UPPER SOUTH B ETHICS COMMITTEE
Agenda for the meeting of Monday, 11 December 2006
APOLOGIES
NEW APPLICATIONS
1.
Evaluation of the effectiveness of a formal community pharmacist review for
people with diabetes who take hypoglycaemic medication on the West Coast
of the South Island of New Zealand
Investigators: Dr C Atmore, Dr J Tracey, J Kilkelly
Ethics Ref: URB/06/12/090
Spokesperson: Sharon Gardiner
2.
A study to determine the ability of plasma BNP signal peptide concentrations
to act as a specific and early clinical biomarker of Acute Myocardial
Infarction: The “SP-AMI” study
Investigators: Prof M Richards, Dr C Pemberton, A/Prof T Yandle, Prof G
Nicholls
Ethics Ref: URB/06/12/091
Spokesperson: Mark Smith
3.
A study to determine the amino acid structure of plasma BNP signal peptide
as a specific and early clinical biomarker of Acute Myocardial Infarction: The
“SSS” study
Investigators: Prof M Richards, Dr C Pemberton, A/Prof T Yandle, Prof G
Nicholls
Ethics Ref: URB/06/12/092
Spokesperson: Mark Smith
4.
A study to determine the diagnostic test performance (sensitivity, specificity,
negative predictive value, positive predictive value, accuracy and prognostic
value) of BNP-SP measurement in detection of ACS (including those with
ischemia short of infarction) within a population of “all-comers” with chest
discomfort: The “SP-ACE” study
Investigators: Prof M Richards, Dr C Pemberton, A/Prof T Yandle, Prof G
Nicholls
Ethics Ref: URB/06/12/093
Spokesperson: David McGregor
5.
Biomarkers Risk-stratifying for Adverse post-operative Cardiac Events: The
“BRACE” study
Investigators: Prof M Richards, Dr C Pemberton, A/Prof T Yandle, A/Prof C
Frampton, Prof J Roake, Dr R Troughton, D Lewis, Prof G Nicholls
Ethics Ref: URB/06/12/094
Upper South B Regional Ethics Committee Agenda 11 December 2006
Spokesperson: David McGregor
6.
Prediction of Retention in a Drug Treatment Therapeutic Community:
Retrospective Review
Investigator: Prof R Mulder
Ethics Ref: URB/06/12/095
Spokesperson: Simon Clarke
7.
Maintaining Independence: Predicting and Preventing Resident Care
Admission
Investigators: C P Heppenstall, T Wilkinson, C Hangar, S Keeling
Ethics Ref: URB/06/12/096
Spokesperson: Kathrine Townshend
8.
Presence of Mycobacterium avium subsp. paratuberculosis (MAP) in the
peripheral blood of healthy Caucasians
Investigators: Dr R Roberts
Ethics Ref: URB/06/12/097
Spokesperson: Robin Fraser
9.
Physiological responses to acute hypobaria in normal volunteers, patients
with chronic obstructive pulmonary disease (COPD) and patients with diffuse
parenchymal lung disease (DPLD)
Investigators: Mr P T Kelly, Dr L Beckert, M P Swanney, J D Stanton, E
Swallow, A/Prof C Frampton
Ethics Ref: URB/06/12/098
Spokesperson: Annette Finlay
10.
Subclinical thyrotoxicosis in an outpatient population - Audit of presentation
plus clinical and biochemical outcome
Investigators: Dr B Robb, Dr B Brownlie, Dr J Turner
Ethics Refs: URB/06/12/099
Spokesperson: Patrick Graham
11.
Stable primary care depression: maintenance vs gradual withdrawal of
fluoxetine
Investigators: Dr D Mangin, Prof L Toop, Prof R Mulder, Dr C Dowson, Prof T
Dowell, Prof B Arroll, Prof E Begg
Investigators:
Ethics Ref: URB/06/12/100
Spokesperson: Annette Finlay
12.
Investigation into the effect of a nutritional supplement on mood and
function in clinical sample of young adolescents with Bipolar Disorder:
naturalistic clinical case series ABAB patient preference design.
Investigators: Dr J Rucklidge, Dr S Moor, Dr L O’Connell, Dr B Kaplan
Ethics Ref: URB/06/12/101
Spokesperson: Sharon Gardiner
Upper South B Regional Ethics Committee Agenda 11 December 2006
MINUTES
Review of minutes from previous meeting, 13 November 2006
CHAIRPERSON’S REPORT
MATTERS ARISING
AMENDMENTS SUBMITTED FOR ETHICAL APPROVAL
1.
Prevalence and importance of abnormalities of glycine betaine metabolism
among patients with cerebrovascular disease: a cross-sectional study
Investigators: Dr J Fink, Prof S Chambers, Prof P George, Dr M Lever, Dr J
Elmslie, Dr W Atkinson
Ethics Ref: URB/06/06/045
Spokesperson: Mark Smith
Protocol amendment has been requested, revised Information Sheet (part A)
provided with changes highlighted
GENERAL BUSINESS
ITEMS OF INFORMATION
1.
Minutes of the Upper South A Regional Ethics Committee meeting held 30 October
2006
2.
Nelson Marlborough District Health Board Annual Report 2005/6 - see weblink:
http://www.nmdhb.govt.nz/publisheddocs/2006annualreport.pdf
3.
Minutes of Chairs’ meeting held on 5 and 6 September 2006
APPLICATIONS GIVEN FINAL APPROVAL UNDER DELEGATED
AUTHORITY
1.
The Impact on Individuals Supporting People Diagnosed with Bipolar
Affective Disorder
Investigators: V Maskill, A/Prof S Luty (Supervisor)
Ethics Ref: URB/06/09/065
Upper South B Regional Ethics Committee Agenda 11 December 2006
The Committee is satisfied that this study is not being conducted principally for the
benefit of the manufacturer or distributor of the medicine or item in respect of which
the trial is being carried out
2.
The influence of olfaction on swallowing-respiratory coordination and
submental muscle contraction
Investigators: Dr ML Huckabee, A/Prof R Jones
Ethics Ref: URB/06/10/077
The Committee is satisfied that this study is not being conducted principally for the benefit of
the manufacturer or distributor of the medicine or item in respect of which the trial is being
carried out
3.
Prospective Study of Piperazine Based Party Pill Toxicity: A Three Part
Researcg Project.
Investigators: Dr. Paul Gee
Ethics Ref: URB/05/11/158
The Committee involved in the approval of this study is accredited by the Health Research Council
and is constituted and operates in accordance with the Operational Standard for Ethics
Committees, April 2006.
4.
The effect of topical negative pressure (TNP) therapy on the microbiology
of lower limb ulcers; an observational pilot study
Investigators: Mr Manar Khashram, Mr David Lewis, Prof. Stephen T
Chambers, Professor JA Roake, Ms Catherine Hammond
Ethics Ref: URB/06/11/087
The Committee involved in the approval of this study is accredited by the Health Research Council
and is constituted and operates in accordance with the Operational Standard for Ethics
Committees, April 2006.
AMENDMENTS GIVEN ETHICAL APPROVAL UNDER DELEGATED
AUTHORITY
1.
Renal Impairment in Decompensated Heart Failure
Investigators: Prof M Richards, Dr S Palmer, Prof Z Endre, A/Prof T Yandle,
Dr R Keenan
Ethics Ref: URB/06/02/008
Information sheet (Sub study 1) version 3 dated 11 October 2006 and Information Sheet
(sub study 2) version 3 dated 17 October 2006 approved after consultation with David
McGregor.
2.
Regional plasma concentrations of vasoactive peptides and correlations with
haemodynamic state in cardiac disease.
Investigators: Prof M Richards, Dr S Palmer, A/Prof T Yandle,
Ethics Ref: URB/06/02/010
Upper South B Regional Ethics Committee Agenda 11 December 2006
Amendments and Information Sheet and Consent Form version 2 dated 11 October
approved after consultation with Mark Smith.
3.
Cholinergic and oxidative stress mechanisms in Sudden Infant Death
Syndrome (SIDS).
Investigators: Dr Anne Dick, Dr Rodney Ford, Professor C C Winterbourn,
Dr C Andre.
Protocol Number: 96/03/032
Amendment and Information Sheet and Consent Form version 3 dated 10 October
approved after consultation with Mark Smith.
4.
Randomised, Double-blind, Placebo-controlled Efficacy and Safety Study of
Colesevelam HCl to Paediatric Patients with Heterozygous Familial
Hypercholesterolemia on a Stable dose of Statins or Treatment Naive to
Lipid-Lowering Therapy
Investigators: Prof R Scott, Prof P George, Prof C Florkowski, Dr A Luckey,
N Hurndell
Ethics Ref: URB/06/06/053
Self Reporting forms version 1 dated 22 August 2006 approved after consultation with
Mark Smith.
5.
A randomised open-label multicenter study of VELCADE with Rituximab or
Rituximab alone in subjects with Relapsed or Refractory, Rituximab Naïve or
Sensitive B-cell Follicular Non-Hodgkins Lymphoma
Investigators: Dr S Gibbons, Dr RL Spearing, Dr M Smith, Dr P Ganly
Ethics Ref: URB/06/02/007
Information Sheet and Consent Form dated 20 October 2006 approved after consultation
with David McGregor.
6.
An open-label, randomised study of VELCADE®/Melphalan/prednisone versus
Melphalan/prednisone in subjects with previously untreated multiple myeloma:
Protocol 26866138-MMY-3002 Ph. 3, 14/10/04: IB Ed #7, 18/03/04:
Investigators: Dr S Gibbons, Dr RL Spearing, Dr M Smith, Dr P Ganly
Ethics Ref: NTX/04/12/008
Information Sheet and Consent Form version 5 dated 20 October 2006 approved after
consultation with David McGregor.
7.
Does suppression of AF promote reverse electrical remodeling of the atria?
Investigators: Dr Ian Crozier, Dr Iain Melton
Ethics Ref: URB/05/02/013
Upper South B Regional Ethics Committee Agenda 11 December 2006
Protocol Amendment #2 dated 19 September 2006 approved after consultation with David
McGregor.
8.
Relationship of Plasma Aminoterminal C-type Natriuretic Peptide to Growth and
Bone Maturation
Investigators: T Prickett, Prof T Yandle (Supervisor), Prof EA Espiner, Prof G
Abbott, Prof AM Richards
Ethics reference: CTY/02/06/105
Additional weight and height measurement approved after consultation with Robin
Fraser.
STUDIES REAPPROVED FOR A FURTHER 12 MONTHS UNDER
DELEGATED AUTHORITY
1.
2.
The effect of glycine betaine supplementation on plasma homocysteine
concentrations in chronic renal failure patients receiving hemodialysis or
continuous ambulatory peritoneal dialysis (CAPD)
Investigators: Dr D McGregor, Prof R Robson, Prof S Chambers, Prof P
George, Dr S Slow
Ethics ref: CTR/04/06/099
Angioplasty and Stent for Renal Artery Lesions
Investigators: Dr D McGregor, Dr M Searle, Prof T Buckenham, Dr A Laing,
N Forrest-Mclernon
Ethics reference: CTY/02/10/169
3.
Morbidity of Insulin treated diabetes in Canterbury: a follow up study
Investigators: Dr. S Dawson, Dr J Willis, Dr Cflorkowski, Dr R Scott
Ethics reference: URB/05/11/151
4.
A study of the dose response association between infant iron status and
later cognitive functioning
Investigators: Dr D Richards, C Dowson, Dr D Fergusson, A/P G Abbott, S
Pitama, Dr P George, Prof L Toop, Prof I Town
Ethics reference: CTY/03/05/083
FINAL REPORTS FOR REPORTING BACK
1.
Respiratory laboratory Quality Assurance: Development of an automated
program for data analysis and identifying a system of best practice.
Investigators: Dr J Stanton
Ethics reference: URB/05/11/153
Spokesperson: Patrick Graham
Upper South B Regional Ethics Committee Agenda 11 December 2006
2.
A Multicentre, Randomised, Double-Blind Study to Evaluate the Safety and
Effectiveness of MK-0431 Monotherapy in Patients with type 2 Diabetes
Mellitus and Chronic Renal Insufficiency Who have Inadequate Glycemic
Control (Protocol MK-0431-028)
Investigators:
Prof R Scott, Dr R Robson, Dr W Isbell, Dr C Florkowski
Ethics Ref: CTR/04/09/170
Allocated to: David McGregor
3.
The measurement of propofol in the expired breath of adults receiving total
intravenous anaesthesia with propofol
Investigators: Dr R French, Dr R Kennedy
Ethics reference: CTY/02/07/120
Allocated to: Mark Smith
4.
A study to formally establish appropriate biological reference intervals for
routine biochemical and haematological test parameters in the top of the
South Island region.
Investigators: G Ludemann
Ethics Ref: NMA/04/09/022
Allocated to: Patrick Graham
5.
Prospective observational audit of patients presenting to the Christchurch
ED with syncopal symptoms
Investigators: Dr Scott Pearson, Dr Martin Than, Dr David Jardine
Ethics Ref: CTR/04/11/225
Allocated to: Rosemary Carruthers
SERIOUS ADVERSE EVENTS
See listing attached for CTY, CTR and URB 1 November 2006 - 30 November 2006
Upper South B Regional Ethics Committee Agenda 11 December 2006