Agenda – November Meeting
File RE08-03-4
Page – 1
LOWER SOUTH REGIONAL
ETHICS COMMITTEE MEETING
TO BE HELD ON TUESDAY 7 NOVEMBER 2006
MEETING ROOM L4.4
FOURTH FLOOR, MINISTRY OF HEALTH
229 Moray Place, Dunedin at 1.15 p.m.
MEMBERS PRESENT:
Mrs. Jenny Beck
(Chair)
Dr. Phil White
(Deputy Chair)
Mrs. Fay McDonald
Mr. Kenneth Copland
Dr. Gail Tripp
Mrs. Gwen Neave
Dr. Rosemary Beresford
Dr. Nikki Kerruish
Mrs. Sandra Elkin
Dr. Alan Payne
Dr. Khyla Russell
APOLOGIES:
Dr. Clare Robertson
IN ATTENDANCE:
Riria Tautau-Grant
Carolyn Mason
LRS/06/11/050
LRS/06/11/051
LRS/06/11/052
LRS/06/11/057
LRS/06/11/054
LRS/06/11/055
LRS/06/11/056
Dr. Rob MacGinley,
Professor Rob Walker
Dr. John Schollum
Dr. Stephen Duffill
Rajiv Verma
Professor Robin Taylor
Administrator
Chairperson Upper South A
Researchers
1.45 p.m.
Researcher
Researcher
2.30 p.m.
3.45 p.m.
MINUTES OF THE PREVIOUS MEETING
-
The minutes of the closed meeting and open meeting held 3 October 2006 to be
confirmed.
Agenda – November Meeting
File RE08-03-4
Page – 2
NEW PROTOCOLS
1. PROJECT KEY: LRS/06/11/049
Full Title:
What is the incidence and awareness of Asthma in the Southland Region
Investigators: Jill Parsons, Lesley Watson, Ed Flagg, Cara Agnew
Localities:
Participant's homes, Southern Institute of Technology
2. PROJECT KEY: LRS/06/11/050
Full Title:
An audit of prescribing patterns in patients who are obese
Investigators: Professor Stephen Duffull, Dr. Ruth Ferguson, Dr. John Schollum
Localities:
School of Pharmacy, University of Otago, Otago District Health Board
-
Dr. Rob MacGinley, Professor Rob Walker, Dr. John Schollum and Dr. Stephen
Duffill will attend the meeting at 1.45 pm
3. PROJECT KEY: LRS/06/11/051
Full Title:
Enoxaparin and the risk of bleeding - an impact study
Investigators: Professor Stephen Duffill, Hesham Al-Sallami, Ruth Ferguson, Natalie
Medlicot, Dr. John Schollum
Localities:
Dunedin Hospital, School of Pharmacy
-
Dr. Rob MacGinley, Professor Rob Walker, Dr. John Schollum and Dr. Stephen
Duffill will attend the meeting at 1.45 pm
4. PROJECT KEY: LRS/06/11/052
Full Title:
A randomised single blind study to improve health related quality of life as
measured by the SF-36 vitality score by correcting anaemia of chronic
kidney related disease with Aranesp® (darbepoetin alfa) in the elderly
(STIMULATE)
Investigators: Dr. John Schollum, Professor Rob.Walker, Dr. Rob. MacGinley, Gaye
Ellis
Localities:
Department of Medical and Surgical Sciences
-
Dr. Rob MacGinley, Professor Rob Walker, Dr. John Schollum and Dr. Stephen
Duffill will attend the meeting at 1.45 pm
5. Project Key: LRS/06/11/053
Full Title:
Double blind randomised controlled trial of an orally administered
probiotic in the treatment of spondylo arthritis
Investigators: Dr. Simon Stebbings, Dr. Michael Schultz, Professor John Highton
Localities:
Rheumatology Outpatient Dept., Microbiology Dept, Chemistry Dept.
Agenda – November Meeting
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6. PROJECT KEY: LRS/06/11/054
Full Title:
Retrospective analysis of dental implant treatment provided at the School
of Dentistry since 1989
Investigators: Rajiv Verma, Dr. Warwick Duncan, Ms. Mary Cullinan, Professor Gregory
Seymour
Localities:
School of Dentistry, University of Otago
-
Rajiv Verma will attend the meeting at 2.30 p.m.
7. PROJECT KEY: LRS/06/11/055
Full Title:
Does obesity influence the pattern of lung function during acute
bronchoconstriction? (the INCA study - Investigating broncho-constriction
in asthma)
Investigators: Professor Robin Taylor, Dr. Tim Sutherland, Mrs. Jan Cowan.
Localities:
Otago Respiratory Research Unit
-
Professor Robin Taylor will attend the meeting at 3.45 p.m.
8. PROJECT KEY: LRS/06/11/056
Full Title:
The management of non-eosinophilic asthma: a randomised controlled
trial
Investigators: Professor Robin Taylor, Dr. Douglas Cowan, Mrs. Jan Cowan.
Localities:
Otago Respiratory Research Unit
-
Duly signed Part 4 declarations received 26/10/2006
9. PROJECT KEY: LRS/06/11/057
Full Title:
The impact of dietary salt (NaC1) intake on arterial wall function in
hypertensive subjects: a randomised controlled cross-over study
Investigators: Dr. Rob MacGinley, Professor Robert Walker, Dr. Wayne Sutherland,
Alwyn Todd, Professor Jim Mann, Dr. John Schollum
Localities:
Dept. of Medical and Surgical Sciences Clinic, Endolab, Chch and Royal
Perth Hospital
-
Dr. Rob MacGinley, Professor Rob Walker, Dr. John Schollum and Dr. Stephen
Duffill will attend the meeting at 1.45 pm
Requested new advertisement which has the date applied.
RE-APPROVALS
1. PROJECT KEY: OTA/03/02/009
Full Title:
Prospective memory in schizophrenia and related disorders
Investigators: Dr Richard Linscott, Associate Professor Robert G Knight, Dr Nick Titov,
Mr Mark
Lewis
Localities:
Department of Physiology, University of Otago
Agenda – November Meeting
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2. PROJECT KEY: LRS/05/17/CPD
Full Title:
Professional development and recognition programme: portfolio
development, is it more than a means to an end?
Investigators: Miss Deborah Ashworth
Localities:
Southland District Health Board
-
Note that this study was approved 2 September 2006
3. PROJECT KEY: LRS/04/12/005
Full Title:
Respiratory and Cardiovascular effects of a bronchodilator drug (200 ug
salbutamol) in medicine, pharmacy and pharmacology students.
Investigators: Martin J Le Nedelec, Associate Professor Darlington.
Localities:
School of Medicines.
-
Ongoing teaching practical
MATTERS ARISING
1.
PROJECT KEY: OTA/02/17/CPD
Full Title:
Giving asthma and COPD medicines to the residents of Dunedin rest
homes
Investigators: Gayan Samarakoon, Nerida Smith
Localities:
Dept of Pharmacology and Toxicology
-
2.
From
Theme
Action
-
Report form returned addressee unknown.
Recommend close out study - cannot notify investigators
Dr. Khyla Russell
Meeting of Māori Members, Ethics Committees, 18 Oct 2006
For your information
Notes from last Lower South Regional Ethics Committee meeting
Notes from meeting of Māori members of Regional Ethics Committees
Copy of letter from Committee to Vice Chancellor
Agenda – November Meeting
File RE08-03-4
Page – 5
CHAIRPERSONS DISCRETIONARY
1.
From:
Theme:
Action:
Anthony Molteno
The Otago Glaucoma Surgery Outcome Study
Ethical approval not required
2.
Project Key: LRS/06/08/CPD
Full Title:
Follow-Up of patients with rheumatoid arthritis
Investigators: Deborah Johnstone, Georgina Chan
Localities:
Department of Rheumatology
CORRESPONDENCE
1.
From:
Theme:
Action:
-
Health Research Council
HRC News Issue No. 53, October 2006
For your information
Circulated 10 October 2006
PROTOCOLS GIVEN FINAL APPROVAL UNDER DELEGATED AUTHORITY
1. PROJECT KEY: LRS/06/09/037
Full Title:
The clinical anatomy of the anterior neck muscles
Investigators: Ewan Kennedy, Professor Helen Nicholson, Associate Profesor Susan
Mercer, Lyndell Kelly
Localities:
Dunedin Public Hospital, Oncology, Dept. of Anatomy and Structural
Biology, Dunedin
2. PROJECT KEY: LRS/06/10/043
Full Title:
The geometry of the solid hypophraryngeal walls
Investigators: Dr. Ming Zhang, Dr. Amy Fong, Professor Terence Doyle, Dr. Albert
Chong
Localities:
Depts. Anatomy and Structural Biology, Radiology, School of Surveying,
University of Otago
3. Project Key: LRS/06/09/038
Full Title:
Measurement of quality of life of New Zealand adults and adolescents with
cystic fibrosis.
Investigators: Malcolm Neall, Dr. Margot Skinner (Supervisor)
Localities:
Participant’s homes, PI’s home.
4. Project Key: LRS/06/10/045
Full Title:
Course and prognosis following first time lateral ankle sprain
Investigators: Dr. Joanne Munn, Dr Haxby Abbott
Localities:
School of Physiotherapy
Agenda – November Meeting
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Certification
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.
FINAL REPORTS
The following final reports have been received, and may be requested from the administrator.
1. Project Key: LRS/06/05/019
Full Title:
A clinical audit of dental implant treatment at the School of Dentistry, 20012005
Investigators: Dr. Warwick Duncan, Ms Angela Ross, Ms Saana Tutbury
Localities:
University of Otago School of Dentistry
-
The study is complete however a masters student will be using results from this
study for his research. The study was presented at the final year students
colloquium day. Smaller samples than originally intended. 117/250
Meeting Ends
Agenda – November Meeting
File RE08-03-4
Page – 7
STUDY STATUS NOVEMBER 2006
Project Key
Title
LRS/06/02/001 Preventing falls in people with intellectual disability: An innovative clinical
placement combining theory, practice and research.
LRS/06/02/002 Improving Maori health & wellbeing through kaitiakitanga: undertaking
research that: - Defines cultural based experiences in the environment that
can be used as a preventative intervention to enhance Maori health &
wellbeing: - Develops tools to assess the effect of different types of cultural
based experiences in the environment on Maori health and wellbeing; and Develops a framework fro pplying the tool and collecting data about health
outcomes for Maori resulting from application of such an intervention.
LRS/06/02/003 Effect of meals rich in thermally oxidised polyunsaturated fat and saturated
fat on circulating numbers of endotelial microparticles.
LRS/06/02/004 Prevalance of a multi-drug-resistant Escherichia coli in residents of rest
homes in Dunedin
LRS/06/02/005 Mechanisms of cerebral blood flow regulation in healthy humans
LRS/06/02/006 Does intervention for sustained attention improve conversational discourse
management in people with Traumatic Brain Injury?
LRS/06/02/007 A pilot study to assess the control of noise and vibration within high-risk
industries.
LRS/06/02/008 Loss of immune tolerance to the normal bowel microbiota as a potential
factor in the pathogenesis of ankylosing spondylitis
LRS/06/02/009 Does the respiratory function of obese individuals return to normal following
surgically-induced weight reduction?
LRS/06/03/010 Salivary cortisol response related to goal monitoring and task involvement
LRS/06/03/011 Factors affecting the perception of Dyspnoea in obese subjects
Approved Date
07/03/2006
Status
Approved
Primary Investigator
Hale, Dr. Leigh
21/03/2006
Approved
Tipa, Dr Gail
04/04/2006
Approved
Sutherland, Dr Wayne
10/08/2006
Approved
Schultz, Dr. Michael
20/09/2006
31/07/2006
Approved
Approved
Ainslie, Dr. Philip N
Davies, Emma
17/05/2006
Approved
McBride, Dr David
05/05/2006
Approved
Stebbings, Dr Simon
03/04/2006
Approved
18/05/2006
Approved
Deferred
LRS/06/03/012 Men’s mental health: What helps and hinders men’s access to community
mental health teams
LRS/06/03/013 What is it like for older women to live with depression? A hermeneutic
15/05/2006
Approved
Taylor, Professor D
Robin
Franz, Dr Elizabeth
Taylor, Professor D
Robin
McKay, Mr Jimi
02/05/2006
Approved
Allan, Jeanette
Agenda – November Meeting
File RE08-03-4
Page – 8
phenomenological study
LRS/06/03/014 Inducible enzymes in keloid scars
LRS/06/03/015 Prospective outcomes of injury study (POIS): Questionnaire development
and pre-testing
LRS/06/04/016 Post-operative pain management following arthroscopic rotator cuff repair. A
comparison of inter-scalene block with subacromial bursal infusion
LRS/06/04/017 The use of Pulse Transit Time (PTT) in the detection of sleep disruption and
respiratory events in children with habitual snoring
LRS/06/05/018 Investigation of the prevalence of heparin-induced antibodies in dialysis
patients routinely exposed to heparin, and it's influence on the risk of
thrombotic and adverse cardiovascular events.
LRS/06/05/019 A clinical audit of dental implant treatment at the School of Dentistry, 20012005
LRS/06/05/020 Long term prosthodontic maintenance for implant overdentures using
different implant systems
LRS/06/05/021 Effect of selenium on inflammatory markers and markers of endothelial
function in patients with coronary artery stenosis in Otago
LRS/06/05/022 A clinical audit of graduate periodontal treatment at the School of Dentistry,
2000-2005
LRS/06/05/023 Study of the long term results of the off label use of an intravitreal injection of
bevacizumab (Avastin) in cases if neovascular age-related macular
degeneration
LRS/06/06/024 Exercise Prescription Teaching Clinic, School of Physical Education,
University of Otago - repeated teaching activity PHSE 313 Exercise
Prescription Practicum - 4th year BPhEd paper, School of Physical
Education
LRS/06/06/025 Synaesthesia: a laboratory and functional MRI study
LRS/06/06/026 The impact of dietary sodium chloride (NaCl) intake on arterial wall function
in normotensive subjects: A randomised controlled cross-over intervention
study.
LRS/06/06/027 Low level laser therapy in the management of achilles tendinopathy: A
feasibility study
LRS/06/06/028 Intravenous immunoglobulin in neurological disorders
15/05/2006
02/05/2006
Approved
Approved
Irvine, Ms Sharleen
Derrett, Dr. Sarah
21/06/2006
Approved
Hartnett, Dr. Nigel
15/05/2006
Approved
Galland, Dr. Barbara
26/06/2006
Approved
Walker, Dr Rob
04/07/2006
Approved
Duncan, Mr W
07/06/2006
Approved
Payne, Dr AGT
17/05/2006
Approved
04/07/2006
Approved
Havre, Dr Nathalie
van
Duncan, Mr W
26/06/2006
Approved
Newkirk, Dr. Mylan
Van
19/07/2006
Approved
Handcock, Mr Phil
12/07/2006
Conditional
Approved
Franz, Dr Elizabeth
MacGinley, Dr. Robert
26/06/2006
Approved
Tumilty, Mr Steve
27/06/2006
Approved
Hammond-Tooke, Dr
Graeme
Agenda – November Meeting
File RE08-03-4
Page – 9
LRS/06/06/029 Validation of the disabilities of the arm, shoulder and hand (Dash)
questionnaire as an outcome measure for upper limb recovery following
stroke.
LRS/06/07/030 Experiencing palliative care in the community for those not enrolled in a
hospice programme
LRS/06/07/031 Manual therapy, exercise, and usual care for osteoarthritis of the hip or
knee: a preliminary randomised controlled trial
LRS/06/08/032 Beating breathlessness by encouraging adherence to asthma medication
and treatment. Study 4: A multifaceted, behavioural-based intervention to
increase adherence in an undergraduate asthmatic sample
LRS/06/09/033 A New Zealand experience of men in a bi-cultural therapeutic community
LRS/06/09/034 Monitoring antibiotic resistance in Samoa
LRS/06/09/035 Bimanual reaction times in mild traumatic brain injury
LRS/06/09/036 A randomised, crossover dose effect trail of paracetemol 40 and 60 mg/kg in
third molar surgery
LRS/06/09/037 The clinical anatomy of the anterior neck muscles
LRS/06/09/038 Measurement of quality of life of New Zealand adults and adolescents with
cystic fibrosis
LRS/06/09/039 Renal dialysis in the elderly: Pilot Study
LRS/06/09/040 A prospective evaluation of matrix metallopoteinase-9 as a predictor of
coronary artery in-stent restenosis
LRS/06/09/041 Replacement of a multi-drug resistant E. coli (MDREC) with the probiotic E.
Coli strain Nissle 1917 (EcN) in rest home residents in the Otago region
LRS/06/10/042 Health implications of salivary composition in head and neck cancer patients
LRS/06/10/043 The geometry of the solid hypophraryngeal walls
LRS/06/10/044 A comparison of fluorescence-guided Er: YAG laser and mechanical scaling
and root planing for no-surgical debridement: a controlled prospective
clinical study.
LRS/06/10/045 Course and prognosis following first time lateral ankle sprain
LRS/06/10/046 Comparison of the effectiveness of an impairment-based manual therapy
and exercise approach versus traditional treatment in the management of
heel pain: a randomised clinical trial
LRS/06/10/047 Culture of human olfactory nucosal tissue in vitro to evaluate bacterial,
14/08/2006
Approved
Quinn, Bronagh
06/09/2006
Approved
McKechnie, Roslyne
Conditional
Abbott, Dr Haxby
06/09/2006
Approved
Grainger, Ms Michelle
N.
20/09/2006
Approved
Conditional
Approved
09/10/2006
26/09/2006
Approved
Approved
Meyer, Karl
Norris, Ms Pauline
Hammond-Tooke, Dr
Graeme
Silva, Mr Rohana
Kumara De
Kennedy, Ewan
Neall, Malcolm V.K.
24/10/2006
Conditional
Conditional
Derrett, Dr. Sarah
Williams, Dr Michael
Conditional
Schultz, Dr. Michael
Conditional
Approved
Conditional
Ryan, Mr Jamie
Zhang, Dr. Ming
Soo, Ling Feng
Approved
Conditional
Munn, Dr. Joanne
Abbott, Dr Haxby
Conditional
Faed, Dr. James
19/09/2006
Conditional
24/10/2006
25/10/2006
Agenda – November Meeting
File RE08-03-4
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fungal and Mycoplasma contamination of olfactory mucosal biopsy samples
and to charaterise conditions that support growth of neural progenitor
(stem) cells, olfactory ensheathing cells and fibroblasts
LRS/06/10/048 Understanding the transmission of risk for physical and mental health
problems from parents to children
LRS/06/11/049 What is the incidence and awareness of Asthma in the Southland Region
LRS/06/11/050 An audit of prescribing patterns in patients who are obese
Conditional
LRS/06/11/051 Enoxaparin and the risk of bleeding - an impact study
Received
LRS/06/11/052 A randomised single blind study to improve health related quality of life as
measured by the SF-36 vitality score by correcting anaemia of chronic
kidney related disease with Aranesp® (darbepoetin alfa) in the elderly
(STIMULATE)
LRS/06/11/053 Double blind randomised controlled trial of an orally administered probiotic in
the treatment of spondylo arthritis
LRS/06/11/054 Retrospective analysis of dental implant treatment provided at the School of
Dentistry since 1989
LRS/06/11/055 Does obesity influence the patters of lung function during acute
bronchoconstriction? (the INCA study - Investigating broncho-constriction in
asthma)
LRS/06/11/056 The management of non-eosinophilic asthma: a randomised controlled trial
Received
Poulton, Associate
Professor Richie
Parsons, Jill
Duffull, Professor
Stephen
Duffull, Professor
Stephen
Schollum, Dr. John
Received
Stebbings, Dr Simon
Received
Verma, Rajiv
Received
Taylor, Professor D
Robin
Received
LRS/06/11/057 The impact of dietary salt (NaC1) intake on arterial wall function in
hypertensive subjects: a randomised controlled cross-over study
LRS/06/02/CPD Campylobacter and Antibiotic use
LRS/06/03/CPD An audit of outcomes for the early intervention in Psychosis Service
LRS/06/04/CPD The impact of head lice on primary school children in Dunedin
LRS/06/05/CPD The changing face of Coeliac disease
LRS/06/06/CPD Medical student's perception of patient aggression
LRS/06/07/CPD The changing face of Coeliac disease
LRS/06/08/CPD Follow-Up of patients with rheumatoid arthritis
Received
Taylor, Professor D
Robin
MacGinley, Dr. Robert
Received
Received
07/03/2006
21/04/2006
21/07/2006
12/10/2006
05/09/2006
19/10/2006
Approved
Approved
Approved
Received
Conditional
Approved
Received
Longman, Mark
Kerr, Kate
Chatterjee, Animesh
Chan, Raymond
MacKay, Jasmine
Chan, Raymond