AGENDA pneumonia

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					                                 MINUTES

                                        OF

                     NORTHERN X ETHICS COMMITTEE

                        WEDNESDAY, 5 October 2005


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



PRESENT:

     Tim Dare                         (Chairperson)
     Jeffrey Harrison                 Scott Macfarlane
     Emma Ngawhare                    Robyn Northey
     Stephanie Palmer                 Louisa Wall
     Patricia Hanlen                  Wayne Miles
     Joanna Stewart



APOLOGIES:

     John France,
     Adina Halpern
     Wayne Miles



ADMINISTRATOR:

     Patricia Chainey


MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 7 SEPTEMBER 2005.

     Confirmed: J. Harrison/L. Wall

INFORMATION/CORRESPONDENCE:

     ‘Exposing the Myth’ – journal extract forwarded by Sally Cook.

                                                                      1
    Noted

    NTX/04/08/106
    A multicentre, randomised, double blind study to evaluate the safety, efficacy
    and tolerability of L-000 899055 monotherapy in obese patients: Protocol L-
    000899055 015-00 R, V. 3.2, 3/6/05Prot/amend Appdx 7, 31/05/05: CIB, Ed, 4,
    19/05/05: Prot/amend 015-01, 16/08/05: Prot/amend 015-02, 25/08/05: PIS/Cons
    V#2, 05/09/05

            Letter from M. Denton re Carcinogenicity Study Update, dated 3 October
             2005.
             Mouse seizure studies – Attachments 1 and 2.

    Noted.

     AKX/03/09/244
     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. Extension 1 to Protocol # CFTY720A2218, 16/07/04

     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. Extension 1 to Protocol # CFTY720A2218, 16/07/0

            Principal investigator advised it has now been confirmed that there is an
             increased risk of macular oedema in patients on FTY720. Only 3 patients
             remaining on FTY720 in Auckland and PI will discontinue study drug in these
             patients and convert them to standard immunosuppression.              Study
             amendment to come.

     Noted.



GENERAL BUSINESS:

    Meetings for 2006.
    It was unanimously agreed that the meeting dates stay as the first week in the
    month.    One HP‟s clinic dates had been set for 2006 and cannot be changed.
    Other members had various obligations for other Wednesday‟s in the month.


    Email from Peter Black, 3/10/05 re Sending serum samples overseas.

    The Chair is to circulate the email to all Committee members for their comments.


                                                                                       2
END OF STUDY REPORTS: (Available on request)

    94/082
    Should we revascularise occluded coronaries for cardiogenic shock?: An
    international randomised trial of early revascularisation 'shock'; Protocol
    19/3/93; Prot/amend 11/9/94; Prot/amend 30/11/94: Prot/amend 01/01:


    2001/212
    Defining the characteristics of lid disease and dry eye:


    ÄKY/02/00/262
    A study of the experiences of patients and referrers, using a Consultation-
    Liaison Psychiatry Service in a General Hospital - A qualitative research study
    using grounded theory methodology


    AKY/03/02/026
    The experience of dyspraxia after stroke.


    AKX/03/03/093
    The experience of 'being pregnant' for women under the age of nineteen:


    AKX/03/06/154
    Adherence to physiotherapy rehabilitation for ankle sprains:        a test of
    protection motivation theory: PIS/Cons V#1, 21/5/03


    AKY/03/10/255
    A Qualitative Exploration into the Knowledge and Perceptions of the Role of
    Psychotropic Medicines on Mental Illness. A Review of Three Groups: Mental
    Health Nurses, Cultural Support Workers and Caregivers


    AKX/03/10/278
    Adherence to physiotherapy for ankle sprains: home-based with adherence
    enhancing adjuncts versus clinic-based management:


    AKX/04/05/131
    Towards consistency in implementation of the strengths model:
    implementation and evaluation of outcomes in the use of Charles Rapp's
    strengths model tools:


    AKY/04/09/248
    Three dimensional modelling of shunt surgery for patients with hydrocephalus.


                                                                                 3
   AKX/04/09/260
   Follow-up of MMR vaccination status in children referred to a paediatric
   immunisation clinic on account of egg allergy:


SERIOUS ADVERSE EVENTS


   93/114
   Adjuvant therapy for premenopausal patients with node positive breast cancer
   who are not suitable for endocrine therapy alone (international breast cancer
   study group trial 13-93).

         80035       Carcinoma of uterus G. 1.

   Received.


   94/144
   Adjuvant therapy for post/peri-menopausal patients with node positive breast
   cancer who are not suitable for endocrine therapy alone (international breast
   cancer study group trial 14-93)

         140599      Malignant melanoma
         140168      Death at home (following 2 episodes of myocardial infarctions)
         140696      (2) Pulmonary embolism/cerebrovascular accident.

   Received.

   94/150
   Adjuvant therapy for premenopausal patients with node positive breast cancer
   who are not suitable for endocrine therapy alone (international breast cancer
   study group trial 13-93).

         135323      Ebdometrial hyperplasia and polyp

   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; Protocol IBCSG 18-98/BIG 1-98;

         PHHO2000CH10911          Cataract
         PHHO2005IT11170          Chondropathy F/U
         100633 – 300690          (29) – various.
         21081 – 300402           (34) – various


   Received

                                                                                       4
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 : Protocol NV15908B, 11/5/99; Prot, V#1.1, 6/6/2000;
Prot/amend, 31/07/01;

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:
2001/210
An extension Protocol to evaluate the long-term effects of treatment with
peginterferon alfa-2a (PEG-IFN) or Roferon-A for patients with chronic hepatitis
B in the original study NV16037: Protocol WV16567, 23 July 01: PIS/Cons V#2,
11/10/2001: IB V#6. 12/01. IB V#7, 3/03

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: Protocol #WV16866,

AKY/04/06/149
Randomised, multicentre, open-label, phase IV study evaluating the efficacy
and safety of 16-week versus 24 week treatment with PEGASYS ® in Interferon-
naïve patients with chronic hepatitis C-genotype 2 or 3 virus infection: Protocol
NV17317, 15/03/04:

      411168       Pericardial effusion
      410160       Pulmonary embolism
      410535       unknown origin fever
      410481       food poisoning

Received

2001/199
Effect of two year's treatment with Norditropin SimpleXx on bone mineral
density in young adults with childhood-onset growth hormone deficiency:
Protocol GHLIQUID-1369, V#2, 12/03/2001

      245004       Breast mass
      245399       Pitting oedema, aggrevated systemic SLE nephritis, anaemia
                    & hypertension.
      244942       Malaise
      245064       Congenital aplastic angemia
      246015       Headache, vomiting, strabismus
      245064       Thrombocytopenia, panocytopenia, granocytopenia
      245873       Abdominal mass
      245484       Pyrexia
      244741       Femoral neck fracture

                                                                                 5
Received.

AKX/02/00/373
COG AAML0122: Phase II window evaluation of the Farnesyl transferase
inhibitor (R115777) followed by 13-cis retinoic acid, cytosine arabinoside and
fludarabine plus hematopoietic stem cell transplantation in children with
juvenile myelomonocytic leukaemia: Protocol AAML0122, 28/05/2002:

      AE#1012376 Gr. 5 infection with Gr. ¾ neutropenia: lung (pneumonia)

 Received.


AKY/03/02/038
A randomised, double blind trial of LdT (Telbivudine) versus Lamivudine, in
adults with compensated chronic hepatitis B:         Protocol # NV-02B-007,
21/08/2002: ÏB Ed# 6.0, 22/07/2002. Protocol NV-02B-007 V#2
And….

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 :
Prot # NV-02B-011 V#2, 1/10/03

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:
Protocol NV-02B-019,V#1

      MCN: AUV – 156      Liver failure (hepatic failure)
      MCN: AUV – 181      syncope

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:         Protocol #
WA17043/U2644g, 12/02/03:        Prot/amend       V#B 19/08/2003.Prot/amend
V#C.24/2/04

AKX/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: Prot. WA16855/U2653g V#B 21 Aug 2003.
Cons Frm (Female Partners) V#1 5/12/03 (WDHB CMDHB)

216561        Haemoptysis/convulsion
216704        Convulsion

Received.


                                                                              6
AKX/03/09/244
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. Extension 1 to Protocol # CFTY720A2218, 16/07/04

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. Extension 1 to Protocol # CFTY720A2218, 16/07/0

      PPHO2004US14590          Macular Oedema
      PHHO2004DE01296          Macular Oedema F/U
      PHHO2005GB13132          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: Protocol
AALL0031

      AE#1014472         Grade 4 ALT/SGPT
      AE#1228855         Grade 4 hyperglycaemia & Grade 3 Psychosis

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: Protocol RNA003142-301

      2005VX000363             Hypokalemia, bronchitis, anaemia
      2005VX000397             Acute pneumonia
      2004RN000056             Deep vein thrombosis
      2004RN000070             Pneumonia
      2005VX000468 (1) & (2)   Myocardial infarction
      2005VX000386             Hyponatremia.

Received.

AKX/04/02/036
VAN GOGH - extension trial. A multicentre, international, randomised, double-
blind, study comparing the efficacy and safety of once-weekly subcutaneous
SanOrg 34006 with placebo in the long-term prevention of symptomatic venous
thromboembolism in patients with symptomatic pulmonary embolism or deep
vein thrombosis who completed 6 months of treatment with vitamin K
antagonist or SanOrg 34006:

                                                                             7
AKY/03/08/203
A Multicentre international randomised, open-label, assessor blind, non-
inferiority study comparing the efficacy and safety of once weekly
subcutaneous SanOrg34006 with the combination of (LMW) Heparin and
vitamin K antagonist (VKA) in the treatment of acute symptomatic pulmonary
embolism (the Van Gogh-PE trial).


      D01200 500396       Post-op bleeding. – death – unlikely relationship with
       study drug.

Received.

AKY/04/04/085
A multicentre, randomised, double-blind, long-term extension study to
determine the safety, tolerability and preliminary efficacy of CCI-779 in
subjects with relapsing multiple sclerosis: Protocol 3066A2-210-WW

      HQWYE053923AUG05 Initial         Rhabdomyolysis

Received

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:

      Local SAE           Post transplant haemorrhage
      Local SAE           Acute renal failure
      Local SAE           Acute rejection (post liver transplant)
      Local SAE           Right sided chest pain not otherwise specified
      2005EU001364        Vascular liver rejection.

Received

AKY/04/09/247
Pilot clinical trial of the C-Pulse device as destination therapy inpatients with
moderate-severe heart failure: Clinical Investigation Plan PRO 01543 Rev. B

      ACH001              Peaceful death

Received


NTX/05/06/064
A randomised, double-blind, controlled evaluation of tenofovir DF versus
adefovir dipivoxil for the treatment of HbeAg positive chronic hepatitis B: Prot
GS-US-174-0103, 23/03/05:
and…..

                                                                               8
   NTX/05/06/065
   A randomised, double-blind, controlled evaluation of tenofovir DF versus
   adefovir dipivoxil for the treatment of presumed pre-core mutant chronic
   hepatitis B: Protocol GS-US-174-0102, 23/03/05

         2005-0008596          Severe Hepatic Flare.

   Received


NEW APPLICATIONS:

     1. NTX/05/10/126
     A randomised controlled trial to look at whether fallopian sperm perfusion
     gives better pregnancy and live birth rates than standard intrauterine
     insemination for patient having artificial insemination with or without
     gonadotrophin or clomiphene stimulation:

     Principal Researcher:      Dr Sonya Jessup, Fertility Plus
     Co-Researchers:            Prof. Cynthia Farquhar, Dr Guy Gudux

     Sonya Jessup attended.

     The Researcher is requested to please provide/amend

     General:
         Additional pages should not have been inserted into the application but be
           separate pages behind the form.

     Application Form:
          P.9 18-21: Insert more realistic dates.
          Locality Assessment from ADHB required.
          F3.2: ADHB MRRC consultation and letter of support.

     Information Sheet
          Insert as the last para, „This study has received ethical approval from the
           Northern X Ethics Committee‟.

     Consent Form
        Full interpreter box required.
        Version no. and date to be a footer.

     Committee Suggestions:
        Consider extending the time of the study and increasing the nos.
         (Declaration Form A would need to have the no. of participants increased, in
         that case).

       Information Sheet:
        Look at using a larger font.
        Insert researchers’ details under the title on the first page.
        Edit to remove the < sign before ‘ACC’
                                                                                     9
     Under P. 1 of IS, 6th para (Compensation) spelling mistake ‘you still might not
      get ant compensation.

Approved subject to the above conditions.

                                                                         P. Chainey



2. NTX/05/10/127
Screening study in Auckland general practice

Principal Researcher:      A/Prof Bruce Arroll, University of Auckland
Co-Researchers:            Dr Stephen Buetow, Dr Timothy Kenealy, Prof Alistair
                           Woodward, Ms Emily Thompson

The Researcher is requested to please provide/amend

Application Form:
     Locality Assessment Form required.
     Provide a draft outline of telephone questionnaire.

Information Sheet
     The Committee considers an Information Sheet is required. Researcher to
      consult the Guidelines NAFG on the newhealth website and provide the
      appropriate form.

Consent Form
   Not required as the completed questionnaire is sufficient.


Approval is deferred until the Chairperson has checked the Information Sheet.

                                                                              T. Dare.


3. NTX/05/10/128
Empowering primary health care nurses in the community management of
diabetes.

Principal Researcher:      Ms Barbara Daly, University of Auckland
Co-Researchers:            A/Prof Bruce Arroll, A/Prof Nicola North, Dr Tim Kenealy,
                           Dr Lorna Dyall, A/Prof. Robert Scragg.

Barbara Daly and Robert Scragg attended

The Researcher is requested to please provide/amend


Application Form:
     Locality Assessment from ADHB, C-M and Waitemata DHBs
     F, 3,2: Maori consultation and letters of support from the three DHBs

                                                                                   10
     Dec Form A (Location) is University of Auck only – should cover the three
      DHBs.
     Provide copy of final Questionnaire when finalised.

Information Sheet
     Replace the HAT statement with, „If you have any queries or concerns
      regarding your rights as a participant in this study, you may wish to contact
      your professional organisation.‟
     Correct the approval statement to „Northern X Ethics Committee‟.
     Insert version no. and date as a footer in both information sheet and consent
      form.

Questionnaire:
  The Committee considered the time stated to complete the questionnaire in
    the Information Sheet was too short. Researcher is requested to ask a nurse
    to trial.
  Clarify the rationale for statistical techniques including use of techniques to
    test psychometric properties of the questionnaire.

Committee Suggestions:
   This is a PhD and should have supervisor’s approval.

Approved subject to the above conditions.
                                                                           T. Dare



4. NTX/05/10/129
The EASAP study: Evalution of Asthma in a South Auckland Population.
Diagnosing asthma accurately and assessing severity in a South Auckland
population of asthmatics - do a range of investigations previously validated in
research environment have clinical relevance and lead in turn to better
management?

Principal Researcher:     A/Prof Jeff Garrett, Middlemore Hospital.
Co-Researchers:           Dr Wei Mei Chua, Dr Lata Jayaram.

Wei Mei Chua attended.

The Researcher is requested to please provide/amend

Application Form:
     Dec. Form B has been destroyed. Declaration Form A is applicable.
     F3.2: Counties-Manukau MRRC consultation and letter of support.
     C. Clinical Trial: Should be „yes‟.
     Submit revised statistical rationale.


Information Sheet
     Provide on letterhead.
     Edit to ensure lay language used, i.e. HRCT (chest cat scan) and Total IgE.

                                                                                11
     Insert a statement stating that all blood samples will be destroyed at the end
      of the study.
     Insert the compensation statement from the Guidelines EA 05/02 under
      Declaration A, P.21.
     Correct the approval statement to „Northern X Ethics Committee‟.

Consent Form
   Correct date of Info sheet as will be updated.

Committee Suggestions:
   Information Sheet/Consent Form: Insert ‘version’ in front of the n#2 in the
    footer.
   Edit Information Sheet for numerous spelling mistakes and grammatical
    errors.

Approved subject to the above conditions.
                                                                              T. Dare



5. NTX/05/10/130
Feasibility study of a novel strategy to increase physical activity in children
(10-14 years).

Principal Researcher:      Dr Cliona Ni Mhurchu
Co-Researchers:            Dr Ralph Maddison, Mr Andrew Jull,
                           Dr Anthony Rodgers

Ralph Maddison attended.

The Researcher is requested to please provide/amend

Application Form:
   P. 1: 1 and 2: As this study is a pilot study, the words „A pilot study‟ should
      be inserted in the title and lay title and also Information Sheet/Consent Form.
   B.13: Procedures for dealing with emergencies. Is there a need for access
      to medical care?
   Confirm using validated data collection tools.

Information Sheet (all)
     Interpreter box to be in Consent forms, not Information Sheets.
     Insert the statement, „If you have a medical condition which limits your ability
      to exercise safely, we would not wish you to apply for inclusion in this study.‟
     Parent‟s Information Sheet/Consent Form: request the educational level
      from the parents, not the children.
     Insert the compensation statement from the Guidelines NAFG under
      Declaration A, P.21.
     Ensure approval statement on both information sheets is „This study has
      received ethical approval from the Northern X Ethics Committee‟.

Consent Form (Parents)

                                                                                   12
         Insert, „I am comfortable with my child participating in this study……..YES/NO‟

Committee Suggestions:
   Pacific Is. Group consultation.
   Look at statistical design.

Approved subject to the above conditions.
                                                                                T. Dare



6.       NTX/05/10/131
An investigation into if art therapy can reduce the level of stress that kidney patients
experience while receiving haemodialysis treatment:

Principal Researcher:          Ms Margot Pakenham, (ADHB)
Supervisor:                    Ms Maureen Woodcock, Whitecliffe College of Arts &
                               Design.

Margot Pakenham attended.

The Researcher is requested to please provide/amend

Application Form:
     P. 1. 1 & 2: As the study is a pilot, the words „A pilot study‟ should be at the
       beginning of the project title and lay title.    Also should be used in the
       Information Sheet & Consent Form.
     P.10: D7: Data cannot be stored by researcher at home, should be stored
       by supervisor in locked cabinet at College and for 10 years.

Information Sheet
     To be on Whitecliffe College letterhead.
     To be headed up „Participant Information Sheet‟
     Researcher‟s contact details to be under the title on front page.
     P. 1: Interpreter not required.
     P. 2: 5th bullet point – delete as it is already mentioned in the 2nd para on P. 1
      under „Participation‟.
     Correct storage information.
     Insert, „Compensation: 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 :
      Website:www.acc.co.nz/claimscare/making-a-claim
     HAT statement to be Northland to Franklin only.
     Under „Statement of approval‟. Separate para should read „This study has
      received ethical approval from the Northern X Ethics Committee‟.
      (Whitecliffe College is not an accredited ethics committee.)
     Insert version no. and date as a footer in both information sheet and consent
      form.

Committee Suggestions:
   The Committee considers the researcher should try and publish the results.

                                                                                     13
      Give a copy of the results to each of the participants and a copy in the
       College Library.

Approved subject to the above conditions.
                                                                              T. Dare


7. NTX/05/10/132
The effect of Gentamicin on the expression of factor IX in a case of severe
haemophilia B due to a nonsense mutation.
Principal Researcher:   Dr Paul Harper, ADHB
Co-Researchers:         Dr Neil van de Water, Dr Paul Ockelford,
                        Prof Peter Browett.

The Researcher is requested to please provide/amend

Application Form:
     Dec Form A required.

Information Sheet
     The Committee had a concern about the inclusion in the benefit section of
      the possibility of newer drugs given the uncertainty of their actual production.
      Researcher to clarify.
     Insert the compensation statement from the Guidelines EA 05/02 under
      Declaration A, P.21.

Consent Form
   Interpreter box not required.

Approved subject to the above conditions.
                                                                             T. Dare.



8. NTX/05/10/133
Post-injury alcohol intervention research (PAIR):         acceptability survey and
chart review.

Principal Researcher:      Dr Shanthi Ameratunga, University of Auckland. (ADHB)
Co-Researchers:            Dr Jamie Hosking, Dr Anthony Rodgers, Dr Chris Bullen
Supervisor:                Dr Shanthi Ameratunga

Jamie Hosking attended.

The Researcher is requested to please provide/amend


General:
  The Committee considered that the Questionnaire and Information Sheet
    should be revised to make clear that there was no reason to believe that the
    study participant‟s injuries were alcohol related.


                                                                                   14
Application Form:
   P. 2: 8.2: Obtain supervisor‟s signature.
   ADHB MRRC letter of support.

Information Sheet
     Re-write this sheet to make the meaning clearer.
     State near the beginning that „We are surveying patients who report with an
      injury. There is no reason to believe alcohol is involved”.
     Title to be changed in both IS and Consent Form to lessen the emphasis on
      alcohol intake.
     The footer should read „Information Sheet‟ only then the Version # and date.

Consent Form
   The first para should have less emphasis on drinking.
   The footer should read „Consent Form‟ only then the Version # and date.

Questionnaire:
   Clarify the rationale for questionnaire design.
   Consent Form: Bullet point and separate into separate paras, all sentences
      beginning with „I‟.

   Committee Suggestions:
   Obtain statistical advice.
   Consider whether non-drinkers will be able to usefully answer the study
    questions.

Approved subject to the above conditions.
                                                                           T. Dare



9. NTX/05/10/134
Evaluation of the subcutaneous implantable defibrillator (S-ICD) system:
Protocol Rev. A, Clinical Summary Rev. A, IB Rev A.
Principal Researcher:     Dr Margaret Hood, ADHB
Co-Researchers:           Dr Warren Smith

Margaret Hood and Warren Smith attended.

The Researcher is requested to please provide/amend

General:
  Approach and Consent: There is a conflict of interest. As the researchers
    have a financial interest in the study, a third party should make the first
    approach to the patient regarding participation in the study – a clinical nurse
    specialist.

Application Form:
   P. 3: 17 (Summary).          Insert the first sentence of explanation into the
      Information Sheet, „The device uses electrodes under the skin of the chest
      wall…..with an electric shock‟.

                                                                                15
     B1 states 3 visits follow-up post implant but the Information Sheet states 1
      visit follow-up . Information Sheet should be changed to conform.

Information Sheet
     To be on letterhead.
     Include information regarding percentage of death rate.
     Insert a statement to indicate the researcher‟s grounds for confidence in the
      safety and efficacy of the device.
     Edit terminology. Change the words „stock holder‟ to „commercial interest‟.
     Follow-up visits – change to 3 (as above)
     Insert the full compensation statement for Declaration B from Guidelines
       NAFG (P. 25).
     HAT statement – change the Health Advocates Trust to „a Health Advocate‟.
     Correct approval statement to „Northern X Ethics Committee)

Consent Form
   To be on letterhead
   Insert lay title.
   Interpreter box required.
   Remove reference to „Subject‟ and replace with „Participant‟
   Please clarify which of the two consent forms – the one at the end of the
    information sheet or the separate consent form – is to be used.
   The one at the end of the IS seems very broad.)

Committee Suggestions:
   Use the lay title on both the Information Sheet and the Consent Form.
   Information Sheet: First para needs splitting for easier reading.
   Explain the symbol <.
   Bullet point the Consent Form for clarity.

Approved subject to the above conditions.
                                                                                  T. Dare.



10. NTX/05/10/135
A brief acceptance intervention for rheumatoid arthritis.

Principal Researcher:        Mr Paul Carver, UoA Student.
Co-Researchers:              Dr Roger Booth, Dr Fiona McQueen.
Supervisor:                  Dr Roger Booth.
Site:                        Greenlane Pain Clinic.

Paul Carver and Roger Booth attended.

The Researcher is requested to please provide/amend

Application Form:
      P. 1: 1: Insert „A pilot study‟ into the title of both Project Title and „Lay Title‟
      and include in Information Sheet and Consent Form:
      P. 1: 2: Expand the lay title – to be more descriptive.

                                                                                        16
     P. 3: More realistic start and finish dates required.
     F3.2: ADHB MRRC consultation and letter of support.
     P.13: F.3 should be „Yes‟

Information Sheet (Participant and GP/Specialist)
     Ensure they are called „Information Sheet‟.
     A more descriptive lay title required (on Participant Information Sheet).
     Researcher‟s contact details in three times. Reduce to one under the lay
      title and take out under „General information‟ and „Who should I contact.‟
     Under Risks & Benefits: Remove „If you have private medical insurance
      please check with your insurance company before agreeing to take part in
      the trial‟. The Committee could not see a relevance to the study.
     Insert version no. and date as a footer in both information sheet and consent
      form.

Consent Form
   To be called „Consent Form‟.
   Change title from „Acceptance Project‟ to more descriptive lay term (as above)
   Insert an interpreter box.

Committee Suggestions:
   Consent Form: Bullet point for clarity
   Clarify recruitment process and allocation of participants.
   Investigate validity of tools in NZ context.
   Initials in the Information Sheet should be in full, i.e. CYFS and TMP.
   Information Sheet: Edit for typos and repeated information, i.e. under
    ‘Participation’: the information is also contained in the 1 st para on P. 1 and
    4th para ‘and those either’. (needs to be checked by supervisor).

Approved subject to the above conditions.
                                                                        P. Chainey



11. NTX/05/10/137
The clinical utility of transcutaneous carbon dioxide monitoring in acute
respiratory conditions:

Principal Researcher:     Dr Pathmanathan Sivakumaran, Middlemore Hospital
Co-Researchers:           Dr Conroy Wong, Dr Andrew Veale,
                          Abhijith Vashishta Bhat.

Conroy Wong and Abhijith Bhat attended.

The Researcher is requested to please provide/amend

Application Form:
   C-M DHB Maori Research Review consultation and letter of support required.

Information Sheet
     To be on Middlemore Hospital letterhead.

                                                                                17
Consent Form
   To be on Middlemore Hospital letterhead.

Committee Suggestions:
   Application form: P.12: D7: Data only required to be kept for 10 years by
    supervisor in a locked situation.

Approved subject to the above conditions.
                                                                        P. Chainey.




12. NTX/05/10/138
Decision making by first time parents regarding childhood vaccination.

Principal Researcher:     Ms Elizabeth Dunn, Whangarei
Supervisor:               Dr Annette Dickinson, Auckland             University   of
                          Technology.

The Researcher is requested to please provide/amend

General:
  Approval is given for this study. The Committee does not believe there are
    sufficient ethical concerns to withhold approval. However it is concerned at
    the very small sample size.       The Committee requests the researcher to
    consider increasing the numbers where possible. The Committee is also
    concerned that there does not seem to be any means of ensuring that the
    sample is representative of the various ways people might reach decisions
    about vaccination. It is also suggested that the researcher consults New
    Zealand literature on vaccination decisions to identify relevance to this study.

Application Form:
      P. 1: Insert „A pilot study‟ into Project Title, Lay Title and headings on
      Information Sheet and Consent Form:
      A4.1: Where are participants being recruited from ? Any DHB involved ?.
      AUT should supply a front page to say the study has been approved by AUT.
      Completed and signed Locality Assessment required.
      Clarify how coverage will be achieved.

Information Sheet
     Under „Can I join the Study‟, Insert a statement that joining the study is
      voluntary.
     Are you planning to speak to both parents – check wording and consistency.
     State the time to be allowed for consideration of joining the study.

Consent Form
   To be called „Consent Form‟

Committee Suggestions:

                                                                                  18
      Edit Information Sheet for spelling and grammtical errors (i.e. comma at the
       end of the title in PIS/Consent).
      PIS and Consent: Version No./date is to be a footer.
      Ensure the words ‘Appendix 2 (or 3 and 4) are removed in the final print out.
      Typists Agreement: Correct the approval statement to ‘Northern X Ethics
       Committee’.
      Consent Form: Edit (as attached)

Approved subject to above conditions.
                                                                           T. Dare.

13. NTX/05/10/139
Free cortisol estimation in human plasma

Principal Researcher:      Mr Mpatisi Moyo, LabPlus, ADHB
Co-supervisors:            Dr James Davidson and Dr Roger Johnson, LabPlus.

The Researcher is requested to please provide/amend

General:
   There were ethical concerns regarding this study and the researcher is
     requested to consult the Guidelines NAFG V-1 on the www.newhealth
     website and resubmit the full application.         The researcher and the
     supervisor are requested to attend the next available meeting..
   The following amendments are required to be included in modified
     application, Information Sheet and Consent Form.
   Signed declarations do not need to be repeated.

Application Form:
     P. 2: 8.2: Supervisor‟s signature is required.
     P. 3: 18 to 21: More realistic start dates to be inserted.
     P. 9: B3, B6 and B8 to be completed.
     P. 10: Locality Organisation involved is only ADHB. Remove „Northern X
       Regional Ethics Committee C/o MOH‟ plus the address listed.
     P. 14: F3 to be „yes‟.
     P. 15: F4: Complete.
     Supply Locality Assessment for ADHB.
     P. 20: Declaration Form A required.

Information Sheet
     Researcher to consult Guidelines NAFG and reconstruct the Information
      Sheet and Consent Form according to the Guidelines.          Insert the
      appropriate statements for this study.
     To be on letterhead
     To be headed „Participant Information Sheet‟
     Researcher‟s name and contact details to be under the title.
     Begin with an invitation.
     State the purpose of the study on the first page.
     Explain how the participants are selected.
     How much time will be given to consider entering the study.
     Insert the HAT statement.

                                                                                 19
      Separate the paragraph regarding concerns about the conduct of the
       research.
      Insert as a separate final paragraph, „This study has ethical approval from
       the Northern X Ethics Committee‟
      Insert version no. and date as a footer in both information sheet and consent
       form.

Consent Form
   Researcher to go back to Guidelines NAFG and construct a Consent Form.
   To be on letterhead.
   Interpreter box required.

Committee Suggestions:
   Researcher’s contact details to be under the Lay Title.

                                           Deferred (T. Dare to contact Researcher)

14. NTX/05/10/140
Accommodation needs and preferences for consumers/tangata whai ora of
mental health services.

Principal Researcher:       A/Prof Mike O‟Brien, Massey University
Co-Researchers:             Chez Leggatt-Cook

Michael O‟Brien attended.

The Researcher is requested to please provide/amend

Application Form:
     Locality Assessment required.
     Pt. 4 requires appropriate signatures.
     Pt. 7: to be completed (for those that cannot consent (consult newhealth
       website: Guidelines NAFG-v1 – P. 23).
     Also provide statement by relative/friend/whanau (P.3 of Pt 7)
     P.10: C1: Should be „No‟ and a Declaration Form A completed.
     Supply a final copy of the interview schedule.

Information Sheets
     Insert as a separate para, “If you have any queries or concerns regarding
       your rights as a participant in this study, you may wish to contact a Health &
       Disability Advocate, telephone no. 0800 555 050 Northland to Franklin.”
       Except for….
     Mental Health Services Providers where the wording should be „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 compensation statement. For Dec. A (Guidelines NAFG P.21)
     Approval statement should read, „This study has received ethical approval
      from the Northern X Ethics Committee‟.
     Insert version no. and date as a footer in both information sheet and consent
      form.


                                                                                  20
       Committee Suggestions:
           Researchers’ contacts should be under the title.
          Advertisements: Replace ‘Attention’ with ‘For’
          Advertisements: For more impact Insert ‘this study has ethical approval from
            the Northern Regional Ethics Committee’
          Consent Forms: Take font size to either 11 or 12 for clarity.
          Look at the statistical design.

       Approved subject to the above conditions.
                                                                                      T. Dare.


AMENDMENTS:

   1.    97/123
   Anti-fracture efficacy of calcium supplementation in normal postmenopausal
   women

          Protocol Amendment 12/9/05 to contact study participants by mail to seek
           permission to access their hospital records and obtain information re the
           hospital admissions and investigate the statistically significant differences in the
           frequency of some vascular events between two groups.

   Approved.



   2     2000/030
   A multicentre, randomised parallel group, placebo-controlled, double-blind
   study with in-house blinding to determine the effect of 156 weeks of treatment
   with MK-0966 on the recurrence of neoplastic polyps of the large bowel in
   patients with a history of colorectal adenomas: Protocol 966-122-01, 24/11/99;
   Prot/Amend 122-02 22/5/2000; Prot/Amend 122-03, 17/01/2002: Prot/amend122-
   10, 11/06/2003: PIS/Cons Study ext. V#2, 19/09/03: Prot/amend # 122-04, 6/5/04,
   IB 28/04/04: PIS/Cons V#7, 04/08/04:

   Auckland and Christchurch sites.

           Protocol amendment # 122-11, V. 4, 9/8/05
           Protocol amendment # 122-20-, V.3, 9/8/05

   Completed – off-study-therapy extension continues as a form of safety follow up.

   Approved.




   3. 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

                                                                                            21
for glaucomatous progression: Protocol # 192944-005-00; IB Amend. #1 22/12/8:
Prot/amend 26/08/01: IS V#2, 10/01: IB Amend #2, 20/06/2002: Prot/Amend #2,
19/03/2002:

      Protocol amendment 192944-005-03.
      IB#3, 16/05/05 + Summary of changes
      Package insert for Namenda + summary of changes.

Approved.



4. 2001/199
Effect of two year's treatment with Norditropin SimpleXx on bone mineral
density in young adults with childhood-onset growth hormone deficiency:
Protocol GHLIQUID-1369, V#2, 12/03/2001: Prot Amend I, 22/05/01. Prot/Amend
II, 9/10/01: PIS/Cons V#2, 14/11/01: Prot/amend. III, 8/08/03: Prot/Amend IV,
7/01/04:

      IB V#3, 22/09/04 (first one received for this study).

Researcher to explain how this IB is relevant to the above study (study for growth
hormone deficiency. IB Indication – adult patients in chronic dialysis).




5.    AKX/02/00/373
COG AAML0122: Phase II window evaluation of the Farnesyl transferase
inhibitor (R115777) followed by 13-cis retinoic acid, cytosine arabinoside and
fludarabine plus hematopoietic stem cell transplantation in children with
juvenile myelomonocytic leukaemia: Protocol AAML0122, 28/05/2002: Amend
#3: Prot/amend V#4, Prot/amend V#5, 9/07/04: Prot/amend V#6, 8/07/05:
PIS/Cons V#7, 30/08/05.

    Protocol Amendment #6. 28 July 2005.
    Information Sheet/Consent Form V# 7. 30 August 2005.

Approved.


Committee Suggestions for Information Sheet for Parent/Caregiver
     P. 1: Under Why is this study being done? 4 th line down, consider deleting
        ‘Although’…
     P.11: Last para beginning ‘There should be no risks involved……your
        physician’. This para needs moving.
     P.12: Under ‘What other options are there? Instead of ‘If you decide not to
        have your child to participate….’ Insert ‘If you decide not to allow your
        child….’




                                                                               22
6.   AKX/04/10/295
Cerebral Hemorrhagae and NXY treatment: A double blind, randomised,
placebo-controlled, parallel group, multicentre phase 11b study to assess the
safety and tolerability of 72 hours intravenouos infusion of NXY-059 in adult
patients with acute intracerebral hemorrhage (ICH). Prot. SA-NXY-0012, Ed 1,
23/10/03, Prot Amend # 1, 16/12/03, Prot Change # 1, 23/06/2004: IB Ed. # 7,
17/02/04: PIS/Cons V#1.0, 20/12/04

     Investigator Brochure Ed. 8, 14/07/05.

Approved.



7.    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
response: Protocol # WA18230, RO 496-4913, 19/10/04: Prot/amend C 12/01/05:
Proced./Admin Manual V#2, 5/01/05: IB PRO70769 (rhuMAb 2H7), 5/1/05: IS/Cons
V#3, 12/04/05


   Protocol Amendment WA18230D, 13 June 2005 + Amendment History.
   Participant appointment card.
   Information Sheet/Consent Form, D G.P. Singh/Dr H. Hart, North Shore Hospital
    V#4, dated 30 August 2005.
   Information Sheet/Consent Form, Dr Peter Gow, Middlemore Hospital, V#4, dated
    30 August 2005.
   Pregnant Partners/Consent Form, Dr G.P. Singh/Dr H. Hart, North Shore Hospital
    V#2, dated 30 August 2005.
   Pregnant Partners/Consent Form, Dr Peter Gow, Middlemore Hospital, V#2, dated
    30 August 2005.
   Additional Research Sample/Consent Form, Dr G.P. Singh/Dr H. Hart, North
    Shore Hospital V#3, dated 30 August 2005.
   Additional Research Sample Pregnant Partners/Consent Form, Dr Peter Gow,
    Middlemore Hospital V#3, dated 30 August 2005.

Approved.


8.   NTX/05/06/064
A randomised, double-blind, controlled evaluation of tenofovir DF versus
adefovir dipivoxil for the treatment of presumed pre-core mutant chronic
hepatitis B: Protocol GS-US-174-0102, 23/03/05:

     IB for Hepsera, Adefovir Dipivoxil, Ed. 13, 10 May 05
     Core Safety Information V# 5.2, 14/06/05

Approved.


                                                                              23
9.   NTX/05/06/065
A randomised, double-blind, controlled evaluation of tenofovir DF versus
adefovir dipivoxil for the treatment of HbeAg positive chronic hepatitis B: Prot
GS-US-174-0103, 23/03/05:

    IB for Hepsera, Adefovir Dipivoxil, Ed. 13, 10 May 05
    Core Safety Information V# 5.2, 14/06/05

Approved.



10. NTX/05/07/078
Temporary pacing in patients using the EBR device system: IB P/N 00022 Rev 3,
Inf/Cons V#2, 15/07/05

    Protocol P/N 00010 Rev. 03,

Approved.


11. NTX/05/08/106
A multicentre, randomised, double blind study to evaluate the safety, efficacy
and tolerability of L-000 899055 monotherapy in obese patients: Protocol L-
000899055 015-00 R, V. 3.2, 3/6/05Prot/amend Appdx 7, 31/05/05: CIB, Ed, 4,
19/05/05: PIS/Cons V#2, 5/09/05

Letter 14/09/05
   Protocol 015-01, dated 16/08/05
   Protocol 015-02, dated 25/08/05
   Information Sheet/Consent Form – CVRU, Greenlane Clinical Centre, V#3,
       dated 14/09/05.
      Information Sheet/Consent Form – CCRep, Middlemore Hospital, V#3, dated
      14/09/05.
      Participant Reported Outcomes:
       Profile of Mood States (POMS)
       Digital Symbol Substitution Test (DSST)
       PHQ-9 Questionnaire

           Pedometer – provided at visit 2
           Instructions to operate pedometer
           Pedometer handbook – benefits of walking
           Fridge magnet
           Document binder
           Count down timer
           Sport radio (mini)
           Water bottle-waist pack
           Walker safety kit
           Diet key-chain calculator

                                                                            24
                Lunch bag
                Menu planning cards
                Milestone certificates.
                Cookbook
                Participant newsletters.

    Letter 19/09/05
        Information Sheet/Consent Form, Greenlane Clinical Centre, V#3, dated
            19/09/05
        Information Sheet/Consent Form, Middlemore Hospital, V#3, dated 19/09/05.

    Approved.

    Researcher to amend the IS/Cons forms as the version no. should be V#4, 19/09/05).

    Researcher to explain how she will distinguish between the effects of the study drug
    and the effects of the non-drug interventions, such as adherence to diet and retention.




REVIEWED/APPROVED UNDER CHAIRPERSON’S DISCRETION:

    AMENDMENTS:

    AKY/03/02/020
    A randomised, double-blind, multicentre study to evaluate the tolerability
    and effectiveness of etoricoxib in patients with rheumatoid arthritis:
    Protocol MK-0663, 8/11/02: Prot/amend 072-01, 16/7/03: PIS/Cons V#4,
    10/11/03: Prot/amend 072-02, 9/07/04: PIS/Cons V#5, 27/04/04: Addendum
    to Cons V#2, 15/11/04: Addendum to Cons V#3, 9/05/05: CIB V#11R,
    15.08.05

          CIB V#11, 15/08/05




    AKX/04/02/021
    Open randomised study to evaluate efficacy and safety of oral valganciclovir
    versus ganciclovir for the treatment of CMV disease in solid organ transplant
    recipients: Protocol MT17758 (VICTOR), V# 1.0, 20/11/03: IB V#5, Dec 2000:
    PIS/Cons V#2, 29/03/04: Prot/amend #01, 3/06/04: Prot/amend #.01, 3/06/04:
    PIS/Cons V#3, 12/08/04: IB V# 7, 01/4: Prot/amend V#1.0, 23/3/05.

          Addition of 4 more patients to the study (12 in total).



    AKX/04/02/021


                                                                                       25
    Open randomised study to evaluate efficacy and safety of oral valganciclovir
    versus ganciclovir for the treatment of CMV disease in solid organ transplant
    recipients: Protocol MT17758 (VICTOR), V# 1.0, 20/11/03: IB V#5, Dec 2000:
    PIS/Cons V#2, 29/03/04: Prot/amend #01, 3/06/04: Prot/amend #.01, 3/06/04:
    PIS/Cons V#3, 12/08/04: IB V# 7, 01/4: Prot/amend V#1.0, 23/3/05.

             Addition of 4 more patients to the study (12 in total).


RETROSPECTIVE REVIEW OF PATIENT/CLIENT NOTES OR DATA.

     Title:               An audit of 1270 brachial plexus blocks

     Researcher:    Michael Lorimer
     Co-researcher: Grant Ruan, Craig Birch.



     Title:               Review of surgical outcomes in scoliosis surgery on patients
                          with syringomyelia.

     Researcher:    Dr Lyndon J. Bradley
     Co-researcher: Mr M.J. Barnes, Mr H.A. Crawford, Dr E. Ratahi



     Title:               Patient undergoing appendectomy with worms

     Researcher:         Nainoor Thakore
     Supervisor:         Dr Vipul Upadhyay



     Title:              A comparison of transport times of patients with traumatic
                         brain injury between a Level 1 trauma centre and Auckland City
                         Hospital.

     Researcher:         Ian Civil, Director of Trauma Services, Auckland City Hospital



     Title:              A population-based study of major trauma in Auckland

     Researcher:     Ian Civil
     Co-researchers: Alex Ng, David Adams, Shas Cacala, Timothy Koelmeyer



     Title:              Contributions to rational drug use by community pharmacists’
                         prescription interventions.

     Researcher:         Dr Therése Kairuz

                                                                                          26
     Co-researcher: Ms Maree Jensen
                    Ka-Hwa Sur (pharmacy undergraduate)



     Title:           To create a database of changes in physiological variables
                      during anaesthesia.

     Researcher:     A/Prof. Michael J. Harrison.
     Co-researchers: Chang Joon Kim, Shalina Navaratnam.


PROGRESS REPORTS (Reviewed and reconfirmed by the Chairperson under CPD).

     97/123Anti-fracture efficacy     of    calcium    supplementation     in   normal
     postmenopausal women


     98/271
     Acute lymphoblastic Leukaemia study VII protocol. A Phase III group wide
     study: Protocol VII V# 18/6/98; Protocol Amend #1, 1/8/00: IS/Cons V#2, 3/7/01
     99/146

     Closed study but ethical approval required to continue to forward patient follow up
     information to Australia.


     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. Protocol RP56976-V-315 26/3/98; Protocol
      Admin. Change #1, 1/3/2000: Prot. Amend. #2, 1/12/2000: PIS/Cons: V#3,
      7/02/01: IB V#9, 12/06/01. Prot Amend #3, 15/05/02., Admin. Chg #2 08/08/03:
      Prot/amend #4, 18/11/04.


     98/047
     Australasian collaborative trial of repeat doses of steroids for the prevention of
     neonatal respiratory disease (ACTORDS:PIS/Cons V#2, 01/05/02: #


     2001/138
     Improving outcomes for suicidal adolescents: PIS/Cons V#2, 5/7/01


     2001/141
     The experience of and response to diagnosis in Alzheimer's disease: PIS/Cons
     V#2, 4/7/01




                                                                                     27
2001/161Prediction of neonatal white matter injury by EEG: PIS/Cons V#01, Oct
01; PIS/Cons V#3, 19/03/02


2001/185
A pilot study: Clinical priority assessment criteria (CPAC) evaluation project:
validity of the coronary artery bypass graft (CABG) surgery priority assessment
tool: IB 9th Ed, .


AKX/02/00/081
Surface electromyograph biofeedback for the treatment of swallowing
disorders: A pilot study: PIS/Cons V#4, 07/06/05


AKY/02/00/162
The prevalence and predictors of airways hyperresponsiveness in sarcoidosis:
PIS/Cons V#2, 05/07/05:


AKX/03/04/113
In the public arena what is shaping perceptions of intervention in childbirth?
PIS/Cons V#2, 20/05/03


AKX/03/07/180
The incidence of increased intra-ocular pressure with pupil dilation in eyes with
open anterior chamber angles:


AKX/03/09/233
The clinical pattern of hepatitis in HBeAg-negative chronic hepatitis B in
Tongans: PIS/Cons V#1, 26/06/2003.

AKX/02/00/003
Assessing and correlating aspects of human cataract by Scheimflug
photography, wavefront aberrometry, clinical assessment and laboratory
analyses: PIS/Cons V# 1.1 Apr 02: PIS/Cons V#1.2 Apr 03: Prot/amend 8/02/05:
PIS/C V#1.3, 01/05


AKY/02/00/127
Medical Research Council (UK) Working Party:         Primary thrombocythaemia
trial 1: PIS/Cons V#2, 15/08/02. PIS/ConsV#3, 8/04


AKY/02/00/230
A comparison of the effects of morphine and fentanyl in the treatment of
recovery room (PACU) pain following day case procedures and the effects of
this on time for discharge home

AKX/03/02/057
Densorimotor integration in diseases of the basal ganglia: PIS/Cons V#3, 8/4/03
                                                                              28
AKX/03/09/244
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. Extension 1 to Protocol # CFTY720A2218, 16/07/04 E1 IB Ed 7,
26/01/04: Prot/amend 1/Ex 1, 4/11/04: Prot/amend 2/Ex 1, 21/04/05: PIS/Cons
V#4, 1/0605

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: Protocol
AALL0031, Amend#1 19/06/03: IB Ed.5, 28/06/02.Prot/amend #2, 13/05/04:
Prot/amend #3, 16/07/04: Prot/amend #4, 02/11/04: Prot/Amend #5B, 23/05/05:
PIS/Cons V#4, 26/05/05: Prot/amend #5B, 23/05/05

+ Abstract.

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.

AKY/04/08/208
The experience of overweight people when participating in physical activity at
their local fitness centre in South Auckland PIS/Cons V#2, 2/09/04:

AKX/04/08/221
Development and testing of the SACS - the substances and choices scale.PIS
SACS/1a V#2, 10/9/04. PIS ACS/1b V#2,10/9/04. PIS SACS/1c V#2, 10/9/04. PIS
SACS/2a V#2, 10/9/04.PIS SACS/2b/V#2, 10/9/04. CF SACS/V#2, 10/9/04.
Questionnaire SACS/V#2, 10/9/04PIS/C Pt2a V#3, 8/05

AKX/04/08/225
A preliminary psychometric investigation of the homework rating scale:
PIS/Cons V#3, 22/1/04, Questionnaire B V#3.

AKX/04/08/228
Gestational diabetes: treatment with metformin compared with insulin - the
offspring follow-up study:

      PIS/Cons V#3, 5/08/05
      Background Information Questionnaire, 07/12/04
      Food & Activity Questionnaire, 03/03/05
      Child Body Composition Data Sheet, 07/08/05
      Adult Body Composition Data Sheet, 07/12/04
      Physical Examination Data Sheet, 07/12/04

                                                                            29
AKX/04/08/229
Psychological wellbeing and life satisfaction determinants in the elderly
through resistance training:

+ Abstract.

AKX/04/08/235
Pilot study of regional citrate anticoagulation for sustained low-efficiency daily
diafiltration: PIS V#2, 7/9/04. CF V#1, 7/9/04.




CLOSURE:

9.00 p.m.




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Description: AGENDA pneumonia