UPPER SOUTH B ETHICS COMMITTEE
Agenda for the meeting of Monday, 10 April 2006
APOLOGIES
Simon Clarke
NEW PROTOCOLS
1.
Subclinical thyrotoxicosis in an outpatient population – Audit of clinical
and biochemical outcome.
Investigators: B Robb, Dr B Brownlie, Dr J Turner
Ethics Ref: URB/06/04/023
2.
CRESCENDO: Randomized, multinational, multicenter, double-blind,
placebo-controlled, two-arm parallel group trial of Rimanoabnt
(SR141716) 20 mg OD for reducing the risk of major cardiovascular
events in abdominally obese patients with clustering risk factors.
Investigators: A/Prof J Elliot, Prof R Scott, A/Prof C Florkowski, Dr A
Luckey
Ethics Ref: URB/06/04/024
3.
Management of Gynaecological Cancer: A study of the perceived acceptable
and the actual waiting time for surgery
Investigators: Dr H Su
Ethics Ref: URB/06/04/025
4.
Psychosocial correlates of physical activity levels and biochemical measures
in a group of New Zealand adults with type two diabetes: implications for the
design of effective interventions in health care settings.
Investigators: D Brinson
Ethics Ref: URB/06/04/026
5.
Design of a nutritional screening tool for lactating mothers of premature
infants
Investigators: L Clark
Ethics Ref: URB/06/04/027
6.
Patterns of medication use in older people in rural Canterbury
Investigators: Dr N Khan
Ethics Ref: URB/06/04/028
7.
Monitoring of Pilot Introduction of Community Stroke Rehabilitation Team
Investigators: Dr H C Hanger
Ethics Ref: URB/06/04/029
Upper South B Ethics Committee Agenda 10 April 2006
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8.
Genetic Profiles of Kidney Disease and Transplant Patients
Investigators: Dr J Irvine, Dr V Cameron, Prof M Richards, Prof Z Endre
Ethics Ref: URB/06/04/030
MINUTES
Review of minutes from previous meeting, 13 March 2006.
CHAIRPERSON’S REPORT
MATTERS ARISING
1.
Service Utilisation following discharge from Totara House
Investigators: M Turner
Ethics Ref: URB/05/05/056
ITEMS OF INFORMATION
1.
Minutes of the Upper South A Regional Ethics Committee meeting held 27
February 2006.
PROTOCOLS GIVEN FINAL APPROVAL UNDER DELEGATED
AUTHORITY
1.
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/06/02/026
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.
A correlation of angiogenesis related factors and prognostic features in
endometrial cancer as studied by tissue micro array
Investigators: Prof P Sykes, J Nagase, J Muys, D Harker
Ethics Ref: URB/06/02/018
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.
Upper South B Ethics Committee Agenda 10 April 2006
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3.
Respiration and swallowing intergration in Parkinson’s disease: on and off
levodopa
Investigators: A Lim, Prof T Anderson, Dr Mhuckabee, L P Leow
Ethics Ref: URB/06/02/006
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.
4.
A narrative approach to Comprehensive Geriatric Assessment with a
special focus on medication-taking
Investigators: L Ritchie, Dr S Keeling
Ethics reference: URB/05/11/156
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.
5.
What is the role of the Nurse Practitioner in the Emergency Department?
Defining the role by developing patient care pathways. A case study
approach
Investigators: J Moore
Ethics Ref: URB/06/02/009
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.
6.
Roche Repository Research Project in association with protocol
WP19270 (URB/05/12/174)
Investigators: Dr R Robson, Dr C Wynne, Dr A Dick
Ethics Ref: URB/06/02/011
The Committee has certified that this clinical trial is being conducted principally
for the benefit of the manufacturer or distributor of the medicine or item in
respect of which this trial is being carried out. Ethical approval is given on the
understanding that participants in the research project will receive an acceptable
level of compensation from Hoffman-La Roche in the event of injury to
participants resulting from their involvement in the research study.
Upper South B Ethics Committee Agenda 10 April 2006
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AMENDMENTS GIVEN ETHICAL APPROVAL UNDER DELEGATED
AUTHORITY
1.
A combined single and multiple ascending dose study to investigate the
safety, tolerability and activity of the oral CETP inhibitor RO4920902 in
healthy male volunteers and the relative pharmacokinetics
characteristics of 2 capsule formulations
Investigators: Dr R Robson, Dr D Waaka, Dr C Wynne, Dr A Dick, Dr R
Gearry, Dr J Irvine
Ethics Ref: URB/05/12/174
Information Sheet and Consent Form version 5 dated 27 February 2006 and version 6
dated 1 March 2006 approved after consultation with a Committee member.
2.
A pilot study of high dose allopurinol in the management of gout.
Investigators: Dr L Stamp, Dr P Chapman, Dr J O’Donnell
Ethics ref: URB/05/03/026
Amendment to extend recruitment and retain samples longer approved after consultation
with a Committee member..
3.
The application of anti-cyclic citrullinated petide autoantibody and
soluble HLA-DR tests to the detection of early rheumatoid arthritis in
New Zealand patients
Investigators: Dr L Stamp, Dr J O’Donnell, Dr P Chapman,
Dr M Spellerberg
Ethics ref: CTR/04/06/095
Information Sheet and Consent Form for Sample Storage dated 1 February 2006
(for participants currently recruited) and Information Sheet and Consent Form dated
1 February 2006 (for participants yet to be recruited) approved after consultation
with a Committee member.
4.
Reproducibility of arterial stiffness and non-invasive endothelial function
measurements in healthy controls and subjects with metabolic syndrome
using pulse wave analysis
Investigators: J Young, Prof R Scott, Dr C Florkowski, P McGregor.
Ethics reference: URB/05/07/084
Information Sheet and Consent Form version 5 dated 13 February 2006 to incorporate
various amendments approved after consultation with a Committee member.
Upper South B Ethics Committee Agenda 10 April 2006
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5.
The reproducibility of resting energy expenditure and RQ measurements
in healthy human volunteers using the Sensormedics V Max System
Investigators: Dr J Elmslie, M Swanney, A/Prof C Frampton
Ethics ref: URB/05/04/037
Advertisement approved after consultation with a Committee member.
6.
The application of anti-cyclic citrullinated petide autoantibody and
soluble HLA-DR tests to the detection of early rheumatoid arthritis in
New Zealand patients
Investigators: Dr L Stamp, Dr J O’Donnell, Dr P Chapman,
Dr M Spellerberg
Ethics ref: CTR/04/06/095
Amendment to extend approval to other novel markers approved after consultation with
a Committee member.
STUDIES REAPPROVED FOR A FURTHER 12 MONTHS UNDER
DELEGATED AUTHORITY
1.
Investigating the relevance of the educational preparedness of Primary
Health Care Nurses (PHCN) supporting families parenting pre-term
infants
Investigators: FA Morgan, V Cullens Supervisor: B Burrell
Ethics ref: CTR/04/06/092
SERIOUS ADVERSE EVENTS
See listing attached for CTY, CTR and URB 1 March 2006 – 31 March 2006
Upper South B Ethics Committee Agenda 10 April 2006
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