NORTHERN Y REGIONAL ETHICS COMMITTEE
JANUARY AGENDA
For the meeting to be held on Wednesday, 25 January 2006
At the Bryant Education Centre, Waikato Hospital Campus, Hamilton
At 11.30 am
MEMBERS ATTENDING
Mr Paul Flanagan (in the chair), Dr John Moodie, Dr John Fitzgerald, Rev Peter
Coughlan, Ms Huhana Hickey, Mr Michael Vale, Dr Rob Crawford, Dr Elizabeth
Spellacy, Ms Christina Bryant, Mrs Claire Stott, Mrs Heather Thompson, Dr Felicity
Dumble.
Administrator: Amrita Kuruvilla
APOLOGIES
None.
APPROVAL OF MINUTES OF PREVIOUS MEETING
Approval of minutes of the meeting held on 14th December 2005
CHAIRPERSON’S REPORT
1.To receive - Report of the Chairperson
GENERAL BUSINESS
1. HRC News letter: Photocopies available on request.
2. The Bioethics Council report ‘ The Cultural, Ethical and Spiritual Aspects of
Animal-to-Human Transplantation’: Photocopies available on request.
3. Article of interest: Ottawa Statement- Proposal for International Registration
of Protocol Information and Results from Human Trials of Health-related
Interventions.
MATTERS ARISING
1. The impact of electronic information management on Maori perceptions to
enrolment in diabetes management programmes.
Investigator: Hugh Kininmonth
Reference: NTY/05/07/044
Locations: Te Korowai Hauora O Hauraki, Thames.
- Awaiting further information from researcher.
2. Structure and function in failing heart.
Investigators: Prof M Cannell, Dr Brett Cowan, Dr P Ruygrok, Dr. Christian
Soeller ,Dr Alistair Young, Dr. Ian LeGrice
Ethics ref: NTY/05/08/050
Locations: Faculty of medicine and health sciences, University of Auckland.
-Approved with conditions. Awaiting further information from researcher.
3. Treatment of postnatal depression: Type of intervention and effects on maternal
health and child outcomes.
Investigators: Kyle Smith, Dr John Fitzgerald, Maureen Speedy.
Ethics ref: NTY/05/10/074
Locations: The Psychology Centre, Waikato Family Centre, Hamilton.
- Response received and under review..
4. Comparison between central venous-arterial carbon dioxide difference and
PiCCO as indicators of cardiac index in intensive care.
Investigators: Dr Kerry Benson-Cooper, Dr Michael Kalkoff, Dr Anthony
Williams, Prof. Jamie Sleigh.
Ethics ref: NTY/05/10/076
Locations: Middlemore Hospital, Whangarei Base Hospital.
- Approved conditionally. Awaiting response from researcher.
6. Cortical thinning in early Huntington’s Disease: Distribution and functional
significance.
Investigators: John Davison, Dr Lynette Tippett, Dr Richard Roxburgh
Ethics ref:
NTY/05/11/082
Locations: University of Auckland Centre for Advanced MRI, participant’s
home.
Response received. Awaiting further information.
7. Bridging the Gap: Multicultural Music Therapy in Long-Term Care(LTC).
Investigators: Esther Leauanae
Ethics ref:
NTY/05/11/083
Locations: Hillcrest Hospital, Parkhaven Hospital
-Response received and under review.
8. An investigation into the relationship between competence to consent to mental
health treatment and civil commitment on a Community Treatment Order
under s.29 of the NZ Mental Health (Compulsory Assessment and Treatment)
Act 1992.
Investigators: Duncan Milne
Ethics ref:
NTY/05/11/087
Locations:
ADHB localites.
-Deferred. Awaiting further information from researcher.
9. Aetiology of keloid and hypertrophic scars: A study of New Zealand specific risk
factors.
Investigators: Dr Peter Brooks, Dr Ian Appleton, Sharleen Irvine
Ethics ref:
NTY/05/11/088
Locations:
Dept of Plastic Surgery, Middlemore Hospital.
- Approved conditionally. Awaiting response from researcher.
10. Evaluation of the Fisher and Paykel high flow humidified nasal interface system
by the measurement of hypopharyngeal inspired oxygen fraction and airway
pressures.
Investigators: Dr Joanne Ritchie, Catherine Gerard, Dr Anthony Williams
Ethics ref:
NTY/05/11/089
Locations:
Dept of Intensive Care Medicine, Middlemore Hospital.
- Approved conditionally. Awaiting response from researcher.
11. A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60mg QD
and 90mg QD) and an active Comparator, Lansoprazole (30mg QD) on Healing
of Erosive Esophagitis. Incorporating amendment 1. Protocol: T-EE04-084.
Investigators: Dr Frank Weilert, Dr ID Wallace.
Ethics ref:
NTY/05/12/094
Locations: Shakespeare Specialist Group, Auckland City Hospital, Tauranga
Hospital, and Waikato Hospital.
- Approved conditionally. Awaiting response from researcher.
12. A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60mg QD
and 90mg QD) and an active Comparator, Lansoprazole (30mg QD) on Healing
of Erosive Esophagitis. Incorporating amendment 1. Protocol: T-EE04-085.
Investigators: Dr Frank Weilert, Dr MR Lane, Dr DW Shaw.
Ethics ref:
NTY/05/12/095
Locations: Shakespeare Specialist Group, Auckland City Hospital, Tauranga
Hospital, and Waikato Hospital.
- Approved conditionally. Awaiting response from researcher.
13. A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60mg QD
and 90mg QD) Compared to Placebo in Maintenance of Healing in Subjects with
Healed Erosive Esophagitis. Incorporating amendment 1. Protocol: T-EE04-086.
Investigators: Dr Frank Weilert, Dr ID Wallace.
Ethics ref:
NTY/05/12/096
Locations: Shakespeare Specialist Group, Auckland City Hospital, Tauranga
Hospital, and Waikato Hospital.
- Approved conditionally. Awaiting response from researcher.
14. A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60mg QD
and 90mg QD) Compared to Placebo in Maintenance of Healing in Subjects with
Healed Erosive Esophagitis. Incorporating amendment 1. Protocol: T-EE04-087.
Investigators: Dr Frank Weilert, Dr MR Lane, Dr DW Shaw.
Ethics ref:
NTY/05/12/097
Locations: Shakespeare Specialist Group, Auckland City Hospital, Tauranga
Hospital, and Waikato Hospital.
- Approved conditionally. Awaiting response from researcher.
15. A Phase III multi-center, randomised, parallel, placebo-controlled, double-blind
study to investigate the safety and efficacy of treatment with Bronchitol (dry
powder mannitol) in the symptomatic treatment of bronchiectasis.
Investigators: A/Prof Jeffrey Garrett, A/Prof John Kolbe, Lata Jayaram, Mark
O’Carroll.
Ethics ref:
NTY/05/12/098
Locations: Middlemore Hospital, Greenlane Hospital.
- Approved conditionally. Awaiting response from researcher.
16. A survey of the use of, understanding about and attitudes towards
Complementary and Traditional Therapies (CAM/TT) amongst a sample of
patients admitted to Gisborne Hospital.
Investigators: Dr Patrick McHugh, Dr Fergus Aitcheson, Dr Bruce Duncan,
Amanda Howard, Prof John Shaw.
Ethics ref:
NTY/05/12/099
Locations: Gisborne Hospital.
- Response received and under review..
17. To improve our understanding of tangata whaiora Maori and whanau needs
from mental health inpatient services when acutely unwell. This project aims to
identify factors that contribute to better outcomes for Maori when admitted to
Te Whetu Tawera (TWT), Auckland City Adult Inpatient Mental Health,
Auckland District Health Board (ADHB).
Investigators: Julie Maria Wharewera-Mika.
Ethics ref:
NTY/05/12/100
Locations: Te Whetu Tawera (TWT), ADHB.
- Approved conditionally. Awaiting response from researcher.
18. Outcome of Cemented vs Uncemented Hemiarthroplasty. A Randomised
Clinical Trial.
Investigators: Dr Mark Wright, Dr Fraser Taylor.
Ethics ref:
NTY/05/12/101
Locations: Auckland City Hospital.
- Approved conditionally. Awaiting response from researcher.
19. Evaluation of two novel methods to verify smoking status.
Investigators: Dr Hayden McRobbie, Dr Chris Bullen, Professor Nikola
Kasabov, Ruey-bin Lin, Dr Shaoning Pang, Dr Anthony Rodgers, Dr Robyn
Whittaker.
Ethics ref:
NTY/05/12/102
Locations: Tamaki Healthcare PHO, Greenlane Clinical Centre, ADHB.
- Approved conditionally. Awaiting response from researcher.
20. Development of a type 1 diabetes and exercise resource suitable for use by
dietitians who specialize in the area of diabetes, and which meets the needs of
patients whith type 1 diabetes.
Investigators: Angela Swan
Ethics ref:
NTY/05/12/103
Locations: Northshore Hospital, Diabetes Centre, WDHB.
- Approved conditionally. Awaiting response from researcher.
21. Reconciling requirements for evidence with treatment of the individual (in Otitis
Media with Effusion).
Investigators:
Wouter TenCate, Georgia Broadhurst, Paul Cheng, Rima
Bennett, Zahoor Ahmad, Jo Wallace, Andrea Kelly, Peter Thorne.
Ethics ref:
NTY/05/12/104
Locations: South Auckland Clinical School.
- Deferred. Response received and under review.
22. The incidence of residual neuromuscular blockade after general anaesthesia
using a muscle relaxant.
Investigators: Sophie Leitch, Dr Doug Campbell, Dr Guy Warman, A/Prof
Michael Harrison, Prof. Alan Merry.
Ethics ref:
NTY/05/12/105
Locations: Auckland City Hospital.
- Approved conditionally. Awaiting response from researcher.
23. Early Prediction of Brain Damage after Acute Brain Injury in Children.
Investigators: Dr John Beca, A/Prof Chris Williams, A/Prof Brian Anderson,
Dr David Buckley, Dr Melinda Nolan, Dr Clair Spooner.
Ethics ref:
NTY/05/12/107
Locations: Starship Hospital.
- Approved conditionally. Awaiting response from researcher.
24. Short and Long-term Efficacy of a School-Based Nutrition and Activity
Programme on Year 01 Male Students.
Investigators: Geoffrey D Juranovich, Dr David Graham, Prof Elaine Rush, Dr
Andrew Kilding..
Ethics ref:
NTY/05/12/108
Locations: Schools.
- Approved conditionally. Awaiting response from researcher.
25. Intraocular Pressure Fluctuations in Response to Water-Drinking provocation
Tests in Patients with Glaucoma..
Investigators: Dr Helen Danesh-Meyer.
Ethics ref:
NTY/05/12/109
Locations: Eye Institute, Auckland.
- Approved conditionally. Awaiting response from researcher.
26. Cardiovascular risk profile and determinants of risk in mental health patients.
Investigators: Monica Zolezzi, Dr. Jeff Harrison, Vladen Totev, Elton Zheng.
Ethics ref:
NTY/05/12/110
Locations: Middlemore, NorthShore and Auckland City Hospitals.
- Approved conditionally. Awaiting response from researcher.
FINAL ETHICAL APPROVAL UNDER CHAIRPERSON’S DELEGATED
AUTHORITY
1. A Phase I, Multi-Centre, Open Label, Dose Escalation Trial Of The Safety And
Pharmacokinetics Of Intravenous PR-104 Given Every 3 Weeks In Patients
With Solid Tumors.
Investigators: Dr Michael Jameson, Dr Ian Kennedy, Dr Marion Kuper, Dr
Jacqui Adams, Dr Jeremy Long, Dr Ziad Thotathill.
Ethics ref: NTY/05/10/078
Locations: Waikato Hospital.
2. Assessing Rheumatology Outcomes Study: Investigation of the Concurrent
Validity of the QE Health Scale(QEHS): Part 2.
Investigators: Kieren Faull, Maraina Taotahi
Ethics ref:
NTY/05/11/080
Locations:
QE Health out patient clinics.
3. The reliability and validity of the StepWatch Step Activity Monitor as a
measure of gait ability in adults with physical disabilities following stroke.
Investigators: Suzie Mudge, A/Prof Susan Stott, Sharon Wlat, Alan Barber
Ethics ref:
NTY/05/11/081
Locations: University of Auckland Gait Laboratory, Dept of Sport and
Exercise Science in Tamaki Campus.
4. The psychosocial rehabilitation of people with burn injuries: Investigating the
needs of patients.
Investigators: Dr Jeanne Reeve, Linda Cameron, Frances James, Paul Brown,
Stephen Mills.
Ethics ref:
NTY/05/11/084
Locations: Participants’ home/Middlemore Hospital/University of Auckland
5. The Management of Pretibial Skin Tears in the Ambulant Elderly in a Rural
General Practice Setting.
Investigators: Dr Paul Kennedy, Sally Davies.
Ethics ref:
NTY/05/11/085
Locations: Te Awamutu Medical Centre.
6. Anxiety levels in women undergoing fetal fibronectin testing for threatened
preterm labour.
Investigators: Dr Emma Parry, Clare Wu Yang, Dr Alistair Haslam.
Ethics ref:
NTY/05/11/091
Locations:
National Women’s Hospital, Waikato Hospital.
7. Sentinel Lymph Node Biopsy versus Axillary Clearance in Operable Breast
Cancer – The RACS SNAC 2 Trial. A multicentre, centrally randomised, phase
III clinical trial of non-inferiority of the Royal Australian College of Surgeons
Section of Breast Surgery in collaboration with the NHMRC Clinical Trials
Centre, University of Sydney. Protocol version 1.0: dated 28/10/2005.
Investigators: Dr Ian Campbell, Lou Hayes.
Ethics ref:
NTY/05/11/092
Locations:
St Anne’s Breastcare centre, Waikato Hospital.
8. IBCSG 23-01: Sentinel Lymph Node Biopsy(Micrometastases) Trial – A
randomised trial of Axillary dissection versus no axillary dissection for patients
with clinically node negative breast cancer and micrometastases in the sentinel
node.
Investigators: Dr Ian Campbell, Lou Hayes, Denis Whittle.
Ethics ref:
NTY/05/11/093
Locations:
St Anne’s Breastcare centre, Waikato Hospital.
9. A phase IA/II multicentre, dose-escalation study of oral AMN107 on a continuous
daily dosing schedule in adult patients with Glivec (imatinib)-resistant/intolerant
CML in chronic or accelerated phase or blast crisis, relapsed/refractory
Ph+ALL, and other haematologic malignancies.
Investigators: Dr Peter Browett, Dr Timothy Hawkins, Dr Leanne Berkahn, Dr
Richard Doocey.
Ethics ref:
NTY/05/12/106
Locations: Auckland City Hospital.
NEW PROTOCOLS
1. Breast International Group Trial 1-98. Fingernail Pilot Sub study. Investigating
properties of fingernails to determine the efficacy of nail structure for evaluating
bone fragility.
Investigators: Dr Ian Campbell.
Ethics ref:
NTY/06/01/001
Locations: Waikato Hospital.
2. The Physical Activity and Disability Survey(PADS): A reliability and validity
study in people with multiple sclerosis.
Investigators: Nicola Kayes, Kathryn McPherson, Denise Taylor, Gregory
Kolt.
Ethics ref:
NTY/06/01/002
Locations: Auckland MS Society.
3. Improving the appropriateness of Therapeutic Drug Monitoring at Waikato
Hospital.
Investigators: Andre Mutavdzic
Ethics ref:
NTY/06/01/003
Locations: Waikato Hospital.
EXTENSIONS / MODIFICATIONS / AMENDMENTS
1. A Randomised, Blinded, Phase 11b Trial of Telbivudine (LdT) versus the
Combination of Telbivudine and Valtorcitabine (Val-LdC) in Patients with
Chronic Hepatitis B.
Ethics ref: NTY/05/03/013
1.For approval:
-Protocol (NV-02C-004) Amendment 1 dated November 2, 2005.
-Protocol Amendment 1- Summary of Changes.
-Revised Patient Information Sheet and Consent -version 4 dated 05 January 052006, Dr Ed Gane (PI, Lead Site 004).
-Revised Patient Information Sheet and Consent -version 4 dated 05 January 052006, Dr Chris Moyes ( Site 010).
2. For approval:
-File note: Discrepancy in consenting process.
-File Note: Reimbursement of petrol vouchers.
2. A Phase 3, double-blinded, randomised study of the safety, tolerability and
analgesic efficacy of multiple doses of Ketorolac Tromethamine administered
intranasally for Postoperative pain following major abdominal surgery.
Ethics ref: NTY/05/06/036
For approval
-Protocol Amendment 4 dated 10 November 2005.
ADVERSE EVENT REPORTS for receiving and noting
1. An open-label randomised, Phase 3 clinical trial of ABX-EGF plus best
supportive care versus best supportive care in subjects with metastatic
colorectoral cancer (ABX-EGF 20020408).
Ethics ref: WAI/04/02/005
A multicenter open-label single arm clinical trial to determine the safety of
ABX-EGF extended therapy in subjects with metastatic colorectoral cancer
(20030194).
Ethics ref: WAI/04/02/006
2 events notified on 1/12/05: US157019-typhlitis, US136163-hypocalcaemia.
4 events notified on 15/12/05: US158652-asthenia, US158830-arterial embolism,
UK159129-hyplocalcaemia, US148571-fistula.
2. Breast int. Group trial 1-98. A phase III study to evaluate letrozole as
adjuvant endocrine therapy for women with receptor (ER and/or PgR) positive
tumours.
Ethics ref: WAI/75/97/482 (2) and (4).
1 event notified on 30/11/05: PHHO2002FR05239-arteritis.
2 events notified 6/12/05: PHH02005BE16108–pseudogout, PHHO2005PL16188osteomyelitis.
1 event notified on 9/12/05: 300359-osteoarthritic change.
1 event notified on 19/12/05: PHHO2005PL16188-arthritis.
1 event notified on 19/12/05: 300606-cervicites.
3. An inter co-operative group, multicentre, randomised double-blind trial in
postmenopausal women with primary breast cancer who have received adjuvant
tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane treatment
with further tamoxifen.
Ethics ref: WAI/25/98/520
3
events notified 8/12/05: MFR2005145166-transient ischemic
MFR2005152968- hypertension, MFR2005154103- tachycardia.
attack,
4. Tamoxifen and Exemestane Trial (TEXT): A Phase III Trial Evaluating the role
of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal
Women with Endocrine Responsive Breast Cancer.
Protocol No: IBCSG 25-02/BIG 3-02 (TEXT), version 1.1, 17 April 2003.
Ethics ref: NTY/05/08/064
3 events notified 20/12/05: MFR2005110299-sensory neuropathy, MFR2005117219vaginal dysplasia, MFR2005120890- bone fracture.
IBCSG monthly summary notified 20/12/05: Sept and October 2005.
IBCSG monthly summary notified 20/12/05: July and August 2005.
5 events notified 20/12/05: MFR2005145166-transient ischemic attack,
MFR2005152968- hypertension, MFR2005154103- tachycardia, MFR2005134090hypersensitivity, MFR2005136143-cerberovascular accident.
5. A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy
and Safety Comparison of One-Year Treatment of Two Doses (5mg (2 actuations
of 2.5 mg) and 10mg (2 actuations of 5mg)) of Tiotropium Inhalation Solution
Delivered by the Respimat Inhaler in Patients with Chronic Obstructive
Pulmonary Disease (COPD). Protocol No: 205.255.
Ethics ref: WAI/02/08/055
1 event notified 11/2/05 at Waikato Hospital: JMR(7688) – COPD exacerbation.
1 event notified 1/7/05 at Waikato Hospital: ENC(7632) – Haemoptysis.
6. A Randomised, Blinded, Phase 11b Trial of Telbivudine (LdT) versus the
Combination of Telbivudine and Valtorcitabine (Val-LdC) in Patients with
Chronic Hepatitis B.
Ethics ref: NTY/05/03/013
2 events notified 24/11/05: AUV-205-death, AUV-85-hepatitis B.
1 event notified 22/12/05: AUV-217-lymphona.
REPORTS RECEIVED for NOTING
1. Clinicians attributions towards individuals with co morbid mental health and
substance use disorders.
Ethics ref: NTY/05/07/046
Final report for noting. Received 11/1/06
Reports of previously Waikato studies
1. A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy
and Safety Comparison of One-Year Treatment of Two Doses (5mg (2 actuations
of 2.5 mg) and 10mg (2 actuations of 5mg)) of Tiotropium Inhalation Solution
Delivered by the Respimat Inhaler in Patients with Chronic Obstructive
Pulmonary Disease (COPD). Protocol No: 205.255.
Ethics ref: WAI/02/08/055
Final report for noting. Received 8/12/05.
For noting: Includes notification letter from sponsor.
Reports of previously Bay of Plenty studies
1. Clinical investigation of an adjustable continence therapy(ACT) periurethral
prosthetic system for treatment of stress urinary incontinence in postprostatectomy patients.
Ethics ref: BOP/01/06/18
Progress report received 4/1/06. For noting.
2. Understanding ageing: An exploratory study of resilience and frailty in older
people in the Bay of Plenty..
Ethics ref: BOP/04/02/008
Final report received 22/12/05. For noting. Publication attached.