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					                                 MINUTES



                       NORTHERN X ETHICS COMMITTEE

                        TUESDAY, 14 SEPTEMBER 2010




                           DOUGLAS ROBB ROOM
                            BUILDING 14, LEVEL 7
                        GREENLANE CLINICAL CENTRE



PRESENT:

     Brian Fergus             Chairperson
     Wayne Miles              Deputy Chairperson
     Robyn Northey            Joanna Stewart
     Linda Kaye               Paul Tanser
     Alaina Campbell          Rosemary Langham

APOLOGIES:
    Ieti Lima
    Jocelyn Byrd




ADMINISTRATOR:

     Patricia Chainey



MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 10 AUGUST 2010

     Confirmed: Wayne Miles/Robyn Northey

     Amendments are required for NTX/10/08/073.
     Study initially deferred by the Committee and changed by the chairperson to be
     ‘Approved subject to Conditions’




                                                                                  1
     NTX/10/08/081
     J. Stewart noted some of her comments were missed in the final minutes.
     Administrator will write to the researchers advising if any minor changes are
     required. This is not expected to cause any ethical issues.




MATTERS ARISING:

     Dr Marewa Glover will be invited to attend the meetings, under contract, as an
     observer and to join in the discussions but will not be eligible to vote.




GENERAL BUSINESS:

    Resignation of Committee Member
    G. Pihama has resigned from the Committee, effective July 2010


    D4 – Approach:

    L. Kaye’s memo was discussed by the Chair and Committee



    Chair's report on Wellington meeting.
      1. Workload sharing between committees
      2. Member training
      3. Members contacting researchers
      4. Consistency across the country
      5. Streamlining things
      6. Appointments to committees
      7. Participation in survey from Napier
      8. Website

    Martin Tollich's paper

    Discussed with Committee



    Small survey for Kate Faasse, Dept of Psychological Medicine at University of
    Auckland

           This study has ethical approval

.
    Noted


                                                                                  2
   Correspondence:
      Letter dated 12/8/10 from Lianne Parkin and Charlotte Paul, University of
         Otago re Using medical information for pharmacoepidemiological research
         For Committee information

   Received



   Approvals for the Month of August 2010

   Attached approval schedule for Committee members


   Approvals and Observational Study approvals for month of August 2010t

   Full applications                                14
   Observational Studies for expedited review       30


   Conflict of Interest:

   NTX/10/09/094 and 097
   J. Stewart declared a conflict of interest as she was co-researcher on both of these
   studies. She refrained from voting but was invited by the Chair to join the discussion
   on the studies.



SERIOUS ADVERSE EVENTS

   As per schedule attached for Committee Members.




NEW APPLICATIONS:

    1.    NTX/10/09/086
    Are biological sex differences associated with a difference in susceptibility to
    noise induced hearing loss in men and women?
    Principal investigator:    Ms Renee Hislop
    Co-Investigators:          Dr Ian Laird (supervisor), Dr Dianne Gardner
    Localities:                Massey University, Auckland DHB


    Approved subject to the following conditions

    The Chairperson or Deputy Chairperson will review the response prior to final
    ethical approval being given under delegated authority

                                                                                       3
Application
   General: Is it possible that personalizing the level could reduce the
      male/female difference?
   Detail what hormone assays are being conducted (in the study design and in
      the PIS)
   P.1: Is contact address correct?
   Provide ADHB and Massey MRRC letters of support
   Locality Assessment through ADHB (pending)
   Declaration A (pending)
   A4.1: Researcher to decide what difference would be clinically important –
      not use the study to see what difference is observed in the first few
      participants and change the design based on that
   A4.2, A5.2: A sample size calculation should be conducted based on what
      difference would be clinically important. The design is also complex with
      repeated measures within participants, requiring appropriate analysis
      methods. The sample size may not be correctly powered – check with PhD
      supervisor
   B8: Provide definitions of level of noise exposure required for exclusion –
      what percentage of people are likely to be excluded?
   B14: Clarify the criteria for study termination
   C1: to be ‘yes’
   C2: to be ‘no’
   Part 5: 1.7 Expand re blood samples

Information Sheet
     Ensure PIS is lay friendly
     Insert researchers’ names and contact details after the lay title
     Give more detail about what is involved, e.g. the timing of the visits, reword
      to make what is happening appropriate for baseline visit as well and give
      details of female blood test (where, why, what will happen to the blood)
     Insert the risks of a blood test, i.e. bruising
     State a mould will be taken of the ear and a probe inserted. Give risks of
      venepuncture
     Change results sentence to say participants will be sent the results if
      requested
     State how the noise test will be conducted – what happens if hearing
      remains impaired following test
     State what the participants are to do if they have a problem after the session
     State that participants will be reimbursed for their costs with a $10 petrol
      voucher at each testing session
     Correct ethical approval statement to Northern X (not Y)

Consent Form
   Insert date of PIS when updated
   Insert ‘I wish to receive a copy of the results….YES/NO’
   Insert ‘I agree to my GP or other current provider being informed of my
     participation in this study/the results of my participation in this
     study….YES/NO’
   PIS & Cons to have same V# and date


                                                                                  4
                                                                   Chair/Dep Chair




2.    NTX/10/09/087
Testing new biomarkers for use in the diagnosis of prostate cancer
Principal investigator: Dr James Watson (supervisor)
Co-Investigators:       Dr Richard Forster, Dr Gill Webster, Dr Andrea Rossi
Localities:             Caldera Health Ltd

James Watson attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   Provide a letter of support from Wayne Russell
   Declaration B required and signed by JP (P. 26)
   Provide a copy of the insurance liability and insurance certificate
   Provide a copy of the invitation letter
   P.4.13: To be ‘yes’
   P.4: 14: To be ‘yes’
   B9: Insert the slight risk of venepuncture
   C1: To be ‘yes’ as participants are being screened
   C2: To be ‘yes’
   D7: Needs to state records kept minimum 10 years (Health Act)

Information Sheet
     Guidelines NAFG to be consulted.
     To be on letterhead
     Need to include the controls in the PIS
     50 health men will be chosen to provide baseline data, while the second
      group will comprise 150 with prostate cancer.
     Insert that when researcher takes a blood sample, there is the possibility of
      bruising.
     Insert compo statement for Declaration B – Guidelines NAFG P. 28
     Insert ethical approval statement
     Insert advocacy statement
     Insert a version no. and date as a footer in both the information sheet and
      the consent form.

Consent Form
   To be on letterhead
   First para to read ‘I have read and I understand information sheet dated….’

                                                                   Chair/Dep Chair


                                                                                  5
3.    NTX/10/09/088
Respiratory effects of insulin sensitisation with metformin: a prospective
observational study
Principal investigator:  Dr Paul Sexton
Co-Investigators:        Prof John Kobe (supervisor), Dr Patricia Metcalf
Localities:              Auckland DHB, University of Auckland

Paul Sexton and John Kolbe attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   P.1: Titles: Both need to state this is a feasibility study
   P. 8: Clarify numbers
   P.3: Supervisor’s signature required
   A5.2: No hypothesis testing should be planned as this is a feasibility study.
      Analysis should only be to obtain estimates of variation and within person
      correlation for planning of future study
   E7: To be ‘no’ – Researcher advised blood not stored. If incorrect and it will
      be stored then also needs to go into the PIS
   B8: States BMI >30 but in protocol P.9 BMI is >25. To be corrected

Information Sheet
     State this study is for a PhD at the beginning
     In description of what this study is for, clarify what this feasibility study can
      achieve, rather than the full study
     Insert that GP may be informed of any results with clinical implications even
      if participant has not given approval
     Blood is being stored, this needs to be stated in PIS and Consent Form
     Expand/explain the side effects
     Correct ethical approval statement to Northern X Regional Ethics Committee
     Ensure PIS and Consent Form have the same footer date

Consent Form
   Insert ‘I agree to my GP or other current provider being informed of my
     participation in this study/the results of my participation in this
     study….YES/NO’

Committee Suggestions:
   Researchers are requested to try and recruit some Maori, if possible

                                                                      Chair/Dep Chair




                                                                                     6
4.    NTX/10/09/089
Locked versus non-locked screws for plating fixation in the treatment of
forearm fractures in skeletally mature patients: a prospective, randomised
controlled study
Principal investigator:  Dr Joshua Sevao
Co-Investigators:        Dr Godwin Choy, Mr Kevin Karpik, Mr Bruce Twaddle
Localities:              Counties-Manukau DHB, Auckland DHB

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   The Committee presume this is a supervised study. A supervisor is required
      and the name and signature stated in P.3,8.1 and 8.3
   As the P.I. is a house officer, how will continuity be achieved for the duration
      of the study?
   Where does the device come from?
   State what is the existing evidence.        (Stevens’ reference is not in the
      reference list)
   Safety: Consider some independent person to review
   What is the usage overseas?
   Who are the ‘orthopaedic staff’?
   MRRC letters of support from CMDHB and ADHB (pending)
   Locality Assessments for CMDHB and ADHB (pending)
   Pt 1, 16: Should be ‘yes’
   B12: States not informing GP but the Consent Form asks if they wish the
      GP to be informed – which is correct?

Information Sheet
     Lay title needs to be bolded and also for the Consent Form

Consent Form
   Remove ‘I agree to an approved auditor….for the study’

                                                                   Chair/Dep Chair




5.    NTX/10/09/090
Auckland regional community stroke study (ARCOS IV).           Measuring and
reducing the stroke burden in New Zealand
Principal investigator:  Professor Valery L. Feigin
Co-Investigators:        A/Prof Kathryn McPherson, Prof Suzanne L. Barker-
                         Collo, Dr Rita Krishnamurthi, Prof Alan P. Barber, Dr
                         Ruth Bonita, Dr Paul Brown, Dr Max Abottt, Ms Varsha
                         Parag, Prof Bruce Arroll, Dr Derrick Bennett (Univ of
                         Oxford)

                                                                                  7
Localities:                Auckland University of Technology, Auckland DHB,
                           Counties-Manukau DHB

Valery Feigan, Rita Krishnamurthi and Suzanne Barker-Collo attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   Locality Assessments for ADHB, CMDHB & WDHB
   MRRC letters of support from ADHB, CMDHB & WDHB
   C1: To be ‘yes’ (screening)
   C2: To be ‘No’
   Committee require justification on the non-consent gathering of minimal data
      and what will be collected
   HRC commented that services have been slow to take on Arcos evidence.
      Will this research make a difference?
   Part 5 unclear if DNA IS being banked.
   Adverts to have prior approval

Information Sheet
     Expand on how researchers are getting the information on how the person
      suffered a stroke and advise that basic information already gathered will be
      retained for all people and then put the invitation wording
     Clarify the storage and use of the saliva sample and DNA
     State that samples can be returned on request (in line with the condition
      stipulated in Maori letter of support)
     State DNA is to be banked and sent to Australia for future use and seek
      consent in the Consent Form
     Insert ‘Auckland District Health Board (ADHB) Maori Ethics Review do not
      support tissue banking in any form, given collective whanau, hapu, iwi
      whakapapa implications. However they have noted individuals have the
      right to make their own decisions.’
     Clarify the time required from participation
     Insert compensation statement
     State that the interview will be kept on the computer
     Correct the advocacy statement
     Correct the ethical approval statement – Northern X Regional Ethics
      Committee

Consent Form
   Remove interpreter box as clear spoken English is required
   Add consent to store DNA

Committee Suggestions
   Committee Considered there is a burden of many questionnaires

                                                                  Chair/Dep Chair


                                                                                8
6.    NTX/10/09/091
ARCOS IV: Measuring and reducing stroke burden in New Zealand.        Motivational
interviewing styroke trial (MIST)
Principal investigator:    Professor Valery L. Feigin
Co-Investigators:          A/Prof Kathryn McPherson, Prof Suzanne L. Barker-
                           Collo, Dr Rita Krishnamurthi, Prof Alan P. Barber, Dr
                           Ruth Bonita, Dr Max Abottt, Ms Varsha Parag, Prof
                           Bruce Arroll, Dr Derrick Bennett (Univ of Oxford)
Localities:                Auckland University of Technology, Auckland DHB,
                           Counties-Manukau DHB

Valery Feigan, Rita Krishnamurthi and Suzanne Barker-Collo attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   Locality Assessments required for ADHB, CMDHB , WDHB & Waikato DHB
   MRRC letters of support required from ADHB, CMDHB , WDHB & Waikato
      DHB
   Section 3: Clarify
   AUT letter does not fit this study.

Information Sheet
     C1: To be ‘Yes’
     C2: To be ‘No’
     Clarify the timing and insert into PIS
     Insert compensation statement
     Correct the advocacy statement (There is no ‘Trust’)
     Correct the ethical approval statement – Northern X Regional Ethics
      Committee
     F6.2: State that Stroke Foundation consultation undertaken

Consent Form
  Insert consent for data to be sent to Australia and returned to NZ for storage
  and to be used for future studies relating to stroke


Committee Suggestions:
   Committee Considered there is a burden of many questionnaires

                                                                Chair/Dep Chair




                                                                                9
7.    NTX/10/09/092
A single site, randomised, double-blind, parallel-group, placebo-controlled
study of intravenous sodium ascorbate in patients with lower limb cellulites:
Protocol V#1, 23/08/10
Principal investigator:  Dr Nigel Harrison
Co-Investigators:        Ms Wendy Coleman, Dr Richard Rankin
Localities:              Whangarei Base Hospital, Northland DHB

Caroline Alsweiler attended via phone

Deferred
            Operational Standard        2.4 Validity of research proposal
                                        2.5 Minimisation of Harm

If the application is to be resubmitted, the following is to be considered and
included: The Researcher is also requested to attend the meeting (in person or
teleconference)

Application
   A2.1: This study is not a pilot. Remove reference to ‘pilot’
   A2.2: State what evidence there is for the stated dose, expand on current
      available safety information.
   A5.2: Baseline characteristics should not be statistically tested – the groups
      are randomised
   B13: Who will comprise the DSMB?           Will members of the DSMB be
      independent of the company? Expand on their funding of it
   Is there any obligation to ‘sponsor’?     Are they receiving data prior to
      publication?
   State examples of use in NZ.
   Part 5: 1.7 and 1.8 have serious inconsistencies. Clarify third party access

Information Sheet
     Simplify the wording. Needs editing and to be put in more lay friendly
      language
     Near the beginning, include a sentence that study participation is voluntary
      and will not affect standard treatment
     Explain what is meant by overdose and how many people have received this
      dose
     Ethical approval statement to read ‘This study has received ethical approval
      from the Northern X Regional Ethics Committee.

Consent Form
   Insert the date of final information sheet in the first para
   If the researchers believe they may want to use blood samples for further
     research then add a request in the consent form, ‘I consent to my blood
     sample being used for further research relating to cellulites

                                                                   Chair/Dep Chair




                                                                               10
8.    NTX/10/09/093
A multi-centre, randomised trial to determine if accelerated partial breast irradiation,
utilising 3D CRT, is as effective as whole breast irradiation following breast
conserving surgery in women with ductal carcinoma in situ or invasive breast
cancer with negatie axillary lymph nodes: Protocol V#4, Amend 3, 27/05/10:
Principal investigator:      Dr Gill Campbell
Co-Investigators:            Dr Maria Pearse, Dr Christine Elder, Dr Chakiath Jose,
                             Dr Hedley Krawitz, Dr Susan Brooks, Dr Glenys Round
Localities:                  Auckland DHB, Waikato DHB

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   The Committee compliments the researchers on a well thought out study
      application.
   ADHB & Waikato DHB MRRC (pending)
   F2.1: Correct the numbers

Information Sheet
     Participants should have the right to withdraw from the trial and if not allowed
      to withdraw their information, this needs to be inserted into the PIS, bolded
      and underlined. Also to go into Consent Form.
     Insert in ADHB PIS: ‘Auckland District Health Board (ADHB) Maori Ethics
      Review do not support tissue banking in any form, given collective whanau,
      hapu, iwi whakapapa implications. However they have noted individuals
      have the right to make their own decisions.’
     Put all the contact information into the tissue PIS

Consent Form
   Interpreter box: Add a first line ‘Deaf’. I wish to have a NZ sign language
     interpreter Yes/No’
   For tissue consent, add statements that participants understand the tissue is
     to be sent overseas, understand stored 15 years and if not used, understand
     could be used for other studies investigating aspects of breast cancer (see
     Guidelines NAFG P. 21-23)

                                                                      Chair/Dep Chair




9.    NTX/10/09/0094
Randomised control trial of an intervention programme based on the cystic
fibrosis model of care in children less than two years of age admitted to
hospital with severe lower respiratory tract infection to prevent chronic lung
disease: Protocol V#1, 23/08/10

Principal Investigator:       Dr Adrian Trenholme


                                                                                     11
Co-Investigators:            Dr Catherine Byrnes, Dr Harley Aish, Mr Henare
                             Mason, Ms Karen Hoare, Dr Diana Lennon, Mrs
                             Joanna Stewart, Prof. William Leung
Localities:                  Counties-Manukau DHB, Bairds Rd Family & Christian
                             Health Centre Otara, Greenstone Family Clinic
                             Manurewa, Mangere Family Doctors Mangere

Adrian Trenholme, Charissa McBride and Joanna Stewart attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   P.5.18: Insert a more feasible start date
   D7: To state data to be stored until age of majority plus 10 years
   CMDHB MRRC letter of support (pending)

Information Sheet
     Clarify the differences
     Edit the timetable
     Edit for more neutral language
     Insert that the blood test may be uncomfortable to the child

Committee Suggestions:
   A flow-chart in the PIS would be of benefit
                                                                     Chair/Dep Chair




10. NTX/10/09/095
An open-label, multi-centre study of the safety of twice daily oxycodone
hydrochloride controlled release tablets in opioid experienced children from
ages 6 to 16 years old inclusive with moderate to severe malignant and/or
non-malignant pain requiring opioid analgesics: Protocol OTR3001, V#2,
22/07/10: IB Ed # 12, 5/10
Principal Investigator:    Dr Andrew Liley
Co-Investigators:          Dr Ross Drake, Dr Timothy Short

Ross Drake, Sarah Thompson and Davina McAllister attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application:
   P.2: Insert co-researchers’ email addresses
   A7: Ensure that the sponsor cannot withhold negative results
                                                                                 12
      C5.3: To be ‘yes’ (cross out the ‘no’)
      P. 16 missing from original copy.
      D4: Is the Plain language statement referred to here the PIS?
      D7: Data to be kept until age of majority + 10 years (Health Act - Children)
      Section F: ADHB MRRC letter of support (pending)
      Agreement (pending)
      Forward the MPS for P.I.
      Pt 5: Edit 4.3 and 4.4
      Pt 5: 4.7: Should be ‘no’ – not being stored for future use that needs to be
       consented.

Information Sheets:
     Edit for more lay language (i.e. ‘supplemental medication’)
     Clarify that samples will be destroyed after analysis
     Add that all medication is being provided by hospital pharmacy so extra visits
      will need to be made to pharmacy/clinic for medication if it is being provided
      at times other than the visits specified in the protocol. If dose changes there
      may be added trips to receive new strength.
     Last page of the participant sheet is worded as if it is the parent
     Confidentiality on parents worded as if for child

Consent Forms
   Insert ‘I consent to blood samples being destroyed at the end of the study
     …YES/NO’
   Parents’ form wording needs changing to be for their child

Committee Suggestions:
   Children’s PIS: Edit: We are trying to find out if………works’ – Ensure more
    neutral – not making it sound as it would necessarily work
                                                               Chair/Dep Chair




11. NTX/10/09/096
Portable airway support in stable chronic obstructive pulmonary disease
Principal investigator:   A/Professor Kathryn McPherson
Co-Investigators:         Dr David Nicholls, Prof. Ahed Al-Jumaily, Prof Olag
                          Diegel, Dr Anthony Leicht,
Overseas investigators:   A/Prof Marion Gray, Dr Justin Travers
Localities:               Auckland University of Technology, Waitemata DHB,
                          Te Whanau Waipareria

Valery Feigan attended for the principal investigator

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application

                                                                                  13
      Locality Assessments for Waitemata DHB, Tamaki PHO, Te Whanau
       Waipareria
      A5.2: As this is a feasibility study, the only reason to conduct statistical test
       is to get a measure of variance and within subject correlation. A difference
       for main study should be what matters clinically
      A5.4: Note researchers will be re-finalising the questionnaire which needs to
       come to the Committee prior to Phase 2.
      Will researchers also resubmit optimal levels developed in Phase 1?
      C1: To be ‘yes’ (screening)
      C2: To be ‘no’
      Vouchers: Why is there an ‘average’ value?
      The ‘Manchester Respiratory Activities of Daily Living Questionnaire is hard
       to read’
      Section F: Not targeting Maori. Do researchers plan to target for Phase 2?
       If so how?

Information Sheet
     Correct ethical approval statement – Northern X Regional Ethics Committee

                                                                      Chair/Dep Chair




12. NTX/10/09/097
Can we reduce Maori and Pacific School Children's hospitalisations to
Pakeha rates?
Principal investigator: Prof Diana Lennon
Co-Investigators:       Mrs Joanna Stewart, , Ms Teula Percival, Ms Philippa
                        Anderson, Ms Elizabeth Farrell, Mr James Hamill, Mr
                        Henare Mason, Ms Jude Woolston
Localities:             Counties Manukau DHB, Wiri Central School

Lizzie Farrell, Philippa Anderson and Joanna Stewart attended

Approved subject to the following conditions

The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority

Application
   P.1: Titles need to include that it is a feasibility study
   Researchers to inform the Committee as to how, under current legislation, a
      public health nurse is able to diagnose. Committee’s understanding is that
      standing orders only allow supply and administration
   Part 4: PI has not signed
   Locality Assessment required for CMDHB
   Explain role of parents who have neglected their child’s/family’s treatment
      needs. Do they get educated?




                                                                                     14
           Too busy – hard to sort out what was research and what was usual practice.
            Is this feasibility of throat and skin investigation in schoolchildren or
            community consultation?

     Information Sheet
          Insert researchers’ names and contact details under the heading.
          Begin with an invitation
          If family not part of research then it needs to be noted that if child has
           infection then PHN referral will be made for other family members and
           investigation and treatment will be offered as per usual processes, or GP will
           be advised
          Expand. Changes in all information sheets/consent form need prior ethical
           approval
          Insert full advocacy statement
          Insert compo statement

     Consent Form
        First para to read ‘I have read and I understand information sheet dated……’
        If researchers extending to family members, consent will need to be obtained

     Committee Suggestions:
        Asian participants.    Should include family members if participants are to be
         swabbed/treated

                                                                        Chair/Dep Chair




Meeting Closed

6.40 p.m.




                                                                                      15
AMENDMENTS REVIEWED BY CHAIRPERSON OR DEPUTY CHAIRPERSON under
delegated authority.


    NTX/05/12/164
    HIV behavioural surveillance study: Gay Auckland Periodic Sex Survey 2008:
    Prot/amend 5/8/10: Q’aire 2011: PIS V#4, 4/8/10.
    Investigators:             Mr Peter Saxton
    Co-Investigators:          Dr Nigel Dickson, Mr Tony Hughes

       Protocol amendment dated 5 August 2010
       Questionnaire 2011
       Participant Information Sheet V#4 dated 4 August 2010



    NTX/08/12/116
    Cognitive function and treatment for testicular cancer:
    Principal Investigator:    Dr Fritha Hanning
    Co-Investigators:          Prof Vernon Harvey, Dr Kathryn Chrystal, Dr Peter
                               Fong, Dr Reuben Broom, Dr Ben Lawrence, Dr Dipti
                               Mittall, Dr Catherine Han

       Change in Principal Investigator from Prof Harvey to Dr Hanning
       Participant Information Sheet/Consent Form V#5, dated 26 August 2010
       Addition of Drs Mittall and Han as co-investigators



    NTX/09/05/042
    Investigation of the mechanisms responsible for ultra treatment resistant
    schizophrenia:
    Co-Investigators:        Ms Meghan Murphy, Prof Rob Kydd, Mr Himadri Seth,
                             Dr. Sandy Simpson
    Localities:              University of Auckland, Waitemata DHB

       Protocol Amendment dated 11 August 2010
        To perform analysis of blood samples obtained for levels of a steroid hormone
        called pregnenolone

       Change in co-investigators:
           Meghan Murphy changed name to Meghan McIlwain
           Addition of Dr Valerie Anderson
       Participant Information Sheet/Consent Form, V#6 dated 3 August 2010
       Participant Information Sheet/Consent Form – Genetic Sub-study, V#6 dated 3
        August 2010
       Participant Information Sheet/Consent Form – MRI study, V#2 dated 3 August
        2010


                                                                                  16
   Control Participant Information Sheet – Electroencephalography Study, V#1
    dated 12 July 2010
   Control Participant Information Sheet – Genetic Sub-study, V#1 dated 12 July
    2010
   Control Participant Information Sheet – MRI Study, V#1 dated 12 July 2010
   Poster (Undated)



NTX/10/02/006
Patient perceptions around alternative options for the delivery of cardiac
rehabilitation: PIS/Cons V#2, 22/2/10: Prot/amend 6/5/10: Prot/amend 3/8/10
Principal Investigator:    Ms Enid Dorey
Co-Investigators:          Dr Robyn Whittaker, Dr Ralph Maddison, Dr Ralph
                           Stewart
Localities:                University of Auckland, Auckland DHB

   Protocol amendment dated 3 August 2010
         To allow cardiac rehabilitation nurse specialist to look retrospectively
         through their records to identify the non-attenders.

   Cover letter V#1 dated 3 August 2010



NTX/10/05/039
The prophylactic hypothermia trial to lessen traumatic brain injury: randomised
controlled trial (POLAR): Prot. ANZIC-RC.DJC003 V#2, 23/6/09: PIS/Cons V#2,
26/05/10: Prot/amend V#3, 1/06/10
Principal Investigator:      Dr Colin McArthur

   Protocol Amendment V#3 dated 1 June 2010



NTX/10/07/069
Strength for task training to optimise locomotor function following stroke: a
pilot randomised controlled trial:Prot/amend 25/08/10: PIS/Cons V#3, 25/08/10
Principal Investigator:    Ms Nada Signal
Co-Investigators:          A/Prof Denise Taylor (Supervisor), Prof Kathryn
                           McPherson,
                           Dr Gwyn Lewis, A/Prof Mark Weatherall, Dr Suzie
                           Mudge,
                           Ms Nicola Kayes, Ms Liz Binns
Localities:               Stroke Foundation, AUT University, Waitemata DHB

   Protocol Amendment dated 25 August 2010
    Changes to the inclusion criteria and recruitment strategy




                                                                                  17
PROGRESS REPORTS

   AKL/2000/155
   A phase III study of ST1571 versus Interferon-alpha (IFN-alpha) combined with
   Cytarabine (Ara-C) in the treatment of patients with newly diagnosed previously
   untreated philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in
   chronic phase (CML-CP); Protocol # CST1571 0106, 14/4/00; Pro/amend #1,
   24/7/00; Prot/amend #2, 1/11/2000, Ext to Prot # CST 1571 0106: Prot/Amend #3,
   23/01/2002: Prot/amend #4, 29/093/04: Addend. V#1, 20/12/05. Prot/amend 5,
   21/12/05: Prot/amend 6, 14/11/07: PIS/Cons #3, 31/3/08: IB V#11, 29/07/09
   Principal Investigator:       Prof Peter Browett

   +Abstract


   AKL/2000/176
   National Wilms tumour group (NWTS) Study V-therapeutic trial and biology study
   CCG 4941, 3/99: PIS V#1 4/8/00: Prot/amend, 19/04/2002
   Principal Investigator:       Dr Ruellyn Cockcroft

   +Abstract


   AKL/2000/199
   Chemotherapy for progressive low grade astrocytoma in children less then ten years
   old; CCG # A9952, Amend #2, 30/05/2000: : PIS/Cons V#2, 21/06/05.
   Principal Investigator:       Dr Stephen Laughton


   AKL/2000/224
   Medical Research Council working party on leukaemia in childhood. Acute myeloid
   leukaemia trial 12; Protocol for children MRC AML 12
   Principal Investigator:          Dr Lochie Teague


   AKY/02/00/151
   Children’s Cancer Group P9641 - Primary Surgical Therapy for Biologically Defined
   Low-Risk Neuroblastoma: PIS/Cons V#2, 14/8/02: Amend #3, 30/08/02
   Principal Investigator:      Dr Lochie Teague


   AKY/02/00/192
   Cytokine gene polymorphisim in paediatric patients receiving tacrolimus or
   cyclosporin for graft-versus-host disease prophylaxis: Protocol PBMTC GVG0112,
   15/03/02: Amend 3/07/02. PIS/Cons V#2, 08/07/02
   Principal Investigator:         Dr Lochie Teague


   AKX/03/07/183

                                                                                  18
Screening of human sera derived from patients with malignant and benign hyper-
gammaglobulinaemias for the presence of glutamate receptor modulating antibodies:
Prot/amend V#03, 05/06/04, Substudy (stroke) Substudy (Rheumatology patients):
Prot/amend:       SLEDAI Protocol: PIS/Cons V#5.5 5/09/06:       substudy (w/o
neuropsychiatric lupus), PIS/Cons V#9, 5/8/10
Principal Investigator         Dr Maggie Kalev

+Abstract


AKX/04/08/224
Linkage analysis, mutational analysis and characterisation of genes causing disease
in the glaucomatous optic neuropathies: PIS/Cons V#4, 4/09/08
Principal Investigator:        Dr Andrea Vincent

+Abstract


NTX/06/04/030
An international multi-centre study of tamoxifen vs anastrozole in postmenopausal
women with hormone sensitive ductal carcinoma in situ (DCIS): Protocol IBIS-II
(DCIS) V. 5/05: Prot/amend V. 8/06: IB Ed. 11, 12/06:Prot/amend V. 6/07: PIS/C
V#7, 12/09/07: Prot/amend 3/09: PIS/Cons V#8, 9/09/09: Prot/amend V. 1/10:
PIS/Cons V#9, 14/04/10
Principal Investigator:         Dr Michael McCrystal


NTX/06/05/053
A pilot study investigating hypothermia in traumatic brain injury in children.: Prot/Manl
Amend V#5, 8/8/08: PIS/C V#3, 8/8/08
Principal Investigator:          Dr John Beca


NTX/06/07/083
A survey-based study of the incidence of depression in adolescent girls with
polycystic ovary syndrome (n= approx 100) compared with normal, healthy
adolescent girls in Auckland, NZ: PIS/Cons V#3, 18/08/06
Principal Investigator:         Dr Stella Ruth Milsom


NTX/06/08/098
Improving arm function in young people with hemiplegia - insights from neuroscience:
PIS/Cons V#4, 11/10/06
Principal Investigator:        Dr Anna Mackey

+Abstract


NTX/06/09/112
Failure of cyclophosphamide therapy in lupus nephritis patients: the role of
bioactivaton phenotype and genotype: Protocol 10/08/06:     Prot/amend V#2,


                                                                                      19
26/10/06: Prot/amends V#3, 27/11/06; V#3, 8/05/07; V#4, 5/09/07; V#5, 29/11/07:
PIS/Cons V#4, 19/12/07 (ChCh V#5)
Principal Investigator:      Dr Nuala Helsby

+Abstract


NTX/07/07/072
A prospective, randomised clinical trial of multimodal analgesia including low dose
dexmedetomidine infusion for pain relief following laparotomy surgery, including
laparotomy assisted bowel resection:Prot/amend 23/2/09: Prot/amendV#3,27/04/10:
PIS/Cons V#4, 27/04/10
Principal Investigator:        Dr Tim Short


NTX/07/68/EXP
Five year Survival after Admission to Geriatrics Service at Auckland Hospital in 2000
Principal Investigator:         Mr Garth MacLeod


NTX/08/03/019
Laparoscopic humidification trial.   Warm humid insufflation for laparoscopic
appendicectomy in children: a randomised controlled trial: Prot/amend V#2, 1/10/09:
PIS/Cons V#3, 1/10/09 Manual V#2, 6/08
Principal Investigator:        Mr James Hamill


NTX/08/05/047
Pharmacokinetics of ketamine and its metabolite, norketamine, during low dose
intravenous infusion in children in hospital with acute pain
Principal Investigator:           Dr Elsa Taylor


NTX/08/06/051
Children’s Oncology Group (COG) ANBL0532: Phase III randomised trial of single
vs. tandem myeloablative consolidation therapy for high-risk neuroblastoma:
Protocol ANBL0532, 29/05/07, Prot/amend #1, 28/1/09: PIS/Cons V#5, 11/05/09:
prot/amend #2, 9/03/10: PIS/Cons V#6, 8/5/10
Principal Investigator:       Dr Lochie Teague


NTX/08/08/072
An intervention at the general practice level to improve immunisation coverage and
timeliness in infants: a randomised controlled trial; PIS/Cons v#2, 24/8/08
Principal Investigator:         Dr Felicity Goodyear-Smith


NTX/09/07/065
The ISAR-SAFE Trial: prospective, randomised, double-blind, placebo-controlled
trial of six months versus twelve months clopidogrel therapy after implantation of a
drug-eluting stent: Protocol V#8, 4/09: PIS/Cons V#2, 4/08/09
Principal Investigator:          Dr Mark Webster

                                                                                   20
   NTX/09/08/074
   Predicting pulmonary hypertension: PIS/Cons V#2, 15/09/09” Prot/amend Substudy:
   24/11/09 PIS/Cons V#1 16/11/09
   Principal Investigator:       Dr Margaret Wilsher


   NTX/09/08/075
   Evaluation of glaucoma and ischaemic optic neuropathy as neurodegenerative
   diseases using structural and functional magnetic resonance imaging: PIS/Cons V#2,
   25/08/09
   Principal Investigator:         Dr Benjamin Thompson


   NTX/09/106/EXP
   CM active evaluation
   Principal Investigator:;      Dr Adrian Field

   +Abstract


   NTX/09/111/EXP
   The effect of non-protocol calcium and vitamin D supplementation on fractures and
   vascular events in the WHI CaD trial
   Principal Investigator:         Dr Mark Bolland

   +Abstract


   NTX/09/119/EXP
   Use of a reminder sticker to improve rates of resuscitation status documentation,
   venous thromboembolism prophylaxis prescribing and removal of unnecessary
   intravenous cannulae in general medical patients: Prot Amendment V#2, 23/10/09
   Principal Investigator:        Dr Simon Briggs


   NTX/09/166/EXP
   Evaluation of Siemens i-pilot and image fusion software on digital subtraction
   angiography at Auckland City Hospital: PIS/Cons V#1, 19/11/09
   Principal Investigator:       A/Prof Andrew Holden

   X
   X
   Principal Investigator:       X




END OF STUDY REPORTS:            COMMITTEE MEMBERS ONLY MAY REQUEST
                                 COPIES


                                                                                  21
AKL/99/047
Hepatoblastoma and hepatocellular carcinoma. SIOPEL 3 liver tumour studies final
version 1/6/98: Prot/amend 10/04: PIS/Cons V#2, 13/5/05
Principal Investigator:    Dr Jane Skeen

+Abstract


NTX/05/02/002
Outcome of interventions from a pelvic floor clinic for defecatory disorders: the
Auckland experience
Principal Investigator:     Dr Ian Bissett

+Abstract


NTX/06/08/094
Development and validation of an interactive anaesthesia warning system for
monitoring the adverse effects that might arise during anaesthesia administration:
PIS/Cons V#5, 2/03/09
Principal Investigator:      Dr Michael Harrison

+Abstract


NTX/06/12/151
Measurement of peak inspiratory flow rates in dyspnoeic patients: Protocol V#3,
26/01/07: PIS/Cons V#6, 9/07/07
Principal Investigator:    Dr. Joanne Ritchie


NTX/07/02/012
Support needs of gynaecologic cancer survivors
Principal Investigator:       Ms Lisa Schneideman Walton


NTX/07/08/081
The effects of stress reduction on surgical wound healing: a randomised controlled
trial: Q’aire V#2, 20/02/08: PIS/Cons V#6, 23/7/08
Principal Investigator:       Dr Elizabeth Broadbent



NTX/08/05/044
Validation of the Edinburgh postnatal depression scale as a screening tool for postnatal
depression in Samoan and Tongan women: PIS/Cons V#3, 17/06/08
Principal Investigator:            Dr Alec Ekeroma

+Abstract


NTX/08/06/056

                                                                                           22
A three-month randomised, prospective, single-blind controlled study to determine
the effect of two dairy lipid preparations on bone and calcium metabolism in normal
post menopausal women: Protocol 3/4/08, PIS/Cons V#2, 4/7/08
Principal Investigator:            Prof Ian Reid

+Abstract


NTX/08/06/058
Parents experiences of incredible years parent management training delivered within
a child and adolescent mental health service
Principal Investigator:     Ms Kaye Wolland

+Abstract


NTX/08/07/069
Respiratory health outcomes of young infants admitted to hospital with severe lower
respiratory infection in the first two years of life, in Counties Manukau: Protocol
V#1.0: PIS/Cons V#2, 7/08: Prot/amend V#2, 27/07/09
Principal Investigator:          Dr Adrian Trenholme


NTX/08/11/108
An evaluation of the wider use of an intensive group parenting programme (Hoki ki te
Rito/Mellow Parenting) for parents experiencing significant parenting problems:
Protocol V. 15/10/08: PIS/Cons V#3, 25/11/08
Principal Investigator:      Dr Sally Merry

+Abstract


NTX/08/22/EXP
Audit of cervical screening in HIV infected women in the Auckland, Northland and
Waikato regions
Principal Investigator:      Dr Simon Briggs

+Abstract


NTX/08/79/EXP
Prothrombinex-VFR usage for reversal of a coagulopathy and thrombogenicity
safety. A retrospective audit
Principal Investigator:    Ms Lousie Bobbit

+Abstract


NTX/09/06/049
Paediatric perspectives on biofeedback computer games to improve health:
PIS/Cons V#2, 17/07/09
Principal Investigator:     Dr Sally Merry

                                                                                      23
+Abstract


NTX/09/07/059
Do implantable cardioverter defibrillator (ICD) patients’ beliefs about their illness
influence the development of anxiety and avoidance behaviours?: PIS/Cons V#2,
2/08/09
Principal Investigator:      Dr. Elizabeth Broadbent

+Abstract


NTX/09/07/067
Feasibility of implementing a sleep education programme amongst New Zealand
youth: PIS/Cons V#2, 31/07/09
Principal Investigator:       Dr Ralph Maddison


NTX/09/97/EXP
The impact of the current influenza amongst pregnant women (or recently post-
partum) women
Principal Investigator:       Dr May Ching Soh

+Abstract


NTX/09/107/EXP
What are the barriers to delivering nursing care in an emergency department of a city
district health board (DHB) in New Zealand: PIS/Cons/Q’aire, V#1.01, 24/08/09
Principal Investigator:       Dr Craig Wootten


NTX/09/109/EXP
Epidemiology of venous thromboembolism (VTE) in hospitalised patients in New
Zealand
Principal Investigator:    Ms Diane Wiseman

+Abstract


NTX/09/111/EXP
The effect of non-protocol calcium and vitamin D supplementation on fractures and
vascular events in the WHI CaD trial
Principal Investigator:      Dr Mark Bolland

+Abstract


NTX/09/116/EXP
Factors involved in variations in the uptake of HPV vaccine in schools in Auckland
District Health Board region

                                                                                        24
Principal Investigator:        Dr Felicity Goodyear-Smith


NTX/09/127/EXP
The experience of young people with juvenile idiopathic arthritis who have been
transferred from paediatric to adult services
Principal Investigator:       Ms Julie Blamires

+Abstract


NTX/09/138/EXP
Review of evidence in consideration of a physician assistant (anaesthesiology)
workforce within Waitemata District Health Board: PIS/Cons/Q’aire V#2, 16/10/09
Principal Investigator:     Bradley Clarke

+Abstract


NTX/10/03/022
Auckland zoological park staff zoonosis survey: Protocol V#5, 21/3/10: PIS/Cons,
Q’aire V#5, 21/3/10
Principal Investigator:      Ms Maureen Forsyth

+Abstract


NTX/10/EXP/024
Development of a resource for the nutritional management of Polycystic Ovarian
Syndrome (PCOS) for CMDHB referred patients
Principal Investigator:     Ms Megan Dabb

+Abstract


NTX/10/EXP/032
E-learning - leading dietitians into the future
Principal Investigator: Ms Sophie Blundell

+Abstract




                                                                                   25

				
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