Northern Y Regional Ethics Committee

Annual Report

2008

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

ISBN 978-0-478-31995-8 (print) ISBN 978-0-478-31998-9 (online) HP 4945

This document is available on the New Zealand Health and Disability Ethics Committees’ 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: Northern Y Regional Ethics Committee Terms of Reference 16

Appendix 2: Applications Received in 2008 25

Northern Y Regional Ethics Committee Annual Report 2008 iii

Chairperson’s Report

This report overviews the work of the Northern Y Regional Ethics Committee from 1 January to 31 December 2008. The report was presented to the committee at its meeting on 28 April 2009.

This is my fourth and final annual report for the Northern Y Regional Ethics Committee. This year has been another full year for the members of the committee, as it has for the members and chairpersons of the other six ethics committees.

During 2008, the committee reviewed 119 full applications and 114 expedited applications. The expedited review process has minimally reduced the work for the full committee, but has increased the workload for chairpersons, particularly deputy chairpersons.

The appointment of suitably qualified committee members continues to be a problem. Vacancies increase the workload and pressure on existing members and can cause gaps in the range of committee expertise. I encourage the Minister of Health to consider reviewing the appointment process and to fill vacancies.

In March 2008, Janice Wilson, deputy director-general at the Ministry of Health announced a strategic review of the ethics committee system, beginning in April 2008, rather than enacting the recommendations of the 2007 operational review. The seven chairpersons were unclear about the purpose and process of this review, and there was no information about this review throughout the year until the chairpersons’ meeting in November 2008. At this meeting, the chairpersons were informed that the Minister of Health had decided the review would be completed without the chairpersons’ involvement. An outcome of this review has seen the further reduction of regional concerns in ethical review, as the Ministry of Health has changed the committees’ terms of reference to potentially allow any of the committees to hear applications. This was to even out differences in workloads among committees.

Advances from the chairpersons’ meetings include the positive and developed approach to compensation matters addressed with the Research Medicines Industry and Medical Protection Society. The attendance of Janice Wilson and, more recently, Bruce Anderson at the meetings has also supported opportunities for airing problems and seeking solutions.

A positive and useful event for all of the committees was the advanced training held in June. Members of all seven committees were invited to a two-day training conference in Wellington. Feedback was very encouraging about the material presented, as well as the opportunity for committee members from around the country to connect and network with others.

The committee continues to be indebted to our administrator, Amrita Kuruvilla, for her professional and friendly support to both the committee members and, especially, the researchers who connect with her as the first (and ongoing) point of contact with our committee.

Northern Y Regional Ethics Committee Annual Report 2008 1

The committee’s appreciation goes to Dr Felicity Dumble, who steps aside following a two- year period as deputy chairperson. Appreciation also goes to Dr Huhana Hickey who resigned from the committee this year to follow her career. Her legal experience was valuable and the committee expresses its gratitude.

My resignation has been tendered, effective 31 December 2008. I have employment and personal commitments that will take priority for 2009. I appreciate having had the opportunity and privilege to participate in this work, and to chair a committed and experienced committee. People I have met through the committee are inspiring and energising. I have a greater appreciation of the work of researchers in the health and disability fields.

I wish to acknowledge Peter Alan who chaired the (former) Waikato Ethics Committee when I was first appointed in September 2002. Peter was a wonderful chair and model for me to follow, and I appreciated the way he worked for the committee and researchers, with a fine eye for ethical detail.

I also wish to also acknowledge Sally Cook, national administrator for all the ethics committees. Sally has been an experienced and available support for the chairpersons in their and the committees’ work.

The committee also acknowledges the passing of Dr Paratene Ngata, Ng āti Porou. Dr Ngata was well recognised for his contribution to M āori health both within Tairawhiti and nationally.

Paul Flanagan Chairperson

2 Northern Y Regional Ethics Committee Annual Report 2008

Committee Membership

Appointments

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

Chairperson Paul Flanagan B Theol, GradDipArts (Psychology), M Couns, PG Cert Couns Supervision, MNZAC Representation Lay member Member category Community representative Gender Male Date of appointment December 2004 Term of appointment 3 years Six-year maximum term December 2008 Expertise Social services, senior lecturer, University of Waikato Iwi affiliations None

Paul’s last meeting was in December 2008. He had completed six years as a member of the committee.

Members Dr John Moodie MB ChB, FRCA, FANZCA Representation Non-lay member Member category Health practitioner Gender Male Date of appointment December 2004 Term of appointment 3 years Six-year maximum term December 2007 Expertise Anaesthetics, clinical research Iwi affiliations None

Dr Moodie’s last meeting was in March 2008. He had completed six years as a member of the ethics committee.

Christina Bryant MA (medical ethics and law), LLB (Hons) Representation Lay member Member category Ethicist Gender Female Date of appointment December 2004 Term of appointment 2 years Six-year maximum term November 2010 Expertise Ethics and law Iwi affiliations None

Northern Y Regional Ethics Committee Annual Report 2008 3

Peter Coughlan Certificate in Social Studies Representation Lay member Member category Community representative Gender Male Date of appointment December 2004 Term of appointment 2 years Six-year maximum term November 2010 Expertise Social studies Iwi affiliations None

Robert Crawford PhD (statistics) Representation Non-lay member Member category Biostatistician Gender Male Date of appointment December 2004 Term of appointment 3 years Six-year maximum term November 2010 Expertise Statistics Iwi affiliations None

Dr Crawford’s last meeting was in March 2008. He regretfully resigned due to work pressures.

Felicity Dumble FAFPHM (RACP), MPH (Hons), MBChB Representation Non-lay member Member category Health researcher Gender Female Date of appointment December 2004 Term of appointment 2 years Six-year maximum term December 2008 Expertise Public health Iwi affiliations None

Huhana Hickey LLB/BSocSc, LLM, PhD Representation Lay member Member category Lawyer Gender Female Date of appointment December 2004 Term of appointment 2 years Six-year maximum term November 2010 Expertise Law Iwi affiliations Waikato, Ng āti Tahinga

Dr Hickey’s last meeting was in June 2008. She regretfully resigned due to work pressures.

4 Northern Y Regional Ethics Committee Annual Report 2008

Claire Stott B Pharm (Hons) Representation Non-lay member Member category Pharmacist/pharmacologist Gender Female Date of appointment December 2004 Term of appointment 3 years Six-year maximum term November 2010 Expertise Pharmacy Iwi affiliations Ng ā Puhi

Claire’s last meeting was in March 2008. She regretfully resigned due to work pressures.

Heather Thomson Representation Lay member Member category Community representative Gender Female Date of appointment December 2004 Term of appointment 3 years Six-year maximum term November 2010 Expertise Community development, rural health, M āori health management Iwi affiliations Te Wh ānau a Apanui

Heather Thomson’s last meeting was in March 2008. She regretfully resigned due to work pressures.

Michael Vale Teachers College Diploma, Dip Rehab Studies, Grad Cert Career Development, PG Dip (education) Representation Lay member Member category Consumer representative Gender Male Date of appointment December 2004 Term of appointment 2 years Six-year maximum term November 2010 Expertise Disability support Iwi affiliations None

John Fitzgerald BA (Hons), MA, MSc (clinical psychology), PhD Representation Non-lay member Member category Health researcher Gender Male Date of appointment July 2005 Term of appointment 3 years Six-year maximum term July 2011 Expertise Clinical psychology Iwi affiliations None

Northern Y Regional Ethics Committee Annual Report 2008 5

Tessa Turnbull MBChB, Dip Obst, FRNZCP, FRACP 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 Expertise General (internal) medicine, obstetrics, geriatric medicine Iwi affiliations None

The following new appointments were made by the Minister of Health in 2008.

Willem Fourie PhD, RN, FCNA(NZ) Representation Non-lay member Member category Health practitioner Gender Male Date of appointment March 2008 Term of appointment 3 years Six-year maximum term March 2014 Expertise Nursing Iwi affiliations None

Sanya Ram B Pharm (Hons) Representation Non-lay member Member category Pharmacist/pharmacologist Gender Female Date of appointment March 2008 Term of appointment 3 years Six-year maximum term March 2014 Expertise Pharmacy Iwi affiliations None

Alistair Stewart BSc, DipSc Representation Non-lay member Member category Biostatistician Gender Male Date of appointment March 2008 Term of appointment 3 years Six-year maximum term March 2014 Expertise Epidemiology and biostatistics Iwi affiliations None

6 Northern Y Regional Ethics Committee Annual Report 2008

Adelaide Collins PhD (Māori development), Grad Dip (social science research), BA (Hons) (history and education studies) Representation Lay member Member category Community representative Gender Female Date of appointment March 2008 Term of appointment 3 years Six-year maximum term March 2014 Expertise Disability issues for M āori, research methodologies Iwi affiliations Ng āti Mahanga, Te Aitanga-a-Māhaki

Raewyn Sporle BSocSc, LLB Representation Lay member Member category Lawyer Gender Female Date of appointment September 2008 Term of appointment 3 years Six-year maximum term September 2014 Expertise Law, child support specialist Iwi affiliations None

Expert advisors The following person provided expert advice to the committee when the committee did not have the expertise required. Dr Elizabeth Spellacy Medical practitioner

Deputy chairperson Felicity Dumble continued as the committee’s deputy chairperson until September 2008. Tessa Turnbull and Willem Fourie took over the role from October 2008.

Northern Y Regional Ethics Committee Annual Report 2008 7

Members’ attendance at committee meetings in 2008

Table 1: Attendance of members at Northern Y Regional Ethics Committee meetings, 2008

Member Sex Lay/ 29 26 25 22 27 24 29 26 23 28 25 16 Total non-lay Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Paul Flanagan M L Y Y Y Y A Y Y Y Y Y A Y 10/12 John Moodie M N A A Y Completed term 1/3 Christina Bryant F L Y A T Y Y Y Y A Y Y Y T 10/12 Peter Coughlan M L Y Y Y Y Y Y Y Y Y Y Y Y 12/12 Robert Crawford M N A Y Y Completed term 2/3 Felicity Dumble F N A Y Y Y Y Y Y Y Y Y Y Y 11/12 Huhana Hickey* F L Y Y Y Y Y Y A A Resigned 6/8 Tessa Turnbull F N Y Y Y Y A A Y Y Y Y Y Y 10/12 Claire Stott F N Y T Y Completed term 3/3 Heather Thomson* F L T T A Completed term 2/3 Michael Vale M L Y Y Y T Y Y Y A Y Y Y Y 11/12 John Fitzgerald M N Y Y Y Y Y Y A Y A A Y Y 9/12 Sanya Ram F N Started Y Y Y Y Y T Y Y Y Y 10/10 March 2008 Alistair Stewart M N Started A Y Y A Y Y Y Y Y Y 8/10 March 2008 Willem Fourie M N Started Y Y Y Y Y Y Y A Y Y 9/10 March 2008 Adelaide Collins* F L Started Y A Y Y Y T Y Y Y Y 9/10 March 2008 Raewyn Sporle F L Started September 08 Y A Y Y 3/4 Members present 9 10 14 11 10 10 10 9 11 9 11 12 No. of applications 11 10 10 13 13 12 7 13 12 7 7 9 124 (5 exp)

Key * = M āori member A = Apology F = Female L = Lay M = Male N = Non-lay T = Teleconference Y = Present

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Training

New member training Training for new members of ethics committees and new administrators was held on 17 April 2008. This training was attended by: • Sanya Ram • Alistair Stewart • Willem Fourie.

The training for new members held on 19 November 2008 was attended by: • Adelaide Collins • Raewyn Sporle.

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.

Ongoing training was attended by: • Paul Flanagan • John Fitzgerald • Tessa Turnbull • Michael Vale • Peter Coughlan • Alistair Stewart • Adelaide Collins • Willem Fourie.

New Zealand Bioethics Conference Paul Flanagan attended the New Zealand Bioethics Conference, Dunedin, February 2008.

Northern Y Regional Ethics Committee Annual Report 2008 9

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

A joint meeting was also held with the Health Research Council Ethics Committee and Institutional Ethics Committee on the evening of 31 January 2008. Discussed at the meeting were:

• the Guidelines for an Accredited Institutional Ethics Committee to Refer Studies to an Accredited Health and Disability Ethics Committee

• reporting to the Health Research Council Ethics Committee.

Twenty Years after the Cartwright Report: What have we learnt Paul Flanagan attended the Twenty Years after the Cartwright Conference held in Auckland, 29 August 2008.

Health Research Council approval

The committee is approved by the Health Research Council until December 2009.

United States Department of Health and Human Services Registration

The Northern Y Regional 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: IRB00004665 – Northern Y Regional Ethics Committee.

10 Northern Y Regional Ethics Committee Annual Report 2008

Response to Cultural Issues

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

Category Number/comment

Number of applications deferred because M āori None guidelines were not read

Number of applications for which consultation with 119 Māori was considered appropriate

Number of applications returned through insufficient None. Evidence of consultation was required and consultation on cultural issues carried out subsequently.

Process the committee has for following through on Referring to Iwi, District Health Boards and M āori consultation research review committees and reviewing evidence of consultation.

Cases of unsatisfactory reasons for not including None Māori

Mechanisms in place to facilitate consultation with District Health Boards, M āori research review Māori by researchers committees, and tertiary institutions have processes in place. Referral to these by the ethics committee.

Examples of M āori not being included in research Research based purely on certain ethnic populations and research on diseases that M āori are assumed not to have.

Note on consultation

By Michael Vale, Tessa Turnbull and Adelaide Collins

The committee is encouraged that many researchers take a serious look at the effect of their research in relation to M āori practices and poorer health outcomes for M āori. Those who seek support from Te Kaumatua Kaunihera at the Waikato District Health Board are helped to gain more clarity on their roles and expectations, and this help-seeking appears to be a growing trend.

Researchers and ethics committee members still show some confusion over the cultural component of the ethics application (that is, whether there is an expectation that all research should have formal Māori sign-off or only research that involves M āori participants). Some researchers pay no more than lip service to the cultural requirements. Applicants in Auckland, outside the District Health Boards, seek support from a variety of M āori individuals and M āori organisations. Information and education from these individuals and organisations varies greatly and sometimes adds to the confusion. The new application that comes into effect in 2009 contains much clearer statements about when and to what extent consultation with M āori is required. It is hoped that this will minimise confusion in the future.

Northern Y Regional Ethics Committee Annual Report 2008 11

Applications

The committee held 12 scheduled meetings from January to December 2008.

Committee application statistics

Table 3: Northern Y-Regional Ethics Committee’s application statistics, 2008

Category Number

Applications reviewed by the full committee Applications approved 101 Applications deferred and subsequently approved 3 Applications deferred as at time of report 1 Applications declined 0 Applications carried forward (approved subject to conditions) 19 Ethics committee approval not required 0 Studies withdrawn by researcher 0 Studies terminated by sponsor 0 Studies transferred to Multi-region Ethics Committee 2

Total number of applications considered by the full committee 124 Applications approved as an audit 0

Expedited review applications Expedited review applications approved 80 Expedited review applications declined review – ethics committee approval not required 16 Expedited review applications declined review – full application required 3 Expedited review applications carried forward (approved subject to conditions) 10

Total number of expedited review applications reviewed 109 (excludes five reviewed at February meeting)

Total number of applications received 233

Other committee statistics

Table 4: Other Northern Y-Regional Ethics Committee’s statistics, 2008

Category Number

Number of matters arising 5 Number of general business items 31 Number of amendments reviewed by committee 50 Number of amendments approved under delegated authority 69

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Second opinions

No second opinions were requested.

Complaints

No formal complaints were received.

Northern Y Regional Ethics Committee Annual Report 2008 13

Issues

The committee considered two issues in 2008.

Committee membership and appointments

The process of membership selection and appointments for the committee has been an area of focus (as it was in 2007), particularly to enable a smooth and timely transition during membership changes. The appointment process has been very slow. The effectiveness and performance of the committee requires that appointments should be made in a timely and satisfactory manner.

Expedited review process

During 2008, the committee’s chairperson and deputy chairperson reviewed 114 expedited applications. Due to the workload, five expedited review applications were reviewed at a full committee meeting. The expedited review process has minimally reduced the work for the full committee but has increased the workload for chairpersons and, particularly, deputy chairpersons.

14 Northern Y Regional Ethics Committee Annual Report 2008

Guidelines for Chairperson’s Delegation

At its meeting on 15 December 2004, the committee agreed to delegate the following authority to the 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 should include a M āori member. The membership of the subcommittee is recommended by the chairperson and members are contacted by the administrator by phone or email to confirm their availability.

If any subcommittee member has a major concern and recommends the application or amendment be reviewed by the full committee, it will be placed on the agenda for consideration at the next committee meeting and the researcher advised.

The matters that the chairperson may approve following this process are:

• student applications, especially where there is a time constraint for the course and where there is minimal potential for harm to participants, such as 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.

All applications and amendments approved under delegated authority are listed on the agenda for the next meeting.

The committee also agreed to delegate the same authority to the deputy chairperson in the absence of the chairperson.

Northern Y Regional Ethics Committee Annual Report 2008 15

Appendix 1: Northern Y Regional Ethics Committee Terms of Reference

Public authority of the Northern Y Regional Ethics Committee (Northern Y REC)

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

Authority of the Northern Y Regional Ethics Committee

The Northern Y REC (in conjunction with Northern X REC) shall have primary responsibility for ethics committee review of health and disability research and innovative practice occurring in the following District Health Board regions: • Northland • Waitemata • Auckland • Counties Manukau • Waikato • Tairawhiti • Lakes • Bay of Plenty.

The Northern Y REC (in conjunction with the Northern X REC) has primary responsibility for any health and disability research that is currently being undertaken in the above DHB regions, provided that such research has previously been given ethical approval by an approved regional ethics committee.

Any other Regional Ethics Committee or the Multi-Region Ethics Committee may, if it has capacity, review health and disability research from the above regions. The Northern Y REC may, if it has additional capacity, review multi-region and national health and disability research or research from any other region.

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 Northern Y REC.

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Relations with other public sector organisations

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

Approval of the Northern Y Regional Ethics Committee

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

Role of the Northern Y Regional Ethics Committee

The primary role of the Northern Y REC is to provide independent ethical review of health research and innovative practice that will be conducted in its region of authority to safeguard the rights, health and wellbeing of consumers and research participants and, in particular, those persons with diminished autonomy. In order to do this, the Northern Y REC shall: i. foster an awareness of ethical principles and practices in the health and disability sector and research community ii. facilitate excellence in health research and innovative practice for the wellbeing of society iii. collaborate with researchers to ensure the interests, rights, dignity, welfare, health, and wellbeing of participants and consumers are protected iv. give due consideration to community views v. consistent with section 4 of the New Zealand Public Health and Disability Act 2000 and He Korowai Oranga, recognise and respect the principles of the Treaty of Waitangi vi. operate in accordance with the Operational Standard for Health and Disability Ethics Committees vii. operate in accordance with any guidance issued or approved by the Minister of Health.

Composition and membership

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

Northern Y Regional Ethics Committee Annual Report 2008 17

Member numbers The number of members of the Northern Y REC should be 12.

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

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

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

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

Member categories The Northern Y REC’s lay membership shall include: • an ethicist • a lawyer • consumer perspectives • community perspectives.

The Northern Y REC’s non-lay members shall include: • two health researchers • a pharmacist or pharmacologist • a biostatistician • two health practitioners.

Whole committee requirements At any time, consistent with the requirements of the New Zealand Public Health and Disability Act requirements for District Health Boards, the Northern Y REC shall have at least two M āori members. Māori members should have a recognised awareness of te reo M āori, and an understanding of tikanga M āori. All members of the Northern Y REC are expected to have an understanding of how the health sector responds to M āori issues and their application to ethical review.

The Northern Y REC’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.

Members should possess an attitude that is accepting of the values of other professions and community perspectives, and it is important for committees to be comprised of people from a range of backgrounds and ethnicities.

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

Terms and conditions of appointment

Members of the Northern Y REC are appointed by the Minister of Health, pursuant to section 11 of the New Zealand Public Health and Disability Act 2000, for a term of office of up to three years. The terms of office of members of the Northern Y REC shall be staggered to ensure continuity of membership. Members may be reappointed from time to time. No member may hold office for more than six consecutive years. After serving the maximum six-year term, members shall not be considered for reappointment until at least three years after their retirement from the Northern Y REC.

Persons who have served six consecutive years on any Health Research Council (HRC)- approved ethics committee shall not be immediately eligible for appointment to the Northern Y REC. Those persons shall not be eligible for appointment to the Northern Y REC until at least three years after their retirement from any HRC-approved ethics committee. Persons who have served less than six years on any HRC-approved committee will be eligible to be appointed to the Northern Y REC for a term that is equal to the difference of six years and the term already served by that person on any HRC-approved ethics committee, or a shorter period.

A person may not be a member of the Northern Y REC and National Ethics Advisory Committee or the Health Research Council Ethics Committee simultaneously.

Unless a person sooner vacates their office, every appointed member of the Northern Y REC shall continue in office until their successor comes into office. Any member of the Northern Y REC may at any time resign as a member by advising the Minister of Health in writing.

Any member of the Northern Y REC may at any time be removed from office by the Minister of Health for inability to perform the functions of office, bankruptcy, neglect of duty, or misconduct, proved to the satisfaction of the Minister.

The Minister may from time to time alter or reconstitute the Northern Y REC, or discharge any member of the Northern Y REC, or appoint new members to the Northern Y REC for the purpose of decreasing or increasing the membership or filling any vacancies.

Chairperson and Deputy Chairperson

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

Northern Y Regional Ethics Committee Annual Report 2008 19

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

The Chairperson and Deputy Chairperson/s may act with the delegated authority of the Northern Y REC between meetings.

Duties and responsibilities of a member

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

General Northern Y REC members should have a commitment to protecting the interests of human participants while promoting and facilitating excellence in research and innovative practice.

There is an expectation that Northern Y REC members will make every effort to attend all Northern Y REC meetings and devote sufficient time to become familiar with the affairs of the Northern Y REC and the wider environment within which it operates.

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

Conflicts of interest Northern Y REC members should perform their functions in good faith, honestly and impartially and avoid situations that might compromise their integrity or otherwise lead to conflicts of interest. Proper observation of these principles will protect the Northern Y REC and its members and will ensure it retains public confidence.

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

When Northern Y REC members believe they have a conflict of interest on a subject that will prevent them from reaching an impartial decision or from undertaking an activity consistent with the Northern Y REC’s functions, they should declare that conflict of interest and withdraw themselves from the discussion and/or activity.

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

Confidentiality and information sharing Agendas and minutes of all Northern Y REC meetings should be available to the public. Copies of proposals should be available to individuals outside the Northern Y REC, subject to deletions in accordance with the Official Information Act 1982, and any deletions necessary to protect the privacy of individual persons. If an applicant would like their proposal to remain confidential, they must give reasons, consistent with the Official Information Act, to satisfy the Northern Y REC that the proposal should remain confidential. The reasons for keeping a proposal confidential are subject to review by the Ombudsmen.

It is desirable for the members of the Northern Y REC to have an opportunity to discuss issues arising from applications with key contacts and support people prior to the consideration of proposals. This process should be encouraged. However, due to the need to protect any personal information, names or identifying details should not be circulated or made known outside the Northern Y REC. The Northern Y REC will need to consider the Privacy Act 1993 and the Health Information Privacy Code 1994 in developing these processes.

Within the Northern Y REC, members with particular community expertise should be consulted and provide advice on the appropriate consultative process for all ethical issues concerning particular communities of interest.

Committee meetings

Meetings of the Northern Y REC shall be held monthly or less frequently, as determined by the workload.

At any meeting, a quorum shall consist of at least seven members or the minimum number constituting a majority. The quorum must include a reasonable representation of members with health practitioner, research, ethical and community/consumer expertise, knowledge and perspectives.

As part of the accountability to the public they protect, it is desirable for the meetings of the Northern Y REC to be open to the public. Meetings of the Northern Y REC should therefore be: i. open meetings for the discussion of broad issues, particularly if the Northern Y REC is reviewing health research ii. closed meetings when necessary to ensure the privacy and confidentiality of participants

Northern Y Regional Ethics Committee Annual Report 2008 21

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

Information about the dates and times of committee meetings should be made available to the public.

Applicants may attend meetings, in person or by teleconference, to talk to their proposal and answer any questions the Northern Y REC may have. Attendance is not mandatory. The Northern Y REC should advise applicants that they may be asked to leave the meeting while the Northern Y REC considers the proposal.

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

Decision-making process Wherever possible, the Northern Y REC should determine matters by consensus decision. Where a consensus cannot be reached, a vote shall apply, with a two-thirds majority of those voting required for any decisions, and the Chairperson having a casting vote.

In relation to research involving Māori, it is important that Māori expertise be available to ensure that all issues are appropriately considered. Where it is not possible for Māori members to attend a Northern Y REC meeting or for those members views to be sought and represented at the meeting, the matter should be deferred.

On occasion, individual members may wish to abstain from some or all of the decision making process because of strong personal moral or religious reasons. Such abstentions shall not affect the approval process.

Ethics committee actions

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

Expert advice and consultation

Members may wish to consult on ethical issues with, for example, individuals, groups, iwi and hap ū, and this should be encouraged and supported. Consultation should be carried out in a timely manner.

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Where the Chairperson or quorum of Northern Y REC members believes there is insufficient expertise on the Northern Y REC to assess an application or an issue, the committee should seek additional expert advice.

Advice may be sought from recognised experts with: i. specialist knowledge in particular fields of science and medicine ii. knowledge of the experiences and perspectives of people with disabilities iii. awareness of gender health perspectives iv. consumer and/or research participant perspectives v. an understanding of community health issues vi. an understanding of relevant cultural perspectives vii. an understanding of developing Māori research methodologies viii. expertise in te reo Māori ix. expertise in ethical theory.

It should be noted that the above list gives examples, without restricting the range, of external expertise that may be sought.

Where external consultation has taken place or advice has been sought, this should be documented, and recorded where appropriate in the Northern Y REC’s decision on a proposal.

Review of committee decisions

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

The decisions of the Northern Y REC 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 Northern Y REC.

Reporting requirements

The following provides a checklist of requirements for annual reporting. Annual reports should be submitted to the Minister of Health and will be tabled by the Minister of Health in the House of Representatives.

The annual report shall include information on the membership of the Northern Y REC, including any change in the Northern Y REC’s membership or other substantive changes the Northern Y REC or its chairperson feels should be noted.

Northern Y Regional Ethics Committee Annual Report 2008 23

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 with conditions, Deferred, Declined) vii. for each protocol deferred or declined, the reason(s) for the decision.

The annual report shall also include: i. A list of training undertaken by Northern Y REC members, and a statement on processes for orientation and training of new Northern Y REC members should be included. ii. A list of complaints received by the Northern Y REC (if any), the actions taken to resolve the complaint and a comment on the outcome of the complaint(s). iii. Any areas of review that caused difficulty for the Northern Y REC in making a decision on any particular protocol(s), and any questions on policy or other matters the Northern Y REC referred to the National Ethics Advisory Committee or the Health Research Council Ethics Committee for comment or guidance.

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

Fees and allowances

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

The Chairperson shall receive an attendance fee of $330 per day plus half a day’s preparation fee. The attendance fee for members is set at $250 per day plus half a day’s preparation fee. In the event that the Chairperson and/or Deputy Chairperson/s are required to undertake additional work under the delegated authority of the Northern Y REC, 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 Northern Y REC members.

Servicing of the Northern Y Regional Ethics Committee

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

24 Northern Y Regional Ethics Committee Annual Report 2008

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 Status at Date of Locality Form Sponsor/funder Consultation investigator received reviewed deferred/declined time of approval organisations undertaken report

NTY/08/01/001 Improving access and grading Dr Eugene Tan 7/12/07 29/01/08 Approved Approved 40/04/08 Waikato Hospital A HRC research grant Te Puna Oranga at evaluations using in-depth subject to WDHB teledermatology (IMAGE IT) conditions

NTY/08/01/002 Effect of high dose perioperative Dr Nathaniel 20/12/07 29/01/08 Approved Approved 18/07/08 Waikato DHB A HRC grant Te Puna Oranga – oxygen on surgical site infections and Chiang subject to WDHB wound healing in vascular surgery conditions

NTY/08/01/003 Open label study of isavuconazole in Dr Graham Mills 21/12/07 29/01/08 Approved Approved 22/04/08 Waikato Hospital B Basilea Pharmaceutica Te Puna Oranga - the treatment of patients with subject to Ltd WDHB aspergillosis and renal impairment or conditions of patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi; protocol no WSA-CS-003; protocol date: amendment 01, 16 October 2007

NTY/08/01/004 Partnering in primary care – feasibility Assoc Prof 7/01/08 29/01/08 Approved Approved 20/03/08 ProCare Health Ltd A CMDHB, ADHB Dr Paparangi Reid – study of the Flinders model for New Margaret subject to Counties Manukau Auckland University Zealand populations Horsburgh conditions DHB Auckland DHB

NTY/08/01/005 Counties Manukau District Health Dr David Schaaf 7/01/08 29/01/08 Approved Approved 26/02/08 Counties Manukau Nil Riripeti Haretuku – Board (CMDHB) evaluation of the subject to DHB Maori Advisor for Kids in Action programme conditions South Seas CMDHB Healthcare

NTY/08/01/006 Assessment of vertebral artery blood Mr Wayne Hing 8/01/08 29/01/08 Approved Approved 7/05/08 Auckland University Nil MRRC at ADHB and flow using diagnostic ultrasound subject to of Technology AUT; NZSP/Taeora during the set up of cervical spine conditions Tinana manipulative positions

NTY/08/01/007 New Zealand health professionals’ Ms Linley 20/02/08 29/01/08 Approved Approved 8/05/08 Mercy Breast Clinic, Nil Charlotte Nasey – JP and patients’ constructions of the Stevenson subject to Epsom experience of breast cancer: a conditions discourse analysis

NTY/08/01/008 A double-blind, randomised, placebo- Dr John Gillies 10/01/08 29/01/08 Approved Approved 4/04/08 P3 Research in B Merck & Co Inc Te Puna Hauora – controlled, multi-centre, parallel subject to Tauranga Tauranga Hospital group, dose-ranging study of MK0633 conditions in adult patients with chronic asthma; study no MK-0633 007-05

Northern Y Regional Ethics Committee Annual Report 2008 25

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

NTY/08/01/009 Discrete choice survey of perceptions Dr Paul Brown 11/01/08 29/01/08 Approved Approved 20/06/08 Auckland DHB Nil Dr Lorna Dyall – Maori of private and public providers of subject to Health Division, surgical procedures conditions University of Auckland, MRRC at ADHB

NTY/08/01/010 A comparison of ultrasound guided Dr Michael 15/01/08 29/01/08 Approved Approved 20/03/08 Starship Children’s A Grant from Auckland Mata Forbes – ADHB transverses abdominis plane block Fredrickson subject to Health Anaesthesia Research and ultrasound guided ilioinguinal conditions Gillies Hospital and Education Trust nerve block in paediatric inguinal Northern Surgical surgery Centre

NTY/08/01/011 ANZ 0501 (LATER): Phase III Dr Ian Campbell 15/01/08 29/01/08 Approved Approved 25/03/08 Waikato Hospital A Novartis Te Puna Oranga – randomised double blind trial in subject to St Anne Breastcare WDHB postmenopausal women who have conditions Centre, Hamilton completed five years of adjuvant endocrine therapy for early, hormone sensitive breast cancer more than one year previous, and who are disease-free at study entry

NTY/08/02/012 Characteristics of non-alcohol/drug Ms Keri 7/02/08 26/02/08 Approved Approved 8/05/08 Pou Tuia Rangahau Nil Te Hauora O Ngati users, particularly non-drinking (or Thompson subject to Ngati Haua areas Haua non-problem-drinking and non- conditions smoking) Maori youth/taiohi (under age 18)

NTY/08/02/013 An investigation of the association Ms Christina 7/02/08 26/02/08 Approved Approved 4/04/08 Waikato DHB Nil Kaumatua Kaunihera – between glucose absorption from Khouri subject to WDHB peritoneal fluid and significant weight conditions gain in peritoneal dialysis patients of the Waikato Dialysis Unit

NTY/08/02/014 Assessing the fibre and fluid intakes Ms Kristy 7/02/08 26/02/08 Approved Approved 4/04/08 Waikato Hospital Nil Kaumatua Kaunihera – of peritoneal dialysis outpatients from Redwood subject to WDHB the Waikato Regional Dialysis Unit conditions and any relationship to constipation

NTY/08/02/015 A 12-week treatment, multi-centre, Dr John Gillies 8/02/08 26/02/08 Approved Approved 3/04/08 P3 Research, B Novartis Te Puna Hauora – randomised, double-blind, placebo subject to Tauranga Pharmaceuticals Tauranga controlled, parallel group study to conditions assess the efficacy and safety of indacaterol (150 µg od) in patients with chronic obstructive pulmonary disease; study no CQAB149B2346

NTY/08/02/016 Does ‘open’ CPAP(oPAP) provide an Dr AG Veale 11/02/08 26/02/08 Approved Approved 22/04/08 Auckland Physiology B Fisher & Paykel MRRC at ADHB, efficacious and comfortable treatment subject to Healthcare CMDHB and WDHB for patients with mild to moderate (as conditions defined by AHI: 5–30/hour OR existing CPAP pressure < 10 cmH2O) obstructive sleep apnea (OSA)?

26 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/03/017 Trial of the malnutrition universal Ms Sarah 4/03/08 25/03/08 Approved Closed 31/03/08 Waikato Hospital Nil Kaumatua Kaunihera – screening tool (‘MUST’) to identify the Fleming subject to WDHB incidence of patients aged over conditions 65 years, who are at risk of malnutrition, admitted to the orthopaedic wards at Waikato Hospital with fractures due to falls

NTY/08/03/018 Mechanism of daily variation in the Dr James 5/03/08 25/03/08 Approved Approved 8/05/08 Auckland City A Project grant from MRRC at ADHB action of neuromuscular blockade Cheeseman subject to Hospital University of Auckland conditions

NTY/08/03/019 Factors affecting treatment Dr Zorica 5/03/08 25/03/08 Approved Approved 4/04/08 Community Alcohol Nil MRRC at Waitemata adherence with naltrexone in the Gruneska subject to and Drug Service DHB treatment of alcohol dependence in conditions older clients attending Auckland’s community alcohol and drug services: clients’ perspectives

NTY/08/03/020 A pilot study to investigate the effect Dr AG Veale 7/03/08 25/03/08 Approved Approved 4/06/08 Auckland Physiology B Sleep Limited MRRC at CMDHB of ultra high temperature (UHT) subject to treated A1 milk, supplement with conditions vitamin C, on sleep function in patients complaining of sleep onset Insomnia

NTY/08/03/021 Evaluation of Te Hikoi o Nga Tane Dr Michelle Levy 7/03/08 25/03/08 Approved Approved 3/06/08 Participants Choice Nil Manager of Pai Ake (the walk of man) and Whanake subject to Solutions Ltd (boys to men) programmes conditions

NTY/08/03/022 Platelet function in intraoperative Dr Nina Civil 7/03/08 25/03/08 Approved Approved 8/05/08 Waikato Hospital A MedTel NZ Limited Kaumatua Kaunihera – autologous whole blood donation for subject to WDHB cardiac surgery – an observational conditions cohort study using thromboelastography and platelet function assay to assess platelet function

NTY/08/03/023 Pilot study identifying thyroid function, Mrs Veronique 7/03/08 25/03/08 Approved Approved 2/02/09 Waikato DHB Nil Kaumatua Kaunihera – selenium, iodine, lipid levels, and Gibbons subject to WDHB cognitive function in older females in conditions the community

NTY/08/03/024 Protocol no PR-104-1004: ‘a phase I, Dr Michael 10/03/08 25/03/08 Approved Approved 3/06/08 Waikato Hospital B Proacta Inc Kaumatua Kaunihera – multi-centre, open-label, dose Jameson subject to WDHB escalation trial of the safety and conditions pharmacokinetics of intravenous PR-104 given with prophylactic G-CSF in subjects with solid tumours’

NTY/08/03/025 Neonatal hypoglycaemia: the sugar Prof Jane 10/03/08 25/03/08 Approved Approved 8/05/08 Waikato Hospital A Waikato Medical Te Puna Oranga – babies study Harding subject to Research Foundation WDHB conditions

Northern Y Regional Ethics Committee Annual Report 2008 27

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

NTY/08/03/026 A double-blind, randomised study of Dr John E 10/03/08 25/03/08 Approved Sponsor decides to Closed Waikato Hospital B Roxro Pharma LLC Te Puna Oranga – the safety, tolerability, analgesic Moodie subject to withdraw study Braemar/Anglesea WDHB efficacy of intranasal ketorolac conditions Hospital tromethamine and oral vicodin for Southern Cross postoperative pain Hospital

NTY/08/04/027 Factors that support abstinence or Dr Tamasailau 26/03/08 22/04/08 Approved Approved 9/07/08 University of Nil Nga Kai Taataki at responsible alcohol consumption Suaalii-Sauni subject to Auckland Waitemata DHB amongst Pacific youth: a qualitative conditions investigation

NTY/08/04/028 The measurement of breath pentane Dr Tim Lowe 4/04/08 22/04/08 Approved Approved 30/07/08 HortResearch Nil HortResearch Kaumatua Kaunihera at by gas chromatography – mass subject to WDHB spectrometry as an indicator of lipid conditions peroxidation induced by exercise

NTY/08/04/029 Reducing DNAs to CAMHS Dr Emily Cooney 26/03/08 22/04/08 Approved Approved 26/06/08 Greenlane Clinical Nil ADHB MRRC at ADHB appointments via a text message subject to Centre reminder conditions

NTY/08/04/030 A phase II randomised, placebo- Dr Edward John 27/03/08 22/04/08 Approved Approved 31/07/08 Auckland Clinical B Merck & Co Inc MRRC at ADHB controlled study to evaluate the safety Gane subject to Studies Ltd and efficacy of MK-7009 administered conditions concomitantly with pegylated- interferon and ribavirin for 28 days in treatment naïve patients with chronic hepatitis c infection; MK7009-01, 26 February 2008

NTY/08/04/031 Retinal structure and function in Prof Michael 2/04/08 22/04/08 Approved Approved 27/06/08 University of Nil Department of MRRC at ADHB patients with sleep disorders Kalloniatis subject to Auckland Optometry, University of conditions Auckland DHB Auckland

NTY/08/04/032 Effects of high dose perioperative Dr Nathaniel 3/04/08 22/04/08 Approved Approved 25/06/08 Waikato Hospital A Bayer Health Care, Te Puna Oranga – oxygen, extended active Chiang subject to HRC, Waikato Medical WDHB perioperative warming and peri- conditions Research Fund operative ilomedin on tissue oxygenation and wound healing in vascular surgery

NTY/08/04/033 Effects of a behavioural intervention Dr Patrick 4/04/08 22/04/08 Approved Approved 7/12/08 Gisborne Hospital A Tairawhiti Maaka Tibble, on health functioning and quality of McHugh subject to Complementary Tairawhiti life in community dwelling adults with conditions Therapies Trust and complementary and a chronic condition – a randomised, JN Williams Memorial traditional therapies wait-list controlled clinical trial Trust research trust board

NTY/08/04/034 Disabled men and experiences of Prof Marta Leete 4/04/08 22/04/08 Approved Approved 3/06/08 Auckland University A AUT University Huhana Hickey – Ngati fatherhood: a qualitative study subject to of Technology Tahinga and Philip conditions Patson – Diversity Works

28 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/04/035 Pacific Islands families study: oral Assoc Prof 4/04/08 22/04/08 Approved Approved 21/01/09 Auckland University Nil Kate Haswell, Assoc health (PIF:OH) Theresa Madden subject to of Technology Dean Maori Health; conditions Dr Lisa Fergusson, Taupua Waiora

NTY/08/04/036 A multi-centre burns unit clinical trial: Dr Sarah Usmar 4/04/08 22/04/08 Approved Approved 2/07/08 Middlemore Hospital A Diversionary Therapy MRRC at CMDHB preparation and distraction using a subject to Technologies multi-modal device during children’s conditions burn wound care procedures

NTY/08/04/037 Process mapping with families of Dr Tamasailau 4/04/08 22/04/08 Approved Approved 9/07/08 CRRC Nil PMHAS Pacific mental health consumers in a Suaalii-Sauni subject to PMHAS community mental health care setting conditions

NTY/08/04/038 The effect of water flow restriction on Dr Denise 7/04/08 22/04/08 Approved Approved 3/06/08 A+ Laboratory Nil Amiria Rereti – Maori microbial hand decontamination after Barnfather subject to Service Development hand washing conditions Manager

NTY/08/04/039 Predictors of foot function in patients Prof Keith Rome 10/04/08 22/04/08 Approved Approved 3/06/08 Auckland DHB A AUT University, MRRC at ADHB and with gout: a three-dimensional CT subject to JD Findlay Trust, CMDHB study conditions Arthritis New Zealand

NTY/08/05/040 Improving informed consent: a Dr Ian Campbell 10/04/08 27/05/08 Approved Approved 26/06/08 Waikato Hospital Nil Grant from Susan Kaumatua Kaunihera at randomised controlled trial of a subject to St Anne Breastcare G Kormen for the Cure WDHB decision aid for women invited to conditions Centre, Hamilton Foundation participate in a breast cancer prevention trial (IBIS–II)

NTY/08/05/041 A randomised controlled trial of mini- Dr Margy Pohl 9/05/08 27/05/08 Approved Approved 28/07/08 Whangarei Hospital A Whangarei Hospital Whangarei Hospital tightrope versus scarf osteotomy for subject to Maori Health hallux valgus conditions Directorate

NTY/08/05/042 A randomised controlled trial of Dr Simon 2/05/08 27/05/08 Approved Approved 12/08/08 Northshore Hospital A University of Auckland Timoti George – Maori problem solving therapy in people Hatcher subject to Waitakere Hospital Mental Health; WDHB with diabetes who have depressive conditions symptoms

NTY/08/05/043 Evaluation of enhanced community Prof Harry Rea 2/05/08 27/05/08 Approved Approved 30/07/08 Counties Manukau Nil CMDHB MRRC at CMDHB geriatric services initiative subject to DHB conditions

NTY/08/05/044 A pluralistic evaluation of the good Dr Philippa 7/05/08 27/05/08 Approved Approved 10/11/08 Waikato DHB Nil Te Puna Oranga – health great learning initiative Miskelly subject to WDHB undertaken by King Country/South conditions Waikato public health nurses

NTY/08/05/045 A study of vitamin D, innate immunity Dr Leong Chai 9/05/08 27/05/08 Approved Approved 27/06/08 Waikato DHB A Waikato Medical Kaumatua Kaunihera – and severity of community acquired Leow subject to Waikato University Research Fund WDHB pneumonia and exacerbations of conditions COPD in adults

NTY/08/05/046 The use of botox in the treatment of Dr Jane Strang 9/05/08 27/05/08 Approved Approved 20/08/08 Waikato DHB Nil Kaumatua Kaunihera – anal fissure subject to WDHB conditions

Northern Y Regional Ethics Committee Annual Report 2008 29

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

NTY/08/05/047 The impact of a memory book and Ms Annabel 9/05/08 27/05/08 Approved Approved 15/07/08 Briargate Resthome Nil Rahuia Kapa, Maori reminiscence DVD on conversations Grant subject to Lady Allum Lifestyle Gains Health Advisor with keyworkers and on conditions Care and Village and Giovanni Armaneo communication related quality of life from WDHB for people wi th dementia in residential care

NTY/08/05/048 An investigation into the lung cancer Ms Amber Riley 9/05/08 27/05/08 Approved Approved 20/08/08 Whangarei Hospital Nil Kaumatua Kainuhera – management pathways for Maori in subject to Northland DHB Northland conditions

NTY/08/05/049 An investigation of changes in the Dr Clare 20/04/08 27/05/08 Approved Approved 10/11/08 University of Nil MRRC at CMDHB speaking voice and singing voice for McCann subject to Auckland patients undergoing thyroid surgery conditions Counties Manukau DHB

NTY/08/05/050 The impact of oranga niho on quality Assoc Prof John 9/05/08 27/05/08 Approved Approved 20/08/08 Raukura Hauora O Nil Kaumatua Kaunihera – of life of rangatahi Maori aged Broughton subject to Tainui WDHB between 16 years and 18 years who conditions reside within the Waikato rohe of Tainui

NTY/08/05/051 A phase II, double blind, placebo- Dr Gerry Devlin 12/05/08 27/05/08 Approved Approved 16/07/08 Waikato Hospital B TASLY Kaumatua Kaunihera – controlled, randomised, multi-centre, subject to Pharmaceuticals Inc WDHB parallel group study to evaluate the conditions efficacy and safety of T89 in patients with chronic stable angina pectoris

NTY/08/05/052 A single-dose, randomised, open- Dr Edward John 12/05/08 27/05/08 Approved Approved 25/06/08 Auckland Clinical B F Hoffmann-La Roche MRRC at ADHB label, four-way crossover study Gane subject to Studies Ltd Inc design with a washout period of at conditions least seven days to investigate the relative bioavailability of RO4588161 following oral administration in healthy subjects

NTY/08/06/053 The practice and understandings of Ms Helen 28/05/08 24/06/08 Approved Parameters of study Withdrawn Holistic Medical Nil Taumata Maunsell- integrative medicine in New Zealand Madden subject to changed, new Centre Peterson at Massey conditions application will be Centre for Advanced University sent at later date Medicine

NTY/08/06/054 Exploring ownership issues in youth Dr Alison Towns 3/06/08 24/06/08 Approved Approved 20/08/08 Participant’s choice Nil ACC Tania Cargo, Vic Woolf, relationships – young men subject to Susan Osborne – Maori conditions consultation group

NTY/08/06/055 Longitudinal study of New Zealand Dr Susan Morton 9/06/08 24/06/08 Approved Approved 31/07/08 ADHB Nil Hauora Waikato, children and families subject to Counties Manukau Ruakura Hauora O conditions DHB Tainui Waikato DHB

NTY/08/06/056 Case study. The experience of the Ms Joyce Mok 6/06/08 24/06/08 Approved Approved 31/07/08 Waikato Hospital Nil Kaumatua Kaunihera – managers: the how of organisational subject to WDHB learning after patient incidents in a conditions hospital

30 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/06/057 A qualitative descriptive study of the Ms Joanna 6/06/08 24/06/08 Approved Approved 31/07/08 North Shore Hospice Nil experiences and preferences of Hathaway subject to Mercy Hospital Chinese immigrant families when conditions receiving hospice services in New Zealand

NTY/08/06/058 An audit of self harm suicide Dr Hossam 6/06/08 24/06/08 Deferred Deferred due to Approved Northland DHB Nil Bella Hutchinson – presentations to Northland District Mahmoud issues regarding subject to Kaunihera Te Health Board emergency study design, safety conditions Potokomanawa departments of participants and privacy and confidentiality; ethical issues as per operational standard: 2.2 informed consent, 2.3 privacy and confidentiality, 2.4 minimisation of harm

NTY/08/06/059 WHO multi-centre study for the Dr GK Parry 6/06/08 24/06/08 Approved Approved 11/12/08 Middlemore Hospital Nil WHO – World Health MRRC at CMDHB development of growth standards subject to Organization from fetal life to childhood: the fetal conditions component

NTY/08/06/060 A study to determine the activity of Dr Lochie 6/06/08 24/06/08 Approved Approved 28/10/08 Starship Children’s B Schering-Plough P/L MRRC at ADHB SCH 717454 in participants with Teague subject to Hospital osteosarcoma or Ewing’s sarcoma conditions that has relapsed after standard systemic therapy

NTY/08/06/061 Heart rate variability, brain natriutic Dr Janaka 6/06/08 24/06/08 Approved Approved Waikato Hospital A Waikato Hospital Kaumatua Kaunihera – peptide and myocardial perfusion Kesara subject to subject to providing equipment WDHB scan as predictors of postoperative Wickremesekera conditions conditions cardiac complication and sudden death in peripheral vascular disease patients

NTY/08/06/062 Evaluation of the Waikato DHB Ms Ruth 6/06/08 24/06/08 Approved Approved 20/08/08 Participant’s choice Nil Te Puna Oranga and outpatients breastfeeding support Hungerford subject to Iwi Maori Council at service conditions Health Waikato

NTY/08/06/063 Access to one’s own health records: Dr David Menkes 6/06/08 24/06/08 Approved Approved 30/10/08 Pharmacy 547, A Waikato Medical Kaumatua Kaunihera – A pilot study of uptake, acceptability, subject to Hamilton Research Foundation WDHB and health outcomes in severe conditions Psychology Centre, mental illness Hamilton participants’ homes

NTY/08/06/064 Fisher & Paykel healthcare database Ms Jessica 10/06/08 24/06/08 Approved Approved 29/07/08 Fisher and Paykel B Fisher & Paykel MRRC at ADHB of subjects with obstructive sleep Hayward subject to Healthcare Healthcare apnea (OSA) conditions Auckland City Hospital Auckland Physiology

Northern Y Regional Ethics Committee Annual Report 2008 31

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

NTY/08/07/065 The effects of exercise loading Mr Wayne Hing 11/07/08 29/07/08 Approved Approved Auckland University Nil Rose Katipa – programme on the patellar tendon in subject to Subject to of Technology Edgewater College patients with painful patellar conditions Conditions Te Reo tendinopathy

NTY/08/07/066 Assessment of stress levels Dr Wendy 2/07/08 29/07/08 Approved Approved 25/11/08 Waikato DHB Nil Kaumatua Kaunihera – associated with infant sleep Middlemiss subject to WDHB, Mikaere conditions Taitoko, Maori research co-ordinator, WINTEC

NTY/08/07/067 The experiences of the development Ms Janette 9/07/08 29/07/08 Approved Approved 21/11/08 Bay of Plenty DHB Nil Te Puna Hauora – of depression after first time stroke Turner subject to Tauranga during hospitalisation conditions

NTY/08/07/068 The perception of weight (POW) and Ms Amy Liu 10/07/08 29/07/08 Approved Approved 13/10/08 ADHB Nil MRRC at ADHB the rainbow of factors relating to the subject to individual’s body image perception in conditions the diabetes population

NTY/08/07/069 A multi-centre, randomised, open Dr John Baker 11/07/08 29/07/08 Approved Approved 30/10/08 ADHB B F Hoffman-La Roche MRRC at ADHB and label, active-comparator controlled subject to Counties Manukau Ltd CMDHB study to assess the efficacy, safety conditions DHB and tolerability of taspoglutide (RO5073031) compared to exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both

NTY/08/07/070 Establishing diagnostic criteria and Dr Jennifer Craig 14/07/08 29/07/08 Approved Approved 30/10/08 ADHB A University of Auckland, MRRC at ADHB optimizing contemporary therapies for subject to Optima meibomian gland dysfunction conditions

NTY/08/07/071 RFB002 [Ranibizumab]: a Dr Dianne Sharp 15/07/08 29/07/08 Approved Approved 3/10/08 Retina specialists B Novartis MRRC at ADHB randomised, double-masked, multi- subject to Pharmaceuticals centre, laser-controlled phase III conditions study assessing the efficacy and safety of ranibizumab (intravitreal injections) as adjunctive and mono- therapy in patients with visual impairment due to diabetic macular edema; clinical trial protocol [RFB002D2301]

NTY/08/08/072 An exploration of the range of Ms Sarah 25/07/08 8/12/08 Approved Approved 7/11/09 Gisborne Hospital A Massey School of Tairawhiti DHB MRRC strategies used by nurses who are Willacy subject to Tairawhiti District Health & Social two years post-graduation in order to conditions Health Board Services Graduate manage ethical dilemmas occurring Massey University Research Fund during clinical practice

32 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/08/073 Coping in caregivers of family Maren Annette 4/08/08 26/08/08 Approved Approved 11/11/08 The Brain Injury Nil Donald Ripia – members with traumatic brain injury Klum subject to Association of Kaiwhakahaere, Senior and the effects on the caregivers conditions Auckland Manager for Maori at quality of life Bay of Plenty Brain Massey University Injury Association (Headway Brain Injury Association) Brain Injury Association Eastern Bay of Plenty (Disability Resource Centre Trust) Rotorua Brain Injury Association Phoenix Rehabilitation Centre Stewart Centre Auckland Stewart Centre 2 Auckland Stewart Centre 3 Waikato Stewart Centre 4 Tauranga Head Injury Society of New Zealand Inc (National Office)

NTY/08/08/074 An exploration of what social Jenny Cheer 5/08/08 26/08/08 Approved Approved 21/11/08 Braeburn House Nil Aroha Woods – Maori inclusion means to people with a subject to Limited Counsellor severe and enduring mental health conditions problem

NTY/08/08/075 A Heideggerian hermeneutic study of Rosana Eteia 6/08/08 26/08/08 Deferred Due to issues Approved 27/11/08 ProMed Urology Nil Te Puna Hauora the meaning of living with prostate Vasconcelos regarding study cancer design, uncertainty about validity of research and concerns over social and cultural responsibility; ethical issues as per Operational Standard 2.4 (57.i and 57.iii) and 2.7.

Northern Y Regional Ethics Committee Annual Report 2008 33

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

NTY/08/08/076 A phase 1, ascending dose and Assoc Prof Philip 6/08/08 26/08/08 Approved Approved Greenlane Clinical B Ophthotech Corp MRRC at ADHB parallel group trial to establish the J Polkinghorne subject to subject to Centre safety, tolerability and conditions conditions pharmacokinetic profile of intravitreous injections of E10030 (anti-PDGF pegylated aptamer) given in combination with Lucentis® 0.5 mg/eye in subjects with neovascular age-related macular degeneration

NTY/08/08/077 Beliefs about heart failure and Lana Jago 7/08/08 26/08/08 Approved Approved 20/10/08 Middlemore Hospital A University of Auckland Counties Manukau DHB adherence to treatment subject to Auckland City and CMDHB conditions Hospital

NTY/08/08/078 The role of dynamic family factors in Dr John 7/08/08 26/08/08 Approved Approved 4/12/08 Psychology Centre, Nil Kaumatua Kaunihera the development and management of Fitzgerald subject to Hamilton Group – WDHB suicidal risk in young people conditions Health Waikato

NTY/08/08/079 A multi-centre, randomised, open Dr John Baker 7/08/08 26/08/08 Approved Approved 30/10/08 CMDHB B F Hoffmann-La Roche MRRC at ADHB and label, active-controlled study to ADHB Inc CMDHB compare the efficacy, safety and tolerability of Taspoglutide (RO5073031) versus insulin Glargine in insulin-naive type 2 diabetic patients inadequately controlled with metformin and sulphonylurea combination therapy

NTY/08/08/080 Pre-operative nutritional status as an Dr Nathanial 8/08/08 26/08/08 Approved Approved 14/11/08 Waikato Hospital A University of Auckland Kaumatua Kaunihera indicator to wound healing in vascular Chiang subject to summer studentship Group – WDHB surgery conditions

NTY/08/08/081 Flixene vascular graft: early Dr Nathanial 8/08/08 26/08/08 Approved Approved 3/10/08 Waikato Hospital A University of Auckland Kaumatua Kaunihera cannulation study Chiang subject to lecturership Group – WDHB conditions

NTY/08/08/082 Validation of OxyVu™ – a Dr Nathanial 8/08/08 26/08/08 Approved Approved 3/10/08 Waikato Hospital A University of Auckland Kaumatua Kaunihera hyperspectral transcutaneous Chiang subject to summer studentship Group – WDHB oxygenation measurement system conditions

NTY/08/08/083 Pilot study of exercise programme for Shane McCardle 11/08/08 26/08/08 Approved Approved Kari Centre A Kari Centre, A+ MRRC at ADHB youth with first episode psychosis on subject to subject to Research Trust antipsychotic medication conditions conditions

NTY/08/09/085 Murine typhus: an emerging disease Dr David Slaney 2/09/08 23/09/08 Approved Approved 25/11/08 ESR Nil Kaumatua Kaunihera – in New Zealand? subject to NZ Blood Service, WDHB conditions Epsom

NTY/08/09/086 A pilot study to monitor light exposure Dr Guy Warman 4/09/08 23/09/08 Approved Approved 25/11/08 Auckland City A University of Auckland MRRC at ADHB and sleep wake cycles in post- subject to Hospital operative cardiac patients and its conditions implications for hospital stay and depression

34 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/09/087 An acute randomised, controlled Dr Peter Gilling 4/09/08 23/09/08 Deferred Due to issues Deferred ProMed Urology B Solace Therapeutics Inc observational preference study of the regarding study Solace™ intra vesical system design, ethical issues (various balloon configurations) in the as per Operational management of female subjects with Standard 2.4 (57.i stress urinary incontinence and iii )

NTY/08/09/088 A trial of a mobile phone-based Dr Robyn 5/09/08 23/09/08 Approved Approved 2/12/08 Auckland A Health Research CTRU Maori Research depression prevention programme for Whittaker subject to Council Advisory Committee adolescents conditions

NTY/08/09/089 A double-blind, randomised control Dr Anna 5/09/08 23/09/08 Approved Approved Waikato Hospital A Emergency Department Kaumatua Kaunihera – trial to compare ondansetron and Nienaber subject to subject to WDHB cyclizine for the prevention of conditions conditions vomiting when ketamine sedation is used in the emergency department during invasive procedures on children

NTY/08/09/090 Survival of patients with primary Dr Spencer 6/09/08 23/09/08 Approved Approved Waikato Hospital B BIOTRONIK Kaumatua Kaunihera – prophylactic ICD indication provided Heald subject to subject to WDHB with intensified care after 1st ICD conditions conditions therapy; protocol date: 10 October 2007

NTY/08/09/091 Investigating the pathways to the Mrs Veronique 5/09/08 23/09/08 Approved Approved 11/11/08 Waikato DHB Nil Kaumatua Kaunihera – diagnosis of central hypopituitarism Gibbons subject to WDHB conditions

NTY/08/09/092 Steroids for fetal lung maturation: Dr Shelley Yip 5/09/08 23/09/08 Approved Approved Auckland DHB A A+ Charitable Trust Mata Forbes, MRRC at effect on maternal glucose levels subject to subject to ADHB conditions conditions

NTY/08/09/093 Comparative trial of immediate ve rsus Dr Anubhav 5/09/08 23/09/08 Approved Approved 24/11/08 Counties Manukau A Department of Hand MRRC and CCRep at delayed mobilisation following volar Sathu subject to DHB Surgery, Middlemore CMDHB plate fixation of distal radius fractures conditions Hospital

NTY/08/09/094 A double-blind, multi-centre placebo- Dr John E 5/09/08 23/09/08 Approved Approved 11/11/08 Waikato DHB B Durect Corporation Maori Health Unit controlled trial of SABER™ – Moodie subject to Southern Cross bupivacaine for post-operative pain conditions Hospital control and opioid sparing/opioid- Braemar Hospital related adverse event reduction following arthroscopic shoulder surgery

NTY/08/09/095 A double-blind, randomised, placebo- Dr John E 5/09/08 23/09/08 Approved Approved 4/11/08 Waikato Hospital B KAI Pharmaceuticals Maori Health Unit – and active-comparator, single-dose Moodie subject to Braemar Hospital Inc WDHB study to assess the efficacy of conditions Southern Cross KAI-1678 administered by Hospital subcutaneous infusion for the treatment of postoperative pain

Northern Y Regional Ethics Committee Annual Report 2008 35

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

NTY/08/09/096 A phase 2, multi-centre, randomised, Dr John E 5/09/08 23/09/08 Approved Approved 23/10/08 Waikato Hospital B Anesiva Inc Maori Health Unit – double-blind, placebo-controlled, Moodie subject to Braemar Hospital WDHB parallel-group dose validation study conditions Southern Cross to evaluate the efficacy and safety of Hospital 4975 patients undergoing unilateral total knee arthroplasty

NTY/08/10/097 WDHB child health and housing Dr Julian King 2/10/08 28/10/08 Approved Approved 2/02/09 Auckland Regional Nil Tihi Ora MAPO programme evaluation subject to Public Health Service conditions

NTY/08/10/098 Unintended pregnancy and Dr Karen Joseph 10/10/08 28/10/08 Approved Approved 23/12/08 Waikato DHB Nil Te Puna Oranga – therapeutic abortion in the subject to WDHB postpartum period: is an opportunity conditions to intervene being missed?

NTY/08/10/099 Does ear acupuncture or acupressure Dr Kim Yates 10/10/08 28/10/08 Approved Approved 23/12/08 Waitemata DHB A Waitemata DHB and MRRC at WDHB relieve pain and anxiety in emergency subject to University of Auckland department patients? conditions

NTY/08/10/100 Giving voice to ICU patients: Dr Annemarie 10/10/08 28/10/08 Approved Approved 2/12/08 Waikato Hospital Nil Kaumatua Kaunihera – communication, memory and Jutel subject to WDHB experience conditions

NTY/08/10/101 Development and validation of a Ms Georgina 10/10/08 28/10/08 Approved Approved Auckland Physiology B Fisher & Paykel MRRC at ADHB continuous positive airway pressure Cuttance subject to subject to Auckland Hospital Healthcare (CPAP) device, for the treatment of conditions conditions Sleep Laboratory obstructive sleep apnea (OSA)

NTY/08/10/102 A pluralistic evaluation of the model Dr Philippa 10/10/08 28/10/08 Approved Approved 3/02/09 Waikato Hospital Nil Kaumatua Kaunihera – of nursing care delivery project Miskelly subject to WDHB conditions

NTY/08/10/103 A randomised multi-centre study Dr Richard 10/10/08 28/10/08 Approved Approved 27/01/09 ADHB A The National Institutes MRRC at ADHB comparing G-CSF mobilised Doocey subject to of Health, National peripheral blood and G-CSF conditions Cancer Institute stimulated bone marrow in patients undergoing matched sibling transplantation for hematologic malignancies (CBMTG protocol 0601)

NTY/08/11/104 Volumetric and growth factors Dr TM 5/11/08 25/11/08 Approved Approved Waikato DHB A Faculty Development Te Puna Oranga – assessment of negative pressure Vasudevan subject to subject to Research Fund, HRC, WDHB wound therapy conditions conditions Bayer Health and Braemar Trust

NTY/08/11/105 Assessment of the psychosocial Ms Rosalind 7/11/08 25/11/08 Approved Approved 3/02/09 Waikato Hospital Nil Kaumatua Kaunihera – needs of parents and children using Case-Doube subject to WDHB paediatric outpatient services in the conditions Waikato

36 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/11/106 Whanau talk: how whanau construct Ms Te 7/11/08 25/11/08 Approved Approved Counties Manukau Nil MRRC at WDHB and diabetes Maramatanga subject to subject to DHB CMDHB Alexandrian conditions conditions Waitemata DHB Hohaia

NTY/08/11/107 Accuracy of MRI assessment of aortic Dr Andrew Kerr 7/11/08 25/11/08 Approved Approved Counties Manukau A The Maurice and Phyllis MRRC at ADHB and stenosis subject to subject to DHB Paykel Trust CMDHB conditions conditions Auckland DHB University of Auckland

NTY/08/11/108 Observational study to identify Ms Sandra Rice 11/11/08 25/11/08 Approved Approved 23/12/08 Glenview Medical Nil Kaumatua Kaunihera – barriers and strengths of certain subject to Centre WDHB medicines for patients with type 2 conditions diabetes

NTY/08/11/109 An Australasian, phase II, multi- Dr Leanne 13/11/08 25/11/08 Approved Approved Auckland DHB A Australasian Leukaemia MRRC at ADHB centre, randomised, dose Berkahn subject to subject to Waitemata DHB & Lymphoma Group intensification study investigating oral conditions conditions fludarabine, oral cyclophosphamide and IV rituximab (poFCivR) tolerance in previously untreated elderly (> 65 years old) patients with chronic lymphocytic leukaemia (CLL); protocol no ALLG CLL5

NTY/08/11/110 A phase II study of oral panobinostat Dr Peter Browett 12/12/08 25/11/08 Approved Approved Auckland DHB B Novartis MRRC at ADHB in adult patients with relapsed/ subject to subject to Pharmaceuticals refractory classical Hodgkin’s conditions conditions lymphoma after failure of high dose chemotherapy with autologous stem cell transfusion and a gemcitabine- or vinorelbine- or vinblastine- containing treatment regimen; protocol no novartis CLBH589E2214

NTY/08/12/111 The impact on parents of deliberate Casey Wilson 26/11/08 16/12/08 Deferred Due to issues Deferred CMDHB Nil He Kaakano-CAMHS self-harm by their children: a study of regarding concerns parental responses, needs, and about informed outcomes for the family consent, minimisation of harm and cultural responsibility; ethical Issues as per operational standard 2.2, 2.5 and 2.7

NTY/08/12/112 Extraordinary journeys: from patient Ms Wendy 26/11/08 16/12/08 Approved Approved Spectrum Care Nil Tuila Tenari of Te to citizen Becker subject to subject to Te Roopu Taurima o Roopu Taurima O conditions conditions Manukau Manukau

Northern Y Regional Ethics Committee Annual Report 2008 37

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

NTY/08/12/113 Investigation into normal values for Mr Wayne Hing 27/11/08 16/12/08 Approved Approved Flexa Clinic A AUT, Flexa Clinic, parameters derived from subject to Subject to Jireh Health Limited Forrest Hill suprasystolic, oscillometric brachial conditions Conditions Northcote Care Physiotherapy, artery waveforms collected non- Chemist Northcote Care invasively from a sample of the Forrest Hill Chemist, Jireh Health Auckland population Physiotherapy Limited

NTY/08/12/114 A randomised control trial using oral Dr Diana Lennon 1/12/08 16/12/08 Approved Approved Starship Children’s A Joan Mary Renolds MRRC at ADHB antibiotics following a short course of subject to Subject to Hospital Charitable Trust intravenous therapy in children with conditions Conditions acute osteomyelitis with or without septic arthritis

NTY/08/12/115 A randomised, double blind, Dr Mike Williams 1/12/08 16/12/08 Approved Approved Clinicanz B Methven NZ Ltd Maori Health RGPG controlled, cross over pilot study of subject to Subject to GP’s clinics the effects of removing chlorine from conditions Conditions shower water on symptoms of eczema

NTY/08/12/116 The effect of an inhaler with ringtones Ms Amy Hai Yan 1/12/08 16/12/08 Approved Approved University of A Child Health Research Papaarangi Reid – on asthma control and school Chan subject to Subject to Auckland Foundation University of Auckland attendance in children conditions Conditions ADHB

NTY/08/12/117 A phase 3, international, multi-centre, Dr John Kolbe 1/12/08 16/12/08 Approved Approved ADHB B Inspire MRRC at ADHB randomised, double-blind, placebo- subject to Subject to Pharmaceuticals, Inc. controlled, parallel group, efficacy conditions Conditions and safety study of denufosol tetrasodium inhalation solution in patients with cystic fibrosis lung disease and FEV> 75% but < 110% predicted; TIGER-2 (inspire 08-110)

NTY/08/12/118 Pacific Island families study: nutrition, Dr Janis 1/12/08 16/12/08 Approved Approved AUT University Nil HRC of New Zealand Pacific Peoples body size and physical activity of Paterson subject to Subject to Advisory Board 9 -year-old children (PIF:NBS-2) conditions Conditions

NTY/08/12/119 The core Pacific Islands families Dr Janis 1/12/08 16/12/08 Approved Approved AUT University Nil Foundation for Pacific Peoples study: towards adolescence (PIF: TA) Paterson subject to Subject to Research, Science and Advisory Board conditions Conditions Technology

38 Northern Y Regional Ethics Committee Annual Report 2008

Studies reviewed in closed meetings

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

NTY/08/08/084 A two-part, randomised, double-blind, Dr Edward John 18/08/08 26/08/08 Approved Approved 22/10/08 Auckland City B Merck and Co Inc MRRC at ADHB placebo-controlled, multiple-rising Gane subject to Hospital dose study to evaluate the safety, conditions Christchurch Clinical tolerability, and pharmacokinetics of Studies Trust MK-3281 in healthy male subjects and safety, tolerability and pharmacokinetics of pharmacodynamics of MK-3281 in hepatitis C infected male patients

Expedited review studies

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

NTY/08/01/EXP the process and effectiveness of Ms Felicity Bright 7/01/08 Approved 16/01/08 Rehab Plus Nil Maori staff members at discharge planning at Rehab Plus Rehab Plus

NTY/08/02/EXP A population-based study of Ms Jane Wylie 7/01/08 Approved 28/01/08 Auckland DHB Nil MRRC at ADHB, responses to Imatinib in the treatment WDHB, CMDHB of chronic myeloid leukaemia in New Zealand: a pilot study

NTY/08/03/EXP Use of ‘CURB’ score to stratify the Dr Gonesh 7/01/08 Ethical 21/02/08 Auckland City Nil severity of community acquired Chandra approval not Hospital pneumonia (CAP) in Auckland City Karmakar required Hospital

NTY/08/04/EXP ASAVR BNP 2007/six-year follow-up Dr Ivor Gerber 7/01/08 Withdrawn 10/02/08 Nil

NTY/08/05/EXP Catering to night staff at Waikato Ms Natasha Quill 9/01/08 26/02/08 Approved Closed 26/02/08 Waikato DHB Nil Maori Waikato Hospital Hospital – feasibility of introducing a Staff health friendly meal food vending machine

NTY/08/06/EXP Establishment of a patient focus Dr Chris 14/01/08 Approved 26/02/08 Waikato DHB Nil group(s) to define aspects of impact McEwan on life of significant, appearance related conditions

NTY/08/07/EXP Retrospective reviews of patients with Dr Roger Yang 31/01/08 26/02/08 Approved Approved 7/04/08 Auckland DHB Nil MRRC at ADHB zimmer rotating hinge knee (RHK) subject to conditions

Northern Y Regional Ethics Committee Annual Report 2008 39

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

NTY/08/08/EXP Observational study of outcome of Dr Louise 1/03/08 Approved 13/08/08 Nil women who have had third and fourth Tomlinson degree anal sphincter tear repairs at Counties Manukau District Health Board

NTY/08/09/EXP Children and youth admissions to a Dr Chohye Park 30/01/08 26/02/08 Ethical Ethical 26/02/08 Nil Kaumatua Kaunihera at regional adult inpatient unit: approval not approval not WDHB characteristics of the admission and required required utilisation of Mental Health Act

NTY/08/10/EXP Tairawhiti tamariki skin infections Dr Cathryn 11/02/08 26/02/08 Declined Declined under Approved 20/05/08 Nil Maori Liaison Officer, project O’Sullivan paragraph/s 4.2, 4.4, TWDHB 8.1 to 8.10, of the Ethical Guidelines for Observational Studies: observational research, audits and related activities, NEAC; declined as an audit as the researcher is collecting sensitive and personal information regarding children; evidence of wider Maori consultation is required

NTY/08/11/EXP Reliability of mini-CEX in Assoc Prof 15/02/08 Approved 17/04/08 Nil anaesthesia: a generalisability study Jennifer Weller based on videos of operating room practice

NTY/08/12/EXP Spinal deformity study group Dr John 7/03/08 Approved 7/04/08 Starship Children’s Nil Ferguson Health

NTY/08/13/EXP Recorded sexual abuse prevalence in Dr Ann Pearl 20/02/08 Approved 28/02/08 ADHB Nil child and family unit patients

NTY/08/14/EXP To examine whether cross sectional Dr Dihan Aponso 18/02/08 Ethical 27/02/08 Nil area of thoracolumbar burst fractures approval not are associated with lamina fractures required

NTY/08/15/EXP The validity of simulation-based Assoc Prof 15/02/08 Approved 17/04/08 Nil training and assessment in Jennifer Weller anaesthesia

NTY/08/16/EXP My paediatrics media: obtaining Dr Ralph 19/02/08 Approved 7/04/08 Auckland DHB Nil multimedia recordings of clinical Pinnock problems for use in an undergraduate paediatric teaching programme

40 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/17/EXP A retrospective analysis of violent Dr Kirsten van 20/03/08 Ethical 2/04/08 Nil incidents in the Child and Family Unit Kessel approval not required

NTY/08/18/EXP Absenteeism: a complex phenomena ; Ms Ciska 26/03/08 Closed 29/04/08 Nil Te Puna Hauora how job involvement, job satisfaction, Vogelzang organisational commitment and support, work family conflict, group cohesion and regional identification affect absenteeism and turnover intentions

NTY/08/19/EXP Palliative care: measuring outcomes Dr David 28/03/08 Approved 4/04/08 Nil and identifying families at risk of MacKintosh psychosocial distress

NTY/08/20/EXP Kaupapa Maori advanced nurse Ms Amber 31/03/08 Approved 4/04/08 Nil General managers of practitioner (KMAN) service patient Logan-Riley Maori health services survey

NTY/08/21/EXP The influence of cultural background Ms Danielle 4/04/08 Approved 15/04/08 Nil Maori co-ordinators of on health beliefs and condition Vignati the DSME programme management in individuals with diabetes

NTY/08/22/EXP Chronic care evaluation – phase II Mr David Rees 8/04/08 Approved 20/06/08 Nil

NTY/08/23/EXP In search of the ideal caseload: a Ms Katherine 17/04/08 Approved 22/04/08 Nil WDHB – Kaumatua comparison study of community Fell Kaunihera mental health caseloads and diagnostic case-mix in New Zealand and England

NTY/08/24/EXP Suitability of actuarial and structured Mr Chris Floyd 22/04/08 Approved 8/05/08 Nil Maori service providers professional judgement risk assessment measures for the regional forensic intellectual disability service of the Waikato DHB

NTY/08/25/EXP Accuracy of tissue transglutaminase Dr Simon Chin 8/05/08 Ethical 26/05/08 Nil antibodies in the diagnosis of coeliac approval not disease in children at Starship required Hospital 2006–07

NTY/08/26/EXP A pilot implementation of the Ms Lucy 9/05/08 Ethical 26/05/08 Nil Liverpool care pathway (LCP) for the Meldrum approval not dying patient at Auckland City required Hospital

NTY/08/27/EXP Green prescription [GRx] Ms Karen 12/05/08 Approved 4/06/08 Nil Maori community communities evaluation – GRx Bennett facilitators communities is an initiative of the Healthy Eating Healthy Action [HEHA] programme

Northern Y Regional Ethics Committee Annual Report 2008 41

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

NTY/08/28/EXP Why do parents and children agree to Dr Ralph 19/05/08 Approved 26/05/08 Nil be involved in medical student Pinnock teaching?

NTY/08/29/EXP An innovative approach to the Dr Jovina Goh 28/05/08 Approved 4/06/08 Middlemore Hospital Nil treatment of subcutaneous panniculitis-like T-cell lymphoma in Polynesian patients with cyclosporin achieves excellent outcomes in comparison to those treated at the Mayo clinic

NTY/08/30/EXP Impact of a postgraduate course in Assoc Prof 28/05/08 Ethical 4/06/08 Nil simulation on clinical teaching Jennifer Weller approval not required

NTY/08/31/EXP Pin associated infection in Dr Stephanie 26/05/08 Approved 4/06/08 Nil MRRC at ADHB supracondylar fractures of the van Dijck humerus in a paediatric population

NTY/08/32/EXP Comparison of efficacy of spray-on Dr Raminder 29/05/08 Approved 4/06/08 Nil and paint-on betadine for skin Dhillon preparation in hand surgery

NTY/08/33/EXP Clozapine use and outcomes in a Dr Selim El-Badri 9/06/08 Approved 18/06/08 Nil Te Kaunihere – New Zealand public mental health RANZCP service

NTY/08/34/EXP Progression of renal complications Mrs Grace Joshy 5/06/08 Approved 4/07/08 Nil Kaumatua Kaunihera – among diabetes patients in New WDHB Zealand: an ethnic perspective

NTY/08/35/EXP Mortality trends among diabetes Mrs Grace Joshy 18/06/08 Approved 4/07/08 Nil Kaumatua Kaunihera – patients WDHB

NTY/08/36/EXP Reduction of the use of seclusion in a Ms Amanda 16/06/08 Approved 30/07/08 Middlemore Hospital Nil Kuia with seclusion New Zealand psychiatric intensive Stokes project working group, care unit CMDHB mental health cultural services

NTY/08/37/EXP A pilot study: exploring the lived Ms Maria 19/06/08 Approved 24/06/08 Nil He Kamaka Oranga experiences of the adult clients’ Whitcombe- involvement with Mobility solutions, a Shingler specialist wheelchair and seating service

NTY/08/38/EXP Evaluation of project REPLACE – Dr Heather 20/06/08 Approved 24/06/08 Nil Kuku Wawatai, Director Healthy Eating Healthy Action Hamerton Maori and community initiative in the Western Bay of Plenty development, BOP Polytech

NTY/08/39/EXP Delays in assessment for vascular Dr Daniel Faulke 25/06/08 Ethical 2/07/08 Nil surgery patients in anaesthesia clinic approval not required

42 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/40/EXP IV paracetamol usage in theatres Ms Amy Hai Yan 25/06/08 Ethical 2/07/08 Nil Chan approval not required

NTY/08/41/EXP Outcome of unstable slipped upper Mr Haemish 25/06/08 Ethical 2/07/08 Nil femoral epiphysis in Auckland Crawford approval not required

NTY/08/42/EXP Audit of gabapentin use in surgical Ms Adele 25/06/08 Ethical 2/07/08 Nil patients at ADHB Petherick approval not required

NTY/08/43/EXP Medication safety issues involved in Ms Zara Homes 25/06/08 Approved 2/07/08 Nil the use of patients’ own drugs (PODs) on wards in Auckland City Hospital

NTY/08/44/EXP Epidemiological profile of CFU Dr Liz Myers 25/06/08 Approved 2/07/08 Nil population over last 10 years

NTY/08/45/EXP What are the important variables to Dr Heather 25/06/08 Approved 2/07/08 Nil consider in the development of an McDowell internet-based questionnaire examining the psychosocial well- being of survivors of childhood cancer?

NTY/08/46/EXP Point of care glucose meter Research Nurse 27/06/08 Approved 18/07/08 Nil comparison study Margaret Light

NTY/08/47/EXP Use of remifentanil patient controlled Dr James 2/07/08 Approved 23/07/08 Nil analgesia (PCA) during labour Broadbent

NTY/08/48/EXP Follow-up of severe allergic reaction Dr Marianne 10/07/08 Approved 13/08/08 Nil Empson

NTY/08/49/EXP Rehabilitation outcomes for known Dr Helwa Abdul 10/07/08 Approved 13/08/08 Nil multiple sclerosis (MS) clients Hafidz admitted from the community

NTY/08/50/EXP Genotype of HPV in excised vervical Dr Kitty Croxson 10/07/08 Approved 13/08/08 Nil squamous cell carcinoma, Auckland, New Zealand, 2002–2004

NTY/08/51/EXP Multi-centre retrospective evaluation Dr Samar Issa 18/07/08 Approved 13/08/08 Nil of stem cell transplantation for central nervous system (CNS) recurrence of systemic non-Hodgkin’s lymphoma (NHL)

Northern Y Regional Ethics Committee Annual Report 2008 43

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

NTY/08/52/EXP Multi-centre case series of patients Dr Samar Issa 18/07/08 Approved 13/08/08 Nil with primary central nervous system lymphoma (PCNSL) and meningeal involvement – incidence in newly diagnosed and relapsed patients, methods of diagnosis, patient characteristics, treatment strategies and clinical outcome

NTY/08/53/EXP Toi Te Ora – public health Mr Russell 15/07/08 Approved 25/07/08 Nil BOPDHB Maori Health ‘knowledge, attitudes and practice’ Ingram-Seal Planning and Funding survey team

NTY/08/54/EXP Clinical characteristics of patients Dr Sally de Boer 22/07/08 Approved 25/07/08 ADHB Nil presenting with community acquired complicated parapneumonic effusions to Auckland City Hospital

NTY/08/55/EXP A retrospective review of overall Ms Lisa Capelle 22/07/08 Approved 28/07/08 Nil survival and disease control for women diagnosed with FIGO stage IB1 to IVA cervical cancer in the New Zealand Northland and Auckland region between 2003 and 2007 and review of their treatment pathway

NTY/08/56/EXP The applicability of Stradling’s Ms Nimi Sharma 22/07/08 Approved 25/07/08 ADHB Nil algorithm for optimal CPAP in Auckland’s OSA patient group

NTY/08/57/EXP Consumer understanding of and Ms Olivia Green 22/07/08 Approved 25/07/08 New Zealand Nil preference for nutrition terminology, Nutrition Foundation PIS/Cons V#1 20/7/08

NTY/08/58/EXP Serological diagnosis of coeliac Dr Heather Astell 23/07/08 Approved 25/07/08 ADHB Nil disease

NTY/08/59/EXP A comparative study of the use of Mr Richard Small 23/07/08 Approved 25/07/08 Counties Manukau Nil CMDHB MRCC three fall risk assessment tools in the DHB community setting

NTY/08/60/EXP Audit of CPAP use in bronchiolitis at Mr Christopher 24/07/08 Approved 29/07/08 Counties Manukau Nil Middlemore Hospital Lash DHB

NTY/08/61/EXP A personal exploration, as a music Na-Hyun Gang 29/08/08 Approved 29/08/08 Nil therapy student, of development and establishing a therapeutic relationship with a child with autistic spectrum disorder

44 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/62/EXP Team based approach to assessing Mr Andrew 25/07/08 Approved 29/09/08 Counties Manukau Nil and managing CVD risk in the McLachlan DHB rheumatology out patient setting using acute predict: electronic clinical decision support

NTY/08/63/EXP A single centre retrospective review Mr Andrew 29/08/08 Approved 29/08/08 Nil of digital pilon fractures McLachlan

NTY/08/64/EXP Treatment of hypotension during Dr Tuang Ik Loy 29/08/08 Approved 29/08/08 Nil spinal anaesthesia for caesarean deliveries: a survey of current practice

NTY/08/65/EXP Blood gas interpretation in Dr Kelly Austin 29/08/08 Approved 29/08/08 Nil emergency medicine doctors

NTY/08/66/EXP Weigh in Weigh Out Programme Dr Kelly Austin 29/08/08 Approved 29/08/08 Nil (WWOP) – a pilot project to establish regular weighing of patients on admission and discharge from Middlemore Hospital

NTY/08/67/EXP Series review of patients managed at Mr Jacques 18/08/08 Approved ADHB Nil Starship Hospital, following injuries Marnewick Subject to from television sets Conditions

NTY/08/68/EXP A 12-month case series of malaria in Dr Joan H 13/08/08 Approved 8/09/08 ADHB Nil Auckland Ingram Counties Manukau DHB Waitemata DHB

NTY/08/69/EXP School drug testing Mr Ronald 12/08/08 Approved 8/09/08 ADHB Nil Alexander Fyfe Couch

NTY/08/70/EXP Bariatric anaesthesia database Dr Ivan Bergman 12/08/08 Approved 8/09/08 ADHB Nil

NTY/08/71/EXP Neonatal intensive care utilisation by Dr Malcolm 12/08/08 Approved 8/09/08 ADHB Nil infants born to women aged 40 years Battin and over: a review of New Zealand data

NTY/08/72/EXP Developing a test for determination of Dr Hima 12/08/08 Approved ADHB Nil drugs of abuse in meconium Madhavaram Subject to Conditions

NTY/08/73/EXP Comparison of the first episode in Mr Aaron 5/09/08 Approved 8/09/08 Counties Manukau Nil CMDHB MRCC psychosis programmes across three O’Connell DHB international sites – New Zealand, Canada and United Kingdom

NTY/08/74/EXP Heart failure survival in Waikato Dr Anita Bell 5/09/08 Approved 8/09/08 Waikato DHB Nil

Northern Y Regional Ethics Committee Annual Report 2008 45

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

NTY/08/75/EXP A case controlled retrospective Mr Jasen Ly 2/09/08 Approved 8/09/08 ADHB Nil review of cardiac surgical patients with bowel ischemia in the postoperative period

NTY/08/76/EXP How does smoothness of recovery Prof James 2/09/08 Approved 8/09/08 Waikato DHB Nil correlate with anaesthetic depth? Wallace Sleigh

NTY/08/77/EXP Diabetes on target (DOT) card Dr Rinki Murphy 24/09/08 Approved 24/09/08 ADHB Nil

NTY/08/78/EXP Autism and auditory evoked Mr Shahrzad 17/09/08 Approved 24/09/08 ADHB Nil potentials Babapour University of Auckland

NTY/08/79/EXP National Burn Centre database and Ms Frances 8/09/08 Approved 6/10/08 Nil ANZBA burn registry – retrospective James application; audit of burn injury, treatment and outcomes for patients admitted for the treatment of burn injury at CMDHB from 2001 to August 2008

NTY/08/80/EXP Exit and recovery initiative Gareth Edwards 1/10/08 Approved 23/12/08 Nil

NTY/08/81/EXP Coagulation screen – use in ED Ms Cameron 19/11/08 Ethical Nil Rosie approval not required

NTY/08/82/EXP Warfarin pharmacogenomics pilot Dr Patrick 2/10/08 Approved 18/12/08 Nil MRRC at ADHB study Gladding

NTY/08/83/EXP Review of patients treated with Dr Mitzi Nisbet 20/11/08 Ethical Nil vertebral tuberculosis infections from approval not 1997 to 2008 at Auckland City required Hospital

NTY/08/84/EXP Waikato diabetes education study Prof Ross 6/10/08 Approved 18/11/08 Nil Te Puna Oranga – proposal Lawrenson WDHB

NTY/08/85/EXP Vitamin D, tonsilitis and dental health Dr David Reid 10/10/08 Approved 18/11/08 Nil MRRC at CDHB in South Auckland children

NTY/08/86/EXP Audit of nebulised bronchodilator use Research Nurse 14/10/08 Ethical 27/10/08 Nil in a respiratory ward Lorraine Forbes- approval not Faulkner required

NTY/08/87/EXP Outcomes of orbital blowout fracture Dr Stephen Ng 14/10/08 Ethical 27/10/08 Nil surgery in children and adolescents approval not required

NTY/08/88/EXP Follow-up quantitative consumer Ms Janis Baines 17/10/08 Approved 27/10/08 Nil survey on food allergen labelling

46 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/89/EXP Factors that influence physical activity Ms Clare Ryan 20/11/08 Approved 18/12/08 Nil in prostate cancer patients

NTY/08/90/EXP Should higher initial energy be Mr Chi Wing 20/10/08 Approved Nil recommended for biphasic external Wong subject to electrical cardioversion conditions

NTY/08/91/EXP Inpatient heart failure treatment Dr Richard Wall 3/11/08 Approved 15/12/08 Nil Kaumatua Kaunihera – compared to treatment guidelines WDHB

NTY/08/92/EXP Partial sleep studies in the CMDHB Mr Conor 7/11/08 Ethical Nil sleep service: an analysis of study O’Dochartaigh approval not failure rates and determinants of required failure

NTY/08/93/EXP Audit injuries sustained at 2006 world Dr Martin Harvey 10/11/08 Approved 1/12/08 Nil championship mountain bike competition

NTY/08/94/EXP Orthopaedic trauma registry Dr David Bartle 10/11/08 Declined under Declined Nil paragraph/s 11.1–11 of the Ethical Guidelines for Observational Studies: observational research, audits and related activities, NEAC; declined as extra information is being sought by way of follow-up questionnaires, the proposed research is of a significant nature and will require Maori consultation and locality assessment and there appears to be two studies which will require separate applications, ie, development of the registry and the pilot study of lower limb injuries in 18–65 year olds

NTY/08/95/EXP SOURCE registry Dr Sanjeveen 19/11/08 Approved Nil Pasupati subject to conditions

NTY/08/96/EXP Impact of process prompt posters on Dr Emma 30/10/08 Approved Nil analgesic delivery, IPPPAD Thomas subject to conditions

Northern Y Regional Ethics Committee Annual Report 2008 47

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

NTY/08/97/EXP Assessment of health care worker Dr David Lang 11/11/08 Full application Declined Nil hand hygiene efficacy in the required emergency department

NTY/08/98/EXP Testing and detection of chlamydia Dr Jane Morgan 25/11/08 Approved 26/11/08 Nil Riana Manuel, Ruakura trachomatis at Waikato DHB PHO, Toiora PHO, Te laboratories Korowai Hauraki PHO

NTY/08/99/EXP Audit of pharmacist documentation in Ms Kim Brackley 24/11/08 Approved 15/12/08 Nil the notes

NTY/08/100/EXP BEACON study no 311941; betaferon Dr Ernest 24/11/08 Approved Nil prospective study on adherence, Willoughby subject to coping and nurse support conditions

NTY/08/101/EXP Enoxaparin usage for VTE prevention Ms Charlotte 24/11/08 Approved 21/01/09 Nil in surgical and maternity wards at Jones ADHB

NTY/08/102/EXP Identifying drug and alcohol use Ms Sarah 24/11/08 Approved Nil within a child and adolescent mental Mitchell subject to health service using the substances conditions and choices scale (SACS)

NTY/08/103/EXP Getting smart about HoNOSCAs Dr Emily Cooney 27/11/08 Approved Nil Kari Centre Maori subject to cultural advisors conditions

NTY/08/104/EXP National burn centre database and Dr Frances 1/12/08 Approved Nil ANZBA burn registry – prospective James subject to application; audit of burn injury, conditions treatment and outcomes for patients admitted for the treatment of burn injury at CMDHB

NTY/08/105/EXP Ultrasound as a treatment for chronic Dr Jim Bartley 1/12/08 Approved 18/02/09 rhinosinusitis

NTY/08/106/EXP Balloon aortic valvuloplasty: a Dr Nigel Wilson 2/12/08 Approved 27/02/09 Nil 10-year experience of procedures (1991– 2000) with long term follow-up

NTY/08/107/EXP How does the current knowledge, Ms Pauline 3/12/08 Approved 10/02/09 Nil experience and educational Owens opportunities of nurses affect the outcomes of ischaemic stroke victims

NTY/08/108/EXP A comparison of estimated versus Dr Lynsey 9/12/08 Approved 27/02/09 Nil measured POP-Q scores, how Hayward accurate are we?

NTY/08/109/EXP Real-time intra-operative tracking and Mr Pavan 12/12/08 Approved 26/01/09 Nil 3D reconstruction of a fractured Gamage femur

48 Northern Y Regional Ethics Committee Annual Report 2008

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

NTY/08/110/EXP Outcomes of using a reverse LISS Dr Shavantha 12/12/08 Approved 15/02/09 Nil MRRC at ADHB plate in the management of proximal Rupasinghe femoral fractures

NTY/08/111/EXP Descriptive epidemiology of refugee Dr Wing Cheuk 12/12/08 Approved Nil health in New Zealand Chan subject to conditions

NTY/08/112/XP Extraordinary journeys: from patient Wendy Becker 26/11/08 Approved 19/03/09 Nil Tuila Tenari of Te to citizen Roopu Taurima O Manukau

NTY/08/113/EXP Alcohol misuse: the role of the Ms Louise 19/12/08 Approved Nil Te Puna Oranga – advanced practice nurse in improving Leonard subject to WDHB detection in patients presenting tot he conditions emergency department of a large, regional hospital

NTY/08/114/EXP Outcome from burn injury – Dr Frances 22/12/08 Approved 27/02/09 Nil development of a routine clinical James assessment process

Northern Y Regional Ethics Committee Annual Report 2008 49