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					                                  MINUTES
                        NORTHERN X ETHICS COMMITTEE

                        WEDNESDAY, 1 FEBRUARY 2006


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



PRESENT:

     Tim Dare                         (Chairperson)
     John France                      (Deputy Chairperson)
     Adina Halpern                    Scott Macfarlane
     Emma Ngawhare                    Robyn Northey
     Stephanie Palmer                 Louisa Wall
     Patricia Hanlen                  Wayne Miles
     Joanna Stewart


APOLOGIES:

     Jeffrey Harrison

ADMINISTRATOR:

     Patricia Chainey



MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 7 December 2005.

     Confirmed:   L. Wall/S. Palmer



MATTERS ARISING:

     There were no matters arising.




                                                               1
INFORMATION/CORRESPONDENCE:

    20/12/05: Letter and Toi te Taiao: the Bioethics Council report „The Cultural
    Ethical and Spiritual Aspects of Animal-to-Human Transplantation‟.

    Received.



    Email 21/12/05 from Massey University.
    Massey University Ethics Committee will not now review health research and will
    leave it to the Regional Ethics Committees.   This now falls into line with the
    University of Auckland‟s requirements.

    Received.

    Care will be needed by the Committee to ensure student researchers complete their
    applications in accordance with the Standard and the Guidelines.



    98/178
    Kathleen Cunningham Foundation Consortium for research on familial breast
    cancer (KconFab): Prot/amend Aug 2001

    Report contained in letter 16 November 2005.

    Received



    Compensation:
    Letter to ACC 22/12/05 regarding compensation from a pharmaceutical company.
    Reply dated 12/01/06.

    Chairperson and lawyer to give comments to Chairs Meeting 9/2/05.

    Received.



    Report:     ‘Depression and unwanted first pregnancy:       longitudinal cohort
    study;

    Received.


    Report: ‘Are experimental treatments for cancer in children superior to
    established treatments?’

    Received.

                                                                                    2
GENERAL BUSINESS:


         1.    Layout in Agenda and Minutes.
         Present layout to be confirmed.

         Confirmed.



         2.    Procedural Reminders

               (a)    Ethical review by Committee Members.
               Reminder that Committee members to ensure that they review
               according to ethical concerns relating to the Ministry of Health
               Standard, Guidelines and Terms of Reference and for the concern to
               go into the Minutes, the reference is required to be quoted.


               Noted.



               (b)   Items for Agenda:
               All members to ensure any required items they may wish to be placed
               on the agenda must come through the Chairperson and the
               Administrator, prior to Agenda cut-of dates. It is the Administrator‟s
               responsibility to put the agenda together.

               Noted. Urgent life-threatening ethical concerns are exempt.

               And some flexibility is allowed, subject to the Chair‟s discretion to be
               exercised in light of factors such as the evening‟s agenda and
               workload, for the tabling of information.


         3.    Northern Region statement in Information Sheets for Maori
               regarding genetic testing.

               ADHB requirements for studies carried out in their hospitals
               (attached.)   Waitemata and C-M DHBs are working on their
               requirements.

               As requirements for each DHB are different, it was agreed that the
               matter be put to the Chairs Meeting and also that the possibility of
               passing this to NEAC be explored as it is a national matter.

               Further, the MOH Guidelines for Tissue Banking are due
               approximately April 2006 and it was felt that the issue should be left
               until those guidelines are available.

                                                                                     3
     In the meantime, the wording approved in the March 2005 Minutes will
     be used.

     Gayl Humphrey, Manager ADHB Research Office attended as a
     member of the public and was requested to give her view . She
     stated that the statement places consent on the individual rather than
     collective.

     There was a view expressed that the ADHB Maori statement places
     emphasis on individual rather than collective concerns. The member
     expressing this view pointed out that Maori must have the opportunity
     to discuss these issues amongst themselves.


4.   Applications/Amendments reviewed under CPD

     In the absence of the Chairperson or in the case of overload, the
     Deputy Chairperson is approved to review and approve the following:

          Advertisements, letters or minor information sheet changes.

          Review and Receive Serious Adverse Events.

          Enquiries as to whether audit or research and retrospective
           audit.

          Amendments that do not adversely affect participant safety.

          Progress Reports.        Confirmation of approval of ongoing
           applications after receipt of the researcher‟s annual report.

          Applications provisionally approved by the Committee subject
           to final approval by the Chairperson, usually after review by
           nominated Committee members.

     The following should be reviewed by a sub-committee as well:

            Student applications, especially where there is a time constraint
     for the course and where there is minimal potential for harm to
     participants eg questionnaires, interviews.

          Applications where the consequences of delaying approval
     would be significant.         A subcommittee, including one health
     professional, will be required to review these applications.

     All applications, amendments and progress reports approved under
     delegated authority are to be listed on the agenda for the next meeting
     for Ratification.



                                                                            4
END OF STUDY REPORTS:

    The following were Received:

    2001/137
    Live donor liver transplantation: (innovative treatment)

    Now standard practice.



    AKX/02/00/318
    A pilot double-blind, placebo controlled study to investigate the effect of
    supplementary nutrition, in the form of a high-concentration (2kcal/1mL)
    nutritionally complete feed, co-administered with medication, on morbidity-
    related nutritional markers, (plasma homocysteine and oxidative stress index)
    in an elderly population: PIS/Cons V#2, 2/12/02

    Abstract.



    AKX/03/02/062
    Alcohol and other drug outcome treatment outcome measures: preliminary
    work towards a measurement system: ADOPT: Treatment Outcome Survey:
    PIS/Cons V#2, 2/5/03: Treatment Outcome Questionnaire V#3, 28/07/03:

    Published Report.

   File to be sent to Wellington M-R to await new application.



   AKY/03/03/075
   Effects of Emotional Disclosure on Disease Activity in Psoriasis.

   Abstract.



   AKX/03/05/118
   A study to determine the effects of pregnancy on the pharmacokinetics of
   metformin:

   Report.



   AKX/03/07/186



                                                                               5
Investigation of the effect of humidification on lung function, cough and mucus
production in patients with chronic airways disease and/or mucociliary
clearance disorders:

Progress Report.


AKY/04/03/049
Investigation as to how early psychosis clinicians address substance abuse
within their client population:

Abstract.


AKY/04/03/051
Respiratory drive in healthy Pacific peoples and caucasian people: Is there a
link in the development of the obesity hypoventilation syndrome?

Report.


AKY/04/04/079
Pilot study for validation of the multi-item life-style screening tool

Abstract.

AKY/04/04/090
The contribution of Art Therapy in the treatment of a pre-teenage girl, with a
diagnosis of Anorexia Nervosa restricting type, within the context of a
multidisciplinary treatment team.

Report.


AKY/04/06/147
Stress and wound healing: using a stress-reduction intervention to improve
the wound-healing of hernia patients

Abstract.

AKX/04/08/232
A pilot study exploring the obstacles in using the patient health question 9
(PHQ-9) as a screening and assessment tool in primary care settings
TaPasefika (Primary Health Organisation) for patients experiencing
depression:

Report.


AKY/04/09/244
Assessment of sexual and reproductive health needs of Maori and Pasefika
young men. PIS/Cons V#3, 1/10/04

                                                                              6
    Report.


    AKX/04/10/283
    Survey of health problems among methadone clients at Auckland Methadone
    Service (AMS) and ADIO needle exchange service clients and their views on
    the involvement of health professionals in the provision of primary healthcare

    Abstract.


    ÄKX/004/10/289
    Multi-disciplinary management of neuroendocrine tumours

    Report


    NTX/05/09/123
    A qualitative participant outcomes analysis of the activeAte Programme pilot:

    Report.


SERIOUS ADVERSE EVENTS

    99/146
    IBCSG Trial 20-98/BIG 2-89. An intergroup, phase III trial to evaluate the activity
    of docetaxel, given either sequentially or in combination with doxorubicin,
    followed by CMF, in comparison to doxorubicin alone or in combination with
    cyclophosphamide, followed by CMF, in the adjuvant treatment of node
    positive breast cancer patients.

    (9) MRF-200210679GDDC INV.FU              Retinal hemorrhage
    2002212529GDDC INV.FU3                    Myelodysplastic syndrome
    200419040GDDC INV.FU2                     Acute myeloid leukemia
    200420527GDDC INV                               Cardiac failure (fatal)
    200420527GDDC INV.FU1                     Cardiac failure (fatal)
    200511165EU INV                           Acute myeloid leukemia
    200513263US INV                           Neurogenic colon/bowel
    200513263US INV.FU1                       Neurogenic colon/bowell with constipation,
                                              abd. pain
    200513263US INV.FU2                       Same

    Received.

    The Researcher is to be advised that the majority of these SAEs are not related to
    this study and are not required by this Committee.


    99/152


                                                                                         7
An inter co-operative group, multicentre, randomised, double-blind trial in
postmenopausal women with primary breast cancer who have received
adjuvant tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane
treatment with further tamoxifen.

2005099435          Restlessness and sleep disorder
2005110299          Sensory Neuropathy & edema limbs
2005120890          Bone fracture
2005117219          vaginal dysplasia
2005152968          Grade III arterial hypertension
2005154103          Supraventricular tachycardia
2005160818          Atrial fibrillation
2005160833          Drop attack

2005145166          transient ischemic attack.

Received.


2000/009
IBCSG 18-98/BIG 1-98. A phase III study to evaluate letrozole as adjuvant
endocrine therapy for post menopausal women with receptor (ER and/or PgR)
positive tumours;

PHH02005BE161080          Chondrocalcinosis pyrophosphate disease
PHH02002FR05239           Arteritis (aggravated)
PHH02005PL16188           Arthritis (diagnosis changed from osteomyelitis

Received.


2000/143
An extension protocol to evaluate the long-term effects of treatment with
peginterferon alfa-2a (PEG-IFN) or interferon (IFN) based therapies for patients
with chronic hepatitis C

413870 FU                 Asthenia - fatal
414787                    myocardial infarction
423533                    acrosyndrome

Received.


2000/167
Multicentre open label expanded access program of Peginterferon alfa-2a (Ro
25-8310) monotherapy and combination therapy with Ribavirin (Ro 20-9963) in
patients with chronic hepatitis C; Protocol BV16209C 24/07/2000:

413870 FU                 Asthenia – fatal

400953                    death unexplained
400616 + FU               urinal infection

                                                                              8
401756 + FU                death unexplained
404382                     sarcoidosis

Received.


AKX/03/01/019
An extension, observational protocol to evaluate the long-term effects of
treatment with peginterferon alf-2a (PEG-IFN) alone or in combination with
lamivudine or with lamivudine alone for patients with HbeAg positive or HbeAg
negative/anti-Hbe positive chronic hepatitis B in the original studies WV16240
and WV16241 respectively:

413879 FU           Asthenia - fatal
423533              Acrosyndrome.

Received.


AKY/03/02/038
A randomised, double blind trial of LdT (Telbivudine) versus Lamivudine, in
adults with compensated chronic hepatitis B:

AKX/03/11/299
A randomised, double blind trial of LdT (Telbivudine) versus Lamivudine, in
adults with decompensated chronic hepatitis B and evidence of cirrhosis

AKY/04/11/312
A randomised trial of switching antiviral therapy from lamivudine to telbivudine
(LdT) vs. continued lamivudine treatment in adults with chronic hepatitis B

MCN: AUV-156 FU liver failure.
MCN: AUV-212I   chronic hepatitis B hepatic failure

Received.


AKY/03/06/143
A randomised, multifactorial, double-blind, parallel-group, dose-ranging study
of the efficacy and safety of Rituximab ( Mabthera® ) in combination with
Methotrexate in patients with active rheumatoid arthritis:

AKY/04/02/017
An Open Label Study of the Efficacy and Safety of Re-Treatments with
Rituximab (Mabthera®) in Patients with Active Rheumatoid Arthritis. PIS/Cons
(Waitemata DHB/CMDHB) V#2 10/3/0

220443              left breast cancer.
21945               blood culture positive for acinetobacter baumannii
219709              acute hepatitis

Received.

                                                                               9
AKX/03/09/244
One year, multicentre, double blinded, double dummy, randomised study to
evaluate the safety and efficacy of two doses of FTY720 combined with-dose
Neoral® and steroids versus Cellcept® combined with full-dose Neoral® and
steroids, in de nova adult renal transplant recipients.

AKX/04/10/294
A 24-month extension to a one-year, multicentre, double blinded, double
dummy, randomised study to evaluate the safety and efficacy of two doses of
FTY720 combined with full-dose Neoral® and steroids versus CellCept®
combined with full-dose Neoral® and steroids, in de novo adult renal
transplant recipients.

PHHO2005US11900               Retinal detachment

Received.


AKY/03/10/264
Children's oncology group AALL0031: a phase III group-wide pilot study: a
children's oncology group pilot study for the treatment of very high risk acute
lymphoblastic leukemia in children a phase III group-wide pilot study

1318064            G4-neuropathy-motor: G3-neuropathy-sensory/cranial-G2 `
                   mood alteration, anxiety: G2 leukoncephalopathy.
1229955            G4- glucose, serum high: G3 psychosis.

PHH02005ES16489 urothelial carcinoma.

Received.

AKX/03/12/330
Randomised, double-blind, multicentre study to compare the safety and
efficacy of Viramidine to Ribavirin in treatment-naïve patients with chronic
hepatitis C:

2005VX000322 FU           gastroenteritis
2005CV000371 FU           exacerbated hearing loss
2004RN000069 FU           exacerbation of atrial fibrillation
2005VX000347 FU           general diffusional rash
2005VX000587 I.           meningitis acute probably bacterial

2005VX000386              hyuponatraemia

Received.


AKX/04/04/098
Chronic heart failure angiotgensin blockade with irbesartan study


                                                                             10
CV149-010-624-004          vasovagal signs
CV131-148-0067-003         Toxic hepatitis

Received.


AKY/04/06/149
Randomised multicentre, open-label, phase IV study evaluting the efficacy and
safety of 16 week versus 24 week treatment with PEGASYS in Interferon-naive
patients with chronic hepatitis C-genotype 2 or 3 virus infection:

313412 – 343516            Various (24)
                                                                        Received.
Study completed – awaiting report.


AKX/04/06/155
An open-label, multicentre, follow-up study to evaluate the safety and efficacy
of levetiracetam (LEV) (oral tablets of 166, 250 or 500 mg b.i.d.) at
individualised doses up to a maximum of 4000 mg/day (or 80 mg/kg/day for
children and adolescents less than 50 kg), in children (more than 4 years old)
adolescents and adults suffering from primary generalised seizures: UCB
Pharma protocol RPCE99G1501/study N167, 5/02/01

8008461 FU                 worsening of pre-existing depression
8013104 I. & FU 1          worsening of bi-polar disorder

Received.


AKY/04/09/247
Pilot clinical trial of the C-Pulse device as destination therapy inpatients with
moderate-severe heart failure

ACH002                     device removal because of infection.

Received.

AKX/04/10/287
International carotid stenting study (ICSS)

Site 30 no 776 AHT         onset of stroke 7/10/05         following   Lt   carotid
                           endarterectomy 21/9/05

Received.


AKY/04/12/339
A randomised placebo-controlled, multicentre, blinded phase I/II study of the
safety of escalating single, intravenous doses of rhuMab 2H7 (Ro 496-4913,
PRO70769) in patients with moderate to severe rheumatoid arthritis receiving
stable doses of concomitant methotrexate but with unsatisfactory clinical

                                                                                11
   response: Protocol # WA18230, RO 496-4913, 19/10/04: Prot/amend C
   12/01/05:  Proced/Admin Manual V#2, Prot/amend WA18230D, 13/6/05:
   Prot/amend WA18230D-1, 13/06/05:

   Annual safety report.

   Received.


   NTX/04/12/009
   An international single-arm protocol to provide expanded access to VELCADE
   (tm) for patients with multiple myeloma who have received at least two
   previous lines of therapy and are refractory to or have relapsed after their last
   therapy for multiple myeloma:

   2005-01192 I.               Hemophagocytic syndrome. Renal insufficiency
   2005-01232 FU1              Hyperpyrexia
   2005-01221 I                Febrile neutropenia, life threatening.

   2005-003347                 acute renal failure
   2005-01299                  hypotonia.

   Received.


   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:

   D01200507560 to D01200508264     Various (24).
   and D01200505735 to D01200505898

   Received.


   NTX/05/08/098
   A phase II study to evaluate the efficacy, safety and pharmacodynamics of
   lapatinib in combination with Paclitaxel as neoadjuvant therapy in patients with
   newly diagnosed inflammatory breast cancer:

   B03933597A to B0401107A                 Various (20)

   Received.


NEW APPLICATION:

     1.   NTX/06/02/001
     A study to determine the pharmacokinetics of intravenously administered
     Flucloxacillin in cerebrospinal fluid of patients treated for presumptive or proven
     meningitis.


                                                                                     12
Principal Researcher:      Dr Mark Thomas, University of Auckland, Auckland DHB
Co-researchers:            Mr Edward Mee,           Dr Rod Ellis-Pegler,
                           Dr Andrew Woodhouse, Dr S. Briggs,
                           Dr Sally Roberts,        Dr Stephen Ritchie,
                           Dr Priscilla Rupali

Site:                      Auckland City Hospital.

The Researcher is requested to please provide/amend

Application Form:
   The Committee were surprised that this application has not first been to the
      ADHB Research Office as Locality Assessment for ADHB required.
   ADHB MRRC letter of support required.
   P.3: 18: More realistic start date, i.e. 1/03/06.
   P.12: C. This is a clinical trial under Accident Compensation therefore „yes‟
      should be marked.

Information Sheet
     The Information Sheet and Consent Form are to be separate
     The words „Research Consent Document‟ to be removed.
     Page numbering to end at P. 4.
     Under „Why are you being asked?‟, an adult is a person from 16 years of age
      not 12 years of age. Researcher to edit.
     Approval statement to be changed to „Northern X Ethics Committee‟

Young Person‟s Information Sheet:
    An information Sheet for this group is required if recruiting under 16 years of
     age.

Consent Form when consenting for others:
   A separate consent form for this group is required.      Researcher to consult
     Guidelines.

Consent Form
   Renumber to be pages 1 and 2.
   Insert „Consent Form‟ at the top of the page.
   Clarify that the storage of samples for „other research‟ is qualified with the
    words „…..for which further consent will be obtained by an accredited New
    Zealand Ethics Committee‟.        Is the researcher intending to do further
    research?
   Does the wording for destruction of samples apply?
   Edit the words at the bottom of the page: „Research Consent Document‟ to
    „Consent Form‟.

Approved subject to conditions above.


Committee Suggestions:
   Under „Participation: study does not need to be in italics.


                                                                                 13
      Under „General Information‟. Edit i.e. „You will be issued with a card……‟
       and a full-stop should be inserted.


2. NTX/06/02/002
Hypothermia in traumatic brain injury in children.

Principal Researcher:      Dr John Beca, Starship Children‟s Hospital
Co-researchers:            Dr David Buckley + 6 Australian Researchers.

Attended:    Dr John Beca.

The Researcher is requested to please provide/amend

Application Form:
   The Committee is concerned that this study has a placebo arm that
      withholds standard treatment.
   P. 1: 1 & 2: As this study is a pilot, the words „A pilot study‟ need to be
      inserted at the beginning of the title in both Full Project Title and Lay Title.
   P.3: 18: Insert a realistic start date.
   P.6: A.3: Study Design: Researcher to explain the science behind „6 and 12
      months post injury‟ – provide names and reference of tests used.
   P. 7: A3.2.2: Statistical advice to be obtained for 50 NZ participants.
   Pt 7 to be completed. (When a participant is unable to make an informed
      choice).

Information Sheet
     Procedures need to be explained.
     Terminology is conflicting.
     Ambiguity: Information Sheet says there will be no change in standard
      treatment (Introduction) but also advises that the participants‟ children will
      receive treatment in addition to standard treatment (P. 4 Para 6).
     Clarify that this study is a pilot and that 50 NZ participants will be recruited.
     Insert version no. and date as a footer in both information sheet and consent
      form.

Consent Form
   Terminology to reflect the child and wording needs to reflect this, i.e. „I
    understand that my child‟s participation in this study is confidential……..‟

As this study is reliant on the Canadian study results, approval is deferred until the
results are available.

The researcher is required to bring the changed application back to the Committee.


3. NTX/06/02/003
A randomised double-blind placebo controlled multi-centre study of the
efficacy and safety of up to 100 days of Valgancyclovir vs. up to 200 days of
Valgancyclovir for prevention of cytomegalovirus disease in high-risk kidney
allograft recipients: Protocol V# NT18435/A, 25/08/05: Genetic sampling
study Protocol # NT18435RG, 12/09/05, 12/09/05: IB RO107-9070, 8th V, 8/05.
                                                                                    14
Principal Researcher:       Dr Ian Dittmer, Transplant Nephrologist, Auckland Renal
                            Transplant Group, Auckland City Hospital.

The Researcher is requested to please provide/amend

Application:
   P. 11: C. Compensation letter needs on letterhead and provide designations
      of signatories.
   Study Design: The committee expressed concerns about randomly allocating
      participants to the 100 day and 200 day valganciclovir treatment arms when
      the evidence presented in the application appeared to clearly indicate that
      100 days treatment resulted in unacceptable CMV viraemia and disease
      rates.
   The committee questions whether the investigators have considered treating
      for the longer duration and comparing the outcomes to the historic sample.
      In considering the risk/benefit ratio of the longer treatment, it would also be
      useful if the investigator could indicate the likely additional toxicity of the 200
      day treatment interval over the 100 day interval and ensure that the patient
      information sheet makes this clear to participants so that they can make a
      more fully informed choice when deciding whether to agree to the longer
      treatment (randomised or not).
   Human Tissue: Human tissue is being collected as part of this trial so the
      answers to 14 and 15 would appear to be "yes". It is clear that samples will be
      sent to analyse CMV characteristics and to test for emergence of resistance.
   In relation to the repository research protocol, it appears that this is a process
      of banking for research which cannot at present be specified. The Committee
      notes the ADHB Maori Research Review Committee requirements for
      samples going off shore and believes it is not clear what the tissue will be
      used for. The application should clearly state what tests will be done on the
      samples and the information sheet and consent form will reflect this. The
      researcher will be aware from the Guidelines that there is a requirement that:
      "If human tissue is stored for later use in a future study and specific consent
      for that use was not previously obtained or does not come within the scope of
      consent that was given, a new application will have to be submitted to an
      accredited New Zealand ethics committee for review when any researcher
      proposes to carry out such a study." Therefore if the tissue to be stored in the
      repository is for future unspecified research, the committee will need to be
      satisfied that the guidelines have been satisfied before approval of this part of
      the trial.

Main Study Information Sheet V#1.0, dated 24 November 2005.
   Title: For clarity, only the lay title from the application form P. 1: 2: to be
      used.
   Typos in sheet need to be rectified.
   Researcher‟s address and contact details to be under the title.
   A separate information sheet for partners is required.

Sponsor‟s Information Sheet:
   Researcher to clarify why there are two „Information Consent Forms.

Main Study Consent Form
                                                                                      15
     To be numbered separately, i.e. P. 13 of 14 to be P. 1 and 2.
     Researcher to clarify who the “partner‟s legally acceptable representative”
      would be ( last page of pregnant partner‟s consent form).

Genetic Study Information Sheet
  Insert ADHB Maori Genetic statement.
  Health Advocate statement: Remove the present statement and replace with
    „If you have any queries or concerns regarding your rights as a participant in
    this study, you may wish to contact a Health and Disability Advocate,
    telephone 0800 555 050 Northland to Franklin. (study only Northern Region.)
    Also remove the words „or someone not involved with Roche‟.
  Insert that blood samples will be kept for no more than 15 years then
    destroyed.

Genetic Consent Form:
  See points under „Application Form‟ concerning future use of tissue.

Approval deferred, relative to Standard „A validity of research (Pt. 2 Ethical
Principles) and Pt. 5, use of human tissue.

Suggestions
   The Committee would prefer a compensation agreement which allows
    participants to seek remedies against the sponsor.
   Concerns were expressed about the level of compensation.



4. NTX/06/02/004
Ä long-term follow-up study to evaluate the safety and efficacy in transplant
recipients treated with modified release tacrolimus FK506E (MR4) based
immunosuppression regimen: Protocol FK506E (MR4), 5/06/02 & Amend 3,
19/08/05: IB Ed. 2, 1/04.

Principal Researcher:     Dr Stephen Munn, NZ Liver Transplant Unit, ADHB
Co-researchers:           A/P John McCall
                          A/P Ed Gane

Attended:    Dr Cecilia Tong.

The Researcher is requested to please provide/amend

General:
  Extension study from AKX/04/07/200. No Maori recruited in original study.

Application Form:
   P. 6: A6: clarify restriction placed on publication of results – „agreement from
      Astellas Pharma GmbH required……‟.
   Locality Assessment Form required.

Information Sheet
     P. 3: Compensation: Insert statement for Dec. B from Guidelines NAFG-v.1.

                                                                                 16
         Clarify the term for which the drug will be „freely available‟. The Committee
          was unsure of the significance of registration as opposed to „commercially
          available.

Consent Form:
   Construct a consent form specifically for this study.

Approved subject to conditions above.


5.       NTX/06/02/005
Pharmacokinetics and pharmacodynamics of alph2-adrenoceptor agonists in
children undergoing cardiac surgery.

Principal Researcher:         A/Prof. Brian Anderson, Starship Children‟s Hospital.
Co-researchers:               Ms Amanda Potts, University of Auckland.
                              Dr Guy Warman, University of Auckland.

Attended:       A/Prof Brian Anderson, Ms Amanda Potts, Dr Guy Warman.

The Researcher is requested to please provide/amend

Application Form:
   P.12: D7: Data to be kept for majority (16 years) + 10 years.
   Letter of support from ADHB MRRC to come.
   Researcher to fully complete Part 7.

Information Sheet
     Remove the words „Research Consent Document‟.                   The title to be
      „Information Sheet for Parents‟. Edit to ensure „your child‟ is used instead of
      „your‟.
     Also create a summarised information sheet for children.
     P. 2: under „Confidentiality‟, correct the time data is to be held (majority + 10
      years).

Approved subject to conditions.


6.       NTX/06/02/006
Comparison of methicillin resistant staphylococcus aureus (MRSA) carriers in the
general population and hospital staff.

Principal Researcher:         Ms Zeena Fadheel, Auckland University of Technology.
Co-researchers:               Mr Colin Swager, North Shore Hospital
Supervisor:                   Ms Holly Perry, Auckland University of Technology.

Attended:       Ms Zeena Fadheel, Ms Holly Perry.

The Researcher is requested to please provide/amend

General:


                                                                                      17
          The Committee were concerned that all possible employment-related risk
           from participation be made clear to participants.

    Application Form:
       P. 1: 2: A short descriptive lay title to be inserted.
       Realistic start date, i.e. mid to end February.
         Locality Assessment required for Waitemata DHB through Research Office
           (Lorraine Neave).
       Maori consultation with Waitemata DHB MRRC required and letter of
          support.
       P. 12: D7: Data to be kept by supervisor in a locked cabinet for 10 years.
       P. 13: Section F:
          F2: HRC booklet needs to be read.
          F3: Proposed research does impact on Maori as presumably there are
          Maori staff.
          F3.1 to end of section: To be completed fully.
         Declaration Form A: To be signed and witnessed by JP.

    Information Sheet
         The Sheet needs to be edited and rewritten according to the Guidelines
          NAFG v-1.
         Researcher‟s/supervisor‟s name and contact details to be under the title and
          check the sheet for repetition and remove.
         Begin the first para with an invitation.
         First para – „5 minutes of your time….‟. Application states 10 minutes –
          correct.
         P. 1:        Under „The study‟ remove the words „Comparison of
          MRSA…….population‟ and place as the lay title at the top of the page.
         Insert (for staff) „If you have any queries or concerns regarding your rights as
          a participant in this study, you may wish to contact your professional
          organisation.‟
         Insert a heading „Compensation‟ and insert/replace the compensation
          statement from the Guidelines for Declaration A, NAFG-v1, P25…‟In the
          unlikely event……or the investigator.‟.
         The last paragraph in the Information Sheet should read, This study has
          received ethical approval from the Northern X Ethics Committee‟.

    Consent Form
       Lay Title to be inserted (replace „for MRSA study‟).

    Questionnaire:
      Insert a descriptive lay title.

    Approved subject to conditions above

    Committee Suggestions:
       A description of the study should be further up the page.
       Edit for errors (North shore should be North Shore).

.


                                                                                       18
7. NTX/06/02/007
Clinical study to determine the efficacy of a therapeutic blue shirt for the
treatment of body acne.

Principal Researcher:      Dr Mark H. Gray, Dermatologist
Co-researchers:            Dr Hugh Bartholomew and Dr Greg Goodman, Australia

The Researcher is requested to please provide/amend

Application Form:
   P.3: There is a discrepancy between the start and finish dates of the trial
      and the proposal to trial for up to 60 days.
   P.5: A3.1: 2: The Committee has major concerns regarding the research
      design and therefore its capacity to produce valid results. There is :
          - no comparator
          - poor description of end point measure
          - no detail regarding the data analysis.
          - Limited to absent consultation on research and statistical design,
              including method.
    P. 7: A7.2 There is no statement regarding the relationship between the
      sponsor and the principle investigator and recognition of potential conflicts of
      interest. A7.2 states that Dr Gray is a co-inventor of the therapeutic blue
      shirt technology.
    P. 9: B10: Clarify why „pregnancy‟ is an exclusion criteria.
    P. 10: C. This is a clinical trial.
   P.10: C1: It is claimed that the trial is not going to benefit the sponsor when
      it would seem that it is indeed going to produce results that have potential
      benefit to the sponsor. Therefore the whole issue of compensations and
      indemnities needs to be considered and addressed.
   P. 12: D7: Data to be kept for 10 years in a locked cabinet.
   P.13: Section F needs to be completed and consultation with Maori
      (researcher to approach Waitemata DHB – Lorraine Neave at North Shore
      Hospital, for help in this regard).
   Considered that Declaration B should be completed (for sponsor) not
      Declaration A (ACC).

Information Sheet
     Required to be on letterhead.
     Researcher contact details to be under the title
     Insert the Health Advocate‟s phone no. (now received)

Study application declined as considered to be a marketing exercise.
The Committee voted 6 to decline and 3 to defer).

A new application can be resubmitted to the Committee.


Committee Suggestions:
   The child’s diary needs to be in much larger print.




                                                                                   19
8. NTX/06/02/008
Human salivary total IgA and IgA subclasses: evaluation of a nephelometric
method and establishment of an adult reference interval.

Principal Researcher:      Ms Andrea Lun, Biochemistry Laboratory, Middlemore
                           Hospital.
Co-researchers:            Dr Ross Boswell Middlemore Hospital
                           Mr Peter Cleave, Middlemore Hospital
Supervisor:                Dr Phil Pearce.

Attended:     Ms Andrea Lun, Dr Ross Boswell.

The Researcher is requested to please provide/amend

Application Form:
   P. 3. 18: Insert a more realistic start date.
   P.12: D7: Data to be kept by supervisor for 10 years in a locked situation at
      Massey University.
   P.13: Section F. Maori consultation required through C-M DHB MRRC.
   P.4: 3: Locality Assessment – not to be through Ethics Committee but C-M
      DHB where research is being carried out. Questions 1 to 4 to be fully
      completed prior to signatures.

Information Sheet
     Insert bold heading, „Participant Information Sheet‟. Lay title of study to be
      under that heading.
     Before „Aims‟, insert a para stating an invitation to participate in the study.
     Insert the compensation statement for Declaration A on P. 25 of Guidelines
      NAFG v-1.

Approved subject to conditions above.


Committee Suggestions:
   Information Sheet:     Suggest ‘Participant’s Rights’ be placed near the
    beginning of the information sheet on P. 1


9. NTX/06/02/009
Introduction and pilot testing of a new patient derived self-assessment
questionnaire to provide a measure of the impact on life (IOL) of visual
disability resulting from the presence of a cataract or cataracts.

Principal Researcher:      Dr Peter Haddad, Park Street Eye Clinic, Tauranga
Co-researchers:            Dr Dean Corbett, Manukau Super Clinic
                           Dr David Pendergrast, Auckland Eye
                           Dr Kerry Chamberlain, Massey University, Albany.

Sites:                     Bay of Plenty and Counties Manukau DHB

Attended:     Ms Alison Barber, Dr Ray Naden


                                                                                  20
The Researcher is requested to please provide/amend

Application Form:
   P. 5: A.3.3: Researchers to clarify the way the data from the clinicians and
       nursing staff will be analysed and used to effect results..
   Declaration A required.
   P.12: D.7. Data to be kept in a locked situation for 10 years (NZ law).

Information Sheet
     Insert the HAT statement.
     Insert as a last para, „This study has received ethical approval from the
      Northern X Ethics Committee‟.
     Insert a compensation statement, „In the unlikely event of a physical injury as
      a result of your participation in this study, you may be covered by ACC under
      the Injury Prevention, Rehabilitation and Compensation Act. If you have any
      questions about ACC, contact your nearest ACC office or the investigator.‟
     Insert version no. and date as a footer in both information sheet and consent
      form.
     Contacts for researchers include Dunedin and Wellington which could make
      this study a multicentre.

Approved subject to conditions above.

Committee Suggestions:
   Information Sheet should have a clear heading, ‘Participant Information
    Sheet’.
   Information Sheet should begin with a invitation to participate.
   Application Form: P. 1/2: Include those Ministry of health personnel who
    have a research role (including data analysis) as co-investigators.


10. NTX/06/02/010
Health related quality of life in patients with dystonia and their caregivers.

Principal Researcher:      Dr Vanessa K. Lim

The Researcher is requested to please provide/amend

Attended:    Dr Vanessa Lim.

Application Form:
   P. 8: B7: Clarify which statement to be used – it is intended to inform GP
      but Information Sheet says that the information is confidential.

Information Sheet
     Information for Caregivers required.
     Besides the Health Advocate‟s statement, there needs to be one for the
      caregivers, „If you have any queries or concerns regarding your rights as a
      participant in this study, you may wish to contact your professional
      organisation‟.


                                                                                  21
      Compensation: Insert the statement from the Guidelines NAFG P. 25 for
       Declaration A.
      Insert version no. and date as a footer in both information sheet and consent
       form.

Approved subject to conditions above.

Committee Suggestions:
   The Committee thought the forms of Q. 25 and 28 were unclear. Researcher
    to consider clarifying them.


11. NTX/06/02/011
The 'crush' technique for coronary bifurcations using drug-eluting stents:
clinical and angiographic follow-up: Protocol V#5, 20/11/05

Principal Researcher:      Dr John Ormiston, Mercy Angiography Unit
Co-researchers:            Dr Peter Ruygrok, Auckland City Hospital
                           Dr Mark Webster
                           Dr Jim Stewart
                           Dr Duncan McNab
                           Dr Suwatchai Pornratanarangsi

Attended:    Mr Hector Gonzalles.

The Researcher is requested to please provide/amend



Application Form:
   P. 5: A3: Study design: Clarify survival data. There is a sensitive issue of
      contacting (if deceased).
   P. 9: B9: „Nil‟ is not an appropriate answer. Requires a summarised
      answer.
   P.9: P10: 2. Procedure performed more than „6 months‟ (or 12 months)?

Information Sheets (2)
     Under „Problems or Questions‟: Statements confusing.
     Insert a statement regarding access to previous clinical data.
     P. 2: „Potential Risks‟: It is presumed that these are known and therefore
      need to be inserted.
     Health Advocates‟ statement. To be a separate para away from contact
      details for Mata Forbes and remove the „and/or‟.           Correct to „Health
      Advocate‟ (not Trust). The para should be under „Problems or Questions‟.
     Insert the correct approval statement for Northern X Ethics Committee.

Consent Forms (2)
    5th bullet point: Remove as not relevant. (there is no sponsor)

Approved subject to conditions above.

Committee Suggestions:
                                                                                 22
            Edit the Information Sheet for missed words.
            The researcher’s name, address and contact details to be placed under the
             title on the first page in the Information Sheet.
            Study design: Some members of the Committee were concerned that the
             study did not allow for ethnicity data collection and analysis, given the high
             incidence of COPD among Maori.


    12. NTX/06/02/012
    Pimecrolimus-eluting Duraflex stent safety evaluation. A non-randomised,
    consecutive enrollment evaluation of the Avantec pimecrolimus-eluting
    Duraflex stent in the treatment of patients with de novo native coronary artery
    lesions: Protocol DVP 0247, 27/12/05: IB DVP 0247, 1/12/05:

    Principal Researcher:         Dr John Ormiston, Auckland City Hospital
    Co-researcher:                Dr Peter Ruygrok, Mercy Angiography

    Attended:       Mr Hector Gonzales.

    The Researcher is requested to please provide/amend

    Application Form:
       P. 6: Clarify historical controls.
       P. 11: Inclusion and Exclusion criteria. – females of child-bearing age –
          presume the exclusion criteria 2) „Female patients of childbearing potential,
          is wrong.
       P. 14: B19: Supply SCOTT letter saying their approval is not required for
          this study.
       P. 13: B16: Clarify is it „five-year follow-up period‟ or twelve months follow-
          up?
       P. 16: F1: Researcher to confirm that the study drug will cease to be „eluted‟
          by the stent after the termination of the study period. If not, the answer to Q.
          F1, P. 16 should be „Yes‟ not no.

    Information Sheets
         Use the lay title from the application only – the full title to be deleted.
         P. 3: Compensation statement: Correct the Committee to „Northern Ethics
          Committee‟.
         HAT statement should be Health Advocate (not Trust).

    Approved subject to conditions above.
                                                                                     Chair

    Committee Suggestions:
       information Sheet: Researcher name and contact details should be under the
        title on the front page.



AMENDMENTS

    1.       AKY/02/00/020
                                                                                        23
Randomised, double-blind, safety and efficacy trial with intravenous
zoledronic acid for the treatment of Paget's disease of bone using risedronate
as a comparator: Protocol CZOL446H2304, Final 22/10/2001: Prot/amend #1,
13/12/2001: Prot/amend #2, 29/05/2002. Prot/amend #3, 22/10/02. Prot/amend
# 4 12/01/2004. . PIS/Cons v#4, 14/09/04, Protocol amend v#5 ZOL446H2304
03/08/2004. Addendum to Protocol amdt 5:

Principal Investigator:   Prof. Ian Reid

     Investigator Brochure Edition 10, 12/08/05 + Summary of Changes.

Approved.


2.    AKY/02/00/046
A multicentre, double-blind, randomised, placebo-controlled study to evaluate
the safety and efficacy of zoledronic acid in the treatment of osteoporosis in
post-menopausal women taking calcium and vitamin D: Prot. CZOL446H2301,
22/10/2001: Prot/amend #1, 25/03/2002. Prot/amend #2, 26/11/02. PIS/Cons
V#4, 10/01/03. 17/03/04: Addtnl PIS/Cons 7/1/04: Ext. Study Prot/, 6/04/05:
PIS/Cons 17/05/05: Prot/Amend # 5, 17/06/05, PIS/Cons Amend 5, 23/09/05:

Principal Investigator:   Prof. Ian Reid

     Investigator Brochure Edition 10, 12/08/05 + Summary of Changes.

Approved.


3.    AKX/02/00/179
Familial intracranial aneurysm (FIA) study:      PIS/Cons V#2, 7/8/2002: MHG
Forms v#1.2, 28/10/02: Prot/amend 18/02/04

Principal Investigator    Prof. Craig Anderson

     Update the process of aneurysm history taking for participants who have been
      diagnosed with an unruptured aneurysm by study MRA.
     Aneurysm screen.

  (New Information Sheet/Consent Form for already consented participants?)

  Approved.



4.     AKX/04/02/022
An international phase 2-3, stratified, randomised, open-label, parallel-group
clinical trial to evaluate the safety and efficacy of a single intravenous bolus
of enoxaparin versus intravenous unfractionated heparin in patients
undergoing non-emergent percutaneous coronary intervention (PCI):
Protocol XRP4563/4001, 16/09/2003: Case Report Form V#7, 6/10/2003:


                                                                               24
Prot/amend #1, 19/05/04, PIS/Cons V#4, 20/10/04, Prot/amend 2, 24/09/04: IB
Ed #13, 21/07/04: Prot/amend #3, 14/12/04: Prot + amends #3, 14/12/04:

Principal Investigator:     Prof. Harvey White

        Protocol amendment to completed study increasing patient follow-up from 30
         days to one year.
        Protocol Amendment 4 dated 17 November 2005.
        Protocol XRP4563/4001 including Amendment 4 dated 17 November 2005.
        Informed Consent Addendum for 1-year Follow-Up Relative Consent V#1,
         dated 18 November 2005.
        Informed Consent Addendum for 1-year Follow-Up Patient Consent V#2,
         dated 16 November 2005.
        Proposed Case Report Form V. 2 November 2005.

Approved.



5.       AKX/04/07/198
Does home based humidification treatment reduce exacerbation frequency for
people with chronic obstructive pulmonary disease (COPD) and bronchiectasis?
PISCons V#2, 2/8/04. CIP V#3, 20/05/05: Supp IS/C V#3, 20/05/05.

Principal Investigator    Professor Harry Rea, Middlemore Hospital
Co-researchers:           A/P Jeff Garrett, Ms Sue McAuley, Dr Lata Jayaram,
                          Middlemore Hospital,
                          Mr Kevin O‟Donnell, Fisher & Paykel Healthcare.

        Further modification to the CT sub-study and minor modification to the
         protocol for the Cough sub-study.
        Changed study monitor to Mr Hans Hockey.
        Variation to Ethics Application (changes to 4.1 (study design), 10.2.
        Clinical Investigation Plan (CIP) V#4, 15/12/05
        Supplementary Information Sheet/Consent Form for CT Scans V#4, 15/12/05
         (Approval statement needs to be changed to Northern Ethics Committee and
         compensation statement should be there).

Approved.


6.     AKY/04/09/247
Pilot clinical trial of the C-Pulse device as destination therapy inpatients with
moderate-severe heart failure: Clinical Investgtn Plan PRO 01543 Rev. B:
IS/Cons V#3, 15/10/04:

Principal Researcher:         Dr Peter Ruygrok.

        C-Pulse Clinical Investigation Plan, Rev. F, 21/12/05
        C-Pulse Clinical Investigators Brochure Rev. E, 21 December 2005.
        C-Pulse Clinical Investigators Brochure Clinical Data Supplement, Rev. A.


                                                                                     25
         Researcher does not consider change in IIS/Cons required.

         Approved.


         7.    AKY/04/12/336
         Bone oedema and rheumatoid arthritis: correlating MRI with histopathology:
         PIS/Cons V#4, 22/07/05:

         Principal Researcher:        Dr Fiona McQueen       University of Auckland.

               Protocol Amendment 05/01/06 – to extend to include patients with
                osteoarthritis having surgery to their hands/feet including joint replacement or
                fusion.
               Participant Information Sheet/Consent Form V#5, 5/01/06.
               Progress Report
               Addition of summer student to score histological slides of bone specimens.
               Addition of North Shore Hospital site.


         Approved.


The following were reviewed and given ethical approval by the Chairperson under
ChairPersons Discretion.

APPLICATIONS FOR THE RETROSPECTIVE REVIEW OF PATIENT NOTES/DATA


Title:                       Record keeping        in   anaesthesia      –   compliance    with
                             standards

Principal Researcher:        Mr Richard Yu, Auckland DHB

Supervisor:                  Prof. Alan Merry, University of Auckland.



Title:                       Penumbra sign in osteomyelitis

Principal Researcher:        Dr Ben MncGuinness, Radiology Registrar, Middlemore
                             Hospital
Co-researcher:               Dr Nichola Wilson, Orthopaedic Dept, Middlemore Hospital.

Supervisor:                  A/Prof. Anthony Doyle, Radiology Dept,
                             Middlemore Hospital.


Title:                       Does D-Dimer predict the likelihood of a positive CT
                             pulmonary angiogram?

Principal Researcher:        Dr Martin Gunn, North Shore Hospital

                                                                                             26
Co-researchers:             Dr Mark Barnet, Dr Phil Misur

Approved as audit but with concern over management of patient contact if a missed
diagnosis is revealed by the audit process. Care will be needed with the process of this
contact.



Title:                      Paediatric Pedestrian Trauma in Auckland

Principal Investigator:     James Hamill, Director, Children‟s Trauma Service,
                            Starship Children‟s Hospital
Co-researcher               Clinton Newbury



Title:                      Predictive factors of prognosis in the patients admitted to
                            Cardiovascular Intensive Care Unit of Auckland City
                            Hospital with pulmonary oedema or cardiogenic shock.

Principal Investigator:     Manuprabha Ratnayake, Dept Cardiology, Auckland City
                            Hospital.
Co-researcher:              Ruvin Gabriel, CIC Unit, Auckland City Hospital.
Supervisor:                 Dr Michael Gilham, CIC Unit, Auckland City Hospital.




AMENDMENTS: - (Approved by Chairperson/Deputy Chairperson under CPD)

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) 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: IB
V#9, 11/08/05: Prot/ament #6 (Gl), 26/01/06

Principal Investigator:      Dr Wayne Miles, Waitemata DHB

 Protocol amendment 006 (Global) dated 26/01/06. Amends the timelines to allaow
  enrolled participants to continue their treatment with aripiprazole until March 2008 or
  until aripiprazole is commercially available, whichever occurs first; and clarifies the
  criteria used to terminate non-compliant patients from the trial.


2001/245
Determinants of stroke impact on individuals, families and the community, 18/12/01

        Access to NHI nos. in accordance with information provided.




                                                                                      27
AKX/02/00/045
Cytotoxic T lymphocytes in malignant melanoma: characterisation and
manipulation for therapeutic benefit: PIS/Cons V#2, 24/04/2002: PIS/Cons V#4,
14/04/03: .. Substudy: Immune cell response, 24/5/04.

      Extend size of Group 3 to 50 (from 25)
      Extend patients in Group 3 to include patients undergoing plastic surgery
       procedures where skin flap trimmings are routinely discarded.
      Information Sheet

Information Sheet and a Consent Form required on letterhead with a new version no. and
date.


AKX/03/04/110
A randomised, placebo-controlled intervention trial of Omega-3 (w-3 PUFA fish oils)
in people with ischaemic stroke

   Audit: Amendment to change laboratory. (Recruitment complete.



AKX/04/07/200
A multicentre, 1:2 randomised, double blind, two arm parallel group study to
evaluate and compare the efficacy and safety of modified release tacrolimus
FK506E (MR4) versus tacrolimus FK 506 in combination with steroids in patients
undergoing primary liver transplantation: Protocol FK-506E-11-03, 30/01/04: IB for
Tacrolimus FK506E (MR4) Ed. 2, 1/04: IB for Tacrolimus FK506, Ed. 5, 7/03:
PIS/Cons V#2, 15/8/04:      Prot/amend #1, 20/09/04: Prot/amend #2, 19/08/05:
Prot/amend #3,5/12/05

      Protocol Amendment #3 dated 5/12/05.
       Auckland City Hospital not participating in the PK substudy.



AKX/04/08/222
Does long-term oxygen therapy improve health-related quality of life in COPD
patients with moderate hypoxaemia? - a randomised controlled trial:

      Requirement to change to a six-week crossover design – each participant to
       receive oxygen and air for 6 weeks in random order with a 2-week washout period
       in between.
      Modification of exclusion criteria to allow patients who have previously been on
       oxygen therapy to participate.

New Information Sheet/Consent Form required.


AKX/04/08/227
Effects of exercise during pregnancy on maternal insulin sensitivity and fetal
outcomes: PIS/Cons V#4, 1/10/05 17/11/04:

                                                                                     28
     Amendment to remove ethnicity requirement.
No change to PIS/Cons required.


AKY/04/10/280
Preventing further heart disease and stroke in general practice: secondary
preventative care following admission to hospital. PIS/Cons V#2, 1 Nov 2004

            Addition of Auckland City Hospital.


NTX/05/03/021
The effects of aging and endurance training on exercising diastolic function in
healthy older males: PIS/Cons V#2, 26/07/05.

     Exercise training duration amendment from 6 months to 4 months.
     PIS/Cons V#3, 14/12/05

NTX/05/07/080
Ketamine during paediatric emergency department procedural sedation:                        a
pharmacodynamic study

           Protocol Amendment to record on video
           PIS/Cons V#3, 12/01/06.


NTX/05/07/087
Ultrasound guided regional anaesthesia: an audit of practice: PIS/Cons V#3,
Jan 06:

Principal Investigator:      Dr Neil MacLennan
Co-Researchers:             Dr Chris Nixon Dr James Lai Dr James King
                            Ms Cressa Graham

           Inclusion of Cressa Graham and Dr James King.
           Change to the Data Collection Sheet to
                  -      include the names of the anaesthetist performing the block and
                         the supervising anaesthetist;
                  -      include the new model of ultrasound machines currently being
                         used at Auckland City Hospital (Micromax NRV),
                  -      start recording the times of sensory loss and motor block when a
                         block is being performed.\
           Participant Information Sheet/Consent Form V#3, dated January 2006.
           Data Collection Sheet.


NTX/05/10/133
Post-injury alcohol intervention research (PAIR):          acceptability survey and chart
review: PIS/Cons V#2 17/10/05

           Chart review change.

                                                                                            29
       Acceptability survey discontinued for present.



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#4, 21/12/05 (Minor amendments to „Procedures‟ and contacts.


PROGRESS REPORTS (CPD)

       94/146
       Adjuvant therapy for premenopausal patients with node positive breast cancer
       who are suitable for endocrine therapy alone (International breast cancer study
       group trial 11-93).


       97/032
       Safer drug administration in anaesthesia: Questionnaire V#2, 8/9/03


       97/256
       Neuropsychological and clinical investigations of Hungtington's Disease:
       PIS/Cons V#2, 31/08/04


       2001/026
       Pilot study of the effects of GC811007 administration on copper and trace metal
       metabolism in non-diabetic subjects and patients with Type 2 diabetes mellitus:
       Protocol V#1, 30/01/2001: Prot/Amend V#2, 14/02/01: Prot/Amend V#3, 5/12/01:
       Prot/Amend #4, 21/01/20021:       Prot/Amend V#5, 25/05/2002: Prot/Amend #6,
       15/05/2002: PIS/Cons V#6, 15/05/2002: IB V#3, 12/08/02


       2001/258
       Dialysis outcomes and practice patterns study: DOPPS II PIS/Cons V#2,
       14/11/01: DOPPS III Questionnaire, PIS/Cons V#3, 10/02/05.

             Abstracts & published Reports.


       2001/280
       A controlled trial of two methods of CME (Continuing medical education)
       versus control group: heart failure management in general practice: PIS/Cons
       V#3,4/10/05



                                                                                    30
AKY/02/00/292
Experience of having Sarcoidosis - psychological distress, perceptions of
illness and beliefs about medications.



AKX/04/06/172
Evaluation of the VentrAssist ™ left ventricular assist system as destination
therapy in end stage cardiac failure (Trial #CP024001): Protocol 27/04/04: IB
30/04/04: Addendum #1, 18/5/04 Addendum #2, 18/05/04: Patient Handbook,
4/05/04: PIS/Cons V#2, 8/04: Prot/amend Rev. 1.0, 8/04


AKX/04/04/098
Chronic heart failure angiotgensin blockade with irbesartan study: Monash
Protocol # CP-02/02, V#7, 9/10/03: PIS/Cons V#2, 25/06/04


AKY/04/08/216
Residential rehabilitation: The lived experience of people withserious brain
injury. PIS/Cons V2, 24/11/2004


AKX/04/09/256
Computer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: A
Prospective, Comparative, Open, Sequential, Multi-Centre Post Market
Surveillance Clinical Investigation Comparing the Alignment Achieved using
the DePuy Ci ™ Minimally Invasive versus the DePuy Non Navigated
Conventional Total Knee Arthroplasty Instruments and Surgical Technique:
PIS/Cons V#3, 12/10/04: Prot/amend #1, 29/04/05.


AKY/04/10/270
Placental growth and inflammatory factors in pregnancy disorders: PIS/Cons
V#2, 13/12/04

List of Publications arising.


AKY/04/10/271
Biomarkers of placental growth and development in maternal plasma: PIS/Cons
V#2, 13/12/04


AKY/04/10/272
Regional variations in cellular composition, viability and inflammatory
activation in fetal membranes at site of rupture prior to, and during, labour and
delivery. PIS/Cons V2, 13/12/4


AKY/04/10/280


                                                                              31
Preventing further heart disease and stroke in general practice: secondary
preventative care following admission to hospital. PIS/Cons V#2, 1 Nov 2004




AKY/04/10/281
Complementary Therapy Use amongst Emergency Medicine patients at North
Shore Hospital. PIS/Cons V#2, 11/04


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

   Draft patient interview (telephone)


AKX/04/10/285
Development of a predictive model of patient body weight from a series of
anthropometric measurements: PIS/Cons V#2, 11/10/04.


AKY/04/11/306
Narratives of recovery and rehabilitation in persons found not guilty by reason
of insanity (NGRI) for homicide: patient and clinician perspectives: PIS/Cons
V#3, 16/05/05


AKY/04/11/310
Lapband obesity surgery, weight loss and hormone study.

      Reconfirmed but on hold until funding is obtained (hoped to be by July 2006)


AKY/04/11/311
Staffing levels' impact on the quality of the outcomes for the residents: is there
a relationship between direct care staffing hours and quality indicators in
residential aged care in New Zealand? PIS V#1


AKX/04/11/319
Evaluation of frequency doubling technolgoy perimetry as a glaucoma
screening took in general practice. PIS/Cons V#1, 6/12/04


AKX/04/11/323
Determinants of coagulation after cardiopulmonary bypass (CPB): PIS/Cons
V#2, 25/11/04



                                                                                     32
   AKX/04/11/327
   Older people, activity and depression: PIS/Cons V#2 2/12/04


   AKX/04/11/328
   Psychoneuroimmunology of infertility: explaining how what we think and feel
   can affect IVF treatment outcome: PIS/Cons V#3, 1/12/2004: Questionnaires
   1,2&3:


   NTX/04/12/006
   The relationship between disorders of reality monitoring and anosognosia of
   hemiplegia following right hemispheric stroke, PIS/C V#1, 30/10/04:


   NTX/04/12/007
   The relationship between the clinical profile and neural changes in individuals
   with Huntington's disease: a retrospective analysis: PIS/Cons V#1, 26/11/04:


   NTX/04/12/011
   Dual vent cardiopulmonary bypass to reduce ischemic brain injury in cardiac
   surgery: Protocol V#1, 25/11/04: Prot/amend V#2, 14/4/05: PIS/Cons V#5,
   25/08/05


   NTX/05/02/009
   Adolescents with a chronic condition: parental and self-expectations and their
   relationship to adjustment: PIS/Cons V#3, 05/05.



CLOSURE:    9.40 p.m.




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