Post approval reviewed The Southern HDEC reviewed a total of 835 post approval items. A graph of the different types reviewed is below. Post approval items reviewed during 2013 Reasons for declining The Southern HDEC is required to clearly identify the ethical standard(s) that it considers not to be met by an application. These ethical standards are contained in the Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (GFUR), Ethical Guidelines for Observational Studies (EGOS) and Ethical Guidelines for Intervention Studies (EGIS). The references in the tables below are to paragraph numbers in these documents. Reference: 13/STH/44 Review Type: Observational Short title: Assessment of Tumour Mitotic Rate in Primary Cutaneous Malignant Melanomas ≤1mm in Thickness Co-ordinating Investigator: Dr Ben Tallon Reference Reason 6.43 EGOS The main ethical discussed by the Committee is the use of stored human tissue for a purpose for which it was not initially submitted, without obtaining informed consent for this particular use. The Committee was concerned that informed consent would not be obtained from the patients, especially as this study may detect new or different information to what was initially reported to the patient. The Committee does not believe that the use of human tissue without consent has been adequately justified for this study and considers this does not align with the ethical guidelines. 6.42 EGOS The consent of participants should generally be obtained for using identified or potentially identifiable data for research. Issues and complaints This section outlines issues faced by the Committee during 2013. Issues causing difficulty in review Online system issues. Lack of appropriate peer review. Provisional responses not being submitted in tracked changes format. Action New online system updates have been drafted, tested and implemented. Peer review template developed and published on HDEC website. Newsletter containing reminder to track changes was published on HDEC website.
Appendix 1: Details of applications reviewed Applications reviewed by full committee Study reference Study status Short title Co-ordinating Investigator Other Investigators Locality/ies Application type 13/STH/10 Approve A study to evaluate Vx135 and GSK2336805 in Chronic HCV patients. Prof Ed Gane Auckland Clinical Studies Ltd,Chris Taylor, CCST Intervention 13/STH/100 Approve NORIBOGAINE THERAPY FOR RELIEF OF OPIOID WITHDRAWAL, PHASE IB (NITROW PIB) Professor Paul Glue Health Research South,Zenith Technology Corporation Limited Intervention 13/STH/107 Approve Media, advertising and other influences on decisions to enter aged care Ms Henderson Intervention 13/STH/11 Approve CPT-SIOP-2009 Tumours of the Choroid Plexus Dr Robin Paul Corbett Auckland District Health Board,CDHB Research Office Intervention 13/STH/122 Approve Behavioral and physiological biomarkers for neurological disorders Dr Masayuki Watanabe Dr Michael MacAskill Observational 13/STH/123 Approve Sialyl Lewis antigen expression in melanoma Dr Michael Jameson Observational 13/STH/124 Approve Reducing FGF23 in CKD Dr. Christopher Hood Dr Samantha Everitt Intervention 13/STH/125 Approve Quetiapine 1 x 200 mg bioequivalence study conducted under fasting conditions and at steady state Dr Noelyn Hung Zenith Technology Corporation Limited,Zenith Technology Corporation Limited Intervention 13/STH/126 Approve Quetiapine 1 x 50 mg bioequivalence study conducted under fasting conditions Dr Noelyn Hung Zenith Technology Corporation Limited,Zenith Technology Corporation Limited Intervention
13/STH/168 Approve Assessment of the investigational coeliac disease drug Nexvax2, when given in multiple doses to men and women with coeliac disease Dr Timothy King Dr Chris Wynne Auckland Clinical Studies Limited,Chris Taylor, CCST Ltd Intervention 13/STH/169 Approve Open-label Study of Sofosbuvir + Ledipasvir in Participants with Chronic HCV who have Advanced Liver Disease or are Transplant Professor Edward Gane Auckland District Health Intervention 13/STH/17 Approve A study comparing efficacy and safety of continuing vs withdrawing Adaliumumab Therapy in subjects with Axial Spondyloarthritis Dr Douglas White Dr Rajiv Gupta CMDHB Research Office,Jan Adams, COO Intervention 13/STH/170 Provisionally approve Prostate Cancer Imaging Study Professor Lamb Intervention 13/STH/171 Approve IDX-04B-001 - Study of single and multiple doses of IDX21437 in healthy people & people with hepatitis C virus Professor Edward Gane Auckland Clinical Studies Limited,Chris Taylor, CCST Intervention 13/STH/174 Provisionally approve Investigation of Inhaled Laninamivir Octanoate in Children with Influenza A or B Dr Chris Wynne Intervention 13/STH/175 Approve A non-interventional translational research follow-up study to the VELOUR clinical trial Dr Mark Jeffery Observational 13/STH/176 Provisionally approve Tyrosine kinase inhibitors and calcium absorption Dr Susannah O'Sullivan Observational 13/STH/177 Approve Investigating recovery from mild traumatic brain injury Dr Gjurgjica Badzakova-Trajkov Auckland District Health Board Observational Trial
13/STH/23 Approve FOXFIREGlobal Prof Michael Findlay Dr Anne O'Donnell,Professor Bridget Robinson,Dr Christopher Jackson,Dr Richard Isaacs ADHB,CCDHB,CDHB Research Office,Dr Kenneth Clark,Health Research South,Marina Dzhelali Intervention 13/STH/24 Approve Opioid Withdrawal Study Professor Paul Glue Health Research South (Ruth Sharpe),Tak Hung,Tak Hung Intervention 13/STH/28 Approve MIB-C Dr. Mary Berry CCDHB Observational 13/STH/29 Approve Levetiracetam neonatal seizure treatment trial Dr Cynthia Sharpe Auckland District Health Board Intervention 13/STH/30 Approve A clinical trial to study the safety and efficacy of in comparison with Lantus in subjects with Type I diabetes Dr Simon Carson CMDHB Research Office,Dr Jinny Willis,G D Richard Stubbs, P3Research Ltd,Southern Clinical Trails - Waitemata Ltd,Waitemata DHB Intervention 13/STH/31 Approve A clinical trial to study the safety and efficacy of in comparison with Lantus in subjects with Type II diabetes Dr Simon Carson CMDHB Research Office,Dr Jinny Willis,G D Clinical Trials,Prof Richard Stubbs, P3 Research Ltd,Southern Clinical Trials - Waitemata,Southern Clinical Trials Ltd Intervention 13/STH/32 Approve ZiPP Study Prof Tim Dr Gilchrist CGM Research Trust Intervention 13/STH/33 Approve Acetazolamide and lihtium induced nephrogenic diabetes insipidus Professor Robert Walker Intervention 13/STH/34 Approve COG ACNS1022 - Phase II Randomised of Lenalidomide in Paediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas Dr Stephen Laughton Auckland District Health Board,CDHB Research Office Intervention
13/STH/37 Approve Assessment of the investigational Hepatitis C VX-135 and Daclatasvir, when taken in different doses by adult patients with Chronic Hepatitis C. Professor Edward Gane Auckland Clinical Studies Limited,Chris Taylor, CCST Intervention 13/STH/38 Approve The PRECICE 8.5mm Mr John McKie CDHB Research Office Intervention 13/STH/39 Approve Telephone support after discharge from hospital Dr Claire Heppenstall Intervention 13/STH/40 Approve Middle Eastern Women's Health Study-Phase II Dr Pamela von Hurst Intervention 13/STH/41 Approve Vitamin D as an adjunct therapy in community acquired pneumonia Prof David Murdoch Dr John Pearson,Dr Malina Storer,Dr Michael Epton,Dr Michael Maze,Dr Michael Hurrell CDHB Research Office Intervention 13/STH/42 Approve PVI in spontaneously ventilating blood donors Dr Sam Grummitt Dr Christian Brett,Dr. Krishna Badami Intervention 13/STH/43 Approve COG AEWS1031 A Phase III Randomised in Ewing Sarcoma Dr Amanda Auckland District Health Board,CDHB Research Office Intervention 13/STH/44 Decline Assessment of Tumour Mitotic Rate in Primary Cutaneous Malignant Melanomas ≤1mm in Thickness Dr Ben Tallon Ben Tallon Observational 13/STH/45 Approve An RCT on efficacy and safety of micronutrients for the treatment of ADHD in children Assoc Prof Julia Rucklidge Intervention 13/STH/52 Approve ICON8 - Weekly Chemotherapy in Ovarian Cancer Dr Kathryn Chrystal Auckland District Health Board Intervention 13/STH/53 Approve 20120138 - Osler 2 Prof Russell Scott Intervention 13/STH/54 Approve GadaCAD1 A/Professor Brett Cowan Associate Professor Alistair Young,Assoc Prof Christopher Occleshaw Alistair Young,Auckland District Health Board Intervention metastatic
13/STH/55 Approve Paracetamol in febrile neutropenia feasibility study Dr Robert Weinkove Dr Richard Hall Institute of Medical Research Intervention 13/STH/56 Approve Genetic studies of malformation disorders Professor Stephen Robertson Observational 13/STH/57 Approve Genetic background of susceptibility to Rheumatic Fever Professor Diana Lennon Dr Nigel Wilson,Dr Pedro Azevedo Auckland District Health Samantha Everitt (CMDHB),Waitemata DHB Observational 13/STH/58 Approve Enroll-HD Dr Richard Roxburgh Auckland District Health Research Office Observational 13/STH/60 Approve Neuromodulation for Uncontrolled Hypertension Dr Mark Webster Dr Seif El-Jack,Dr James Blake,Dr Scott Harding Auckland District Health Board,CCDHB,CDHB Research Office,CMDHB Research Office,Waitemata District Health Board Intervention 13/STH/62 Approve Determining if early ankle exercises are beneficial after ankle fracture surgery. Dr Alex Jae-Jin Lee Intervention 13/STH/67 Approve A clinical trial to study the safety and efficacy of linaclotide in participants with Irritable Bowel Syndrome with Constipation (IBS-C) Assoc. Prof Michael Schultz CDHB,Dr Ian Wallace,Health Research South,Prof Richard Stubbs, P3 Research Ltd Intervention 13/STH/68 Approve 3, A Randomized, Double-Blind, Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain Dr Dean Quinn Julia Mathieson, Southern Clinical Trials Ltd,Prof Richard Stubbs, P3 Research,Prof Richard Stubbs, P3 Research,Rachel Harris Director Southern Clinical Trials Waitemata Intervention 13/STH/69 Approve MDV3100-14: PROSPER - Enzalutamide in CRPC Associate Professor Gilling Mr Michael Alan Holmes,Dr Nikolay Nedev,Dr Chee Choong Peter Fong,Dr Stephen Williams Auckland District Health Board,cdhb,Dr Kenneth Clark,Michael Holmes Urology Services ltd,MidCentral Health,Tauranga Urology Research Limited Intervention Trial
13/STH/7 Approve Use of GreenGeneF in Severe Haemophilia A Subjects. Dr Mark CDHB Research Office Intervention 13/STH/70 Approve Assessment of Tumour Mitotic Rate in Primary Cutaneous Malignant Melanomas ≤1mm in Thickness Dr Ben Tallon Ben Tallon Observational 13/STH/71 Approve Capsular Repair Arthroscopic Surgery of the Hip Doctor Matthew Intervention 13/STH/78 Approve TRIO 022 Professor Bridget Robinson CDHB Intervention 13/STH/8 Approve Trans-Tasman Eye Anomalies Study (TEA Study) Mr Justin Mora Dr Andrea Vincent,Mr Shaheen Shah Observational 13/STH/84 Approve Optimising PEEP in mechanically ventilated patients Associate Professor Geoffrey Shaw CDHB Intervention 13/STH/87 Approve SB 9200 - Phase 1a/1b MAD Study SB 9200 in Treatment Naïve HCV Prof Murray Barclay Primorus Intervention 13/STH/89 Approve Homicide, mental illness and parole Dr Jeremy Skipworth Observational 13/STH/9 Approve An Open Label Study of Sofosbuvir in Patients with Chronic HCV Prof Ed Gane Auckland Clinical Studies Ltd,Chris Taylor, CCST Intervention 13/STH/90 Approve DEXA Analysis of Delta TT acetabular cups and HMAX stem. Mr William Farrington Waitemata DHB Intervention 13/STH/91 Approve Investigating Idelalisib with Bendamustine and Rituximab in previously treated Chronic Lymphocytic Leukemia Dr David Simpson CCDHB,Waitemata DHB Intervention
13/STH/92 Approve A Randomized, Open-Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® With DOXIL®/CAELYX® Monotherapy for the Treatment of Epithelial Ovarian, Primary Peritoneal Dr Anne O'Donnell Intervention 13/STH/93 Approve Long-term impact of brain injury Professor Valery Feigin Jan Adams, COO Observational 13/STH/94 Approve Cervical and Breast Screening for Women with Intellectual Disability Dr Brigit Mirfin-Veitch Cindy Johns,Sharon Brandford,Spectrum Care Trust Board Observational 13/STH/95 Approve Suicide in Older New Zealanders Dr Gary Cheung Dept of Psychological Medicine, FMHS, UOA Observational 13/STH/97 Approve Evaluation of the IASD System II Professor Robert Doughty Dr Timothy Watson Auckland District Health Board Intervention Applications reviewed by expedited review Study reference Study status Short title Co-ordinating Investigator Investigators Locality/ies Application type 13/STH/103 Approve Movement computer gaming and standing balance. Dr Kimberlee Jordan Intervention 13/STH/105 Approve Immunity & Fertility Dr Anitra Carr Primorus Clinical Trials Ltd,University of Otago,Christchurch Research & Enterprise Intervention 13/STH/106 Approve Deaths from asthma in children and young people between 2002 - 2011 Professor Edwin Mitchell Dr Lynne Hutchison Observational Relapsed
13/STH/112 Approve Genital HPV Infection: Prevalence in Early Pregnancy Dr Celia Devenish Dr Rachael McConnell Observational 13/STH/119 Approve Prevalence of HIV, and Hepatitis B and C among New Zealand needle exchange attendees Dr Geoff Noller Observational 13/STH/12 Approve Exercise for primary dysmenorrhea Ms Priya Kannan Dr Cathy Chapple,Dr Dawn Miller,Dr Leica Claydon Health Research for University of Otago Dept Physiotherapy Intervention 13/STH/121 Approve The relationship between oral bacteria, cough reflex sensitivity, and pneumonia. Ms Sarah Davies cdhb Observational 13/STH/13 Approve Insulin signal peptide, a novel measure of pancreatic insulin A/Prof Richard Troughton CDHB Research Office Observational 13/STH/132 Approve Innate Factors in the Early Clearance of Tuberculosis Dr Ayesha Verrall Dr Lisa Houghton,Dr Bachti Alisjahbana,Prof Philip Hill,A/Prof Reinout van Crevel,A/Prof Katrina Sharples Observational 13/STH/133 Approve CNP secretion and the ovary Dr Thomas Upton Observational 13/STH/134 Approve Developing a dementia-friendly Christchurch: Perspectives of people with dementia Dr Matthew Croucher Ms Karen Smith,Dr Susan Gee Observational 13/STH/135 Approve Hallucinations, Delusions, and Dissociation in with psychiatric illnesses. Prof Martin Dorahy Miss Rachael Palmer Observational 13/STH/139 Provisionally approve NZ Care NMD Survey Ms Miriam Rodrigues Observational 13/STH/141 Invalid Application Fentanyl levels and pain in PACU Assoc Prof Dr R Ross Kennedy Intervention 13/STH/145 Approve Chromosomal microarray at Tauranga Hospital Doctor Pion Das Observational 13/STH/146 Invalid Application IMACS Dr Peter Ruygrok Observational
13/STH/147 Approve The Impact of Alcohol on the Emergency Department at Christchurch Public Hospital and the Source of Alcohol consumed Dr Michael Ardagh cdhb Observational 13/STH/148 Approve Capillary-venous glucose gradient in type 1 diabetes Dr Helen Lunt Mrs Helen Heenan,Dr Huan Chan cdhb Intervention 13/STH/150 Approve Fentanyl levels and pain in PACU Assoc Prof Dr R Ross Kennedy Ms Marshall,Dr Tim Chapman Intervention 13/STH/151 Approve Recovery from Obesity in Primary Healthcare Professor Doug Sellman Dr Clive Hunter,Dr Margaret Metherell,Helen Johnson,University of Otago Intervention 13/STH/153 Approve Impact of Interventions Utilised in Miscarriage Management Mrs Amy Hensley Health Research Observational 13/STH/154 Approve Breathing control training in Psychogenic Seizures Associate Professor Roderick Duncan cdhb Intervention 13/STH/155 Approve The molecular basis of Crohn's disease Prof Michael Schultz Health Research South Observational 13/STH/157 Approve The Needs of Children's Questionnaire. Ms Mandie Jane Foster cdhb Observational 13/STH/160 Approve Is increased oral hydration during preparation associated with improved clarity and quality of bowel cleansing? Registered Nurse Yuriko Wilkins Auckland District Health Observational 13/STH/162 Invalid Application Breath Exposure and Response II Dr Malina Storer Intervention 13/STH/172 Approve Global SYMPLICITY Registry Dr Seif El-Jack Observational 13/STH/173 Approve Breath Exposure and Response II Dr Malina Storer CDHB Intervention 13/STH/182 Approve Stemming the tide of pancreatogenic diabetes Dr. Max Petrov Intervention 13/STH/186 Approve Sensing City Health Informatics Dr Michael Epton cdhb Observational 13/STH/190 Approve Medical Decision Tools in Abdominal Aortic Aneurysm Treatment Dr Khashram Observational 13/STH/192 Approve St John NZ OHCA Registry: Anonymised data sharing with Aus-ROC Dr Bridget Dicker Dr Tony Smith Observational
13/STH/196 Provisionally approve RCT to evaluate effectiveness of Replicine Functional Keratin products for skin tears Dr Clive Marsh Intervention 13/STH/199 Invalid Application Lutonix Extremity (LEG)Registry Dr Martin Krauss Dr Martin Krauss Observational 13/STH/203 Provisionally approve More than the baby blues? Dr Sara Filoche Observational 13/STH/206 Approve Exercise intervention for primary dysmenorrhea Ms Priya Kannan Dr Cathy Chapple,Dr Dawn Miller,Dr Leica Claydon,Professor David Baxter Intervention 13/STH/207 Invalid Application VTE Prophylaxis Study Dr Beau Klaibert Observational 13/STH/25 Approve Pulmonary embolism elective hip and knee arthrosplasty Dr Richard Seigne Observational 13/STH/26 Approve Ovarian cancer and contraception Professor Ann Richardson Professor John Potter,Dr Mary Jane Sneyd,Mrs Pat Coope Professor Philip SCHLUTER Observational 13/STH/27 Approve Cardiovascular Outcomes in a Clinic Outpatient Cohort Professor Peter George CDHB Observational 13/STH/3 Approve Efficacy of current antibiotic prophylaxis against Propionibacterium acnes in shoulder surgery. Dr John English Intervention 13/STH/35 Approve Postoperative pain relief following wisdom teeth surgery. Mr. Adrian Best Health Research South Intervention 13/STH/36 Approve Spinal Cord Injury and Physical Activity in the Community (SCIPA Com) Ms Joanne Nunnerley Professor Allison,Professor Mary Galea,Professor Sarah Dunlop Intervention 13/STH/49 Approve Monitoring of hearing during ear surgery Mr Philip Bird Dr Greg O'Beirne,Miss Melissa Babbage,Miss Sarah Rahmat Intervention 13/STH/50 Approve Swallowing Impedance Biofeedback Mr Chris Chester Intervention 13/STH/51 Approve Breath Exposure and Response I Dr Michael CDHB Research Office Intervention
AKL/2000/270 Approve ANBL00B1 Neuroblastoma biology studies and banking of samples Dr Rob Corbett Auckland District Health Intervention AKL/2000/270 Invalid Application ANBL00B1 Neuroblastoma biology studies and banking of samples Prof Ian Morison Intervention AKX/03/09/247 Approve Precise 4 Assoc. Prof Richard Gearry Intervention CDP870-28 Invalid Application RAPID study Dr Daniel Intervention CEN/11/09/047 Approve The effects of the "Circle Of Security Parenting" parent education group intervention on a New Zealand community sample Dr Nicola Atwool Intervention CEN/11/11/063 Approve Long-Term GA27927/Spruce of rhuMAb BETA7 in Patients with Moderate to Severe Ulcerative Colitis Assoc. Prof Richard Gearry Intervention CEN/12/03/003 Approve Comparing cognitive therapies for stress disorder Dr Jennifer Jordan Intervention CEN/12/4/008 Invalid Application Ultrasound assessment of uterine cavity length in women who are breastfeeding vs. women who are not breastfeeding Dr Paterson Intervention CTB/04/11/234 Approve Collection of DNA Professor David Fergusson Intervention CTR/03/07/122 Approve LCH III Treatment Protocol of the Third International Study for Langerhan's Cell Histiocytosis. Dr Amanda Lyver Auckland District Health Board Intervention CTR/03/11/199 Approve Gene Expression and Genotype in Heart Failure Research Professor Vicky Cameron Intervention CTR/04/06/095 Approve Markers of early RA Associate Professor Lisa Stamp Intervention CTY/01/09/124 Approve TROG Melanoma Dr Steve Williams Intervention CTY/01/10/141 Approve Molecular Analysis of Solid Tumours in Childhood by Genetic Profiling Prof Ian Morison Intervention CTY/01/10/142 Approve Molecular Analysis of Neuroblastoma in Childhood by Genetic Profiling Prof Ian Morison Intervention
LRS/11/09/041 Approve Does Cabergoline Prevent Weight Regain in People with Obesity? Associate Professor Patrick Manning Health Research South (Ruth Sharp) Intervention LRS/11/09031 Invalid Application 16th International Histocompatibility Workshop: "One HLA antibody test predicts future survival" Dr Paul Dunn Intervention LRS/11/12/052 Invalid Application A comparison of how the body absorbs and processes two different formulations of capecitabine Dr Chris Wynne Intervention LRS/11/12/052 Approve A comparison of how the body absorbs and processes Dr Chris Wynne Intervention LRS/11/12/054 Approve The effectiveness of acupressure in decreasing pain and anxiety in injured athletes. Dr Anthony Schneiders Intervention LRS/11/EXP/038 Approve Right ventricular pulsus alternans Dr Sean Coffey Intervention LRS/12/01/005 Approve Studying individual variation in lipoprotein(a) Professor Sally McCormick Intervention LRS/12/05/012 Approve denervation in dialysis patients Professor Robert Walker Intervention LRS/12/EXP/001 Approve Rheumatoid Arthritis, Men and Exercise: A Qualitative Study Mr Warren Scott Intervention LRS/12/EXP/003 Approve Emotional reactions to hand, and arm injuries Ms. Elizabeth Mayland Intervention LRS/12/EXP/007 Approve The perceived benefit of the "Coping with Forgetfulness Dr Isabelle Moebs Intervention LRS-11-07-026 Invalid Application RV3-BB Oral Rotavirus Vaccine Dr Pam Jackson Intervention MEC/05/06/067 Approve The BOOST-NZ Study Professor Brian Darlow Intervention MEC/05/06/074 Approve study, CDP870-028. Dr Daniel Ching Intervention MEC/05/08/101 Approve New Zealand Drivers Study Dr Dorothy Begg Intervention MEC/05/09/108 Approve The PPROMT Dr Rosemary Reid Intervention MEC/05/10/130 Approve Genetics of gout in New Zealand Dr Tony Merriman Auckland District Health Board Intervention
MEC/09/06/063 Approve Cephalon Bright Study Dr Peter Ganly Intervention MEC/09/07/068 Approve Epigenetics and genetics of myelodysplasia. Professor Ian Morison Intervention MEC/09/07/074 Approve randomised double double dummy carbidopa levodopa intestinal gel S 187.3.002 Prof Tim Anderson Intervention MEC/09/07/075 Invalid Application Open Label, 12 Months safety and efficacy study of levodopa-intestinal gel in levodopa-responsive Parkinson's disease subjects, protocol # S 187.3.003 Prof Tim Anderson Intervention MEC/09/08/084 Approve Investigation of genetic susceptibility alleles in Ankylosing spondylitis and the prevalence and severity of clinical features Dr Simon Stebbings Auckland District Health Board Intervention MEC/09/08/094 Approve Structure of glaucoma surgery blebs Professor Anthony Molteno Intervention MEC/09/09/098 Approve The New Zealand Institute for Rare Disease Research Human Tissue Bank Professor Michael Eccles Intervention MEC/09/10/117 Approve Self-care in New Zealand: Patient and nurse perspectives Mrs Mandy Wilkinson Intervention MEC/09/65/EXP Approve Effects of cancer control activities Assoc. Prof. Brian Cox Intervention MEC/10/03/026 Invalid Application Assessment of the investigational drug AMG 139, Dr Wynne Intervention MEC/10/064/EXP Approve Life, Health and Activities Survey Assoc. Prof. Brian Cox Intervention MEC/10/073/EXP Approve AS Database Dr Macintyre Intervention MEC/10/08/084 Approve Dialysis outcomes in those aged >65 years Professor Robert Walker Intervention MEC/10/09/086 Approve Developing biomarkers for a predictive test of Alzheimer's disease Prof Robert Knight Intervention MEC/10/09/090A Approve Apremilast Palace 1 study. Dr Daniel Ching Intervention MEC/10/09/090B Approve Apremilast Palace 4 study. Dr Daniel Ching Intervention MEC/10/102/EXP Approve Audit of the use of antipsychotics in dementia units in New Zealand Dr June Tordoff Intervention
MEC/12/EXP/029 Approve The use of regression and Bayesian spatial and temporal mapping techniques to overcome data gaps in the reporting of enteric notifiable disease. Dr Rob Lake Intervention MEC/12/EXP/041 Approve Attitudes, and beliefs of health professionals in general practice regarding obesity and their impact on obese New Zealand men. Mrs Fiona Intervention Approve Zometa for Androgen-Sensitive Advanced Prostate Cancer Mr Peter Davidson Intervention Invalid Application Zometa for Androgen-Sensitive Advanced Prostate Cancer Mr Peter Davidson Intervention MEC12/04/042 Invalid Application Decision making about upper limb reconstructive surgery Dr Jennifer Dunn Intervention MED/05/03/026 Invalid Application The Maori Community Heart Study Dr Suzanne Pitama Intervention Nil Invalid Application Christchurch Breast Cancer Patient Register Dr Gavin Harris Intervention Nil Invalid Application Christchurch Breast Cancer Patient Register Dr Gavin Harris Intervention NTX/11/02/005 Approve Ultrasound in nerve injury Dr Jillian Lee Auckland District Health Intervention NTX/11/08/072 Approve Microsleeps and Cerebral Blood Flow in People with Obstructive Sleep Apnoea (OSA) Dr Carrie Innes Intervention NTY/10/12/102 Approve Metric Dr Bernie Fitzharris Intervention NTY/10/12/106 Approve How does Pseudomonas survive in cystic fibrosis? Professor Iain Lamont Intervention NTY/11/02/023 Invalid Application R668-AD-1026 Dr Anna Millar-Coote Intervention NTY/11/02/023 Approve R668-AD-1026 Dr Dean Millar-Coote Intervention NTY/12/04/026 Approve Pregnancy and iodised salt in bread Dr Sheila Skeaff Intervention NTY/12/05/038 Approve ARTEMIS-1: Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1 Prof Tim Anderson Intervention
OTA/95/10/113 Approve Rare Disease Surveillance A/Prof Nigel Dickson Observational OTA/99/02/008 Approve Development of multiple source all cause injury databases Ms Gabrielle Davie Intervention URA/05/10/130 Approve CALYPSO Dr Bernie Fitzharris Intervention URA/06/12/083 Approve Biomarkers in Healthy Donors Dr Anthony J Kettle Intervention URA/07/06/048 Approve An observational of the diagnostic utility of three biomarker processes in the assessment of patients presenting to Christchurch Hospital with chest pain of possible cardiac origin Dr MARTIN THAN Intervention URA/07/06/048 Invalid Application An observational study of the diagnostic utility of three biomarker processes in the assessment of patients presenting to Christchurch Hospital with chest pain of possible cardiac origin Dr MARTIN THAN Intervention URA/07/10/075 Invalid Application Christchurch Breast Cancer Patient Register Dr Gavin Harris Intervention URA/07/10/075 Approve Christchurch Breast Cancer Patient Register Professor Bridget Robinson Intervention URA/08/05/034 Approve Markers of early RA Associate Professor Lisa Intervention URA/08/05/036 Approve Assessment of a skin fluorescent test for diagnosing diabetes Dr Brett Shand Intervention URA/08/09/EXP Approve EUSTAR Associate Professor Lisa Stamp Intervention
URA/12/03/008 Approve The AAA(Adjunctive Allopurinal and Azathioprine) Study Prof Murray Barclay Intervention URA/12/05/015 Approve Factors affecting recovery after mild traumatic brain injury. Dr Debbie Snell Intervention URA/12/EXP/015 Approve Smoking in pregnancy demonstration project Mrs Gail Prileszky Intervention URA/12/EXP/021 Approve Pertussis vaccine safety during pregnancy Dr Tony Walls Intervention URB/05/03/026 Approve Pilot high dose allop in gout Associate Professor Lisa Intervention URB/05/07/079 Approve Methotrexate polyglutamate concentrations in rheumatoid arthritis. Associate Professor Lisa Stamp Intervention URB/06/02/013 Approve WT 2001 02 Relapsed Wilm's Tumour Study. Dr Rob Corbett Intervention URB/06/03/017 Approve Novel markers in inflammatory arthritis Associate Professor Lisa Stamp Intervention URB/06/12/093 Approve Signal Peptide in Acute Coronary Events “SP-ACE” Professor Mark Richards Intervention URB/07/03/011 Approve Biomarkers in ACute Heart Failure (BACH) Professor Mark Richards Intervention URB/07/29/EXP Approve Utilising the EQ5D self-report questionnaire in priority setting and health service planning Dr Tammy Pegg Intervention URB/09/03/011 Approve Early Start Field Trial Professor Fergusson Intervention URB/09/03/012 Approve The COMET study: two cognitive psychotherapies for depression Dr Jennifer Jordan Intervention URB/09/08/037 Approve Progressive Changes of Potential Indicators in Parkinson's Disease Prof Tim Anderson Intervention URB/09/24/EXP Approve Osiris - Expanded use of Prochymal Infusion for GVHD Assoc Prof Michael J Sullivan Intervention URB/10/06/019 Approve Assessing the validity of a previous study using nebulisers that produce different flow rates Mrs Sara Moore Intervention URB/10/06/019 Approve Association of cough reflex testing with aspiration Mrs Sara Moore Intervention URB/10/06/021 Approve Epidemiology of WG Associate Professor Lisa Stamp Intervention
URB/10/11/043 Approve Evaluation of breath test for tuberculosis Professor Stephen Chambers Intervention URB/10/12/055 Approve The HOME Study A/Prof Richard Troughton Intervention URB/10/12/059 Approve Accomplishing nursing in the acute care hospital setting Ms Sarah Lake Intervention URB/10/EXP/063 Approve Men's Help Informal Seeking Mr Meisner Intervention URB/11/02/005 Approve VTE in patients having chemotherapy Dr Anthony Rahman Intervention URB/11/09/031 Approve Christchurch Health and Development Study Professor Fergusson Intervention URB/11/11/039 Approve Prospective Oesophageal Stent Study Dr Gary Lim Intervention URB/11/11/045 Approve Bacterial killing by white blood cells from individuals with cystic fibrosis Dr Anthony J Kettle Intervention URB/11/12/054 Approve A study assessing the similarity of Humira® and a new rheumatoid arthritis drug, BI 695501. Dr Chris Wynne Intervention URB/11/EXP/042 Approve Therapeutic Position Preference in Pregnancy Ms Jane Ashby Intervention URB/12/02/004 Approve What are the influences on employment/normal daily activities in individuals with moderate or severe injuries as a result of the Christchurch (February 22nd) earthquake? Ms Joanne Nunnerley Intervention URB/12/02/009 Approve Improving dabigatran dosing by kidney blood markers and P-glycoprotein genetics Dr Paul Chin Intervention URB/12/05/015 Approve NZ very preterm young adults study Professor Brian Darlow Intervention URB/12/05/016 Approve 21 year review of upper limb surgery for tetraplegia Dr Jennifer Dunn Intervention WGT/03/06/062 Approve Atopy and Asthma at age 6 amongst the infant cohort study Associate Professor Philip Pattemore Intervention WGT/96/07/082 Invalid Application Hair nicotine and wheeze Associate Professor Philip Pattemore Intervention