Get documents about "NORTHERN YR EGIONAL ETHICS COMMITTEE - Get Now DOC
Document Sample
NORTHERN Y REGIONAL ETHICS COMMITTEE
MINUTES OF THE MEETING
Held on Tuesday, 26 May 2009
At the Ministry of Health, BNZ Building, 354 Victoria St, Hamilton
At 11.30 am
MEMBERS ATTENDING
Dr Willem Fourie (in the chair), Dr Tessa Turnbull, Mr Michael Vale, Dr Adelaide
Collins, Ms Sanya Ram, Mr Alistair Stewart, Dr John Fitzgerald, Ms Raewyn Sporle.
Administrator: Amrita Kuruvilla
APOLOGIES
Ms Christina Bryant.
APPROVAL OF MINUTES OF PREVIOUS MEETING
Approval of minutes of the meeting held on 28 April 2009.
-Approved.
CHAIRPERSON’S REPORT
Receive -Report of the Chairperson.
-The committee was informed that the meeting for Regional Ethics Committee
Chairpersons held in Wellington on 21 May 2009 was attended by Tessa Turnbull.
GENERAL BUSINESS
1. Proposed ongoing training to be held on 26 and 27th June in Wellington – The
Deputy Chairperson requested all the committee members to attend the training.
2. FRST meeting to be held by Bioethics group, Dunedin School of Medicine –
Adelaide Collins agrees to attend the meeting in Hamilton on 10 June 09 and
Mike Vale in Auckland on 11 June 09 on behalf of the committee.
MATTERS ARISING
1. A phase 1, ascending dose and parallel group trial to establish the safety,
tolerability and pharmacokinetic profile of intravitreous injections of E10030
(anti-PDGF pegylated aptamer) given in combination with Lucentis® 0.5 mg/eye
in subjects with neovascular age-related macular degeneration.
Investigators: Dr Philip Polkinghorne, Dr Mark Donaldson, Dr Andrew
Riley.
Ethics ref: NTY/08/08/076
Locations: Greenlane Clinical Centre.
- Approved conditionally. Awaiting response from researcher. Ethical approval to
be withdrawn this month if response was not received from the researcher.
2. Pilot study of exercise programme for youth with first episode psychosis on
antipsychotic medication.
Investigators: Shane McCardle, Dr Sally Merry, Dr Emily Cooney, Sarah
Stanley.
Ethics ref: NTY/08/08/083
Locations: Kari Centre in Auckland.
- Approved conditionally. Awaiting further response from researcher. Researcher
requested more time to submit a response. Ethical approval to be withdrawn next
month if response is not received from the researcher.
3. An Acute Randomized, Controlled Observational Preference Study of the
Solace™ Intra Vesical System (Various Balloon Configurations) In the
Management of Female Subjects with Stress Urinary Incontinence
Investigators: Peter J Gilling, Mark R Fraundorfer, Andre M Westenberg, Liam
C Wilson
Ethics ref: NTY/08/09/087
Locations: Promed Urology Ltd, Tauranga.
- Deferred. Response from researcher delay due to device design changes.
4. A double blind, randomized control trial to compare ondansetron and cyclizine
for the prevention of vomiting when ketamine sedation is used in the
emergency department during invasive procedures on children.
Investigators: Dr Anna D Nienaber, Dr Martyn Harvey
Ethics ref: NTY/08/09/089
Locations: Waikato Hospital
- Approved conditionally. Awaiting response from researcher. Ethical approval to
be withdrawn this month if response is not received from the researcher.
5. Volumetric and Growth Factors Assessment of Negative Pressure Wound
Therapy.
Investigators: Dr T Vasudevan, Dr Nathaniel Chiang, Dr C Holdaway, Dr D
Ferrar, Dr P Haggart.
Ethics ref: NTY/08/11/104
Locations: Waikato Hospital.
- Approved conditionally. Awaiting response from researcher. Ethical approval to
be withdrawn this month if response is not received from the researcher.
6. Investigation into normal values for parameters derived from suprasystolic,
oscillometric brachial artery waveforms collected non-invasively from a sample
of the Auckland population.
Investigators: Dr Wayne Hing, Kirsty Neal, Dr Andrew Lowe, Prof Ahmed
Al-Jumaily, Dr Maggie Ma.
Ethics ref: NTY/08/12/113
Locations: Flexa Clinic, Forrest Hill Physiotherapy, Northcote Care
Chemist, Jireh Health Limited.
- Approved conditionally. Awaiting response from researcher. Ethical approval to
be withdrawn this month if response is not received from the researcher.
7. A pilot study to test the effectiveness of a Computerised CBT resource for Maori
adolescents experiencing mild to moderate depressive disorder.
Investigators: Matt Shepherd, Kim Todd. Supervisor: Dr Sally Merry
Ethics ref: NTY/09/01/003
Locations: Tuakau College, Te Aho Tapu Trust
- Approved conditionally. Awaiting response from researcher.
8. An Evaluation of the Rangatahi Maori Sexual and Reproductive Health Strategy
for Hamilton: The “Rangatahi Realising Potential” Project.
Investigators: Naina Watene, Keri Thompson, Dr Michelle Levy, Louise
Were.
Ethics ref: NTY/09/02/009
Locations: Te Runanga O Kirikiriroa
- Approved conditionally. Awaiting response from researcher.
9. Validation and application of melamine co-polymer UV indicator for assessing
hand washing proficiency.
Investigators: Dr David Lang, Dr Wayne Hazell
Ethics ref: NTY/09/02/012
Locations: CMDHB
- Deferred. Awaiting response from researcher.
10. Procalcitonin in blood and sputum as a marker of bacterial infection in acute
exacerbations of bronchiectasis.
Investigators: Dr Conroy Wong, Dr Susan Taylor, Dr Lata Jayaram, Dr
David Holland, Sarah Mooney.
Ethics ref: NTY/09/02/015
Locations: CMDHB
- Approved conditionally. Response received and under review.
11. Prophylaxis with Lactobacillus GG plus Lactoferrin in very low birth weight
neonates in a Neonatal Intensive Care Unit: a randomised study to reduce late
onset sepsis and necrotizing enterocolitis.
Investigators: Dr Michael Meyer, Tanith Alexander
Ethics ref: NTY/09/02/017
Locations: Middlemore Hospital
- Approved conditionally. Response received and under review.
12. Percutaneous pulmonary valve (Melody) for patients with congenital heart
disease.
Investigators: Dr Clare O’Donnell, Dr Nigel Wilson
Ethics ref: NTY/09/02/019
Locations: ADHB
-Approval postponed. Awaiting response from further consultation .
13. A grounded theory study of older adult’s recovery from fracture of the hip.
Investigators: David Healee. Supervisor: Dr Antoinette McCallin.
Ethics ref: NTY/09/03/020
Locations: Auckland region.
- Approved conditionally. Response received and under review.
14. Assessment of Vitamin D levels in patients with cutaneous lupus.
Investigators: Dr Paul Jarrett, Dr Giridar Raj.
Ethics ref: NTY/09/03/022
Locations: CMDHB
- Approved conditionally. Response received and under review.
15. A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate
the Safety and Efficacy of MN-221 When Administered Intravenously as an
Adjunct to Standard Therapy to Adults With an Acute Exacerbation of Asthma.
Investigators: Dr Wayne Hazell, Dr Louise Finnel, Dr Eunicia Tan.
Ethics ref: NTY/09/01/03/023
Locations: CCRep, Middlemore Hospital
- Approved conditionally. Response received and under review.
16. Clinical and dermoscopic evaluation of melanocytic naevi exposed to ultraviolet
radiation during narrowband UVB phototherapy.
Investigators: Dr Amanda Oakley, Dr Marius Rademaker, Dr Anthony
Yung, Dr Eugene Tan.
Ethics ref: NTY/09/03/024
Locations: Waikato Hospital
- Approved conditionally. Awaiting response from researcher.
17. Randomised, double-blind, placebo-controlled study of the efficacy of Mobicosa
in the treatment of osteoarthritis.
Investigators: Dr Mike Williams, Dr Chris Tofield, Dr Nick Gailer, Dr Dirk
Venter, Dr Maryann Watson.
Ethics ref: NTY/09/03/026
Locations: GP’s clinics and Clinicanz offices.
- Approved conditionally. Awaiting response from researcher.
18. Should recovery practices within mental health services be monitored? If so,
how can organisational recovery orientation be measured? A qualitative inquiry.
Investigators: Lola Ianovski. Supervisor: Kate Diesfeld.
Ethics ref: NTY/09/03/030
Locations: Auckland region.
- Approved conditionally. Awaiting response from researcher.
19. Prospective randomised trial comparing GTN, Botox-A and GTN with Botox –
A in the treatment of anal fissure.
Investigators: Dr Shahab Siddiqi, Dr Simi Lolohea, Dr Muhammad Asim.
Ethics ref: NTY/09/04/032
Locations: Waikato DHB
- Deferred. Awaiting response from researcher.
20. A randomised comparison of combined suprascapular and axillary (circumflex)
nerve block with interscalene block for postoperative analgesia following
arthroscopic shoulder surgery.
Investigators: Dr Darcy Price, Dr Michael Lorimer, Dr Amitha Abeysekera.
Ethics ref: NTY/09/04/033
Locations: Southern Cross North Harbour Hospital
- Approved conditionally. Awaiting response from researcher.
21. The Lower Limb Tasks Questionnaire; is it useful in the assessment of function
in low back pain sufferers?
Investigators: Roma Forbes, Prof Peter McNair, Peter Larmer.
Ethics ref: NTY/09/04/034
Locations: Avondale Physiotherapy
- Approved conditionally. Awaiting response from researcher.
22. The impact of cognitive and physical disability on the use of multi-touch
interfaces after traumatic brain injury.
Investigators: Phil Howard, Duncan Babbage.
Ethics ref: NTY/09/04/035
Locations: CAVIT Rehabilitation (Auckland), Stewart Centres in
Epsom, Papatoetoe, Hamilton, Tauranga and Gisborne.
- Approved conditionally. Awaiting response from researcher.
23. Youth e-therapy in Alternative Education and Youth Work Programmes:
Evaluation of a computerised cognitive behavioural therapy (CCBT)
Programme, for adolescents who have mild to moderate depression and are in
Alternative Education or Intensive Youth Work Programmes.
Investigators: Theresa Fleming. Supervisor: Dr Sally Merry.
Ethics ref: NTY/09/04/036
Locations: HOWPAR Alternative Education, 274 YOUTHCORE
- Approved conditionally. Awaiting response from researcher.
24. A cost benefit analysis of conducting sponsored clinical drug trials in a publicly
funded New Zealand hospital.
Investigators: Lynette Murphy, Dr William Maguire, Dr Willem Fourie.
Ethics ref: NTY/09/04/037
Locations: Manukau Institute of Technology
- Approved conditionally. Awaiting response from researcher.
25. Active Comparator Trial of Taspoglutide vs Pioglitazone as Add-on to
Sulfonylurea Monotherapy or Metformin Plus Sulfonylurea Combination
Therapy ( Protocol BC21893).
Investigators: Dr Ajith Dissanayake, Dr Paul Drury.
Ethics ref: NTY/09/04/038
Locations: CMDHB, ADHB
- Approved conditionally. Awaiting response from researcher.
NEW PROTOCOLS
1. A phase III multicenter, randomized, parallel, controlled, double blind study to
investigate the safety and efficacy of inhaled mannitol over 12 months in the
treatment of bronchiectasis.
Investigators: A/Prof Jeffrey Garrett, A/Prof John Kolbe, Dr Mark
O’Carroll, Dr Chris Lewis, Dr Conor O’Dochartaigh.
Ethics ref: NTY/09/05/039
Locations: CMDHB, ADHB
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr Garrett joined the meeting by
teleconference.
Application Form:
-Please clarify if there is any risk to those on the placebo arm and if those on the placebo
treatment will have to stop any other ongoing treatment.
-Please clarify what is meant by the investigator database.
-A4.1.Please clarify what is meant by ‘competitive recruitment’. How many participants
are likely to be recruited in each site?
-A6. The committee strongly recommends that the results of the study should be
published and not where permission is given.
-B14. It is mentioned that Pharmaxis reps will be visiting the sites to ensure patient
safety. Please confirm that it is actually the investigators’ responsibility to ensure that
patient safety is maintained.
Information Sheet and Consent Form:
- The Information Sheet refers to the Australian Privacy Act and guidelines. Please revise
the Information Sheet for New Zealand and refer to the NZ RMI guidelines.
-The Information Sheet refers to a potential benefit to those not on a placebo arm. Please
clarify for the participants if there is any risk to those on a placebo arm and if those on
the placebo treatment will have to stop any other ongoing treatment.
-The Information Sheet should clearly include in bold letters what the participants will
and will not be compensated for as stated in Section C of the application form.
-PIS. Page 10. 3rd Line. Insert ‘and injuries’ after circumstances.
2. A Prospective Cohort Study Investigating Determinants of Survival In Melanoma
Patients With A Positive Regional Node. (UK MREC NO: 07/Q1205/83)
Investigators: Prof Marius Rademaker, Prof J Newton Bishop, others.
Ethics ref: NTY/09/05/040
Locations: Waikato DHB
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.
Application Form:
-#18. Please amend the starting and closing dates according to NZ ethics approval.
-Please clarify if there is going to be any prospective or retrospective recruitment.
-C. The committee considers that this study is a clinical trial. Please tick the ‘yes’ box.
-Please provide a copy of the scientific review mentioned in the application.
-The questionnaires should be modified for New Zealand.
-Please amend #55 and other similar questions in the questionnaire as they appear odd.
Rather the questions should be framed regarding working hours, exercise etc.
Information Sheet and Consent Form:
-CF. Page 2. 5 b). Please clarify why the tissue samples are mentioned as a ‘gift’ to
research. Please clarify what research it will used for and who the researchers are. This
information should be included in the PIS .
-The PIS should include the details of the genetic testing as mentioned in Part 5 , #3 of
the application form and that the samples will be stored for 20 years as mentioned in the
CF.
-PIS. Please note that “some Iwi disagree with storage of tissue or blood samples
citing whakapapa, and advise their people to consult prior to participation in research
where this occurs. However, it is acknowledged that individuals have the right to
choose to participate.” The committee advises that the above statement or a similar
statement should be included under the section on cultural responsibility to ensure
participant awareness and informed consent.
3. Australian and New Zealand Study of PDT in Choroidal Amelanotic Melanoma
(ANZSOPICAM).
Investigators: Dr Peter Hadden, William Campbell, Michael Giblin, Max
Conway, John McKenzie, Sid Finnigan, William Glasson, James Muecke.
Ethics ref: NTY/09/05/041
Locations: University of Auckland
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.
Application Form:
-#18. Please amend the starting and closing dates.
-Please clarify if a visual diagnosis or histological diagnosis is to be made.
Please clarify if recruitment will be conducted outside Auckland also? If so please
provide details of recruitment.
-Please clarify how the study will be funded.
-The committee expressed concern that the participants in this study are to undergo a
treatment that has little clarity and history and that the participants will be moving from
an already effective treatment. The committee requests that the study should be
conducted on a very small number of participants to test the effectiveness of the
treatment before embarking on a major clinical trial. Please comment.
-The committee requests information about the 9 patients and the results of the
Melbourne trial to confirm the claims stated in this application. Also please provide a
history of the standard treatment as there is to be a comparison of those results to this
proposed study.
-A3.2.1. The study has been portrayed as a clinical trial but there is no comparison group
as is usual in most clinical trials. Please clarify.
-A3 and B5. Please provide more information on the sample size and the method of
analysis.
-F3.2. As some Maori maybe of European ancestry and therefore be able to participate in
this study, the committee requests that the researcher should consult with Maori research
review groups and provide evidence of the consultation.
Information Sheet and Consent Form:
-Please include the voluntary clause statement to the beginning of the Information
Sheets. (Please refer to the guidelines).
-PIS. Section 7. The committee considered the statement to be highly emotive as it
induces patients to take part in this trial while portraying previous or other treatments
as drastic. Please modify the statement.
-The Information Sheets and Consent Forms should have a statement that ethical
approval has been given by the Northern Y Regional Ethics Committee.
-PIS. Please include all the contraindications and possible side-effects.
4. The effect of calcium supplements on bone density in postmenopausal women: a
20-year follow-up study.
Investigators: Prof Ian Reid, Dr Mark Bolland, A/Prof Andrew Grey, Dr
Anne Horne.
Ethics ref: NTY/09/05/042
Locations: University of Auckland
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.
Application Form:
-F3.1. Please clarify why it is stated that Maori women are unlikely to have osteoporosis.
It is likely that Maori women may have Pakeha or Asian ancestry.
-F3.2.The committee requires evidence of consultation with Maori .
-Part 5. #1.9. and #3. Please clarify why the blood samples are being stored for 5 years
and what further research will be conducted using these samples? This information
should be incorporated in the PIS.
Information Sheet and Consent Form:
-The Information Sheets and Consent Forms should have a statement that ethical
approval has been given by the Northern Y Regional Ethics Committee.
-Information Sheet. Please note that “some Iwi disagree with storage of tissue or
blood samples citing whakapapa, and advise their people to consult prior to
participation in research where this occurs. However, it is acknowledged that
individuals have the right to choose to participate.” The committee advises that the
above statement or a similar statement should be included under the section on
cultural responsibility to ensure participant awareness and informed consent.
5. The effect of primary hyperparathyroidism on bone mineral density in
postmenopausal women: a 15 year follow-up study.
Investigators: A/Prof Andrew Grey, Dr Mark Bolland, Prof Ian Reid, Dr
Anne Horne.
Ethics ref: NTY/09/05/043
Locations: University of Auckland
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.
Application Form:
-B10. Please include in the exclusion criteria those who have had surgery or treatment
for the condition.
-F3.2.The committee requires evidence of consultation with Maori .
Information Sheet and Consent Form:
-Please include the voluntary clause statement to the beginning of the Information
Sheets. (Please refer to the guidelines).
-The Information Sheets and Consent Forms should have a statement that ethical
approval has been given by the Northern Y Regional Ethics Committee.
-Information Sheet. Please note that “some Iwi disagree with storage of tissue or
blood samples citing whakapapa, and advise their people to consult prior to
participation in research where this occurs. However, it is acknowledged that
individuals have the right to choose to participate.” The committee advises that the
above statement or a similar statement should be included under the section on
cultural responsibility to ensure participant awareness and informed consent.
6. Pharmacy 410 Research Dissertation Project – Assessing respiratory inhaler
technique in adult New Zealanders and who is responsible for demonstrating it.
Investigators: Cole Evans, Christopher Chew, Christine Bang, Sae Hee Baik,
George Saad, Linda Bryant. Supervisor: Diane Wiseman .
Ethics ref: NTY/09/05/044
Locations: North Shore Community pharmacies.
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Diane Wiseman and others joined the
meeting by teleconference.
Application Form:
-F3.2.The committee requires evidence of consultation with Maori .
Information Sheet and Consent Form:
-Please include the voluntary clause statement to the beginning of the Information
Sheets. (Please refer to the guidelines).
-PIS. Please modify the purpose of the study to clarify that the individual participant’s
inhaler technique will not be judged.
-Please include a date and version number for all the Information Sheets and Consent
Forms.
- The pharmacists’ consent form should be included in the Information Sheet.
-PIS and CF. Please modify the statement to clarify that the information will be kept for
10 years.
-PIS and CF. Please include a statement for the patients to give permission for the
researchers to contact/consult with their pharmacist.
-Please include the following statement and contact details for the Health and
Disability Advocate in the Information Sheet.
“If you have any questions or concerns about your rights as a participant in this
research study you can contact an independent health and disability advocate. This is
a free service provided under the Health and Disability Commissioner Act.”
Telephone: (NZ wide) 0800 555 050
Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT)
Email (NZ wide): advocacy@hdc.org.nz
-The Information Sheets and Consent Forms should have a statement that ethical
approval has been given by the Northern Y Regional Ethics Committee and please
remove the reference to national and multi-regional studies.
7. Acceptance of a computer-based heart imagery programme in the exploration of
beliefs about heart failure and adherence to symptom management among
Maori.
Investigators: Eva Morunga. Supervisor: A/Prof Linda Cameron.
Ethics ref: NTY/09/05/045
Locations: CMDHB
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Eva Morunga , Erana Cooper and Prof
Cameron joined the meeting by teleconference.
Application Form:
-Please clarify in what capacity is Erana Cooper a Maori advisor for this study. The
committee requests that the researcher should approach the Maori Research Review
Committee at CMDHB for consultation regarding Maori.
-B10. Please clarify what is meant by cognitive deficits and how that will be assessed and
by whom.
-B10. Please clarify why the inclusion criteria is limited to those below the age of 80 and
not above that age. The committee requests that if the people over the age of 80 who are
well enough wish to participate in the study then they must be included.
-E3. Please clarify why Maori will not be spoken as some participants may prefer to
interact in Te Reo Maori.
-E6. The committee requests that participants may not edit the transcripts but only check
the transcripts for accuracy.
Information Sheet and Consent Form:
-Please include a consent form for whanau.
-PIS. Page1. Viewing the computer programme is not mentioned as part of the study.
Please modify the statement.
-Please include a date and version number for all the Information Sheets and Consent
Forms.
8. An Open-Label, Multicenter, Protocol to Observe the Effects of Pegylated
Interferon Alfa-2a (PEGASYS®) as Monotherapy in Patients With Chronic
Hepatitis B who have Participated in Previous Roche or Roche Partner
Protocols.
Investigators: A/Prof Edward Gane, Dr Christian Schwabe, Dr Arlo Upton,
Dr Nicola Cranshaw, Dr Philippa Tanner, Dr Maggie Ow, Dr Ken Tan.
Ethics ref: NTY/09/05/046
Locations: Auckland Clinical Studies
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr Gane joined the meeting by
teleconference.
Application Form:
-A1.1. Please clarify what is meant by ‘access to treatment not available’.
-Please clarify why there is no DSMB in this study.
-Please clarify how many participants are there in PP22512 trial? Will all those
participants be moved to this new trial in NZ and overseas?
-Please clarify if genetic testing is being conducted in this study. If so then a Part 6 is
required.
Information Sheet and Consent Form:
- PIS. Page 17. Please clarify if genetic testing is being conducted in this study. If it is not
then please remove the reference to that in the PIS.
-Information Sheet. Please note that “some Iwi disagree with storage of tissue or
blood samples citing whakapapa, and advise their people to consult prior to
participation in research where this occurs. However, it is acknowledged that
individuals have the right to choose to participate.” The committee advises that the
above statement or a similar statement should be included under the section on
cultural responsibility to ensure participant awareness and informed consent.
General Comment:
-The committee suggests that the researchers should consult with the South-east Asian
groups as they are the target groups for this trial.
9. A Randomised Double Blind Placebo Controlled Pilot Study Of Intranasal
Midazolam Versus Oral Lorazepam For The Relief Of Dyspnoea And Effects
On Quality Of Life In Severe Respiratory Disease.
Investigators: Fiona Horwood, Diana Hart, Anurajith Seneviratna, Gray
Maingay, Nicola Corna, Irene Zeng.
Ethics ref: NTY/09/05/047
Locations: CMDHB
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Fiona Horwood joined the meeting by
teleconference.
Application Form:
-A3. The sample size for this study is suitable for a pilot study and as the researcher has
indicated that it was the intention to conduct a pilot, please revise the application form,
Information Sheets and Consent Forms to indicate that this is a pilot study.
-A3.2.1. Please answer the question.
-A3.3. Please clarify why this study is qualitative.
-F3.2.The committee requires evidence of consultation with Maori .
-Please provide a signed and completed Locality assessment form from CMDHB.
-Please clarify if this study drugs require SCOTT approval.
Information Sheet and Consent Form:
-Please list all the side-effects and contraindications of the medications used in the study
in the Information Sheet.
-Information Sheet. Please note that “some Iwi disagree with storage of tissue or
blood samples citing whakapapa, and advise their people to consult prior to
participation in research where this occurs. However, it is acknowledged that
individuals have the right to choose to participate.” The committee advises that the
above statement or a similar statement should be included under the section on
cultural responsibility to ensure participant awareness and informed consent.
EXTENSIONS / MODIFICATIONS / AMENDMENTS
1. Clinical Investigation of the ProACT(TM) Adjustable Continence Therapy for
Treatment of Post Prostatectomy Stress Urinary Incontinence.
Ethics ref: NTY/05//05/026
For approval:
-Request to undertake a sub-study of a group of patients enrolled in the study to collect
additional data on the specific location of the ProACT devices.
- Revised Investigational Plan/Protocol version UM02 rev 1.7 dated December 23 2008.
-Copy of letter to the FDA requesting changes to above protocol and letter from FDA
consenting to changes.
-PIS and CF version UM02 rev 1.7 dated December 23 2008.
Due to the additional data collected and tests involved, the committee declined to
approve the sub-study and requests that a full application should be submitted.
2. Protocol Number PR-104-1002. A Phase 1, Multi-Center, Open-Label, Dose
Escalation Trail of the Safety and Pharmacokinetics of Intravenous PR-104 Given
Weekly in Subjects with Solid Tumours dated 25 September 2006.
Ethics ref: NTY/06/10/103
For approval:
-PR104-1002 Protocol version 1.0 Amendment 1.0 dated 31st March 2009..
-PR104-1002 summary of changes pertaining to Amendment 1.0 .
-Waikato Hospital PIS and CF version 3.0 dated 14th Apr 2009.
-Auckland City Hospital PIS and CF version 3.0 dated 14th Apr 2009.
-Waikato Hospital PIS and CF for permission to access stored tissue samples version 1.0
dated 14th Apr 2009.
-Auckland City Hospital PIS and CF for permission to access stored tissue samples
version 1.0 dated 14th Apr 2009.
- Approved with conditions. The following statement to be included in all the
Information Sheets: “Some Iwi disagree with storage of tissue or blood samples citing
whakapapa, and advise their people to consult prior to participation in research
where this occurs. However, it is acknowledged that individuals have the right to
choose to participate.” The committee advises that the above statement or a similar
statement should be included under the section on cultural responsibility to ensure
participant awareness and informed consent.
The Information Sheets should explain what tests will be conducted on the samples.
3. A Study of Vitamin D, innate immunity and Severity of Community Acquired
Pneumonia and Exacerbations of COPD in Adults.
Ethics ref: NTY/08/05/045
For approval:
-Request regarding protocol violations and suggested amendments .
-Approved the request for changes. The committee suggests that a combination of
options 1 and 2 as suggested by the researcher should be used. Therefore a
retrospective written consent should be obtained and in cases where consent cannot
be obtained because the patient is incapacitated or deceased and next of kin is not
available to consent, the data should be withdrawn from the study.
4. RFB002, [Ranibizumab] A randomized, double-masked, multicenter, laser-
controlled Phase III study assessing the efficacy and safety of ranibizumab
(intravitreal injections) as adjunctive and mono-therapy in patients with visual
impairment due to diabetic macular edema. Clinical Trial Protocol [RFB002D2301].
Ethics ref: NTY/08/07/071
For approval:
- Amendment 4 : 16 March 2009.
-PIS and CF version 4 dated 16 March 2009.
- Investigators Brochure Edition 7 dated 11 December 2008.
- Approved.
5. Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Trial of
Selenomethionine as Modulator of Efficacy and Toxicity of Chemoradiation in
Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Ethics ref: NTY/07/12/135
For approval:
-Protocol RPCI # I 107807 incorporating Amendment 3: March 2, 2009.
-Summary of changes- Protocol RPCI # I 107807 incorporating Amendment 3: March 2,
2009.
- Approved.
ADVERSE EVENT REPORTS for receiving and noting
No: Ethics Ref No: Dates notified No: of Reference/Description
events
1. NTY/08/12/117 18/5/09 various Serum sickness….
-Noted
2. NTY/08/08/079 18/5/09 2 Lactic acidosis, acute renal failure
-Noted
3. NTY/08/07/069 18/5/09 2 Lactic acidosis, acute renal failure
-Noted
4. NTY/07/05/047 12/5/09 1 Hepatic failure,Polymorphic
25/2/09 1 ventricular tachycardia
-Noted
5. NTY/05/12/106 17/4/09 various Fall…..
-Noted. Please clarify if the DSMB
has noted these events and the
possibility that these could be
related to the study drug.
6. NTY/08/07/071 24/4/09 1 Acute coronary syndrome
-Noted
REPORTS RECEIVED FOR NOTING
Number Ethics Reference Number Progress/Final reports
1. NTY/07/05/047 Progress report dated 12/5/09.
Request for extension of time.
-Noted. Extension of ethical
approval.
2. NTY/06/11/111 Progress report dated 4/5/09
-Noted
3. NTY/07/03/025 Progress report dated 6/5/09
-Noted
4. NTY/08/01/007 Progress report dated 28/4/09
-Noted
5. NTY/06/12/131 Progress report dated 21/4/09
-Noted
6. WAI/03/09/069 Annual report dated 20/4/09
-Noted
FINAL ETHICAL APPROVAL UNDER CHAIRPERSON’S DELEGATED AUTHORITY
1. Pioglitazone in the treatment of acromegaly.
Investigators: A/Prof Andrew Grey, Dr David D W Kim, Prof Ian Holdaway
Ethics ref: NTY/09/01/004
Locations: ADHB
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.
-Approval noted
2. Does providing normal results earlier improve reassurance?
Investigators: Anna Patience, Prof Keith Petrie, Dr Nezar Amir, Dr Greg Gamble, Dr
Christopher Ellis.
Ethics ref: NTY/09/02/013
Locations: NorthShore Hospital, Waitakere Hospital
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.
-Approval noted
3. Part I: A blinded prospective randomised split mouth trial to observe bone height stability
around two different dental implants with the same attachment device used to secure lower
dentures.
Part II: A Prospective assessment of quality of life for the use of dental implants to secure lower
dentures.
Investigators: Dr Andrew Newsom, Dr John Bridgman
Ethics ref: NTY/09/02/018
Locations: Tauranga Oral & Maxillofacial surgery, Dental Implant Centre in Tauranga
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.
-Approval noted
4. Prenatal Complication and Psychological Stress.
Investigators: Carol Barber, Nicola Starkey.
Ethics ref: NTY/09/03/021
Locations: Waikato Hospital
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.
-Approval noted
5. Oranga Tāne Māori.
Investigators: Wayne Johnstone, Prof Ross Lawrenson, Dr Jacquie Kidd, Veronique Gibbons,
Erena Kara, Kingi turner, Rawiri Blundell, Kay Berryman.
Ethics ref: NTY/09/03/027
Locations: Waikato DHB
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.
-Approval noted
6. Optimising Ultrasound Guided Infraclavicular Brachial Plexus Block for Ambulatory Hand
Surgery.
Investigators: Dr Michael Fredrickson, Dr Philip Wolstencroft.
Ethics ref: NTY/09/03/028
Locations: SX North Harbour Hospital, The Northern Surgical Centre
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.
-Approval noted
7. Optimising Analgesia after Hip Replacement Surgery: A comparison of Patient Controlled
Lumbar Plexus Block and patient controlled IV Opioid Analgesia.
Investigators: Dr Michael Fredrickson, Dr Vincent Fong, Dr Tony Danesh-Clough.
Ethics ref: NTY/09/03/029
Locations: Southern Cross Brightside Hospital
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.
-Approval noted
8. Title: The Usefulness of Urodynamics in Children.
Investigators: Ms Jessica Win, Mr Vipul Upadhyay.
Supervisors: Joanne Rowe, Bridie Kent
Ethics Ref: NTY/09/14/EXP
-Approval noted
9. Audit of uptake of cervical screening in immunocompromised women; a comparison with
national NSCR recommendations.
Investigators: Dr Emma Lim, Dr Jane Morgan, Dr Richard Fielding
Ethics Ref: NTY/09/20/EXP
-Approval noted
The meeting concluded at 2.47 pm.
-------------------------------------------------------------------------------------------------------
