective review of children treated in Auckland Starship Hospital.

Dr Hui Lau 19/06/2006 7/05/2006 Approved subject to conditions

Withdrawn Auckland City Hospital Starship Children’s Health

A Applying for grant ADHB MRRC

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NTX/06/07/087 Use of evidence-based guidelines for cardiovascular disease and diabetes in primary health care nursing: PIS/Cons V#4, 1/08/06.

Ms Ann McKillop


Approved 28/08/2006 A Ministry of Health awarded $2000 from primary health care nursing scholarships towards operational costs

CEO of TeTai Tokerau PHO; Clinical Manager of Ngati Hine Health Trust; TeTai Tokerau Nurses’ Capacity Hui; Motatau Marae

NTX/06/07/088 Increasing our understanding of whanau/family meetings and the whanau/family’s perception of the quality of those meetings in the paediatric intensive care unit at Starship Children’s Hospital: PIS/Cons V#3, 23/08/06.

Mr Andrew Thompson


Approved 29/08/2006 Auckland DHB A M ori Health Research Committee; The Werry Centre

NTX/06/08/089 The effects of knee joint aspiration and corticosteroid injection on quadriceps muscle performance and lower limb function in patients with chronic arthritis: PIS/Cons V#2. 14/09/06.

Dr Peter McNair



A Physical Rehabilitation Research Centre

ADHB MRRC

NTX/06/08/090 A prospective study for evaluation of the cost effectiveness of magnetic resonance imaging of the wrist for clinical suspected scaphoid fracture: PIS/Cons V#2, 28/11/06.

Dr Bhavani Peddinti



A Manukau Radiology Institute; ACC pending

C-M M ori Research Review Committee

NTX/06/08/091 Hypothermia for cardiac arrest in paediatrics (HypCAP) – pilot study.


Approved 12/10/2006 A Have applied to: The Neurological Foundation; The Health Research Council

To be reviewed by the ADHB M ori Research Review Committee

NTX/06/08/092 To evaluate the usefulness of serum markers of hepatic fibrosis (hyaluronic acid 2 macroglobulin, GGT and bilirubin) in determining the amount of hepatic fibrosis in patients with all forms of liver disease: PIS/Cons V#2, 22/08/06.


14/07/2006 8/02/2006 Approved Approved 29/08/2006 Auckland DHB Auckland City Hospital

A Research funds of Assoc Prof G Jeffrey

ADHB MRRC

NTX/06/08/093 Towards percutaneous necrosectomy: evaluation of chemicals and enzymes to liquefy pancreatic necrosis: PIS/Cons V#3, 4/10/06.

Prof JA Windsor



A Existing funds within the Pancreas Research Group

M ori Research Review Committee

NTX/06/08/094 Development and validation of an interactive anaesthesia warning system for monitoring the adverse effects that might arise during anaesthesia administration: PIS/Cons V#3, 29/09/06.

Dr Michael Harrison


Approved 28/08/2006 Auckland DHB Auckland City Hospital

A Software provided by Engineering Research Institute

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NTX/06/08/095 An open label, non-comparative expanded access study of the Raf-kinase Inhibitor Sorafenib as a subsequent to first-line therapy in patients with advanced renal cell carcinoma: a phase II – expanded access study: Prot AUS 1, V#1, 02/06. IB V#6, 9/09/04: IB Amend # 1.0, 10/01/06: PIS/Cons V#2, 14/09/06.

Dr Fritha Hanning

14/07/2006 8/02/2006 Deferred Clarification of compensation details

Approved 25/01/2007 Auckland DHB A Bayer to provide study drug, and funding other research costs

ADHB MRRC

NTX/06/08/096 A cross-sectional study to assess the bone mineral density and factors influencing bone metabolism in long-term opioid-dependent people on methadone maintenance treatment: PIS/Cons V#3, 23/08/06.

Prof Ian Reid 14/07/2006 8/02/2006 Approved subject to conditions

Approved 25/09/2006 University of Auckland Auckland Methadone Service Waitemata DHB

A University of Auckland through HRC programme grant currently held by Prof Reid

Waitemata DHB MRRC

NTX/06/08/097 The effects of exercise during pregnancy on long-term maternal and offspring health outcomes: a follow-up study: prot/amend 21/11/06: PIS/Cons V#3, 21/11/06.

Dr Paul Hofman


Approved 11/09/2006 University of Auckland Auckland DHB Waitemata DHB

A Paykel Clinical Research Unit

ADHB and Waitemata DHB MRRCs

NTX/06/08/098 Improving arm function in young people with hemiplegia – insights from neuroscience: PIS/Cons V#4, 11/10/06.

Ms Anna Mackey


Approved 16/08/2006 Auckland DHB University of Auckland Waitemata DHB Counties Manukau DHB

A HRC Emerging Researchers Grant

Papaarangi Reid UoA; Waitemata DHB; Anne Murphy; Cerebral Palsy Society of NZ; ADHB MRRC

NTX/06/08/099 The needs of patients with glioblastoma multiforme: the patients’ and carers’ perspective.

Dr Wendy Margaret Muircroft


Withdrawn St Josephs Mercy Hospice

A No budget – part of registrar training/ assessment

Kaiatawhai; Mercy Hospice Auckland

NTX/06/08/100 An evaluation of the community living service (CLS) for mental health service users in the Counties Manukau District Health Board region: PIS/Cons V#2, 30/08/06.

Ms Liz Stewart 17/07/2006 8/02/2006 Approved subject to conditions


A C-M DHB provider arm budget

CLS Improvement Group representatives from all six NGOs; C-M DHB MRRC; Mental Health Development Team

NTX/06/08/101 Development of a flow cytometry method for the measurement of Zap-70 in B chronic lymphocytic leukaemia.

Ms Catherine (Kate) Marson


Approved 29/08/2006 Auckland DHB A LabPlus ADHB MRRC

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NTX/06/08/102 An international, multicentre, randomised double-blind, double-dummy, parallel group study of three months or six months’ treatment with SSR126517E (3.0 mg sc once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism with or without symptomatic deep venous thrombosis: Protocol SSR126517E, SSR29261, 27/03/06: CIB SSR29261 Avidin, 2/011/06 Ed E02: CIB SSR126517E, 6/04/06 Ed E04.

Dr Paul Ockelford


Approved 24/10/2006 Auckland DHB Waitemata DHB Counties Manukau DHB

B Sanofi-Aventis Australia Pty Ltd

ADHB; Waitemata DHB and Counties Manukau MRRCs letters of support

NTX/06/08/103 Feasibility, reliability, validity and acceptability of the mini-CEX assessment process during the anaesthesia training programme: PIS/Cons V#2, 10/08/06.

Assoc Prof Jennifer Weller



A Funding requested from newly established ANZCA project grant

ADHB MRRC

NTX/06/08/104 Humidity measurements on healthy volunteers made with a fast response hygrometer to determine the optimum humidification for noninvasive ventilation: Protocol V#2, 3/3/06: PIS/Cons V#2, 3/10/06.

Dr Anthony Williams


Approved 31/10/2006 F&P Healthcare Counties Manukau DHB

B Fisher & Paykel Healthcare

CMDHB K Hiini

NTX/06/08/105 Overcoming depression: the acceptability and effectiveness of a computer-based cognitive behavioural self-help programme as an adjunct to treatment for depression and anxiety.

Ms Rebecca Scheibmair


Redesign changes required

Approved 11/10/2006 Massey University Nil Application to Regional Mental Health Director: funding available from Massey University Postgraduate Research Fund

Letter of support from Leainne Nathan

NTX/06/09/106 Assessing sexual function and its associated factors in renal patients undergoing dialysis at Auckland using the modified ASEX scale:PIS/Cons V#3, 15/11/06.

Mr Fredric Doss

17/08/2006 9/06/2006 Deferred Op Stand 2.1, 2.3, 2.4, 2.7


Nil ADKS NZ Kidney Foundation/ ADHB MRRC

NTX/06/09/107 A group-wide phase II study of Sulindac and Tamoxifen in patients with desmoid tumours that are recurrent or not amenable to standard therapy: Protocol ARST0321 Amend #1, 25/04/05, Amend #2 and #4, 09/12/05, Amend #3, 9/09/06: PIS/Cons V#4, 24/10/06.

Dr Scott Macfarlane


Approved 12/10/2006 Auckland DHB A Normal paediatric oncology care

ADHB MRRC

NTX/06/09/108 The impact of different ways of expressing cardiovascular treatment benefits on patients’ decisions about treatment: Prot/amend 14/12/06, PIS/Cons V#4, 14/12/06.

Assoc Prof Bruce Arroll



A Extensive consultation by Te Tai Tokerau PHO: Assoc Prof Papaarangi Reid; Tumuaki; FMHS; UoA

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NTX/06/09/109 A study to investigate the effects of controlled whole body vibration on gait and balance, motor capacity and health-related quality of life in the elderly: Protocol V#2, 30/09/06.

Dr Patricia Metcalf



B VTI Limited N/A

NTX/06/09/110 The development of (a) a screening tool to assess the psychological well-being and difficulties in adolescents with type 1 diabetes and (b) recommendations for service development to meet the psychological needs of adolescent service users of the Paediatric Diabetes Service, Auckland District Health Board (ADHB): PIS/Cons V#3, 9/2/07.

Ms Katharine Jayne Huggard



A UoA Department Psychology Research Expenses Grant ($1000); Paediatric Diabetes Service ADHB (minimal staff time)

Mata Forbes/ L Hetaraka-Stevens; Tamaki Healthcare, ADHB MRRC

NTX/06/09/111 Patterns of prescription medicine use in a New Zealand town: the use of community pharmacy dispensing databases for identifying inequalities in medicines use.

Dr Simon Horsburgh

18/08/2006 9/06/2006 Deferred Op Stand para 57: confidentiality

Approved 10/10/2006 University of Otago Nil University of Otago Research Facilitator – M ori and M ori Affairs advisor. Ngati Porou Hauora; Turanga PHO; Ngai Tahu

NTX/06/09/112 Failure of cyclophosphamide therapy in lupus nephritis patients: the role of bioactivaton phenotype and genotype: Protocol 10/08/06: PIS/Cons V#2, 14/09/06: Prot/amend V#2, 26/10/06: Prot/amend V#3, 27/11/06.

Dr Nuala Helsby


Approved 21/09/2006 Counties Manukau DHB Auckland DHB University of Auckland

A Dr Papaarangi Reid/ C-M MRRC/ ADHB MRRC

NTX/06/09/113 Do patient’s beliefs about asthma and its treatment influence the use of preventer medications for asthma? PIS/Cons V#2, 18/09/06: Questionnaire.

Ms Jodie Main 18/08/2006 9/06/2006 Approved subject to conditions


A University of Auckland basic running costs (minimal)

Sue Crengle; Department of M ori Health; UoA

NTX/06/09/114 Core affect and its role in the maintenance of subjective wellbeing of people with intellectual disability: PIS/Cons V#1, 18/09/06.

Ms Kathleen Jane Martindale



A Researcher Tony Trinick; Associate Dean M ori; Faculty of Education; UoA

NTX/06/09/115 Inter-examiner reliability of examination techniques used to detect the presence of spinal dysfunction.

Dr Kelly Holt 18/08/2006 9/06/2006 Approved subject to conditions

Approved 2/10/2006 NZ College of Chiropractic

A NZ College of Chiropractic

NZ College of Chiropractic M ori Cultural Advisor

NTX/06/09/116 Let’s beat diabetes general public survey research to contribute to evaluation of the Counties Manukau District Health Board’s let’s beat diabetes initiative:Survey Protocol: Screening Protocol: Questionnaire V#1, 17/08/06: PIS/Cons V 10-06: Prot/amend 2/11/06.

Dr Allan Wyllie 18/08/2006 9/06/2006 Approved subject to conditions


A Counties Manukau DHB/ Ministry of Health

Counties Manukau MRRC

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NTX/06/09/117 Quantitative analysis of vigabatrin induced visual loss with optical coherence tomography of the retinal nerve fibre layer and correlation with visual field defects: PIS/Cons V#1, 8/06.

Assoc Prof Helen Danesh-Meyer



A University of Auckland Staff Research Fund

Auckland DHB MRRC

NTX/06/09/118 Stimulation of virus-specific t-cells by candidate therapeutic vaccines against chronic hepatitis B: PIS/Cons V#2, 18/09/06.

Dr John Taylor 21/08/2006 9/06/2006 Approved subject to conditions

Approved 2/10/2006 University of Auckland Auckland DHB Counties Manukau DHB

A HRC C-M MRRC; ADHB MRRC

NTX/06/09/119 A randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to investigate the MRI efficacy and safety of six months’ administration of firategrast (150–1200 mg twice daily) in subjectsj with relapsing-remitting multiple sclerosis: pharmacogenetis substudy: Protocol A4M105038, 25/07/06: IB V#4, Ed 5, (Firategrast) 16/09/05: IB supplement, 13/02/06: PIS/Cons V#2, 18/09/06.

Dr Ernest Willoughby


Approved 29/09/2006 Auckland DHB Wellington Hospital

B GlaxoSmith Kline Multinational trial; conforms to Treaty

NTX/06/09/120 An observational study on the effect of the perioperative use of gabapentin in recovery from knee arthroplasties: Protocol LAB-0106-8.0, 12/05.

Dr Martin Minehan


Withdrawn Waitemata DHB A Existing resources/ personal time

Waitemata DHB MRRC

NTX/06/10/121 A randomised prospective trial of the Sigmas RP total knee joint replacement versus the PFC Sigma RP-F (high flex) system total knee replacement: PIS/Cons V#2, 12/02/07.

Dr Mark Clatworthy


Approved 20/02/2007 Auckland bone and joint surgery Ascot Hospital

A Existing research funds

ADHB MRRC

NTX/06/10/122 A pilot phase II study for children with infantile fibrosarcoma: Children’s Oncology Group Protocol Amend #2, (COG) ARST03P1, 1/12/06: PIS/Cons V#2, 12/10/06.

Dr Ruellyn Cockroft


Closed 30/10/2006 Auckland DHB A Normal care/ partly funded by Child Cancer Foundation

ADHB MRRC

NTX/06/10/123 Correlation between clinical, radiological and functional outcome for distal radius fractures treated with closed reduction and percutaneous wire fixation: PIS/Cons V#2, 17/10/06.

Mr Bruce C Twaddle


Approved 7/11/2006 Auckland DHB A Part funded by ACC (FU/X-Rays)

ADHB MRRC

NTX/06/10/124 Reducing post-stroke attention deficits: a randomised controlled trial: PIS/Cons V#2, 13/10/06: Amend 6/11/06.

Ms Suzanne Barker-Collo



A HRC Dr Sue Cregle; UoA Clinical Trials Research Unit MR Advisory Committee; Waitemata and C-M MRRC required

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Date of approval



NTX/06/10/125 Long-term functional and neuropsychological outcomes after stroke in New Zealand: Protocol V#1. 4/09/06: PIS/Cons V#2, 10/06: Prot/amend V#2, 30/11/06.

Prof Valery Feigin



A HRC Dr M Dudley; Dr S Crengle; Mr Malakai Ofanoa/ Dr David Schaaf; Dr Erana Cooper

NTX/06/10/126 Factors associated with the acquisition of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBLPE) in the Auckland community: PIS/Cons V#2, 7/11/06.

Dr David Holland



A No funding required

C-M MRRC letter of support

NTX/06/10/127 A phase IIb/III randomised, placebo-controlled clinical trial to study the safety and efficacy of MK-0364 in obsese patients and in overweight patients with obesity-related co-morbidities: Protocol 0364 037-00 24/08/06: IB MK-0364, 13/06/06: PIS/Cons V#3, 16/11/06.

Dr Jocelyne Benatar


Approved 21/11/2006 Auckland DHB Counties Manukau DHB

B Merck Sharp and Dohme

ADHB MRRC/ C-M DHB MRRC

NTX/06/10/128 Procedural distress in the Children’s Emergency Department: measurement, ranking and identifying the evidence-practice gap (summer studentship): PIS/Cons V#2, 20/10/06.

Dr David Herd 14/09/2006 10/04/2006 Approved subject to conditions


A Summer studentship grant

ADHB MRRC letter of support

NTX/06/10/129 A pathway to wellbeing based on the experiences of kaumatua and health professionals of services for kaumatua in Home and Older Adult Services (HOAS) at Waitemata District Health Board.

Mr Tom Ruakere


Withdrawn Waitemata DHB University of Auckland

A GERAC/WDHB Mo Wai te Ora; Te Taumata Kaumatua o te Wai Awhina; JU Sherard; Nga Kai Tataki Research Advisory Group; Onepoto Awhina Community House

NTX/06/10/130 STOMP2-can a multimedia mobile phone programme help young people to stop smoking? Protocol 9/06: PIS/Cons V. 2/10/06: Pilot Study Q V#2, 18/12/06: PIS/Cons V#1, 30/11/06.

Dr Robyn Whittaker



A HRC Programme Grant

CTRU M ori Research Advisory Committee

NTX/06/10/131 The high dependency care course at Auckland City Hospital: an evaluation of the impact of the course on the knowledge, skills and attitudes of nursing staff who have completed the course: PIS/Cons V#3, 13/02/07.

Ms Kathy Wright



A Majority of funding: Rebecca Roberts Scholarship

ADHB MRRC

NTX/06/10/132 In the Children’s Emergency Department, does topical amethocaine increase the success of intravenous cannulation compared to EMLA and what are the cost implications? (summer studentship): PIS/Cons V#4, 19/12/06

Dr David Herd 14/09/2006 10/04/2006 Approved subject to conditions


A Summer studentship grant

ADHB MRRC

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NTX/06/10/133 Evaluation of a pilot smokefree and smoking cessation service for Asian smokers and their families registered with Harbour Primary Health Organisation (PHO): the Asian Smokefree Communities (ASC) project: PIS/Cons V#2, 9/11/06.

Dr Robyn Whittaker


Approved 23/11/2006 Harbour PHO Nil MoH/Waitemata DHB

N/A – Asian

NTX/06/10/134 A randomised, open-label study to compare the safety and efficacy of conversion from a calcineurin inhibitor to sirolimus versus continued use of a calcineurin inhibitor in cardiac transplant recipients with mild to moderate renal insufficiency: Protocol # 0468E7-408-GL: IB 8/06: PIS/Cons V#3, 16/11/06.

Dr Cara Wasywich


Approved 27/11/2006 Auckland DHB B Wyeth Pharmaceuticals

Auckland DHB MRRC

NTX/06/10/135 Clinical evaluation of a non-invasive fetal electrocardiographic monitor in pregnancy earlier than labour.

Prof Peter Stone


Approved 15/01/2007 University of Auckland Auckalnd DHB

A Maxima Medical Centre, Netherlands, financed computer hardware

ADHB MRRC letter of support

NTX/06/11/136 A prospective study to evaluate quality of life (QOL) for patients with cerebral metastases with and without whole brain radiation therapy (WBRT):PIS/Cons V#2, 13/11/06.

Dr Gillian Campbell


Approved 30/11/2006 Auckland DHB A Grant being sought from Genesis Oncology Trust

ADHB MRRC/ consultation Dr Sara Rishworth; Mr Kingi Davis Kaiatawhai at Mercy Hospice

NTX/06/11/137 An observational study assessing the activity of 5-Lipoxygenase in acute coronary syndrome and pharmacogenetic study: Protocol V#1, 21/08/06.

Dr Patrick Gladding

5/10/2006 11/01/2006 Deferred Funding not received Withdrawn Auckland DHB A Applied for from Auckland Medical Research Foundation

ADHB MRRC

NTX/06/11/138 A randomised placebo controlled crossover trial investigating an interaction between herbal medication and aspirin: PIS/Cons V#2, 18/12/06.

Assoc Prof Mark Webster


Approved 11/01/2007 Auckland DHB A Will come from National Heart Foundation

ADHB MRRC

NTX/06/11/139 The impact of a group exercise programme on usual walking performance following stroke. A single blinded randomised controlled trial: PIS/Cons V#3, 17/01/07.

Ms Suzie Mudge



A SAM units purchased/ fund for wages yet to be secured/ application to Neurological Foundation

ADHB MRRC

NTX/06/11/140 Communication and authority relationships in surgical teams. Is there a problem?

Dr Kathleen Callaghan


Approved 23/11/2006 University of Auckland Waikato Hospital

Nil Faculty of Medical & Health Sciences UoA summer studentship

Te Puna Oranga – Health Waikato letter of support

NTX/06/11/141 A measure of the quality of professional life and its relationship to individual and organisational resilience: PIS V#2, 17/11/06.

Mr Peter Huggard



Nil University of Auckalnd summer studentship process

ADHB MRRC

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NTX/06/11/142 Assessing safety culture by means of the safety climate survey.

Dr Kathleen Callaghan



Nil ADHB MRRC

NTX/06/11/143 Comparison of left and right ventricular volume measurements with real-time three-dimensional echocardiography and cardiac magnetic resonance imaging in congenital heart disease.

Ms Nee Scze Khoo


Approved 15/11/2006 Auckland DHB A ADHB ADHB MRRC

NTX/06/11/144 Study of the PFx closure system in subjects with cryptogenic stroke, transient ischaemic attack, migraine or decompression illness. The Paradigm 11ca Protocol CA0005 Rev C, 11/09/06: Prot/Amend Rev D, 20/02/07: IB Rev F, 14/02/07, PIS/Cons V#3, 23/02/07.

Dr Peter Ruygrok


Approved 23/11/2006 Auckland DHB B Cierra Inc ADHB MRRC

NTX/06/11/145 Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer: Protocol IBCSG 34.05/SWOG 0230 V Amend #4 Rev.4, 15/09/06,

Dr David Porter


Approved Subject to Conditions

Auckland DHB A ANZ BCTG data management costs; AstraZeneca supplying goserelin free of charge

ADHB MRRC

NTX/06/11/146 A randomised, open-label, controlled, multicentre, two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 ug with peg alpha-2a monotherapy and with telbivudine monotherapy in treatment naive patients with HBeAg-positive CHB: Protocol # CLDT600A2406, 26/07/06: IB Ed 9./0, 16/06/06: Prot/amend 1, 3/11/06: PIS/Cons V#3, 15/01/07.

Assoc Prof Ed Gane



B Novartis Pharmaceuticals

M ori Ethics Review Panel C-M DHB

NTX/06/11/147 A double-blind, parallel, randomised comparison of two doses of MitoQ and placebo for the treatment of patients with raised liver enzymes due to hepatitis C: Protocol MTQ-HC-001, 3/10/06 : IB Ed #3, 10/09/06: PIS/Cons V#2.0, 27/11/06: Admin/amend 3/10/06.



Approved 18/12/2006 Auckland DHB B Antipodean Pharmaceuticals

ADHB MRRC

NTX/06/11/148 Genetic associations with physical function in older adults: baseline and training-relations.

Dr Justin Keogh



11/12/2006 Auckland University of Technology

A Maria Rameka/ Dr Simeon Cairs; AUT

NTX/06/11/149 A phase 3, open-label, follow-on study of multiple courses of Aztreonam Lysinate for Inhalation (AI) in cystic fibrosis patients (AIR-CF3) Protocol CP-AI-006, 6/07/06: IB Ed 3, 15/12/04.

Dr John Kolbe 16/10/2006 11/01/2006 Approved subject to conditions


B Corus Pharma Inc ADHB MRRC

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NTX/06/11/150 Listening, seeing and doing: the relationship of cochlear implant recipient’s listening to, making meaning of and identifying music: PIS/Cons V#2, 18/11/06.

Mr Trevor Thwaites



A Funded by S Fennell

Auditory Department Greenlane Clinic/ Auckland DHB MRRC

NTX/06/12/151 Measurement of peak inspiratory flow rates in dyspnoeic patients.

Dr Joanne Ritchie



Counties Manukau DHB Auckland DHB

A Fisher & Paykel Healthcare

NTX/06/12/152 A randomised, double-blind, placebo-controlled, study of the effects of fluoride on bone turnover, bone density and bone histology in osteopenic post-menopausal women: PIS/Cons V#2, 13/12/06.

Dr Andrew Grey



A Researchers’ HRC programme grant

ADHB MRRC

NTX/06/12/153 Excella first-in-man study: a consecutive enrolment evaluation of the elixir novolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: Protocol ELX-CL-0602 Rev B 16/11/06: Protocol Rev C, 17/01/07: IB ELX-CL-0601 Rev B, 10/10/06: PIS/Cons V#2: Prot/ amend 1, 15/02/07 Rev C for OTC substudy: PIS/Cons V#1, 16/02/07.

Dr Mark Webster


Approved 8/02/2007 Auckland DHB Mercy Angiography Unit

B Elixir Medical USA ADHB MRRC/ ACH and Mercy Angiography

NTX/06/12/154 Phase III trial evaluating the role of adjuvant pegylated liposomal doxorubicin (PLD, Caelyx(r), Doxil (r) ) for women (age 66 years or older) with endocrine nonresponsibe breast cancer who are not suitable for being offered a ‘standard chemotherapy regimen’: Protocol IBCSG 32-05/BIG 1-05 V 1.0, 2/8/05: PIS/Cons V#2, 3/1/07.

Dr Vernon Harvey


Approved 7/02/2007 Auckland DHB Oncology 161

A $2000/patient, Schering-Plough will provide Caelyx

Mata Forbes/ ADHB MRRC

NTX/06/12/155 (Stage 1): A pre-screening initiative to assess HbA1c(%) values in subjects with type 2 diabetes mellitus and determine eligibility for a phase IIb clinical study with SGLT-2 inhibitor GSK189075 (KG2PS101: (Stage 2) A dose-ranging study of GSK189075 versus placebo in the treatment of type 2 diabetes mellitus in treatment naive subjects (KG2105255): (Substudy) Pharmacogenetic Research for the dose-ranging study of GSK189075 versus placebo in the treatment of type 2 diabetes mellitus in treatment naive subjects (KG2105255): Protocol KG2105255, 12/08/06:Protocol KG2PS101, 18/08/06: IB V#2, 11/08/06: IB suppl # 1, 14/08/06: PIS/Cons V#2, 15/12/06.

Dr Nick Gailer 14/11/2006 16/11/2006 Approved subject to conditions

Approved 22/02/2007 Greenhithe Medical Centre 5 Cross Roads Medical Centre Bairds Rd Family & Christian Health Centre

B GlaxoSmith Kline Bill Wiki; M ori Advisory Officer; Otara; Maori Research Advisor; North Shore Hospital/ J Armstrong; M ori Health Rotorua GP Group/ J Haoku; Te Puna Oranga

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NTX/06/12/156 The incidence and effect of tubing condensate during bi-level ventilation in the home.

Dr Andrew Veale

16/11/2006 12/06/2006 Withdrawn Sponsor decision Withdrawn Counties Manukau DHB

B Fisher & Paykel Healthcare

M ori Health Unit C-M

NTX/06/12/157 The ARV study – angiographic assessment of normal right ventricular morphology: Protocol V#1, 16/11/06: PIS/Cons V#4, 15/01/07.

Dr Jamil Ahmed


Approved 1/02/2007 Auckland DHB A Local funding – Auckland City Hospital Cardiology Department

ADHB MRRC

NTX/06/12/158 The psychological impact of genetic testing for long QT syndrome in children, adolescents, adults and their families: a New Zealand study: PIS/Cons V#3, 2/07.

Ms Sarah Watson


Approved 20/02/2007 Auckland DHB University of Auckland

A Limited resources from Department of Psychology, University of Auckland

Mata Forbes/ Erina Cooper/ ADHB MRRC

NTX/06/12/159 Is chronic obstructive pulmonary disease due to defective tissue repair? PIS/Cons V#2, 8/02/07.

Assoc Prof Peter Black



A Grant-in-aid from Asthma and Respiratory Foundation

Papaarangi Reid/ ADHB MRRC

NTX/06/12/160 A 24-week, double-blind, double-dummy, randomised, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease (REFLECT-1) Protocol No AVA105640, 15/08/06: IB V#01, 20/03/06: PIS/Cons V#2 14/12/06.

Dr Phil Wood 20/11/2006 12/06/2006 Approved subject to conditions

Approved 7/02/2007 Memory Clinic B GlaxoSmith Kline Nga Kai Taataki; Waitemata DHB

NTX/06/12/161 Linkage analysis, mutational analysis and characterisation of genes causing disease in corneal dystrophies, ectasias and anterior segment dysgenesis: PIS/Cons V#2 17/01/07.

Dr Andrea Vincent



A UoA Research Committee/ application to HRC/ NL Lotteries/ Auckland Medical Research Foundation

Mata Forbes, ADHB MRRC

NTX/06/12/162 The role of insulin-like growth factor 2 (IGF2) in growth and insulin resistance study: PIS/Cons V#2, 18/12/06.

Dr Rinki Murphy


Approved 11/01/2007 Liggins Institute Auckland DHB

A $37,800 grant RACP; $20,000 grant application Novo Nordisk Diabetes Grant scheme/further applications for AMRF/HRC

Karen Pratt; Turner Support Group; ADHB MRRC

NTX/06/12/163 A randomised, double-blind, multicentre, placebo-controlled study of adjuvant lapatinib in women with early-stage ErbB2 overexpressing breast cancer: Protocol EGF105485, 21/04/06: IB V#6, 30/03/06.

Dr Vernon Harvey


Approved 22/02/2007 Auckland DHB Oncology 161

B GlaxoSmith Kline ADHB MRRC

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Meeting reviewed



Date of approval



NTX/06/12/164 Removal of seclusion facilities in an inpatient rehabilitation facility – the effect on patients, staff and unit function.

Prof Rob Kydd 20/11/2006 12/06/2006 Approved subject to conditions


Counties Manukau DHB University of Auckland

A C-M DHB Mental Health Service Funds

C-M DHB MRRC

NTX/06/12/165 Assessment of bioactivity of dairy-derived proteins: screening trials to measure the effrects of a dairy protein bolus on satiety, energy intake and serum markers of appetite regulation and body weight control in a group of lean, healthy men: Protocol 24/01/07.

Dr Sally Poppitt

20/11/2006 12/06/2006 Deferred Op Stand para 13 2.4 Approved 22/02/2007 University of Auckland

B LactoPharma (Fonterra/ FoRST)

Assoc Prof Michael Walker; M ori Centre of Research Excellence; UoA; Dr Jason Turuwhenua; M ori in Science; UoA

Applications considered in ‘closed’ meetings Full title Primary

investigator Date

received Meeting reviewed



Date of approval



A phase 3, double-blind, multicentre, multinational, randomised, placebo-controlled trial evaluating Aztreonam lysinate for inhalation in cystic fibrosis patients with pulmonary P aeruginosa (AIR-CF1): Protocol CP-AI-007 V#3, 24/10/05: IB Ed 3, 15/12/04: Prot/amend V#4, 11/08/06.

Dr John Kolbe 16/01/2006 2/01/2006 Deferred Op stand Pt 2.5 Approved 19/04/2006 Auckland DHB University of Auckland

B Corus Pharma Inc ADHB MRRC

The life cycle of placental trophoblasts in health and diseases of pregnancy: PIS/V#1, 14/07/06.

Dr Larry Chamley



A ADHB MRRC

Novel method for identification of bacteria: PIS/Cons V#3, 13/12/06.

Assoc Prof Anthony Roberton

16/05/2006 6/07/2006 Deferred Paras 34–36 op standard


Nil ADHB MRRC

Effects of caffeine on cognitive (tested by task response times on a hand-held computer) and physical (tested by the time to run a 4–5 km course) function, observation vigilance (tested in observation-post (OP) simulated activities) and firing accuracy (on a live firing-range) and communications (through 3D- or similar type communication systems) on four-day three-night sleep-deprived soldiers simulated exercise: PIS/Cons V#2, 23/06/06.

Major David Voss


Approved 3/07/2006 NZ Army A C-M DHB MRRC

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Applications reviewed by the Chairperson under delegated authority


Date received

Meeting reviewed



Date of approval



NTX/06/01/CPD Do non-steroidal anti-inflammatory drugs interfere with the antiplatelet effects of aspirin (NADIA)? Protocol V#8, 30/01/06.

Dr Mark Webster

19/01/2006 Approved 30/03/2006 Auckland DHB Auckland City Hospital

A Greenlane Hospital Research and Education Fund

ADHB MRRC

NTX/06/02/CPD Survival from in-hospital cardiac arrest in Auckland City Hospital during 2004.

Ms Jennifer Miles

8/02/2006 Approved 13/03/2006 Auckland DHB Nil ADHB MRRC

NTX/06/03/CPD What are the levels of knowledge and actions of first aid undertaken by patients with regards to minor burns treatment prior to arrival at hospital?

Mr Parneet Gill 24/02/2006 Approved 23/05/2006 Nil

NTX/06/04/CPD Assessment of management of children with diabetes mellitus under the care of the Starship Endocrinology Service.

Dr Philippa Carter

11/05/2006 Approved 4/07/2006 University of Auckland Auckland DHB

Nil

NTX/06/05/CPD Variability in the measure of intraocular pressure in the aging New Zealand population: a retrospective study.

Ms Cindy Tsai 8/05/2006 Approved 5/07/2006 University of Auckland

Nil

NTX/06/06/CPD Is explortion mandatory for penetrating zone II injuries of the neck?

Mr Phillip Insull

30/05/2006 Approved 5/07/2006 Counties Manukau DHB

Nil

NTX/06/07/CPD Autism and music therapy: one child’s journey through the process of music therapy: PIS/Cons V#1, 15/06/06.

Ms Anna Melissa Maitland

27/06/2006 Approved 1/08/2006 Massey University Nil No consultation as yet until researcher knows which cultural group her participants will identify with

NTX/06/08/CPD Review of the adherence to guidelinges of therapeutic treatment of acute gout at a busy New Zealand emergency department.

Dr Andrew Williams


Nil

NTX/06/09/CPD Review of clinical details, histopathology and outcome of childhood medulloblastoma at Starship Hospital.

Dr Hui Lau 12/07/2006 Approved 12/06/2006 Auckland City Hospital

Nil

NTX/06/10/CPD Benchmark 2 counterpulsation outcomes registry.

Mr Tim Willcox 8/05/2006 Approved 31/05/2006 Auckland DHB A

NTX/06/11/CPD An approach to risk reduction and risk management for cardiovascular disease and type 2 diabetes with nurse leadership in primary care.

Assoc Prof Margaret Horsburgh

31/05/2006 Approved 27/07/2006 University of Auckland

Nil

NTX/06/12/CPD A retrospective audit of early neurologic deficits following obstetric epidurals at National Women’s Hospital.

Dr Anna Mary St.Clair Inglis

30/05/2006 Approved 31/07/2006 Auckland DHB A

NTX/06/13/CPD Comparison of assertive community treatment (ACT) model in the UK, USA, New Zealand and Canada.

Ms Jane Vanderpyl


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Date received

Meeting reviewed



Date of approval



NTX/06/14/CPD Blood conservation audit in the paediatric intensive care unit.

Ms Laura-Clare Whelan

13/07/2006 Approved 8/08/2006 Auckland DHB Nil

NTX/06/15/CPD Are some of the re-admissions to intensivecare and high dependency preventable? A retrospective study of the readmission to Mercy Ascot intensive care and high dependency units for the year of 2006.

Mr Steve Kirby 18/08/2006 Approved 30/08/2006 University of Auckland

Nil N/A – retrospective review

NTX/06/16/CPD Paediatric pre and post septal periorbital infections are different diseases: a retrospective review of 262 cases.

Dr Andrew Botting


NTX/06/17/CPD Ther burden of renal disease in Maori with diabetes in South Auckland.

Dr Mark Marshall


A

NTX/06/18/CPD The Counties-Manukau Community House haemodialysis initiative: clinical experience.

Dr Mark Marshall


A

NTX/06/19/CPD Analysing the potential of anti-inflammatory therapeutics for the treatment of macular degeneration.

Dr Kaa-Sandra Chee

16/10/2006 Approved Subject to Conditions

University of Auckland Counties Manukau DHB

A W&B Hadden Endowment; consumables by School of Medicine Foundation Grant

Sue Raynel (Tuhoi); Gwen Te Pania-Palmer; Department M ori Pacific Health; UoA; Mata Forbes; Colin Mantell; Assoc Prof Paparangi Reid

NTX/06/20/CPD Auckland, Waitemata and Counties Manukau DHBs Child and Youth Pathway of Care project.

Dr Hugh Clarkson


A

NTX/06/21/CPD Eye care in paediatric intensive care patients.

Ms Michelle Fisher

24/10/2006 Approved 13/11/2006 A

NTX/06/22/CPD A prognostic study of people with somatoform disorders.

Dr Simon Hatcher

18/10/2006 Approved 13/11/2006 A

NTX/06/23/CPD Chest drain insertion versus video assisted thorascopic surgery for the treatment of paediatric empyema.

Mr John Corboy

17/10/2006 Approved 13/11/2006 A

NTX/06/24/CPD Nutrition labels: understanding and use by ethnicity and income in New Zealand: PIS V#2, 13/12/06, Survey V#3, 20/12/06.

Dr Cliona Ni Mhurchu

17/11/2006 Approved 8/01/2007 University of Auckland Waitemata DHB

A – M ori Advisory Research Committee; University of Auckland

NTX/06/25/CPD School-based immunisation: a study of the effect of different communications about the MeNZB(tm) vaccine in Auckland schools.

Dr Nikki Turner

20/11/2006 Approved Subject to Conditions

University of Auckland Counties Manukau DHB Waitemata DHB

A University of Auckland summer studentship fund

Kia Mataara Well Health Taumata Waitemata DHB/ C-M DHB

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NTX/06/26/CPD Retrospective clinical audit, comparing published data on bronchiolitis from 1991–1994 with bronchiolitis ventilation and management statistics 2003–2006.

Ms Cate Richards

30/11/2006 Approved 4/12/2006 A

NTX/06/27/CPD An audit of patient clinical notes for acute disseminated encephalomyelitis (ADEM) admitted to the paediatric ICU.

Mr Tavey Dorofaeff

22/11/2006 Approved 4/12/2006 Nil

NTX/06/28/CPD Child pedestrian injuries: reducing the before-and after-school injury peaks.

Mr James Hamill


NTX/06/29/CPD Do patients with ACD (Alvcolar Capillary Dysplasia) and other infants that require ECMO (extra corporeal membrane oxygenation) have appreciable differences with regard to physiology or degree of pulmonary hypertension or branch pulmonary artery size. An audit of the experience of Starship Children’s Hospital Paediatric Intensive Care.

Mr Tavey Dorofaeff


NTX/06/30/CPD PORT study (patient outcomes in renal transplant).

Dr Helen Pilmore


NTX/06/31/CPD Management of community acquired pneumonia – are two antibiotics justified?

Dr Rajiv Gupta 13/12/2006 Approved 13/12/2006 Nil

NTX/06/32/CPD Charcot foot and ankle in South Auckland population.

Dr May Ching Soh

11/12/2006 Approved 14/12/2006 Nil

NTX/06/33/CPD High frequency probe tone tympanometry in normal hearing infants within the ages of one to five months.

Dr Andrea Kelly

12/12/2006 Approved 19/12/2006 University of Auckland Auckland DHB

A

NTX/06/34/CPD Finding evidence of integrative practice between primary and secondary mental health services using a retrospective file audit to identify relevant clinical processes from text, forms and documents.

Mr Tom Woods


NTX/06/34/CPD Finding evidence of integrative practice between primary and secondary mental health services using a retrospective file audit to identify relevant clinical processes from text, forms and documents.

Mr Tom Woods


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Appendix 2: Northern X Regional Ethics Committee Terms of Reference

Public authority of the Northern X Regional Ethics Committee

The Northern X REC is established as a Ministerial committee under section 11 of the New Zealand Public Health and Disability Act 2000. These Terms of Reference outline the role and functions of the Northern X REC.

Authority of the Northern X Regional Ethics Committee

The Northern X REC shall have responsibility for ethics committee review of health and disability research and innovative practice occurring in the following District Health Board regions: • Northland • Waitemata • Auckland • Counties Manukau • Waikato • Tairawhiti • Lakes • Bay of Plenty. The Northern X REC is jointly responsible with the Northern Y Regional Ethics Committee for any health and disability research that is currently being undertaken in the above DHB regions, provided that such research has previously been given ethical approval by an approved regional ethics committee.

Relation to the Operational Standard for Health and Disability Ethics Committees

These Terms of Reference have precedence over the Operational Standard for Health and Disability Ethics Committees (Operational Standard) on any point of conflict, but otherwise, the Operational Standard applies to the Northern X REC.

Relations with other public sector organisations

The Northern X REC shall liaise with other relevant ethics committees on matters of common interest, such as jurisdiction over borderline cases. The Northern X REC shall inform the Ministry of Health and the National Ethics Advisory Committee of any matters that arise in its operation that potentially have policy significance.


Approval of the Northern X Regional Ethics Committee

The Northern X REC has to be approved for the purposes outlined in the following enactments: • the Injury Prevention, Rehabilitation, and Compensation Act 2001 • the Health Research Council Act 1990 • the Health Information Privacy Code 1994.

Role of the Northern X Regional Ethics Committee

The primary role of the Northern X REC is to provide independent ethical review of health research and innovative practice that will be conducted in its region of authority to safeguard the rights, health and wellbeing of consumers and research participants and, in particular, those persons with diminished autonomy. In order to do this, the Northern X REC shall:

i. foster an awareness of ethical principles and practices in the health and disability sector and research community

ii. facilitate excellence in health research and innovative practice for the wellbeing of society

iii. collaborate with researchers to ensure the interests, rights, dignity, welfare, health, and wellbeing of participants and consumers are protected

iv. give due consideration to community views

v. consistent with section 4 of the New Zealand Public Health and Disability Act 2000 and He Korowai Oranga, recognise and respect the principles of the Treaty of Waitangi

vi. operate in accordance with the Operational Standard for Health and Disability Ethics Committees

vii. operate in accordance with any guidance issued or approved by the Minister of Health.

Composition and membership

Guiding principle

The primary guiding principle for appointing members to the Northern X REC is to ensure that the Northern X REC has the appropriate expertise, skills, knowledge and perspectives to conduct ethical review of the best quality.

Member numbers

The number of members of the Northern X REC should be 12.


Lay/non-lay membership

One half of the total membership shall be lay members, including a lay Chairperson and a non-lay Deputy Chairperson. A lay person is a person who is not:

• currently, nor has recently been, a registered health practitioner (for example, a doctor, nurse, midwife, dentist, pharmacist)

• involved in conducting health or disability research or who is employed by a health agency and who is in a sector of that agency which undertakes health research

• construed by virtue of employment, profession or relationship to have a potential conflict or professional bias in a majority of protocols reviewed.

Member categories

The Northern X REC’s lay membership shall include: • an ethicist • a lawyer • consumer perspectives • community perspectives. The Northern X REC’s non-lay members shall include: • two health researchers • a pharmacist or pharmacologist • a biostatistician • two health practitioners.

Whole committee requirements

At any time, consistent with the requirements of the New Zealand Public Health and Disability Act requirements for District Health Boards, the Northern X REC shall have at least two Māori members. Māori members should have a recognised awareness of te reo Māori and an understanding of tikanga Māori. All members of the Northern X REC are expected to have an understanding of how the health sector responds to Māori issues and their application to ethical review. The Northern X REC’s membership should include expertise in the main kinds of health and disability research (for example, interventional, observational, kaupapa Māori and social research) and in both quantitative and qualitative research methods. Members should possess an attitude that is accepting of the values of other professions and community perspectives, and it is important for the committee to be comprised of people from a range of backgrounds and ethnicities.


Despite being drawn from groups identified with particular interests or responsibilities in connection with health and community issues, Northern X REC members are not in any way the representatives of those groups. They are appointed in their own right, to participate in the work of the Northern X REC as equal individuals of sound judgement, relevant experience and adequate training in ethical review.

Terms and conditions of appointment

Members of the Northern X REC are appointed by the Minister of Health, pursuant to section 11 of the New Zealand Public Health and Disability Act 2000, for a term of office of up to three years. The terms of office of members of the Northern X REC shall be staggered to ensure continuity of membership. Members may be reappointed from time to time. No member may hold office for more than six consecutive years. After serving the maximum six-year term, members shall not be considered for reappointment until at least three years after their retirement from the Northern X REC. Persons who have served six consecutive years on any Health Research Council (HRC)-approved ethics committee shall not be immediately eligible for appointment to the Northern X REC. Those persons shall not be eligible for appointment to the Northern X REC until at least three years after their retirement from any HRC-approved ethics committee. Persons who have served less than six years on any HRC-approved ethics committee will be eligible to be appointed to the Northern X REC for a term that is equal to the difference of six years and the term already served by that person on any HRC-approved ethics committee or a shorter period. A person may not be a member of the Northern X REC and National Ethics Advisory Committee or the Health Research Council Ethics Committee simultaneously. Unless a person sooner vacates their office, every appointed member of the Northern X REC shall continue in office until their successor comes into office. Any member of the Northern X REC may at any time resign as a member by advising the Minister of Health in writing. Any member of the Northern X REC may at any time be removed from office by the Minister of Health for inability to perform the functions of office, bankruptcy, neglect of duty, or misconduct, proved to the satisfaction of the Minister. The Minister may from time to time alter or reconstitute the Northern X REC, or discharge any member of the Northern X REC, or appoint new members to the Northern X REC for the purpose of decreasing or increasing the membership or filling any vacancies.

Chairperson and Deputy Chairperson

The Minister shall appoint a member of the Northern X REC to be its Chairperson. The terms and conditions of appointment for a member of the Northern X REC also apply to the person appointed as Chairperson. The Chairperson shall preside at every meeting of the Northern X REC at which they are present.


The Northern X REC shall appoint a non-lay member as Deputy Chairperson. The Chairperson and Deputy Chairperson may act with the delegated authority of the Northern X REC between meetings.

Duties and responsibilities of a member

This section sets out the duties and responsibilities generally expected of a person appointed as a member of the Northern X REC. This is intended to aid Northern X REC members by providing them with a common set of principles for appropriate conduct and behaviour.

General

Northern X REC members should have a commitment to protecting the interests of human participants while promoting and facilitating excellence in research and innovative practice. There is an expectation that Northern X REC members will make every effort to attend all Northern X REC meetings and devote sufficient time to become familiar with the affairs of the Northern X REC and the wider environment within which it operates. Members have a duty to act responsibly with regard to the effective and efficient administration of the Northern X REC and the use of Northern X REC funds.

Conflicts of interest

Northern X REC members should perform their functions in good faith, honestly and impartially and avoid situations that might compromise their integrity or otherwise lead to conflicts of interest. Proper observation of these principles will protect the Northern X REC and its members and will ensure it retains public confidence. Northern X REC members attend meetings and undertake Northern X REC activities as independent persons responsible to the Northern X REC as a whole. Members are not appointed as representatives of professional organisations or particular community bodies. The Northern X REC should not, therefore, assume that a particular group’s interests have been taken into account because a Northern X REC member is associated with this group. Members should declare, and the committee regularly review their actual and potential conflicts of interest. When Northern X REC members believe they have a conflict of interest on a subject that will prevent them from reaching an impartial decision or from undertaking an activity consistent with the Northern X REC’s functions, they should declare that conflict of interest and withdraw themselves from the discussion and/or activity.


A member of the Northern X REC who has a proposal before the Northern X REC or who has an involvement in the proposal such as a supervisory role shall not take part in the Northern X REC’s assessment of that proposal. The member may be present to answer questions about a proposal but should take no part in the discussion surrounding the consideration of the proposal or any decision relating to the proposal. This will allow proposals to be considered in a free and frank manner. The Northern X REC must exhibit transparency in avoiding or managing any real or perceived conflict of interest.

Confidentiality and information sharing

Agendas and minutes of all Northern X REC meetings should be available to the public. Copies of proposals should be available to individuals outside the Northern X REC, subject to deletions in accordance with the Official Information Act 1982, and any deletions necessary to protect the privacy of individual persons. If an applicant would like their proposal to remain confidential, they must give reasons, consistent with the Official Information Act 1982, to satisfy the Northern X REC that the proposal should remain confidential. The reasons for keeping a proposal confidential are subject to review by the Ombudsmen. It is desirable for the members of the Northern X REC to have an opportunity to discuss issues arising from applications with key contacts and support people prior to the consideration of proposals. This process should be encouraged. However, due to the need to protect any personal information, names or identifying details should not be circulated or made known outside the Northern X REC. The Northern X REC will need to consider the Privacy Act 1993 and the Health Information Privacy Code 1994 in developing these processes. Within the Northern X REC, members with particular community expertise should be consulted and provide advice on the appropriate consultative process for all ethical issues concerning particular communities of interest.

Committee meetings

Meetings of the Northern X REC shall be held monthly or less frequently, as determined by the workload. At any meeting, a quorum shall consist of at least six members or the minimum number constituting a majority. The quorum must include a reasonable representation of members with health practitioner, research, ethical and community/consumer expertise, knowledge and perspectives. As part of the accountability to the public they protect, it is desirable for the meetings of the Northern X REC to be open to the public. Meetings of the Northern X REC should therefore be:


i. open meetings for the discussion of broad issues, particularly if the Northern X REC is reviewing health research

ii. closed meetings when necessary to ensure the privacy and confidentiality of participants

iii. closed meetings when applicants provide good and sufficient reasons for this to occur, and the minutes of the meeting should reflect these reasons.

Information about the dates and times of committee meetings should be made available to the public. Applicants may attend meetings, in person or by teleconference, to talk to their proposal and answer any questions the Northern X REC may have. Attendance is not mandatory. The Northern X REC should advise applicants that they may be asked to leave the meeting while the Northern X REC considers the proposal. Subject to the provisions set out in this document, the Northern X REC may regulate its own procedures.

Decision-making process

Wherever possible, the Northern X REC should determine matters by consensus decision. Where a consensus cannot be reached, a vote shall apply, with a two-thirds majority of those voting required for any decisions, and the Chairperson having a casting vote. In relation to research involving Māori, it is important that Māori expertise be available to ensure that all issues are appropriately considered. Where it is not possible for Māori members to attend a Northern X REC meeting or for those members views to be sought and represented at the meeting, the matter should be deferred. On occasion, individual members may wish to abstain from some or all of the decision-making process because of strong personal moral or religious reasons. Such abstentions shall not affect the approval process.

Ethics committee actions

For each application it reviews, the Northern X REC must state to its applicant whether its action is to approve, approve subject to conditions, defer, or decline that application. It must state its grounds for any action to defer or decline. For any action to approve subject to conditions, it must specify the conditions, the grounds for these, and its process for assessing whether these conditions are subsequently met. In all cases, it must state which matters its action is based upon, and which are instead matters of comment, information, or advice to its applicant.


Expert advice and consultation

Members may wish to consult on ethical issues with, for example, individuals, groups, iwi and hapū, and this should be encouraged and supported. Consultation should be carried out in a timely manner. Where the Chairperson or quorum of Northern X REC members believes there is insufficient expertise on the Northern X REC to assess an application or an issue, the committee should seek additional expert advice. Advice may be sought from recognised experts with: i. specialist knowledge in particular fields of science and medicine ii. knowledge of the experiences and perspectives of people with disabilities iii. awareness of gender health perspectives iv. consumer and/or research participant perspectives v. an understanding of community health issues vi. an understanding of relevant cultural perspectives vii. an understanding of developing Māori research methodologies viii. expertise in te reo Māori ix. expertise in ethical theory. It should be noted that the above list gives examples, without restricting the range, of external expertise that may be sought. Where external consultation has taken place or advice has been sought, this should be documented, and recorded where appropriate in the Northern X REC’s decision on a proposal.

Second opinions and appeals

At any stage in its deliberations, the Northern X REC may seek a second opinion from the Health Research Council Ethics Committee, in accordance with the Operational Standard. The decisions of the Northern X REC may be appealed to the Standing Committee on Appeals convened by the National Ethics Advisory Committee, in accordance with the Terms of Reference of the National Ethics Advisory Committee and any guidance promulgated by the Standing Committee on the appeals process.

Training for members

Training should be provided for new members and chairpersons within six months of appointment to the Northern X REC.


Reporting requirements

The following provides a checklist of requirements for annual reporting. Annual reports should be submitted to the Minister of Health and will be tabled by the Minister of Health in the House of Representatives. The annual report shall include information on the membership of the Northern X REC, including any change in the Northern X REC’s membership or other substantive changes the Northern X REC or its chairperson feels should be noted. The annual report shall also include a list of the national and multi-region research and innovative treatment protocols reviewed in the preceding year outlining the following details: i. the research title ii. principal investigator iii. institutions where the research is to be/has been undertaken iv. date of first review v. date of final outcome vi. outcome (which will be one of: approved, approved subject to conditions, deferred,

declined) vii. for each protocol deferred or declined, the reason(s) for the decision. The annual report shall also include:

i. A list of training undertaken by Northern X REC members, and a statement on processes for orientation and training of new Northern X REC members should be included.

ii. A list of complaints received by the Northern X REC (if any), the actions taken to resolve the complaint and a comment on the outcome of the complaint(s).

iii. Any areas of review that caused difficulty for the Northern X REC in making a decision on any particular protocol(s), and any questions on policy or other matters the Northern X REC referred to the National Ethics Advisory Committee or the Health Research Council Ethics Committee for comment or guidance.

In compiling annual reports, the Northern X REC should take care not to provide information that would involve a breach of the Privacy Act 1993 and/or the Health Information Privacy Code 1994.

Fees and allowances

Members of the Northern X REC are entitled to be paid fees for attendance at meetings. The level of attendance fees are set in accordance with the State Services Commission’s framework for fees for statutory bodies.


The Chairperson shall receive an attendance fee of $330 per day (plus half a day’s preparation fee). The attendance fee for members is set at $250 per day (plus half a day’s preparation fee). The Chairperson and Deputy Chairperson shall receive an allowance of up to one extra day each per month to cover additional work undertaken under the delegated authority of the Northern X REC by the Chairperson and Deputy Chairperson. The Ministry of Health shall pay actual and reasonable travel and accommodation expenses of the Northern X REC members.

Servicing of the Northern X Regional Ethics Committee

The Ministry of Health shall employ staff and provide resources to service, advise and administer the Northern X REC out of the allocated budget for ethics committees.

HealthandDisabilityEthicsCommittees

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