Upper SouthBRegional Ethics Committee
Annual Report
2012
Published in May 2014
by the Ministry of Health
PO Box 5013, Wellington, New Zealand
ISBN 978-0-478-42827-8(online)
HP5894
This document is available on the New Zealand Health and Disability Ethics Committees’ website:
Contents
About the Committee......
Membership and attendance......
Membership......
Attendance......
Applications reviewed......
Average decision times......
Appendix 1: Details of applications reviewed......
Applications reviewed by the full pathway......
Applications reviewed by the expedited pathway......
Upper South B Regional Ethics Committee – 2012 Annual Report1
About the Committee
The Upper South B 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:
- Nelson Marlborough
- West Coast
- Canterbury
- South Canterbury.
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 Upper South B 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 Upper South B Regional Ethics Committee is registered (number IRB00004668) 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.
Membership and attendance
Membership
Lay members
Ms Patricia Costigan (Chair)
Membership category: / Community representativeDate of appointment: / 11 January 2007
Current term expired: / 19 November 2012
Ms Patricia Costigan is a Christchurch District Court Judge (1988–2011).Prior to this she was a partner at Dougall Stringer Solicitors (1986–1988), a Sole Practitioner Solicitor (1983–1986), a Staff Solicitor at Corcoran Thwaites & Brown Solicitors (1980–1983), and at Cuningham Taylor and Thomson, Solicitors, (1974–1979).Judge Costigan obtained a Bachelor of Laws (Hons) from the University of Canterbury in 1974.She was a member of the Christchurch College of Education Council (1999–2003) and was Chairperson of the Arohata District Prison Board (1993–1999).Judge Costigan has also volunteered her time in the past to the Christchurch Altrusa Club (1976–1985) and the Court Theatre, as a member of the Board of Trustees (1993–2001).She also served as the first woman member of the Canterbury District Law Society from 1984 until her appointment as a District Court Judge.
Mrs Judene Edgar
Membership category: / Community representativeDate of appointment: / 10 June 2010
Current term expired: / 10 June 2013
Judene Edgar is currently a Councillor with the Tasman District Council (2007–present), a Director of Tasman Fundraising and Development Ltd (2005–present), the Board Secretary of the Cawthron Institute Trust Board (2004–present), and an Editor with the Nelson Marlborough District Health Board
(2003–present).Prior to this she was a Research Co-ordinator at the Wellington School of Medicine and Health Sciences, University of Otago (2004–2006).Ms Edgar completed a Bachelor of Behavioural Science at La Trobe University, Australia (1998).She is currently a Trustee of the Nelson Bays Primary Health Trust (2010–present), Trustee of the Tasman Regional Sports Event Trust (2010–present) and Secretary of the Richmond Pool Charitable Trust (2006–present).Ms Edgar is a member of the Institute of Directors in New Zealand and the Fundraising Institute of New Zealand.She has presented papers at four conference proceedings.
Ms Raewyn Idoine
Membership category: / Consumer representativeDate of appointment: / 10 June 2010
Current term expired: / 10 June 2013
Ms Raewyn Idoine is currently a Director of Learning State Limited, the industry training organisation for state sector employees.Her recent roles include Stakeholder Engagement Manager for the Tertiary Education Commission (2007–2009) and Owner/Manager of a number of large private tertiary institutions. Ms Idoine was registered as a nurse at Auckland Public Hospital (1976).Other positions she has undertaken include: Judge of the New Zealand Hospitality Awards (2004–2007),Head Assessor of the New Zealand Tourism Awards (1999–2006) and member of the Ministry of Education Tertiary Advisory Group (1996–2004).
Ms Selma Scott
Membership category: / LawyerDate of appointment: / 10 June 2010
Current term expired: / 10 June 2013
Ms Selma Scott is currently the Principal of Scott & Co (2003–present).Prior to this she was a Solicitor at Iosefa & Co (2002–2003), Glover Sewell (2001–2002), a Barrister Sole (2000–2001), and Sapolu (1990). Her previous roles included Pacific Legal Education Coordinator at the Christchurch Community Law Centre (2000–2001), Review Officer at the Accident Compensation Corporation (1991–1998), Probation Officer at the Department of Justice (1988–1990), and Tenancy Officer at Housing Corporation
(1987–1988).Ms Scott completed a Bachelor of Laws (1985) and Bachelor of History (1981) at University of Canterbury.She was a member of the Ministry of Pacific Island Affairs Ministerial Advisory Council (2005–2010).She is a board member of the Pacific Business Trust (2007–current), and Chair of the Niu Economic and Enterprise Development Trust (2002–present).She is a member of the Human Rights Review Tribunal (2009–present) and the State Housing Appeal Authority (2008–present).She is a Voluntary Solicitor at Community Law Canterbury (2000–present) and the Citizens Advice Bureau
(2008–present).
Non-lay members
Dr Melissa Copland
Membership category: / Pharmacist/pharmacologistDate of appointment: / 13 March 2008
Current term expired: / 13 March 2011
Dr Melissa Copland is a self-employed pharmacist at Queenstown Pharmacy, part of the Queenstown Medical centre facility (2001–present).Prior to this she was a Senior Teaching Fellow and Research Fellow at the University of Otago School of Pharmacy (1996–2001).Dr Copland completed her PhD (Pharmaceutical Sciences and Immunology – 2003) and a Bachelor of Pharmacy (Honours) (1994) at the University of Otago.She is currently a Ministerial Appointment to the Ministry of Health Medicines Classification Committee (MCC), a member of the PHARMAC Pharmacology and Therapeutics Advisory Committee (PTAC), an Honorary Clinical Lecturer at Auckland University School of Pharmacy and a Fellow of the NZ College of Pharmacists.Previously, Dr Copland has been a Director of the Wakatipu Primary Health Organisation.Dr Copland has published five peer reviewed journal articles and presented more than ten papers at international scientific meetings.
Mrs Annette Finlay
Membership category: / Health researcherDate of appointment: / 9 December 2004
Current term expired: / 13 March 2011
Mrs Annette Finlay (Tainui, Te Arawa) is currently a Quality & Risk Co-ordinator/Privacy Officer/Maori Advisor for Nurse Maude in Christchurch (2007–present).Mrs Finlay was a Surveyor and Auditor for Quality Health Telarc New Zealand (2005–2011).She is currently a member of the Upper South B Regional Ethics Committee (2004–present).Prior to this she was the Team Leader of Maori Health Services at Christchurch Hospital (2004–2007) and a Registered Nurse in the Otolaryngology and Ophthalmology Unit of Christchurch Hospital (1995–2007); a Registered Nurse with the Garden City Nursing Agency Limited (1993–1995).Mrs Finlay completed a Bachelor of Health Sciences at Charles Sturt University, Bathurst, Australia (1997), a Certificate in Adult Teaching (1997) and a Diploma in Nursing Studies (1993) at Christchurch Polytechnic.Mrs Finlay is a member of Roopu Kawawhakaruruhau Maori Advisory Group and a part-time lecturer in the Hauora Maori Paper at Christchurch Polytechnic Institute of Technology and has recently become an Auditor for the NZ Nursing Council.
Dr Sarah Gunningham
Membership category: / Health researcherDate of appointment: / 10 June 2010
Current term expired: / 10 June 2013
Dr Sarah Gunningham is currently a Postdoctoral Fellow at the University of Otago (2008–present).Prior to this she was an Assistant Research Fellow and PhD student at the University of Otago (1996–2008).DrGunningham completed a PhD at the University of Otago (2008), a Master of Science at the University of Otago (2003) and a Bachelor of Science at the University of West of England (1995).She was registered as a General Nurse at Royal United Hospital (1982) and worked as a nurse 1982–1996 completing a Diploma of Nursing at London University (1986) and Certificates of Teaching and Assessing in Clinical Practice (1989), and General Intensive Care (1987) at the Bristol and Weston School of Nursing.Dr Gunningham has published one book, 15 refereed journal articles and presented papers at six conference proceedings.
Dr Mary Livingston
Membership category: / Health practitionerDate of appointment: / 10 June 2010
Current term expired: / 10 June 2013
Dr Mary Livingston is a Christchurch-based specialist in dental public health.She works currently as a private practitioner in a group practice in Waltham. Dr Livingston worked for the Canterbury District Health Board for 25 years, 10 of which was spent as Clinical Director of the Hospital Dental Service.She was previously Chair of the Dental Council (2006–2009) and has been a member of various iterations of the Council from 2001 until 2010.Dr Livingston holds professional memberships and has held official positions with a variety of dental associations at both the national and local level.
Mr Magnus McGee
Membership category: / BiostatisticianDate of appointment: / 13 March 2008
Current term expired: / 13 March 2011
Mr Magnus McGee is currently a statistician for the Colorectal Cancer Control in New Zealand Project (August 2007–present) and a Statistician and SAS Programmer for Te Rau Hinengaro at the Christchurch School of Medicine and Health Sciences (2004–present).Prior to this he was a statistician for the Computer Aided Detection Evaluation Trial for the Epidemiology, Mathematics and Statistics Department of Cancer Research United Kingdom (2003–2004).Mr McGee completed a Master of Medical Statistics and Information Technology at the University of Leicester, United Kingdom (1989) and a Bachelor of Science (Honours) at the University of Glasgow, United Kingdom (1987).He is currently a member of the Health Research Society of Canterbury (2005–present) and a previous member of the Aberdeen Research Ethics Committee (2002–2003).Mr McGee has published over 40 articles and presented papers at conference proceedings such as the as New Zealand Statistical Association Conference (2009) and Aberdeen Centre for Energy Regulation and Obesity 7th Symposium (2003).
Attendance
The Upper South B Regional Ethics Committee held two meetings between January and June 2012.
Members / Meetings / TotalJan / Feb / Mar / Apr / May / June
Lay members / Cm / Patricia Costigan (Chair) / / / 2/2
E / Dr Jane Cooper
Cn / Ms Judene Edgar / / A / 1/2
Cm / Mrs Jo Gregan
Cn / Mrs Raewyn Idoine / / / 2/2
L / Ms Selma Scott / / A / 1/2
Non-lay members / P / Dr Melissa Copland / / A / 1/2
HR / Mrs Annette Finlay / A / / 1/2
HR / Dr Sarah Gunningham / / / 2/2
HP / Dr Mary Livingston / / / 2/2
B / Mr Magnus McGee / A / A / 0/2
HP / Dr Martin Than
Attendance / 7 / 5 / 12/18
Applications considered / 12 / 6 / 18
Key: / L / Lawyer / P / Pharmacist/pharmacologist / / present
E / Ethicist / B / Biostatistician / A / apologies
Cm / Community representative / HP / Health practitioner / X / absent
Cn / Consumer representative / HR / Health researcher / not applicable
Applications reviewed
The Upper South B Regional Ethics Committee received61 applications between January and June 2012.Of these, 19 were reviewed by the full committee, and 20were reviewed between meetings at the direction of the Chair (“expedited review”). 22 were withdrawn or did not require HDEC review.
At each of its meetings between January and June 2012, the Committee reviewed an average of 9.5 applications.
Full / Approved / 18Declined / 0
No final decision (as at 30 June 2012) / 1
Total / 19
Expedited / Approved / 19
Declined / 1
No final decision (as at 30 June 2012) / 0
Withdrawn / ethical approval not required / 22
Total / 42
Total applications reviewed / 61
A summary of these applications can be found in Appendix A.
Average decision times
In 2012, the average decision times were 4.7 days for “expedited” applications and 51days for “full” applications, including any time taken for researchers to respond to approval conditions.
Upper South B Regional Ethics Committee – 2012 Annual Report1
Appendix 1: Details of applications reviewed
Applications reviewed by the full pathway
Project key / Full title / Principal investigator / Outcome / Review type / Status at time of report / Locality organisations / Sponsor/funder / Consultation undertaken / Days to reviewURB/12/02/001 / The relationship between empathy and burnout in registered nurses working in hospital inpatient units / Mr Dave Carlyle / Approved subject to conditions / Full / Approved / Christchurch Hospital
Hillmorton Hospital / Manager, Te Korowai Atawhai;Te Pora Ehau;Vi Anderson;and Elizabeth Cunningham / 49
URB/12/02/003 / A prospective, randomised, double blind, placebo controlled study to compare the safety and efficacy of subcutaneous denosumab 60mg six monthly in acute spinal cord injury in males and females. Protocol version 1.9 / Dr Nigel Gilchrist / Approved subject to conditions / Full / Approved / CGM Research Trust
Burwood Spinal Unit / 33
URB/12/02/004 / Within the context of the ICF framework, what are the influences on return to employment/productivity in individuals injured as a result of the Christchurch earthquake? / Ms Joanne Nunnerley / Approved subject to conditions / Full / Approved / Canterbury District Health Board / Elizabeth Cunningham / 69
URB/12/02/005 / A double blinded, randomised, prospective study to evaluate the use of the Scratch Test in conjunction with standard examination technique (palpation +/- percussion) to significantly enhance the ability to locate the lower liver edge / Dr Alexander Huelsen / Approved subject to conditions / Full / Approved / Gastroenterology, Christchurch Hospital / Gastroenterology Research Trust / Peter Mason – Lin and Pete Mason & Associates / 49
URB/12/02/006 / The relationship between the provision of information and pre-test anxiety in patients attending a breathing test for the first time / Emily Rose Ingram / Approved subject to conditions / Full / Approved / Canterbury DHB / Te Komiti Whakarite / 61
URB/12/02/007 / Health anxiety CBT vs TAU for patients with non-cardiac chest pain / Professor Roger Mulder / Approved subject to conditions / Full / Approved / Canterbury District Health Board / Elizabeth Cunningham – Research Manager Maori / 83
URB/12/02/008 / Evaluating BRCA1 and BRCA2 sequence variants in breast and/or ovarian cancer families / Dr Logan Walker / Approved / Full / Approved / University of Otago, Christchurch / It is advised on form A that funding is to be sought from various funding agencies as at 25January 2012 / Elizabeth Cunningham / 13
URB/12/02/009 / Estimated glomerular filtration rate formulae and P-glycoprotein for the prediction of dabigatran pharmacokinetics and pharmacodynamics for guiding dosing in adults / Dr Paul KL Chin / Approved subject to conditions / Full / Approved / Christchurch Hospital / Department of Clinical Pharmacology Trust Funds managed by Canterbury District Health Board and University of Otago. Health Research Council / 55
URB/12/02/009 / Estimated glomerular filtration rate formulae and P-glycoprotein for the prediction of dabigatran pharmacokinetics and pharmacodynamics for guiding dosing in adults / Dr Paul KL Chin / Full / Received / Canterbury DHB / HRC / Te Komiti Whakarite;CDHB
URB/12/02/010 / Estimated glomerular filtration rate formulae for the prediction of gentamicin clearance and dosing in adults / Dr Paul KL Chin / Approved subject to conditions / Full / Approved / Canterbury DHB / Department of Clinical Pharmacology Trust Funds manged by Canterbury District Health Board and University of Otago. Health Research Council / Te Komiti Whakarite / 55
URB/12/02/011 / Mental health nurses’ understanding of the concept of self-management for service users with the diagnosis of borderline personality disorder / Dr Lisa Whitehead / Approved subject to conditions / Full / Approved / Canterbury District Health Board
University of Otago / University of Otago Māori Consultation Committee / 145
URB/12/02/012 / Health care needs of patients with advanced COPD in Canterbury / Dr Amanda Landers / Approved subject to conditions / Full / Approved / Nurse Maude / Annette Finlay;Suzanne Pitama / 28
URB/12/05/015 / The New Zealand 1986 VLBW cohort as young adults: mapping the road ahead / Professor Brian Darlow / Approved / Full / Approved / University of Otago
Hagley Radiology / HRC
Child Health Research Foundation
Canterbury Neonatal Unit Trust Fund / Elizabeth Cunningham / 21
URB/12/05/016 / 21-year review of upper limb surgery for tetraplegia / Dr Jennifer Dunn / Approved / Full / Approved / Post-doctoral fellowship, University of Otago / Elizabeth Cunningham / 21
URB/12/05/017 / What are the perceptions, concerns and experiences of adolescents regarding sexual health care, when living with a cancer diagnosis? / Dr Gary Bellamy / Approved subject to conditions / Full / Approved / Canterbury District Health Board / Health Work New Zealand Funding / Te Komiti Whakarite / 57
URB/12/05/018 / The effects of Dabigatran on ECT, HEMOCLOT, dRVVT, TEG and Thrombin generation in comparison to low molecular weight heparin and Warfarin anticoagulation within therapeutic range / Amr BinSadiq / Received / Full / Approved / Canterbury Health Laboratories / Elizabeth Cunningham / 36
URB/12/02/002 / An open-label, prospective, single oral dose study evaluating the pharmacokinetics, safety and tolerability of oseltamivir (Tamiflu) in adult subjects on peritoneal dialysis (PD) using a rapid cycle regimen to simulate automated peritoneal dialysis (APD) and in adult subjects with creatinine clearance from 10–30 mL/min not on dialysis / Dr Richard Robson / Approved subject to conditions / Full / Approved / Christchurch Clincal Studies Trust (CCST)
Auckland Clinical Studies / Roche Products (New Zealand) Ltd / Mr John McManus and Mrs Maureen McManus;Maori Advisors;Christchurch Clinical Studies Trust / 16
URB/12/05/013 / Protocol 1302.1. Pharmacokinetics and safety of BI 695502 in healthy subjects: a randomised, single-blind, single-dose, parallel-arm, active-comparator clinical Phase I study / Dr Chris Wynne / Approved subject to conditions / Full / Approved / Christchurch Clinical Studies Trust
Auckland Clinical Studies Ltd / Boehringer Ingelheim Pharma GmbH & Co KG / John and Maureen McManus and Maui Hudson / 31
URB/12/05/014 / A Phase IIA open label, adaptive, randomised clinical trial of Dalotuzumab(MK-0646) treatment in combination with irinotecan versus cetuximab and irinotecan for patients with metastatic rectal cancers (mRC) expressing high IGF1/low IGF-2 levels / Dr Mark Jeffery / Approved subject to conditions / Full / Approved / Christchurch Hospital / Te Komiti Whakarite / 69
Applications reviewed by the expedited pathway
Project key / Full title / Primary investigator / Review type / Status at time of report / Consultation undertaken / Days to reviewURB/12/EXP/039 / What is the current clinical practice of intravenous fluid prescription and the post operative outcomes on the adult patient undergoing elective resection for colon cancer: a retrospective audit conducted at a major New Zealand tertiary hospital? / Ms Ann Marie Mullen / EXP / Closed