Northern Y Regional Ethics Committee Annual Report 2010 Published in July 2011 by the Ministry of Health PO Box 5013, Wellington, New Zealand ISBN: 978-0-478-37301-1 (online) HP5378 This document is available on the New Zealand Health and Disability Ethics Committees’ website: http://www.ethicscommittees.health.govt.nz Northern Y Regional Ethics Committee – 2010 Annual Report 2 Contents About the Committee .....................................................................................4 Chairperson’s report .....................................................................................5 Membership and attendance.........................................................................6 Membership ........................................................................................................... 6 Attendance ............................................................................................................ 9 Training and conferences .................................................................................... 10 Chairperson’s meetings ....................................................................................... 10 Applications reviewed .................................................................................11 Comparison with previous years .......................................................................... 11 Median approval times ......................................................................................... 11 Issues and complaints ................................................................................12 Issues causing difficulty in review ........................................................................ 12 Complaints received ............................................................................................ 12 Appendix 1: Details of applications reviewed ...........................................13 Applications reviewed by full committee............................................................... 13 Applications reviewed by “expedited review”........................................................ 19 Northern Y Regional Ethics Committee – 2010 Annual Report 3 About the Committee The Northern Y Regional Ethics Committee is a Ministerial committee established under section 11 of the New Zealand Public Health and Disability Act 2000. Its members are appointed by the Minister of Health through the public appointments process. The primary function of the Committee is to provide independent ethical review of health research and innovative practice in order to safeguard the rights, health and wellbeing of consumers and research participants and, in particular, those persons with diminished autonomy. In conjunction with the Northern X Regional Ethics Committee, the Committee has 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 Committee is required by its Terms of Reference to submit an Annual Report to the Minister of Health. The Annual Report must include information on the membership of the Committee, a summary of the applications reviewed during the year, details of any complaints received (and how they were resolved), and areas of review that caused difficulty in making decisions, among other matters. Approvals and registrations The Northern Y Regional Ethics Committee is approved by the Health Research Council’s Ethics Committee for the purposes of section 25(1)(c) of the Health Research Council Act 1990. The Northern Y Regional Ethics Committee is registered (number IRB00004665) with the United States’ Office for Human Research Protections. This registration enables the committee to review research conducted or supported by the US Department of Health and Human Services. Northern Y Regional Ethics Committee – 2010 Annual Report 4 Chairperson’s report This is my first report for the Northern Y Regional Ethics Committee. I have been Chairperson since June 2010. I wish to acknowledge the participation and contribution of each Committee member. 2010 has been another full year for the members of the Committee. During 2010 the Northern Y Committee reviewed 107 applications and 95 expedited applications. The Committee reviewed an average of 9.7 applications for each meeting. The Committee continues to meet at the office of the Ministry of Health in Hamilton. We continue to be indebted to our Administrator Ms Amrita Kuruvilla, for her efficient support and integrity, to not only Committee members, but also researchers with whom she has regular contact. It is encouraging that many of the researchers attend or telephone conference into their meetings. Their involvement greatly assists with the review process. There has only been one membership change within the Committee in 2010. Kerry Hiini joined the Committee at the June 2010 meeting. The ethics committees are awaiting the advice of the Health Select Committee, which will bring some direction for Committee members and also researchers. The reappointment process continues to be of concern. However, I note that it will be appropriate for the appointment process to wait until after the Health Select Committee report has been received. I would also like to thank the deputy chairpersons, Dr Tessa Turnbull and Dr Willem Fourie, for their invaluable contribution to the committee. I acknowledge the hours of each member’s full and busy lives, and thank them for their time and the contribution that they have made to supporting health and disability research. I also acknowledge that Northern Y Committee has a very supportive and co-operative working environment which makes this Committee very effective and efficient. Ms Raewyn Sporle Chairperson Northern Y Regional Ethics Committee Northern Y Regional Ethics Committee – 2010 Annual Report 5 Membership and attendance One new member was appointed to the Northern Y Regional Ethics Committee in 2010, filling one vacancy. There were five or six lay members and six non-lay members throughout the year. No meetings were postponed or cancelled due to inability to make quorum. Membership Lay members Ms Raewyn Sporle (Chair) Membership category: Date of appointment: Current term expires: Lawyer 11 September 2008 3 June 2011 Ms Raewyn Sporle was appointed Chairperson in June 2010. Ms Sporle is currently a self employed Barrister & Solicitor specialising in Family Law, Criminal Law and Employment Law. Ms Sporle is a current Trustee of the Waikato Breast Cancer Trust (2006-present), and Trustee of Trust Waikato (2010-present). Ms Sporle is a previous Chairperson of St Joseph’s Board of Trustees, Fairfield, Hamilton, and holds professional memberships with the New Zealand Law Society, the Waikato / Bay of Plenty Law Society Society, New Zealand Family Law Society. She is also a trained Mediator (LEADR). Ms Christina Bryant Membership category: Date of appointment: Current term expires: Ethicist 9 December 2004 3 June 2011 Ms Christina Bryant is a partner in the litigation and dispute resolution department of Hesketh Henry in Auckland (2003-present), with a special interest in medico-legal claims. She was formerly a Senior Solicitor, practising exclusively in the medico-legal field, at Capsticks, London, England (1999-2002) and an Associate Solicitor at Simpson Grierson, Auckland (1995-1998). Ms Bryant completed a Bachelor of Laws with Honours (1995), and a Bachelor of Arts (1995) at the University of Auckland and an MA in Medical Ethics and Law from Kings College, University of London, England (1999). She was admitted as a Barrister and Solicitor of the High Court of New Zealand in 1995 and as a Solicitor of the Supreme Court of England and Wales in 2000. Ms Bryant has been a member of this Committee since 2004 and is a member of the Auckland Medico-legal Society. Dr Adelaide Collins Membership category: Date of appointment: Current term expires: Consumer representative 6 March 2008 6 March 2011 Dr Adelaide Collins (Ngati Mahanga; Te Aitanga-a-Mahaki) is currently the Director of the Maori Development Research Centre (2004-present). Dr Collins completed a Doctorate of Maori Development (2005), a Graduate Diploma of Social Science Research (1998) and a Bachelor of History and Education Studies (Honours; 1997) at the University of Waikato. She is a previous member of the Fairfield College Board of Trustees (2002-2004), a student representative on the University of Waikato Human Ethics Committee (2000) and Treasurer for Te Papaorotu Marae (2006-present). Dr Collins holds professional membership with the Association of Social Science Researchers and the Professional Historians Association of New Zealand. She was awarded the National Maori Academic Excellence Award (2006). Northern Y Regional Ethics Committee – 2010 Annual Report 6 Mr Kerry Hiini Membership category: Date of appointment: Current term expires: Community representative 3 June 2010 3 June 2013 Mr Kerry Hiini (Ngati Hine; Tapuika) is currently a Planning and Funding Manager for Auckland District Health Board (2007-present). Prior to this he was a Programme Manager of Funding and Planning for Counties Manukau District Health Board (2002-2007). Mr Hiini is currently completing a Postgraduate Diploma in Public Health at Massey University and completed a Diploma of Health Management at the University of Auckland (1996). He is a current member of the Kowhai Intermediate Board of Trustees (2007-present) and a previous member of the Te Whao Urutaki Board of Trustees (2005-2006), the Newton Central Primary School Board of Trustees (2005-2006) and the Counties Manukau District Health Board Ethical Issues Review Committee (2006) to name a few such positions. Mrs Mary Anne Gill Membership category: Community representative Date of appointment: 3 September 2009 Current term expires: 3 September 2012 Mrs Mary Anne Gill is Communications Director at Waikato District Health Board (2007present). Prior to this she was a journalist at the Waikato Times (1994-2007) and before that owned and operated her own community newspaper in Taumarunui (Ruapehu Press 19891994). Mrs Gill completed a National Certificate in Retailing at Wellington Polytechnic (1975) and was one of the youngest Woolworths (NZ) female Managers. She was an elected trustee for the Fairfax New Zealand Superannuation Fund (2003-2007), and a board of trustees’ representative for St Patrick's Catholic School (Taumarunui 1989-1994) and St John’s College, Hamilton (1998-2002). Mrs Gill was the first woman president at Narrows Golf Club (2003-2007) in its 75 years history and led the club through some radical changes which today sees it as one of Waikato's top golf clubs. Mr Mike Vale Membership category: Date of appointment: Current term expires: Consumer representative 9 December 2004 3 March 20101 Mr Mike Vale is currently Community Leader of the Mt Tabor Trust 2010-present). Prior to this he was the Co-ordinator of the Community Development Employment Programs Scheme, Australia (2001-2002). Mr Vale completed a Post Graduate Diploma of Education at the University of Auckland 2006, a Graduate Certificate in Career Development at the Auckland University of Technology 1999, a Diploma in Rehabilitation Studies at Victoria University 1996 and a Teachers College Diploma at Palmerston North Teachers College 1974. He is a current consumer representative member of the Northern Y Regional Ethics Committee (2004-present). Non-lay members Dr John Fitzgerald Membership category: Date of appointment: Current term expires: Health researcher 7 July 2005 11 September 2011 Dr John Fitzgerald is Director and Consultant Clinical Psychologist at the Psychology Centre (since 2001). Prior to this he was a Clinical Psychologist for the Taranaki Area Health Board and Taranaki Healthcare Limited (1992-2001). Dr Fitzgerald completed his PhD at the University of Waikato (2002), a Master of Clinical Psychology at the University of Birmingham, England (1988), a Master in the Psychology of Mental Handicap at the University of Keele, England (1983) and a Bachelor of Social Science at Wolverhampton 1 Members continue in office until replaced. Northern Y Regional Ethics Committee – 2010 Annual Report 7 Polytechnic, England (1982). He also has qualifications in Management of Non-Profit Organisations, Clinical Supervision, and Family and Marital Therapy. He has published a number of articles, and regularly presents research work at conferences/workshops. He holds professional memberships with the New Zealand Psychological Society and the New Zealand College of Clinical Psychologists. He is currently Editor of the New Zealand Journal of Psychology. Dr Willem Fourie Membership category: Health practitioner Date of appointment: 6 March 2008 Current term expires: 6 March 2011 Dr Willem Fourie is currently the Dean of the Faculty of Nursing and Health Studies. Until August 2010 he was Research Leader and Deputy Head of the Health Studies Department at the Manukau Institute of Technology (2006-present). Prior to this he was the Programme Leader and Deputy Head of the Health Studies Department at the Manukau Institute of Technology (2001-2006). Dr Fourie completed a Doctorate in Mental Health Nursing at the University of the Free State, South Africa (1995), a Master of Nursing at the University of Fort Hare, South Africa (1987), a Diploma in Nursing Education (1990) and a Bachelor of Nursing (1982) at the University of Port Elizabeth, South Africa. He is currently an Ethics Advisor for the Manukau Institute of Technology’s Ethics Committee (2004-present), the Chair of the Auckland Region College of Nurses Aotearoa (2004-present) and a Fellow of the College of Nurses Aotearoa (2003-present). Dr Fourie is also a member of the Nurse Educators in the Tertiary Sector (2001-present) and an International Advisor for the Journal of Health South Africa Gasondheid (2000-present). He has published several articles and presented papers at the International Health Conference (2005), the ITPNZ Research Conference (2004) and the APNZ e-Fest (2003) to name a few. Ms Sanya Ram Membership category: Date of appointment: Current term expires: Pharmacist/pharmacologist 6 March 2008 6 March 2011 Ms Sanya Ram is currently a Senior Tutor in Pharmacy Law at the University of Auckland (2005-present). Prior to this she was the Acting Medical Services Manager (2003) at Boots Healthcare Australia and Senior Regulatory and Medical Affairs Associate (2001-2003) at Boots Healthcare New Zealand. Ms Ram completed a Bachelor of Law at the University of Auckland (2006) and a Bachelor of Pharmacy at the University of Otago (1997). Ms Ram has also completed a Project Management Course from the Australian Institute of Management (2003) and is a member of the Medicines Review Committee (2010). Dr Etuate Saafi Membership category: Health researcher Date of appointment: 3 September 2009 Current term expires: 3 September 2012 Dr Etuate Saafi is currently a Senior Research Fellow & Research Manager at Massey University. Prior to this he was a Health Research Council of New Zealand Postdoctoral Research Fellow at the University of Auckland (2004-2007). Dr Saafi completed a Master of Business Administration (2008) and a Master of Biochemistry and Molecular Biology with Honours (1995) at Massey University, a Doctorate in Biological Sciences at the University of Auckland (2004) and a Bachelor of Science at Victoria University (1991). He is currently a member of the Health Research Council of New Zealand Pacific Health Research Committee and the Counties Manukau District Health Board Pacific Health Advisory Committee. Dr Saafi's research interests have been in the area of Type 2 Diabetes and he has published and presented at a range of conferences. Northern Y Regional Ethics Committee – 2010 Annual Report 8 Mr Alistair Stewart Membership category: Date of appointment: Current term expires: Biostatistician 6 March 2008 6 March 2011 Mr Alistair Stewart is currently a Senior Research Fellow at the University of Auckland (1998present). Prior to this he was a Research Fellow at the University of Auckland (1991-1998). Mr Stewart completed a Diploma of Statistics (1972) and a Bachelor of Mathematics (1971) at the University of Otago. He is a previous member of the Health Research Council Funding Assessing Committee (1998-2002) and holds professional memberships with the New Zealand Statistical Association, the Royal Statistical Society, the American Statistical Association and the Biometrics Society. Mr Stewart has published over 190 peer reviewed journal articles on topics such as the decline in SIDS mortality (2007) and the epidemiology of plagiocephaly (2010). Dr Tessa Turnbull (Deputy Chair) Membership category: Health practitioner Date of appointment: 21 December 2006 Current term expires: 3 June 2013 Dr Tessa Turnbull is a General Practitioner and previously Senior Partner at Katikati Medical Centre. She completed a Fellowship with the Royal New Zealand College of General Practitioners (1987), a Diploma of Obstetrics at Auckland University (1977), and a Bachelor of Medicine and Bachelor of Surgery at the University of Otago (1969). Dr Turnbull was a Director of PHARMAC Seminar Series (2006-2007), a member of the Board for Osteoporosis New Zealand (1996-2006), and President of the Royal New Zealand College of General Practitioners (1997-1998), to name a few such positions. She holds professional memberships with the Royal New Zealand College of General Practitioners and the Royal Australasian College of General Practitioners. Dr Turnbull is currently doing some sessional work and is also a Fellowship Assessor for the RNZCGP. Attendance The Northern Y Regional Ethics Committee held 11 meetings in 2010. Meetings Jan Feb Mar Apr May Jun Aug Sep Oct Nov Dec total Ms Raewyn Sporle (Chair) 11/11 Ms Christina Bryant 7/11 Dr Adelaide Collins 8/11 Mr Kerry Hiini - - - - - 6/6 Ms Mary-Anne Gill 8/11 Mr Mike Vale 11/11 Dr John Fitzgerald 11/11 Dr Willem Fourie 8/11 Ms Sanya Ram 10/11 Dr Etuate Saafi 11/11 Mr Alistair Stewart 10/11 Dr Tessa Turnbull 11/11 Attendance 11 10 8 11 10 10 11 10 11 10 10 - Applications considered 11 5 14 13 6 10 8 8 11 9 12 107 Non-lay members Lay members Name Key: () present () apologies Northern Y Regional Ethics Committee – 2010 Annual Report (-) not applicable 9 Training and conferences Mr Mike Vale attended the New Zealand Bioethics Conference in Dunedin in January 2010. Mr Kerry Hiini attended a training and orientation day for new members of ethics committees on 12 November 2010. Chairperson’s meetings Ms Raewyn Sporle attended a meeting of the Chairs on 23 August 2010. Northern Y Regional Ethics Committee – 2010 Annual Report 10 Applications reviewed The Northern Y Regional Ethics Committee reviewed 202 applications in 2010. Of these, 107 were reviewed by the full committee, and 95 were reviewed between meetings at the direction of the Chair and Deputy Chairs (“expedited review”). Expedited Full At each of its meetings during 2010, the Committee reviewed an average of 9.7 applications. Approved 70 Declined 1 No final decision (as at 31 December 2010) 28 Ethics approval not required / Withdrawn 8 Total 107 Approved 67 Declined 5 No final decision (as at 31 December 2010) 6 Ethics approval not required / Withdrawn 17 Total 95 Total applications reviewed 202 A summary of these applications can be found in Appendix A. Comparison with previous years The graph below compares the number of applications reviewed in 2010 with previous years. 300 250 200 150 100 50 0 expedited full 2005 2006 2007 2008 2009 2010 0 0 87 109 114 95 112 141 138 124 128 107 Median approval times In 2010, the median approval times were 34 days for “expedited” applications and 88 days for “full” applications. Northern Y Regional Ethics Committee – 2010 Annual Report 11 Issues and complaints This section outlines issues faced by the Committee during 2010. Issues causing difficulty in review No major issues were noted which caused difficulty in review. Issues referred to NEAC and/or the HRC Ethics Committee NIL Complaints received In 2010, the Committee received an application which was deferred due to concerns regarding validity of study design. The researcher responded in an email complaining of the Committee’s decision to defer the study. The Committee considered seeking a second opinion from another HDEC Committee but choose to have discussions with the researcher of the study following which, the Committee agreed that in their response to the researcher the Committee would continue to express concern regarding the scientific validity of the study. The researcher then responded adequately to the Committee’s concerns and the study was subsequently approved. Northern Y Regional Ethics Committee – 2010 Annual Report 12 Appendix 1: Details of applications reviewed Applications reviewed by full committee Māori consultation 21/04/2010 Reason (where status is deferred or declined) n/a Approved 13/04/2010 n/a Kaumatua Kaunihera NDHB Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/01/001 A randomised single-blind comparison of the effectiveness of the high-level disinfectants Tristel wipes (chlorine dioxide), Cidex OPA (ortho-phthaldehyde) and PeraSafe (peracetic acid/peractyl ions) for use with flexible nasoendoscopes. Protocol Number: TSL-002. Patient satisfaction following primary total hip replacement for osteoarthritis: a randomised controlled trial of posterior versus lateral approaches (ACTRN 12609000552280). Action Research To Develop A Community Focussed Intervention That Facilitates Social Participation For New Zealand Children Who Have Had A Traumatic Brain Injury. Psychological and Psychosocial Functioning of Paediatric Burn Patients using Microskin: A Multi-centre Randomised Control Trial. The efficacy of split night studies ion producing a therapeutic CPAP pressure with ongoing treatment compliance. Two hypoglycaemia packs containing novel glucose treatments compared with conventional treatment of mild-to-moderate hypoglycaemia in conscious patients with diabetes mellitus in a general medial ward. Coping with Family transitions: The role of Individual and Family Resilience. Activity Coaching for Improving Usual walking in Individuals with Neurological Disorders. Interspinous Spacer for Lumbar Spinal Stenosis: A cohort study following results of Superion Interspinous Spacer. High resolution ultrasound of the Neck for assessment of mylohyoid muscle defectsin the first degree relatives of patients with Plunging ranulas. The influence of maternal age on the growth and metabolism of offspring. What are the factors that influence a new graduate nurses’ decision to remain in the Coronary Care Unit and Emergency Department. A cross-sectional observational study of the timing and pattern of emergence of permanent teeth in children of different ethnic origin between the ages of 5 and 13 years. A single ascending dose, tolerability and pharmacokinetic study of RO5303253 with a pilot food-effect investigation in healthy subjects, an exploratory pharmacokinetic, pharmacodynamic, and safety assessments in chronic hepatitits C genotype 1 patients following 5 days of oral administration. Protocol No: PP25195. Dr Brandon Hitchcock Tauranga Hospital, Whakatane Hospital 18/12/2009 26/01/2010 Approved 30/11/2009 26/01/2009 NTY/10/01/002 NTY/10/01/003 NTY/10/01/004 NTY/10/01/005 NTY/10/01/006 NTY/10/01/007 NTY/10/01/008 NTY/10/01/009 NTY/10/01/010 NTY/10/01/011 NTY/10/02/012 NTY/10/02/013 NTY/10/02/014 Dr Jonathan Francis Mason Te Puna Hauora BOPDHB Ms Margaret Jones Starship Children's Health 5/01/2010 26/01/2010 Approved 21/04/2010 n/a Nga Kai Tataki Waitemata DHB Ms Frances James CMDHB 5/01/2010 26/01/2010 Approved 5/07/2010 n/a MRRC at CMDHB Professor Colin Sullivan Waikato Hospital 5/01/2010 26/01/2010 Ethical approval not required n/a n/a Kaumatua Kaunihera - WDHB Ms Claire O'Brien CMDHB 5/01/2010 26/01/2010 Approved 15/04/2010 n/a MRRC at CMDHB Dr John Fitzgerald The Psychology Centre 6/01/2010 26/01/2010 Withdrawn n/a n/a not completed Dr Suzie Mudge Neuro Rehab Results Rope Neuro Rehab 8/01/2010 26/01/2010 Approved 23/03/2010 n/a Mr Carl Harmer Whangarei Hospital 12/01/2010 26/01/2010 Withdrawn n/a n/a Associate Dean of Maori Health;Maori physiotherapists Kaumatua Kaunihera NDHB Dr Prabha Jain CMDHB 5/01/2010 26/01/2010 Approved 20/10/2010 n/a MRRC at CMDHB Liggins Institute 18/01/2010 26/01/2010 Approved 17/06/2010 n/a MRRC at CMDHB Counties Manukau District Health Board Waitemata District Health Board Auckalnd Regional Dental Service 22/01/2010 23/02/2010 Ethical approval not required n/a n/a MRRC at CMDHB 15/02/2010 23/02/2010 Approved 27/04/2010 n/a Nga Kai Tataki at Waitemata DHB Auckland District Health Board Auckland Clinical Studies Ltd 9/02/2010 23/02/2010 Approved 23/03/2010 n/a Mr Vernon Chungson Dr Sathananthan Kanagaratnam Professor Edward John Gane Northern Y Regional Ethics Committee – 2010 Annual Report 13 Māori consultation Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/02/015 Preparing the Remedy: Rongoatia. 23/02/2010 Approved 8/06/2010 A phase III, randomised, double-blind, placebo-controlled parallel group safety and efficacy study of linagliptin (5 mg administered orally once daily) over 12 weeks followed by a 40 week double-blind extension period (placebo patients switched to glimepiride) in drug naïve or previously treated type 2 diabetic patients with moderate to sever renal impairment and insufficient glycaemic control. Infection Rates in Normal Saline vs ½ Strength Betadine as Surgical Skin Preparation for Excision of Skin Lesions of the Face: randomised Controlled Trial. Congenital Hypothyroidism Screening – Are we preserving Intellectual Function? Study 08-114: Open-label Extension of Study 08-110 – Multi-Centre Study of Denufosol Tetrasodium Inhalation solution in Patients with Cystic Fibrosis Lung Disease. A study to examine patient involvement in decision-making regarding future care and treatment options. Te Huinga A Matariki Ki Tuhoe Counties Manukau District Health Board 9/02/2010 NTY/10/02/016 Ms Alexandra Lesley Watene Dr John Baker Reason (where status is deferred or declined) n/a 5/02/2010 23/02/2010 Approved 27/04/2010 n/a Dr Fiona Neary Waikato District Health Board 17/02/2010 23/03/2010 Approved 18/11/2010 n/a Te Puna Oranga at WDHB Dr Paul Hofman Liggins Institute 22/02/2010 23/03/2010 n/a n/a MRRC at ADHB Professor John Kolbe Auckland District Health Board 1/03/2010 23/03/2010 Approved Subject to Conditions Approved 5/05/2010 n/a MRRC at ADHB Professor Merryn Gott Auckland District Health Board Greenstone Family Clinic Onehunga Accident and Medical Centre Waikato Hospital 19/02/2010 23/03/2010 Approved 10/06/2010 n/a MRRC at ADHB 5/03/2010 23/03/2010 Approved 4/06/2010 n/a Dr Jim Peters at University of Auckland;Te Puna Oranga at Waikato DHB MRRC at CMDHB NTY/10/03/017 NTY/10/03/018 NTY/10/03/019 NTY/10/03/020 Nga Kopuawai Hapu Authority MRRC at CMDHB NTY/10/03/021 Children with Hypoglycaemia and their Later Development (CHYLD). Ms Judith Ansell NTY/10/03/022 Improving the process of assessment for inability to work and granting sickness benefit for people with chronic mental illness. Dr Anthony Djurkov Counties Manukau District Health Board Te Rawhiti CMHC 1/03/2010 23/03/2010 Declined 7/07/2010 NTY/10/03/023 The experience of mild stimulation IVF in New Zealand: A qualitative study: PIS/Cons V#2, 9/08/10 Mobile phone text support of guided selfhelp for eating disorders: a feasibility study. Dr Deborah Payne IVF Auckland 5/03/2010 23/03/2010 Approved 18/06/2010 The committee declined the study because of inadequate information, unclear study design and the strong possibility of harm to potential participants. The committee expressed concern that some of the tests to be used in this study are part of larger tests which are restricted access for use by Registered Psychologists and accredited test users only. The Information Sheet and Consent Form is also inadequate for this study. n/a Dr Ruth Driver 5/03/2010 23/03/2010 Approved 18/06/2010 n/a MRRC at ADHB Can resistance training improve upper limb function and quality of life in essential tremor patients? Dr Justin Keogh Auckland District Health Board Tairawhiti District Health Board New Zealand Essential Tremor Support Group Excercise Solutions Auckland University of Technology 5/03/2010 23/03/2020 Approved 2/07/2010 n/a Maori Advancement Advisory Committee group at AUT University NTY/10/03/024 NTY/10/03/025 Northern Y Regional Ethics Committee – 2010 Annual Report Kawa Whakaruruhau Committee at AUT 14 Māori consultation 28/07/2010 Reason (where status is deferred or declined) n/a Approved 8/09/2010 n/a MRRC at CMDHB and WDHB 23/03/2010 Approved 5/07/2010 n/a MRRC at CMDHB 5/03/2010 23/03/2010 Approved 27/04/2010 n/a MRRC at ADHB Waikato Skin Research association at Tristram Clinic, Waikato Clinical Research 2008 Ltd 8/03/2010 23/03/2011 Withdrawn n/a n/a MRRC at ADHB Ms Hannah Cleland Cambridge Community House 8/03/2010 27/04/2010 Approved 18/06/2010 n/a Te Puna Oranga Waikato DHB Ms Jan Lockett-Kay Tairawhiti District Health Board 30/03/2010 27/04/2010 Ethical approval not required n/a n/a Maaka Tibble - Maori Health Manager at TDHB Ms Shelaine Zambas Auckland District Health Board Waitemata District Health Board Hearing Voices Network Whitiki Maurea 31/03/2010 27/04/2010 Approved 18/06/2010 n/a MRRC at AUT;Auckland DHB and Waitemata DHB 31/03/2010 27/04/2010 Approved 1/09/2010 n/a Kaumatua group Dr Kerry Gibson Massey University 6/04/2010 27/04/2010 Approved 3/06/2010 n/a Dr Kerry Gibson Massey University 6/04/2010 27/04/2010 Approved 9/07/2010 n/a Donald Ripia - Maori Advisor - Massey University Donald Ripia - Maori Advisor - Massey University Research Nurse Kim van Wissen Waikato Hospital 7/04/2010 27/04/2010 Approved 18/06/2010 n/a Te Puna Oranga Waikato DHB Dr Oleg Kiriaev Counties Manukau District Health Board 7/04/2010 27/04/2001 Approved 2/06/2010 n/a MRRC at CMDHB Dr Andrew Robert Johnston Auckland City Hospital 8/04/2010 27/04/2010 Approved 11/08/2010 n/a MRRC at ADHB Dr Elizabeth Finn Waitemata District Health Board 8/04/2010 27/04/2010 Approved 15/06/2010 n/a Nga Kai Tataki Maori Research Review Committee;Waitemata DHB Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/03/026 Evaluation of automated urine microscopy by UF1000i® for urine collected from asymptomatic healthy volunteers. Duration of colonisation with extendedspectrum beta-lactamase-producing Enterobacteriaceae (ESBLPE) among WDHB and CMDHB patients. A randomised trial of intradermal versus subcutaneous local anaesthesia for pain prevention during arterial blood gas puncture in a nurse-led oxygen clinic. Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with ribavirin for 4 (Part 1) and with or without ribavirin for 24-48 weeks (Part 2) in patients with chronic HCV genotype 1 infection (randomized, open label, Phase II). A phase 2, proof of concept and dose finding study, investigating treatment efficacy of LEO 29102 cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1mg/g, 1.03 mg/g) LEO 29102 cream vehicle, and Elidel® (pimecrolimus) cream 10 mg/g, after cutaneous administration twice daily for 4 weeks (LEO 29102-C21) How well do the services in Cambridge meet the needs of people who are on the journey of recovery from mental illness. From Registered Nurse to Nurse Manager: What is the preparation required for registered nurses undertaking management and leadership roles? Nurses experiences of the outcome of using advanced physical assessment skills on patients. Dr Arlo Upton Labtests Limited 5/03/2010 23/03/2010 Approved Ms Dragana Drinkovic Counties Manukau District Health Board Waitemata District Health Board Middlemore Hospital 5/03/2010 23/03/2010 5/03/2010 Professor Edward J Gane Auckland Clinical Studies Ltd Auckland District Health Board Prof Amanda Oakley He whakamarama rua I te wairangi o te hinengaro: At the interface – A bicultural understanding of psychoses. A narrative inquiry into parents’ understanding of their child’s psychological assessment. ‘Clients’ experiences of psychotherapy’: a narrative inquiry (this forms part of a broader study called the Mirror Project: Clients’ experiences of psychologists work). What is the experience of the family when an adult patient is taken home to die from an intensive care unit? A Quality Improvement Initiative To Assess The Effectiveness Of An Education Programme In Vitamin D Usage Amongst Aged Related Residential Care (ARRC) Facility In The South Auckland Area. Randomisation of gender specific total knee joint replacements (TKJR) with standard TKJR and anthropometric study of the distal femur in New Zealand as it pertains to TKJR. Patients’ and their whanau/families’ perspectives of hospital care on one hospital ward in one District Health Board. Mr Jhanitra Gavala NTY/10/03/027 NTY/10/03/028 NTY/10/03/029 NTY/10/03/030 NTY/10/04/031 NTY/10/04/032 NTY/10/04/033 NTY/10/04/034 NTY/10/04/035 NTY/10/04/036 NTY/10/04/037 NTY/10/04/038 NTY/10/04/039 NTY/10/04/040 Ms Charlene Swanevelder Northern Y Regional Ethics Committee – 2010 Annual Report MRRC at ADHB 15 Māori consultation 19/05/2010 Reason (where status is deferred or declined) n/a Approved 12/07/2010 n/a Te Puna Hauora Tauranga 27/04/2010 Approved 22/06/2010 n/a Maori Health Unit at Waikato and Mr Peter Mason in Christchurch 20/04/2010 25/05/2010 Approved 6/01/2011 n/a Betty Williams Hauraki Kaumatua;Te Puna Oranga - WDHB Waikato District Health Board 20/04/2010 25/05/2010 Deferred n/a Te Puna OrangaWDHB Dr Matthew David Henderson Waikato District Health Board 20/04/2010 25/05/2010 Approved Subject to Conditions n/a Deferred due to lack of sufficient information for the committee to make a decision. Operational Standard sections are 2.0 and 2.4. n/a Ms Karen Lindsay Auckland District Health Board 6/05/2010 25/05/2010 Approved 6/09/2010 n/a Dr Frank van Haren Waikato Hospital 7/05/2010 25/05/2010 Approved 28/07/2010 n/a Dr Andrew G. Veale Fisher & Paykel Healthcare Ltd New Zealand Respiratory & Sleep Institute Waikato District Health Board 10/05/2010 25/05/2010 Withdrawn n/a n/a 17/05/2010 22/06/2010 Approved 4/08/2010 n/a MRRC at ADHB and Te Puna Oranga at Waikato DHB Associate Professor John Broughton Raukura Hauora O tainui 21/05/2010 22/06/2010 Approved 8/09/2010 n/a Raukura Hauora O Tainui;Te Puna Oranga of WDHB Dr Alan Barber Auckland City Hospital 24/05/2010 22/06/2010 Approved 27/08/2010 n/a MRRC at ADHB Dr Clare Hocking The Auckland Regional Pain Service ( T.A.R.P.S) 2/06/2010 22/06/2010 Approved 8/09/2010 n/a MRRC at ADHB Dr Philippa Miskelly Waikato District Health Board 3/06/2010 22/06/2010 Approved 11/08/2010 n/a Prof Wayne Cutfield Liggins Institute 3/06/2010 22/06/2010 Approved 31/08/2010 n/a Te Puna Oranga WDHB MRRC at ADHB Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/04/041 Extended Evaluation of Project Energize. Dr David Graham Sport Waikato Te Korowai Hauora O Hauraki Te Kohao Health Ltd SWPIHC Nga Miro Trust Inc 8/04/2010 27/04/2010 Approved NTY/10/04/042 What is the severity, type and frequency of pain experienced by patients in the first three months after a unilateral total knee replacement? A Multi-Center, Prospective, Observational, Extension trial Following DURECT Protocol C803-017 to investigate the Long-term Safety of SABER™ BUPIVACAINE Following Arthroscopic Shoulder Surgery. Spiritual Self-Schema (3S) Therapy for Comorbid Depression or Anxiety Disorders with Substance Abuse or Dependence in a Rural Community Setting – a Pilot Study. Analgesia for patients with fractured neck of femur at Waikato Hospital: An audit of current practices followed by introduction of the use of fascia iliaca catheters for analgesia. Comparison of outcomes. Dr Tony Lamberton Grace Orthopaedic Center, Tauranga 12/04/2010 27/04/2010 Dr John E Moodie Waikato Clinical Research Leinster Orthopaedics CGM Research Trust Doctor's private practices 13/04/2010 Ms Carlene Bone Rural Mental Health and Addictions Service, Thames Dr Joe Taylor Instillation of Methylene Blue into dominant arterial supply of Colorectal malignant specimen resections increases the lymph node count. Investigation of the utility of the Mindbody Psychotherapy Approach (MBTA) in Chronic Spontaneous Urticaria unresponsive to medical therapy. The effects of different volume replacement strategies on plasma levels and gene expression of inflammatory mediators, and on sublingual microcirculation in critically ill patients. OpenCPAP efficacy and comfort trial 2010/2011. A randomized, 3 arm, multicentre, phase III study to evaluate the efficiacy and safety of T-DM1 combined with pertuzumab or TDM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2- positive progressive or recurrent locally advanced or metastatic breast cancer (MBC). Protocol Number BO22589/B dated 18th February 2010. Reducing disease burden and health inequalities arising from chronic disease among Indigenous children: as early childhood caries intervention. Brain Injury in Surgery Study (BISS). Dr Marion KuperHommel The involvement of significant others within a chronic pain management programme: The views of programme participants and their significant others. A Pluralistic Evaluation of the Pebbles and Kohatu Nursing Leadership Programmes. Does post maturity affect the glucose metabolism and body composition of prepubertal children? NTY/10/04/043 NTY/10/05/044 NTY/10/05/045 NTY/10/05/046 NTY/10/05/047 NTY/10/05/048 NTY/10/05/049 NTY/10/06/050 NTY/10/06/051 NTY/10/06/052 NTY/10/06/053 NTY/10/06/054 NTY/10/06/055 Northern Y Regional Ethics Committee – 2010 Annual Report Te Puna Oranga;Kaumatua Kaunihera - Waikato DHB Kaumatua Kaunihera _ WDHB 16 Māori consultation 8/09/2010 Reason (where status is deferred or declined) n/a Approved 30/08/2010 n/a A/Prof Papaarangi Reid - Tumuaki FMHS 22/06/2010 Approved Subject to Conditions n/a n/a Te Puna Oranga at WDHB 4/06/2010 22/06/2010 Approved 28/07/2010 n/a Te Puna Oranga WDHB University of Auckland 10/08/2010 24/08/2010 Approved 6/01/2011 n/a Professor Kathryn McPherson Waikato DHB Waikato Primary Health Organisation Toiora Primary Health Organisation North Waikato Primary Health Organisation Auckland DHB -select- 10/08/2010 24/08/2010 Approved 20/10/2010 n/a Genetic Influences on Clinical, Cognitive, and Rehabilitation outcome in Traumatic Brain Injury Minimally Invasive versus Standard Open Reduction of Proximal Humerus Fractures Autobiographical memory and sense of self in Alzheimer's Disease Professor Rob Kydd University of Auckland 10/08/2010 24/08/2010 Approved 1/12/2010 n/a Mr Bruce C Twaddle Auckland Hospital 10/08/2010 24/08/2010 n/a n/a Ms Sally Prebble 10/08/2010 24/08/2010 18/10/2010 n/a NTY/10/08/065 Selenium as a Modulator of Efficacy and Toxicity of Chemotherapy and Radiation on Normal and Malignant Cells Dr Michael Jameson University of Auckland Waitemata District Health Board Waikato Hospital University of Waikato -select- Approved Subject to Conditions Approved 10/08/2010 24/08/2010 Approved 6/09/2010 n/a NTY/10/08/066 The effect of “Family Connections”, a program for whānau of persons with borderline personality disorder, on family wellbeing Biomarkers for Hydrogen Sulphide (H2S) Exposure Pilot Project Feto-placental dysfunction – The origins of fetal dysmaturity in post term and growth restricted pregnancies. Epigenetic Markers in Infants Born Large for Gestational Age Dr Alice (Alesta) Stephan Waikato District Health Board Supporting Families Waikato 10/08/2010 24/08/2010 Approved 20/10/2010 n/a Professor Julian Crane Rotorua District Council 10/08/2010 24/08/2010 Approved 20/10/2010 n/a Professor Peter Stone National Women's Health Liggins Institute 7/09/2010 28/09/2010 Approved 18/11/2010 n/a MRCC at ADHB Dr Fredrik Ahlsson National Women's Health Liggins Institute 8/09/2010 28/09/2010 Approved 23/11/2010 n/a MRRC at ADHB Outcomes of Prostate Specific Antigen (PSA) testing in General Practice. Dexamethasone as an ankle block adjuvant for foot surgery. Professor Ross Lawrenson Dr Michael Fredrickson GP practices 17/09/2010 28/09/2010 n/a 17/09/2010 28/09/2010 Approved Subject to Conditions Approved n/a 17/11/2010 n/a The effect of local anaesthetic volume and concentration on the duration of peripheral nerve blockade Dexamethasone as a sciatic block adjuvant for foot and ankle surgery. Dr Michael Fredrickson Southern Cross Brightside Hospital Auckland Surgical Centre Southern Cross Brightside Hospital 17/09/2010 28/09/2010 Approved 28/09/2010 n/a 17/09/2010 28/09/2010 Approved 17/11/2010 n/a Prospective randomised control trial of skin closure in total knee Arthroplasty: suture versus staples. Dr Marc Hirner Southern Cross Brightside Hospital Auckland Surgical Centre Whangarei Hospital 17/09/2010 28/09/2010 Approved 18/11/2010 n/a Kaumatua Kaunihera at WDHB A/Prof Papaarangi Reid - University of Auckland A/Prof Papaarangi Reid - University of Auckland A/Prof Papaarangi Reid - University of Auckland Cultural advisor for NDHB Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/06/056 Critical Success Factors in Kaupapa Maori AOD residential treatment: Maori Youth Perspectives. Dr Ria Schroder Te Runanga O Kirikiriroa Inc National Addiction Centre, Christchurch School of Medicine & Health Sciences, University of Otago 4/06/2010 22/06/2010 Approved NTY/10/06/057 Phase III multi-centre open-label randomized controlled trial of selective internal radiation therapy (SIRT) versus sorafenib in locally advanced hepatocellular carcinoma. Effects of High-Dose supplemental Oxygen on tissue oxygenation and wound healing in vascular patients undergoing angioplasty and stenting. VerifyNow Assessment of Maori Platelet Inhibition Relative to European New Zealanders. (VAMPIRE). An Investigation of Gender Differences in Psychosis: The Role of Childhood Trauma and Attachment Experiences of recovery and adaptation after disabling traumatic brain injury Dr Adam Bartlett Auckland District Health Board 4/06/2010 22/06/2010 Dr Nathaniel Chiang Waikato District Health Board 4/06/2010 Dr Gerard Devlin Waikato District Health Board Ms Jennifer Marie O'Callaghan NTY/10/06/058 NTY/10/06/059 NTY/10/08/060 NTY/10/08/061 NTY/10/08/062 NTY/10/08/063 NTY/10/08/064 NTY/10/08/067 NTY/10/09/068 NTY/10/09/069 NTY/10/09/070 NTY/10/09/071 NTY/10/09/072 NTY/10/09/073 NTY/10/09/074 Dr Michael Fredrickson Northern Y Regional Ethics Committee – 2010 Annual Report Te Puna Oranga WDHB 17 Māori consultation 24/11/2010 Reason (where status is deferred or declined) n/a Approved 24/12/2010 n/a Maori Health Unit at HVDHB 26/10/2010 Approved 6/01/2011 n/a 6/10/2010 26/10/2010 Approved 16/11/2010 n/a Maori Health BOPDHB University of Auckland 8/10/2010 26/10/2010 Approved 6/01/2011 n/a Maori Research Advisory Committee CTRU Dr Christian Schwabe Auckland Clinical Studies Ltd 8/10/2010 26/10/2010 Approved 16/11/2010 n/a MRRC at ADHB Mere Balzer Te Hauora O Ngati Haua 8/10/2010 26/10/2010 Ethical approval not required n/a n/a Ngati Haua Dr Ryan G Paul Waikato Hospital Agresearch 8/10/2010 26/10/2010 Approved 6/01/2011 n/a Te Puna Oranga WDHB Leptospirosis in New Zealand: diagnostics, strain typing and transmission. Dr Jackie Benschop Waikato DHB Pinnacle Group Ltd 8/10/2010 26/10/2010 Approved Subject to Conditions n/a n/a NEW PARENTS: A trial of an antenatal programme In adult patients with type II diabetes mellitus and obstructive sleep apnea, does treatment with continuous positive airways pressure therapy improve measures of glycaemic control and quality of life? A randomised, controlled, multidose, multicentre, adaptive phase II/III study in infants with proliferating infantile hemangiomas, requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months ) to placebo (double blind). Protocol: V00400 SB 201. Pilot trial on the effect of water filtration on atopic dermatitis? COG AEWS07B1 – A COG Study for Collecting and Banking Ewing Sarcoma Specimens. The effect of experimental knee pain on quadriceps cortimotor excitability. Mr Warwick Pudney Waitemata District Health Board Middlemore Hospital 8/11/2010 26/10/2010 Approved 6/01/2011 n/a 8/10/2010 26/10/2010 Approved 6/01/2011 n/a Hon Assoc Prof Marius Rademaker Waikato Clinical Research Waikato Hospital Auckland Dermatology Mercy Hospital 15/10/2010 26/10/2010 Approved 24/11/2010 n/a Maori Advisory groups at each institution Dr Ben Tallon 29/10/2010 23/11/2010 n/a 2/11/2010 23/11/2010 Approved Subject to Conditions Approved Subject to Conditions n/a Dr Mark Winstanley Skin Centre, Mount Maunganui Starship Childrens Hospital n/a n/a Director of Maori Health - BOPDHB MRRC at ADHB Professor Peter McNair Auckland University of Technology 3/11/2010 23/11/2010 Approved Subject to Conditions n/a n/a NTY/10/11/090 Aged residential Care Healthcare Utlization Study (ARCHUS) Phase 2: Randomised trial of multidisciplinary teams in residential aged care. Dr Martin Connolly 3/11/2010 23/11/2010 Approved Subject to Conditions n/a n/a NTY/10/11/091 Creating and sustaining Mentally Healthy Communities: An interpretive study about the experience of respite care of ante/postnatal women with an acute serious mental health crisis. Ms Judith McAra Waitemata District Health Board Auckland District Health Board Counties Manukau District Health Board Counties Manukau District Health Board Affinity Services Ltd 4/11/2010 23/11/2010 Approved Subject to Conditions n/a n/a Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/09/075 An Open-label Study to Characterize the Pharmacokinetics and Safety of Oxycodone Hydrochloride q 12h Controlled-Release (ORF) Tablets in Pediatric Patients Aged 6 to 16 Years inclusive who Require Opioid Analgesia.OTR 1020. Service Provision For Patients with Disabilities: A Patient Questionnaire to Review Practices on the Medical Ward at Hutt Hospital. Active video games and older adults: Assessing the safety and energy expenditure of Nintendo Wii. The adult legacy of Acute Rheumatic Fever; Rheumatic Heart Disease and its complications in the Eastern Bay of Plenty 2000 – 2009. Effects of exercise on tobacco withdrawal symptoms and neurobiological factors during temporary smoking abstinence: A cross-over trial. WP25505- A single center randomized two part study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of single doses of RO5444101 in healthy subjects. Rites of Passage: Strengthening the capacity of Maori communities to support whanau aspirations for Whanau Ora. Regulation of myostatin and IGF-1 by growth hormone. Dr John Currie Waikato Hospital 17/09/2010 28/09/2010 Approved Dr. Sisira Jayathissa Hutt Valley District Health Board 7/10/2010 26/10/2010 Dr Ralph Maddison Selwyn Village, Auckland University of Auckland 7/10/2010 Dr John Malcolm Bay of Plenty DHB Dr Ralph Maddison NTY/10/10/083 NTY/10/10/084 NTY/10/10/076 NTY/10/10/077 NTY/10/10/078 NTY/10/10/079 NTY/10/10/080 NTY/10/10/081 NTY/10/10/082 NTY/10/10/085 NTY/10/10/086 NTY/10/11/087 NTY/10/11/088 NTY/10/11/089 Ms Nicola Corna Northern Y Regional Ethics Committee – 2010 Annual Report Kaumatua Kaunihera at WDHB MRRC at Waitemata DHB MRRC at CMDHB Maori Research Facilitation Committee - AUT MRRC at Waitemata DHB MRRC at CMDHB 18 Reason (where status is deferred or declined) n/a Māori consultation Taeora Tinana n/a Deferred due to concerns regarding validity of study design and minimization of harm to the participants. Operational Standard section 2.0 and 2.4. n/a Approved Subject to Conditions n/a n/a Kaumatua Kaunihera WDHB Approved Subject to Conditions Approved Subject to Conditions n/a n/a n/a n/a MRRC at Waitemata DHB MRRC at ADHB and CDHB 14/12/2010 Approved Subject to Conditions n/a n/a Dr Rees Tapsell 19/11/2010 14/12/2010 Approved Subject to Conditions n/a n/a Auckland District Health Board Canterbury District Health Board University of Auckland 19/11/2010 14/12/2010 Approved Subject to Conditions n/a n/a Ngai Tahu Research Consultation Committee. MRRC at ADHB and CDHB 15/11/2010 14/12/2010 n/a n/a Rangahau Whanau Dr Bernie Fitzharris Christchurch Hospital Dunedin Hospital Capital and Coast District Health Board 19/11/2010 14/12/2010 Approved Subject to Conditions Approved Subject to Conditions n/a n/a MRRC at Christchurch and Dunedin Hospitals Professor Rob Walker Dunedin Hospital 26/11/2010 14/12/2010 Approved Subject to Conditions n/a n/a Survey of the prevalence of viral hepatitis in Dunedin Dr Michael Schultz 26/11/2010 14/12/2010 Approved Subject to Conditions n/a n/a Does plasma matrix metalloproteinases level predict outcomes in patients who have mitral valve prolapse? Analysis of Pseudomonas gene in cystic fibrosis. Dr John W Chu Dunedin Hospital Southern Community Laboratories Southern District Health Board Ngai Tahu Research Consutlation Committee Ngai Tahu Consutlation Group 26/11/2010 14/12/2010 Approved Subject to Conditions n/a n/a Professor Iain L Lamont University of Otago 26/11/2010 14/12/2010 Approved Subject to Conditions n/a n/a A randomised controlled trial comparing peri-articular infiltration analgesia versus lumbar plexus block following total hip arthroplasty. Professor Geoffrey Horne Capital and Coast District Health Board 2/12/2010 14/12/2010 Deferred n/a Deferred due to concerns regarding validity of study design, lack of information and minimization of harm to the participants. Operational Standard section 2.0 and 2.4. Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Reason (where status is deferred or declined) Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision NTY/10/11/092 Pacific Islands Families Study: Hearing Status of 11 year olds (PIF: HS) Does regular specific movement of the pelvis and lumbar spine reduce the incidence of future low back pain in children aged 9 – 10 years? A randomised controlled trial. Dr Janis Paterson Auckland University of Technology Auckland 1/11/2010 23/11/2010 n/a 5/11/2010 23/11/2010 Approved Subject to Conditions Deferred Defining the optimal dose of intra-prostatic Botulinum Toxin Type A in men with refractory urinary retention who are fit for surgery Investigation into Viability and Gene Expression of Umbilical Vein Endothelial Cells in an Ex Vivo Whole Cord Model In Vivo Kinematic Pilot study of the Reverse shoulder Arthroplasty. COG AALL0932 – Treatment of Patients with Newly Diagnosed Standard Risk BPercusor Acute Lymphoblastic Leukaemia. Balancing individual rights with public safety: An exploration into the decisionmaking of the Mental Health Review Tribunal. Development of a measure of self-identity and personhood after traumatic brain injury (TBI). Response Post Tyrosine Kinase inhibitor: Assessment of Sensitivity and Therapeutic Response to Next Line Therapy in CML: CML 10. The experiences of Maori with aphasia and their whanau. A Phase III randomised open label study comparing GSK1120213 to Chemotherapy in subjects with Advanced or Metastatic BRAF V600E/K mutation – positive Melanoma. The impact of renal tubular function on drug handling in elderly people. Dr Michael Holmes Waikato Hospital Urology(Waikato Ltd) 5/11/2010 23/11/2010 Approved Subject to Conditions Dr Ray Cursons University of Waikato Waikato Hospital 8/11/2010 23/11/2010 Mr Peter Poon Northshore Hospital 22/11/2010 14/12/2010 Dr Lochie Teague Starship Childrens Hospital Christchurch Hospital 19/11/2010 14/12/2010 Ms Kate Thom New Zealand 19/11/2010 Dr William Levack Brain Injury Association Waikato Head Injury Society Professor Peter Browett NTY/10/12/104 NTY/10/12/105 NTY/10/11/093 NTY/10/11/094 NTY/10/11/095 NTY/10/12/096 NTY/10/12/097 NTY/10/12/098 NTY/10/12/099 NTY/10/12/100 NTY/10/12/101 NTY/10/12/102 NTY/10/12/103 NTY/10/12/106 NTY/10/12/107 Ms Julia Hill Ms Karen McLellan n/a Pacific Advisory Board Kaumatua Kaunihera WDHB Ngai Tahu Research Consutlation Committee Ngai Tahu Research Consultation Committee Applications reviewed by “expedited review” Project Key Title Principal Investigator Northern Y Regional Ethics Committee – 2010 Annual Report Locality/ies Māori consultation 19 Project Key Title Principal Investigator NTY/10/EXP/001 Open Rotator Cuff Repairs in Patients 70 years and older: review of one orthopaedic surgeon's patients. Physiological and drug data from anaesthetics: Observational study for pharmacological modelling and simulation. Retrospective review of the use of Very Low Calorie Diets (VLCD) before bariatric surgery; patient compliance and barriers to compliance. A descriptive observational study to determine if there are any differences in ethnicity of individuals presenting to Auckland City Hosptial late after stroke (greater than 24 hours after symptom onset) in comparison to individuals presenting to hospital early after stroke (less than 24 hours after symptom onset) during 2009. Birth Outcomes for Women Labouring in Primary Maternity Units: a Retrospective Case-Control Study in South Auckland. 1. Mode of Delivery and Transfer in Labour. Analgesia for aptients with fractured neck-of-femur at Waiakto Hospital: An audit of current practices followed by introduction of the use of fascia iliaca catheters for analgesia. Ultrasounded Guided Interscalene Catheter Placement: The optimum distance for catheter advancement. Routine administration of distal peripheral nerve blockade for wrist and hand surgery An analysis of the factors affecting dialysis modality choice and outcome of each different dialysis modality in Waikato Hospital, New Zealand. Predictors of severity of H1N1 infection at hospital presentation. A Pediatric Emergency Research Networks Study. Birth Outcomes for Women Labouring in Primary Maternity Units: A Retrospective Case Control Study in South Auckland. 2. Maternal Morbidity. Birth Outcomes for Women Labouring in Primary Maternity Units: A Retrospective Case Control Study in South Auckland. 3. Perinatal morbidity. Functional outcome of total hip arthroplasty in developmental dysplasia of the hip, slipped upper femoral epiphysis and Perthes' disease. The Belonging Initiative - Evaluation of the first year 2009 - 2010. Factor usage and impact on bleeding frequency in patients with severe Haemophilia phenotypes following access to expanded adult Haemophilia physiotherapy initiative over one year period. Evaluation of Waka Ama Health Promotion: Te Tai Tokerau Oranga Tane Maori Texting between doctors in clinical teams at Waikato Hospital - An observational survey. NTY/10/EXP/002 NTY/10/EXP/003 NTY/10/EXP/004 NTY/10/EXP/005 NTY/10/EXP/006 NTY/10/EXP/007 NTY/10/EXP/008 NTY/10/EXP/009 NTY/10/EXP/010 NTY/10/EXP/011 NTY/10/EXP/012 NTY/10/EXP/013 NTY/10/EXP/014 NTY/10/EXP/015 NTY/10/EXP/016 NTY/10/EXP/017 NTY/10/EXP/018 Māori consultation Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Dr Bruno de Cravalho 24/12/2009 n/a Approved 21/02/2010 Reason (where status is deferred or declined) n/a Ms Jacqueline Hannam 5/01/2010 n/a Approved 4/02/2010 n/a Ms Pauline Taylor 8/01/2010 n/a Approved 2/03/2010 n/a Ms Anna McRae 14/01/2010 n/a Ethical approval not required n/a n/a Dr David John Bailey 20/01/2010 n/a Approved 9/04/2010 n/a Dr Joe Taylor 29/01/2010 n/a Declined 9/03/2010 Full application required Dr Michael Fredrickson 20/01/2010 n/a Approved 2/03/2010 n/a Dr Michael Fredrickson 20/01/2010 n/a Approved 2/03/2010 n/a Dr Claire Louise Parke 9/02/2010 n/a Approved 26/04/2010 n/a Mr Stuart Dalziel 25/02/2010 n/a Approved 12/03/2010 n/a Dr David John Bailey 8/04/2010 n/a Approved 9/04/2010 n/a MRRC at CMDHB and ADHB Dr David John Bailey 2/03/2010 n/a Approved 9/04/2010 n/a MRRC at CMDHB Mr Matthew Boyle 28/02/2010 n/a Approved 12/03/2010 n/a Ms Lorna Sullivan 19/02/2010 n/a Approved 26/03/2010 n/a Mr Ian d'Young 18/02/2010 n/a Declined 12/04/2010 Full application required Mr Marion Bartrum 1/03/2010 n/a Approved 12/04/2010 n/a Mr Wayne Johnstone 22/02/2010 n/a Withdrawn n/a n/a Dr Manar Khashram 16/03/2010 n/a Ethical approval not required n/a n/a Northern Y Regional Ethics Committee – 2010 Annual Report Locality/ies MRRC at CMDHB Maori Health Service Coordinator 20 Māori consultation n/a Reason (where status is deferred or declined) n/a Approved 28/05/2010 n/a Kaumatua Kaunihera WDHB n/a Approved 17/05/2010 n/a 26/03/2010 n/a Approved 18/05/2010 n/a Mr Matthew Boyle 23/03/2010 n/a Approved 4/04/2010 n/a Dr Stephen Ng 12/04/2010 n/a Approved 31/05/2010 n/a Mr Liesje Donkin 26/03/2010 n/a Approved 23/04/2010 n/a Dr Paul Sexton 7/04/2010 n/a Approved 25/05/2010 n/a Dr John E Moodie 8/04/2010 n/a Declined 8/04/2010 Full application required Ms Aislinn Carr 20/04/2010 n/a Approved 17/06/2010 n/a Dr Laurie Morrison 21/05/2010 n/a Approved 22/06/2010 n/a Ms Julia Braid 16/04/2010 n/a Withdrawn n/a n/a Associate Professor Brian McKenna 20/04/2010 n/a Approved 2/07/2010 n/a Dr Jeannie Oliphant 22/05/2010 n/a Ethical approval not required n/a n/a Dr Christopher Lewis 11/05/2010 n/a Ethical approval not required n/a n/a Dr David Spriggs 11/05/2010 n/a Approved 14/07/2010 n/a Dr Mark Barrow 11/05/2010 n/a Approved 13/07/2010 n/a Dr Archana Pandit 22/05/2010 n/a n/a 25/05/2010 n/a Ethical approval not required Approved n/a Dr Andrea Zarkovic 5/10/2010 n/a Ms Rosie Winters 20/05/2010 n/a Approved 15/06/2010 n/a Ms Vicki Young 8/06/2010 n/a Approved 13/07/2010 n/a Ms Toni Ashmore 14/06/2010 n/a Approved 27/06/2010 n/a Mr David Wilson 21/06/2010 n/a Approved 13/07/2010 n/a Project Key Title Principal Investigator NTY/10/EXP/019 Evaluation of the substances and Choices Scale Brief Intervention (SACS BI) training for Child, Youth and Family (CYF). Rheumatoid Arthritis and Psychiatric Comorbidity - implication of Consultation Liaison Service. The correlation of the ABCD2 score with the degree of internal carotid artery stenosis. Comparitive Activity of carbapenem Testing ETest Study II ( COMPACT II) in Asia Pacific. Functional outcome of total hip arthroplasty in developmental dysplasia of the hip, slipped upper femoral epiphysis, and Perthes' disease. Growth of periocular basal cell carcinoma - the impact of waiting time for elective surgery Understanding the perceptions of Maori and Paciific Island parents towards childhood immunisations. Diagnosis of airflow obstruction among obese subjects A Multi-Center, Prospective, Observational, Extension trial Following DURECT Protocol C803-017 to investigate the Long-term Safety of SABER™ BUPIVACAINE Following Arthroscopic Shoulder Surgery. Multidisciplinary tiered approach to itch. Evaluation of the Extension to Breast and Cervical Screening Programme Nurses participating in healthcare design: an interpretive study Problem Gambling Services for Prison Inmates in New Zealand An audit of the clinincal management of Lichen sclerosus at the Auckalnd Sexual Health Service Endobronchial ultrasound (EBUS) in Auckland: prospective audit of a new service. Potentially Serious Drug interactions in Medical Patients accepted for admission to hospital in Australia and New Zealand Exploring experienced doctors, and nurses' perceptions and expereinces of professional identity, interprofessional collaboration and leadership. Ocular Trauma Epidimiology - Ten years retrospective study. Vision-sparing surgery and adjuvant high dose brachytherapy treatment of lacrimal sac tumors. Registered Nurses' perspectives of delayed or missing nursing care in a New Zealand hospital. A Prospective Audit of Perioperative Feeding in Burns Patients Taupo Youth Emergency Accomodation Needs Survey A retrospective analysis of the prescribing of ziprasidone and aripiprazole in acute adult mental health inpatient wards at Auckland District Health Board NTY/10/EXP/020 NTY/10/EXP/021 NTY/10/EXP/022 NTY/10/EXP/023 NTY/10/EXP/024 NTY/10/EXP/025 NTY/10/EXP/026 NTY/10/EXP/027 NTY/10/EXP/028 NTY/10/EXP/029 NTY/10/EXP/030 NTY/10/EXP/031 NTY/10/EXP/032 NTY/10/EXP/033 NTY/10/EXP/034 NTY/10/EXP/035 NTY/10/EXP/036 NTY/10/EXP/037 NTY/10/EXP/038 NTY/10/EXP/039 NTY/10/EXP/040 NTY/10/EXP/041 Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Dr Amanda Wheeler 19/03/2010 n/a Ethical approval not required Ms Sangeeta Dey 15/03/2010 n/a 26/04/2010 Dr Sally Roberts Dr Manar Khashram Northern Y Regional Ethics Committee – 2010 Annual Report Locality/ies Christchurch Hospital Percy Reedy Kaumatua Nagati Porou Maori reps from the MOH Maori Health service at Tauranga Hospital Maori providers from reference groups 21 Project Key Title Principal Investigator NTY/10/EXP/042 Prospective evaluation of Chest X-ray in Acute Paediatric asthma and Preschool Wheeze: Pilot Study Review of carcinoid tumours of the appendix in children in Auckland 1965 2009 Extracorporeal membrane oxygenation (ECMO) nurses'perceptions of caring for teh sickest patients with 2009 influenza A (H1N1): a two-phase qualitative study. Complications related to Obesity in THJR and TKJR in Maori and Pacific Island population at Counties Manukau DHB between June 1999 and June 2005. Strategic health information systems: Examining evidence-based policy and 'meaningful use'. Smoking cessation following emergency care: an observational study of success rates of a brief smokefree intervention in emergency care. Three month prospective audit of colonoscopy in Auckland DHBs using the ProVation reporting system. Long-term outcome following surgery for spinal stenosis Visiting in ICU: the New Zealand landscape Piloting a 'satisfaction survey' for hospice patients in New Zealand An examination of research carried out by the Mental Health Foundation on the subject of the over representation of Maori people in mental health services. Defining sub-groups of Constipation: A Symptomatic Approach to Sub-typing Severe Constipation. The experience of employment of people who have particiapted in the Kiwifruit Action initiative: A phenomenological study. Language anxiety: A study of difficulties faced by international medical students for whom English is an additional language during clinical practice in a New Zealand university. Single Injection Infraclavicular vs Distal Peripheral Nerve Block for Wrist and Hand Surgery. Retrospective review of childhood empyema in South Auckland 1998 - 2009 managemnt and outcomes Assessing the New Zealand Clinical Priority Access Criteria for Fertility Treatment against a Fertility Prediction Model (CPAC study) Dyspareunia and Sexual Function postpartum - Prospective study in South Auckland. Newborn screening in Cystic Fibrosis NTY/10/EXP/043 NTY/10/EXP/044 NTY/10/EXP/045 NTY/10/EXP/046 NTY/10/EXP/047 NTY/10/EXP/048 NTY/10/EXP/049 NTY/10/EXP/050 NTY/10/EXP/051 NTY/10/EXP/052 NTY/10/EXP/053 NTY/10/EXP/054 NTY/10/EXP/055 NTY/10/EXP/056 NTY/10/EXP/057 NTY/10/EXP/058 NTY/10/EXP/059 NTY/10/EXP/060 NTY/10/EXP/061 NTY/10/EXP/062 NTY/10/EXP/063 NTY/10/EXP/064 Māori consultation Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Dr Michael Shepherd 24/06/2010 n/a Approved 13/07/2010 Reason (where status is deferred or declined) n/a Dr Alison Scott 24/06/2010 n/a Approved 13/07/2010 n/a Ms Wendy Wang 24/06/2010 n/a Approved 11/08/2010 n/a Dr Simon Kim 24/06/2010 n/a Approved Subject to Conditions n/a n/a Ms Noura Ragaban 24/06/2010 n/a Approved 28/07/2010 n/a Ms Courtney Rouse 29/06/2010 n/a Approved 14/07/2010 n/a Dr Estella Johns 29/06/2010 n/a Approved 14/07/2010 n/a Dr Alistair Hadlow 29/06/2010 n/a Approved 5/08/2010 n/a Ms Helen Greenway 29/06/2010 n/a Approved 14/07/2010 n/a Dr Gary Bellamy 28/06/2010 n/a Approved 14/07/2010 n/a Mr Abraham Matonga 28/06/2010 n/a Approved 2/09/2010 n/a Dr Ian Bissett 25/06/2010 n/a Approved 15/07/2010 n/a Ms Janie de Malmanche 25/06/2010 n/a Approved 10/08/2010 n/a Maria Ngatai Kaumatua for Turning Point Trust Ms Mazura Anuar 2/07/2010 n/a Approved 15/07/2010 n/a Matiu Dickson University of Waikato on general Maori Health issues 11/06/2010 n/a Approved 8/07/2010 n/a Dr Caroline Mahon 6/07/2010 n/a Ethical approval not required n/a n/a Professor Cindy Farquhar 8/07/2010 n/a Approved 11/08/2010 n/a Dr Roopinder Gill 8/07/2010 n/a Approved 11/08/2010 n/a Ms Jacqui Everitt 9/07/2010 n/a Approved 10/08/2010 n/a Vitamin D status of psychiatric inpatients: proposal for a study in Hamilton, New Zealand. Audit of 15 degrees tilt for Caesarean section Case Report Fatal Methaemoglobinaemia Associate Professor David Menkes 13/07/2010 n/a Approved 11/08/2010 n/a Mr Conrad Engelbrecht Dr Martin Harvey 29/07/2010 n/a n/a n/a 11/08/2010 n/a Ethical approval not required Approved 3/09/2010 n/a An Exploratory Study into Measuring medication Safety in New Zealand Mr Jerome Ng 26/08/2010 n/a Approved 11/10/2010 n/a Dr Michael Fredrickson Northern Y Regional Ethics Committee – 2010 Annual Report Locality/ies Anaesthesia Institute MRRC at CMDHB Ra Earp - CE of Mary Potter Hospice MRRC at CMDHB Te Puna Oranga at WDHB 22 Project Key Title Principal Investigator Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Reason (where status is deferred or declined) Māori consultation Hospitals. NTY/10/EXP/065 NTY/10/EXP/066 NTY/10/EXP/067 NTY/10/EXP/068 NTY/10/EXP/069 NTY/10/EXP/070 NTY/10/EXP/071 NTY/10/EXP/072 NTY/10/EXP/073 NTY/10/EXP/074 NTY/10/EXP/075 NTY/10/EXP/076 NTY/10/EXP/077 NTY/10/EXP/078 NTY/10/EXP/079 NTY/10/EXP/080 NTY/10/EXP/081 NTY/10/EXP/082 NTY/10/EXP/083 NTY/10/EXP/084 NTY/10/EXP/085 NTY/10/EXP/086 Three dimensional computed tomographic assessment of hip anatomy: interobserver and intraobserver reliability. In flight interventions in an interhospital transport team Accuracy and Cost of using Masimo Pulse Co-Oximeters for Haemoglobin measurement. Upper limb infections admitted to Middlemore hospital - a case for appropriate and specific antibiotic coverage. Successful resuscitation from Bupivacaine Induced Cardiovascular Collapse with Intravenous Lipid Emulsion following Femoral Nerve Block in an Emergency Department What determines a successful trial of void (TOV) after Transurethral resection of the prostate (TURP)? Improved Health Outcomes for Ageing People with Intellectual Disability Pilot. The role and implications of play therapy for hospitalised children. Parental perceptions of the impact on their family as a result of their child's admission to hospital for lower respiratory infection. Clinicians' perspectives on interventions with recidivist drink-drivers. Mr Matthew Boyle 30/08/2010 n/a Ethical approval not required n/a n/a Ms Fay Malcolmson 20/08/2010 n/a Withdrawn n/a n/a Dr Brendon Manikkam 3/09/2010 n/a Approved 11/11/2010 n/a Dr Derek Buchanan 20/09/2010 n/a Approved Subject to Conditions n/a n/a Dr Martin Harvey 17/09/2010 n/a Approved 9/11/2010 n/a Dr Michael Holmes 17/09/2010 n/a Approved Subject to Conditions n/a n/a Dr John Parsons 15/09/2010 n/a n/a 17/09/2010 n/a Ethical approval not required Approved n/a Ms Meg Smith 8/10/2010 n/a Ms Charissa McBride 19/10/2010 n/a Approved 26/11/2010 n/a Henare Mason;MRRC at CMDHB Ms Michelle Jackson 19/10/2010 n/a Approved 19/11/2010 n/a In adult patients with type II diabetes mellitus and obstructive sleep apnea, does treatment with continous positive airways pressure therapy improve glycaemic control. Clinical outcome of keyhole surgery to the back of the ankle An audit of the quality of administration of the WHO Surgical Safety Checklist in a New Zealand Tertiary Hospital. Post Partum Haemorrhage at Middlemore Hospital 2008 - a retrospective audit. How does shift work affect eating patterns in health care workers? Upper limb infections admitted to Middlemore hospital - A case for appropriate and specific antibiotic coverage. Reandron Adverse Effects Study. Ms Nicola Corna 18/10/2010 n/a Approved 9/11/2010 n/a Dr Vili Nosa(PAcific Health) and Giovanni Armaneo - WDHB Maori Research Advisor MRRC at CMDHB Dr Francis Ting 15/10/2010 n/a Approved 19/11/2010 n/a Ms Nicole Kyla Vogts 18/10/2010 n/a Ethical approval not required n/a n/a Dr Jaime O'Loughlin 15/10/2010 n/a n/a n/a Dr Anne Jaquiery 14/10/2010 n/a Approved Subject to Conditions Approved 19/11/2010 n/a Dr Derek Buchanan 11/10/2010 n/a Approved 10/11/2010 n/a Mr Jozef Kamp 11/10/2010 n/a n/a Dr Derek Buchanan 10/10/2010 n/a Ethical approval not required Approved n/a Hand Flexor Tendon Repair: 3 techniques compared - modified kessler, adelaide and tsai repair. The efficacy of exhaust suit and laminar flow system in reducing airborne contamination in orthopaedic joint replacement. A tracer particle study. Epidermal Growth Factor Receptor Mutations in Non-small-cell-Lung Cancer. Treatment Choices for Sleep Problems 10/11/2010 n/a Dr Marc Hirner 8/10/2010 n/a Declined 8/11/2010 Full application required Dr Ray Cursons 7/10/2010 n/a Approved 26/11/2010 n/a Dr Karma Galyer 1/11/2010 n/a Approved 19/11/2010 n/a Identification and Mangement of Child and Youth Mental Health Problems in the Emergency Department. Dr John Fitzgerald 3/11/2010 n/a Approved 19/11/2010 n/a Northern Y Regional Ethics Committee – 2010 Annual Report 23 Project Key Title Principal Investigator NTY/10/EXP/087 Do you mind seeing the student doctor?' Rural general practice patient attitudes to the involvement of student doctors in their clinical care. Identification of potential Key Performance Indicators (KPIs) for quality service delivery for patients with bowel cancer in the Auckland region. Long-term outcomes for forensic mental health service users, 2001-2010 Abdominal aortic aneurysm survival trends and ethnicity data in Waikato Hospital Do bacteria of the external ear canal contribute to middle ear infection in children? Exploring the organisational implications of health informatics robots in supporting healthcare in a residential aged care facility. Evaluation of the WDHB CALD cross cultural competency training programme. An evaluation of the impact of introducing an early warning score, new vital sign chart, and standard escalation protocl, on early detetection of physiological deteriotion and prevention of in-hospital cardiac arrest, in a major tertiary hospital in New Zealand Toiora: Conceptualisation and measurement for iwi and Maori communities. NTY/10/EXP/088 NTY/10/EXP/089 NTY/10/EXP/090 NTY/10/EXP/091 NTY/10/EXP/092 NTY/10/EXP/093 NTY/10/EXP/094 NTY/10/EXP/095 Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Dr Rachel Thomson 9/11/2010 n/a Approved Subject to Conditions n/a Reason (where status is deferred or declined) n/a Mr William Diprose 5/11/2010 n/a Approved 11/11/2010 n/a Ms Zoe Dyer 25/10/2010 n/a n/a n/a Ms Simone Oldham 19/11/2010 n/a Ethical approval not required Approved 26/11/2010 n/a Ms Rebecca Katharine White 16/11/2010 n/a Declined 26/11/2010 Full application required Dr Karen Day 30/11/2010 n/a Approved Subject to Conditions n/a n/a Associate Professor Robyn Dixon 30/11/2010 n/a Approved 10/01/2011 n/a Mr David Drower 30/11/2010 n/a Ethical approval not required n/a n/a Ms Jodi Porter 7/12/2010 n/a Approved 23/12/2010 n/a Northern Y Regional Ethics Committee – 2010 Annual Report Locality/ies Māori consultation 24