Post approval reviewed The Northern B HDEC reviewed a of 586 post approval items. A graph of the different types reviewed is below. Post approval items reviewed during 2013 Reasons for declining The Northern B 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/NTB/10 Review Type: Intervention title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection Co-ordinating Investigator: Professor Murray Barclay Reference Reason 3.11 EGIS It was not clear to the Committee that the risks of the research were proportional to the benefits of the research. The researcher needs to be more explicit about the possible benefits of this study and how the risks might be mitigated. 5.30 EGIS Intervention studies should not be performed with vulnerable groups if they can be adequately performed with groups. 6.66 EGIS The investigators have an obligation to ensure the availability of health care services that are essential to the safe conduct of a study, for participants, study team and for the wider population. Reference: 13/NTB/128 Review Type: Intervention Short title: Metacognitive Therapy for Anorexia Nervosa: An open in the South Island Eating Disorder Service Co-ordinating Investigator: Associate Professor Janet Carter Reference Reason 5.4 EGIS The committee is unclear about the study design and therefore is unable to judge whether the protocol and information provided best answers the study question. It is not clear that the study minimises risk. 6.56 EGIS An independent Data Monitoring Committee should also be considered in early phase studies, whether or not randomised, of a high-risk intervention; for example: where vulnerable populations, such as children or people with mental illness, are studied 4.22 EGIS The potential conflict of interest between participant and researcher is not adequately covered, as well as any justification for recruiting during the first visit to the rehabilitation center. trial
Appendix 1: Details of applications reviewed Applications reviewed by full committee Study reference Study status title Co-ordinating Investigator Other Investigators Locality/ies Application type 12/NTB/2 Approve of a brief treatment for common mental health syndromes in primary care Ms Fiona Mathieson Intervention 13/NTB/10 Decline A 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults Prof Murray Barclay Primorus Intervention 13/NTB/102 Approve life determinants of long term outcomes in cystic fibrosis (CF FAB) Professor Claire Wainwright Observational 13/NTB/103 Approve Engaging in stroke rehabilitation Ms Felicity Bright Dr Nicola Kayes,Professor Kathryn McPherson Dr Samantha Everitt Observational 13/NTB/104 Approve Outcome from general anaesthesia in infants with cystic fibrosis ( CF GAIN) Professor Claire Wainwright Observational 13/NTB/105 Approve SONAR Dr Helen Linda Pilmore Dr Kannaiyan Rabindranath Auckland District Health Board,Frances McNulty,Health Research South Intervention 13/NTB/107 Approve COMBAT CF: Can azithromycin prevent bronchiectasis in infants with CF Dr Catherine Byrnes Intervention 13/NTB/11 Approve Nutritional therapy and gut inflammation in Crohn's disease Mrs Catherine Wall Professor Andrew Prof. Richard Gearry CDHB Research Office Intervention Trial
13/NTB/116 Approve Redesigning Daily Occupations Dr Kirk Reed Kate O'Connor Intervention 13/NTB/120 Approve 3D Imaging of Neonatal And Paediatric Subjects Dr Michael Meyer Dr Samantha Everitt (CMDHB) Observational 13/NTB/123 Approve 178-CL-101.To find out in patients with overactive bladder (OAB) if combinations of two drugs (Solifenacin Succinate and Mirabegron) are safe, well tolerated and have efficacy, compared to placebo and Mr Stephen Mark Canterbury Urology Research Points Research Ltd,John Tuckey,michael holmes,Patrick James Meffan,Tauranga Urology Research Ltd Intervention 13/NTB/124 Approve Type 2 diabetes in dialysis patients Dr Jasmine Tan Clinical A/Prof John Collins,Professor Tim Cundy Auckland District Health Board Observational 13/NTB/125 Approve MDMA and tinnitus Dr Grant Searchfield Intervention 13/NTB/126 Approve OPTIMIST A Prof Peter Dargaville Dr Mariam Buksh Intervention 13/NTB/128 Decline Metacognitive Therapy for Anorexia Nervosa Associate Professor Janet Carter Intervention 13/NTB/129 Approve An investigation into the tolerability of Manuka CyclopowerTM chewable tablets Dr Chepulis Intervention 13/NTB/130 Approve Evaluation of TAF vs TDF in patients with HBeAg positive Chronic HBV Prof Edward Gane Auckland Clinical Studies Limited,Christopher Moyes Intervention 13/NTB/131 Approve Evaluation of TAF vs TDF in patients with negative Chronic HBV Prof Edward Gane Auckland Clinical Studies Limited,Christopher David Moyes Intervention 13/NTB/143 Approve Effectiveness and Safety of FG-4592 for the treatment of anaemia in people with CKD not on dialysis Dr David M. Voss Dr Kannaiyan Rabindranath Dr Samantha Everitt (CMDHB),Jan Adams, COO Intervention 13/NTB/144 Provisionally approve Aspiration therapy for treating obesity Dr Dinesh Lal Intervention Trial
13/NTB/145 Decline The Dynamic Patterns of Thinking in Attention-Deficit/Hyperactive Disorder (ADHD) Dr Fabian Intervention 13/NTB/146 Approve (ANZ 1201 / BIG 6-11) NeoPHOEBE: Pi3k inhibition in Her2 OverExpressing Breast CancEr Dr Marion Intervention 13/NTB/147 Provisionally approve Zoledronic acid in DMD Dr Craig Jefferies Intervention 13/NTB/148 Approve A study to Evaluate the Safety, Tolerability, and Activity of NGM282 in patients with Type 2 Diabetes. Dr Ajith Dissanayake Dr Dean Quinn,Dr Edward Watson,Dr Paul Noonan,Prof Russell Scott Dr Jinny Willis,Dr Samantha Everitt (CMDHB),Prof Richard Stubbs, P3 Research Ltd,Prof Richard Stubbs. P3 Research Ltd,South Pacific Clinical Trials Ltd Intervention 13/NTB/151 Approve Chart review of renal biopsies in type 2 diabetic patients Dr Jasmine Tan Clinical A/Prof John Collins,Dr Jonathan Zwi Auckland District Health Board,Dr Samantha Everitt (CMDHB),Waitemata DHB Observational 13/NTB/155 Approve Abnormal Scaring and Fibrotic Conditions Professor Swee T Tan Hutt Valley DHB Observational 13/NTB/156 Approve OPEN-LABEL DUPILUMAB IN PARTICIPANTS OF PREVIOUS DUPILUMAB CLINICAL TRIALS. Dr. Gordon Dean Miller G D Intervention 13/NTB/159 Decline Novaco Anger Management Study Miss Ashleigh Clarke Intervention 13/NTB/163 Approve Positive Psychology for Suicidal Behaviour (PPSB) Mr Kosta Tabakakis Intervention 13/NTB/165 Approve EGFR Testing in New Zealand A/Prof Mark McKeage Auckland District Health Board Observational
13/NTB/168 Approve Effects of low dose everolimus and/or BEZ235 on vaccine response in the elderly Dr Dean Richard Quinn Barney Montgomery,Clinical Trials at Riccarton Clinic ltd,Dr Dean Quinn P3 Research Wellington Unit,Dr Jinny Willis,Dr Phillipa Murray ,Dr Samantha Everitt (CMDHB),Dr Simon Carson,G D Carr,Prof Richard Stubbs, P3 Research Tauranga,South Pacific Clinical Trials Limited,Southern Clinical Trails - Waitemata Ltd Intervention 13/NTB/170 Provisionally approve MK 431A 289 A of the Safety and Efficacy of MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus Inadequate Glycemic Control on Metformin Dr Craig Jefferies Cutfield Intervention 13/NTB/172 Approve Aged Residential Care Healthcare Implementation Project (ARCHIP) Professor Martin Connolly Intervention 13/NTB/173 Approve NETwork! Genomics retrospective project Dr Benjamin Lawrence Observational 13/NTB/175 Approve Dosing of busulfan and methotrexate Dr Lochie Teague Auckland District Health Board Intervention 13/NTB/180 Approve Predictive value of airway response to aspiration Dr Anna Miles Observational 13/NTB/181 Approve Prenatal Environment and Neurodevelopment (PEN) Pilot Study Dr Suzanne Stevens Auckland District Health Board, Westwives midwifery centre Observational 13/NTB/183 Approve Population reference ranges for periostin Professor Richard Beasley Medical Research Institute of New Zealand Observational 13/NTB/184 Approve Periostin sampling time variation study Dr Richard Beasley Medical Research Institute of New Zealand Observational 13/NTB/185 Approve Longitudinal study of serum periostin levels in asthma Dr Richard Beasley Observational Trial
13/NTB/186 Approve Serum periostin level in patients with bone fractures Dr Richard Beasley Observational 13/NTB/187 Approve Serum periostin levels in participants undergoing dental extractions Dr Richard Beasley Observational 13/NTB/19 Approve A Study to Test if Ibrutinib is Safe and Works Well in Patient’s with Certain Types of Leukaemia Dr W. Patton ADHB,CDHB Research Office Intervention 13/NTB/190 Approve Periostin levels in those of Chinese descent Dr Richard Beasley Medical Research Institute of New Zealand Observational 13/NTB/191 Approve Change in serum periostin level in severe exacerbation of asthma Professor Richard Beasley Observational 13/NTB/192 Approve NeuroVISION Dr Douglas Campbell Auckland District Health Board Observational 13/NTB/193 Approve A validation Dr. CC Grant Ms Rajneeta Saraf Observational 13/NTB/194 Approve A long term, follow-up clinical trial studying the effects of GLPG0634 given to participants with Rheumatoid Arthritis Dr Daniel Ching Timaru Rheumatology Studies Intervention 13/NTB/20 Approve FENICE Mrs Rachael Parke Dr Bruce KING,Ms Jennifer Goodson Auckland District Health Board,Bay of Plenty DHB,CDHB Research Office Observational 13/NTB/23 Approve Walking up and down in children with CP Miss Meghan Edmonston Dr Mark Boocock,Dr Denise Taylor,Dr stott,Ms Nada Signal,Professor Peter McNair Auckland District Health Board Observational 13/NTB/24 Approve MK-3475 vs Ipilimumab for advanced Melanoma Dr Bernie Fitzharris CCDHB,CDHB Intervention
13/NTB/52 Approve Frequency of eating disorders in teenagers with type 1 diabetes Dr Stephanie Cox Dr Juliet Berkeley CDHB Research Office Observational 13/NTB/54 Approve CAAN-AF Dr Martin Stiles Adams, COO Intervention 13/NTB/55 Approve A clinical trial studying the effects of GLPG0634 and methotrexate given to participants with Rheumatoid Arthritis Dr Daniel Ching Dr alan doube,Dr Joe Singh Jan Adams, COO,Timaru Rheumatology Studies,Waitemata DHB Intervention 13/NTB/56 Approve ADMINISTRATOR DO NOT USE - A clinical trial studying the effects of GLPG0634 given to participants with Rheumatoid Arthritis. Dr Daniel Ching Timaru Rheumatology Studies Intervention 13/NTB/6 Approve MELVAC Dose Escalation Dr Catherine Barrow CCDHB,Malaghan Institute of Medical Research Intervention 13/NTB/62 Approve PT003006 A 24 week Efficacy and Safety study of inhaled glycopyrrolate and formoterol fumarate compared to Placebo MDI in individuals with moderate to very severe COPD. Dr Dean Richard Quinn Veale,CMDHB Research Office,Jan Adams, COO,Prof Richard Stubbs, P3 Research,RMC Medical Research Ltd Intervention 13/NTB/64 Approve SUDDICU inception cohort study Dr paul Observational 13/NTB/65 Approve A randomized, double blind, placebo controlled, dose ranging study to evaluate dupilumab in patients with moderate to severe, uncontrolled asthma. Dr Richard Beasley Associate Professor Jim Reid Cate Tyrer, Manager, Quality & Risk ,Medical Research Institute of New Zealand,RMC Medical Research Intervention 13/NTB/66 Approve AAA study Dr David Squirrell Intervention 13/NTB/67 Approve The effect of statins on circulating concentrations of NTproCNP A/Prof Richard Troughton CDHB Research Office Intervention
13/NTB/68 Approve A to collect blood biomarker samples from patients with Chronic Hepatitis B who received treatment with Pegasys (Peginterferon Alpha-2a) ±Nucleo(s)tide Analogue Prof Edward Gane Auckland District Health Board Intervention 13/NTB/69 Approve Can Acids in Combination with Exercise Training Improve Glycaemic Control and Cardiovascular Health in Type-2 Diabetics? Mr Kim Gaffney CCDHB,Sally Lark, Massey University Intervention 13/NTB/7 Approve A Clinical to test different doses of a new medication IPI145 given with Methotrexate to treat Rheumatoid Arthritis Dr Kumar Research Office Intervention 13/NTB/71 Approve A to Evaluate Cardiovascular Outcomes in Patients with Type 2 Diabetes Treated with ITCA 650 Dr John Baker Dr Edmond Walford,Dr Gordon Dean Jocelyne Benatar,Prof Russell Scott Auckland District Health Board,CMDHB Research Office,G D Millar-Coote,Lipid & Diabetes Research Group,Prof Richard Stubbs, P3 Research,Waitemata DHB Intervention 13/NTB/72 Approve Non high risk chest pain patients are safe for discharge Dr Andrew Observational 13/NTB/73 Decline A to determine if adding canagliflozin to metformin therapy is effective, safe and well tolerated in patients with Type 2 Diabetes Mellitus who are unable to control their blood sugar with die Dr Michael Williams Dr Dean Quinn,Dr Jeremy Krebs,Dr Gordon Dean G D Millar-Coote,Lakeland Clinical Trials,Prof Richard Stubbs from P3 Research Ltd Intervention 13/NTB/76 Approve Treatment of Chronic Hepatitis B. Dr. William Abbott Observational 13/NTB/78 Approve Early Results of SUFE Treatment Mr Andrew Graydon Observational Coote trial
13/NTB/8 Approve An investigation into safety and tolerability of Manuka Cyclopower Dr Lynne Chepulis Ms Evelyn Francis Intervention 13/NTB/80 Approve Investigating the microbiological contamination of drugs adMinistered for anaesthesia in the operating theatre Mrs Derryn Gargiulo Professor Alan Merry,Dr Craig Webster,Associate Professor Janie Sheridan Auckland District Health Board Intervention 13/NTB/81 Approve AI452016 Prof Edward Gane Auckland District Health Board Observational 13/NTB/82 Approve TEAM: A pilot of Early Activity and Mobility in ICU dr paul young Auckland District Health Board,CCDHB Intervention 13/NTB/83 Approve ConSEPT: A PREDICT study. Dr Stuart Dalziel Auckland District Health Board Intervention 13/NTB/84 Approve ProVIDe: Protein intake in early life and later development Ms Barbara Cormack Professor Frank Bloomfield Auckland District Health Adams, COO Intervention 13/NTB/85 Approve A screening study to identify adult and adolescent individuals with Down Syndrome for eligibiity to participate in a future Drug Treatment Research Study. Professor Ed Mitchell Auckland Clinical Studies Ltd,CCDHB,Health Research South Intervention 13/NTB/92 Approve (duplicate) A clinical trial studying the effects of GLPG0634 given to participants with Rheumatoid Arthritis. Dr Daniel W T Ching Dr Joe Singh Timaru Rheumatology Studies,Waitemata DHB Intervention 13/NTB/96 Approve NOCTURNAL HYPOXAEMIA AND GOUT: A Feasibility Study Miss Christine Little Miss Shyama Abraham Research Office Intervention 13/NTB/97 Approve An Investigation of Apremilast in Psoriatic Arthritis Subjects Dr Daniel W T Ching Research Office ,Jan Adams, COO,Timaru Rheumatology Studies. Intervention 13/NTB/98 Approve An Investigation of Cabozantinib in Hepatocellular Carcinoma Patients previously treated with Sorafenib Prof Edward Gane Auckland District Health Board Intervention
13/NTB/99 Approve COG ANBL12P1: High Risk Neuroblastoma Dr Mark Winstanley Auckland District Health Board Intervention Applications reviewed by expedited review Study reference Study status Short title Co-ordinating Investigator Other Investigators Locality/ies Application type 13/NTB/1 Approve SMART Professor Valery L. Feigin Dr Theadom,Dr Rita Krishnamurthi Dr Kenneth Adams, COO,Waitemata DHB Intervention 13/NTB/100 Approve Comparison of different patient pathways to the diagnosis of melanomas in Waikato, New Zealand Prof Mark Elwood Jan Adams, COO,Tristram Clinic Observational 13/NTB/101 Approve CAFE NZ Dr Rachel Vicars Intervention 13/NTB/110 Approve The fish spike study Ms Hannah Collins CMDHB Research Office Intervention 13/NTB/117 Approve Invasive GAS disease in New Zealand, 2002 - 2012 Dr Deborah Williamson Observational 13/NTB/118 Approve The burden of Haemophilus influenzae meningitis in the post vaccine era Dr Yeri Ahn Dr Samantha Everitt (CMDHB) Observational 13/NTB/121 Approve Development of Type 2 diabetes Mellitus following Gestational Diabetes Mellitus Dr Shekhar Sehgal Dr John Baker Observational 13/NTB/132 Approve Kiwifruit Extract for the alleviation of constipation Prof Sally D Poppitt Mr Wilson Yip Prof. Gillian Intervention 13/NTB/133 Approve Differentiated Thyroid Cancer Outcomes in the Auckland Region: A 5-Year Cohort 2003-2007 Dr Johnston Dr Laura Hill CMDHB Research Office Observational 13/NTB/134 Approve Cardiac disease in kidney failure Associate Professor Helen Pilmore Observational 13/NTB/136 Approve Mindfuness pain intervention Miss Jessica Leov Intervention 13/NTB/137 Approve Case based cohort study of Sawmill workers exposed to persistent organic pollutants Doctor Grahame Jelley Mr Hohepa Joseph Harawira Dr Grahame Jelley Observational
13/NTB/138 Approve METS Study Dr Kathryn Dr Doug Campbell Auckland District Health Board Observational 13/NTB/141 Approve Efficacy of “InterRAI” and “SCREEN” for detecting suboptimal dietary intake in the elderly Dr Hamish Jamieson cdhb Observational 13/NTB/15 Approve Intergenerational Communication Practices and Themes within Whanau Dr Stephanie Palmer Ms Rachel McClintock Observational 13/NTB/150 Approve Merino Encircle Compression Stockings in patients requiring compression stockings Dr Janine Pilcher Mrs Angela Bayley Intervention 13/NTB/152 Approve Qualitative analysis of the psychological impact of halo traction in paediatric scoliosis patients Dr Sanka Bambarawana Observational 13/NTB/158 Approve Nasal flora and Staphylococcus aureus Dr Stephen Ritchie University of Auckland Intervention 13/NTB/164 Approve Screening and brief intervention for substance misuse in mental health Dr Newcombe Dr Susanna Galea Waitemata DHB Observational 13/NTB/169 Approve Diabetes retinal screening cohort study Dr. Tom Robinson Auckland District Health Board Observational 13/NTB/17 Approve Written emotional disclosure and surgery Dr Elizabeth Broadbent Auckland District Health Board,Dr Samantha Everitt (CMDHB) Intervention 13/NTB/174 Approve Epidemiology Cohort Study on Severe Sepsis in Waikato Region Dr Prashanth Hari Dass Observational 13/NTB/178 Provisionally approve Growth and Bone Mineral Density 5 years post Paediatric Liver Transplant Dr Amin Sheikh Observational 13/NTB/18 Approve The Gestational Diabetes Mellitus Study of Detection Thresholds (GEMS) Professor Caroline Crowther Intervention 13/NTB/195 Approve Alcohol and Other Drug Treatment Court Evaluation Ms Gabrielle Clezy Mr Julian King Observational 13/NTB/196 Provisionally approve Cellulitis in children: A QI collaborative Dr Jennifer Njenga Observational 13/NTB/198 Approve Rheumatic M/emm typing in Children Professor Lennon Observational 13/NTB/199 Approve Mortality and morbidity following sub-massive PE Dr Chinthaka Samaranayake Dr Samantha Everitt (CMDHB) Observational 13/NTB/200 Provisionally approve A study of the lived world of the patient with Borderline Personality Disorder Ms Marlene Dor Observational 13/NTB/202 Provisionally approve Bony Mallet Fracture study Ms Karen Smith Miss Clara Miller Observational
13/NTB/204 Approve Notes review to evaluate an educational intervention AP Jennifer Weller Professor Alan Merry,Dr David Cumin,Mr Ian Civil,Dr Matt Boyd Observational 13/NTB/207 Approve Epidemiology of Non-Melanoma Skin Cancers (NMSC) in the Auckland Region Mr Richard Martin Waitemata District Health Board Observational 13/NTB/21 Approve Use of the STOPP criteria to identify potentially inappropriate prescribing Dr Sarah Gray Dr Mary Seddon Samantha Everitt (CMDHB) Observational 13/NTB/22 Approve Treatment and the Influence of Pharmacist Counselling Doctor Peter Sizeland Mr Rajan Ragupathy Jan COO Intervention 13/NTB/27 Approve Description of adenovirus lower respiratory tract infection in children and outcomes Dr Geetika Badkar Dr Samantha Everitt (CMDHB) Observational 13/NTB/4 Approve Thyrotoxicosis in Maori Dr Jade Tamatea Observational 13/NTB/41 Approve PREVIEW:NZ Prof Sally D Poppitt Dr Anne-Thea McGill,Dr Lisa Te Morenga SBS HOD Biological Sciences Gillian Intervention 13/NTB/63 Approve CPAP: Evaluation of Therapy Comfort Dr Rachel Vicars Intervention 13/NTB/79 Approve EPOCH Dr Susan Wells Associate Professor Chris Bullen,Dr Natasha Rafter Manaia Primary Health Organisation,Te Tai Tokerau PHO Intervention 13/NTB/88 Approve Developmental Screening of Refugee Children Under 5 Years Old Arriving in New Zealand (NZ) Dr Santuri Rungan Observational 13/NTB/89 Approve Paediatric pain audit - a pilot study Dr Andrew Liley Auckland District Health Board Observational 13/NTB/91 Approve Incidence and outcome of renal transplant recipients with BK viraemia and/or virus nephropathy. Dr Chun-Yuan Hsiao Auckland District Health Board,Waitemata DHB Observational Minimal dataset form applications reference Study status Short title Co-ordinating Investigator
NTY/11/EXP/088 Approve Mapping gastro-oesophageal cancer in the region Doctor Soizick Mesnage NTY/12/01/003 Approve Tramadol vs. Morphine for refractory postoperative pain in the recovery room Dr Kelly Byrne NTY/12/01/011 Approve Study Evaluating the Neuropsychiatric Safety and Efficacy of 12 Weeks Varenicline Tartrate 1mg BID and Bupropion Hydrochloride 150mg BID for Smoking Cessation in Subjects With and Without a History of Dr Michael Williams NTY/12/02/019 Approve Iodine contrast-induced thyrotoxicosis Dr Kim Simcox NTY/12/05/034 Approve AMICI Dr Gerald Devlin NTY/12/05/039 Approve Cardiac Assessments Treatment Study - CATS Dr Michael Williams NTY/12/06/050 Approve Evaluation of adding the Incredible Years Specialist Service for high risk families Ms Dianne Lees NTY/12/5/034 Invalid Application AMICI Dr Gerald Devlin NTY/12/5/034 Invalid Application AMICI Dr Gerard Devlin NTY/12/EXP/018 Approve Psoriasis and lichen sclerosus Dr Harriet Cheng NTY/12/EXP/026 Approve Real life Correlates Dr. Sangeeta Dey NTY/72/96/382 Invalid Application International Breast Cancer Intervention Study A/Prof Ian Campbell NTY/72/96/382 Approve International Breast Cancer Intervention Study A/Prof Ian Campbell URA/11/10/063 Approve Can Macitentan reduce finger ulceration in people with systemic sclerosis? Dr Solanki