Minutes NTX July 08

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					                                   MINUTES


                     NORTHERN X ETHICS COMMITTEE

                           TUESDAY, 8 JULY 2008



                           KARAKA MEETING ROOM
                                    AT
                            MINISTRY OF HEALTH
                              UNISYS BUILDING
                           650 GREAT SOUTH ROAD
                            PENROSE, AUCKLAND.



PRESENT:

    Vanya Kovach                    (Chairperson)
    Wayne Miles                     (Deputy Chairperson)
    Robyn Northey                   Emma Ngawhare
    David Sinclair                  Trevor Sherwin
    Natalie Gauld                   Sonya Hunt
    Jocelyn Byrd



    Review of the four sponsored studies was carried out by Rosemary Carruthers
    (lawyer from Lower South Committee) and comments were relayed to the Deputy
    Chairperson.


APOLOGIES:

    Linda Kaye
    Joanna Stewart


ADMINISTRATOR:

     Patricia Chainey



MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 10 JUNE 2008

     Confirmed: S. Hunt/N. Gauld

                                                                              1
MATTERS ARISING:

      1.   Compensation issues.

           Update given by V. Kovach.

           a) NTX/08/03/023 (initial review 11/03/08) A Phase Ib randomised,
           placebo-controlled clinical trial to study the safety and efficacy of
           MK-7009 in hepatitis C infected patients: Protocol MK-7009 004-03
           V.5.2, 31/10/07: IB V.10.0, 22/01/08
           Principal Investigator: Dr Ed Gane

           Now has ethical approval.



           b) NTX/08/04/031 (initial review 8/4/08)
           Contact lens fit in children: clinical evaluation of proclear dailies vs
           BENZ45G dual focus contact lenses in children: Protocol CV-08-10,
           2/08
           Principal Investigator:  Dr John R. Phillips

           Update. Letter sent 28/5/08

           No reply to this letter to date



           c) NTX/08/05/045 (initial review 13/05/08) – SCOTT obtained 16/5/08
           A Phase I, randomised, open label, four-way, cross-over study to
           compare the pharmacokinetics of RO4876904 from a new tablet
           formulation and an existing capsule formulation in healthy subjects:
           Protocol#WP21670 A, 14/04/08: IB V#3, 4/08
           Principal Investigator: Dr Ed Gane

           Now has ethical approval.



      2.   Chairs/Deputy Chairs Meeting 27/06/08

           A verbal report was given by the Chairperson/Deputy Chairperson



      2.   National application numbers for 2007 and to June 2008.

           Noted.

                                                                                 2
GENERAL BUSINESS:

  1.   Schedule of approvals – new applications and Observational Studies

          Schedule attached.



  2.   NTX/05/08/094
       A multi-centre, randomised, double-blind, parallel group, placebo
       controlled trial to evaluate the efficacy and safety of activated recombinant
       factor VII(rFVIIa/NovoSeven/NiaStase) in severely injured trauma patients
       with bleeding refractory to standard treatment: Protocol F7Trauma-1711,
       V.1, 13/05/05, IB Ed 14, 20/07/05: Prot/Amend 6.01.06: Prot/Amend V#3,
       17/11/06: PIS/Cons V#5, 20/08/07& 07/09/07: Prot/amend V#4 11/01/08: IB
       19/11/07:
       Principal Investigator: Dr Yatin Young

       Advice 12/6/08 that this study has been terminated by the sponsor following the
       results of the planned interim analysis for futility, conducted by the independent
       DSM.

       Received.

  3.   NEAC Ethics of Intervention Studies – discussion document and draft
       ethical guidelines for intervention studies.

       The document was distributed to Committee member for later discussion.



       NTX/06/11/146
       A randomised, open-label, controlled, multicentre, two-year study
       comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in
       combination with peg alpha-2a sq 180 ug with peg alpha-2a monotherapy
       and with telbivudine monotherapy in treatment naive patients with HBeAg-
       positive CHB: Protocol # CLDT600A2406, 26/07/06: IB Ed. 9./0, 16/06/06: IB
       Supp. 1 21/12/07Prot/amend 1, 3/11/06: Prot/amend V#2, 14/3/07, V#3,
       6/09/07: Prot/amend 2, 14/3/07: Prot/amend 3, 7/09/07:
       Principal Investigator: Dr Ed Gane

       Advice from Novartis that the study is to be terminated under Section 16 of
       agreement. Study was discontinued in January 2008 due to an increased risk
       of peripheral neuropathy.

       The researcher advised that the study participants returned to their usual
       medical care. As the drug appears to be not locally licensed. In which case the
       participants returned to their standard care.


                                                                                       3
       Received.




SERIOUS ADVERSE EVENTS

   As per schedule attached for Committee Members.




RESUBMISSION:

     NTX/08/04/030
     CoreValue International ReValving™ Registry: Percutaneous Aortic Valve
     Replacement (PAVR) with the CoreValve ReValving™ System (CRS):
     Protocol CV-PAVR-R2007-V2, 1/08/07: IB Rev 1, 25/3/08
     Principal Investigator:;   Dr John Ormiston

     Approved subject to the conditions below.

     Application
        P.3, 9: This is not a Multi-Region application – to be marked „no‟.

     Information Sheet:
          P.3. Incorrect ethical approval heading and statement. Heading to be
           „Statement of ethical approval‟. The wording to be „This study has received
           ethical approval from the Northern X Regional Ethics Committee‟.
          Under „Risks and Benefits‟, explain that there is no benefit to the participant
           but that the registry may provide information which will be of benefit to
           others who undergo the procedure.

     Consent Form
        To be updated as amended I.S. required.

     Committee Suggestions
        The committee suggests that the lay title – and title on the PIS and Consent
         Form – be amended to: „The ReValve Registry: a registry of those who
         have undergone a non-surgical technique in the treatment of a diseased
         aortic valve.


                                                                        Chair/Dep. Chair



NEW APPLICATIONS:

    1.     NTX/08/07/060
    CYP2C19 pharmacogenetics in cancer: the effect of disease progression
    Principal investigator: Dr Nuala Helsby, ADHB

                                                                                        4
Co-Investigator             Dr George Laking, Regional Cancer & Blood Service

Nuala Helsby attended.

Approved subject to the conditions below

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

Application
   P. 1: Lay title is not lay-friendly
   Letter of support from ADHB MRRC yet to be received
   Locality Assessment from ADHB required.

Information Sheet
    Soften the wording in the first sentence and replace blunt statement about
      cancer diagnosis
    Insert that study results will be available if required.
    Insert a heading and information on „What will happen to my blood samples‟
    Add information about allergic reaction under side effects, identifying the
      symptoms which a participant would need to look out for, and report.
    Correct ethical approval statement „This study has received ethical approval
      from the Northern X Regional Ethics Committee‟.
    Page nos. to be 1 to 4

Consent Form
   Bullet point for clarity (i.e. P. 2 re GP being informed)
   Insert „I wish to have my blood samples returned……YES/NO‟
   Page nos. to become 1 and 2
   Insert “I wish to have a summary of the results of the research sent to me
    YES/NO”

Committee Suggestions:
   PIS: Under Side Effects” Consider removing „hair loss‟ as this is a very
    uncommon side effect and probably extremely unlikely in this group, given the
    dosing used.
   Consider informing GP as this information may be of value in later years

                                                                Chair/Dep. Chair




2.     NTX/08/07/061
Comparison of Routes of Local Anaesthetic Administration for Laparosopic
Inguinal Hernia Repair
Principal investigator: Mr Andrew Bowker, Laparoscopy Auckland
Co-Investigator         Dr Gail Pearson


                                                                                5
Andrew Bowker attended.

Approved subject to the conditions below

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

Application
   Pilot study: needs to be in title.
   Locality Assessment required from Laparoscopy Auckland.
   Declaration B (sponsored research) submitted. As study under Declaration
      A, this will be destroyed.
   B6: States a card is issued. Researcher to provide a copy of the card.
   B12: States no such risks are expected. What happens if there are?
   D4: Is there anyone else who could make the initial approach and then
      discuss at consultation, e.g. information given out when appointment made.
   F3.2: States Maori consultation in hand with ADHB MRRC but letter of
      support to be received.
   Declaration B also signed – needs to be destroyed as not a sponsored trial.
   B10. Include “Competent English speaker” under inclusion criteria, as no
      suitable translators available.

Information Sheet
    To be on letterhead.
    First line: Remove “additional” from “additional pain relief options”.
    Clarify the study aims including information about usual practice of this
      surgeon and current state of research.
    Insert “The doctor or nurse will check with you on the day of the surgery that
      you still wish to go ahead”.
    Remove “If you require an interpreter, I can help arrange one for you”.
    Compensation: Remove the first sentence as an instruction to researcher
      and not to be in I.S.
    Correct ethical approval statement to …….Northern X Regional Ethics
      Committee‟

Consent Form
   To be on letterhead.
   Include „I wish to have a summary of results…..YES/NO‟
   Remove interpreter boxes, as no suitable translators available


                                                                  Chair/Dep. Chair




3.    NTX/08/07/062
An investigation of the relationship between emotional awareness and eating
disorder illness severity over 18 weeks of treatment

                                                                                 6
Principal investigator:      Dr Roger Mysliwiec, Greenlane Clinical Centre
Co-Investigator              Ms Kara Woodward
                             Four Australian researchers

Kara Woodward attended on behalf of the Principal Investigator

Approved subject to the conditions below

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

Application
   P.1: Lay title to be more descriptive, i.e. Emotional awareness and eating
      disorders..
   P3: 17: To include that the research is for a PhD thesis and that Dr
      Mysliwiec is collecting NZ data and is responsible for this study in NZ, and
      also for ensuring ethical use of the data by the Australian Investigator Natalie
      Costin.
   P.4: Start date to be more realistic.
   B10: Include women more than 16 years. Exclude non-English speakers
   C: It is a clinical trial – to be marked „yes‟ and it is under ACC.
   . D8: Who is Richard Lane? If he is involved in the study then he needs to
      be come a co-investigator and P.1/2 is to contain his details.
   E4: To be answered.
   E7: Insert that there is potential for a follow-up study and this needs to be in
      the Information Sheet and Consent Form. Include in this that consent for
      future use of the data will be sought from an Australian ethics committee.
   Letter of support from ADHB MRRC
   Locality Assessment required through Dr David Sage, ADHB.

Information Sheet
    Describe what study is about.
    Change lay title, as above and be consistent throughout, i.e. „emotional
      awareness‟ not „emotions‟.
    Near beginning of PIS stated that the study is for PhD/Masters thesis .
    Clarify the aims of the study.
    Outline full study including the Australian arm. Include a brief description of
      the scenarios.
    Explain the word „de-identified‟ in lay terms.
    Clarify when individual scores will be available to the treating pyschologist
      and explain that this does not necessarily mean that participants will have
      access to their own scores.
    State the data will be stored in Australia.
    Compensation statement required for Declaration A (Guidelines NAFG P.21)
    P.2: under „Confidentiality‟: change „shredded after 7 years‟ to „10 years‟.
    Insert correct advocacy statement.
    Outline process if researchers identify safety risk.
    Correct Committee in ethical approval statement to……‟Northern X Regional
      Ethics Committee‟

Consent Form

                                                                                    7
      Wording in first para to be completed, i.e. „….designed to…………..‟
      Insert „I agree to my data being stored in Australia for future use as a follow-
       up study.
      Insert „I am aware the exception to confidentiality will be if the interviewer
       has significant concerns about my safety others
      Remove interpreter box from consent form

Questionnaires
   To be on letterhead
   All to have clear titles.
   To have a footer with version no. and date.
   LEAS-A: Q8: „How would your colleague feel?‟ makes no sense, as the
      scenario, as written, does not say that the colleague knows about your
      doctor‟s advice. Is this omission intentional? If not, edit.

                                                                      Chair/Dep. Chair




4.     NTX/08/07/063
A pilot study with the IDEAL™ bioabsorbable coronary stent platform eluting
sirolimus (WHISPER) STUDY: Protocol #CLP-0001.C, V. 28/04/08: IB V.
13/08/07
Principal investigator:    Dr John Ormiston, Cardiac Services, Auckland DHB
Co-Investigator            Auckland City Hospital: Dr Mark Webster, Dr Peter
                           Ruygrok, Dr Jim Stewart, Dr Tom Johnson, Dr Paisan
                           Nakpathomkum
                           North Shore Hospital: Dr Seif El Jack, Dr Guy
                           Armstrong.

John Ormiston and Jan Kurd attended.

Approved subject to the conditions below

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

Application
   P.1: Change Full project title to include „First in Man‟ instead of „a pilot study‟.
      As study is not a pilot study. Ensure the „first in man‟ issue is well addressed
      in the invitation letter and the P.I.S.
   P.3: 18/19/21: Full dates to be inserted – not use of „Q4‟
   C: Under C4, detail how cover for protocol deviation/negligence will occur.
      Provide evidence that researchers have cover for injuries to participants
      caused by protocol deviation and/or negligence. The committee requires that
      this be at least of the level offered by the Medical Protection Society.
   E8: if possible, the initial approach should be another doctor.
   Letter of support from ADHB MRRC
   Signed copy of indemnity agreement between PI/sponsor
   Certificate of Insurance

                                                                                      8
     NRL assessment to come.
     B19. The committee requires that SCOTT approval be sought, in order that
      scientific aspects of the study, which may be beyond the competence of the
      committee to assess, be examined

Invitation letter:
     P.1 4th last para: remove „If something happens that is not part of the trial
        you would be covered by ACC‟.
     Edit wording „only‟ and „just‟.
     Include that stent contains salicylic acid.

Information Sheet
     Mention the recent exposure in man, i.e. 8 participants from March 2008.
     P.3: Under „Stent Implant Procedure‟: Bullet points and/or sub-headings
      would make the information easier for lay people to understand.
     Describe what will happen to the blood samples.
     Describe the scanner (diameter).
     There are 2 statements regarding pregnancy – clarify which one applies.
     P.7: Duration of participation. The last sentence needs to be reworded.
      Suggest “ . . .you should be excluded from taking part . . “
     Under „Compensation‟ correct name of committee to „The Northern X
      Regional Ethics Committee‟
     Advocacy no. incorrect – should be 0800 555 050
     Under „statement of approval‟. Correct to „Statement of ethical approval‟
      and correct wording to „This study has been given ethical approval from the
      Northern X Regional Ethics Committee‟.
     P 7. Include information about insurance cover for injuries to participants
      caused by deviation from protocol and/or researcher negligence.

Committee Suggestions:
   Consent Form: Page nos. should be 1 and 2 not 9 and 10.           Also correct
    spelling of „Whisper‟.

                                                                  Chair/Dep. Chair



5.     NTX/08/07/064
Speech and language of children with cleft lip and/or cleft palate
Principal investigator:  A/Prof Suzanne Purdy, University of Auckland
Co-Investigators         Ms Tonia McCarry, Ms Maeve Morrison (CMDHB), Mr
                         Alayne McKee

Maeve Morrison and Tonia McCarry as Co-Investigators attended on behalf of the
Principal Investigator.

Approved subject to the conditions below

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


                                                                                 9
Application
   P.1: The Committee would prefer that the Tonia McCarry becomes principal
      investigator and A/Prof Suzanne Purdy is the supervisor. The application
      would need to be changed accordingly. (especially P. 2 and supervisor‟s
      signature obtained).
   Letter of support from CMDHB MRRC
   P.3: Start date not realistic.
   P.5.A3.1: Re-look at this section to ensure all information about proposed
      tests is in the P.I.S.
   P.5. A.3.2.2.: Statistical advice needs to be obtained and report sent to
      Committee.
   P.12: D7: Data to be kept to age of majority plus 10 years (Health Act –
      children).
   Provide examples of proposed tests.

Information Sheets
    Expand what the study is about – in good lay language.
    P.1: Last para – replace „them‟ with „your child‟.
    P2: Explain that in unusual cases, the assessments may take up to four
      hours.
    P. 2: Remove amount of voucher and replace with „A voucher will be offered
      to help with travel costs‟.
    Any use of digital camera/taping/hearing test information needs to be included
      and agreed to in the Consent Form.
   Insert a version no. and date as a footer in both the information sheet and the
      consent form.
    PIS for Manager: Insert „If you have any queries or concerns regarding your
      rights as a participant in this study, you may wish to contact your professional
      organisation‟
    PIS for Manager: Insert “You will only be asked for records when the parents
      or legal guardians have consented”

Consent Forms
   To be headed Consent Form
   Holding data and consent form for 10 years is duplicated – edit.
   Ensure new date of information sheet put into first para.
   Insert: “I agree that the researches may have access to my child‟s clinical
    records for the purposes of this study”
   No need for a separate consent form for the manager

Committee Suggestions:
   That other cultural groups, where there is a high incidence of cleft palat,e are
    consulted.
   Application: P.3.17: Correct „left‟ lip to „cleft lip‟ in para 2.

                                                                    Chair/Dep. Chair




6.    NTX/08/07/065

                                                                                   10
Whey proteins and satiety: the effects of beverages supplemented with dairy
whey proteins on hunger, satiety and energy intake in a group of overweight
women
Principal investigator:   A/Prof Sally Poppitt, University of Auckland
Co-Investigators          Dr A-T McGill, Dr Y-K Chan, Ms Janice Proctor

Anne-Thea McGill, Kai Chan and Janie Proctor attended.

Approved subject to the conditions below

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

Application
   C4: Clarify.        Sponsor does not exclude liability for injury caused by
      researcher negligence but in P.I.S. says that researchers‟ insurance covers it.
      Provide evidence of researchers‟ insurance cover, demonstrating that it does
      cover injury from negligence or departure from study protocol.
   Supply an outline of telephone screening questions.

Advertisement
   Insert ‟18 – 45 years old‟

Information Sheet
    Insert a statement that contact will be made with the GP should the
      researchers discover untoward problems.
    P.2/3 under „study 1‟ and „study 2‟. „General health questions‟ not sufficiently
      informative – suggest „questions about health, diet (including alcohol
      consumption), exercise, menstrual cycle and an in-depth questionnaire on
      your eating behaviour and your feelings about eating.‟

Consent Form
   Insert the statement „I am aware that if the principal investigator has
    significant concerns about the safety of myself or to others, confidentiality
    may be broken as required by law or applicable professional codes of
    practice.‟

                                                                   Chair/Dep. Chair




7.     NTX/08/07/066
Validation of sarcoidosis health questionnaire, a disease-specific health
related quality of life measure for patients with sarcoidosis
Principal investigator:     Dr Sally de Boer, Auckland DHB
Co-Investigators            Dr Margaret Wilsher, Mrs Nicky Good, Mrs Wendy
                            Fergusson

Sally de Boer attended

Approved subject to the conditions below

                                                                                  11
The Chairperson or Deputy Chairperson will review the response prior to final
ethical approval being given under delegated authority.

Application
   Letter of support from ADHB MRRC
   A3.2.2.: Complete. (Arlene Zang?)
   B5: No. of participants from private practice? Complete (25?)

Information Sheet
    Include full information on what kind of questions there will be.
    Insert that participants can complete in rooms or ADHB clinic.

Questionnaires:
  All questionnaires to have footers with version # and date.

Committee Suggestions:
   Provide a feedback sheet –„what effect the disease has on you?‟, „what
    impact on daily life?‟ and “has the SHQ allowed you to fully report the impact
    of your disease?”

                                                                     Chair/Dep. Chair




8.     NTX/08/07/067
Urinary coproporphyrin isomers and liver fibrosis study
Principal investigator:   Mr David Song
Co-Investigators          Dr James Davidson, Dr Weldon Chiu, Dr Ed Gane, Dr
                          Gerald Woollard

Approved subject to the conditions below

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

Application
   P.1.2: Lay title required
   Provide Locality Assessment for CMDHB
   Maori consultation and letter of support
   A3.1: Describe how controls will be recruited and consent gained.
   A3.1: Will serial urine samples be taken in conjunction with serial liver
      biopsies?
   B8: Provide an expanded answer.
   C: This is a clinical trial. Form A needs to be completed.
   D4: Clarify who will make the initial approach to participants (preferably not
      the principal investigator) – the sentence is incomplete.
   D7: Storage of information must be by the institution, rather than the
      researcher.


                                                                                  12
     D9: A summary is sufficient to send to participants. This option should be
      included on the Consent Form.
     Provide Pt 5 (Use of human tissue)
     F3: Expand as per the Guidelines. What impact could this condition or
      research have on Maori?
     F4: Should be „yes‟ not „no‟ and explain why.
     Clarify where healthy volunteers will be recruited.

Information Sheet
    Needs full edit to revise whole of information sheet as language is
      inadequate. Refer to Guidelines NAFG and ensure that the I.S. is in good lay
      language.
    Title to be „Participant‟ Information Sheet
    A Participant Information Sheet is needed for Controls.
    If samples are to be stored only until batch processing, this does not count as
      long term storage, so does not need separate consent. Consent would be
      needed if samples stored for future research.
    Include advocacy statement
    Compensation statement for Declaration A required (Guidelines NAFG P. 21
    Ethical approval statement to be a stand-alone para.
    Needs full editing as English is bad throughout
    Version nos. to be same for information sheet and consent form.

Consent Form
   A Consent Form is needed for controls.
   Remove „or other research‟ from „I consent to the researchers storing a
     specimen of my urine……………..‟ If the urine is only being retained until
     processed in a batch, this sentence is not needed.
   Remove the two paras beginning „I wish‟ re ethnicity data. There is no
     special mention in application form particularly in F3 nor the PIS. Therefore
     it should not be specific in the Consent Form.
   Add „I understand my blood and urine test samples will be destroyed at the
     end of the study.
   Explain why ethnicity is on this form and for what reason.

Committee Suggestions
   Pre-testing the Participant Information Sheet with lay people is advisable.

                                                                   Chair/Dep. Chair




9.     NTX/08/07/68
Calfactant for acute respiratory distress syndrome: Protocol Amend #1, 3/4/08
Principal investigator:     Dr John Beca
Co-Investigator             Dr Colin McArthur, Ms Laura-Clare Whelan, Ms
                            Lynette Newby
Overseas Co-investigators: Dr Doug Wilson, Dr Jonathan Truwit (USA)



                                                                                  13
John Beca attended by teleconference and Colin McArthur and Catherine
Simmonds attended the meeting.

Approved subject to the conditions below

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

Application
   Researcher to confirm that the drug is TSE-free.
   Provide copy of letter from MPS that P.I. is a member.
   P.1.1: full project title should be expanded to say for „adults and children…‟
   P. 1: Lay title to be expanded to explain the initials.
   Insurance Certificate (received)
   Signed Indemnity Agreement between sponsor and P.I.
   B.11: Remove contact by telephone.
   The research nurse or intensive care specialist is to do the initial approach.
   C: Compensation: Needs to be at least to the level offered by ACC. The
      committee requires that C2 (a) or (b) be ticked, and that all of C3 be ticked
      “yes”, to be consistent with ACC cover. C4 (a) and (b) acceptable on
      confirmation that the researchers and all acting under them are indemnified
      by the Medical Protection Society for injuries to participants caused by
      deviation from protocol or negligence.
   P.15: Children involved. Data to be kept until age of majority plus 10 years
      (Health Act)
   F3.2: Mention review from ADHB MRRC.
   B8: Explain reasons for holding that there is equipoise. Evidence of SCOTT
      approval to be forwarded
   The Committee requires assurance from the sponsor that there will be no
      pressure put on researchers to recruit participants if recruitment numbers are
      low

Information Sheets
    To have the name of the Principal Researcher (J. Beca) inserted as principal
      investigator and Colin McArthur as co-investigator. (Declarations/Locality are
      in the name of J. Beca).
    Clarify who will be study co-ordinator? Laura Whelan or Lynette Newby – or
      both?
    P.1: Fully explain the process particularly around placebo.
    From application form: P.10. B8. Insert into the information sheet that
      Calfactant is not presently used in standard care except with infants, and
      explain situation of equipoise in lay language. Insert that larger study is
      required to confirm usefulness of treatment.
    Under „Participation‟ add that the participant is able to withdraw from the
      research at any time but that the researchers will continue to collect data on
      mortality, though they will do this through records only. Explain the necessity
      for this, and advise that those who are unwilling for this to happen should not
      consent to be in the study
    Needs to reflect exactly how child participants are going to be „tested‟ –
      „treated‟.
    Correct/insert the full advocacy statement (Guidelines P. 19.8.9

                                                                                  14
     Correct ethical approval statement committee name to Northern X Regional
      Ethics Committee.

Statement by Relative/Friend/Whanau
    As there is a separate PIS and consent for parents this is not necessary in
      this form

Consent Form
   To have the name of the Principal Researcher (J. Beca) inserted as principal
    investigator and Colin McArthur as co-investigator.
   Remove „This study has been given ethical approval….ethical procedures‟ as
    only required in information sheets.
   Insert in both consent forms “I understand that I am agreeing to the
    researchers having access, via records, to information about mortality, even if
    my relative/whanau/child withdraws from the study”

                                                                   Chair/Dep. Chair




10.    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
Principal investigator:   Dr Adrian Trenholme, Counties Manukau DHB
Co-Investigator           Dr Diana Lennon, Ms Charissa McBride, Mrs Joanna
                          Stewart, Dr Wendy Walker, Dr Teuila Percival, Dr
                          Emma Best, Mr Henare Mason, Dr Iona Thomas

Charissa McBride attended.

Approved subject to the conditions below

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

Application
   P.9: B11: Explain more fully, i.e. medical records, parent enquiry,
      examination of children‟s chest X-ray.

Information Sheet
    Clarify if chest X-Ray refused, would proposed participants still be able to be
      in the study.
    Title of information sheet to be “Information for Parents and Legal Guardians”

Committee Suggestions:
   Edit Consent Form for capitals etc.




                                                                                 15
AMENDMENTS:

    1.     NTX/04/12/002
    A three year randomised, double-blind, placebo-controlled trial to determine
    the duration of effect of zoledronate on bone turnover markers and on bone
    density: PIS/Cons V#2, 12/01/05
    Principal Investigator:    Prof Ian Reid
    Co-Investigators:              Mrs Diana Wattie, Dr Mark Bolland, Dr Andrew Grey, Dr
                                   Anne Horne

             2-year observational extension
             Extension Study PIS/Cons V#1 dated 22/05/08

    Approved



    NTX/06/10/124
    Reducing post-stroke attention deficits: a randomised controlled trial:
    PIS/Cons V#2, 13/10/06: Amend 6/11/06: Prot/amend 20/02/07:
    Principal Investigator:       Ms Suzanne Barker-Collo
    Co-Investigators:             Prof Valery Feigin, Dr Carlene Lawes, Mr Hugh Senior, Ms
                                  Varsha Parag, Dr Anthony Rodgers, Ms Xenia Chen, Ms
                                  Margaret Dudley

              Protocol Amendment 2.0, 9/06/08:
              Primary Objective: To assess the effectiveness of APT to improve attention
              in post-acute stroke survivors with attention deficit from baseline to 6 months
              after stroke compared to usual care.

             Study to continue recruitment until such time as the required sample size
              (N=78) to detect change in IVA-CPT is reached.

    Prior to ethical approval for this protocol amendment, Researcher is required to
    provide evidence that statistical advice has been obtained and confirms that the
    study is still viable following this protocol amendment.



    NTX/07/08/084
    A 52-week open-label extension study of the long-term safety and efficacy of
    rosiglitazone extended-release (RSG XR) in subjects with mild-to-moderate
    Alzheimer’s disease (REFLECT-5): Prot. AVA102677 19/03/07: IB V#2,
    17/04/07: Prot/amend #1, 6/08/07: PIS/Cons 4, 18/12/07
    Principal Investigator:     Dr Philip Wood

             Protocol Amendment 3 dated 10/04/08
             PIS/Cons V#5, dated 30 May 2008.

    Approved




                                                                                             16
      NTX/07/11/113
      A randomized pilot study to assess efficacy of ß-blockade for reducing
      energy expenditure in patients with liver cirrhosis: PIS/Cons V#2, 12/12/07
      Principal Investigator: Associate Professor Lindsay D Plank
      Co-investigators:       Associate Professor John L McCall,
                              Associate Professor Ed Gane

            Substudy of insulin resistance: Additional measurement
                Oral glucose tolerance test (OGTT)
                Botnia clamp

            PIS/Cons V#3, 18/04/08

      Approved subject to the conditions below

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

      Amendment required to PIS/Cons – Correct advocacy statement to be inserted.



      NTX/07/11/121
      An open label, sequential, dose escalation, repeat-dose study of the safety,
      pharmacokinetics, pharmacodynamics and immunogenicity of PRTX-100 in
      adult patients with chronic idiopathic thrombocytopenic purpura (ITP):
      Protocol PRTX-100A-201, 24/07/07: PIS/Cons V#3, 5/02/08: Prot/Amend 1,
      12/07: PIS/Cons V#4, 5/03/08: IV V#3, 19/03/08
      Principal Investigator:  Dr Hilary Blacklock


            Protocol Amendments
                 1. PRTX-100A-2-1 Amendment 2 dated 19 May 2008
                 2. PRTX-100A-201 Change summary and memo
                 3. PIS/Cons V#5 dated 16 June 2008.

      Approved



      MEETING CLOSED:

      7.45 p.m.


The following were reviewed and given ethical approval by the Chairperson or the Deputy
Chairperson under delegated authority.


APPROVALS and OBSERVATIONAL STUDY APPROVALS:

    See attached schedule (Under general Business).

                                                                                    17
APPLICATIONS REVIEWED UNDER CPD:

     OBSERVATIONAL STUDIES: AUDIT NOT REQUIRING ETHICAL APPROVAL:



AMENDMENTS REVIEWED UNDER DELEGATED AUTHORITY

     AKY/04/10/282
     Clinical Priority Assessment Criteria (CPAC) Evaluation Project: Cornonary
     Artery Bypass Graft (CABG) Surgery Priority Assessment Tool: Economic
     Substudy. PIS V#2, 27/9/2004
     Principal Investigator:  Dr Jacqueline Cumming.
     Co-Investigator:         Dr Terri Green, Dr Elana Curtis, Dr Mary Seddon, Dr
                              Ralph Stewart.

            Amendment for the economic substudy to access data for a group of patients who
             had early CABG surgery.
            Progress Report: Reconfirmed for 6 months only.


     NTX/05/11/153
     A 24-month, multi-centre, randomised, open-label non-inferiority study of
     efficacy and safety comparing two exposures of concentration-controlled
     Certican (everolimus) with reduced Neoral (cyclosporine) versus 3.0 g MMF
     (mycophenolate mofetil) with standard dose Neoral in de novo heart
     transplant recipients: Prot.# CRAD001A2310, 29/08/05: PIS/Cons V#5,
     29/09/06: IB Ed#9, 27/08/07:Prot/amend 6 15/1/08: PIS/Cons V#6, 25/02/08:
     Compassionate Substudy Prot/amend # 1, 12/08/03.
     NTX/05/11/142

            Compassionate substudy
            PIS/Cons 1, 12/10/03

            Protocol Amendment 7, 17/04/08
            PIS/Cons V#7, 23/06/08



     A 24-month, multicentre, randomised, open-label, non-inferiority study of
     efficacy and safety comparing concentration-controlled Certican(r) in two
     doses (1.5 and 3.0 mg/day starting dose) with reduced Neoral versus 1.44 g
     Myfortic(r) with standard dose Neoral in de novo renal transplant recipients:
     Protocol # CRAD001A2309, 17/06/05, Prot/amend #1 22/11/05 & #2 30/12/05:
     IProt/amend #3, 2/01/01/08: PIS/Cons V#4, 30/06/08: IB Ed 12, 12/07
     Compassionate Substudy: Prot/Amends 1&2, 28/04/06
     Principal Investigator:     Dr Helen Pilmore



                                                                                        18
       Amended PIS/Cons V#4, 30/06/08 to include the rare association between
        progressive multi-focal leukoencephalopathy and mycophenolate:


NTX/07/07/076
An intervention to improve management of medical emergencies by intensive
care teams: PIS/V#2, 25/10/07
Principal Investigator:  Mr Robert Frengley
Co-Investigator:         A.Prof Jennifer Weller, Dr Peter Dzendrowskyj, A.Prof
                         Alan Merry, Dr Jane Torrie, Dr Bevan Yee, Dr Lara
                         Hopley, Dr Michael Kalkoff, Whangarei Hospital
                         Dr Troy Browne, Tauranga Hospital, Dr Janet Liang,
                         North Shore Hospital
Sites:                   Waikato DHB, Counties Manukau DHB, Auckland DHB,
                         University of Auckland, Mercy Hospital, Northland DHB,
                         Waitemata DHB.

       Addition of North Shore Hospital.


NTX/07/09/091
Randomised controlled trial of VY advancement flap versus laterial
sphincterotomy in the repair of anal fissure: PIS/Cons V#3, 25/01/08
Principal Investigator:  Mr Michael Hulme-Moir
Co-Investigators:        Dr Hisham Hammodat, MrjJohn Jarvis

       The addition of Mr John Jarvis, Consultant Colorectal Surgeon as a further
        co-investigator,


NTX/07/09/098
A randomised controlled pilot study to assess the effect of the cysteinyl
leukotriene receptor antagonist, montelukast, on plasma biomarkers and
transcriptional profile of leucocytes in patients with acute coronary
syndrome: PIS/Cons V#3, 1/11/07: Prot/amend V#4, 15/04/08
Principal Investigator: Dr Patrick Gladding
Co-Investigators:       Dr Mark Webster, Dr Ralph Stewart, Prof. Harvey White,

       Protocol Amendment V#4 dated 15 April 2008.

The subcommittee stated that the risk is sufficient that it must be clearly stated in
the information sheet/consent form and therefore PIS/Cons V#4 needs to be
amended.


NTX/07/12/137
Assessment of pituitary function in children who sustained traumatic brain
injury (TBI) in infancy: PIS/Cons V#6, 2/7/08.
Principal Investigator:     Dr Wayne Cutfield
Co-Investigators:          Dr Patrick Kelly, Dr Natasha Heather, Dr Paul Hofman,
                           Dr. Craig Jefferies, Dr Rhys Jones, Mr James Hamill, Mr
                           Andrew Law

                                                                                  19
                            University of Auckland, Liggins Institute

   Addition of Mr Andrew Law as co-investigator
   PIS/Cons V#5, 2/7/08


NTX/08/03/013
Characterisation of serrated pathway syndrome: PIS/Cons V. 14/4/08
Principal Investigator:  Dr Susan Parry
Co-Investigators:        Ms Julie Arnold, Ms Sonja Woodall
                         Auckland DHB

   Questionnaire „Of serrated neoplasia‟ V#3, dated May 2008
   Smoking Questionnaire (V# and date to be advised)


NTX/08/03/014
Evaluation of safety and efficacy of the Flexstent peripheral stent system in a
‘first-in-man’ study: Protocol FSS-001 V#1, 14/02/08: IB Issue 1, Rev 0:
PIS/Cons V#2, 1/4/08: Prot/amend 1, V#2, 19/05/08.

   Addendum to the Protocol V#1 14/2/08 dated 19 May 2008 to include extra
     patient
   Protocol FSS0001 V#2, Amendment 1 dated 19 May 2008.
   Participant Information Sheet/Consent Form V#3 dated 3 July 2008
   Investigator‟s Brochure, Doc# 071-00002 Issue #1, Rev. A dated 7 May 2008.

NTX/08/03/018
Waitemata District Health Board ‘WellatWork’ Survey: PIS/Cons V#2, 10/04/08
Principal Investigator:   Ms Micalla Williden
Investigators:            Dr Clara Soper, Ms Jan O‟Connor-Brown
Supervisor:               Prof. Grant Schofield
                          Waitemata DHB, Auckland University of Technology

   Amendment to broaden participant recruiting base.
   Participant Information Sheet/Consent Form V#3 dated 3 July 2008.
   Survey invitation (undated)



NTX/08/03/EXP
The Process and effectiveness of discharge planning at Rehab Plus:
    Prot/amend, Focus Group Survey of staff
Principal Investigator:   Ms Felicity Bright

       Protocol amendment to include a focus group survey of staff to gain further
        information about core teams and discharge planning.
       Letter to Staff
       Focus Group Guiding Questions




                                                                                20
    NTX/08/54/EXP
    Case report on warfarin monitoring and travel: Prot/amend r/6/08: PIS/Cons
    V#2, 5/6/08
    Principal Investigator: Ms Natalie Gauld
    Co-Investigator:        Ms Anne Blumgart, Middlemore Hospital

       Extend study participants to 3 subjects
       PIS/Consent Form V#2 5/6/08


    NTX/08/56/EXP
    Research into elderly patient anaesthesia and surgery outcome numbers: an
    audit of post operative complications in Australia and New Zealand
    hospitals: Protocol V.2, 8.04/08: Prot/amend 1.4, 17/06/08
    Principal Investigator:;  Dr Vanessa Beavis
    Co-Investigators:         Dr Tim Short (ADHB)
                              Dr Stuart Walker & Dr Francois Stapelberg (CMDHB)

     Protocol V#1.4 dated 17 June 2008
     Case Report Form V.2.1 dated June 2008


    NTX/08/04/036
    Screening trials to assess the effects of lipid emulsions on satiety, energy intake and
    serum markers of appetite regulation & body weight control: preliminary studies in a
    group of lean, healthy men: Protocol 10/03/08: PIS/Cons V#2, 19/06/08:
    Principal Investigator:      Dr Sally Poppitt, University of Auckland
    Co-Investigators:            Dr. Anne-Thea McGill, Ms Caroline Strik, Ms Janie Proctor,
                                 Dr Kai Chan

           Delivery System Substudy, 19/05/08



PROGRESS REPORTS:


   AKL/96/117
   Prospective, randomised, double-blind placebo controlled study of oral sodium
   clodronate in patients with locally advanced prostate adenocarcinoma (PRO4)
   Principal Investigator:    Dr Chakiath Jose


   AKL/96/266
   The placental bed in women with recurrent miscarriage and phospholipid
   antibodies.
   Principal Investigator: Dr Larry Chamley


   AKL/98/055
   An open-label follow-on study of the long-term safety of aripiprazole in patients
   with chronic schizophrenia. Protocol 31-97-303 2/12/97; Prot/amend 001 (Gl)

                                                                                        21
24/3/98; 002 (Global) 17/8/98; NZ 01 24/4/98; Prot/amend NZ 01, 24/04/98:
Prot/amend 004 (Gl) 23/11/04: IDB V#8, Addnd #2, 4/3/05, Addnd #3, 9/05/05:
Prot/amend #5, 13/04/05: Prot/amend #6 (Gl), 26/01/06: IB V#11, 8/08/07 Addend
1, 22/10/07: Prot/amend 07 (V#8), 10/12/07
Principal Investigator:    Dr Wayne Miles


AKL/2001/130
Effect of pre- and post-operative immunonutrition on clinical outcome in
patients with end-stage liver disease undergoing liver transplantation - a
randomised double-blind controlled trial: PIS V#1, 28/06/01: Cons V#2,
21/05/01: PIS/Cons V#4, 07/07/05:
Principal Investigator:    Assoc Prof Lindsay D Plank
Co-Investigators:          Mr John McCall, A Prof Ed Gane, Prof Stephen Munn,
                           Dr Sachin Mathur


AKY/03/07/166
Investigation of methods to detect respiratory irregularities in OSA:
PIS/Cons V#6, 30/04/08
Principal Investigator:    Ms Jessica Hayward


AKY/04/03/055
A multinational, multicentre, randomised, double-blind, placebo controlled,
parallel group study to evaluate the effect of early glatiramer acetate treatment
in delaying the conversion to clinically definite multiple sclerosis (CDMS) of
subjects presenting with a clinically isolated syndrome (CIS): Protocol
GA/9010 (PreCISE), V#5, 11/09/03: Global Amend #2, 7/06/06; IB Ed 4, 3/06: IB
Addndm #1, 4/07: PIS/Cons V#5, 22/08/06: Prot/amend#3, 13/12/07: Prot/
amend#4, 30/01/08: PIS/Cons Addend 26/03/08.
  Substudy: Prot # GA/9010A, 30/01/08: PIS/Cons GA/9010A V#2 26/03/08
Principal Investigator:    Dr Ernest Willoughby


AKX/04/03/072
A children’s oncology group protocol for collecting and banking paediatric
research specimens including rare paediatric tumours (COG ABTR01B1):
Protocol V. 13/10/03 PIS/Cons V#2, 7/04/04
Principal Investigator:    Dr Lochie Teague
Co-Investigators:          Dr D Mauger, Dr N Cole, Dr R Cockroft, Mr D Nicholls


AKY/04/11/315
A pilot study investigating the feasibility of using the measurement of serum 5-
HIAA as a surrogate clinical market for the antivascular activity of non-
steroidal anti-flammatory agents (NSAIDSs) and anticancer therapies: Protocol
CTNZ_04_3 V#3, 3/03/05: Questnr V#8, 8/08/05: Prot/amend V#4,
17/8/05,Prot/amend V#6, 1/09/06: Prot/Amend V#7, 26/07/07: Prot/Amend V#8,
17/12/07: PIS/Cons V#11, 7/1/08
Principal Investigator:     Dr Dragan Damianovich


                                                                              22
Co-Investigators:          Prof Bruce Baguley, Prof Michael Findlay, Dr Katrina
                           Sharples


NTX/05/03/012
A randomised double blind placebo controlled trial of site-specific clonidine
patches in treatment of neuropathic wound pain following caesarean section:
Protocol V#5, 05/05: PIS/Cons V#6, 3/06
Principal Investigator:    Mrs Francesca Storr
Co-Investigators:          Ms Jane Suckling, Dr Glyn Richards, Ms Lynne
                           Garforth, Dr Tim Skinner, Dr Simon Mitchell


NTX/05/06/057
Randomised, double-blind phase II trial of NY-ESO-1 ISCOMATRIX(R) vaccine
and ISCOMATRIX(R) adjuvant alone in patients with resected stage IIc, III or IV
malignant melanoma. (Clinical Trial No. LUD 2003-009): IB V#5, 2/05, Prot.
17/02/05.
Principal Investigator: Dr Mike McCrystal
Co-Investigators:       Mr Richard Harman, Mrs Shas Cacala, Mr Mike Hulme-


NTX/05/06/060
Recovery of hand function following stroke: PIS/Cons V#6, 25/09/07
Principal Investigator:   A/Prof Winston Byblow.
Co-Investigator:          Ms Cathy Stinear, Dr Alan Barber, Ms Suzanne
                          Ackerley, Ms Melanie Fleming, Mr Toby Verryt, Mrs
                          Lynley Roberts, Ms Pratima Poudel Acharya


NTX/05/06/062
Phase III randomised trial of concomitant radiation, cisplatin and tirapazamine
(SR259075) versus concomitant radiation and cisplatin in patients with
advanced head and neck cancer: Protocol EFC5512, 28/10/04: Prot/amend 1
EFC5512, 14/01/05: Prot/amend 2, 1/08/05: Addend to Prot/amend 3, 19/01/06:
PIS/Cons V#6, 06/06/06: IB V#11, 16/5/06
Principal Investigator:    Dr Andrew Macann
Co-Investigators:          Dr Hedley Krawitz, A/Prof M. Mckeage, Dr Michael
                            McCrystal


NTX/05/07/088
A 3-year double blind extension to CZOL446H23021 to evaluate the long-term
safety and efficacy of zoledronic acid in the treatment of osteoporosis in post-
menopausal women taking calcium and vitamin D:
 CZOL446H2301E1, 6/04/05: PIS/Cons V#2, 20/06/05: Prot/amend #1, 4/11/05:
Prot/amend 3 8/10/07, PIS Adden 2 15/01/08: IB Ed. 12, 14/12/07
Principal Investigator:    Prof Ian Reid




                                                                                  23
Co-Investigators:           Dr Mark Bolland, Ms Diana Horner, Ms Ruth Ames


NTX/06/03/022
A randomised controlled trial:     should aspirin be stopped prior to
dacryocystorhinostomy? PIS/Cons V#3, 10/07
Principal Investigator: Dr Ryan Eidsness
Co-Investigator:        Dr Paul Rosser


NTX/06/04/036
Mutations in the protein Z dependent protease inhibitor gene and small for
gestational age pregnancies:
Principal Investigator:   Dr Laura Young
Co-Investigators:         A Prof Lesley McCowan, Dr Paul Harper, Dr Claire
                          McLintock, Dr Peter Browett, Dr Neil Van de Water


NTX/06/06/068
Sleep and arousal in infants exposed to methamphetamine in utero: PIS/Cons
V#2, 26/06/06
Principal Investigator:    Prof Ed Mitchell
Co-Investigators:          Dr Trecia Wouldes, Alistair Stewart, Dr Barbara Galland


NTX/06/06/069
A randomised, open-label study to compare the rate of new non-melanoma
skin cancer in maintenance renal allograft recipients converted to a Sirolimus-
based regim versus continuation of a calcineurin inhibitor-based regimen:
Protocol 0468H1-407-AUS, 15/06/05: Prot/amend 1 046H1-407-WW, 11/05/06:
PROT/AMEND 3, 2/04/07: PIS/Cons V#5, 26/07/07: IB Ed 16, 04/07.
Principal Investigator:  Dr Helen Pilmore
Co-Investigators:        Dr. Denesh Patel, Dr Laurie Williams, Dr Ian Dittmer, Dr
                          Maha Yehia, Dr John P. Collins, Dr. Sharen Supershad,
                          Dr Paul Manley


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
Co Investigators:         Dr Shay McGuiness, Ms Rachel Parke, Ms Heidi Buhr,
                          Ms Catherine Gerard, Dr Daniel Dallimore


NTX/06/12/164
Removal of seclusion facilities in an inpatient rehabilitation facility - the effect
on patients, staff and unit function: PIS/Cons V#2, 19/04/07
Principal Investigator:      Prof Rob Kydd




                                                                                 24
Co-Investigators:          Dr David Hughes, Mr John Wells, Ms Liz Stewart, Mr
                           Paul Sheridan


NTX/06/04/CPD
Assessment of management of children with diabetes mellitus under the care
of the Starship Endocrinology Service: Cons V#113/08/07.
Principal Investigator:    Dr Craig Jefferies


NTX/06/10/CPD              Benchmark 2 counterpulsation outcomes registry.
Principal Investigator:    Mr Tim Willcox


NTX/07/03/019
A study investigating the use of heated humidification of low flow oxygen in
children: PIS/Cons V#2, 2/05/07
Principal Investigator:    Ms Laura-Clare Whelan
Co-Investigators:          Ms Elaine McCall, Dr Annette Dickinson, Dr John Beca,
                           Dr Cameron Grant, Mr Christian Saville


NTX/07/03/022
Pilot study to determine whether osteopontin may be a suitable tumour marker
for hepatocellular carcinoma (HCC) in patients with cirrhosis due to hepatitis
B: PIS/Cons V#2, 3/04/07
Principal Investigator:   Assoc Prof Ed Gane
Co-Investigators:         Dr. Bill Stableforth, Mr John Hornell, A/Prof. John
                           McCall, Dr Michael Beard


NTX/07/03/027
A placebo controlled, cross-over trial investigating the effect of dairy-derived
proteins on circulating lipids and related cardiovascular risk factors in a group
of mildly hypercholesterolaemic individuals. Protocol V#1, 16/02/07: PIS/Cons
V#2, 13/06/07: Prot/amend 22/6/07
Principal Investigator:      Dr Sally Poppitt
Co-Investigators:            Dr Anne Thea McGill, Mr Kai Chan


NTX/07/04/030
A pilot double blind randomised trial of indomethacin for closure of patent
ductus arteriosus in very preterm infants. The Iindomethacin ductus closure
effect trial: The INDUCE trial: Protocol 14/03/07: PIS/Cons V#2, 2/05/07
Principal Investigator:     Dr Mariam Buksh
Co-Investigators:           Dr David Knight, Dr V Kumara, Dr S Alkindi


NTX/07/05/042
Epidemiology of refractive error and visual acuity in New Zealand school
children: PIS/Cons V#2, 20/05/07
Principal Investigator:    Dr Geraint Phillips

                                                                              25
Co-Investigators:          Ms Nicola Anstice, Dr Keely Bumsted-O‟Brien


NTX/07/05/046
Effective social work practice in a multidisciplinary team, a contextual inquiry
centred in the multidisciplinary team: a qualitative case study: PIS/Cons V#3,
23/09/07
Principal Investigator:     Ms Linda Rose Haultain


NTX/07/06/057
Prevalence of pulmonary hypertension in sarcoidosis: PIS/Cons V#2, 10/07/07
Principal Investigator:   Dr Sally de Boer
Co-Investigators:         Dr Margaret Wilsher, A Prof Robert Doughty, A Prof
                          David Milne, Ms Wendy Fergusson, Dr John Kolbe


NTX/07/06/061
TROG 0602: A multi-centre feasibility study of accelerated partial breast
irradiation using three dimensional conformal radiation therapy for early breast
cancer: Protocol TROG 06.02 V. 29/03/07: PIS/Cons V#2, 25/06/07: Prot.amend
V. 29/03/08
Principal Investigator:     Dr Chellaraj Benjamin
Co-Investigators:           Dr Glenys Round, Dr Gillian Campbell, Dr Christine
                            Elder, Dr Thayavalappil Hemanth, Dr Chakiath Jose, Dr
                            Hedley Krawitz, Dr Andrew Macann, Dr. Maria Pearse,
                            Dr Susan Brooks


NTX/07/05/044
Self-regulation styles as predictors of dietary patterns and treatment outcomes
in people undergoing bariatric surgery for the treatment of obesity: PIS/Cons
V#2, 4/6/07.
Principal Investigator:     Ms Olivia Jane Museth
Co-Investigator:            Dr Linda Cameron


NTX/07/05/047
Weight bearing in the treatment of acute achilles tendon ruptures:          a
randomised controlled trial: PIS/Cons V#2, 4/06/07: PIS/Cons (Waitemata) V#3,
20/02/08
Principal Investigator:    Dr Alpesh Patel
Co-Investigators:          Dr Simon Young, Dr Stephanie van Djick


NTX/07/07/059
Epidemiology of severe lower respiratory illness in the paediatric population in
Counties Manukau: PIS/Cons V#1, 03/08: Prot/amend V#2.l0, 3/08:
Principal Investigator:   Dr Adrian Trenholme




                                                                              26
Co-Investigators:          Dr Dianna Lennon, Ms Charissa McBride, Dr Emma
                           Best, Mrs Joanna Stewart, Dr Felix Ram, Dr Wendy
                           Walker, Dr Teuila Percival


NTX/07/31/CPD
Can we reduce episodes of haemoglobin desaturation in full term babies
restrained in infant car seats? PIS/Cons V#1, 30/05/07
Principal Investigator:     Dr Shirley Tonkin
Co-Investigators:           A Prof Alistair Gunn, Dr Christine McIntosh, Dr
                            Simon Rowley


NTX/07/41/EXP
Views of mental health staff on what predicts adverse events: PIS/Cons V#6,
8/05/07
Principal Investigator:   Assoc Prof Sandy Simpson
Co-Investigators:         Dr Verity Humberstone, Dr Sylvia Altvorst

NTX/07/44/EXP
An audit of anaesthesia record keeping at Mercy-Ascot hospital
Principal Investigator:    Prof Alan Merry


NTX/07/45/EXP
Risk factors for multiple IV attempts in a children’s emergency department
Principal Investigator:      Dr Nishi Alex
Co-Investigators:            Dr Amelia Murray


NTX/07/60/EXP
Busy clinicians, generation Y students - how is learning happening in the
hospitals? A case study from paediatrics: PIS/Cons V#1 0607
Principal Investigator:    Dr Alison Jones


NTX/07/62/EXP
Driveway runovers: the influence of the built environment. A case control
study
Principal Investigator:  Dr Michael Shepherd


NTX/07/67/EXP
Consent to send information to International Bone Marrow Transplant
Registries: PIS/Cons V#6, 1/04/08
Principal Investigator:    Dr Lochie Teague
Co-Investigators:          Dr Nyree Cole




                                                                             27
     NTX/07/68/EXP
     Five year Survival after Admission to Geriatrics Service at Auckland Hospital in
     2000
     Principal Investigator:     Mr Garth MacLeod


     NTX/07/78/EXP
     Evaluation of the perfusion downunder database
     Principal Investigator:     Mr Tim Willcox
     Co-Investigators:           Ms Katherine Place, Dr Rob Baker, Mr Richard
                                 Newland


     NTX/08/02/EXP
     Enrolment in a heart failure chronic care management programme
     Principal Investigator:     Mr Akbar Ashrafi
     Co-Investigators:           Dr Mayanna Lund




END OF STUDY REPORTS:

     AKL/2000/065
     The Auckland Outpatient Antipsychotic Audit
     Principal Investigator:  Dr Amanda Wheeler


     2000/109
     A 48-month multi-centre, randomised, double-masked, placebo-controlled
     clinical study to evaluate the effectiveness and safety of oral Memantine in
     daily doses of 20 mg and 10 mg in patients with chronic open-angle glaucoma
     at risk for glaucomatous progression: Protocol # 192944-005-00; Prot/amend
     26/08/01: IS V#2, 10/01: Prot/Amend #2, 19/03/2002: Prot/amend 192944-005-03,
     IB#3, 16/05/05.
     Principal Investigator:      Dr Stephen Best


     NTX/05/06/053
     The relationship between health-related quality of life (as measured by the
     SAQOL-39) and severity of aphasia following stroke:

     Principal Investigator:    Dr Clare McCann


     NTX/05/06/056
     A case-control study of falls occurring in the home environs in the Auckland
     region in people aged 25 to 60 years resulting in hospitalisation: Protocol
     14/04/05: PIS/Cons 31/07/06: Questionnaire 27/06/05
     Principal Investigator:    Dr Shanti Ameratunga

                                                                                  28
NTX/05/10/136
A double blind randomised placebo controlled multi centre phase II parallel
dose ranging study to assess the antifibrotic activity of GI262570 in chronic
hepatitis C subjects with hepatic fibrosis who have failed prior antivirala
therapy: Protocol GI262570, 23/08/05: Prot/amend V#2, 24/03/06, Prot/amend
V#3, 22/05/06: Prot/amend V#4, 8/6/06: PIS/Cons V#7, 11/10/06: IB V#7,
15/08/05: IB V#8, 15/11/06 Pharmacogenetic sub-study, PIS/Cons V#3, 13/04/07:
IB V#7, 15/08/5: IB V#8, 15/11/06:
Principal Investigator:     Dr Ed Gane, Auckland City Hospital


NTX/05/12/166
Controlled double-blind randomised study of BAY59-7939 in the extended
prevention of VTE in patients undergoing elective total hip replacement -
RECORD 2 study-regulation of coagulation in orthopaedic surgery to prevent
DVT and PE: Protocol BAY 59-7939 V#2, 27/10/05: IB V#12 + Amend 1,
10/10/06: PIS/Cons V#4
Principal Investigator:  Dr Sanjeev Chunilal


NTX/07/04/035
The influence of transitivity and homophony on the retrieval of instrumental
verbs in aphasia:PIS/Cons V#3, 20/07/07
Principal Investigator:      Dr Clare McCann


NTX/07/04/037
Verb retrieval in fluent and non-fluent aphasia: a clinical study:
Principal Investigator       Dr Clare McCann


NTX/07/05/048


NTX/07/05/049
NTX/07/66/EXP
Care Plus implementation in Manaia PHO: Measurement of successful
implementation
Principal Investigator: Dr Kyle Eggleton


NTX/07/70/EXP
What causes frequent hospital admissions in gout?
Principal Investigator: Ms Ingrid Hutton


NTX/08/03/020
Analysis of B vitamin status of peritoneal dialysis (PD) and haemodialysis (HD)
patients under the care of Starship Children’s Hospital, Renal Service. To


                                                                               29
determine if routine assessment and or supplementation of B vitamins is
required: PIS/Cons V#2, 3/3/08
Principal Investigator:   Ms Tania Don
Co-Investigators:         Ms Stella Friedlander, Dr William Wong




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