Central Regional Ethics Committee Annual Report 2010 Published in July 2011 by the Ministry of Health PO Box 5013, Wellington, New Zealand ISBN: 978-0-478-37302-8 (online) HP5379 This document is available on the New Zealand Health and Disability Ethics Committees’ website: http://www.ethicscommittees.health.govt.nz Central Regional Ethics Committee – 2010 Annual Report 2 Contents About the Committee .....................................................................................4 Chairperson’s report .....................................................................................5 Membership and attendance.........................................................................6 Membership ........................................................................................................... 6 Attendance .......................................................................................................... 10 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”........................................................ 17 Central Regional Ethics Committee – 2010 Annual Report 3 About the Committee The Central 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. 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: Taranaki Whanganui Midcentral Hawkes Bay Capital and Coast Wairarapa Hutt Valley. 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 Central 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 Central Regional Ethics Committee is registered (number IRB00004666) 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. Central Regional Ethics Committee – 2010 Annual Report 4 Chairperson’s report It is a privilege to present this report on behalf of the Central Regional Ethics Committee. I have only had six months with the Committee, being appointed in June. I would like to acknowledge Deputy Chair Professor Mark Weatherall for his support and dedication to his role, during this time, both as Acting Chairman and Biostatistician. Mark is now moving on to other avenues and his expertise will be sorely missed. Thanks must also go to Helen Colebrook, past Chair, for her guidance of the Committee over the years. Joe Asghar and Nina Sawicki have also retired from the Committee, with Paul Barnett, Angela Ballantyne and Gael Donoghue joining it. A very successful training day for new members of all committees was held in November. These days are essential when guidelines can be open to interpretation and ensures that committees are in sync. A Chair’s day was held in August, which was of great benefit to me not only as an information source but also to meet with the Chairs of the other committees and share any problems we may be experiencing. The 2010-year for the Central Committee saw a slight decrease in the number of applications compared with 2009 with fifty percent of these being by expedited review. Expedited reviews place an increased workload on the Chair and Deputy Chair but on balance means that timelines are improved. The turn around time of any application that comes before the Committee is reliant on the quality of documentation. This is particularly noticeable with student applications where, I feel; their supervisors don’t always give them the support and guidance necessary to provide a well completed document. As with all applications time is wasted waiting for all the required documentation. The Administrator to our Committee, Sonia Scott with back up from Jacqi Bartlett, carries a large workload. She deserves a huge vote of thanks not only from the Committee for their efforts but also from the researchers as she constantly updates the research protocol files with frequent amendments and ensure that the correct documentation is received. Lastly thank you to our Committee, you have been a huge support, we are working well as a team, which can only benefit the process we are in place to manage. Mrs Helen Walker Chairperson Central Regional Ethics Committee Central Regional Ethics Committee – 2010 Annual Report 5 Membership and attendance Five new members were appointed to the Central Regional Ethics Committee in 2010, replacing two former members and filling three vacancies. There were four to six lay members and five or six non-lay members throughout the year. Two meetings were postponed or cancelled due to inability to make quorum. Membership Lay members Mrs Helen Walker (Chair) Membership category: Date of appointment: Current term expires: Community representative 17 June 2010 17 June 2013 Mrs Helen Walker is currently the Chairperson of Health Hawkes Bay, a member of the Medical Laboratory Sciences Board and the owner and Financial Controller of Kilgaren Farming Partnership (1981-present). She completed a Bachelor of Science at Massey University (1975) and a Certificate in Company Direction through the New Zealand Institute of Directors (2002). Mrs Walker is a previous Director of Unison Networks Ltd (2004-2010) and the Hawke’s Bay District Health Board (2001-2007). She is currently the President of the Waipawa Musical and Dramatic Club (1999-present) and a member of the Waipawa Municipal Theatre Refurbishment Fundraising Committee. Dr Angela Ballantyne Membership category: Date of appointment: Current term expires: Ethicist 17 June 2010 17 June 2013 Dr Angela Ballantyne is a Senior Lecturer in Professional Skills, Attitudes and Ethics at Otago University, Wellington. Originally from New Zealand, Dr Ballantyne has worked in a wide range of international settings, including Australia, England, Europe and the United States. She received her PhD in Bioethics from Monash University (Australia), and spent a year of her doctorate program undertaking research at Imperial College London. She has subsequently worked in schools of medicine, primary health care and philosophy. She was the Technical Officer for Genetics and Ethics for the Human Genetics unit at the World Health Organisation in Geneva in 2005. Prior to returning to New Zealand, Dr Ballantyne was a Visiting Scholar at the Yale University Interdisciplinary Center for Bioethics. Her academic interests include research ethics, vulnerability, exploitation and feminist bioethics. Mr Paul Barnett Membership category: Date of appointment: Current term expires: Lawyer 17 June 2010 17 June 2013 Mr Paul Barnett is currently the Principal Lawyer at Barnett Law (2004-present). Prior to this, he was a Partner at Chapman Tripp (1980-2004). He has completed a Master of Laws (1973) and a Bachelor of Laws with Honours (1971) at Victoria University of Wellington. He is Deputy Chair of the Board of Ronald McDonald House Wellington Trust (2005-present), a cost reviser for the Wellington branch of the New Zealand Law Society (2009-present) and was a Cost Reviser for the Wellington District Law Society (1990-2008). Central Regional Ethics Committee – 2010 Annual Report 6 Mrs Susan Corbett Membership category: Community representative Date of appointment: 23 July 2009 Current term expires: 23 July 2012 Mrs Susan Corbett is currently a Senior Lecturer at Victoria University (2002-present). Prior to this she was a Senior Legal Advisor at the Ministry of Justice (2001-2002). Mrs Corbett completed a Master of Laws at Victoria University (1998), and a Certificate of Proficiency in Cell Biology (1972) and a Bachelor of Science (1971) at Auckland University. She is currently Chair of the Victoria University Pipitea Human Ethics Committee (2007-present), and was a member of the Massey University Human Ethics Committee (1998-2000). Mrs Corbett has published more than 20 journal articles, a book chapter, and two conference papers. Mr Fuimaono Karl Pulotu-Endemann Membership category: Date of appointment: Current term expires: Consumer representative 11 September 2008 11 September 2011 Mr Karl Pulotu-Endemann has run Alo-o-Tuatagaloa, a health consultancy, since 1994. He has a nursing background and sits on a number of boards and committees, including the Psychologists Board (2000 -present), Mental Health Advocacy Coalition (1997-1998) (2007present) and the Weltec Human Ethics Committee (2008-current). Mr Pulotu-Endemann has been involved in HIV/AIDS prevention programmes through the NZ AIDS Foundation, the Pacific Island AIDS Trust, the “Like Minds Like Mine” campaign, ALAC’s Social Marketing of Reducing Alcohol Harm, and the Ministry of Health’s Healthy Eating Healthy Action (HEHA) programme among Pacific people. Ms Hilary Stace Membership category: Consumer representative Date of appointment: 21 February 2008 Current term expires: 21 February 2011 Ms Hilary Stace is currently a Research Fellow and PhD candidate at the Health Services Research Centre, School of Government, University of Victoria (2004-present). Her research interest is disability policy, particularly Autism Spectrum Disorder, and she has been a Board member of Autism New Zealand, represented family members of people with autism on the Ministry of Health’s Consumer Consortium, and been on the Implementation Advisory Group for the New Zealand Autism Spectrum Disorder Guideline. She is currently on the Board of the New Zealand Guidelines Group and is an external member of the DSAC of Capital & Coast Health DHB. She jointly teaches the research ethics paper for VUW’s Post Graduate Diploma in Clinical Research. Ms Stace has published over 30 articles and presented papers at 11 conferences. Non-lay members Mrs Gael Donoghue Membership category: Date of appointment: Current term expires: Pharmacist/pharmacologist 17 June 2010 17 June 2013 Mrs Gael Donoghue is a Pharmacist working as a Pharmaceutical Manager at Lucanus Corporation (2004-present). She is also working part time at the Open Polytechnic of New Zealand as a tutor and assessor (2000-present). Prior to this she worked in the Central Districts region as a Field Educator for the Pharmaceutical Society of New Zealand (19932003). Mrs Donoghue is both a Member (1960) and a Fellow (1998) of the Pharmaceutical Society of New Zealand. She was a member of the Drugs Advisory Committee (1984-1988). She was also the pharmacist member on the Manawatu Well Child Health Forum (20032010) and a member of the Executive of the New Zealand College of Pharmacists (19952000). She has held the post of President of the Central Districts Pharmaceutical Society of Central Regional Ethics Committee – 2010 Annual Report 7 New Zealand on a number of occasions, most recently (2004-2005) and has a history of community service committee membership. Dr Diana Martin Membership category: Date of appointment: Current term expires: Health researcher 21 February 2008 21 February 2011 Dr Diana Martin is currently the Principal Scientist at the Institute of Environmental Science and Research Limited (1996-present). She is also an Adjunct Research Fellow at Victoria University (1996-present) and a Permanent Advisor on the meningococcal vaccine strategy to the Ministry of Health (1996). Prior to this Dr Martin was the Senior Scientist and Managing Scientist of the Special Pathogens Group (1988-1996). She completed a PhD at the University of London, England (1971) a Master of Science (Honours; 1965) and a Bachelor of Science (1963) at the University of Otago. Dr Martin is currently an Advisor to an interdisciplinary team on meningococcal vaccine design and implementation at the University of Calgary, Alberta, Canada, a Policy Advisory Committee member of the Health Research Council (2003-present), a member of the Meningococcal Disease Committee for the Communicable Disease Network of Australia (2002-present) and a Scientific Advisor for the National Meningitis Trust of New Zealand (1999-present) to name a few. She holds professional memberships with the New Zealand Institute of Medical Laboratory Science, the New Zealand Microbiology Society, is an associate member of the Royal College of Pathologists Australasia and a Fellow of the Royal Society of New Zealand. Dr Lynne Pere Membership category: Date of appointment: Current term expires: Health practitioner 17 June 2010 17 June 2013 Dr Lynne Pere (Kāi Tahu, Ngāti Kahungunu, Kāti Māmoe, Rangitāne, Ngāti Porou) is a Māori Health Postdoctoral Research Fellow with the Health Services Research Centre, Victoria University of Wellington. She completed a Doctorate at Massey University (2006), a Postgraduate Diploma in Public Heath at the Christchurch School of Medicine (2000) and a Master of Arts at Victoria University Wellington (1997). She also completed a Diploma in Nursing at Whitireia Community Polytechnic (1995). Dr Pere holds professional memberships with Massey University’s Te Mata o te Tau/Academy for Māori Research and Scholarship Fellow, the University of Auckland’s Te Kupenga o MAI (National Programme for Māori and Indigenous Post-graduate Advancement) at Ngā Pae o te Māramatanga, the New Zealand Federation of Graduate Women, and Te Kaunihera o Ngā Māori o Aotearoa/National Council of Māori Nurses. Dr Dean Quinn Membership category: Health practitioner Date of appointment: 23 July 2009 Current term expires: 23 July 2012 Dr Dean Quinn is currently Unit Director at Bowen P3 Research Hospital (2004-present). Prior to this he was a Clinical Research Associate at the Medical Research Institute of New Zealand (2004). Dr Quinn completed a Bachelor of Science with Honours at Victoria University, Wellington (1998) and a Bachelor of Medicine and Bachelor of Surgery at the University of Otago (1993). He is a member of the Bowen Child Care Management Committee (2007-2010). Dr Quinn is the author of 4 published articles. Central Regional Ethics Committee – 2010 Annual Report 8 Dr Mark Weatherall Membership category: Biostatistician Date of appointment: 21 February 2008 Current term expires: 21 February 2011 Dr Mark Weatherall is currently an Associate Professor at the University of Otago, Department of Medicine, Wellington (2006-present). Prior to this he was a Senior Lecturer at the University of Otago, Department of Medicine, Wellington (1997-2006). Dr Weatherall completed a Master of Applied Statistics (2003) and a Bachelor of English and Statistics (1999) at Massey University. He has also completed a Bachelor of Medicine and Surgery at the University of Otago (1984) and made a Fellow of the Royal Australasian College of Physicians (1991). Dr Weatherall is a previous member (1991-1999), national executive member (1999-2003) and secretary (2001-2003) of the Australian and New Zealand Geriatrics Society and a national executive member (1994-2003) and president (2000-2003) of the New Zealand Continence Association. He has published over 60 articles in the past five years on topics such as the effects of cannabis on pulmonary structure, function and symptoms and the effect of environment and task on gait parameters following stroke. Former members Mr Joe Asghar (until 17 June 2010) Membership category: Date of appointment: Pharmacist/pharmacologist 9 December 2004 Mrs Helen Colebrook (until 17 June 2010) Membership category: Date of appointment: Lawyer 9 Dec 2004 Dr Nina Sawicki (until 8 August 2010) Membership category: Date of appointment: Health professional 23 July 2009 Central Regional Ethics Committee – 2010 Annual Report 9 Attendance The Central Regional Ethics Committee held 7 meetings in 2010. Meetings Non-lay members Lay members Members Key: Feb Mar May Jul Sep Oct Dec total Mrs Helen Walker (Chair) - - - 4/4 Dr Angela Ballantyne - - - 3/4 Mr Paul Barnett - - - 4/4 Mrs Helen Colebrook (until 17 June 2010) - - - - 1/3 Ms Susan Corbett 6/7 Fuimaono Karl Pulotu-Endemann 4/7 Ms Hilary Stace 7/7 Mr Joe Asghar (until 17 June 2010) - - - - 3/3 Mrs Gael Donoghue - - - 4/4 Dr Diana Martin 6/7 Dr Lynne Pere - - - 1/4 Dr Dean Quinn 7/7 Dr Nina Sawicki (until 8 August 2010) - - - 1/4 Dr Mark Weatherall 6/7 Attendance 8 7 7 9 7 10 9 - Applications considered 8 6 10 11 12 7 11 65 () present () apologies (-) not applicable Training and conferences Mrs Helen Colebrook attended the New Zealand Bioethics Conference in Dunedin in January 2010. Dr Angela Ballantyne, Mr Paul Barnett and Mrs Gael Donoghue attended a training and orientation day for new members of ethics committees on 12 November 2010. Chairperson’s meetings Mrs Helen Walker attended a meeting of the Chairs on 23 August 2010. Central Regional Ethics Committee – 2010 Annual Report 10 Applications reviewed The Central Regional Ethics Committee reviewed 125 applications in 2010. Of these, 65 were reviewed by the full committee, and 60 were reviewed between meetings at the direction of the Chair (“expedited review”). Expedited Full At each of its meetings during 2010, the Committee reviewed an average of 9.5 applications. Approved 42 Declined 2 No final decision (as at 31 December 2010) 19 Withdrawn 2 Total 65 Approved 45 Declined 0 No final decision (as at 31 December 2010) 9 Ethical approval not required 6 Total 60 Total applications reviewed 125 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. 160 140 120 100 80 60 40 20 0 expedited full 2005 2006 2007 2008 2009 2010 0 0 48 61 56 60 128 139 86 67 96 66 Median approval times In 2010, the median approval times were 25 days for “expedited” applications and 71 days for “full” applications. Central 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 None cited by Chair. Issues referred to NEAC and/or the HRC Ethics Committee NIL Complaints received None cited by Chair. Central Regional Ethics Committee – 2010 Annual Report 12 Appendix 1: Details of applications reviewed Applications reviewed by full committee Reason (where status is deferred or declined) Concerns with study design Māori consultation 21/03/2010 n/a Kimi Ora School Approved 4/03/2010 n/a Taranaki DHB Maori Health Department 9/02/2010 Declined 19/02/2010 N/A 26/01/2010 9/02/2010 Approved Subject to Conditions n/a Concerns around validity of research, suitability of researcher and minimisation of harm n/a Dr Tim Blackmore 19/02/2010 9/02/2010 Approved 31/03/2010 n/a Cheryl Goodyer, CCDHB Associate Professor Stewart Mann 19/02/2010 10/02/2010 Approved 5/02/2010 n/a University of Otago The Type, Grade, Stage at Diagnosis, and Survival Rates in Endometrial Cancers in new Zealand Maori and non-Maori population. A randomised, controlled crossover trial of the effect of high concentration oxygen on obese hospitalised patients. Identity formation online and offline in type 1 diabetic emerging adults Dr Dushyant Maharaj 1/11/2010 11/02/2010 Approved 20/08/2010 n/a 22/02/2010 9/03/2010 Approved 18/05/2010 n/a Matire Harwood 22/02/2010 9/03/2010 Approved 26/04/2010 n/a Macular Changes in Causasian Eyes Glaucoma Filtration Surgery Dr Anthony Wells 22/02/2010 9/03/2010 Approved 2/04/2010 n/a Trish Young, Wellington School of Psychology N/A 22/02/2010 9/03/2010 Approved 17/05/2010 n/a 22/02/2010 9/03/2010 Approved 2/04/2010 n/a Local Maori representatives Ms Anne Butt 22/02/2010 9/03/2010 Approved 14/06/2010 n/a RAG-M (Wellington) Professor Kay Matthews 26/04/2010 11/05/2010 Approved 14/06/2010 n/a Tuahine Northover; Marg Hiha 26/04/2010 11/05/2010 Approved 9/08/2010 n/a Ngai Tahu Research Consultation Committee; RAG-M (Wellington) Project Key Title Principal Investigator CEN/10/02/01 The Type, Grade at Diagnosis, and survival Rates in Endometrial Cancer in New Zealand Maori and non-Maori A study of oral motor control therapy with surface electromyography (sMEG) biofeedback to develop active relaxation and reduction of spasticity with Spastic Cerebral Palsy A phenomenological study of five teenage mothers and their experinces in the neonatal unit at Taranaki base Hospital, New Plymouth Exploring the thematic contects of a nightmare experienced by a patient aith anorexia nervosa in residential care at the Central District Eating DIsorders Service, Johnsonville, Wellington A quality investigation into the Provision of General Practice health care to Bhutanese, Congolese and Burmese UNHCR refuggees in the MidCentral District Health Board Area. A Study to Assess the Extent of past H1N1 Influenza Infection in Children Presenting to Hospital in the Wellington Regionin 2010 Myocardial Enzyme Release in LongDistance Cyclists CEN/10/02/02 CEN/10/02/03 CEN/10/02/04 CEN/10/02/05 CEN/10/02/06 CEN/10/02/07 CEN/10/02/10 CEN/10/03/08 CEN/10/03/09 CEN/10/03/10 Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision Dr Dushyant Maharaj 20/01/2010 9/02/2010 Declined 19/05/2010 Ms Emma Necus 20/01/2010 9/02/2010 Approved Ms Jane Bocock 22/01/2010 9/02/2010 Mr Craig Jackson 22/01/2010 Mr Janine Rasmussen Dr Sarah Jefferies Locality/ies Wellington Hospital Dr Antonia Lyons Wellington Hospital University of Otago Eye Department CEN/10/03/11 Maori Perspectives on Hospice Care Ms Elizabeth Taylor CEN/10/03/12 Comparing A Six Minute Walk Test with a Standard Hour Holter Monitor for the Assessment of Ventricular Rate Control in Permanent Atrial Fibrillation Exploring Clinician Perspectives and Experience of Barriers to Accessing the PAR Sevice An Evaluation of the Outcomes for up to One Hundred Hawke's Bay Children Assessed in the Before (B4) Schol Checks with Severe Behaviour Disorder The Oral Health of Individuals with Haemophilia: a Mixed Methods Investigation Dr John Wilson CEN/10/03/13 CEN/10/05/014 CEN/10/05/015 Professor W Murray Thomson Central Regional Ethics Committee – 2010 Annual Report Hutt Valley Hospital Capital and Coast District Health Board 13 Māori consultation n/a Reason (where status is deferred or declined) n/a Approved 20/06/2010 n/a Ngai Tahu Research Consultation Committee 11/05/2010 Approved 12/07/2010 n/a 26/04/2010 11/05/2010 Approved 20/06/2010 n/a Odele Stehlin? Institute for Parkinson's and Brain Research, 66 Stewart Street, Christchurch 27/04/2010 11/05/2010 Approved 20/06/2011 n/a He Oranga Pounamu; RAG-M (Canterbury) Christchurch Resettlement Service 13/04/2010 11/05/2010 Approved 14/06/2010 n/a Ngai Tahu Research Consultation Comittee Ms Jessie Bakker 27/04/2010 11/05/2010 Approved 26/06/2010 n/a Ngai Tahu Research Consultation Committee Dr Parry Guildford 19/05/2010 11/05/2010 Approved 14/06/2010 n/a Parry Guilford Dr Tasmin Roberts 2/03/2010 20/07/2010 Approved 4/03/2010 n/a Nick Roskruge; Chris Cunningham; Marewa Glover Hemiama Hughes; Chris Hill 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 CEN/10/05/016 Is There a relationship Between Blood Glucose Levels in People with Diabetes who had a Plan and Those who Did Not, On the Day of Their Investigation Procedure? A Retrospective Survey Of Clinical Notes. Comparison of DIST Versus Euglycaemic Hyperinsulinaemic Clamp Before and After Roux-en-Y Gastric Bypass for the Measurement of Insulin Resistance Within the Current Primary Health Care System How Easy is It for Registered Nurses Employed by Maori Health care Providers to WOrk in a Holistic Way with People with Type 11 Diabetes Attitudes that influence Decision-Making Among Parents and health Care Workers for Pandemic Influenza Vaccination in Southland Region, New Zealand The Effect of Swallowing Manoeuvers on Anterior Hyoid Movement and Relaiability of Outcome Measurement Ms Kerrie Ann Skegg MidCentral District Health Board Diabetes Lifestyle Centre 26/04/2010 11/05/2010 Approved Subject to Conditions Dr Richard Stubbs Wakefield Hospital 26/04/2010 11/05/2010 Ms Liz Day 26/04/2010 Dr Christopher Chung Dr Maggie-Lee Huckabee Post-migration: risk and protective factors supporting refugee and migrant resettlement in New Zealand Motality Rates Congestive Heart Failure Patients Prescribed Conditions Positive Airway Pressure: a Ten Year, MatchedControl Study The Epigenetic Chemoprevention of Cancer Evaluation of the effect of continuous heparin administration on patent ductus arteriosis closure in preterm infants The Effect of An Acute Bout of Exercise on Smoking Withdrawal Symptoms (craving) in Maori Fit to Practice: Exploring the Work Experience of Registered Nurses who have become disabled during the Course of their Careers Relatives' matched with staff's experience of the moment of death in tertiary referral hospital Would an Extended Care Paramedic Model of Care Improve Outcome for Patients? Does the type of continuous positive airway pressure interface effect the required therapeutic pressure in patients with obstructive sleep apnoea? The medium term effectiveness of autologous blood injections as an additional treatment to an eccentric strengthening programme for mid portion Achilles tendinopathy- a double blind randomised control trial. Risky Crossings Dr Lynne Briggs An Investigation into the Experiences and Outcomes of Participants in the Health Conditions Service Wellbeing Group Intervention An Exploratory Investigation into those Factors which determine Safe Patient Selection in Single Strop Helicopter Winching Operations CEN/10/05/017 CEN/10/05/018 CEN/10/05/019 CEN/10/05/020 CEN/10/05/021 CEN/10/05/022 CEN/10/05/023 CEN/10/07/009 CEN/10/07/024 CEN/10/07/025 CEN/10/07/026 CEN/10/07/027 CEN/10/07/028 CEN/10/07/029 CEN/10/07/030 CEN/10/07/031 CEN/10/07/032 Massey University Dr James Faulkner Massey University 28/06/2010 20/07/2010 Approved 6/09/2010 n/a Ms Juliana Korzon Whitireia Community Polytechnic 30/06/2010 20/07/2010 Approved 29/08/2010 n/a Cheryl Goodyer, CCDHB; Bridget Robson Dr Sinead Donnelly 30/06/2010 20/07/2010 Received n/a n/a Ms Sarah Hoyle 1/07/2010 20/07/2010 Approved 1/10/2010 n/a Ms Jessie Bakker 1/07/2010 20/07/2010 Approved 9/08/2010 n/a Ngai Tahu Research Consultation Committee Ngai Tahu Research Consultation Committee Chris Cunningham 1/07/2010 20/07/2010 Approved 21/09/2010 n/a Raymond Kaiki, Te Whare Puawai O Te Tangata Trust Ms Maria Marais 1/07/2010 n/a Withdrawn n/a n/a Parry Guilford Ms Evelyn Aranas 1/07/2010 20/07/2010 Received n/a n/a Lisa Cherrington Dr Paul Nealis 1/07/2010 20/07/2010 Received n/a n/a DT Wallace, RNZAF Cultural Advisor Dr James Bell Central Regional Ethics Committee – 2010 Annual Report Massey University 14 Project Key Title Principal Investigator CEN/10/07/033 Reproducibility of Heidelberg Retinal Tomograph (HRT) II and Spectralis Optical Coherence Tomograph (OCT) Measurements with Alterations in Refractive Status in Caucasian Eyes A Randomised, Repeat-Dose, PlaceboControlled, Double-Blind Study to Evaluate and Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder, when Administered either in the Morning or in the Evening, in Male and Female Asthmatic Subject. (Study Number HZA114624) The Perceptions and Attitudes Towards Service User Involvement from the Perspectives of Mental Health and Addiction Nurses Working in a Community Setting Wahine Hauora : Reducing Barriers to Care for Pregnant Maori Women 20 and their Infants Accuracy of Computer Navigated IntraOperative Cup Position Readings Referenced from a Functional Plane Dr Anthony Wells CEN/10/09/038 CEN/10/09/034 Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision 1/07/2010 20/07/2010 Approved 9/08/2010 Reason (where status is deferred or declined) n/a Māori consultation Dr Dean Quinn P3 Research Wellington 30/08/2010 14/09/2010 Approved 13/10/2010 n/a Ms Vicky Brown MidCentral District Health Board 30/08/2010 14/09/2010 Approved 2/11/2010 n/a Ngai Tahu Research Consultation Committee Dr Beverley Lawton University of Otago 30/08/2010 14/09/2010 Approved 1/11/2010 n/a Dr Michael van Niekerk Hawke's Bay Hospital 30/08/2010 14/09/2010 Approved 8/10/2010 n/a A Qualitative Research Project Examining Nurses’ Experiences in Administering the B4 School Checks Linette Davidson Taranaki District Health Board Ruanui Health Centre 30/08/2010 14/09/2010 Approved 25/11/2010 n/a CEN/10/09/039 The Evaluation of Virucidal Agents in Environmental and Food Setting Ms Joanne Hewitt Institute of Environmental Science and Research Ltd 30/08/2010 14/09/2010 Approved 2/11/2010 n/a Ngai Tahu Research Consultation Committee Lewis Ratapu, HBDHB; Suzanne Pitama, University of Otago Warren Nicholls, Ngati Ruanui Tahua Trust Health Services; Te Whare Punanga Korereo Board Maui Hudson, ESR Maori Development CEN/10/09/040 A Feasibility Study of EGFR Testing for Maori Patients with Non-Small-Cell Lung Cancer (HRC Ref ID: 10/675) Lesley Batten MidCentral District Health Board 30/08/2010 14/09/2010 Approved 8/10/2010 n/a Whakauae Research, Ngati Hauiti; Dr Te Kani Kingi & Dr Mihi Ratima CEN/10/09/041 Central Corneal Thickness in a Māori Population in Hawke’s Bay In search of the most effective protocol to treat hypoglycaemia in type 1 diabetes: A randomized trial testing 3 different hypoglycaemia treatment protocols to rate the efficacy at relieving symptoms in adolescents and adults with Type 1 Diabetes. Clinical usability assessment of updated infant ventilation tube Dr Alex Buller 7/09/2010 14/09/2010 n/a n/a Lewis Ratapu, HBDHB n/a Deferred for a number of reasons, mainly relating to study design. RAG-M (CCDHB) WDHB Kaumatua Kaunihera Research Subcommittee A trial product evaluation of a new infant nasal cannulae used to deliver heated humidified oxygen therapy Supported Self Management in Chronic Kidney Disease The effect of a Health Enhancing Physical Activity Programme (HEPAP) on transient ischaemic attack (TIA) and non-disabling stroke: a randomised controlled pilot trial. The Treatment of Sleep and Therapeutic Unwinding and Relaxation at Night Study (TOS and TURN Study) Elevations of Highly Sensitive Cardiac Troponin T in Obstructive Sleep Apnoea Syndrome and the Effect of CPAP Treatment. In patients needing primary total hip replacements for osteoarthritis or avascular necrosis (AVN), does the use of tranexamic acid just prior to surgery CEN/10/09/035 CEN/10/09/036 CEN/10/09/037 CEN/10/09/042 CEN/10/09/043 CEN/10/09/044 CEN/10/09/045 CEN/10/10/046 CEN/10/10/047 CEN/10/10/048 CEN/10/10/049 Mr Lindsay McTavish Capital and Coast District Health Board 7/09/2010 14/09/2010 Approved Subject to Conditions Deferred Dr Arun Nair Neonatal Intenstive Care Unit, Waikato Hospital 27/08/2010 14/09/2010 Approved 27/09/2010 n/a Dr John Beca Starship Childrens Hospital Waikato NICU 27/08/2010 14/09/2010 Approved 14/09/2010 n/a Ms Janine Palmer Hawkes Bay District Health Board Capital and Coast District Health Board Massey University 6/09/2010 14/09/2010 Approved 19/11/2010 n/a Lewis Ratapu, HBDHB 30/09/2010 12/10/2010 Approved 1/12/2010 n/a Nick Roskruge, College of Sciences 30/09/2010 12/10/2010 Approved 1/12/2010 n/a Malcolm Robson, Transcultural Services 30/09/2010 12/10/2010 Received n/a n/a Ngai Tahu Research Consultation Committee 4/10/2010 12/10/2010 Received n/a n/a Lewis Ratapu, HBDHB Dr James Faulkner Dr Sarah Romans Leong Leow Dr James Blackett Central Regional Ethics Committee – 2010 Annual Report Wellington Hospital Kenepuru Hospital Wellsleep 15 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 30/09/2010 12/10/2010 Approved 20/12/2010 n/a 4/10/2010 12/10/2010 Approved 22/10/2010 n/a Chris Cunningham; Sharon Reid, Aukati Kai Paipa; Cheryl Davies, Tu Kotahi Chris Cunningham 22/10/2010 n/a Withdrawn n/a n/a 23/11/2010 7/12/2010 Approved Subject to Conditions n/a n/a Dr John Walden Lynda Creighton, Tu Meke PHO; Jean Te Huia, Kahunguna Health and Community Services Chris Cunningham reduce the transfusion rate and units transfused when compared to a placebo. CEN/10/10/050 Randomised controlled (RCT) trial of Nicotine Inhaler and nicotine patch for smoking cessation in highly nicotine dependent smokers. A comparative bioavailability study to compare the pharmacokinetics and pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered by Fluticasone propionate/Salmeterol combination in a capsule-based inhaler and a multidose dry powder inhaler, in patients with moderate asthma and patients with moderate to severe COPD. (Study Number ASR114334). Tupu Ake: Developing a kaupapa Māori definition of resiliency for rangatahi in Taranaki. Towards Relevant Psycho-Oncological Intervention for Men : Identifying ZSources of distress and Developing an Intervention Concept Professor Julian Crane CEN/10/12/054 The Kahungunu Infant Safe Sleep (KISS) Study Professor Barry Taylor 23/11/2010 7/12/2010 Approved Subject to Conditions n/a n/a CEN/10/12/055 The Effect of Hyperuricaemia on the Inflammatory Response of Blood-Derived Immune Cells from Hyperuricaemic Individuals before and after Urate Lowering Therapy What is the best method to assess the severity of ongoing respitory events in very preterm infants prior to discharge? Ms Rene McLaughlin 23/11/2010 7/12/2010 Approved Subject to Conditions n/a n/a Dr Tasmin Roberts 23/11/2010 7/12/2010 Approved Subject to Conditions n/a n/a A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Trial to Investigate the Effects of Paracetamol in the treatment of Influenza Exploring Access to Breast Cancer Services by Chinese Women Dr Kyle Perrin 23/11/2010 7/12/2010 Approved 12/01/2011 n/a Miss Zhang Wei 23/11/2010 7/12/2010 Approved Subject to Conditions n/a n/a Upper Body Ergometry Training in Individuals with Multiple Sclerosis The Recognition and Processing of Molecules from Livestock Nematode Parasites by Human Dendritic Cells Sudden Unexpected Death in Infancy (SUDI) Case-Control Feasibility Study Dr Lynette Hodges 23/11/2010 7/12/2010 n/a 23/11/2010 7/12/2010 Approved Subject to Conditions Received n/a Dr Ian Sutherland n/a n/a Tanira Kingi, AgResearch Professor Ed Mitchell 23/11/2010 7/12/2010 Received n/a n/a Long-Term Sequelae of Acute Post Streptococcal Glomerulonephritis : Follow up Patients Identified in an Auckland-wide 1994-1998 Cohort Dr William Wong 23/11/2010 7/12/2010 Approved Subject to Conditions n/a n/a Papaarangi Reid, FHMS, University of Auckland Mata Forbes, ADHB; Henare Mason, CMDHB CEN/10/10/051 CEN/10/11/052 CEN/10/12/053 CEN/10/12/056 CEN/10/12/057 CEN/10/12/058 CEN/10/12/059 CEN/10/12/060 CEN/10/12/061 CEN/10/12/062 Dr Dean Quinn P3 Research Wellington Ms Bry Kopu Dr Christine Stephens Central Regional Ethics Committee – 2010 Annual Report MidCentral District Health Board Taranaki District Health Board Whanganui District Health Board Cancer Society of New Zealand Arohanui Hospice Central PHO Ngati Ruanui Health Centre Patea Medical Trust Toiora Healthy Lifestyles Ltd Southcare Medical Practice Wellington Hospital Ngai Tahu Research Consultation Committee; Whanau Care Services at CCDHB Matire Harwood Ngai Tahu Research Consultation Committee 16 Project Key Title Principal Investigator CEN/10/12/063 Emotional Communication Between Nurses and Parent of a Child in Hospital : An Ethnographic Study Ms Ruth Crawford Locality/ies Date Received Date of first review at meeting Status as at 31 December 2010 Date of final decision 23/11/2010 7/12/2010 Received n/a Reason (where status is deferred or declined) n/a Māori consultation Māori consultation Te Aira Henderson, Midcentral DHB Applications reviewed by “expedited review” 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 CEN/10/EXP/01 A Needs Assessment to Identify if Specific Kai Preparation and Cooking Skills is a barrier to Healthy Eatign for Adult Maori with Diabetes or at Risk od Diabetes, Principally Enrolled in Valley PHO and A resident in Wainuiomata Reducing Health Disparities for Low Decile Children and Families: A Nurse-Led Response Outcome of the Towards Well-being Suicide Prevention Programme: Stage Two 2005 to 2008 Use of Public and Private Health Services by Maori and Non-Maori women: An audit of uterine biopsy laboratory results Facilitating Whanau Resilience Through Maori Primary Health Intervention Spectral Domain Optical Coherence Tomography - Changes in the Optic Nerve Head and Macula after Cataract Surgery An audit of anaemia in medical inpatients at Palmerston North Hospital Forensic Mental Health Consumers' Subjective Experiences of Legal Synthetic Cannabinoids/ Case Series of Forensic Mental Health Clients Developing Symptoms in the Context of Legal Synthetic Cannabinoid Use Barriers and opportunities associated with intra and inter sectoral collaboration in the contex of long-term conditions programme in New Zealand Private and Primary Care-Based Adult Sleep Services: Towards Services that Reduce Disparities The Utility of a Standardised Haemodynamic Protocol for the Management of Patients Undergoing High Risk Cardiac Surgery HUNX 480 Proposal Dietetic Student Project in Residential Care Comparison of the Different Correction Formulae in the Measurement of Intraocular Pressure Use of Patient Specific Functional Scale (PSFS) and Other Outcome Measures Amongst Physiotherapists in private Practices in Central Wellington SInce November 2009 HEHA Community Action Project: A Case Study of how HEHA was Implemented Among Pacific Communities in the Hutt Valley Transfusion Rates and Thrombosis in Arthroplasty Backpocket Antibiotic Precription in Primary Care: Does it Work? Ms Tammy Kaiwai n/a 16/02/2010 n/a Approved 20/02/2010 Reason (where status is deferred or declined) n/a Ms Catrina Riley n/a 16/02/2010 n/a Ethical approval not required n/a n/a Mr Don Smith n/a 20/02/2010 n/a Approved 1/03/2010 n/a Dr Beverley Lawton n/a 16/02/2010 n/a Approved 20/02/2010 n/a Dr Alexander Sasse n/a 2/03/2010 n/a Approved 4/03/2010 n/a Dr Anthony Wells n/a 2/03/2010 n/a Approved 4/03/2010 n/a Dr Bart Baker n/a 19/03/2010 n/a n/a n/a Ms susanna EveryPalmer n/a 2/03/2010 n/a Ethical approval not required Approved 17/03/2010 n/a Ms Sandeep Reddy n/a 19/03/2010 n/a Approved 2/04/2010 n/a Dr Te Hereripine Sarah-Jane Paine n/a 19/03/2010 n/a Approved 21/03/2010 n/a Dr Laurence Walker n/a 16/04/2010 n/a Approved 20/04/2010 n/a Dr Alexandra Chisholm Dr Anthony Wells n/a 31/03/2010 n/a Approved 21/03/2010 n/a n/a 31/03/2010 n/a Approved 2/04/2010 n/a Ms Cheryl Hefford n/a 21/04/2010 n/a Approved 26/04/2010 n/a Ms Milli Burnette n/a 21/04/2010 n/a Approved 26/04/2010 n/a Dr Ciaran Thrush n/a 7/05/2010 n/a n/a n/a Mr David Lim n/a 7/05/2010 n/a Ethical approval not required Approved 17/05/2010 n/a CEN/10/EXP/02 CEN/10/EXP/03 CEN/10/EXP/04 CEN/10/EXP/05 CEN/10/EXP/06 CEN/10/EXP/08 CEN/10/EXP/09 CEN/10/EXP/10 CEN/10/EXP/11 CEN/10/EXP/12 CEN/10/EXP/13 CEN/10/EXP/14 CEN/10/EXP/16 CEN/10/EXP/17 CEN/10/EXP/18 CEN/10/EXP/19 Central Regional Ethics Committee – 2010 Annual Report 17 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 CEN/10/EXP/20 Determinating Regional Burdent of Chlamydia: An Audit of Laboratory Data (Nov 2006-2010) Improving the understanding burn injury: cause, treatment and outcome. The Australia and New Zealand Burn Association Bi-National Burn Registry Ongoing follow-up of participants from Cognitive-Behavioural Group Therapy for Anxiety-related Insomnia intervention Programme Cardiovascular Risk Assessment: A retrospective Chart Audit of Nurse-Led Service Delphi Surveys Dr Sally Rose n/a 7/05/2010 n/a Approved 8/05/2010 Reason (where status is deferred or declined) n/a Dr Frances James n/a 18/05/2010 n/a Approved 20/06/2010 n/a Ms Carolyn Taylor n/a 30/04/2010 n/a Approved 20/05/2010 n/a Ms Susan Ball n/a 18/05/2010 n/a Approved 14/06/2010 n/a Ms Jean Clark n/a 2/06/2010 n/a n/a n/a Goal orientation, mental toughness, precompetition anxiety and the incidence of injuries in amateur rugby league participants The Hawkes Bay District Health Board Productive Community Services Programme Pre-Implementation Survey How does interprofessional education for primary care health professionals foster teamwork? Exploring if Samoan men make any lifestyle changes folowing cardio-vascular risk assessment (CVRA) Cardiovascular Risk Assessment: A retrospective chart audit of nurse-led services Plunket Nurse Needs Assessment and Decision Making: What's the Story? The Role of the Primary Health Nurse In Advance Directives: A New Zealand Enhancing Quality of Life Through Singing: A music therapy study in Huntington's Disease Analysing discourse in intercultural health settings: constructing identities in meetings Sleep of Older People with Dementia and Those who Live with Them An Investigation into the impact of early oral diet on patient recovery following elective colorectal surgery An assessment of blood glucose control in surgical patients with diabetes: A study of the first 24 hours after continuous insulin infusion Staff perceptions of how music therapy can support the spiritual care of palliative patients in a New Zealand/ Aotearoa hospice Rhetoric or reality: The consumer voice in interdisciplinary decision making Does Leg Length Effect Functional Outcomes Following Total Hip Replacement Promoting Communication and Socialisation through Music Therapy for Children with Cerebral Palsy Review of Use of Rechus Sheath Catheters Repeatability of Primary Selective Laser Trabeculoplasty in Patients with Primary Open Angle Glaucoma Ms Carolyn Taylor n/a 20/08/2010 n/a Ethical approval not required Received n/a n/a Ms Victoria Speers n/a 20/05/2010 n/a Approved 14/06/2010 n/a Dr Sue Pullon n/a 15/06/2010 n/a Ethical approval not required n/a n/a Ms Tuaupua Taueetia Su’a n/a 15/06/2010 n/a Approved 16/06/2010 n/a Ms Susan Ball n/a 15/06/2010 n/a Approved 14/06/2010 n/a Ms Alison Hussey n/a 25/06/2010 n/a Approved 20/06/2010 n/a Ms Raewyn Davidson n/a 12/07/2010 n/a Approved 12/07/2010 n/a Ms Sacha van Beek n/a 16/07/2010 n/a Approved 16/07/2010 n/a Ms Mariana Virginia Lazzaro Salazar n/a 16/07/2010 n/a Approved 16/07/2010 n/a Ms Rosemary Gibson n/a 2/08/2010 n/a Approved 9/08/2010 n/a Ms Dorothy Tstitsi Chimwayange Mushawa Fathimath Arifa Abdul Hakeem n/a 16/07/2010 n/a Approved 16/07/2010 n/a n/a 16/07/2010 n/a Approved 16/07/2010 n/a Ms Keryn Squires n/a 16/07/2010 n/a Approved 16/07/2010 n/a Dr Joan Skinner n/a 16/07/2010 n/a Approved 16/07/2010 n/a Dr James Andrew Blackett n/a 3/08/2010 n/a Approved 9/08/2010 n/a Hong Ching Kho n/a 12/07/2010 n/a Approved 3/07/2010 n/a Dr Sarah Blair n/a 3/08/2010 n/a Received n/a n/a Dr Anthony Wells n/a 20/08/2010 n/a Ethical approval not required n/a n/a CEN/10/EXP/21 CEN/10/EXP/22 CEN/10/EXP/23 CEN/10/EXP/24 CEN/10/EXP/25 CEN/10/EXP/25 CEN/10/EXP/26 CEN/10/EXP/27 CEN/10/EXP/28 CEN/10/EXP/28 CEN/10/EXP/29 CEN/10/EXP/30 CEN/10/EXP/32 CEN/10/EXP/33 CEN/10/EXP/33 CEN/10/EXP/34 CEN/10/EXP/35 CEN/10/EXP/36 CEN/10/EXP/37 CEN/10/EXP/39 CEN/10/EXP/40 CEN/10/EXP/41 Central Regional Ethics Committee – 2010 Annual Report Māori consultation 18 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 CEN/10/EXP/42 Retrospective Audit of Door to Needle Times for the Antibiotic Treatment ofPatients Presenting with Presumed Pneunmonia, and other Associated Clinical Quality Indicators Comparison of laparoscopic adjustable gastric band versus sleeve gastrectomy in a provincial centre - a single surgeon's experience. What do Registered Nurses know and practice about early mobilisation in patients diagnosed with deep venous thrombosis. Evaluation of a new patient information booklet and DVD in Palmerston North Regional Hospital. An audit of limitations of medical treatment in hospital patients who have suffered medical emergencies. Goal Orientation, mental toughness, precompetition anxiety and the incidence of injuries in amateur rugby league participants Infant feeding and Intussusception - A Pilot Study Measurement of femoral stern migration using 'Polymig' computerised analysis software. Attitudes towards antipyretic use in Intensive Care Units Risky Crossings: The perceptions and experiences of managers in dealing with therapeutic boundary crossings amongst registered mental health nurses and their service users. An audit to monitor the consequences of a planned roster change in intensive care registrars. Integrated Secondary Specialist Service in Primary Care Team Diabetes Management A review of outcome following 'Evolve' radial head replacement. Debriefing after Simulation of Anaesthetic Crises: Current Practices. Audit of platelet function testing in acute coronary syndrome patients in Wellington Hospital Improving the Continuity of Care for Pregnant Women with High Needs - an Evaluation Validation of the New Zealand Cardiac Surgery Prioritisation Tool Nursing attitudes towards antipyretic use in Intensive Care Units Late morbidity in patients with testicular cancer The Prevalence and Patient Perspective of Cannabis Use in the Emergency Department Dr David Tripp n/a 19/08/2010 n/a Received n/a Reason (where status is deferred or declined) n/a Dr Bernard McEntee n/a 19/08/2010 n/a Approved 3/09/2010 n/a Ms Kathy Wade n/a 19/08/2010 n/a Approved 14/09/2010 n/a Dr Patries Herst n/a 19/08/2010 n/a Approved 1/09/2010 n/a Dr Cameron Knott n/a 19/08/2010 n/a Approved 13/09/2010 n/a Mr Doug King n/a 26/08/2010 n/a Approved 9/08/2010 n/a Dr Sarah Prior n/a 13/09/2010 n/a Approved 5/10/2010 n/a Professor Geoffrey Horne n/a 13/09/2010 n/a Received n/a n/a Dr Caroline Murphy n/a 13/09/2010 n/a Approved 5/10/2010 n/a Ms Maria Marais n/a 13/09/2010 n/a Received n/a n/a Dr Christopher Poynter n/a 6/08/2010 n/a Approved 13/09/2010 n/a Dr Jeremy Krebs n/a 14/09/2010 n/a Approved 14/09/2010 n/a Dr Andrew Thompson n/a 18/10/2010 n/a Received n/a n/a Professor Alexander Garden Dr Scott Harding n/a 22/10/2010 n/a Approved 22/10/2010 n/a n/a 26/11/2010 n/a Approved 23/11/2010 n/a Mr Martin Hefford n/a 22/11/2010 n/a Approved 26/11/2010 n/a Dr Alexander Sasse n/a 29/11/2010 n/a Received n/a n/a Dr Caroline Murphy n/a 29/11/2010 n/a Received n/a n/a Professor Neil Pearce n/a 29/11/2010 n/a Approved 1/12/2010 n/a Dr Paul Quigley n/a 22/12/2010 n/a Received n/a n/a CEN/10/EXP/43 CEN/10/EXP/44 CEN/10/EXP/45 CEN/10/EXP/46 CEN/10/EXP/47 CEN/10/EXP/48 CEN/10/EXP/49 CEN/10/EXP/50 CEN/10/EXP/51 CEN/10/EXP/52 CEN/10/EXP/53 CEN/10/EXP/54 CEN/10/EXP/55 CEN/10/EXP/56 CEN/10/EXP/57 CEN/10/EXP/58 CEN/10/EXP/59 CEN/10/EXP/60 CEN/10/EXP/61 Central Regional Ethics Committee – 2010 Annual Report Māori consultation 19