Multi-region Ethics Committee

Annual Report

2008

Published in September 2009 by the Ministry of Health PO Box 5013, Wellington, New Zealand

ISBN 978-0-478-31987-3 (print) ISBN 978-0-478-31988-0 (online) HP 4941

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

Contents

Chairperson’s Report 1

Committee Membership 3

Response to Cultural Issues 11

Applications 12

Issues 14

Guidelines for Chairperson’s Delegation 15

Appendix 1: Multi-region Ethics Committee Terms of Reference 16

Appendix 2: Applications Received in 2008 26

Multi-region Ethics Committee Annual Report 2008 iii

Chairperson’s Report

This report summarises the activities of the Multi-region Ethics Committee from 1 January to 31 December 2008. The report was presented to the committee at its meeting on 21 July 2009.

The report gives details of the applications considered for ethical evaluation during the 2008 calendar year. In 2008, 237 applications were received, of which 164 applications were considered by the full committee, and 72 expedited review applications were reviewed by a deputy chairperson or subcommittee under delegated authority. One application was withdrawn before review.

On average, each full meeting reviewed 13 applications. In circumstances similar to those mentioned in the 2006 and 2007 annual reports, an extra meeting was needed in October. Thus, monthly meetings always contained a full agenda that required considerable organisation on the part the committee’s two administrators. For this input, the administrators have the committee members’ commendation and appreciation.

Two new members, Dr John Baker and Dr Paul Copland, joined the committee in August, replacing Dr Simon Jones whose term expired in June 2008 and Dr Martin Tolich who resigned in November 2007. The committee thanks them for their contribution to the committee.

A requisite quorum of at least seven members, made up from a mix of lay and non-lay members, was achieved for all meetings except one where adverse weather interfered with previously booked travel arrangements. The work on this agenda was re-scheduled to a later date.

Notwithstanding the recruitment activity noted above, delays in the appointment of new members to health and disability ethics committees remain a problem. The appointment of chairpersons is a particularly troublesome matter where the absence of appropriate succession planning, together with the very limited opportunities to mentor such individuals, has the potential to threaten both the continuity and effective functioning of these committees. It may be that the length of term of appointment for chairpersons needs to be considered separately, so the experience of longer-serving members can be more flexibly utilised.

The persistence of concern around this area can be illustrated by reference to last year’s annual report of the Multi-region Ethics Committee where it was noted by the then chairperson, Dr Martin Tolich, that: The chair’s request for an efficient reappointment process was not fulfilled. In 2007, rather than the appointment transition occurring in December, these appointments did not occur until March 2008. This process was unsatisfactory in 2006, and continues to be unsatisfactory in 2007.

Multi-region Ethics Committee Annual Report 2008 1

The matter of the inflexibility around appointing chairpersons was brought to a head after Dr Tolich resigned as inaugural chairperson in November with his last meeting in January 2008. For the period up to and including the May meeting, meetings were chaired by deputy chairperson Associate Professor Cynthia Darlington after which the role fell to Dr Barry Smith (the second deputy chairperson) for the remainder of the year. This does not seem to be a satisfactory situation in terms of the appointment process.

Another issue of continuing concern for committee members lies with the inadequacies seen in the way applicants engage with Māori. In a noticeable proportion of applications, the quality of Māori consultation is either absent or at best perfunctory. This aspect of health research in New Zealand requires improvement given the degree of disparity in health status between Māori and other segments of New Zealand’s population. It is hoped that action around the development of a Māori ethics framework being consistently requested by Māori members of the health and disability ethics committees will lead to a greater understanding of the issues involved.

Changes in the organisation of health research along with developments in medical technology continue to raise challenges for those involved in ethical evaluation. However, the broad range of backgrounds and the combined expertise of members of the Multi-region Ethics Committee and its administrative support have enabled it to deal effectively with a wide range of ethical matters. As the acting chairperson, I express my warm appreciation for the unswerving level of commitment and care all members display to this important task.

Barry Smith Acting Chairperson

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Committee Membership

Appointments

The Minister of Health appointed the following committee members under section 11 of the New Zealand Public Health and Disability Act 2000.

Chairperson (January) Martin Tolich BA (Auck), MA (Auck), PhD (California, Davis) Representation Lay member Member category Ethicist Gender Male Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2008 Professional affiliations Programme co-ordinator, sociology, Anthropology Department, University of Otago Iwi affiliations None

Deputy chairperson Cynthia Darlington BA (Class I), PhD (Sydney) Representation Non-lay member Member category Pharmacist/pharmacologist Gender Female Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2010 Professional affiliations Department of Pharmacology and Toxicology, University of Otago; Editorial Board, CNS Editor, current opinion in investigational drugs Iwi affiliations None

Deputy chairperson (elected July 2008) Barry Smith QSM, BSc, MPhil (Auck), PhD (Essex), GradDipArts (Music) (Waik) Representation Lay member Member category Community representative, Māori Gender Male Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2007 Expertise Research methods, research ethics, Māori research

Multi-region Ethics Committee Annual Report 2008 3

Professional affiliations National School of Performing Arts; Te Wānanga o Aotearoa ki Rotorua; chairperson, Lakes District Health Board Research and Ethics Committee; social research consultant Iwi affiliations Te Rarawa, Ngāti Kahu

Members Maliaga Erick Degree in social work, Graduate Certificate in Dual Diagnosis 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 Professional affiliations Auckland District Health Board Iwi affiliations Niuean

Graham Mellsop MBChB (Otago), DPM, MD (Melb), FRANZCP 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 2009 Professional affiliations Royal College of Psychiatrists; professor of psychiatry, Waikato Clinical School, Faculty of Medical and Health Services, University of Auckland Iwi affiliations None

Sheila Williams BSc (Hons) (Hull), PGDipSc (Otago), DSc (Otago) Representation Non-lay member Member category Biostatistician Gender Female Date of appointment November 2004 Term of appointment 3 years Six-year maximum term November 2010 Professional affiliations Department of Preventative and Social Medicine, University of Otago Medical School Iwi affiliations None

Christopher Wynne MBChB (Otago), FRANZCR, FAChPM Representation Non-lay member Member category Health practitioner Gender Male Date of appointment November 2004 Term of appointment 3 years Retirement date July 2010

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Professional affiliations Clinical director, consultant radiation oncologist, Oncology Service, Christchurch Hospital; oncologist, Canterbury Breastcare; clinical investigator, Christchurch Clinical Studies Trust Iwi affiliations None

Carolyn Weston QSM Representation Lay member Member category Consumer representative Gender Female Date of appointment November 2004 Term of appointment 2 years Six-year maximum term November 2009 Expertise Disabilities, advocacy Iwi affiliations None

Georgina Johnson GDipNFP (Unitec) Representation Lay member Member category Community representative, Māori Gender Female Date of appointment July 2005 Term of appointment 3 years Six-year maximum term July 2011 Professional affiliations Executive member, National Association of Out of School Care and Recreation; executive member, Tairawhiti Youth Workers Collective; Māori Women’s Welfare League Iwi affiliations Ngāti Porou, Ngāti Raukawa

Margaret Horsburgh RN, BA, Dip Education, MA (Auck), EdD (Charles Stuart), ANZAME Representation Non-lay member Member category Health practitioner Gender Female Date of appointment December 2006 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliations Associate professor of nursing, University of Auckland; College of Nurses Aotearoa; Institute of Directors; Spectrum Care Trust; Expert Advisory Group on Primary Health Care Nursing; Performance-Based Research Fund Health Panel for the Tertiary Education Commission Iwi affiliations None

Richman Wee LLB, LLM (Houston), PGDipArts (Phil) Representation Lay member Member category Lawyer Gender Male Date of appointment December 2006 Term of appointment 3 years Six-year maximum term December 2012

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Professional affiliations Project manager for the Human Genome Research Project, University of Otago; advisory committee member for Asian Health Research and Evaluation, University of Auckland Iwi affiliations None

Russell Franklin MBChB (Otago), PhD (Monash), FRACP Representation Non-lay member Member category Health practitioner Gender Male Date of appointment June 2007 Term of appointment 3 years Six-year maximum term June 2013 Professional affiliations: Managing director of Corporate HealthCare; Child and Youth Mortality Review Committee Iwi affiliations None

Helen Moriarty MBChB (Otago), MGP (Otago), DPH (Otago), PGCertHealSc (Otago), PGDipTertT (Otago), FNZCGP, FAChM, RACP Representation Non-lay member Member category Health practitioner Gender Female Date of appointment June 2007 Term of appointment 3 years Six-year maximum term June 2013 Professional affiliations Senior Lecturer, Primary Health Care and General Practice, Wellington School of Medicine; EACD, ALAC Council Iwi affiliations None

Members (January–July 2008) Simon Jones MBChB (Bristol), Dip FFP, RCOG, MRCOG, FRANZCOG Representation Non-lay member Member category Health practitioner Gender Male Date of appointment July 2005 Term of appointment 3 years Six-year maximum term July 2008 Professional affiliations Consultant gynaecologist, Christchurch Women’s Hospital; specialist, The Oxford Clinic, Christchurch; senior clinical lecturer, University of Otago; Faculty of New Zealand Institute of Advanced Laparoscopic Surgery Iwi affiliations None

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Members (appointed August 2008) John Baker BSc (Hons) (chemistry), MBChB (Otago), FRACP, FRCPA Representation Non-lay member Member category Health practitioner Gender Male Date of appointment August 2008 Term of appointment 3 years Six-year maximum term August 2014 Professional affiliations Clinical director, Clinical Trials Unit at Middlemore Hospital; Diabetes Projects Trust Iwi affiliations None

Paul Copland PhD (Otago) Representation Lay member Member category Ethicist Gender Male Date of appointment August 2008 Term of appointment 3 years Six-year maximum term August 2014 Professional affiliations None Iwi affiliations None

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Members’ attendance at committee meetings

Table 1: Attendance of members at Multi-region Ethics Committee meetings, 2008

Member Sex Lay or Date of meeting Total non-lay member 22 19 18 15 20 17 15 19 16 14 21 18 9 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Oct Nov Dec

Martin Tolich (ethicist) M L Y Resigned January 2008 1/1

Cynthia Darlington F N NS Y Y Y Y A Y Y Y Y Y Y NS 10/13 (pharmacist/pharmacologist)

Maliaga Erick F L Y Y Y Y Y Y Y A A A A A Y 8/13 (consumer representative)

Barry Smith* M L Y Y Y Y Y Y Y Y A Y Y Y Y 12/13 (community representative)

Graham Mellsop# M N Y NS NS Y Y NS T NS Y A Y Y NS 7/13 (health practitioner)

Sheila Williams F N Y Y A NS Y Y Y Y A A Y Y Y 9/13 (biostatistician)

Christopher Wynne# M N NS Y Y Y Y Y NS Y Y Y Y NS Y 10/13 (health practitioner)

Carolyn Weston F L NS Y T Y Y Y Y Y Y Y Y Y Y 12/12 (consumer rep)

Simon Jones# M N Y Y A Y NS Y Completed term July 2008 4/6 (health researcher)

Georgina Johnson* F L Y Y Y Y Y Y Y Y Y Y Y Y Y 13/13 (community representative)

Margaret Horsburgh# F N Y Y NS NS Y NS Y Y NS A Y Y Y 8/13 (health practitioner)

Richman Wee M L Y A Y A Y Y Y Y Y A A Y A 8/13 (lawyer)

Russell Franklin# M N Y Y Y Y Y Y Y Y NS Y Y Y Y 12/13 (health practitioner)

Helen Moriarty# F N Y Y Y Y Y T Y Y Y T NS NS Y 11/13 (health practitioner)

John Baker# Appointed August 2008 Y NS Y Y Y 4/5 (health researcher)

Paul Copland Appointed August 2008 Y Y Y Y Y 5/5 (ethicist)

Additional expertise

Helen Colebrook Y

No. of members present 11 11 9 10 12 10 11 10 9 9 11 11 11

No. of applications 15 10 15 15 14 8 15 12 13 11 15 11 10 164

Key A = apology F = female L = lay member M = male N = non-lay member NS = not scheduled to attend (rotating member) T = teleconference Y = present # = rotating member * = Māori member

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Training

New member training Training for new members of the health and disability ethics committees and new administrators was held in April and November 2008.

The April training was attended by: • Russell Franklin • Helen Moriarty.

The November training was attended by: • John Baker • Paul Copland.

Ongoing training Ongoing training for members was held in Wellington, 16–17 May 2008. Topics included:

• the role of the Standing Committee on Therapeutic Trials

• reviewing phase I and II studies

• xenotransplantation, the role of the Gene Technology Advisory Committee, committees and the Minister of Health

• the use of tissue – controlling samples

• qualitative research – observational studies review

• how to feed information back to researchers in a positive manner.

Chairpersons’ meetings Barry Smith attended the chairpersons’ meetings on 31 January, 27 June, and 13–14 November 2008.

Cynthia Darlington attended the chairpersons’ meeting on 13–14 November 2008.

Committee forums The Multi-region Ethics Committee together with the regional committees based in Auckland, Wellington, and Dunedin held open forums for the research community in July and August 2008.

New Zealand Bioethics Conference Barry Smith attended the New Zealand Bioethics Conference held in Dunedin, 2–3 February 2008.

Multi-region Ethics Committee Annual Report 2008 9

Twenty Years after the Cartwright Report: What have we learnt? Margaret Horsburgh attended the Twenty Years after the Cartwright Conference held on 29 August 2008 in Auckland.

Ninth Global Forum on Bioethics in Research Barry Smith and Helen Moriarty attended the Ninth Global Forum on Bioethics in Research in Auckland, 3–5 December 2008.

The theme of the forum was the ethics of research involving indigenous people and vulnerable populations.

Change to the terms of reference

The terms of reference for the ethics committees (see Appendix 1) were changed in July 2008. 1. While the Committees’ primary responsibility for applications within their jurisdiction remains unchanged, any other regional ethics committee or the Multi-region Ethics Committee may now, if it has capacity, review multi-region and national health and disability research or research from any region. 2. Committees may choose to elect a second Deputy Chairperson. The second Deputy Chairperson may either be a health professional or a lay member. 3. The Chairperson and Deputy Chairpersons may claim an allowance of up to four days per month for additional work between meetings. 4. Committee decisions may be reviewed by the Health Research Council Ethics Committee under the Health Research Council Act 1990.

Health Research Council approval

The Health Research Council approved the Multi-region Ethics Committee until December 2010.

United States Department of Health and Human Services registration

The Multi-region Ethics Committee is registered with the United States Department of Health and Human Services. This registration enables the committee to review research funded by the United States Government. The registration number is IRB00004663 – Multi-region Ethics Committee.

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Response to Cultural Issues

Table 2: Multi-region Ethics Committee’s response to cultural issues, 2008

Category Number/comment

Number of applications deferred because Māori 0 guidelines were not read

Number of applications for which consultation with 106 out of 165 applications received had not had Māori was considered appropriate consultation at time of meeting

Number of applications returned because of insufficient 16 returned due to consultation being insufficient or discussion on cultural issues lack of discussion on the impact for Māori 4 applicants asked to consult with the Pacific community 4 applicants asked to consult with other ethnic communities within their regions

Process the committee has for following through on Written evidence of consultation and support for the consultation study from the appropriate Māori review committee/s or appointed institutional representative/s

Mechanisms in place to facilitate consultation with District Health Boards, university or institution Māori Māori by researchers research review committees/representatives are available to researchers

Examples of Māori not being included in research 1 study’s focus was the Chinese community in New Zealand

Number of applications stalled because of lack of 0 support from a Māori Research Review Committee

Multi-region Ethics Committee Annual Report 2008 11

Applications

The Multi-region Ethics Committee held 12 scheduled meetings in 2008. One additional meeting was originally scheduled to be held on 7 October 2008 was held on 14 October 2008 to consider applications that could not be reviewed at the scheduled meetings.

Committee application statistics

Table 3: Multi-region Ethics Committee application statistics, 2008

Category Number

Applications approved 129 Applications deferred and subsequently approved 12 Applications deferred and subsequently carried forward (approved subject to) 3 Applications deferred and withdrawn by researcher 2 Applications declined 0 Applications declined and subsequently resubmitted 2 Applications carried forward (approved subject to conditions) 7 Ethics committee approval not required 1 Applications withdrawn by researcher prior to the meeting 1 Applications withdrawn following the meeting 4 Applications terminated by sponsor 1 Applications presently suspended by sponsor 3 Applications approved that have finished and the file is closed 2

Total number of applications considered by the full committee 165*

Expedited review applications Expedited review applications approved 72

Total number of expedited review applications reviewed 72

Total number of applications reviewed 237

Notes Under the new terms of reference, the committee was also able to send four applications to the Lower South Regional Ethics Committee for review in September due to the large number of applications received. * Includes three carried over from review from December 2007 to January 2008 due to large number of applications received.

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Other committee statistics

Table 4: Other Multi-region Ethics Committee statistics, 2008

Category Number

Number of matters arising 12 Number of general business items 49 Number of amendments reviewed by committee 17 Number of amendments approved under delegated authority 1461

Innovative practice

No innovative practice applications were received.

Second opinions

No second opinions were requested.

Complaints

Two complaints were received. 1 A complaint was received by a researcher about a teleconference held during the review of their application. The researcher received an explanation and apology from the committee. 2 A complaint was received by a researcher about the process surrounding the review of their application. Their complaint was noted and their application subsequently approved.

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Issues

Delay in appointment process

The Multi-region Ethics Committee is extremely concerned by the delay in the appointment process that has seen the committee without a chairperson since February. This delay has placed extra pressure and workload on the deputy chairpersons.

Lack of succession planning

The committee is also concerned by the lack of succession planning that is in place and notes that a large number of committee members will be completing their terms in the next couple of years.

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Guidelines for Chairperson’s Delegation

At the committee’s meetings on 19 February and 20 May 2008, the committee agreed to delegate the following authority to the acting chairperson and/or deputy chairpersons. In July 2008 with the change to the terms of reference, the committee appointed Barry Smith acting chairperson.

The chairperson may approve under delegated authority: • advertisements, letters, or minor information sheet changes • applications provisionally approved by the committee subject to final approval by the chairperson, usually after review by nominated committee members.

The chairperson may approve the matters listed below after review by a minimum of one health professional. A subcommittee of health professional and lay members may be involved, and where possible such a subcommittee should include a Māori member. The chairperson recommends the membership of the subcommittee, and the administrator contacts members by phone or email to confirm their availability for the subcommittee. If any subcommittee member has a major concern and recommends the application or amendment be reviewed by the full committee, the application or amendment will be placed on the agenda for consideration at the next committee meeting, and the researcher will be advised.

The chairperson may approve, following this process:

• 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

• amendments that do not adversely affect participant safety

• confirmation of approval of ongoing applications after receipt of the researcher’s annual report.

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Appendix 1: Multi-region Ethics Committee Terms of Reference

Public authority of the Multi-region Ethics Committee (MEC)

The MEC 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 MEC.

Authority of the Multi-region Ethics Committee

The MEC shall have primary responsibility for ethics committee review of national and multi- region health and disability research and innovative practice occurring in New Zealand.

Multi-region or national research is defined as research conducted by the investigator(s) in more than one Regional Ethics Committee region or nationally, with identical methods and following the same protocol.

The MEC is responsible for any national and multi-region research for which it has given ethical approval, or any research given ethical approval by a regional ethics committee that has been transferred to its authority.

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 on any point of conflict, but otherwise, the Operational Standard applies to the MEC.

Relations with other public sector organisations

The MEC shall liaise with other relevant ethics committees on matters of common interest, such as jurisdiction over borderline cases. The MEC 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.

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Approval of the Multi-region Ethics Committee

The MEC 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 Multi-region Ethics Committee

The primary role of the MEC is to provide independent ethical review of national and multi- region health research and innovative practice that will be conducted in New Zealand 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 MEC 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. operate consistently with section 4 of the New Zealand Public Health and Disability Act 2000 and He Korowai Oranga, by recognising and respecting 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 MEC is to ensure that the MEC has the appropriate expertise, skills, knowledge and perspectives to conduct ethical review of the best quality.

Member numbers The MEC shall consist of not more than 16 members appointed by the Minister of Health.

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Lay/non-lay membership At any time the MEC shall have six lay members and at least six (though no more than 10) non-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.

Membership categories The MEC’s lay membership shall include: • an ethicist • a lawyer • consumer perspectives • community perspectives.

The MEC’s non-lay members shall include: • at least two health researchers • at least one pharmacist or pharmacologist • at least one biostatistician • at least two health practitioners.

Whole committee requirements At any meeting of the MEC, there shall be at least seven, but no more than 12 members in attendance in total. There must be a balanced representation of lay and non-lay members in attendance. Health researchers and health practitioners may rotate (on a regular basis) their attendance at meetings.

At any time, consistent with the requirements of the New Zealand Public Health and Disability Act requirements for District Health Boards, the MEC 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 MEC are expected to have an understanding of how the health sector responds to Māori issues and their application to ethical review.

The MEC’s membership should include expertise in the main kinds of health and disability research (eg, interventional, observational, kaupapa Māori, and social research), and in both quantitative and qualitative research methods.

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Members should possess an attitude that is accepting of the values of other professions and community perspectives, and it is important that the MEC 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, MEC 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 MEC as equal individuals of sound judgement, relevant experience and adequate training in ethical review.

Terms and conditions of appointment

Members of the MEC 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 MEC 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 MEC.

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 MEC. Those persons shall not be eligible for appointment to the MEC 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 committee will be eligible to be appointed to the MEC 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 MEC 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 MEC shall continue in office until their successor comes into office. Any member of the MEC may at any time resign as a member by advising the Minister of Health in writing.

Any member of the MEC 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 MEC, or discharge any member of the MEC, or appoint new members to the MEC for the purpose of decreasing or increasing the membership or filling any vacancies.

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Chairperson and Deputy Chairperson The Minister shall appoint a lay member of the MEC to be its Chairperson. The terms and conditions of appointment for members of the MEC also apply to the person appointed as Chair. The Chairperson shall preside at every meeting of the MEC at which they are present.

The MEC shall appoint a non-lay member as Deputy Chairperson and may appoint a lay or non-lay member as a second Deputy Chairperson.

The Chairperson and Deputy Chairperson/s may act with the delegated authority of the MEC 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 MEC. This is intended to aid MEC members by providing them with a common set of principles for appropriate conduct and behaviour.

General MEC 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 MEC members will make every effort to attend MEC meetings and devote sufficient time to become familiar with the affairs of the MEC and the wider environment within which it operates. Health researchers and health practitioners may rotate their attendance, in which case there is an expectation that those members will make every effort to attend on their rotation. In the event that they are unable to attend, they should notify the committee administrator. Members should be rotated as evenly as possible in order that they can build up experience and expertise.

Members have a duty to act responsibly with regard to the effective and efficient administration of the MEC and the use of MEC funds.

Conflicts of interest MEC 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 MEC and its members and will ensure it retains public confidence.

MEC members attend meetings and undertake MEC activities as independent persons responsible to the MEC as a whole. Members are not appointed as representatives of professional organisations or particular community bodies. The MEC should not, therefore, assume that a particular group’s interests have been taken into account because a MEC member is associated with this group. Members should declare, and the committee regularly review their actual and potential conflicts of interest.

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When MEC 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 MEC’s functions, they should declare that conflict of interest and withdraw themselves from the discussion and/or activity.

A member of the MEC who has a proposal before the MEC or who has an involvement in the proposal such as a supervisory role shall not take part in the MEC’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 MEC must exhibit transparency in avoiding or managing any real or perceived conflict of interest.

Confidentiality and information sharing Agendas and minutes of all MEC meetings should be available to the public. Copies of proposals should be available to individuals outside the MEC, 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, to satisfy the MEC 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 MEC 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 MEC. The MEC will need to consider the Privacy Act 1993 and the Health Information Privacy Code 1994 in developing these processes.

Within the MEC, 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

The meetings of the MEC will generally be held monthly, however, additional meetings may be held as necessary in order to manage workload.

At any meeting, a quorum shall consist of at least seven members. The quorum must include either the Chairperson or the Deputy-Chairperson. The quorum must include a reasonable representation of lay members and non-lay members to ensure expertise, knowledge and perspective is appropriate for the applications being reviewed.

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As part of the accountability to the public they protect, it is desirable for the meetings of the MEC to be open to the public. Meetings of the MEC should therefore be: i. open meetings for the discussion of broad issues, particularly if the MEC 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 MEC may have. Attendance is not mandatory. The MEC should advise applicants that they may be asked to leave the meeting while the MEC considers the proposal.

Subject to the provisions set out in this document, the MEC may regulate its own procedures.

Decision-making process Wherever possible, the MEC 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 MEC 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 MEC 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, the MEC 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.

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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 MEC members believes there is insufficient expertise on the MEC 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 MEC’s decision on a proposal.

Review of committee decisions

At any stage in its deliberations, the MEC may seek advice regarding procedures or proposals from another health and disability ethics committee.

The decisions of the MEC may be reviewed by the Health Research Council Ethics Committee under the Health Research Council Act 1990.

Training for members

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

Multi-region Ethics Committee Annual Report 2008 23

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 MEC, including any change in the MEC’s membership or other substantive changes the MEC 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 MEC members, and a statement on processes for orientation and training of new MEC members should be included. ii. A list of complaints received by the MEC (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 MEC in making a decision on any particular protocol(s), and any questions on policy or other matters the MEC referred to the National Ethics Advisory Committee or the Health Research Council Ethics Committee for comment or guidance.

In compiling annual reports, the MEC 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 MEC 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.

24 Multi-region Ethics Committee Annual Report 2008

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. In the event that the Chairperson and/or Deputy Chairperson/s are required to undertake additional work under the delegated authority of the MEC, they will be remunerated for the additional work at the same rate of remuneration as their attendance fee, up to a maximum of four days per month. The Ministry of Health shall pay actual and reasonable travel and accommodation expenses of the MEC members.

Servicing of the MEC

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

Multi-region Ethics Committee Annual Report 2008 25

Appendix 2: Applications Received in 2008

Appendix 2 details the applications the committee received in the 2008 calendar year.

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/07/12/176 The Australian and New Zealand MS Dr Deborah 3/12/07 22/01/08 Approved Approved 6/03/08 A Elizabeth Cunningham – Genetics Project (ANZgene) Mason subject to Christchurch conditions

MEC/07/12/178 An open-label follow-up trial of the Dr John Gillies 3/12/07 22/01/08 Approved Approved 13/05/08 P3 Research B Boehringer Ingelheim Te Puna Hauora efficacy and safety of chronic subject to Tauranga, administration of the combination of conditions Caversham Medical telmisartan 40 mg + amlodipine Centre, Middlemore 10 mg or the combination of Hospital telmisartan 80 mg + amlodipine 10 mg tablets alone or in combination with other antihypertensive medications in patients with hypertension; study no.1235.8

MEC/07/12/179 A phase IV randomised, observer- Dr Rod Ellis- 3/12/07 22/01/08 Approved Approved 5/03/08 Auckland Clinical B CLS Ltd Kaitakawaenga blind, placebo controlled, multi-centre Pegler subject to Studies, Youth Health Rangahau Maori / study to evaluate the efficacy safety conditions Centre, Caversham Te Runanga o Otakou and tolerability of CSL Limited’s Medical Centre Incorporated influenza virus vaccine in adults aged ≥18 to < 65 years

MEC/08/01/001 A randomised, multi-centre single- Dr Mark Webster 6/12/07 22/01/08 Approved Approved 13/03/08 Auckland City B Conor Medsystem Inc, blind comparison of the Conor cobalt subject to Hospital, USA chromium reservoir based stent with conditions Christchurch sirolimus elution versus the TAXUS Hospital, Mercy Liberte paclitaxel-eluting coronary Angiography Unit, stent system in de novo native North Shore Hospital coronary artery lesions

MEC/08/01/002 The Van Gogh study: a multi-centre, Dr Chris Lynch 3/12/07 22/01/08 Approved Withdrawn 25/03/08 Waikato University, B Solvay Pharmaceuticals ADHB Māori Review randomised, double-blind, parallel- subject to Van der Veer Committee, Te Puna group, placebo and pramipexole conditions Institute, Auckland Oranga, Research Office controlled study to assess efficacy City University University of Otago and safety of SLV308 as adjunct therapy to L-dopa in patients with Parkinson’s disease experiencing motor fluctuations

MEC/08/01/003 An extension of the Van Gogh study: Dr Chris Lynch 3/12/07 22/01/08 Approved Withdrawn 25/03/08 Waikato University, B Solvay Pharmaceuticals ADHB Māori Review an open label SLV308 safety subject to Van der Veer Committee, Te Puna extension to study S308.3.004 in conditions Institute, Auckland Oranga, Ngai Tahu patients with Parkinson’s disease City University Research Consultation experiencing motor fluctuations Committee

26 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/01/004 Investigation of biological factors in Assoc Prof John 6/12/07 22/01/08 Approved Approved 11/04/08 Auckland City Nil ADHB Māori review colon tumours from cancer patients Koea subject to Hospital, committee, Ngai Tahu self-identified as Maori, Pacific conditions Christchurch Hospital research consultation Islander and New Zealand European committee in New Zealand

MEC/08/01/005 A randomised, double-blind, placebo- Dr John Gillies 6/12/07 22/01/08 Approved Approved P3 Research B Boehringer Ingelheim HE&R services, controlled parallel group efficacy and subject to Tauranga, P3 Kaitakawanga Rangahau safety study of BI 1356 (5 mg conditions Research Wellington, Māori, Te Puna Hauora, administered orally once daily) over Caversham Medical CMDHB Māori research 24 weeks in type 2 diabetic patients Centre, Middle more review committee, with insufficient glycaemic control Hospital, Te Komiti Whakarite despite metformin therapy Christchurch Hospital

MEC/08/01/006 Oral insulin for prevention of diabetes Dr Jinny Willis 6/12/07 22/01/08 Approved Approved 3/11/08 Christchurch A Te Komiti Whakarite in relatives at risk for type 1 diabetes subject to Hospital, Liggans mellitus (protocol TN-07) conditions Institute, University of Auckland, Wellington Hospital

MEC/08/01/007 Developing our understanding of the Jo Innes 10/12/07 22/01/08 Approved Approved 1/04/08 Hutt Valley DHB Nil Māori Liaison HVDHB patient experience of the Central subject to Region’s reconstructive breast conditions surgery services

MEC/08/01/008 International collaborative infantile Dr Claire 3/01/08 22/01/08 Approved Approved 2/04/08 Starship Children’s A Ngai Tahu research spasms study (ICISS) Spooner subject to Hospital, Wellington consultation committee, conditions Hospital ADHB Māori review committee

MEC/08/01/009 CHORUS – a randomised trial to Dr Peter Sykes 3/01/08 22/01/08 Approved Approved 19/03/08 Christchurch A Ngai Tahu research determine the impact of timing of subject to Hospital, Dunedin consultation committee surgery and chemotherapy in newly conditions Hospital diagnosed patients with advanced epithelial ovarian, primary peritoneal of fallopian tube carcinoma

MEC/08/01/010 A qualitative exploration of the Robyn 3/01/08 22/01/08 Approved Approved 9/05/08 Victoria University, A Te Whare Marie, experiences of adolescents and Langlands subject to Capital and Coast Te Kairauhi Tauira young adults who engage in non- conditions DHB, Hutt Valley suicidal deliberate self-harm DHB behaviours

MEC/08/01/011 A multi-centre, randomised, double- Prof Russell 1/07/08 22/01/08 Approved Approved 20/03/09 Christchurch A Te Komiti Whakarite, blind, placebo and active controlled Scott subject to Hospital, Auckland ADHB Māori research study to assess the efficacy, and conditions City Hospital, review committee, HE&R tolerability of MK-6213 Wellington Hospital Services Ltd co-administered in patients with primary hypercholesterolemia

MEC/08/01/012 BEACON II = biolimus eluting A-9 Dr Gerald 7/01/08 18/02/08 Approved Approved 14/03/08 Dunedin Hospital B Biosensors International Ngai Tahu research coronary stent obviating luminal Wilkins subject to Pte Ltd consultation committee narrowing conditions

Multi-region Ethics Committee Annual Report 2008 27

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/01/013 A prospective, multi-centre, Dr Pamela Smart 8/01/08 22/01/08 Approved Approved 19/03/09 Nil Ngai Tahu research observational patient data registry subject to consultation committee program compiling data on patients conditions receiving the bio matrix stent

MEC/08/01/014 A double-blind, randomised, placebo- Dr Dean Quinn 8/01/08 Withdrawn Withdrawn 19/12/08 B Merck & Co Inc controlled, multi-centre parallel group, prior to dose-ranging study of MK-0633 in meeting adult patients with chronic asthma

MEC/08/02/015 He Mokopuna, He Taonga: health Dr Cherryl Smith 30/01/08 18/02/08 Deferred Research design Approved 17/12/09 Nil and wellbeing of grandparents raising mokopuna

MEC/08/02/016 A New Zealand brain tumour study – Dr Janice Royds 3/01/08 18/02/08 Approved Approved 2/04/08 Auckland DHB A Ngai Tahu research towards a greater understanding of subject to Wellington Hospital consultation committee, brain tumour biology conditions ADHB review committee

MEC/08/02/017 Reporting of randomised controlled Assoc Prof Peter 3/01/08 18/02/08 Approved Approved 19/03/08 A trials in New Zealand Herbison subject to conditions

MEC/08/02/018 A phase III, randomised, double- Dr Michael 4/02/08 18/02/08 Approved Approved 27/03/08 Otago School of Nil Ngai Tahu research blind, placebo-controlled multi-centre Jameson subject to Medicine & Health consultation committee study of ASA404 in combination with conditions Sciences paclitazel and arboplatin as first-line treatment for locally advanced or metastatic (stage IIIb / IV) non-small cell lung cancer (NSCLC)

MEC/08/02/019 Genetic variations that underlie the Dr Alison Fitches 4/02/08 18/02/08 Approved Approved 29/04/08 University of Otago A Ngai Tahu research mood disorders subject to consultation committee conditions

MEC/08/02/020 An open label follow-on study of Dr John Baker 4/02/08 18/02/08 Approved Closed 30/04/08 Middlemore Hospital B DiObex, Inc Te Puna Oranga, safety and pharmacodynamic effects subject to Christchurch Te Komiti Whakarite, of 24 weeks of treatment with conditions Hospital, Wellington Counties Manukau DHB DIO-902 in combination with Hospital, Waikato MRRC metformin and atorvastatin in Hospital subjects with type 2 diabetes mellitus; protocol no. DIO-503 version 1 dated 30 November 2007

MEC/08/02/021 The barriers and facilitators for Joanne 4/02/08 18/02/08 Approved Approved 29/04/09 Burwood Spinal Unit, A employment by individuals following Nunnerley subject to Auckland Spinal Unit spinal cord injury in New Zealand; conditions part 3 of 3

28 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/02/022 A phase III, multi-centre, double- Dr Dean Quinn 4/02/08 18/02/08 Approved Approved 11/04/09 B Merck & Co Inc blind, randomised study to evaluate subject to the safety and efficacy of the addition conditions of sitagliptin compared with the addition of glimepiride in patients with type 2 diabetes mellitus with inadequate glycaemic control on metformin MK-803-01

MEC/08/02/023 An open label, extended use study of Dr Chris Wynne 5/02/08 18/02/08 Approved Approved 27/03/08 Christchurch Hospital B Neurobiological Te Komiti Whakarite human corticotrophin-releasing factor subject to Wellington Hospital Technologies Inc (hCRF) intended for patients who conditions participate in the dexamethasone- sparing studies, NTI 0302, NIT0303 or other designated studies

MEC/08/03/024 Research on Chinese prison inmates Mr Simon Tam 20/02/08 18/03/08 Deferred Research design Withdrawn 11/07/08 A – is their crime linked/associated to gambling?

MEC/08/03/025 Possible medication-related errors as Dr Stephen 20/02/08 18/03/08 Approved Approved 27/03/08 Parkinson’s New A Waitemata District experienced by people with Buetow subject to Zealand Health Board – Pereme Parkinson’s disease conditions University of Porter also Kaumatua to Auckland Parkinson’s New Zealand

MEC/08/03/026 Follow-up of a New Zealand national Prof Brian 22/02/08 18/03/08 Approved Approved 22/07/08 University of Otago A Ngai Tahu research cohort of very low birth weight infants Darlow subject to consultation committee at 22 years of age conditions

MEC/08/03/027 Perceptions of bio-identity in organ Dr Rhonda Shaw 28/02/08 18/03/08 Approved Approved 21/07/08 Victoria University A donation and transplantation subject to conditions

MEC/08/03/028 A phase 3, multi-centre, randomised, Dr Philip Wood 28/02/08 18/03/08 Approved Approved 19/06/08 The Memory Clinic – B Wyeth Australia Pty Ltd double-blind, placebo-controlled, subject to North Shore parallel group efficacy and safety trial conditions Signet Research – of bapineuzumab (AAB-001, ELN Christchurch 115727) in subjects with mild to moderate Alzheimers disease who are apolipoprotein e є4 non-carrier

MEC/08/03/029 Collective consent and the Dr Jessica 3/03/08 18/03/08 Approved Approved 29/04/08 Wellington, Nil Research Centre of development of hauora practice led Hutchings subject to Whanganui, Māori Health & frameworks for health related new conditions Auckland, Development technologies Christchurch, Professor Chris Dunedin, Gisborne Cunningham Dr Te Kani Kingi

Multi-region Ethics Committee Annual Report 2008 29

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/03/030 A phase III randomised study of Dr Gary 3/03/08 18/03/08 Approved Approved 29/04/08 Palmerston North A Te Puna Oranga, brivanib (BMS – 532664) in Forgerson subject to Hospital Te Komiti Whakarite, combination with cetuximab (erbitux) conditions Wellington Hospital Kaumatua Mid Central versus placebo in combination with Waikato Hospital, Health, HE&R Services cetuximab (erbitux) in patients Christchurch Hospital previously treated with combination chemotherapy for metastatic colorectal carcinoma; NCIC CTG protocol no. CO.20; BMS protocol no. CA182009

MEC08/03/031 Research priorities by Maori with Dr Adelaide 3/03/08 18/03/08 Declined Research design and Approved 15/08/08 Hamilton – Maori Nil disabilities and their whanau Collins information provided Development Research Centre Dunedin – Donald Beasley Institute

MEC/08/03/032 Docetaxel plus six-month androgen Assoc Prof David 3/03/08 18/03/08 Approved Approved 3/06/08 Wellington Hospital A Wellington – Colleen suppression and radiation therapy vs Lamb subject to Christchurch Hospital Wineera, HE&R Services six-month androgen suppression and conditions Ltd radiation therapy for patients with high-risk localised or locally advanced prostrate cancer: a randomised controlled trial

MEC/08/03/033 A randomised phase III study Dr Vernon 3/03/08 18/03/08 Approved Approved 9/05/08 Auckland Hospital A ADHB review committee, comparing trastuzumab plus Harvey subject to Christchurch Hospital Te Whare Rapuora PN, docetaxel (HT) followed by 5-FU, conditions Dunedin Hospital Te Komiti Whakarite, epirubicin, and cyclophosphamide Palmerston North Ngai Tahu (FEC) to the same regimen followed Wellington Hospital by single-agent trastuzumab as Nelson Hospital adjuvant treatments for early breast Cancer Trials NZ – cancer; protocol no. FBCSG-01-2007, University of version 5.4, 31 October 2007 Auckland Oncology 161

MEC/08/03/034 A randomised, single blinded, Dr Scott Harding 3/03/08 18/03/08 Approved Approved 23/10/08 Wellington Hospital A Te Komiti Whakarite, controlled trial comparing device subject to North Shore Hospital ADHB Māori Research implantation in patients with conditions Auckland City Review Committee, therapeutic levels of anticoagulation Hospital HE&R Services Ltd, (INR 2.0–3.0) to those with an Waikato Hospital Te Puna Oranga INR <1.5 at the time of surgical Christchurch Hospital procedure; clinical trial protocol dated October 2008, version 5

MEC/08/03/035 A randomised double-blind parallel Dr F Weilert 3/03/08 18/03/08 Approved Approved 1/05/08 Waikato Hospital B Eisai Ltd Te Puna Oranga, study of rabeprazole extended- subject to Middlemore Hospital Te Puna Hauora, release 50 mg versus esomeprazole conditions Tauranga Hospital CMDHB MRRC 40 mg for healing and symptomatic relief of moderate to severe erosive gastroesophageal reflux disease (GERD); protocol no. E3810-G00- 301, dated 28 November 2007; amendment 01 dated 24 March 2008

30 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/03/036 A randomised double-blind parallel Dr F Weilert 3/03/08 18/03/08 Approved Approved 9/05/08 Waikato B Eisai Ltd Te Puna Oranga, study of Rabeprazole extended- subject to Auckland Te Puna Hauora, release 50 mg versus Esomeprazole conditions CMDHB MRRC 40 mg for healing and symptomatic relief of moderate to severe erosive gastroesophageal reflux disease (GERD); protocol no. E3810-G000- 302, dated 28 November 2007; amendment 01, dated 24 March 2008

MEC/08/03/037 76-weeks, worldwide, multi-centre, Prof Russell 12/03/08 18/03/08 Approved Approved 21/05/08 Christchurch Hospital B Merck Sharp and Te Puna Oranga, double-blind, randomised, placebo- Scott subject to Wellington Hospital – Dohme Te Komiti Whakarite controlled study to assess the conditions Cardiology tolerability and efficacy of anacetrapib Department when added to ongoing therapy with Wellington Hospital – a statin in patients with Diabetes Research hypercholesterolemia or mixed North Shore Hospital hyperlipidemia; MK-0859, protocol Waikato Hospital version 5.0 dated 19 December 2007, protocol amendment 1 01901 dated 10 June 2008, investigators’ brochure version 3.1 dated 31 January 2008

MEC/08/03/038 A randomised, double-blind, placebo- Dr David Voss 12/03/08 18/03/08 Approved Approved 9/05/08 Auckland Hospital A Middlemore DHB, ADHB controlled, factorial design trial to subject to Middlemore Hospital Review Committee, Ngai assess the effect of aspirin and fish conditions Dunedin Hospital Tahu oil in the prevention of early thrombosis in arterio-venous fistulae in patients with stage IV or V kidney disease requiring haemodialysis

MEC/08/03/039 “Does high or low oxygen saturation Prof Brian 10/03/08 15/04/08 Approved Approved 22/05/08 Christchurch A ADHB Review targeting in infants of less than Darlow subject to Women’s Hospital Committee 28 weeks gestation influence grey conditions Auckland City and white matter damage as seen on Hospital cranial MRI scans at term equivalent?” Add on to MEC/05/06/067

MEC/08/04/040 Clinical characteristics of multiple Dr Jennifer 31/03/08 15/04/08 Approved Suspended 9/05/08 Auckland City A ADHB Review sclerosis in Māori in New Zealand Somerfield subject to Hospital Committee conditions

MEC/08/04/041 Does cross-sectoral collaboration Dr Gail Tipa 31/03/08 15/04/08 Ethical Ethical A hold the key to Māori achieving their approval not approval not environmental goals? Using mahinga required required kai as the vehicle for exploring opportunities

Multi-region Ethics Committee Annual Report 2008 31

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/04/042 A comparison of prasugrel and Prof Harvey 31/03/08 15/04/08 Approved Approved 22/05/08 Auckland Hospital B Eli Liliy & Company Wellington Māori clopidogrel in acute coronary White subject to Christchurch Hospital advisory group, syndrome (ACS) subjects with conditions Middlemore Hospital Te Komiti Whakarite, unstable angina/non-ST-elevation North Shore Hospital Counties Manukau DHB myocardial infarction (UA/NSTEMI) Wellington Hospital review committee, ADHB who are medically managed – the review committee TRILOGY ACS study; protocol no. H7T-MC-TABY (a), dated 06 February 2008; protocol sample banking addendum H7T-MC-TABY(1) dated 30 August 2007; protocol sample banking addendum H7T-MC-TABY(2) dated 30 August 2007; protocol sample banking addendum H7T-MC-TABY(2.1) dated 22 May 2008

MEC/08/04/043 Surveys to monitor mental health Dr Allan Wyllie 31/03/08 15/04/08 Approved Approved 13/06/08 Phoenix Research A Like Minds Like Mine promotion media campaigns subject to Māori Committee conditions

MEC/08/04/044 A phase III, double-blind, Prof Harvey 31/03/08 15/04/08 Approved Approved 22/05/08 Auckland City B F Hoffman – La Roche ADHB review committee, randomised, placebo-controlled White subject to Hospital Ngai Tahu, Te Komiti study, to evaluate the effects of conditions Taranaki Base Whakarite, Counties RO4607381 on cardiovascular (CV) Hospital Manukau Māori Review risk in stable CHD patients, with a Nelson Hospital Committee, Te Puna documented recent acute coronary Wellington Hospital Oranga syndrome (ACS); protocol NC20971 Middlemore Hospital version B, dated 28 January 2008 Dunedin Hospital Waikato Hospital Christchurch Hospital

MEC/08/04/045 The effect of bimodal stimulation on Chris Radford 31/03/08 15/04/08 Approved Approved 12/06/08 University of A Māori Research Advisory speech and pitch perception in subject to Canterbury University of Canterbury children with cochlear implants conditions

MEC/08/04/046 A multi-centre, double-blind Dr Steve 31/03/08 15/04/08 Approved Approved 16/06/08 Christchurch Hospital B ADMA Biologics Inc ADHB Maori review randomised, placebo-controlled, Gibbons subject to Starship Children’s committee dose-ranging trial evaluating the conditions Hospital safety and efficacy of RI-001 in medically immunosuppressed respiratory syncytial virus (RSV) infected patients at risk of lower tract RSV illness – ADMA-001

MEC/08/04/047 A multi-centre, randomised, double- Dr Frank Weilert 31/03/08 15/04/08 Approved Approved 19/09/08 Waikato B Abbott Laboratories Te Puna Oranga, blind, placebo-controlled study of subject to Auckland Te Komiti Whakarite human anti-TNF monoclonal antibody conditions Shakespeare Group adalimumab for the induction and Wellington maintenance of clinical remission in Christchurch subjects with moderately to severely active ulcerative colitis

32 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/04/048 He Kakano: Māori views and Dr Paul 31/03/08 15/04/08 Approved Approved 26/05/08 Nil experiences of fertility, reproduction Reynolds subject to and ART conditions

MEC/08/04/049 2008/09 New Zealand adult nutrition Dr Niki 31/03/08 15/04/08 Approved Approved 21/05/08 Nil survey Stefanogiannis subject to conditions

MEC/08/04/050 PORTEC 3: randomised phase III trial Dr Carol 31/03/08 15/04/08 Approved Approved 5/05/08 Wellington Blood and A Colleen Wineera – comparing concurrent chemoradiation Johnson subject to Cancer Centre Wellington, Te Puna and adjuvant chemotherapy with conditions Palmerston North Oranga, Waikato DHB, pelvic radiation alone in high risk and Hospital Te Komiti Whakarite advanced stage endometrial Christchurch Hospital carcinoma Waikato Hospital

MEC/8/04/051 The socioeconomic factors Mr Charles 1/04/08 15/04/08 Deferred Unclear methodology Approved 24/06/08 Family Centre Nil HRC associated with food security and Waldegrave physical activity for Māori and Pacific people

MEC/08/04/052 Cardiac atlas project Dr Alistair Young 1/04/08 15/04/08 Approved Approved 19/06/08 Auckland City Nil ADHB Māori Review subject to Hospital Committee, Middlemore conditions Middlemore Hospital Review Committee

MEC/08/04/053 Risk of schistosomiasis among Dr Oliver Morgan 3/04/08 15/04/08 Approved Approved 21/04/08 Nil recreational users of the Nile River in Uganda

MEC/08/05/054 An evaluation of the green Dr Robyn Dixon 16/04/08 20/05/08 Approved Approved 25/06/08 Albany Nil prescription (GRx) active families subject to Wellington sites conditions Waitakere

MEC/08/05/055 A phase III randomised, double-blind, A 28/04/08 20/05/08 Approved Approved 3/07/08 Auckland City B Bayer Healthcare AG ADHB, Te Komiti placebo-controlled study of sorafenib Hospital Whakarite as adjuvant treatment for Christchurch Hospital hepatocellular carcinoma after surgical resection or local ablation A+4100

Multi-region Ethics Committee Annual Report 2008 33

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/05/056 A phase II, multi-centre, randomised, Dr John Gillies 1/05/08 20/05/08 Approved Approved 13/06/08 P3 Research B Biocryst placebo-controlled, study to evaluate subject to Tauranga Pharmaceuticals Inc the efficacy and safety of two doses conditions Hinemoa Family (300 mg and 600 mg) of peramivir in Health Centre, subjects with uncomplicated acute Rotorua influenza; protocol no. BCX Greenhithe Medical 1812-212, version 1.0, dated Centre, Auckland 16 January 2008 Bairds Road Family Superseded by a phase II, multi- and Christian Health centre, randomised, placebo- Centre, Auckland controlled, study to evaluate the Caversham Medical efficacy and safety of intramuscular Centre, Dunedin peramaivir 600 mg in subjects with Southern Clinical uncomplicated acute influenza; Trials Ltd, protocol no. BCX1812-212, version Christchurch 2.0, dated 15 May 2008; protocol St George’s Hospital version 3.0 dated 9 June 2008

MEC/08/05/057 Identifying genetic and protein Prof Andre van 2/05/08 20/05/08 Approved Approved 3/10/08 Dunedin Hospital A Ngai Tahu, Te Puna markers for distinct forms of Raj subject to Waikato Hospital Oranga, ADHB Māori cardiovascular disease in New conditions Auckland City Review committee, Zealand Hospital Te Komiti Whakarite Christchurch Hospital

MEC/05/08/058 A phase III trial evaluating the role of Dr Bernie 5/05/08 20/05/08 Approved Approved 25/07/08 Christchurch Hospital A Te Komiti Whakarite, continuous letrozole versus Fitzharris subject to Waikato Hospital Te Puna Oranga intermittent letrozole following four to conditions St Anne Breastcare six years of prior adjuvant endocrine Centre, Hamilton therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer

MEC/08/05/059 A phase III randomised, parallel Dr Sanjeev 5/05/08 20/05/08 Approved Approved 1/09/08 North Shore Hospital B Boehringer-Ingelheim Te Puna Oranga – group, double-blind, active controlled Chunilal subject to Christchurch Hospital Australia Ltd Waikato, Te Wai Awhina study to investigate the efficacy and conditions Waitemata DHB – North Shore safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg Enoxaparin once daily for 28–35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty; renovate II 1160.64

MEC/08/05060 A multinational, multi-centre, Dr J McLachlan 5/05/08 20/05/08 Approved Approved 7/08/08 Waikato Hospital B Sanofi-Aventis Australia Te Puna Oranga – randomised, double-blind study subject to North Shore Hospital Pty Ltd Waikato, Te Wai Awhina comparing the efficacy and safety of conditions Auckland City – North Shore AVE5026 with enoxaparin for the Hospital primary prevention of venous thromboembolism in acutely ill medical patients with restricted mobility

34 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/05/061 A randomised, open-label, multi- Dr G Corbett 5/05/08 20/05/08 Approved Approved 15/10/08 Waikato Hospital B Biogen Idec Te Puna Oranga, centre, phase 2/3 study to evaluate subject to Christchurch Hospital Te Komiti Whakarite, the safety and efficacy of lumiliximab conditions Wellington Hospital ADHB Māori Review in combination with fludarabine, Auckland City Committee cyclophosphamide, and rituximab vs Hospital fludarabine, cyclophosphamide, and Palmerston North rituximab alone in subjects with Hospital relapsed chronic lymphocytic leukaemia

MEC/08/05/062 A randomised, double-blind, placebo- Dr Craig 5/05/08 20/05/08 Approved Approved 22/08/08 Auckland City B Takeda Global Te Puna Oranga, controlled, study of the efficacy and Hourigan subject to Hospital Research & Te Komiti Whakarite, safety of TAK-242 vs placebo in conditions Hawke’s Bay Hospital Development Centre ADHB Māori Review subjects with sepsis induced Christchurch Hospital Ltd Committee cardiovascular and respiratory failure Middlemore Hospital Tauranga Hospital Nelson Hospital

MEC/08/05/063 Gender and medicine: identities and Geraldine 5/05/08 20/05/08 Declined Research design Declined Nil bodies beyond the male/female Christmas binary code

MEC/08/05/064 A phase III, randomised, double- Dr Ruth 5/05/08 20/05/08 Approved Approved 1/08/08 Christchurch Hospital B The Vaccines Company Te Komiti Whakarite, blind, multi-centre study of proteinase Spearing subject to Auckland City USA ADHB Review 3 PRI peptide mixed with mondatide conditions Hospital Committee ISA 51 Vg adjuvant and administered with GM-CSF in elderly patients with AML in first complete remission or adults in second complete remission: a pivotal study

MEC/08/05/065 A multi-centre study evaluating the Dr Peter 5/05/08 20/05/08 Deferred Committee does not Approved 26/08/08 Auckland City B Osprey Medical Pty Ltd Ngai Tahu, ADHB review safety of the Osprey medical contrast Ruygrok have relevant Hospital committee removal system expertise – expert Christchurch Hospital advice required

MEC/08/05/066 The adequacy of musculoskeletal Georgina Chan 5/05/08 20/05/08 Approved Approved 4/12/08 Auckland Medical Nil Ngai Tahu education in medical school in New subject to School Zealand conditions Wellington School of Medicine Christchurch School of Medicine Dunedin School of Medicine

Multi-region Ethics Committee Annual Report 2008 35

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/05/067 Prevalence of facial affect recognition Angela Bizak 5/05/08 20/05/08 Approved Approved 3/07/08 Psychology Clinic, Nil Mr Turoa Haronga difficulties after traumatic brain injury subject to Wellington Kaumatua School of conditions CAVIT Rehabilitation Psychology at Massey – Wellington, Auckland Stewart Centres – Epson Phoenix Rehabilitation – Hamilton Eastern Institute of Technology

MEC/08/06/068 A phase 2 study to evaluate the Dr Stephen Mark 27/05/08 17/06/08 Approved Approved 5/08/08 Canterbury Urology B Light Sciences safety and effectiveness of using the subject to Research Trust Oncology Inc Litx BPH system in patients with conditions Tauranga Urology lower urinary tract symptoms (LUTS) Research Ltd due to benign prostatic hyperplasias Wellington Urology (BPH) who are candidates for Research Group interventional therapy; protocol no. Roundhay Medical LSO-OL012 dated 25 February 2008, Centre Nelson revision D dated 8 July 2008 UroSurgery Ltd Cardinal Points Research Trust Ltd

MEC/08/06/069 Exploration of the decision making Jennifer Dunn 30/05/08 17/06/08 Approved Approved 24/07/08 Burwood Hospital Nil Ngāi Tahu research process for upper limb reconstructive subject to Auckland Spinal Unit committee, Ranga surgery in persons with tetraplegia conditions Hauora

MEC/08/06/070 A cross-sectional, hospital-based, Dr Peter Sykes 30/05/08 17/06/08 Deferred Research design and Approved 22/12/08 Dunedin Hospital B GlaxoSmithKline Kline Ngai Tahu, ADHB retrospective, epidemiological study information provided Christchurch Australia Pty Ltd Review Committee, on human papilloma virus (HPV) type Women’s Hospital Te Puna Oranga distribution in adult women diagnosed Auckland City with invasive cervical cancer (ICC) in Hospital New Zealand (HICaNZ) Palmerston North Hospital Waikato Hospital Wellington Hospital

MEC/08/06/071 A phase IIb, multi-centre, double- Prof Russell 3/06/08 17/06/08 Deferred Research design and Approved 26/09/08 B Merck Sharp and Nga Kai Tataki blind, placebo, dose-ranging finding Scott information provided Dohme clinical trial of MK-0941 in patients with type 2 diabetes mellitus with inadequate glycaemic control on basal insulin

MEC/08/06//072 Children’s Oncology Group Dr Rob Corbett 3/06/08 17/06/08 Approved Approved 23/07/08 Christchurch Hospital A Te Komiti Whakarite, ANBL0531: response- and biology- subject to Starship Children’s ADHB Review based therapy for intermediate risk conditions Health Committee neuroblastoma

36 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/06/073 A randomised, double-blind, placebo- Dr Frank Weilert 3/06/08 17/06/08 Approved Terminated Waikato Hospital B Asphelia controlled trial of ASP1002 (Trichuris subject to Shakespeare Pharmaceuticals, Inc suis Ova [TSO]) therapy for conditions Specialist Group moderately active Crohn’s disease Christchurch Hospital

MEC/08/06/074 A multi-centric, randomised, double- Assoc Prof Peter 3/06/08 17/06/08 Approved Approved 25/07/08 Middlemore Hospital B Abbott Laboratories Counties Manukau DHB, period, double-blind study to Gow subject to Waikato Hospital Te Puna Oranga, Hutt determine the optimal protocol for conditions Timaru Hospital Valley DHB Review treatment initiation with methotrexate Hutt Hospital Committee and adalimumab combination therapy in patients with early rheumatoid arthritis

MEC/08/06/075 Initial chronic human validation study: Dr Margaret 4/06/08 17/06/08 Approved Approved 14/07/08 Auckland City B Cameron Health ADHB Review subcutaneous implantable defibrillator Hood subject to Hospital Committee, Te Komiti conditions Christchurch Hospital Whakarite

MEC/08/07/076 Transnationals in Pacific health Dr Judith 19/06/08 15/07/08 Approved Approved 18/09/08 Nil Pacific community through the lens of tuberculosis Littleton subject to groups conditions

MEC/08/07/077 Investigating cognitive function for Dr Ian Campbell 23/06/08 15/07/08 Approved Approved 14/08/08 Waikato Hospital Nil Te Komiti Whakarite, patients participating in the subject to St Anne Breast Care Te Puna Oranga suppression of ovarian function trial conditions Christchurch Hospital (SOFT) in selected centres

MEC/08/07/078 A 24-month extension to a Dr Nigel Gilchrist 24/06/08 15/07/08 Approved Approved 14/08/08 CGM Research Trust B Merck Sharp and ADHB Review randomised, double-blind, placebo- subject to Osteoporosis Dohme Committee controlled study to assess the safety, conditions Research Group, tolerability, and efficacy of MK-8022 Auckland City (Cathepsin-K inhibitor) in the Hospital treatment of postmenopausal women with osteoporosis

MEC/08/07/079 Exploration of experiences and Trudi Conway 30/06/08 15/07/08 Approved Approved 7/08/08 Back up New Nil perceptions of spinal cord injured subject to Zealand, Napier people who attend outdoor conditions Outward Bound, recreational programmes Picton

MEC/08/07/080 A randomised, double-blind, placebo- Dr Mark 30/06/08 15/07/08 Approved Approved 3/09/08 Auckland City B Boehringer Ingelheim ADHB Review controlled parallel group study to O’Carroll subject to Hospital Committee, Te Puna investigate the safety and efficacy of conditions Waikato Hospital Oranga two doses of tiotrpium bromide(2.5 ug and 5 ug) administered once daily via the respimat device for 12 weeks in patients with cystic fibrosis

MEC/08/07/081 A pivotal trial to determine the Dr David Porter 30/06/08 15/07/08 Approved Approved 25/08/08 Auckland City B Ariad Pharmaceuticals Colleen Wineera – efficacy and safety of AP23573 when subject to Hospital Wellington, DHB, administered as maintenance therapy conditions Wellington Blood and Te Komiti Whakarite, to patients with metastatic soft-tissue Cancer Centre ADHB Review or bone sarcomas Christchurch Hospital Committee

Multi-region Ethics Committee Annual Report 2008 37

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/07/082 A 78-week open label extension to Dr John Gillies 30/06/08 15/07/08 Approved Approved 25/09/08 Middlemore Hospital B Boehringer Ingelheim Middlemore DHB, ADHB trials assessing the safety and subject to Christchurch Hospital Review Committee, Ngai efficacy of BI 1356 (5mg) as conditions P3 Research Tahu monotherapy or in combination with Tauranga other antidiabetic medications in P3 Research type 2 diabetic patients; study no. Wellington BI 1218.40 Caversham Medical Centre – Dunedin

MEC/08/7/083 Baby friendly community initiative Ms Lanuola 30/06/08 15/07/08 Approved Approved 28/08/08 Wairarapa Public Nil evaluation Asiasiga subject to Health Unit conditions Nelson Marlborough DHB Turuki Healthcare – Mangere West Fono Trust – Waitakere

MEC/08/07/084 A phase III study to assess the Dr Chris Wynne 30/06/08 15/07/08 Approved Suspended 1/09/08 Christchurch Hospital B Merck & Co Inc Te Komiti Whakarite, tolerability and efficacy of MK-0822 subject to Auckland Hospital ADHB Review (Odanacatib) in reducing the risk of conditions Committee developing bone metastases and prolonging disease-free survival in women with breast cancer

MEC/08/07/085 Evaluation of community cancer Dr Julian King 30/06/08 15/07/08 Approved Approved 18/09/08 Te Kahui Hauora Nil support services projects subject to Trust, Rotorua conditions Tamaki Trust, Auckland West Coast PHO, Greymouth

MEC/08/07/086 Protocol F1K-MC-EVDP: a Dr C McArthur 30/06/08 15/07/08 Approved Approved 4/11/08 Auckland City B Eli-Lilly ADHB Review randomised, double-blind, placebo- subject to Hospital Committee, Counties controlled, multi-centre, phase 3 conditions Middlemore Hospital Manukau Review study of drotrecogin alfa (activated) Christchurch Hospital Committee, Te Komiti administered as a continuous 96-hour Wellington Hospital Whakarite, Te Puna infusion to adult patients with septic Waikato Hospital Oranga shock

MEC/08/07/087 Surveys to monitor discrimination Dr Allan Wyllie 30/06/08 15/07/08 Deferred Study design Approved 5/03/09 A experienced by users of mental health services

MEC/08/07/88 A phase III study to assess the Dr Peter Gillings 30/06/08 15/07/08 Deferred Insufficient Suspended 12/12/08 Roundhay Medical B Merck & Co Inc tolerability and efficacy of MK-0822 Information provided Centre – Nelson (Odanacatib) in prolonging bone Cardinal Points metastasis-free survival in men with Specialist Centre hormone-refractory prostate cancer CURT Medical Trials Trust Tauranga Urology Research Ltd

38 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/07/089 A multi-centre, double-blind, Prof Russell 1/07/08 15/07/08 Approved Approved 19/09/08 Christchurch B Merck & Co Inc Te Komiti Whakarite, randomised, 12-month, placebo- Scott subject to Hospital, North Shore Counties Manukau controlled study to evaluate the lipid- conditions Hospital, Middlemore Review Committee lowering effect, safety and tolerability Hospital of AVE5530 25 mg/day and 50 mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia

MEC/08/07/90 A multi-centre, randomised, double- Prof Russell 1/07/08 15/07/08 Approved Approved 4/08/08 Christchurch Hospital A Te Komiti Whakarite, blind, placebo-and active controlled Scott subject to Middlemore Hospital Counties Manukau study to assess the efficacy, and conditions Review Committee tolerability of MK-6213 co-administered in patients with primary hypercholesterolemia

MEC/08/08/091 A randomised, double-blind, parallel Dr Sharon 23/07/08 19/08/08 Approved Withdrawn 9/10/09 B Astellas Pharma GmbH, group, placebo and active controlled, English subject to Germany multi-centre study to assess the conditions efficacy and safety of the Beta-3 agonist YN178 (50 mg qd and 100 mg qd) in subjects with symptoms of overactive bladder

MEC/08/08/092 A randomised, double-blind, parallel Dr Sharon 23/07/08 19/08/08 Approved Approved 17/10/08 B Astellas Pharma GmbH, group, active controlled, multi-centre English subject to Germany long-term study to assess the safety conditions and efficacy of the Beta-3 agonist YM178 (50 mg qd and 100 mg qd) in subjects with symptoms of overactive bladder

MEC/08/08/093 Elixar medical clinical evaluation of Dr Mark Webster 23/07/08 19/08/08 Approved Approved 9/09/08 North Shore Hospital B Elixar Pharma ADHB Review the Novolimus-eluting coronary stent subject to Middlemore Hospital Committee, Counties system: a randomised study with a conditions Christchurch Hospital Manukau, Te Komiti single-arm registry (ELX-CL-0801), Auckland City Waikerie EXCELLA II study Hospital

MEC/08/08/094 Defining the genetics of congenital Prof Stephen 23/07/08 19/08/08 Approved Approved 10/10/08 Dunedin School of A Ngai Tahu Research malformations in children Robertson subject to Medicine review committee conditions

MEC/08/08/095 Determinants of abdominal aortic Prof JA Roake 23/07/08 19/08/08 Approved Approved 3/10/08 Christchurch Hospital A Te Komiti Whakarite aneurysm growth subject to conditions

Multi-region Ethics Committee Annual Report 2008 39

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/08/096 A randomised, open-label, multi- Assoc Prof Ed 28/07/08 19/08/08 Approved Approved 25/09/08 Auckland City B F Hoffmann-La Roche ADHB Review centre study examining the effects of Gane subject to Hospital, Inc Committee, Te Puna 24 versus 48 weeks of combination conditions Christchurch Oranga therapy with PEGASYS Hospital, Waikato (Peginterferon alfa-2a 40KD) plus Hospital COPEGUS (Ribavirin) on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3 who do not achieve a rapid viral response

MEC/08/09/097 A multi-centre, double-blind, Dr Barry Snow 28/07/08 19/08/08 Approved Approved 18/09/08 Auckland City Nil ADHB Review randomised, placebo-controlled, subject to Hospital, Van der Committee parallel-group withdrawal-design conditions Veer Institute study to assess the clinical effect of droxidopa in subjects with primary autonomic failure, dopamine beta hydroxylase deficiency or non- diabetic neuropathy and symptomatic neurogenic orthostatic hypotension (protocol no. droxidopa-302)

MEC/08/09/098 Nga Tohu o te Ora: traditional Māori Maui Hudson 31/07/08 19/08/08 Approved Approved 19/09/08 Lakes District Health Nil Te Matatau, Lakes DHB, wellness outcome measures subject to Board Nga Ringa Whakahaere conditions Te Matarau Ltd o te Iwi Maori Nga Ringa Whakahaere o te Iwi Maori

MEC/08/09/099 A feasibility study of a structured Assoc Prof 1/08/08 19/08/08 Approved Approved 4/12/08 Hutt Valley DHB A Hutt Valley DHB, ADHB means of eliciting goals in William Taylor subject to Capital & Coast DHB Review Committee rehabilitation conditions MidCentral DHB Auckland DHB

MEC/08/09/100 Twice-daily oral erect thrombin Dr John Gillies 1/08/08 19/08/08 Approved Approved 18/09/08 P3 Research B Boehringer Ingelheim Te Komiti Whakarite inhibitor dabigatran etexilate in the subject to Tauranga long-term prevention of recurrent conditions Canterbury DHB symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism; RE-SONATE study; study no. BI 1160.63

MEC/08/09/101 A phase III randomised, double Dr John Gillies 1/08/08 19/08/08 Approved Approved 18/09/08 P3 Research B Boehringer Ingelheim blinded, placebo-controlled, parallel subject to Tauranga group trial to evaluate efficacy and conditions P3 Research safety of tiotropium inhalation solution Wellington delivered via Repeat® inhaler Canterbury (5 µg/day) over 48 weeks as add-on Respiratory Research controller therapy on top of usual care Group in patients with severe persistent asthma; study BI 205.417

40 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/09/102 Stomach cancer in Maori Dr Lis Ellison- 6/08/08 19/08/08 Approved Approved 8/09/08 Massey University A Loschmann subject to conditions

MEC/08/09/103 Exploring Samoan women’s attitudes Dr Ausaga 29/08/08 16/09/08 Approved Approved 3/11/08 Victoria University Nil Porirua Midwifery towards antenatal and midwifery care Faaselele subject to Community Group Tanuvasa conditions

MEC/08/09/104 A randomised, double-blind, five Dr Dean Quinn 29/08/08 16/09/08 Deferred Further information Approved 3/11/08 P3 Research B Pearl Therapeutics Te Puna Hauora period, placebo and active-controlled, required Wellington cross-over, multi-centre, study Caversham Medical evaluating single administration of Centre three doses of Formoterol MDI in St George’s Hospital patients with moderate to severe COPD, compared to open-label marketed Formotereol (FORADIL® AEROLIZER®) as an active control; study no. PT0050801

MEC/08/09/105 A phase II study to determine the Dr John Gillies 29/08/08 16/09/08 Deferred Study design and Approved 4/02/09 P3 Research B Alder Therapeutics Te Puna Hauora safety, efficacy, and personnel Tauranga pharmacokinetics of multiple Christchurch Hospital intravenous doses of ALD518 80 mg, and 320 mg versus placebo administered to patients with non small cell lung cancer related fatigue and cachexia; study no. ALD518-CLIN-004

MEC/08/09/106 A phase IIa randomised, double- Dr John Gillies 29/08/08 16/09/08 Approved Approved 5/11/08 P3 Tauranga B Merck & Co Inc blind, parallel-group, placebo and subject to P3 Wellington active controlled, clinical trial to study conditions Greenhithe Medical the efficacy and safety of MK-0974 Centre Hinemona co-administered with Ibuprofen or Family Health Centre acetaminophen / paracetamol in patients with migraine with or without aura; study no. 046-00

MEC/08/09/107 A phase III, randomised, placebo- Dr John Wyeth 29/08/08 16/09/08 Approved Approved 22/10/08 Bowen Hospital B Millennium Connections Nga Kete controlled, blinded, multi-centre study subject to Christchurch Hospital Pharmaceuticals Inc E Rua of the induction and maintenance of conditions Shakespeare clinical response and remission by Specialist Group MLN0002 in patients with moderate to severe ulcerative colitis; protocol no. C13006; protocol date: 26 June 2008; superseded by protocol no. C13006; a phase 3, randomised, placebo-controlled, blinded, multi- centre study of the induction and maintenance of clinical response and remission by vedolizumab (MLN0002) in patients with moderate to severe ulcerative colitis; amendment 1 dated 28 October 2008

Multi-region Ethics Committee Annual Report 2008 41

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/09/108 A phase III, randomised, placebo- Dr John Wyeth 29/08/08 16/09/08 Approved Approved 28/10/08 Bowen Hospital B Millennium Connections Nga Kete controlled, blinded, multi-centre study subject to Christchurch Hospital Pharmaceuticals Inc E Rua of the induction and maintenance of conditions P3 Research clinical response and remission by Tauranga MLN0002 in patients with moderate CURT Medical Trials to severe Crohn’s disease; protocol Trust Board no. C13007; protocol date 26 June Dunedin Hospital 2008; superseded by a phase 3, Shakespeare Clinical randomised, placebo-controlled, Group blinded, multi-centre study of the Waikato Hospital induction and maintenance of clinical response and remission by vedolizumab (MLN0002) in patients with moderate to severe Crohn’s disease; amendment 1 dated 28 October 2008

MEC/08/09/109 A phase 3, open-label study to Dr John Wyeth 29/08/08 16/09/08 Approved Approved 22/10/08 Bowen Hospital B Millennium Connections determine the long-term safety and subject to CURT Medical Trials Pharmaceuticals Inc efficacy of MLN0002 in patients with conditions Trust Board ulcerative colitis and Crohn’s disease; Christchurch Hospital superseded by a phase 3 open-label Waikato Hospital study to determine the long-term Shakespeare safety and efficacy of vedolizumab Specialist Group (MLN0002) in patients with ulcerative Dunedin Hospital colitis and Crohn’s disease; P3 Research amendment 1 dated 28 October 2008 Tauranga

MEC/08/09/110 Investigation of interfaces for use with Jessica Hayward 29/08/08 16/09/08 Approved Approved 17/04/09 Fisher & Paykel B Fisher & Paykel continuous positive airway pressure subject to Healthcare Healthcare (CPAP) therapy conditions Adult Sleep and Ventilation Service New Zealand Sleep and Breathing

MEC/08/09/111 Multi-centre, randomised, pilot Assoc Prof 29/08/08 16/09/08 Deferred Safety of study drug Approved 22/10/08 Auckland Clinical B F Hoffmann-La Roche ADHB Review phase 1 study to evaluate the Edward J Gane Studies, CCST Inc Committee, Te Komiti combination of HCT polymerase Whakarite inhibitor (RO5024048 and HCV protease inhibitor (RO5190591) in genotype 1 chronic hepatitis C patients

MEC/08/09/112 A randomised, double blind, placebo- Assoc Prof 29/08/08 16/09/08 Deferred Safety of study drug Approved 3/11/09 Auckland Clinical B F Hoffmann-La Roche controlled study to determine the Edward J Gane Studies, CCST Inc pharmacokinetic, safety and tolerability profile and antiviral activity of multiple oral doses of AZD7295 in otherwise healthy male and female hepatitis C carriers with compensated liver disease

42 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/09/113 C-07-63: a three-month, multi-centre, Dr Anthony 5/09/08 16/09/08 Approved Closed 3/11/08 Capital Eye B Alcon Research Ltd HE&R services double-masked study comparing the Wells subject to Specialists safety and efficacy of the fixed conditions Eye Institute combination tarvoprost/brinzolamide eye drops, suspension vs TRAVATAN vs AZOPT in patients with open-angle glaucoma or ocular hypertension

MEC/08/09/114 C-08-10: a multi-centre double Assoc Prof 5/09/08 16/09/08 Approved Approved 22/01/09 Eye Institute B Alcon Research Ltd HE&R Services masked study of the safety and Helen Danesh- subject to Capital Eye efficacy of travoprost APS compared Meyer conditions Specialists to TRAVATAN in patients with open- angle glaucoma or ocular hypertension

MEC/08/09/115 Goals and self regulation skills in Professor 12/09/08 16/09/08 Approved Approved 24/02/09 Accident A Ngai Tahu research brain injury rehabilitation: an RCT Kathryn subject to Compensation committee McPherson conditions Corporation University of Otago Wellington AUT University

MEC/08/10/116 Abortion among Asian women in New Lien Trinh 5/09/08 14/10/08 Deferred Research design Approved Greenlane Clinical A Asian community groups Zealand: what do we know? subject to Centre conditions Auckland Medical Aid Centre University of Otago

MEC/08/10/117 A single-blind randomised controlled Dr Natalie 29/08/08 14/10/08 Approved Approved 3/11/08 Auckland University A trial of nicotine-free cigarettes as an Walker subject to adjunction to usual nicotine conditions replacement therapy (NRT)-based cessation practice (patch, gum and/or lozenge), in people who wish to stop smoking.

MEC/08/10/118 Access to ACC for people with pre- Sally Duckworth 5/09/08 14/10/08 Approved Approved 24/11/08 Accident A existing disabilities (physical, blind/ subject to Compensation vision impaired and intellectual) conditions Corporation Litmus Ltd

MEC/08/10/119 RAVES – radiotherapy adjuvant Dr Maria Pearse 5/09/08 14/10/08 Approved Approved 27/11/08 Auckland City A ADHB MRRC versus early salvage: a phase III subject to Hospital multi-centre randomised trial conditions Waikato Hospital comparing adjuvant radiotherapy with Palmerston North early salvage radiotherapy in patients Hospital with positive margin(s) Christchurch Hospital Dunedin Hospital Auckland Radiation Oncology

Multi-region Ethics Committee Annual Report 2008 43

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/10/120 Factors influencing the timing of first Dr Martha Silva 5/09/08 14/10/08 Approved Approved 17/12/08 University of Nil trimester pregnancy terminations subject to Auckland conditions Whangarei Hospital Epsom Day Unit Auckland Medical Aid Centre Waikato Hospital Thames Hospital Tokoroa Hospital Wairarapa DHB

MEC/08/10/121 Relationship between oocyte Prof John Hutton 5/09/08 14/10/08 Approved Approved 17/11/08 Fertility Associates A Māori Partnership board secretory factors (as measured in subject to CMDHB cumulus cells) with fertilization rates conditions and subsequent embryo development in human IVF

MEC/08/10/122 A phase 1 multi-centre, open-label, Prof Michael 5/09/08 14/10/08 Approved Approved 16/01/09 Auckland City B Novartis ADHB Review dose-escalation study to assess the Findlay subject to Hospital Pharmaceuticals Committee, Te Puna pharmacokinetics of ASA 404 in adult conditions Wellington Hospital Oranga, Te Komiti cancer patients with impaired hepatic Waikato Hospital Whakarite function and with normal hepatic Christchurch Hospital function

MEC/08/10/123 A phase III, randomised, open-label, Dr Peter Browett 5/09/08 14/10/08 Approved Approved 23/12/08 Auckland City B Celgene Corporation ADHB Review #-arm study to determine the efficacy subject to Hospital Committee, Te Komiti and safety of lendlidome (revlimid) conditions Wellington Hospital Whakarite plus low-dose dexamethasone when Christchurch Hospital given until progressive disease of for 18 four-week cycles versus combination of melphalan, prednisone and thalidomide given for 12 six-week cycles in patients with previously untreated multiple myeloma who are either 65 years of age or older or not candidates for stem cell transplantation (IMF 07-01)

MEC/08/10/124 International epidemiologic study of Dr Susan M 10/09/08 14/10/08 Approved Approved 26/11/08 Auckland DHB A worldwide distribution of type-specific Bigby subject to Waitemata DHB human papilloma virus (HPV) DNA in conditions Counties Manukau invasive cancers and pre-neoplastic DHB lesions of the vulva, vagina, anus, Northland DHB penis and head–neck tumours Waikato DHB Lakes District Health Board Tairawhiti District Health Board Taranaki District Health Board Whanganui District Health Board Hawkes Bay DHB

44 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/10/125 Hepatitis B vaccination, how long Alexander Milne 19/09/08 14/10/08 Deferred Research design Withdrawn A does protection last? Evidence from a 20-year vaccine booster study

MEC/08/10/126 A randomised controlled trial of the Prof Julian 19/09/08 14/10/08 Approved Approved 24/10/08 Wellington Hospital Nil effects of probiotics on the Crane subject to development of atopy and allergic conditions disease in early childhood (a follow-up genotyping children at four years of age)

MEC/08/10/127 A double-blind, placebo-controlled Dr John Gillies 6/10/08 21/10/09 Approved Approved 4/12/08 P3 Tauranga B Merck & Co Inc extension to the study MK-0633 in subject to P3 Wellington adult patients with chronic asthma conditions Waikato Hospital (extension to protocol 007)

MEC/08/10/128 A randomised, double-blind, active Dr Dean Quinn 6/10/08 21/10/08 Approved Approved 2/02/09 P3 Wellington B Boehringer Ingelheim controlled study to evaluate the subject to P3 Tauranga impact of stepwise withdrawal of conditions Waikato Hospital inhaled corticosteroid treatment in University of patients with severe to very severe Auckland chronic obstructive pulmonary Middlemore Hospital disease (COPD) on optimised Dunedin Hospital bronchodilator therapy; study no. Christchurch Hospital BI 352.2046

MEC/08/10/129 A randomised phase III study of Dr Chris Wynne 6/10/08 21/10/8 Approved Approved 16/12/08 Christchurch Hospital A ADHB Review temozolomide and short-course subject to Auckland City Committee, Te Komiti radiation versus short course conditions Hospital Whakarite radiation alone in the treatment of newly diagnosed glioblastoma multiforme in elderly patients

MEC/08/10/130 Personality characteristics of, and Dr Marc Wilson 6/10/08 21/10/08 Approved Approved 12/12/08 Victoria University Nil effects of participation on, reality subject to television participants conditions

MEC/08/10/131 HIV post-diagnosis survey Ms Sue 6/10/08 21/10/08 Approved Approved Otago University Nil Ngai Tahu Research McAllister subject to Committee conditions

MEC/08/10/132 A phase 1/2a, randomised, double- Dr Jeff Brown 6/10/08 21/10/08 Approved Approved Palmerston North A blind, placebo-controlled, dose- subject to subject to Hospital escalation to evaluate the safety, conditions conditions Wellington Hospital tolerability, immunogenicity and Waikato Hospital vaccine-like viral shedding of MEDI-534, a live, attenuated intranasal vaccine against respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) in healthy six- to 24-month-old children and in two-month-old infants

Multi-region Ethics Committee Annual Report 2008 45

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/10/133 A double-blind, randomised, placebo- Dr Michael 6/10/08 21/10/08 Approved Approved 4/12/08 North Shore Hospital B GlaxoSmithKline Kline Te Whai Awhina review controlled phase III study to assess McCrystal subject to Christchurch Hospital Pty Ltd committee, Te Komiti the efficacy of recMAGE-A3 + conditions Wellington Hospital Whakarite AS15ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma

MEC/08/10/134 Optimal programming to improve Dr Iain Melton 6/10/08 21/10/08 Approved Approved 19/02/09 Christchurch Hospital B Daichi Sankyo Pharma Te Komiti Whakarite mechanical indices, symptoms and subject to Development exercise in cardiac resynchronisation conditions therapy

MEC/08/10/135 A phase III, randomised, double- Dr Hamish Hart 6/10/08 21/10/08 Approved Approved 13/11/08 Waikato Hospital, B Daichi Sankyo Pharma blind, double-dummy, parallel group, subject to Hutt Hospital, Development multi-centre, multi-national study for conditions Auckland City evaluation of efficacy and safety of Hospital, Middlemore DU-176B vs warfarin in subjects with Hospital P3 Research atrial fibrillation – effective Tauranga, Nelson aNticoaGulation with factor xA next Hospital generation in atrial fibrillation (ENGAGE-AF); protocol no. DUI176b-C-U301 TIMI-48; protocol version 1.0, dated 15 September 2008, amendment version 2.0 dated 3 February 2009

MEC/08/10/136 Study title: a randomised, double- Prof Harvey 6/10/08 21/10/08 Approved Approved 17/12/08 Middlemore Hospital, B Janssen-Cilag Pty Ltd ADHB Maori Research blind, placebo controlled, event- White subject to Waikato Hospital, Review Committee driven multi-centre study to evaluate conditions Dunedin Hospital, the efficacy and safety of North Shore Hospital Rivaroxaban in subjects with recent acute coronary syndrome

MEC/08/10/137 Inhibition of δ-protein kinase C for the Prof Harvey 6/10/08 21/10/08 Approved Approved 10/12/08 B KAI Pharmaceuticals reduction of infarct size in acute White subject to myocardial infarction (PROTECTION conditions AMI); protocol KAI-9803-004, dated 1 August 2008, clinical investigator’s brochure KAI-9803, edition 6, dated 15 August 2008

MEC/08/10/138 A clinical outcomes study of Prof Harvey 6/10/08 21/10/09 Approved Approved 12/12/08 Auckland City B GlaxoSmithKline Kline Darapladib vs placebo in subjects White subject to Hospital, Pty Ltd with chronic coronary heart disease conditions Christchurch to compare the incidence of major Hospital, Dunedin adverse cardiovascular events Hospital, Hutt (MACE); STABILITY – the hospital, Middlemore stabilisation of atherosclerotic plaque Hospital, Nelson by initiation of darapLadIb therapy; Hospital, North Shore clinical trial protocol dated Hospital, Palmerston 23 September 2008: investigator’s North Hospital brochure version 5 dated 3 October 2008

46 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/10/139 An international, multi-centre, Dr Hilary 6/10/08 21/10/08 Approved Approved 12/12/08 Christchurch Hospital B Merck & Co Inc Te Wai Awhina – North randomized, double-blind study of Blacklock subject to Wellington Hospital Shore, ADHB Review vorinostat (MK-0683) or placebo in conditions Waitemata District Committee combination with Bortezomib in Health Board patients with multiple myeloma Auckland District Health Board Middlemore Hospital

MEC/08/10/140 The effects of imprisonment of the Dr Mike Roguski 6/10/08 21/10/08 Approved Approved A health of prisoners and their families subject to subject to conditions conditions

MEC/08/10/141 A study to find out how many platelet Dr Krishna 6/10/08 21/10/08 Deferred Research design Approved A donors have antibodies against Badami subject to human tissue antigens conditions

MEC/08/11/142 The effects of Comvita manuka Dr Patries Herst 3/11/08 18/11/08 Approved Approved 2/02/09 Otago District Health A Mark Brunton Ngai Tahu honey on oral mucositis in patient subject to Board treated with radiation therapy to the conditions Capital and Coast head and neck District Health Board MidCentral DHB

MEC/08/11/143 A multi-centre, open-label study with Assoc Prof Barry 3/11/08 18/11/08 Approved Approved 5/03/09 Auckland City B Chelsea Therapeutics a two-week randomised placebo- Snow subject to Hospital Inc controlled withdrawal period to conditions Van der Veer Institute assess the long term safety and for Parkinson’s and clinical benefit of Droxidopa in Brain Research subjects with primary autonomic failure, dopamine beta hydroxylase deficiency of non-diabetic neuropathy and symptomatic neurogenic orthostatic hypotension a follow on study to (protocol no. Droxidopa-302) MEC/08/08/097

MEC/08/11/144 A phase III randomised double blind Dr Sanjeev 3/11/08 18/11/08 Approved Approved 19/02/09 Waitemata DHB A ADHB Maori Research parallel-group study of the efficacy Chunilal subject to Christchurch Hospital Review Committee and safety of oral dabigatran etexilate conditions Auckland City (150 mg bid) compared to warfarin Hospital (INR 2.0-3.0) for six-month treatment Middlemore Hospital of acute symptomatic venous thromboembolism following initial treatment for at least five days with a parenteral anticoagulant approved for this indication (Recover II 1160.46)

MEC/08/11/145 Disabled by illness or injury: does it Dr Sarah Derrett 3/11/08 18/11/08 Approved Approved Auckland DHB Nil ADHB Review matter? subject to subject to Counties Manukau Committee, Counties conditions conditions DHB Manukau DHB, Ngai Tairawhiti District Tahu Research Health Board Otago District Health Board Southland DHB

Multi-region Ethics Committee Annual Report 2008 47

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/11/146 Randomised, double-blind placebo Dr John Gillies 3/11/08 18/11/08 Approved Approved 4/02/09 P3 Research B Boehringer Ingelheim controlled parallel group study to subject to Tauranga assess the efficacy and safety of conditions P3 Research 48 weeks of once daily treatment of Wellington orally inhaled BI 1744 CL (5 ug Middlemore Hospital [2 actuations of 2.5 ug] and 10 ug [2 actuations of 5 ug]) delivered by the Respimat inhaler in patients with chronic obstructive pulmonary disease (COPD); study BI 1222.11

MEC/08/11/147 A phase IIa multi-centre, randomised, Dr John Gillies 4/11/08 18/11/08 Approved Withdrawn P3 Research B Merck & Co Inc placebo-controlled clinical trial to subject to Tauranga study the safety and efficacy of conditions Southern Clinical MD-0974 for migraine prophylaxis in Trials Ltd patients with episodic migraine study Greenhithe Medical 049-00 Centre CURT Medical Trials Trust Board

MEC/08/11/148 Multi-centre, randomised, double- Dr David Gibbs 4/11/08 18/11/08 Approved Approved 18/12/08 Christchurch Hospital B Boehringer Ingelheim ADHB Maori Research blind phase III trial to investigate the subject to Wellington Hospital Review Committee efficacy and safety of oral BIBF 1120 conditions MidCentral DHB plus standard pemetrexed therapy Auckland City compared to placebo plus standard Hospital pemetrexed therapy in patients with IIIB/IV or recurrent non-small cell lung cancer after failure of first line chemotherapy

MEC/08/11/149 A phase IIa multi-centre randomised Prof Russell 4/11/08 18/11/08 Deferred Further information Approved 18/02/09 Christchurch Hospital B Merck Sharpe & Dohme Nga Kai Tataki WDHB – double-blind placebo controlled trial Scott required Waitemata DHB Te Komiti Whakarite of MK-0941 in patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin

MEC/08/11/150 A randomised double-blind vehicle Mr Andrew Jull 4/11/08 18/11/08 Approved Approved 2/02/09 Auckland DHB B CoDa Therapeutics Henare Mason, Chair controlled parallel group dose ranging subject to Counties Manukau MRAC University of multi-centre study of the efficacy and conditions DHB Auckland safety of NEXAGON in the treatment Waikato DHB of participants with venous legs Nurse Maude ulcers Association

MEC/08/11/151 A phase 3 multi-centre randomised Dr Sharon 4/11/08 18/11/08 Approved Approved Counties Manukau B Celgene Corporation Counties Manukau DHB, double-blind placebo controlled Jackson subject to subject to DHB/Middlemore Te Wai Awhina – North parallel group study of the efficacy conditions conditions Hospital Shore and safety of Lenalidomide (Revlimid) Canterbury DHB/ as maintenance therapy for patients Christchurch Hospital with B-cell chronic lymphocytic Waitemata DHB/ leukaemia following second line North Shore Hospital therapy (the continuum trial Protocol: and Waitakere CC-5013-CLL-002) Hospital

48 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/11/152 Randomised controlled trial of Dr James Faed 4/11/08 18/11/08 Approved Approved Dunedin Hospital A treatment for chronic spinal cord subject to subject to injury: combined olfactory mucosal conditions conditions autotransplantation and rehabilitation therapy compared with rehabilitation therapy alone

MEC/08/12/153 Gender and medicine: Identities and Geraldine 24/11/08 9/12/08 Deferred Research design Approved Victoria University of A Family Planning, Social bodies beyond the male/female Christmas subject to Wellington Inclusion and binary code conditions Participation Ministry of Social Development, Out there

MEC/08/12/154 PLATINUM QCA: “a prospective, Dr Douglas 24/11/08 9/12/08 Approved Approved 8/04/08 Christchurch Hospital B Boston Scientific CMDHB multi-centre trial to assess an McLean subject to Middlemore Hospital Cooperation everolimus-eluting coronary stent conditions Dunedin Hospital system (PROMUS element)” Wellington Hospital North Shore Hospital

MEC/08/12/155 PLATINUM: “a prospective, Dr Dougal 24/11/08 9/12/08 Approved Approved Christchurch Hospital B Boston Scientific randomised multi-centre trial to McClean subject to subject to Wellington Hospital Cooperation assess an everolimus-eluting conditions conditions Ascot Hospital coronary stent system (PROMUS Middlemore Hospital ELEMENT) for the treatment of up to two de novo coronary artery lesions

MEC/08/12/156 A phase 2 study of the safety and Dr Rob Walker 24/11/08 9/12/08 Approved Approved 20/03/09 Christchurch B Takeda Global Ngai Tahu Research efficacy of AF37702 injection for the subject to Hospital, Dunedin Research & Committee, Te Komiti maintenance treatment of anemia in conditions Hospital Development Centre Whakarite peritoneal dialysis participants Ltd previously treated with epoetin

MEC/08/12/157 A multi-centre, long-term follow-up, Dr Nigel Gilchrist 25/11/08 9/12/08 Approved Approved 8/01/09 CGM Research Trust B CBio Ltd Nga Kete E Rua, CM open label trial to assess the efficacy subject to QE Health Māori Research Review and safety of Ppn10 in subjects with conditions Middlemore Hospital committee, Kuini Rirpeti rheumatoid arthritis CBIO2008-01 Waikato DHB Kaunihera QE Health dated 10 September 2008 Hutt Valley DHB Waitemata DHB

MEC/08/12158 Investigating the genetics of the Assoc Prof 25/11/08 9/12/08 Approved Approved 25/02/09 Central & South A control of movement in humans Elizabeth Franz subject to Regional Genetics conditions Service Northern Regional Genetics Service

Multi-region Ethics Committee Annual Report 2008 49

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/12/159 Youth e-therapy – evaluation of Dr Sally Merry 25/11/08 9/12/08 Approved Approved 24/02/09 East Health Trust A computerised cognitive behavioural subject to PHO self-help programme for adolescents conditions Pakuranga Medical with mild to moderate depression Centre Botany Terrance Medical Centre Tikipunga High School Kapiti Youth Support Highland Park Medical Centre Auckland Grammar School Rotovegas Youth Health Centre Kamo High School 198 Youth Health Centre Christchurch

MEC/08/12/160 A quantitative study into Family Frances Bird 5/12/08 9/12/08 Approved Approved 188 Specialist A Planning’s 16–19-year-old clients’ subject to subject to Centre, St Hailers knowledge about and attitudes to conditions conditions abortion

MEC/08/12/161 A phase III, randomised, double- Prof Russell 17/12/08 9/12/08 Approved Approved 23/02/09 Christchurch Hospital B Boehringer Ingelheim blind, placebo-controlled parallel Scott subject to P3 Research, (NZ) Ltd group safety and efficacy study of conditions Tauranga BI1356 (5 mg), compared to placebo Middlemore Hospital as add on to insulin and/or sulphonylurea over 52 weeks in type 2 diabetic patients with severe chronic renal impairment

MEC/08/12/162 Surveillance of HIV and hepatitis C Charles 5/12/08 9/12/08 Approved Approved 28/04/09 ADIO Auckland A prevalence among attendees of Henderson subject to NEWS Hamilton needle exchanges throughout New conditions DHDP: Napier, Zealand Palmerston North, Wellington SHRP Invercargill NICHE Nelson Rodger Wright Centre, Christchurch RWC West Coast Outreach Christchurch NEXT Timaru DIVO Timaru

50 Multi-region Ethics Committee Annual Report 2008

Expedited review applications

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/01/EXP ASAP study – audit of severe acute Dr Senton 3/01/08 Approved 17/01/08 Nil pancreatitis feeding practices: a Henderson prospective, observational, multi- centre study of nutritional therapy in severe acute pancreatitis patients within Australasia

MEC/08/02/EXP Short-term evaluation of the ACC Alice Kan 8/01/08 Approved 17/01/08 Nil modified tai chi programme

MEC/08/03/EXP Use of G-CSF (granulocyte colony Dr Susanta 17/01/08 Approved 17/01/08 Nil stimulating factor) to mobilise and Ghosh collect granulocytes from volunteer unrelated donors for therapeutic purposes

MEC/08/04/EXP Utility of primary care computer Prof Murray 29/01/08 Approved 11/02/08 Nil records for product vigilance Tilyard

MEC/08/05/EXP An assessment tool for success Mark Garisch 1/02/08 Approved 11/02/08 factors in the implementation of new technology using the inter-RAI minimum data set – home care (MDS-HC) comprehensive geriatric assessment tool as a case study

MEC/08/06/EXP Influenza vaccination coverage 2002– Barbara Warren 08/02/008 Approved 11/02/08 Nil 2006 in high-risk patients under 65 years of age: a descriptive observational study using general practice data to estimate the influenza vaccination coverage rates in eligible patients under 65 with chronic underlying medical conditions over a five year period in New Zealand

MEC/08/07/EXP Specialist nursing in New Zealand: Kathy Holloway 8/02/08 Approved 11/02/08 Nil development of a framework

MEC/08/08/EXP Exploring the nature of the Shane Scahill 8/02/08 Approved 11/02/08 Nil relationship between organisational culture and performance within community pharmacies in New Zealand

Multi-region Ethics Committee Annual Report 2008 51

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/09/EXP Classification and frequency of Prof Murray 14/02/08 Approved 14/03/08 Nil patient reasons for consulting in New Tilyard Zealand general practice for the international health terminology standards development organisation (IHTSDO)

MEC/08/10/EXP The role of community capacity Dr Sarah Lovell 28/02/08 Approved 14/03/08 Nil building in health promotion: New Zealand and Ontario experiences

MEC/08/11/EXP Reliability and validity of the BESTest Sue Lord 6/03/08 Approved 21/05/08 Nil – a preliminary Investigation

MEC/08/12/EXP Health informatics skills and Cornelia Krebs 11/03/08 Approved 11/04/08 Nil competencies in midwifery: a national survey of midwifery education programmes in New Zealand

MEC/08/13/EXP Unintentional injuries at home among Bridget Kool 27/03/08 Approved 29/04/08 Nil the working-aged: the role of alcohol, recreational drug use and fatigue

MEC/08/14/EXP A questionnaire to assess the music Kate Rutledge 27/03/08 Approved 29/04/08 Nil perception and appreciation of hearing aid users

MEC/08/15/EXP A comparison of the views of patients Prof Graham 2/04/08 Approved 29/04/08 Nil and examiner’s or registrar interview Mellsop skills as a reflection of OCI validity

MEC/08/16/EXP What are the critical success factors Noelene 7/04/08 Approved 1/05/08 Nil for achieving good quality outcomes Whitehead for residents in age related residential care? A mixed methods study exploring efficiency, effectiveness, benchmarking and quality act ivies in private hospitals in New Zealand?

MEC/08/17/EXP The impact of climate change on Emma Britton 10/04/08 Approved 1/05/08 Nil enteric disease incidence in New Zealand

MEC?08/18/EXP Radiotherapy for rectal cancer: who Duncan 16/04/08 Approved 21/05/08 Nil should receive it? Shannon

MEC/08/19/EXP Validation of the interRAI MDS Dr Diane 16/04/08 Approved 22/05/08 Nil contact assessment Jorgenson

MEC/08/20/EXP Benchmarking transfusion across Dr Richard 23/04/08 Approved 21/05/08 Nil New Zealand Charlewood

MEC/08/21/EXP Palliative care provision for people Dot Smyth 28/04/08 Approved 21/05/08 Nil living in rural New Zealand

52 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/22/EXP ATV related injuries in New Zealand Kate Anson 2/05/08 Approved 21/05/08 Nil children requiring hospitalisation

MEC/08/23/EXP An examination of the new graduate Dr Marion Gray 7/05/08 Approved 1/05/08 Nil and recent migrant occupational therapists perspectives on work preparedness, professional development and work environment issues

MEC/08/24/EXP Monitoring drug safety through Dr Lianne Parkin 7/05/08 Approved 1/05/08 Nil linkage of existing prescription and outcome data

MEC/08/25/EXP The great life project: a research Brigit Mirfin- 9/05/08 Approved 17/06/08 Nil partnership between the self- Veitch advocacy advisory committee and the Donald Beasley Institute

MEC/08/26/EXP The Australian College for Paula O’Sullivan 12/05/08 Approved 29/05/08 Nil Emergency Medicine fellowship examination – a survey of exam preparation and perceived validity and effect

MEC/08/27/EXP A follow-up study of people Dr Simon 19/05/08 Approved 29/05/08 Nil presenting to four District Health Hatcher Boards after self-harm (AKX/04/11/326)

MEC/08/28/EXP What is the nurse practitioners’ Fiona Unac 19/05/08 Approved 29/05/08 Nil access to diagnostic testing?

MEC/08/29/EXP What can be learnt from application Dilky Rasiah 26/05/08 Approved 29/05/08 Nil for community exceptional circumstances (CEC) funding?

MEC/08/30/EXP A survey of the experiences of Dr Lēonie 26/05/08 Approved 29/05/08 Nil migration to New Zealand by nurses Walker qualified overseas

MEC/08/31/EXP GP and practice nurse perceptions of Jane Alexander 26/05/08 Approved 29/05/08 Nil the role of nurse practitioners in primary health care

MEC/08/32/EXP Pre-dialysis nurses’ perceptions of Rachael Walker 28/05/08 Approved 17/06/08 Nil effective care

MEC/08/33/EXP Incidence of skin cancer in solid Raakhi Mistry 29/05/08 Approved 29/05/08 Nil organ transplant recipients

MEC/08/34/EXP Allopurinol toxicity in New Zealand: a Dr Lisa Stamp 12/06/08 Approved 18/06/08 Nil case control study

Multi-region Ethics Committee Annual Report 2008 53

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/35/EXP Doctors and nurses: survey of the Dr Joseph Scott- 18/06/08 Approved 18/06/08 Nil use of standing orders in New Jones Zealand primary care

MEC/08/36/EXP New Zealand smoking toolkit pilot Janine Paynter 12/06/08 Approved 2/07/08 Nil study

MEC/08/37/EXP A study of the prescribing of Anna Denton 24/06/08 Approved 16/07/08 Nil corticosteroids in a selected sample of New Zealand hospices and the influences on such prescribing

MEC/08/38/EXP Spectrum of MECP2 mutations in Dr Anthony 20/06/08 Approved 16/07/08 Nil New Zealand Rett syndrome patients Raizis

MEC/08/39/EXP Review of MPS/MAS counselling Dr Tim Cookson 30/06/08 Approved 16/07/08 Nil service

MEC/08/40/EXP Burn injuries and socioeconomic Raakhi Mistry 30/06/08 Approved 16/07/08 Nil deprivation

MEC/08/41/EXP The utility of routine medical Dr Chris Sames 30/06/08 Approved 16/07/08 Nil examination of occupational divers: a retrospective, longitudinal cohort study

MEC/08/42/EXP Health-screening of employees by Natalie Gould 7/07/08 Approved 16/07/08 Nil pharmacists

MEC/08/43/EXP Smoking during pregnancy – an Ms Lesley Dixon 9/07/08 Approved 16/07/08 Nil Analysis of the New Zealand College of Midwives midwifery database information

MEC/08/44/EXP A prospective observational study of Ms Lynette 17/07/08 Approved 13/08/08 Nil blood products in Australian and New Newby Zealand intensive care units

MEC/08/45/EXP New Zealand general practice patient Mr Jonny Duder 22/07/08 Approved 13/08/08 Nil population

MEC/08/46/EXP Assessment of the uptake of Prof Stephen 22/07/08 Approved 5/08/08 Nil evidence-based practice in hospital Duffull pharmacy

MEC/08/47/EXP Selective laser trabeculoplasty as a Mr Albert 23/07/08 Approved 21/08/08 Nil primary or medication – sparing Vosseller therapy in glaucoma

MEC/08/48/EXP Research funder perceptions of John Kennelly 24/07/08 Approved 21/08/08 Nil quality in health care

54 Multi-region Ethics Committee Annual Report 2008

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/49/EXP Mental health nurses’ beliefs about Michael Connolly 29/07/08 Approved 8/08/08 Nil smoking by inpatients

MEC/08/50/EXP Injury surveillance of New Zealand Dr Steve Targett 4/08/08 Approved 8/08/08 Nil professional rugby players

MEC/08/51/EXP Evaluation of healthy food and Dr Janet Clinton 7/08/08 Approved 1/09/08 Nil nutrition initiatives in schools and early childhood education settings

MEC/08/52/EXP Application of molecular diagnostics Dr Stephen On 12/08/08 Approved 2/09/08 Nil to assess the prevalence of epsilobacteria in human gastroenteritis

MEC/08/53/EXP Visual scanning as a Rebekah 12/08/08 Approved 1/09/08 Nil physiotherapeutic programme post Wirawan stroke

MEC/08/54/EXP Immunisation disparities and vaccine- Dr Daniel Exeter 21/08/08 Approved 2/09/08 Nil preventable diseases in New Zealand

MEC/08/55/EXP Models of casemix for the New Dr Malcolm 13/08/08 Approved 13/08/08 Nil Zealand mental health system Stewart

MEC/08/56/EXP HEHA strategy evaluation: Dr Jackie 29/08/08 Approved 30/09/08 Nil Implementation, improvement and Cumming value for money

MEC/08/57/EXP Drug driving in New Zealand: a Kate Hammond 4/09/08 Approved 3/10/08 Nil survey of community attitudes, experiences and understanding

MEC/08/58/EXP Unexplained renal stones and/or Dr Nigel Dickson 23/09/08 Approved 26/09/08 Nil acute renal failure in infants

MEC/08/59/EXP Improving health systems Professor Peter 16/10/08 Approved 16/10/08 Nil performance: enhancing hospital Davis outcomes

MEC/08/60/EXP Understanding schools’ experiences Dr Susannah 14/11/08 Approved 14/11/08 Nil in supporting students’ needs with Roddick teacher aide allocation

MEC/08/61/EXP Consumers with chronic conditions Dr Nicolette 9/10/08 Approved 14/11/08 Nil and chronic conditions and care: Sheridan perspective of Pacific older people

MEC/08/62/EXP Yersiniosis in New Zealand: what is Nada Hanna 10/10/08 Approved 14/11/08 Nil the problem?

MEC/08/63/EXP Childhood adversity and mental Dr Kate Scott 20/10/08 Approved 14/11/08 Nil health outcomes

Multi-region Ethics Committee Annual Report 2008 55

Project key Full title Primary Date Meeting Outcome Why deferred/ Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed declined time of approval organisations undertaken report

MEC/08/64EXP Supervision of junior doctors in the Scott Orman 5/11/08 Approved 5/11/08 Nil emergency department: a survey of supervision practices in ACEM- accredited emergency department in Australasia and reviewer of departmental policies and legislature requirements

MEC/08/65/EXP Study of patients with chronic Dr Ni Aung 7/11/08 Approved 10/12/08 Christchurch Hospital Nil myelogenous leukaemia in South Island New Zealand

MEC/08/66/EXP Placing community capacity building Dr Sarah Lovell 11/11/08 Approved 16/12/08 Nil in the health sector

MEC/08/67/EXP Clinical audit of RhD immunoglobulin Dr Richard 27/11/08 Approved 2/12/08 Nil in New Zealand Charlewood

MEC/08/68/EXP A study on traditional, complementary Ms Holly 4/12/08 Approved 16/12/08 Nil and alternative health practitioners in Donnelly Tairawhiti and the East Coast region

MEC/08/69/EXP Working New Zealand: health and Joanna Broad 4/12/08 Approved 4/12/08 Nil disability innovation fund: mild to moderate health service evaluation

MEC/08/70/EXP Improving health systems Prof Peter Davis 4/12/08 Approved 5/12/08 Nil performance: enhancing hospital outcomes

MEC/08/71/EXP Evaluation of commercially available Dr Q Sue Huang 12/12/08 Approved 16/12/08 Nil serologikits ELISA kist fan an arbovirus (West Nile virus) using retrospective sera samples previously tested for an arbovirus (Dengue virus)

MEC/08/72/EXP Vaginal candidiasis consultations in Ms Natalie Gould 24/12/08 Approved 3/02/09 Nil New Zealand pharmacy

MEC/08/73/EXP An audit of time and financial costs Ms Catharine 24/12/08 Approved 3/02/09 Nil involved in the review process of Simmonds multi-centre clinical trials in Australia and New Zealand

56 Multi-region Ethics Committee Annual Report 2008