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NORTHERN Y REGIONAL ETHICS COMMITTEE

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NORTHERN Y REGIONAL ETHICS COMMITTEE ...

    NORTHERN Y REGIONAL ETHICS COMMITTEE

    AUGUST AGENDA

    To be held on Wednesday, 22 August 2007

    At the Ministry of Health, BNZ Building, 354 Victoria St, Hamilton

    At 11.30 am

MEMBERS ATTENDING

Mr Paul Flanagan (in the chair), Dr John Fitzgerald, Rev Peter Coughlan, Mrs Claire

    Stott, Mrs Heather Thompson, Dr John Moodie, Dr Felicity Dumble, Dr Rob

    Crawford, Ms Huhana Hickey, Mr Michael Vale, Dr Tessa Turnbull.

    Visitor: Carole Linehan Health and Disability Advocate for the Midland region. Administrator: Amrita Kuruvilla

APOLOGIES

Ms Christina Bryant.

APPROVAL OF MINUTES OF PREVIOUS MEETING

Approval of minutes of the meeting held on 25 July 2007.

    CHAIRPERSON‟S REPORT

To receive -Report of the Chairperson

GENERAL BUSINESS

    1. Letter from Prof David Simmons to the committee regarding Te Wai O Rona

    study.

    2. Copy of letter from Gaylene Roberts-Chair of Kaumatua Kaunihera

    Research subcommittee to Hon. Pete Hodgson Minister of Health regarding

    research issues for Maori.

MATTERS ARISING

1. To determine the efficacy of treatment of type I Amiodarone Induced

    Thyrotoxicosis (AIT) with combination of carbimazole and cholestyramine

     versus carbimazole alone.

    Investigators: Dr Malgorzata Brzozowska, Dr John Conaglen, Dr Louise

    Wolmarans, Dr Michael Swarbrick, John Speed.

    Ethics ref: NTY/06/09/086

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    Locations: Waikato Hospital.

    - Approved as an amendment to the original study. Awaiting further response.

2. A product evaluation of a paediatric nasal interface used to deliver humidified

     oxygen therapy.

    Investigators: Dr David Buckley, Laura-Clare Whelan, Steven Korner, Elaine

    McCall, Christian Saville.

    Ethics ref: NTY/06/12/128

    Locations: ADHB.

    - Response received and under review.

3. Ethnic women‟s experience of traumatic birth and PTSD following childbirth.

    Investigators: Nimisha Waller, Ruth Desouza, Kaberi Rajendra.

    Ethics ref: NTY/06/12/140

    Locations: Auckland University of Technology.

    - Approved conditionally. Awaiting further response from researcher.

4. A research project to evaluate the Smokefree Auahi Kore Hari pilot in Kohanga

    Reo in the Manurewa and Clendon area.

    Investigators: Manaia Paki King, Megan van de Kuilen, Janet Chen, Hiku

    Mackey, Luisa Falanitule, Dr Andrew Lindsay.

    Ethics ref: NTY/07/01/009

    Locations: Auckland Regional Public Health Service.

    - Approved conditionally. Awaiting response from researcher. Ethical approval

    expires this month as response has not been received from the researcher.

5. Treatment of idiopathic orbital inflammatory syndrome (IOIS) with periorbital

    injections of triamcinolone acetonide.

    Investigators: Dr Stephen Ng, Dr Season Yeung.

    Ethics ref: NTY/07/03/021

    Locations: Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

6. “Pre- and post-water-fluoridation Oral Health survey in Northland.”

    Investigators: Dr Sunitha Gowda, Dr Neil Croucher.

    Ethics ref: NTY/07/04/032

    Locations: School Dental Clinics or Mobile Dental Caravans.

    - Approved conditionally. Awaiting further response from researcher.

7. Congestive Heart Failure Outreach Program of Education The COPE Study

    New Zealand..

    Investigators: Monica Zolezzi, Lejla Brkic.

    Ethics ref: NTY/07/04/036

    Locations: Middlemore Hospital.

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    - Approved conditionally. Awaiting response from researcher.

8. Lexical activation during auditory processing in language disorders following

     stroke: a cross-modal priming study.

    Investigators: Dr Clare McCann, Rachel Matthews, Suzanne Purdy.

    Ethics ref: NTY/07/04/039

    Locations: University of Auckland, participants homes.

    - Response received and under review.

9. Communication of young children with long-term tracheostomies.

    Investigators: Dr Clare McCann, Katie Ward, Dr Colin Barber.

    Ethics ref: NTY/07/04/040

    Locations: Starship Hospital, University of Auckland, Participants Homes.

    - Response received and under review.

10. A pilot study to establish the incidence of needle stick injuries to practice nurses

    employed in the private sector in the Auckland region.

    Investigators: Dr William Fourie, Bev Johnson.

    Ethics ref: NTY/07/04/043

    Locations: Auckland.

    - Approved conditionally. Awaiting response from researcher.

11. A phase II randomised controlled trial of atorvastatin therapy in intensive care

    patients with severe sepsis.

    Investigators: Dr Colin McArthur, Dr Tony Williams.

    Ethics ref: NTY/07/05/047

    Locations: Auckland City Hospital, Middlemore Hospital.

    - Approved conditionally. Awaiting response from researcher.

12. A Randomised Control Trial comparing intra-articular tenoxicam with oral

    tenoxicam in acute monoarticular gouty arthritis.

    Investigators: Dr Claire Shadwell, Dr Martyn Harvey.

    Ethics ref: NTY/07/05/050

    Locations: Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

13. A Single-blind, Randomised Control Trial to compare two different splints for

    fifth metacarpal fractures after manipulation.

    Investigators: Dr Anna Nienaber, Dr Martyn Harvey.

    Ethics ref: NTY/07/05/051

    Locations: Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

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14. A Double-Blind, Randomised Control Trial of the Efficacy of Prophylactic

    Antibodies in Preventing Wound Infection of Simple Traumatic Wounds in the

     Emergency Setting.

    Investigators: Dr David Lord, Dr Martyn Harvey, Dr Paul Brydon.

    Ethics ref: NTY/07/05/052

    Locations: Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

    15. The neurophysiological effects of spinal manipulation.

    Investigators: Heidi Taylor, Bernadette Murphy.

    Ethics ref: NTY/07/05/054

    Locations: New Zealand College of Chiropractic, University of Auckland.

    - Approved conditionally. Awaiting response from researcher.

    16. Refugee health on arrival in New Zealand and six months later.

    Investigators: Tony Cooper, Jill Conway, Barry Kirker, Surpreet Cheema,

    Nicola Henderson, Johanna Schmidt, Gary Poole.

    Ethics ref: NTY/07/05/055

    Locations: Auckland Refugees as Survivors Center, Auckland.

    - Response received and under review.

    17. “Which weaning regime is more effective? Humidified high-flow nasal cannula

    or non-humidified high-flow nasal cannula for weaning off Nasal CPAP”:- A

    randomised control trial comparing two weaning regimes.

    Investigators: Christine Woolerton, Helen Barwick, Melanie Trewothen, Lee

    Carpenter, Jim Fowler.

    Ethics ref: NTY/07/06/056

    Locations: Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

18. An exploratory descriptive study of what New Zealand families believe

    constitutes successful management of unsupervised childcare.

    Investigators: Deborah Trenberth.

    Ethics ref: NTY/07/06/057

    Locations: Participant‟s residence or community.

    - Response received and under review.

19. An investigation of the relationship between housing and adolescent health.

    Investigators: Rebecca Broadbent.

    Ethics ref: NTY/07/06/058

    Locations: Participant‟s residence.

    - Deferred. Response received.

    20. Patient and Family Perspectives of Hospice Services.

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    Investigators: Yvonne Bray, Dr Felicity Goodyear-Smith, Dr Willem Landman,

    Lorraine Johnson.

    Ethics ref: NTY/07/06/060

    Locations: South Auckland Hospice and patients homes.

    - Response received and under review.

    21. A diabetes related lower limb pathology control demonstration intervention for

     Maori.

    Investigators: Liane Penney, Angela Bayley, Lyvia Marsden, Edith McNeill, Dr

    Guy Naden, Belinda Ihaka, Sonia Rapana, Dr Daniel Poratt.

    Ethics ref: NTY/07/06/061

    Locations: Auckland.

    - Approved conditionally. Awaiting response from researcher.

    22. Defining „peer‟ in youth peer support: young people with experience of mental

    distress and mental health professionals talk about ethics and effectiveness of

    peer support in adolescent mental health recovery.

    Investigators: Lola Voronova.

    Ethics ref: NTY/07/06/062

    Locations: AUT or participants choice.

    - Response received and under review.

    23. Pilot testing new measures of a) Quality of Care and b) Quality of Life for people

    with intellectual and physical impairment and c) Attitudes to Disability.

    Investigators: Prof Kathryn McPherson, Nicola Kayes, Prof Rex Billington, Dr

    William Taylor, Kate Diesfeld, Jo Fadyl, Christine Cummins.

    Ethics ref: NTY/07/06/063

    Locations: Laura Fergusson Trust, Creative Abilities, Parkinson‟s Society,

    MS Society.

    - Response received and under review.

    24. Clinical Validation of the Gout Response Criteria.

    Investigators: Dr Nicola Dalbeth, Dr William Taylor, Prof Ralph Schumacher.

    Ethics ref: NTY/07/06/064

    Locations: CMDHB, ADHB.

    - Response received and under review.

    25. Assessing patients‟ understanding of their risk of cardiovascular disease in a

    primary care setting.

    Investigators: Dr Michelle Trumpelmann, Dr Felicity Goodyear-Smith, Prof

    Bruce Arroll, Susan Dawkins.

    Ethics ref: NTY/07/06/065

    Locations: Medical Centre @ Apollo, University of Auckland.

    - Response received and under review.

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     26. Pregnancy Diabetes Ethnic Fetal Growth Study.

    Investigators: Dr G.K. Parry, Nerida Titchiner, Janet Rowan, Vivien Wong,

    john Baker, Carl Eagleton, David Ansell, Jane Zuccollo.

    Ethics ref: NTY/07/06/067

    Locations: Middlemore Hospital.

    - Response received and under review.

    27. Have genes related to growth and metabolism epigenetically been altered in

    children and adolescents born prematurely?

    Investigators: Wayne Cutfield, Paul Hofman, Caroline de Wit, Jan-Maarten Wit.

    Ethics ref: NTY/07/06/068

    Locations: The Liggins Institute.

    - Approved conditionally. Awaiting response from researcher.

    28. Randomised, placebo-controlled, multicentre study to assess the efficacy and

    safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV)

    infection who are otherwise eligible to initiate antiviral therapy (peginterferon

    alfa-2a plus ribavirin). ENABLE 1.

    Investigators: A/Prof Ed Gane, Dr David Orr, Dr Philip Wong, Dr Tim King,

    Dr Kumudith Ekanayake.

    Ethics ref: NTY/07/06/069

    Locations: Auckland City Hospital.

    - Approved conditionally. Awaiting response from researcher.

    29. Randomised, placebo-controlled, multicentre study to assess the efficacy and

    safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV)

    infection who are otherwise eligible to initiate antiviral therapy (peginterferon

    alfa-2a plus ribavirin). ENABLE 2.

    Investigators: A/Prof Ed Gane, Dr David Orr, Dr Philip Wong, Dr Tim King,

    Dr Kumudith Ekanayake.

    Ethics ref: NTY/07/06/070

    Locations: Auckland City Hospital.

    - Approved conditionally. Awaiting response from researcher.

    30. Mental imagery as an adjunct to rehabilitation for acute back pain: A pilot

    study.

    Investigators: Dr Sandra Bassett, Prof Kathryn McPherson, Prof Philip Schluter,

    A/Prof Harry Prapavessis, Dr Craig Hall, Dr Ralph Maddison, Glenn Gallagher,

    Leah Pearsall.

    Ethics ref: NTY/07/07/071

    Locations: Papakura and Glenn Gallagher physiotherapy clinics.

    - Approved conditionally. Awaiting response from researcher.

    31. A pilot study of the impact of oranga niho on quality of life of rangatahi Maori.

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    Investigators: A/Prof John Broughton, Joyce Maipi, Prof Murray Thomson,

    Marie Person.

    Ethics ref: NTY/07/07/072

    Locations: Raukura Hauora O Tainui.

    - Approved conditionally. Awaiting response from researcher.

32. Physical Activity and Gouty Arthritis: factors influencing physical activity

    amongst gout patients and the impact of an arthritis-specific exercise

     programme on physical activity levels and gout specific health outcomes.

    Investigators: Dr Ingrid Hutton, Dr Nicola Dalbeth, Dr Peter Gow.

    Ethics ref: NTY/07/07/073

    Locations: Rheumatology service, CMDHB.

    - Approved conditionally. Awaiting response from researcher.

    33. Genetics of gout on the East Coast (Te Tai Rawhiti).

    Investigators: Dr Tony Merriman, Dr Jade Hollis-Moffat, Dr Paratene Ngata,

    Dr Jennifer Harre Hindmarsh, Terry Ehau.

    Ethics ref: NTY/07/07/074

    Locations: Ngati Porou Hauora Board, University of Otago.

    - Approved conditionally. Awaiting response from researcher.

34. Risking Connection: An introduction to a trauma informed service working with

    women who experience depression from a staff perspective.

    Investigators: Janis Prosser.

    Ethics ref: NTY/07/07/075

    Locations: Women‟s Wellness Company – IRIS, Hamilton.

    - Approved conditionally. Awaiting response from researcher.

35. To determine the causation of single day sick leave absence in a NZ Teaching

    Hospital.

    Investigators: Dr M. Kahan.

    Ethics ref: NTY/07/07/076

    Locations: Waikato DHB.

    - Deferred. Awaiting response from researcher.

36. The impact of Body Mass Index on Semen Parameters.

    Investigators: Dr Jye Ru Lu, Prof Cynthia Farquhar.

    Ethics ref: NTY/07/07/077

    Locations: Fertility PLUS at ADHB.

    - Approved conditionally. Awaiting response from researcher.

37. Use of Real-Time PCR to Quantify Bacterial Translocation in Colon Cancer.

    Investigators: Shanthi Parkar, Dr Graeme Dickson, Dr Mohammed Al-Ansari,

    Emma Redgate.

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    Ethics ref: NTY/07/07/079

    Locations: HortResearch, Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

38. Sustaining one‟s own health and wellness when supporting a stroke survivor: A

     grounded theory of spouses‟ and partners perspectives.

    Investigators: Natasha Moloczij, Dr John Smith, Dr Lynne Giddings.

    Ethics ref: NTY/07/07/080

    Locations: Laura Fergusson Trust, Stroke Foundation, AUT University.

    - Approved conditionally. Awaiting response from researcher.

39. Collection of pre-screening data for use in future clinical trials.

    Investigators: Dr John Gillies, Dr Ted Walford.

    Ethics ref: NTY/07/07/081

    Locations: P3 Research in Tauranga.

    - Deferred. Awaiting response from researcher.

40. A Randomized, Double-Blind, Active-And Placebo-Controlled, Parallel-Group,

    Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of

    CG5503 Immediate-Release Formulation in the Treatment Of Acute Pain From

    Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension.

    Investigators: Dr John Moodie, Dr John Currie, Dr Robert Carpenter.

    Ethics ref: NTY/07/07/082

    Locations: Southern Cross Hospital in Hamilton.

    - Response received and under review.

41. Reflex effects of a spinal adjustment on automatic nervous system function.

    Investigators: Kelly Holt, Barry Rushton, Heidi Haavik-Taylor.

    Ethics ref: NTY/07/07/083

    Locations: NZCC Student Health Centre in Auckland.

    - Deferred. Awaiting response from researcher.

42. The presence , severity and impact of depression among patients aged 16 years

    and over, with chronic skin disease, in a New Zealand Dermatology Outpatient

    department.

    Investigators: Jane Bennett.

    Ethics ref: NTY/07/07/084

    Locations: Waikato Hospital.

    - Approved conditionally. Awaiting response from researcher.

43. How do attitudes, beliefs and perceptions of Tongan asthma patients in

    Auckland influence access to primary health care?

    Investigators: Tenisia Hager, Lorraine Ritchie, Beverley Burrell, Dr Makafalani

    Tatafu.

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    Ethics ref: NTY/07/07/085

    Locations: Auckland and Counties Manukau regions.

    - Approved conditionally. Awaiting response from researcher.

FINAL ETHICAL APPROVAL UNDER CHAIRPERSON‟S DELEGATED

    AUTHORITY

1. Exploring Pacific attitudes to food, food consumption, weight loss and weight

     management.

    Investigators: Kenneth Aiolupotea, Karyn Neemia, Winston Timaloa, Yvonne

    Timaloa.

    Ethics ref: NTY/06/10/096

    Locations: CMDHB.

    2. Project Energize Substudy does Project Energize impact on bone and metabolic

    markers of health in 7 year old children who are in Project Energize programme

    schools receiving supplemental milk and fruit, compared to children from

    matched Project Energize control schools?

    Investigators: Dr David Graham, Prof Elaine Rush, Prof David Simmons, Sarah

    Appleton.

    Ethics ref: NTY/06/10/100

    Locations: Waikato DHB.

3. A Randomized Multicenter, Placebo-Controlled And Active Reference

    (Glatiramer Acetate) Comparison Study To Evaluate The Efficacy And Safety

    Of BG00012 In Subjects With Relapsing-Remitting Multiple Sclerosis.

    Investigators: Dr Paul Timmings, Dr Christopher Lynch.

    Ethics ref: NTY/07/03/019

    Locations: Waikato DHB.

4. Population dynamics of aged human satellite cells as a function of habitual

    physical activity.

    Investigators: Dr Heather Smith, Ana-Mishel Spiroski, Dr Mridula Sharma, Dr

    Phil Blyth.

    Ethics ref: NTY/07/04/041

    Locations: University of Auckland, AgResearch Ruakura in Hamilton.

5. Randomised, double-blind, placebo-controlled, parallel group clinical study of

    Isotretinoin 5mg capsules (once daily) in the treatment of persistent low grade

    adult acne for 16 weeks followed by an open label phase of 16 weeks. Protocol

    Number ZPS-365.

    Investigators: Dr Marius Rademaker, Dr John Wishart.

    Ethics ref: NTY/07/05/044

    Locations: Tristram Clinic.

6. The Development of a Database for the Continuing Assessment and Support of

    Members of the Organization known as Saw Mill Workers Against Poisons Inc

    (SWAP).

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    Investigators: Prof G. Raumati Hook, Gwenda Paul.

    Ethics ref: NTY/07/05/045

    Locations: Ngati Awa Health Services in Whakatane.

     7. Inhibition of the phosphoinositide 3-kinase pathway in acute myeloid leukaemia.

    Investigators: Prof Peter Browett, Dr Leanne Berkahn, Dr Peter Shepherd, Dr

    Bruce Baguley, Dr Mike Findlay, Dr Peter Black, Katrina Sharples.

    Ethics ref: NTY/07/05/046

    Locations: ADHB.

8. An exploratory study of factors that influence the retention of Pacific health

    professionals working in Pacific community health providers and Primary

    Health Organisations in New Zealand.

    Investigators: Catherine Poutasi.

    Ethics ref: NTY/07/05/048

    Locations: Waikato Hospital.

9. Counties Manukau alcohol and other drug intervention: Staff survey.

    Investigators: Dr Jane Vanderpyl, John Wells.

    Ethics ref: NTY/07/05/053

    Locations: CMDHB.

10. Gene expression and muscle architecture in the M. gastrocnemius of children

    with hemiplegia cerebral palsy before and 6 months after BTX-A injection.

    Investigators: Dr Kirsten Legerlotz, Dr Heather Smith, Dr Susan Stott, Dr Phil

    Blyth, Dr Wayne Hing.

    Ethics ref: NTY/07/06/059

    Locations: Starship Hospital, University of Auckland, AUT.

    11. Quiescence and Stemness how to induce epigenetic plasticity in Human

    embryonic Stem Cells.

    Investigators: Bjorn Oback, Gabriela Gebrin Cezar.

    Ethics ref: NTY/07/06/066

    Locations: AgResearch Hamilton.

12. “Eyes over the top” A descriptive study of the needs of parents after their young

    child is discharged from hospital following an admission with an acute illness: a

    study from one New Zealand DHB.

    Investigators: Andrea Mockford.

    Ethics ref: NTY/07/07/078

    Locations: Waikato DHB.

13. A Best Practice Package: early Intervention for Whanau Violence (Phase I).

    Investigators: Erana Cooper.

    Ethics ref: NTY/07/07/086

    Locations: Ngati Hine Health Trust.

    14. Title: Neonatal Postmortems The nurses role. Investigators: Leanne Baker, Denise Wilson.

    Ethics Ref: NTY/07/34/EXP

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