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Central Regional Ethics Committee Annual Report 2012 Published in May 2014 by the Ministry of Health PO Box 5013, Wellington, New Zealand ISBN 978-0-478-39332-3 (online) HP 5489 This document is available on the New Zealand Health and Disability Ethics Committees’ website: http://www.ethicscommittees.health.govt.nz Contents About the Committee .......................................................................................... 1 Membership and attendance .............................................................................. 2 Membership ........................................................................................................................ 2 Attendance .......................................................................................................................... 5 Applications reviewed ......................................................................................... 6 Average decision times ....................................................................................................... 6 Appendix 1: Details of applications reviewed ..................................................... 7 Applications reviewed by the full pathway .......................................................................... 7 Applications reviewed by the expedited pathway ............................................................. 10 Central Regional Ethics Committee – 2012 Annual Report iii 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 – 2012 Annual Report 1 Membership and attendance Membership Lay members Mrs Helen Walker (Chair) Membership category: Community representative Date of appointment: 17 June 2010 Current term expired: 17 June 2013 Mrs Helen Walker is currently the Deputy Chairman and Audit Chairman for Health Hawkes Bay Ltd, member of the Medical Sciences Council, a Kaitiaki/Guardian of the Turnbull Library 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). On a voluntary basis she is the President of the Waipawa Musical and Dramatic Club (1999–present) a member of the Waipawa Municipal Theatre Refurbishment Fundraising Committee and Trustee and Treasurer of the New Zealand Singing School. Dr Angela Ballantyne Membership category: Ethicist Date of appointment: 17 June 2010 Current term expired: 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: Lawyer Date of appointment: 17 June 2010 Current term expired: 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 – 2012 Annual Report 2 Mrs Susan Corbett Membership category: Community representative Date of appointment: 23 July 2009 Current term expired: 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. Ms Hilary Stace Membership category: Consumer representative Date of appointment: 21 February 2008 Current term expired: 21 February 2011 Dr Hilary Stace is currently a Research Fellow 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, been on the Implementation Advisory Group for the New Zealand Autism Spectrum Disorder Guideline and been an external member of the DSAC of Capital Coast DHB.. She is currently on the Board of the New Zealand Guidelines Group. She jointly teaches the research ethics paper for VUW’s Post Graduate Diploma in Clinical Research. Dr Stace has published over 30 articles and presented papers at 14 conferences. Non-lay members Dr Andrea Corbett Membership category: Health practitioner Date of appointment: 2 September 2011 Current term expired: 30 June 2012 Dr Andrea Corbett is currently a senior academic staff member at the School of Nursing, Western Institute of Technology (2001–present). Prior to this she was Clinical Nurse Leader at Wairarapa Health’s Assessment, Treatment and Rehabilitation Service (2000–2001). Dr Corbett completed a PhD at Monash University (2008) and a MPhil in Nursing at Massey University (2003), along with numerous nursing qualifications since becoming a Registered Nurse in 1978. She is currently Chair of the Positive Aging Centre of Excellence and a Trustee of Taranaki Community Health Trust. Mrs Gael Donoghue Membership category: Pharmacist/pharmacologist Date of appointment: 17 June 2010 Current term expired: 17 June 2013 Mrs Gael Donoghue is a pharmacist working as a pharmaceutical manager at Lucanus Corporation (2004–present), and worked at the Open Polytechnic of New Zealand as a tutor and assessor (2000–2011). Prior to this she worked in the Central Districts region as a Field Educator for the Pharmaceutical Society of New Zealand (1993–2003). Mrs Donoghue is a Fellow of the Pharmaceutical Society of New Zealand, of which she was also made the first Life Member in 2010. She was a member of the Drugs Advisory Committee (1984–1988). She was also the pharmacist member on the Manawatu Well Child Health Forum (2003–2010) and a member of the Executive of the New Zealand College of Pharmacists (1995–2000). She has held the post of President of the Central Districts Pharmaceutical Society of New Zealand on a number of occasions (most recently in 2004–2005) and has a history of community service and committee membership. Central Regional Ethics Committee – 2012 Annual Report 3 Dr Diana Martin Membership category: Health researcher Date of appointment: 21 February 2008 Current term expired: 21 February 2011 Dr Diana Martin was the Principal Scientist at the Institute of Environmental Science and Research Limited (1996–2011). She was also an Adjunct Research Fellow at Victoria University (1996–2011) 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 Russell Membership category: Health practitioner Date of appointment: 17 June 2010 Current term expired: 17 June 2013 Dr Lynne Russell (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 Russell 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. Central Regional Ethics Committee – 2012 Annual Report 4 Attendance The Central Regional Ethics Committee held four meetings between January and June in 2012. Members Meetings Non-lay members Lay members Feb Key: Mar April June July Total 4/4 4/4 Cm Mrs Helen Walker (Chair) E Dr Angela Ballantyne L Mr Paul Barnett Cm Ms Susan Corbett A A Cn Fuimaono Karl Pulotu-Endemann Cn Ms Hilary Stace HP Dr Andrea Corbett P Mrs Gael Donoghue HR Dr Diana Martin A HP Dr Lynne Russell A A A 1/4 HP Dr Dean Quinn B Dr Mark Weatherall Attendance 5 6 6 4 21/27 Applications considered 5 7 13 11 36 1/3 4/4 3/4 4/4 0 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 Central Regional Ethics Committee – 2012 Annual Report not applicable 5 Applications reviewed The Central Regional Ethics Committee received 74 applications between January and June 2012. Of these, 36 were reviewed by the full committee, and 35 were reviewed between meetings at the direction of the Chair (“expedited review”). 3 applications were withdrawn or did not require HDEC review. Expedited Full At each of its meetings between January and June 2012, the Committee reviewed an average of nine applications. Approved 29 Declined 0 No final decision (as at 30 June 2012) 7 Withdrawn / ethical approval not required 0 Total 36 Approved 29 Declined 0 No final decision (as at 30 June 2012) 6 Withdrawn / ethical approval not required 3 Total Total applications reviewed 38 74 Average decision times In 2012, the average decision times were 15 days for “expedited” applications and 90 days for “full” applications, including any time taken for researchers to respond to approval conditions. Central Regional Ethics Committee – 2012 Annual Report 6 Appendix 1: Details of applications reviewed Applications reviewed by the full pathway Primary investigator Date received Review type 30/01/2012 Full Status at time of report Locality organisations Sponsor / funder Consultation undertaken Days to review Tu Kotahi Maori Asthma Trust 51 Project key Full title CEN/09/06/037 Collection of glioblastoma tumour tissue from patients to investigate whether targeting tumour stem cells can improve immunotherapy Mr Ian Hermans CEN/12/03/001 A comparison of the bronchodilator effect of budesonide/formoterol combination inhaler when delivered via pressurised metered dose inhaler (pMDI) and dry powder inhaler (DPI) in stable asthma: the Symbicort and Vannair short-term equivalence study. Protocol number BF01 Dr Mitesh Patel 21/02/2012 Full Approved CEN/12/03/002 Multidisciplinary operating room simulation training to improve team performance Associate Professor Jennifer Weller 21/02/2012 Full Approved Simulation Centre for Patient Safety, Tamanaki Campus CEN/12/03/003 Efficacy of cognitive therapies during an active earthquake sequence – a feasibility study Dr Jenny Jordan 15/02/2012 Full Approved University of Otago, Christchurch CEN/12/03/005 Maori mental health recovery: success stories of non-Maori clinical and ex-clients who identify as Maori Mr Inez Skogstad 22/02/2012 Full Approved Hawkes Bay District Health Board CEN/12/04/006 Reducing surgical site infection in Caesarean section: is there a role Dr Jana Morgan for antibacterial sutures? 21/03/2012 Full Approved Dunedin Hospital Maori Liaison Officer; Dunedin Women’s and Children’s Health Department 175 CEN/12/04/007 Psychosocial determinants of glycaemic control in children and adolescents with type 1 diabetes mellitus 21/03/2012 Full Approved Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago Ngai Tahu Maori Research Unit 36 Hospital and University Maori Consultation is underway 303 Approved Wellington Hospital Malaghan Institute of Medical Research Dr Ben Wheeler 14 NZ Lottery Health Elizabeth Cunningham 57 69 Dunedin Hospital CEN/12/04/008 CEN/12/04/009 Uterine cavity length in postpartum women who are exclusively breastfeeding: is atrophy responsible for a higher perforation rate at IUD insertion? Dr Helen Paterson Troponin levels and structural heart disease in asymptomatic patients Dr Alexander Sasse Central Regional Ethics Committee – 2012 Annual Report 21/03/2012 Full Approved Women’s and Children’s Hospital Otago Radiology 21/03/2012 Full Approved Wellington Hospital 111 7 Project key Full title Primary investigator Date received Review type Status at time of report Locality organisations Sponsor / funder CEN/12/04/012 The effect of respiratary muscle endurance training on cardiorespiratory fitness in phase II cardiac rehabilitation patients Dr James Faulkner 21/03/2012 Full Approved Massey University Cardiac Rehabilitation Clinic CEN/12/06/013 An open label study of the safety and tolerability of memantine in paediatric patients with autism, aspergers or pervasive developmental disorder not otherwise specified (PDD-NOS). Protocol number: MEM-MD 91 dated 05 April 2012 Dr Andrew Marshall 21/05/2012 Full Approved Wellington Hospital Quintiles CEN/12/06/014 An open label study of the safety and tolerability of memantine in paediatric patients with autism, aspergers or pervasive developmental disorder not otherwise specified (PDD-NOS). Protocol number: MEM-MD 69 dated 10 April 2012 Dr Andrew Marshall 21/05/2012 Full Approved Wellington Hospital Quintiles CEN/12/06/015 A double blind placebo controlled randomised withdrawal study of Dr Andrew Marshall the safety and efficacy of memantine in paediatric patients with autism, aspergers disorder, or oervasive developmental disorder not otherwise specified (PDD-NOS) previously treated with memantine. Protocol number MEM-MD-68 dated 5 April 2012 21/05/2012 Full Approved Wellington Hospital Quintiles CEN/12/06/016 Evaluation of a single dimension gel electrophoresis with immunofixation, with and without heparin, as an alternative to 2D crossed electrophoresis, as a method for detecting haparin binding site defects in antithrombin deficiency Mr Janko Legner 22/05/2012 Full Approved Capital and Coast District Health Board CEN/12/06/017 Molecular analysis of rheumatic fever autoantibodies using phage display Dr Nicole Jane Moreland 22/05/2012 Full Approved Waikato District Health Board Consultation undertaken Dr Nick Roskruge; Kai Arahi Maori Days to review 41 109 Maori Consultation Group; Wellington 109 116 Research Advisory Group for Maori 150 36 University of Auckland, Auckland CEN/12/06/018 Observational study assessing TSI levels in response to medical therapy, surgery and radioactive iodine in patients with Graves’ disease Dr Marianne Elston 22/05/2012 Full Approved Waikato Hospital CEN/12/06/020 Huarahi rongoa ki a ngai tatou: Maori views on rongoa Maori and primary health Dr Amohia Boulton 22/05/2012 Full Approved Whakauae Research Services, Wanganui CEN/12/06/021 Talking to babies in a neonatal intensive care unit: the impact of verbal soothing on measures of infant stress during heel prick procedures Miss Lucie Zwimpfer 23/05/2012 Full Approved Wellington Hospital ? University of Otago PhD Scholarship 72 Whakauae Research Services 62 Ngai Tahu 75 Hutt Valley DHB Maori Health Unit 136 Hawkes Bay Medical Research Foundation Grant CEN/12/06/023 The role of renin-angiotensin system and other markers in haemangioma Central Regional Ethics Committee – 2012 Annual Report Professor Swee T Tan 22/05/2012 Full Approved Hutt Valley District Health Board 8 Project key Full title Primary investigator Date received Review type Status at time of report Locality organisations CEN/12/06/024 Phase I/II BNC105P combination study in partially platinum sensitive Dr Michelle ovarian cancer patients in first or second relapse. Protocol number Vaughan ANZGOG-1103 22/05/2012 Full Approved Christchurch Hospital CEN/12/06/025 A double-blind, randomised, placebo-controlled, multicentre study to Professor Russell evaluate safety, tolerability and efficacy of AMG 145 on LDL-C in Scott subjects with heterozygous familial hypercholesterolaemia. Protocol 20110117 22/05/2012 Full Approved Lipid and Diabetes Research Group CEN/12/06/026 C3 – cancer, comorbidity and care: cancer care journeys and clinical Associate Professor decision-making – patient and clinician responses to consultation Louise Signal (HRC REF: 11/202) 11/06/2012 Full Approved Wellington Hospital, CCDHB CEN/12/06/027 How do we know what we’re doing works? Evaluating Kapiti youth support Ms Robyn Bailey 11/06/2012 Full Approved Kapiti Youth Support CEN/12/06/028 STRIDER: a randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction (New Zealand and Australia) Dr Katie Groom 12/06/2012 Full Approved Auckland District Health Board Sponsor / funder Amgen Inc Consultation undertaken Days to review Te Komite Whakarite – pending 50 Peter Mason – Pending 118 92 North Shore Hospital, WDHB 32 National Research Centre for Growth and Development 112 National Women’s Health CEN/12/06/029 A multicentre, prospective, double-blind, non-interventional study evaluating the short-term prediction of preeclampsia / eclampsia / HELLP in pregnant women with suspected preeclampsia. Study No. CIM RD000817 Dr Peter Abels 12/06/2012 Full Approved Capital and Coast District Health Board Roche Diagnostics 65 Christchurch Womens Hospital Combined randomised and observational study of surgery for type B Dr Chris Hoffman ankle fracture treatment 12/06/2012 CEN/12/06/032 What resources exist for methamphetamine users and their families to access information about treatments, and what barriers prevent peoples from accessing these resources Dr David Newcombe 11/06/2012 Full Approved Community Alcohol and Drug Services (CADS) 64 CEN/12/06/033 Tricyclic antidepressant used for somnolence properties in patients with radiculopathy Mr Carl Chisholm 13/06/2012 Full Approved Capital Coast DHB 71 The addition of sleep behaviour change in a healthy lifestyles programme for adolescents with whanau (families) Dr Geoff Kira CEN/12/06/030 CEN/12/06/034 Central Regional Ethics Committee – 2012 Annual Report Full Approved Wellington Hospital 119 Waikato Hospital Mana Orthopaedics 13/06/2012 Full Approved Sport Wellington 61 9 Applications reviewed by the expedited pathway Project key Full title Primary investigator Review type Status at time of report Days to review CEN/12/EXP/001 A review of rapid response team activation parameters in New Zealand hospitals Dr Alex Psirides EXP Approved 19 CEN/12/EXP/002 Measuring the experience of racism among medical students and impacts on health and workforce intentions Dr Melissa McLeod EXP Approved 20 CEN/12/EXP/003 General practice and specialist palliative care: an exploration of their relationship in terms of the generalist specialist model of palliative care provision Mr Michael Barry O’Donnell Keane EXP Approved 0 CEN/12/EXP/007 How do patients, enrolled in mainstream primary care, with multiple long-term conditions, self-manage their health Ms Helen Francis EXP Approved 53 CEN/12/EXP/009 Relationships of preoperative fluid management of geriatric patients admitted with hip fracture and perioperative patient outcomes of reported confusion, and postoperative intravenous fluid requirement and length of stay Victoria C Ward EXP Approved 0 CEN/12/EXP/010 Study on hospital communication: the patient’s understanding of their admission and the physician’s perception of what the patient llamaran Kumarasamy knows EXP Approved 0 CEN/12/EXP/011 To analyse outcomes of radial head fractures comparing open reduction internal fixation with radial head replacement Christopher Lowden EXP Approved 10 CEN/12/EXP/012 The values of nurse working in New Zealand medical ward environments Ms Helen Rook EXP Approved 7 CEN/12/EXP/014 Pathways to inflated responsibility beliefs and locus of control in a clinical sample Ms Kirsty Fraser EXP Approved 11 CEN/12/EXP/015 Introduction of the McKenzie classification system for the knee – assessment and treatment of knee derangements: a case series Ingeborg Bahle EXP Approved 25 CEN/12/EXP/016 Work-related back pain: an exploration of nurses’ experiences and responses Pooraj Rumon EXP Approved 20 CEN/12/EXP/017 An analysis of emergency calls in a New Zealand tertiary hospital before and after the introduction of a mandatory medical emergency team (MET) response system Dr Alex Psirides EXP Approved 20 CEN/12/EXP/020 A profile of an older person’s mental health inpatient service in a public hospital setting Ms Vanessa Pullan EXP Approved 13 CEN/12/EXP/021 What influence do nurses think the symptoms of PMS have on women diagnosed with serious mental illness Ms Deanne Batten EXP Approved 13 CEN/12/EXP/023 Sensitivity and specificity of the medial priority dispatch system in detecting cardiac arrest in New Zealand Ms Aimee Fake EXP Approved 21 CEN/12/EXP/024 What are nurses perspectives on the use of personal restraint on an inpatient mental health unit? O’Jan Nuku EXP Approved 16 CEN/12/EXP/025 Evaluating the introduction of hysteroscopic sterilisation within the Hawkes Bay DHB Dr Olivia Smart EXP Approved 17 CEN/12/EXP/026 An observational study evaluating the use of secondary prevention cardiac medications at the time of hospital discharge following CABG operations before and after implementation of a pre printed intensive care unit medication chart Dr Sumeet Reddy EXP Approved 13 CEN/12/EXP/027 Research priorities for Te Omanga Hospice Dr Kay de Vries EXP Approved 10 CEN/12/EXP/028 An observational study evaluating the use of secondary prevention cardiac medications at the time of hospital discharge following CABG operations before and after implementation of a preprinted intensive care unit medication chart Dr Summet Kumar Reddy EXP Approved 20 CEN/12/EXP/029 Exploration of family/whanau/caregivers of people with dementia about their experiences of end of life care Dr Kay de Vries EXP Approved 20 CEN/12/EXP/030 Open label use of tissue plasminogen activator (tPA) and DNase in the treatment of pleural infection Dr Nicola Smith EXP Approved 8 Central Regional Ethics Committee – 2012 Annual Report 10 Project key Full title Primary investigator Review type Status at time of report Days to review CEN/12/EXP/031 Survival from out of hospital cardiac arrest in New Zealand in relation to socioeconomic status and arrest location Ms Aimee Fake EXP Approved 4 CEN/12/EXP/032 An evaluation into the short-term cognitive effects of electroconvulsove therapy, and the development of a screening measure to monitor these cognitive changes Ms Anneke Thornton EXP Approved 7 CEN/12/EXP/033 Investigation into whether there is a measurable difference in advanced echocardiographic assessment of LV myocardial mechanics when the RV pacing lead is placed in the apex or the RV outflow tract Ms Angela Morgan EXP Approved 8 CEN/12/EXP/034 An evaluation of an emotion regulation programme for people with an intellectual disability Ms Jenna McWilliams EXP Approved 4 CEN/12/EXP/035 Ethical climate – an exploratory study Ms Anne Humphries EXP Approved 3 CEN/12/EXP/036 Nutritional management of paediatric oncology patients with acute lymphoblastic leukaemia (ALL) in a shared care centre Dr Varsha Gandhi EXP Approved 19 CEN/12/EXP/039 Validation of the test of masticating and swallowing solids (TOMASS): detecting motor deficits produced by sensory anaesthesia of Dr Maggie-Lee the oral cavity Huckabee EXP Approved 33 Central Regional Ethics Committee – 2012 Annual Report 11