Investigators by P1OBWG

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									             NORTHERN Y REGIONAL ETHICS COMMITTEE
                         MINUTES OF THE MEETING

                      Held on Tuesday, 15 December 2009
       At the Ministry of Health, BNZ Building, 354 Victoria St, Hamilton
                                   At 11.30 am



MEMBERS ATTENDING

Mr Michael Vale (in the chair), Dr Tessa Turnbull, Mr Alistair Stewart, Dr Adelaide
Collins, Dr John Fitzgerald, Ms Sanya Ram, Ms Raewyn Sporle, Dr Etuate Saafi,.

Administrator: Amrita Kuruvilla

APOLOGIES

Ms Christina Bryant, Dr Willem Fourie, Mrs Mary Anne Gill .

APPROVAL OF MINUTES OF PREVIOUS MEETING

Approval of minutes of the meeting held on 24 November 2009.
-Approved.

CHAIRPERSON’S REPORT

Received -Report of the Chairperson.
-The Chairperson presented a summary of the Chairs Group meeting which was held
in Wellington on 3 Dec 09.
-The Chairperson also recognized that the committee had only one Maori
representative and that the committee required two Maori representatives .

GENERAL BUSINESS

None received.

MATTERS ARISING

1.     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 about delays due to device design changes.
       Further studies are being conducted overseas and the researchers are awaiting the
       outcome of these studies before amendments to the ethics application are
       submitted. Response from researchers is requested by 30/12/09.

2. Transurethral Direct Current Ablation Therapy for Benign Prostatic
   Hyperplasia. Protocol 100001.
     Investigators:   Dr Peter Gilling, Dr Mark Fraundorfer, Dr Andre
     Westenberg, Dr Liam Wilson.
     Ethics ref:    NTY/09/07/056
     Locations:      Tauranga Public Hospital.

       - Deferred. Awaiting response from researcher. Ethical approval to be withdrawn
       next month if response is not received from the researcher.

3. Clinical Investigation of the ProACT™ Adjustable Continence Therapy for
   Treatment of Post Prostatectomy Stress Urinary Incontinence – Placement Sub
   Study.
       Investigators: Dr Peter Gilling.
       Ethics ref:    NTY/09/07/062
       Locations:      Tauranga Hospital

       - Approved conditionally. Awaiting response from researcher. Ethical approval
       to be withdrawn next month if response is not received from the researcher.

4. Pilot evaluation of the efficacy of a novel automated flow control device used for
    IV infusion.
        Investigators: Dr John Baker.
        Ethics ref:    NTY/09/08/071
        Locations:      CMDHB.

       - Approved conditionally. Awaiting response from researcher.

5. A Single-Masked, Placebo Controlled, Multi-Center Pilot Study To Determine
   The Safety And Efficacy Of Orbital Injections Of A Fixed Dose Of LIP-102
   (Salmeterol Xinafoate (SX) And Fluticasone Propionate (FP) For Injection) In
   Patients With Symptomatic Exophthalmos Associated With Thyroid-Related
   Eye Disease (TED) (Protocol No. LIPO-102-CL-06).
      Investigators: Dr Richard Hart, Dr Ekta Aggarwal.
      Ethics ref:    NTY/09/08/073
      Locations:      Greenlane Clinical Centre.

       - Approved conditionally. Awaiting response from researcher.

6. Anatomical Anterior Cruciate Ligament Reconstruction. A Cohort study
   following the clinical outcomes of patients following Anterior Cruciate Ligament
   reconstruction, using a single bundle repair that is more anatomical.
       Investigators: Dr Carl Harmer, Dr Marc Hirner.
       Ethics ref:    NTY/09/08/076
      Locations:      Kensington Hospital

      - Approved conditionally. Awaiting response from researcher.

7. Validation of Silhouette Mobile™ - A handheld wound measurement device.
       Investigators: Dr Nathaniel Chiang, Dr T Vasudevan, Dr Paul Haggart, Ms
       Anna Kang, Dr David Ferrar, Dr Chris Holdaway.
       Ethics ref:    NTY/09/08/080
       Locations:      Waikato Hospital

      - Approved conditionally. Response received and under review.

8. Introducing the “WAIKATO” Risk Score = Predictive tool for Hospital Acquired
    Infections (HAI).
        Investigators: Dr Nathaniel Chiang, Dr T Vasudevan, Dr Paul Haggart, Ms
        Siew Ling Ong, Dr David Ferrar, Dr Chris Holdaway, Dr Anna Timmings.
        Ethics ref:    NTY/09/08/081
        Locations:      Waikato Hospital

      - Approved conditionally. Response received and under review.

9. Quality Of Life Amongst Pacific People Living With Type 2 Diabetes Mellitus In
    New Zealand.
      Investigators: Claire O’Brien. Supervisor: Dr John Parsons.
      Ethics ref:    NTY/09/09/083
      Locations:      CMDHB

      - Approved conditionally. Awaiting response from researcher.

10. Provision of acute care to young people: a consumer and health provider
   perspective.
      Investigators: Dr Robyn Dixon, Terryann Clark, Cate Fleckney.
      Ethics ref:    NTY/09/09/087
      Locations:      CMDHB

      - Approved conditionally. Response received and under review.

11. Studies of human lymphoid tissue.
       Investigators: A/Prof Rod Dunbar, Prof John McCall, Dr Adam Bartlett.
       Ethics ref:    NTY/09/09/092
       Locations:      ADHB

      - Approved conditionally. Awaiting response from researcher.

12. “Te Kaponga” – Whanau Maori and Mental Health: Snapshots of Strengths,
    Resiliency and Recovery.
       Investigators: Mere Balzer, Naina Watene, Alison Barnett, Keri Thompson.
       Ethics ref:    NTY/09/09/093
       Locations:      Te Runanga o Kirikiriroa
       - Approved conditionally. Awaiting response from researcher.

13. Prospective evaluation of a model to predict outcomes following Endovascular
    Aortic Aneurysm Repair (EVAR).
       Investigators: Dr Nathaniel Chiang, Dr Thodur Vasudevan, Dr Paul
       haggard, Dr Chris Holdaway, Dr David Ferrar.
       Ethics ref:   NTY/09/09/094
       Locations:     Waikato Hospital

       - Deferred. Awaiting response from researcher.

14. A Study into the efficacy of Child Protection Procedures and Policies in
   Auckland District Health Board in maintaining child safety.
      Investigators: Robyn Butler. Supervisor: Prof Helen Cowie.
      Ethics ref:    NTY/09/10/096
      Locations:      ADHB.

       - Deferred. Awaiting response from researcher.

15. What are the factors associated with, and the experiences of, successful weight
    maintenance in the Adult Weight Management Programme in the Waikato
    region.
       Investigators: Bryan Gibbison. Supervisor: Kathy Shaw.
       Ethics ref:    NTY/09/10/097
       Locations:      WDHB

       - Approved conditionally. Response received and under review.

16. Cross cultural communication with patients in the hospital setting.
       Investigators: Jeremy Rossaak, John Windsor, Malcolm Johnston, Patricia
       Cook, Clint Lovett.
       Ethics ref:    NTY/09/10/099
       Locations:      Tauranga Hospital

       - Approved conditionally. Awaiting response from researcher.

17. Does Project Energize work? Evaluation of physical activity interventions in
    primary schools.
       Investigators: Dr David Graham, Prof Elaine Rush, Stephanie McLennan,
       Kasha Latimer, Sarah Bristow, Prof Tim Olds.
       Ethics ref:    NTY/09/10/100
       Locations:      Sport Waikato

       - Approved conditionally. Awaiting response from researcher.

18. Total knee joint replacement; Intra-operative periarticular infiltration of local
    anaesthetic.
       Investigators: Mark Wright, Woosung Kim, Jacob Munro, Cameron Walker,
       Trevor Coe, Susan Callaghan.
       Ethics ref:    NTY/09/10/101
      Locations:      ADHB

      - Approved conditionally. Awaiting response from researcher.

19. A randomised double-blind placebo-controlled trial of Neratinib (HKI-272)
    after     Trastuzumab      in    women     with     early-stage  HER-2/neu
    overexpressed/amplified breast cancer.
        Investigators: A/Prof Vernon Harvey, Dr Reuben Broom, Dr David Porter,
        Dr mike McCrystal, Dr Richard Sullivan, Dr Rita Sasidharan, Dr Amanda
        Ashley.
        Ethics ref:    NTY/09/10/102
        Locations:      Auckland Hospital and Oncology 161

      - Approved conditionally. Awaiting response from researcher.

20. Evaluating the beneficial effect of fruit/fruit-derived supplement consumption
    on the body’s immune and repair/recovery mechanisms and investigating how it
    may boost the health benefits of regular exercise.
       Investigators: Dr Roger Hurst, Kirsty Lyall, Dr Suzanne Hurst, Dr Birgit
       Schrage.
       Ethics ref:    NTY/09/10/105
       Locations:      Plant and Food Research, Hamilton

      - Approved conditionally. Awaiting response from researcher.

21. Mauri Ora – growing healthy tamariki (children), whanau (families) and hapu
    (extended family groups) in Tuhoe communities.
        Investigators: Haromi Williams, Hemi Hireme, Ngawaiata Turnbull.
        Ethics ref:    NTY/09/10/106
        Locations:      Hinepukohurangi Trust

      - Approved conditionally. Response received and under review.

22. Measuring Blood Serum Androgen Levels in Women Following Hysterectomy.
      Investigators: Prof Cynthia Farquhar, Dr Reshma Desai.
      Ethics ref:    NTY/09/10/107
      Locations:      University of Auckland

      - Approved conditionally. Awaiting response from researcher.

23. Analgesia in posterior lumbar interbody fusion surgery: a prospective, double-
    blind, randomised, placebo-controlled study comparing perioperative
    intravenous dexamethasone with intrathecal morphine.
        Investigators: Dr Matthew Boyle, Dr John Ferguson, Dr Michael Barnes.
        Ethics ref:    NTY/09/11/108
        Locations:      Mercy Hospital - AKL

      - Approved conditionally. Awaiting response from researcher.

24. Radial vs. Femoral PCI Access Site Study.
      Investigators: Dr Gerard Devlin, Dr Cherian Sebastian, Dr Chris Nunn, Dr
      Yuli Ten, Dr Madhav Menon.
      Ethics ref:    NTY/09/11/109
      Locations:      Waikato Hospital
      - Approved conditionally. Awaiting response from researcher.

25. Evaluation of breastfeeding support services for Maori whanau in Te Tai
   Tokerau.
      Investigators: Amber Logan-Riley, Dr George Gray.
      Ethics ref:    NTY/09/11/110
      Locations:      NDHB, Te Hauora o te Hiku o te Ika, Te Runanga o te
      Rarawa, Ngati Hine Health trust, Plunket.

      - Approved conditionally. Awaiting response from researcher.

26. Immune defence proteins in human milk: differences between pre-term and
    term deliveries.
       Investigators: Tom Wheeler, Dr Arun Nair, Dr Liz Carpenter, Dr Rex
       Humphrey, Dr Kerst Stelwagen, Janet Black.
       Ethics ref:    NTY/09/11/111
       Locations:      WDHB, Agresearch

      - Approved conditionally. Awaiting response from researcher.

27. Identifying Aspiration and Reducing Pneumonia in Stroke Patients using Cough
    Reflex Testing.
       Investigators: Helen McLauchlan, Anna Miles, Maggie-Lee Huckabee,
       Edward Wong, Alan Barber.
       Ethics ref:    NTY/09/11/113
       Locations:      CMDHB, ADHB

      - Approved conditionally. Awaiting response from researcher.

28. A Multicenter, Long-Term Follow-Up Study Of The Safety And Efficacy Of
    Two Dose Levels Of Botox® (Botulinum Toxin Type A) Purified Neurotoxin
    Complex In Patients With Urinary Incontinence Due To Neurogenic Detrusor
    Overactivity. Protocol Number 191622-094-00.
       Investigators: Dr John Tuckey, Dr Ian Mundy, Dr Jenifer Somerfield.
       Ethics ref:    NTY/09/11/114
       Locations:      Gilgit Road Specialist Centre

      - Approved conditionally. Awaiting response from researcher.

NEW PROTOCOLS

1. Genetics of familial pituitary tumours.
       Investigators: A/ Prof John Conaglen, Dr Sarina Lim, Dr Marianne Elston.
       Ethics ref:     NTY/09/12/115
       Locations:       Dr Marta’s Lab, UK , Waikato Hospital.
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr Lim joined the meeting by
teleconference.

Application Form:
-#13. As blood samples are being taken for the study, and is considered as human tissue,
please tick the ‘yes’ box and complete Part 5 of the application.
-#18. Please amend the starting dates of the study.
-A4.2. Please clarify the number of participants in New Zealand.
-E9. The committee requests that reasonable travel costs must be reimbursed.
-Please clarify if family members have to contribute to additional costs if they are also
tested.
-Part 6. Please complete #3 and clarify the answer in #5.3 .
Information Sheet and Consent Form:
-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 should be
included under the section on cultural responsibility to ensure participant awareness
and informed consent. The Principal Investigator must be prepared to discuss the
implications with the patient before the patient agrees to participate.
-PIS. What control will the investigators in New Zealand have over the samples that
are stored in London in case of future research on those samples? Please clarify very
clearly in the PIS if the researchers in New Zealand do not have any control over the
future use of tissue samples.
-PIS. Page 2. Please remove the statement that participation will be stopped if the
surgeon feels it is not in their best interests to continue. Please clarify why the
statement was included.
-The PIS mentions the research sponsor. Please correct this as the study is not
sponsored.
-PIS. Detailed information regarding any costs of participation in the study must be
included in the PIS.

2. The effect of a computer-based patient education programme on rehabilitation
    adherence and shoulder function when used as an adjunct to physiotherapy in
    patients with shoulder injuries: a pilot study.
       Investigators: Heather Clark, Sandra Basset, Andrew Higgins.
       Ethics ref:    NTY/09/12/116
       Locations:      Physio Rehab Clinic, Glen Gallagher Clinic.

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.

Application Form:
-B8. Please include that access to a DVD player must be an inclusion criteria.
-B8. Please clarify why those under 25 are being excluded.
Information Sheet and Consent Form:
-The committee requests that it must be clarified in the PIS that the study is a pilot study
as explained in the application form.
-Please differentiate clearly between the normal treatment and the research, using
headings.

3. Bioenergetic and immunological profile in non-alcoholic fatty liver disease.
       Investigators: Dr Adam Bartlett, Dr Anthony Phillips, A/Prof Ed Gane,
       Anthony Hickey, Prof John McCall, Dr Rod Dunbar, Dr David Orr.
       Ethics ref:    NTY/09/12/117
       Locations:      ADHB.

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 dates of the study.
-C. The committee considered that the study is not a clinical trial. Form A is not required.
-Please provide a completed Locality Assessment Form from ADHB.
-Please note that any future use of the tissue samples other than what is specified in this
protocol will require ethics approval.
Information Sheet and Consent Form:
-The committee requests that the PIS should be rewritten in lay language for ease of
participant understanding.
-The PIS should clarify that though the participants have agreed for the liver samples to
be taken , it is possible that a liver sample may not be taken in some cases.
-PIS and CF. Please clarify in both the documents that the samples will be destroyed.

4. A Randomised Phase III Trial To Assess Response Adapted Therapy Using
   FDG-PET Imaging In Patients With Newly Diagnosed, Advanced Hodgkin
   Lymphoma. ALLG HD8.
      Investigators: Dr Leanne Berkahn, Dr Timothy Hawkins, Dr Peter Browett,
      Dr Richard Doocey, Dr Nigel Patton.
      Ethics ref:    NTY/09/12/118
      Locations:      ADHB

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.

Application Form:
-F. Please provide evidence of Maori consultation.
-Please provide a completed Locality Assessment Form from ADHB.
Information Sheet and Consent Form:
-Please move the voluntary participation clause from page 9 to the beginning of the
Information Sheet.
-Please clarify in the PIS that patients may be asked to travel to Australia.
-Please clarify in the PIS that the samples can be returned to the patients.
-Please clarify in the PIS the sample size of the study with the number of participants in
New Zealand and internationally.

5. Clients Expectations and Perceptions of how Religious and Spiritual Beliefs are
    Addressed by Public Mental Health Services.
       Investigators: Bronwyn Clark. Supervisor: Dr Jennifer Stillman.
       Ethics ref:     NTY/09/12/119
       Locations:       Waitemata DHB

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.

Application Form:
-The committee considered that the study design had weaknesses as the patients are self-
selected. The study results may be skewed if all the participants say ‘yes’ or all say ‘no’.
Please provide feedback regarding the possibility that participants may all say ‘yes’ or
all say ‘no’ or if the same persons self- select repeatedly.
-D6. The data storage should be amended to 10 years.
-Please provide a completed Locality Assessment Form from Waitemata DHB.
-Please ensure that the questionnaire is detachable so as to prevent identification of the
study participant.
Information Sheet and Consent Form:
-The PIS should include a statement that care will not be affected by the patients’
decision to participate or not.

6. Evaluation Of The Asian Mental Health Service Development Initiative
   (AMHSDI) In Counties Manukau District Health Board (CMDHB).
      Investigators: A/Prof Elsie Ho, Kitty Ko.
      Ethics ref:    NTY/09/12/120
      Locations:      CMDHB

Upon review the committee noted that there were no ethical concerns regarding health
and disability issues with the study and therefore the study does not require ethical
review by a Health and Disability Ethics Committee.

7. Resilient Whanau: Wellbeing through innovation and traditional practice (WHA
    08/01).
       Investigators: Tania Broughton, Drina Hawea, Kay Robin, Reweti Ropiha,
       Shirley Keown, Wirangi Tarewa Pera, Dr Nicolette Sheridan, Dr Jennifer
       Harre Hindmarsh.
       Ethics ref:    NTY/09/12/121
       Locations:      Turanga Health

Deferred. due to concerns regarding validity of research proposal, lack of privacy and
confidentiality, cultural and social responsibility and lack of sufficient information to
make a decision. Ethical issues from the Operational Standard 2006 are from sections
2.3, 2.4. and 2.7. Tania Broughton joined the meeting by teleconference.

Application Form:
-The main title should be the same as the lay title and refer to ‘kaumatua’ and not
‘whanau’.
-#18. Pl,ease amend the starting and closing dates for the study.
-A3.The committee expressed concerns about the rigour and the endpoints of the
programmer. If qualitative what purposeful questions will be asked to gain saturation of
themes? If quantitative what information is being sought and how will it be analysed?
What objectives are being measured? What are the end points? What agreement do the
researchers have about getting the information for the study?
-A3.1. Please list the critical success factors. How do the researchers know that these are
the critical success factors?
-A6.1. Please clarify if the researchers are developing the service or assessing the service.
-A6.3. Please clarify the measures taken to protect privacy in the videos taken. Please
clarify who will take the video, how it will taken and the storage measures.
-A7. Please provide assurance that the results of the study will be published. More
information is needed on why there may be restrictions on the publications of results.
What kind of information will be not be published and who makes the decision?
-B8. Please include some inclusion and exclusion criteria for the study.
-Please clarify how people will be identified later on in the study.
-D1. Will the data be de-identified?
-D 1. Please clarify how the researchers will preserve the anonymity of the participants in
such a close group.
-Please clarify how the information collected is being analysed.
-Please clarify if the researchers will be asking the participants’ consent/permission to
access their health records.
-F. Please provide a letter of support form the Marae Chairperson or a person outside of
the research group that the Kaumatua have been consulted. Consultation should occur
outside of the Turanga Health group.
-F4.1. What permission does the researchers have to access historical information?
-Part 3. Please clarify if the researchers are aware of the confidentiality aspects of the
publication of the book about the programme.
-The Locality Assessment Form should be signed by a Manager other than the
investigators of the study.
Information Sheet and Consent Form:
-Please clarify who the general PIS is for.
- Please clearly state in the PIS if the material collected will be used elsewhere.
-The PIS and CF should include a statement that the participants health records are being
accessed.
-The PIS should include a list of all the types of medical and health documents that may
be accessed by the researchers.
-Please include in the PIS that though confidentiality is encouraged in focus groups it
cannot be guaranteed.
-CF. Please amend the statement to indicate consent for either audio taping or
videotaping.
-The Information Sheet and Consent Form should include a sentence stating that ethical
approval has been given by the Northern Y Regional Ethics Committee.

8. Mycoplasma genitalium: A cross sectional study of the prevalence in women
   attending the Auckland Sexual Health Service and its association with cervicitis
   and pelvic inflammatory disease (PID).
       Investigators: Dr Jeannie Oliphant, Dr Sunita Azariah.
       Ethics ref:    NTY/09/12/122
       Locations:      Auckland Sexual Health Service Clinics

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr Oliphant joined the meeting by
teleconference.
Application Form:
-#8. A supervisor’s signature is required.
-A4.1. Please describe the value of the extra 90 patients. Are they included with the
sample size or outside the sample size
-Please clarify who is funding the tests.
-F. Please provide evidence of Maori consultation.
-Please provide a completed Locality Assessment Form from each locality.
Information Sheet and Consent Form:
-CF. Bullet point 1. Please spell out MG.
-CF. Please remove the approval for an auditor statement as it is not applicable.
-CF. Please clarify if the patients will be informed of positive results or if they will be
informed regardless. Please amend the statement accordingly.
-The Information Sheet and Consent Form should include a sentence stating that ethical
approval has been given by the Northern Y Regional Ethics Committee.

9. Assessment of an Online Self-management Programme to Improve Adherence in
    Heart Failure Patients.
       Investigators: Lana Jago, Prof Linda Cameron, Dr Mayanna Lund, Dr
       Robert Doughty, Dr Burkhard Wunsche.
       Ethics ref:    NTY/09/12/123
       Locations:      CMDHB, ADHB

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.

Application Form:
-A3. Please provide a description in the analysis on how the researchers are going to have
longitudinal data.
-Please provide more information on the effects of the different types of internet
connections on the study.
-F. Please provide evidence of Maori consultation.
-Part 4. Section 2 has been signed by an investigator. Please provide the signature of
from a person who is not involved in the study.
-As this is a clinical trial please provide a completed Form A.
Information Sheet and Consent Form:
-Please move the voluntary participation clause to the beginning of the Information
Sheet.
-The committee requests that the PIS should clarify the time commitment on the
computer.

10. Can supplemented dietary fibre improve insulin sensitivity in obese adolescents?
    A randomized cross-over trial of a high fibre isocaloric diet compared to an
    isocaloric diet alone in an adolescent community with a high incidence of obesity.
        Investigators: Dr Martin de Bock, Prof Wayne Cutfield, Dr Paul Hofman, Dr
        Craig Jefferies.
        Ethics ref:    NTY/09/12/124
        Locations:       Liggins Institute
Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr de Bock joined the meeting by
teleconference.

Application Form:
-A3. Please clarify if the crossover study design is suitable for this study.
-A3. As per the attached literature, similar studies have a washout period. Please clarify
why there is no wash-out period for this study.
-B12.2. As the answer is ‘yes’ please include this in the PIS.
-D7. Please amend storage of data to 10 years.
-F. In the discussions with Dr Peter please clarify if there was any specific discussion
regarding storage of tissue and blood as per Maori. What was Dr Peter’s response?
-Please provide completed Locality Assessment Forms from the participating schools.
Information Sheet and Consent Form:
-Please rewrite the PIs in lay-language for ease of participant understanding and also
clarifying the time commitment for the study.
-As all the children are able to consent for themselves, please provide a Consent Form for
who are 16 years and above and an Assent Form for those below 16 years.
-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 should be
included under the section on cultural responsibility to ensure participant awareness
and informed consent.
-CF. Please change the statement consenting to 3 dexa scans and not one.
-The Information Sheet and Consent Form should include a sentence stating that ethical
approval has been given by the Northern Y Regional Ethics Committee.

11.Asssessment of maternal nutrition during the periconceptional period in women
   undergoing in-vitro fertilization (IVF) treatment.
       Investigators:   Prof Wayne Cutfield, Alice Redward, Prof Sir Peter
       Gluckman, Dr John Peek.
       Ethics ref:    NTY/09/12/125
       Locations:      Fertility Associates - AKL

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Alice Redward and Dr Cutfield joined
the meeting by teleconference.

Application Form:
-A1.1. Please clarify who is comparing the age and age and sex match controls results.
-A4.2. Please justify the sample of 140 participants.
-Why is there a 10 day period? How is this chosen?
-C. The committee considered that this study is not a clinical trial.
-D2. Please clarify how Alice will contact the participants. Will they be asked to consent
to be contacted?
-F. The committee requests that a more comprehensive Maori consultation should take
place for future studies and will suggest an appropriate group in the new year.
Information Sheet and Consent Form:
-Please remove the ACC clause form the PIS as the study is not a clinical trial.
-CF. Please divide the paragraph into separate statements with a ‘yes/no’ option.

12. The genetics of self harm: are some genes associated with suicidal intent of self
    harm and do they predict response to therapy.
       Investigators: Dr Simon Hatcher, A/Prof Andrew Shelling.
       Ethics ref:    NTY/09/12/126
       Locations:       NDHB, WDHB, CMDHB

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr Hatcher joined the meeting by
teleconference.

Application Form:
-A3.1. Are the patients pre-consented into the ACCESS programme?
-B12.2. It is mentioned that the GP will be informed and the PIS states that the GP will
not be informed. Please clarify and correct the inconsistency.
-D7. Please amend storage of data to 10 years.
-Please clarify if the ‘specific genes’ will be identified?
-Part 3. Please provide further information on identifying genes and if they relate to self-
harm. How much scientific background is there for the gene studies on self-harm?
-Part6. #5.1. The answer is no and #5.2 says ‘yes’. Please correct the inconsistency.
-Please provide completed Locality Assessment Forms.

13. A randomised open-label study comparing the safety and efficacy of ritonavir
    boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir boosted lopinavir
    and raltegravir in participants virologically failing first-line NNRT/2N(t)RTI
    therapy: the SECOND-LINE study.
       Investigators: Dr Mark Thomas, Dr Simon Briggs, Dr Sarah Nisbet, Dr
       Rupert Handy, Dr Joan Ingram, Dr Steve Ritchie.
       Ethics ref:    NTY/09/12/127
       Locations:      Auckland City Hospital

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority. Dr Thomas joined the meeting by
teleconference.

Application Form:
-#18. Please amend the starting and closing dates.
-Please clarify if the researchers will be able to get all the participants with the 2 year
period.
-A5.2. Please provide a description of the analysis .
-If the primary analysis/outcome at 48 weeks is not enough to show effects will the study
be continued for 96 weeks?
-What are the brands of the drugs and are they registerd in New Zealand? This
information should be included in the PIS.
-Please clarify if the Raltegravir is funded and who is the sponsor.
-B13. Is the DSMB sponsor funded?
-Please clarify what level of funding is there from the sponsor The sponsor’s names
should be included in the PIS.
-D3. Can the patients be approached by others than the research team as it may less of an
influence on the patients.
-Please clarify that as Form a is singed that there is no benefit tot eh manufacturer. This
should be consistent throughout the application form.
Information Sheet and Consent Form:
-Please move the voluntary participation clause to the beginning of the Information
Sheet.
-PIS. First page. Last sentence. Please clarify if the study medicine is registered in New
Zealand.
-PIS. 2nd last page. 3rd last para. Please clarify that only the RNA of HIV will be
analysed.
-A separate PIS and CF for pharmocogenetics is required.
-Please include in the PIS and CF that blood will be sent overseas.
-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 should be
included under the section on cultural responsibility to ensure participant awareness
and informed consent.

14. Clinical Trial Protocol CRAD001R2301: A randomized, double-blind, multi-
    centre phase III study comparing everolimus (RAD001) plus best supportive
    care versus placebo plus best supportive care in patients with advanced gastric
    cancer after progression on prior systemic chemotherapy.
       Investigators:   Dr Michael Findlay, Dr Amanda Ashley, Dr Dragan
       Damianovich, Dr Barrie Evans, Dr Paul Thompson.
       Ethics ref:    NTY/09/12/128
       Locations:      ADHB

Approved with conditions. The Chairperson will review the response prior to final ethical
approval being given under delegated authority.

Application Form:
-A7. The committee requests that there should be a time limit to the sponsor’s
restrictions. It is requested that there should be only a reasonable delay to publish the
results.
-Please clarify if there is any doctor-patient influence to participate as it is the
investigator who will be recruiting the patients.
-Please provide more information about the patients who will get the placebo. What
options are available to them and what does that mean to them. Are there any other
alternative treatments for the patients on the placebo?
-The committee reviewed and approved the attached pamphlets .
Information Sheet and Consent Form:
-Please provide a one page summary sheet for the PIS.
-Please move the voluntary participation clause to the beginning of the Information
Sheet.
-PIS and CF. Please include that any future use of the tissue samples will be done only
after ethical approval is sought.
-CF for biomarkers. 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 should be
included under the section on cultural responsibility to ensure participant awareness and
informed consent.
-CF for biomarkers. Please include the clauses from the guidelines. Sections 4.8.

EXTENSIONS / MODIFICATIONS / AMENDMENTS

1. A Randomised, Placebo-Controlled, Double-Blind Phase II Trial of Peri-
Operative Cimetidine in Early Colorectal Cancer.
Ethics ref:     NTY/09/09/090
For approval:
-Protocol version 2, dated 27/11/09.
-PIS version 3 dated 27/11/09.
- Approved.

2. 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.
Ethics ref:     NTY/09/03/023
For approval:
-Investigator Brochure, Edition 5 dated August 6, 2009.
-Protocol MN-221-CL-007, Amendment 4 dated August 6, 2009.
-PIS and CF – Part B Final Version 7, Middlemore dated 12 Nov 2009.
-PIS and CF –Acute-Part A Version 1.1, Middlemore dated 12 Nov 2009.
- Approved.



ADVERSE EVENT REPORTS for receiving and noting

No:      Ethics Ref No:    Dates notified     No: of Reference/Description
                                              events
   1.   NTY/09/04/038      23/9/09            various Myocardial infarction….
                                                      -Noted
   2.   NTY/08/08/079      1/12/09            various Myocardial infarction….
                                                      -Noted
   3.   NTY/08/06/069      1/12/09            various Myocardial Infraction
                                                      -Noted
   4.   NTY/08/07/071      25/11/09           1       Death
                           2/12/09            3       Pulmonary embolism…
                                                      -Noted
   5.   NTY/08/06/060      19/11/09           2       Pain..
                           19/11/09           2       Anorexia..
                                                      -Noted
   6.   NTY/07/12/135      18/11/09           1       Ca right base of tongue
                                                      -Noted
   7.   NTY/07/01/007      12/11/09           1       Pneumonia
                                                      -Noted
REPORTS RECEIVED FOR NOTING

Number               Ethics Reference Number                  Progress/Final reports
    1.                      NTY/07/09/101                     Annual report dated 12/11/09.
                                                              -Noted

    2.                      NTY/07/04/032                     Final report dated 26/11/09.
                                                              -Noted

    3.                      NTY/08/08/079                     Annual report dated 2/12/09.
                                                              -Noted

    4.                      NTY/08/07/069                     Annual report dated 2/12/09.
                                                              -Noted



FINAL ETHICAL APPROVAL UNDER CHAIRPERSON’S DELEGATED
AUTHORITY

1. A randomized, double-blind, placebo-controlled, multi-center phase III study of RAD001
adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of
RAD001 versus matching placebo after patients have achieved complete remission with first-line
rituximab-chemotherapy. Protocol Number: RAD001N2301
Investigators: Prof Peter Browett, Dr Timothy Hawkins, Dr Leanne Berkahn, Dr Richard
Doocey, Dr Nigel Patton, Dr Nicola Eaddy.
Ethics ref:      NTY/09/06/051
Locations:                  ADHB.
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 Novartis
Pharmaceuticals Australia Pty Ltd in the event of injury to participants resulting from
their involvement in the research study.
-Approval noted

2. ‘Stepping up to Better Health’ a pilot study.
Investigators: Fay Cobden-Grainge, Susan Duraisamy, Anna Rolleston.
Ethics ref:    NTY/09/06/052
Locations:                 Manukau Institute of Technology.
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. Giving Asthma Support to Patients (GASP): assessment of an online asthma management
programme.
Investigators: Dr Felix SF Ram, Wendy McNaughton, Janice van Mil.
Ethics ref:   NTY/09/09/082
Locations:                Harbour Health PHO.
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. A longitudinal investigation of cortical thinning in pre-symptomatic Huntington’s Disease:
Distribution and functional significance.
Investigators: Sasha Moses, Dr Lynette Tippett, Dr Richard Roxburgh.
Ethics ref:    NTY/09/09/085
Locations:                University of Auckland
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. What are surgical patients’ expectations with regard to giving informed consent for student
doctors to be involved in their surgery and care.
Investigators: Andreya Brown, Ross Lawrenson, A/Prof Warwick Bagg, Dr Philip Malpass.
Ethics ref:     NTY/09/10/098
Locations:                 WDHB
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. Multi-level intervention to reduce suicidal behaviour: a New Zealand controlled community
intervention study.
Investigators: Dr Sunny Collings, Prof Tony Dowell, Dr James Stanley, Dr Simon Hatcher, June
Atkinson, Nandika Currey, Prof Diego De Leo.
Ethics ref:     NTY/09/10/103
Locations:                 CMDHB, NDHB, BOPDHB, Hawkes Bay DHB, Taranaki DHB, Mid-
Central DHB, Capital Coast & Otago 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

7. Kia Ngawari: Investigating Palliative Care of Maori and their Whanau.
Investigators: Dr Tess Moeke-Maxwell, A/Prof Linda Waimarie Nikora, Prof Ngahuia Te
Awekotuku.
Ethics ref:    NTY/09/10/104
Locations:                University of Waikato
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


The meeting concluded at 4.30 pm.

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