Former Members Dr Etuate Saafi (resigned April 2014) Membership category: Health researcher (non-lay) Date of appointment: 1 July 2012 Attendance The Northern A HDEC held 11 meetings in 2014. Members Meetings Total Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Lay members Cn Dr Brian Fergus A 10/11 Cn Ms Buckland A A A 8/11 L Ms Michele Stanton 11/11 Cm Mr Kerry Hiini 11/11 HP Ms Shamim Chagani A 10/11 Non-lay members HR Dr Etuate Saafi A A A 0/3 HP Dr Mark Smith 4/4 HR Dr Bartholomew A A A A A 6/11 HR Dr Christine Crooks 11/11 HP Dr Mathew Zacharias Co-opted from STH HDEC 1/1 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 Training and conferences Dr Mark Smith attended an ethics training day for new members in Auckland in October 2014. Chairpersons’ meetings Dr Brian Fergus attended two Chairs’ day meetings in 2014. Both meetings were held in Wellington. Trial
Appendix 1: Details of applications reviewed. Applications reviewed by full committee reference status Short title Co-ordinating investigator Application type Date application validated Date of first decision Provisional response received Date of final decision 14/NTA/10 Decline A Study of RG1662 in Adults and Adolescents with Down syndrome (CLEMATIS) Prof Ed Mitchell Intervention 30/01/2014 15/04/2014 14/NTA/11 Approve IFOOD Mrs Katrina Pace Intervention 30/01/2014 18/02/2014 14/NTA/12 Approve IBS Discomfort Elimination Assessment (IDEA) Study Dr Alasdair Patrick Intervention 30/01/2014 18/02/2014 14/NTA/13 Approve Wellbeing for children Mrs Emma (Ema) Tokolahi Intervention 30/01/2014 18/02/2014 14/NTA/16 Decline Alios BioPharma Dr. Thorsten Stanley Intervention 30/01/2014 18/02/2014 14/NTA/4 Approve Endometrial Carcinoma – A Retrospective Study at a Single Community Hospital Dr Bigby Observational 30/01/2014 18/02/2014 14/NTA/7 Approve Reduced-dose rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) Dr Mark Smith Intervention 30/01/2014 18/02/2014 14/NTA/22 Approve PHYSACTO™ Dr Andrew G. Veale Intervention 27/02/2014 17/03/2014 14/NTA/25 Approve TOBA - BTK Associate Professor Andrew Holden Intervention 27/02/2014 17/03/2014 14/NTA/26 Approve Safety and Performance Study of the Shockwave Lithoplasty System Associate Professor Andrew Holden Intervention 27/02/2014 17/03/2014 14/NTA/31 Approve ASPECT - A double-blind study to assess the safety and efficacy of intravenous Ceftolozane/Tazobactam with that of Meropenem in Ventilated Nosocomial Pneumonia Dr Shay McGuinness Intervention 27/02/2014 15/04/2014 8/07/2014 22/07/2014 14/NTA/32 Approve LEE011X2106 Dr Rita Sasidharan Intervention 27/02/2014 17/03/2014 22/05/2014 21/07/2014 trial Trial
14/NTA/217 Provisionally approve Prophylactic administration of vancomycin prior to total knee arthroplasty in the obese patient via the intraosseous route Mr Simon Young Intervention 27/11/2014 10/12/2014 23/12/2014 14/NTA/218 Approve Staphylococcus aureus transmission in New Zealand schools Prof David Murdoch Observational 27/11/2014 10/12/2014 14/NTA/220 Approve FX006 for the Treatment of Pain in Patients with Osteoarthritis of the Knee Dr Dean Intervention 27/11/2014 10/12/2014 22/12/2014 22/12/2014 Applications reviewed by expedited review Study reference Study status Short title Co-ordinating investigator Application type Date application validated Date of first decision Provisional response received Date of decision 14/NTA/2 Approve Retrospective review: Does MRI predict prognosis for children who suffer cardiac arrest to PICU Dr John Beca Observational 21/01/2014 28/03/2014 14/NTA/6 Approve Hypersexuality Observer-rated Scoring Scale (HOSS) – A Pilot Study Dr. C. K. Dennisa Davidson Observational 21/01/2014 24/02/2014 14/NTA/1 Approve Hauora Kanohi ki te Kanohi Gayl Humphrey Intervention 29/01/2014 24/02/2014 7/03/2014 7/04/2014 14/NTA/15 Approve Exercise capacity and heart function in post-term born adolescent Miss Mrinal Murali Observational 31/01/2014 31/03/2014 24/04/2014 28/04/2014 14/NTA/19 Approve high flow therapy for the treatment of Cheyne-Stokes Respiration Dr Rachel Vicars Intervention 5/02/2014 3/03/2014 4/03/2014 14/03/2014 14/NTA/20 Approve Sodium intake and fluid control study Ms Sandra McLellan Intervention 12/02/2014 26/03/2014 14/NTA/23 Approve Phobia Cure Study Professor Bruce Arroll Intervention 21/02/2014 31/03/2014 2/04/2014 11/04/2014
14/NTA/28 Approve Cardiac Catheterisation augmented with cardiac MRI Dr Cara Wasywich Intervention 27/02/2014 3/04/2014 14/NTA/29 Approve A retrospective audit of feeding practices in preterm infants admitted to the Special Care Baby Unit at Whangarei hospital Miss Ashleigh Share Observational 27/02/2014 28/03/2014 14/NTA/30 Approve Whooping in the Paediatric Intensive Care Unit Associate Professor Cameron Grant Observational 27/02/2014 31/03/2014 1/04/2014 4/04/2014 14/NTA/37 Approve Mortality outcomes for versus non-Maori following diabetes-related lower limb amputations Mr Stephen (Steve) York Observational 6/03/2014 28/03/2014 14/NTA/27 Approve Review of Health Literacy Environments in hospitals and health clinics Miss Reid Observational 7/03/2014 31/03/2014 1/05/2014 1/05/2014 14/NTA/38 Approve The efficacy of the LNG-IUS (MirenaTM) in women with abnormal uterine bleeding Dr. Valentina Shaw Observational 7/03/2014 31/03/2014 24/04/2014 24/04/2014 14/NTA/54 Approve Use of the Maze Navigation Test (MNT) to predict on road driving performance in patients with dementia Dr Etuini Ma'u Observational 2/04/2014 15/04/2014 9/05/2014 19/05/2014 14/NTA/56 Approve The “AntiBPs in PET” study Professor Peter R Stone Intervention 7/04/2014 15/04/2014 1/09/2014 5/09/2014 14/NTA/58 Approve The Investigation of Interfaces for Positive Airway Pressure Therapy Miss Cheung Intervention 16/04/2014 28/04/2014 6/05/2014 29/05/2014 14/NTA/57 Approve T2 mapping of cartilage Assoc Prof Nicola Dalbeth Observational 17/04/2014 28/04/2014 30/04/2014 7/05/2014 14/NTA/63 Approve Usability assessment for a new High Flow Cannula Dr Robert Kirton Observational 29/04/2014 5/05/2014 14/05/2014 12/06/2014