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					                                   MINUTES


                      NORTHERN X ETHICS COMMITTEE

                           TUESDAY, 14 JULY 2009


                                   2.00 P.M.

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




PRESENT:

     Trevor Sherwin      (Deputy Chair acting as Chair for this meeting)
     Natalie Gauld       (Acting Deputy Chair)
     Emma Ngawhare       Robyn Northey
     Joanna Stewart      Lynda Kaye
     Jocelyn Byrd


Expert advisors or expert advice provided by

     Tessa Turnbull      (Health Practitioner, Northern Y Ethics Committee)
     Sanya Ram           (Pharmacist/Pharmacologist, Northern Y Ethics Committee)


APOLOGIES:

     Vanya Kovach
     Wayne Miles
     Sonya Hunt
     David Sinclair


ADMINISTRATOR:

      Patricia Chainey


                                                                                    1
MINUTES OF NORTHERN X ETHICS COMMITTEE HELD 9 JUNE 2009

     Confirmed: R. Northey/J. Byrd



MATTERS ARISING:

         Deputy Chair absent:
          24 June -27 July




GENERAL BUSINESS:

         Committee Training, 26/27 June in Wellington
          The following members/administrator, travelled to Wellington to join other
          Committee members and administrators for a 2-day training session. The
          session was very informative:

              Natalie Gauld
              Emma Ngawhare
              Robyn Northey
              Joanna Stewart
              Sonya Hunt
              Linda Kaye
              Pat Chainey

          Apologies from Vanya Kovach owing to illness




    Correspondence:

          NTX/09/05/038
          A phase IIb, randomised, placebo-controlled, dose-ranging study of MK-
          5442 in the treatment of postmenopausal women with low-normal bone
          mineral density (BMD) or osteoporosis:
          Principal Investigator:    Prof Ian Reid

               Sponsor (Merck) advised researchers that NZ site will not be participating
                as the study team has determined that fewer countries and sites will be
                needed to enroll the study.

          Received and noted that NZ arm is withdrawn




                                                                                             2
   Conflict of Interest:

   NTX/09/07/062 and NTX/09/07/063
   Natalie Gauld declared a potential conflict of interest as she works for the principal
   investigator of the above studies but at a different location. Ms Gauld is not involved
   in these studies.



   APPROVALS and OBSERVATIONAL STUDY APPROVALS:

   Schedule attached for Committee members




SERIOUS ADVERSE EVENTS

   Schedule attached for Committee members




NEW APPLICATIONS:

     1.     NTX/9/07/055
     Real-time continuous glucose monitoring in children at insulin pump
     initiation
     Principal investigator: Dr Craig Jefferies, ADHB
     Co-Investigators:       Mrs J. Holt, A/P P. Hofman, Ms C. Adamson, Mrs G.
                             Harris, Dr F. Mouat, Prof W. Cutfield

     Craig Jefferies attended

     Approved subject to conditions below.

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

     The Researcher is requested to please provide/amend:

     General:
       Clarify whether patients have given consent to their data being stored on the
         Starbase diabetes database. If so, clarify whether this includes consent for
         the data to be used for research purposes.
       Identify just what information will be extracted from this database.
       What level of identification will it have?
       Will any information on the retrospective group be obtained from anywhere
         other than this database?



                                                                                         3
Application
  P.1: Lay Title – Edit to be more explanatory in lay terms
  P.1/2: Include Dr Peter Reed’s name and contact details as he is considered
     to be a co-investigator
  18: Insert more feasible start date
  ADHB MRRC consultation and letter of support required
  Section F: MRRC consultation to be reflected in this section
  Section F: consultation incomplete

Information Sheet
     Title to be ‘Participant Information Sheet’ – delete the word ‘guide’
     Reformat for clarity:
     Clarify why research is being done.
     Explain that participants will not be identified in any way.
     Include potential risks
     Note why real time glucose monitors are used
     Explain if participants will get real time glucose monitors if not in study
     Review P.2: to reflect parental role
     Insert compensation statement for Dec A. G/L NAFG-2009 P.28
     Under ‘who should I contact……J. Holt’s ph. Contact should be there as well
     Separate Mata Forbes’ contact details into a separate para as not relevant to
      Health Advocate’s details.
     Last page: Correct ethical approval statement….’Northern X Regional Ethics
      Committee’

Child Information Sheet and Young adult Information Sheet
    Need to be titled as such
    Ensure correct ethical approval is inserted
    Remove Advocates ‘Trust’ statement as incorrect and replace with the
       correct one from the main information sheet. There is no Trust

Consent Form
   Auditor statement: Name of Committee needs to begin with capitals.
   Parents Consent Form: 4th to last para: there is no sponsor, remove the
     word ‘sponsor’
   Consent Form and Assent Form: Last page – states ‘if you have any
     concerns about the study’. To be removed as advocacy statement in PIS is
     relevant. Should be headed ‘Study contacts’.

                                                                Chair/Deputy Chair




2.    NTX/9/07/056
Metabolic risk reduction following bariatric surgery
Principal investigator:    Dr Shelley Yip, Auckland DHB
Co-Investigators:          Mr Grant Beban, Prof. Tim Cundy,
                           Richard Babor, Dr Brandon Orr-Walker
                           Dr Gilliam Whalley
Supervisor:                Dr Rinki Murphy

                                                                                 4
Sites:                      Auckland DHB, Counties Manukau DHB

Shelley Yip attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   P. 1/2: Correct postal addresses required with departments included
   A3.1: Explain why it is acceptable for the health care provider to not act if
      unacceptable glucose levels are found
   A4.2: Clarify whether there is any information about the sd of the change.
      As suggested, from the sd’s quoted, it appears as if it is not normally
      distributed with a correlation of mean and variance, so it is difficult to
      calculate sample size from this summary data. Using the quoted sd’s the sd
      of the difference would be considerably larger than that used. Can some
      real data be used to get estimate of sd of change of transformed data to
      ensure the study is adequately powered?
   A5.2: The Committee considers that there is no point in statistically testing
      baseline characteristics of the 3 groups. The data is collected at several
      time points so analyses need to incorporate the within person correlation
      among time points.       Analyses should firstly investigate the group time
      interactions. Further statistical consultation is required.
   A6.1, F3 and Information Sheet: Clarify how this study can inform on who
      will gain from the surgery. The study is not powered to look at factors
      affecting a change.
   D7: Data to be kept in a locked cabinet by supervisor for 10 years
   E8: Explain what is happening to the blood. Is it being stored for future
      use? If so, what for and how long? This needs to be made clear and
      consistent between application form, part 5, information sheet and consent
      form.
   F5.3:       This study is of major importance to Pacific peoples and the
      Committee recommends that consultation is carried out with them.
   Locality Assessments form pending from ADHB and CMDHB
   Letter of support from CMDHB MRRC
   NRL letter

Information Sheet
     PIS required on Middlemore Hospital letterhead and details inserted
      accordingly.
     Edit: Either the information needs to be appropriately worded for all groups,
      or there needs to be a separate information sheet for those having
      cholecystectomy
     More information is required on what the researchers are actually going to
      do.
     PIS & P.5: Standardise information on blood – needs to be consistent.


                                                                                 5
      Clarify the wording of part 1 ‘to restrict to the outcome the study is powered
       to achieve’ ‘
      If information is being collected from participant’s clinical notes, this needs to
       be explained in the information sheet.
      Correct ethical approval statement….Northern X Regional Ethics Committee.

Consent Form
   First para: insert the date of the PIS (when updated)
   Ensure the Consent Form is appropriate for the different operations.
   Insert ‘I consent to information being gathered from my medical
     notes……YES/NO
   Insert ‘I consent for data to be stored for future related studies’
   Insert ‘I consent to blood and urine samples being destroyed at the end of
     the study……YES/NO

Questionnaire:
   Remove questions that are not related to the study as this is an added
      burden

                                                                    Chair/Deputy Chair




3.     NTX/9/07/057
Priming to enhance rehabilitation after stroke
Principal investigator: Dr Cathy Stinear, UoA
Co-Investigators:       A/P Winston Byblow, Prof. Alan Barber, Dr Ines Eisner-
                        Janowicz
Sites:                  University of Auckland, Auckland City Hospital, Rehab +

Cathy Stinear, Alan Barber and Ines Eisner-Janowicz attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:


Application
   ADHB MRRC consultation/letter of support
   A3.1: Give assurance that all participants would be expected to be four
      weeks as inpatients.
   B8: Insert Parkinsons as an exclusion.
   C1: Should be ‘yes’. Rest of the form, Part A and PIS is correct

Information Sheet
     Edit: Giving blood is optional.


                                                                                       6
      Wording needs to be appropriate for both arms of the study, if sent home
       early.
      P.3: Blood Test: Clarify whether the storage of blood for future gene testing
       id a requirement to be in the study? If not, this should be worded as a
       request on the Consent Form – if participant is prepared to let this be done.
       Failure to give permission for this does not exclude participant from the
       study.
      Correct the source of funding as it is not that stated in the application form.
      P.2: Edit bullet point 6: ‘your therapist’ not ‘their’
      P.4: under ‘Blood Test’ Storing tissue therefore insert ‘Auckland District
       Health Board (ADHB) Maori Ethics Review do not support tissue banking in
       any form, given collective whanau, hapu, iwi whakapapa implications.
       However they have noted individuals have the right to make their own
       decisions.’ .
      Remove the word ‘experimenter’
      Correct ethical approval statement to Northern X Regional Ethics Committee
       (Not Committee Y)

Consent Form
   Insert correct updated PIS footer date in first para.
   Correct PIS footer date when updated.
   Insert ‘I understand that the information obtained from my medical files will
     be to assess eligibility’
   12. add….’for a future related study’.

                                                                  Chair/Deputy Chair


4.    NTX/9/07/058:     IN COMMITTEE
Evaluation of the physiological and cognitive effect of repeated low level
blast exposure during specialised military training using neurocognitive
assessment, serum biomarkers and brain imaging
Principal investigator:     Dr Charmaine M. Tate
Co-Investigators:           Seven Overseas co-investigators

Dr Tate was unable to attend as she was in the USA

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   Provide all questionnaires that are to be used for this study, for Committee
      review (marked ‘yes’ on check list but not supplied).
   Justify the need for 22-25 blood samples per participant.
   Will a letter be supplied from the U.S. confirming destruction of blood
      samples.


                                                                                    7
           Using individuals as their own control – will other things happen during the
            time of exposure that could affect the results?
           B14: Is there anything in mental health findings that should be included.
            What will happen if it is found that damage is occurring? What will be done?
            How does the Committee know information will be provided to the co-
            operative group?
           What happens to the careers of any participant for whom baseline
            abnormalities are found, or who have abnormalities during the research?

                                                                       Chair/Deputy Chair



     5.    NTX/9/07/059
     Do implantable cardioverter defibrillator (ICD) patients' beliefs about their
     illness influence the development of anxiety and avoidance behaviours?
     Principal investigator:     Dr Elizabeth Broadbent, UoA
     Co-Investigators:           Mr Brynley Swinson, UoA, Dr Liz Painter, ADHB

     Elizabeth Broadbent, Liz Painter and Brynley Swinson attended

     Approved subject to conditions below.

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

     The Researcher is requested to please provide/amend:

     Application
        ADHB MRRC letter of support pending
        P. 1: Lay title: Expand in lay terms. also lay summary (suggest using
           wording from PIS)
        B8: Add ‘English speaking only’ to inclusion criteria
        D4: Approach: Remove Liz Painter’s name. Approach to be by nurses only

     Information Sheet
          P.2: Under ‘Confidentiality’, edit ‘medication information to ‘medical notes’

     Committee Suggestions:
        Edit: Spacing required.

                                                                       Chair/Deputy Chair

6.   NTX/9/07/060
     The EPPI Trial:         Enoxaparin for the prevention of pre-eclampsia and
     Intrauterine growth restriction - a pilot randomised placebo-controlled trial:
     Protocol 1/6/09
     Principal investigator:      Dr Katie Groom UoA/ADHB
     Co-Investigators:            Dr Claire McLintock, A/p Lesley McCowan, P)rof.
                                  Peter Stone

     Katie Groom attended

                                                                                           8
Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   ADHB Locality Assessment
   ADHB MRRC letter of support
   A5.3 & B14: Consult a statistician as statistical advice is required
   B13: States there is a DSMB: Give information on who will make up the
      DSMB.
   Pt 5/Consent Form: Clarify genetic testing as 1.11 says no genetic analysis.
      Consent Form says different. 3. states ‘no’ to tissue storage for future use:
      Consent Form says different.
   Clarify the genetic testing to be used

Information Sheet
       This study is titled a pilot. The information sheet needs to reflect this. It
          is designed to gather information to allow the planning of a larger study to
          answer the research questions, not to answer them itself.
       Make it clear that half the women taking part will receive the placebo
          treatment and that this treatment will do no good.
       P. 2’ Heading ‘Are there any reasons why women (should be ‘some’
          women should not take part…….)
       P.2: 6: Remove the wording ‘Insert for Form A and B trials’.
       Heading ‘What will happen to the blood tests once the study is
          completed?’ Complete as there is no information here.
       Under pharmaceutical comments: Explain ‘platelets.
       Insert more information re standard care/study care (which is different to
          standard care).
       Give more information on risks, %. Researchers cannot say there are
          ‘no risks’ – edit to ‘low risk’.
       P. 5: Replace ‘What happens if something goes wrong?’ with heading
          ‘Compensation’ and insert the statement for Dec A (Guidelines NAFG-
          2009 P. 28).
       Ethical approval statement to read ‘Northern X Regional Ethics
          Committee’ and to be the last stand-alone para.

Consent Form
   Remove the words under 6. ‘Insert for Form A and B trials’
   Add to ‘I consent to the researchers storing a specimen of my blood for its
     later use as a part of this study or other research’ the words ‘relating to
     pregnancy difficulties’ (or similar)
   Remove the word ‘sponsor’ in the 3rd to last para on P. 2.

                                                                  Chair/Deputy Chair



                                                                                    9
7.    NTX/9/07/061
Burns and silver in children: a randomised controlled study of silver-based
burns dressing in a paediatric emergency department
Principal investigator:    Dr Matthew Brown, ADHB
Co-Investigators:          Dr Michael Shepherd, Ms Eleanor Herd, Ms Kathryn
                           Johnson, Dr Richard Wong, Dr Stuart Dalziel

Matthew Brown and Michael Shepherd attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   Researchers to confirm that this study is being done as part of professional
      training, not a formal qualification which would require participants to be
      informed of this in the PIS.
   P. 3: Supervisor’s signature required
   A4.2: Explain where the expected standard deviation came from
   B17: Clarify topical application – should a medicines form be completed?
   P.17, D6 & 7: Data to be kept in a locked filing cabinet by supervisor until
      age of majority (16) plus 10 years (children).
   ADHB MRRC letter of approval pending

Information Sheet
     To be headed ‘Participant Information Sheet’ only
     Provide an information sheet and consent form for older children able to
      consent for themselves.
     First para to begin with an invitation
     State that researchers will be extracting information from the child’s medical
      records.
     Describe where and how long information will be stored for.
     Child’s version needs to invite them to take part
     Insert compensation para (G/Lines 2009 P.28 for Dec A)
     Correct ethical approval statement to ‘Northern X Regional Ethics
      Committee)

Consent Form
   To be headed ‘Consent Form’
   The Parent Consent Form should be worded such that the parent is
     consenting for the child to take part, not themselves, and to state that child’s
     assent will also be required.
   Provide an Assent form for the younger children who are unable to consent
     themselves.
   Provide a Consent Form for children capable of consenting for themselves
     and an assent form for their parents.

                                                                                  10
        Heading ‘request for interpreter’ needs to be a smaller side heading
        Date of PIS in first para needs to be the same as the updated information
         sheet.

                                                                    Chair/Dept Chair




8.       NTX/9/07/062
A multicentre, prospective, observational, non-interventional cohort study
evaluating on-treatment predictors of response in subjects with HBeAg positive or
HBeAg negative chronic Hepatitis B receiving therapy with PEGASYS®
(peginterferon alfa-2a 40KD): Protocol MV22009, V.A, 18/12/08: IBV#11, 7/08
Principal investigator:       A/Prof Ed Gane, NZ Liver Transplant Unit, ADHB
Co-Investigators:             Dr Frank Weilert (Waikato Hospital), Dr Chris Moyes
                              (The Hepatitis Foundation, Whakatane
                              ADHB: Dr Rachael Harry, Dr David Orr, Dr Tien Huey
                              Lin, Dr Ashok Raj
Sites:                        ADHB, Waikato DHB, The Hepatitis Foundation

Ed Gane and Faye Manu attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   Overseas designed study
   ADHB and Hepatitis Foundation Locality Assessments (pending)
   A7: Ensure there is no restriction on publication of final results.
   B14: Study should not stop trial if AE’s found although may change use of
      drug.
   Pt 4 for Hepatitis Foundation (pending)
   Part 5 (blood and serum) required as taking blood and information to be put
      into Information Sheet and Consent Form.
   Clarify the difference between standard care and study care
   Signed indemnities for ADHB, WDHB & Hep Foundation (pending)
   MRRC letters of support for ADHB, WDHB & Hep Foundation (pending)
   Dec B for Waikato and Hepatitis Foundation sites

Information Sheets
     Recommend Investigator’s contact details be put under name
     Include information on blood tests
     Outline what extra tests will be performed as part of the study (outside of
      standard care).
     Pt. 12: Clarify ‘Your data will be collected anonymously’.
     Include     information     of    Pegasys     risks/benefits    (common     side
      effects/interactions etc) including precautions relating to risk of pregnancy.
                                                                                   11
      Insert a more descriptive lay title instead of just ‘S-COLLATE’

Consent Form
   Last page – Replace ‘Health Advocates Trust’ with Health & Disability
     Advocate’




9.     NTX/9/07/063
MV22430 (Son of Neptune): A follow-up study to evaluate the long-term post
treatment effects of peginterferon alfa-2a (PEG-IFN)in patients with HBeAg
positive chronic hepatitis B from the original study WV19432 (Neptune):
Protocol MV22430 V#1, 19/12/08: IB V#11, 7/08
Principal investigator:   A/Prof Ed Gane, NZ Liver Transplant Unit, ADHB
Co-Investigators:         Dr Frank Weilert (Waikato Hospital),
                          ADHB: Dr Rachael Harry, Dr David Orr, Dr Tien Huey
                          Lin, Dr Ashok Raj
Sites:                    ADHB and Waikato DHB,

Ed Gane and Faye Manu attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   Follow-up study from NTX/07/02/010
   ADHB & Waikato MRRC letters (pending)
   Signed indemnities required (ADHB & Waikato)
   Provide insurance certificate for this study
   P. 5: Clarify safety
   B14: Clarify terminating the study regarding SAEs
   P.3

Information Sheets
     Provide Investigator’s contact details under P.I.’s name

Consent Form
   Last page – Replace ‘Health Advocates Trust’ with Health & Disability
     Advocate’ but information only required on information sheets.


Committee Suggestions:
   PIS: A more descriptive lay title is recommended.
                                                                  Chair/Deputy Chair




                                                                                 12
10. NTX/9/07/064
Relating food preferences to sensory odour ability
Principal investigator:    Dr Sara Jaeger, NZ Institute for Plant & Food
                           Research Ltd
Co-Investigators:          Dr Richard Newcomb, Dr Joanna Gamble, Dr Kelly
                           Atkinson

Kelly Atkinson attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   Follow-on study to NTX/09/04/035 and NTX/08/11/111
   Section F: Consultation with Maori required.   What impact is there on
      Maori?

Information Sheet
     P.2: ‘What are the Benefits…’:     Inappropriate sentence and needs to be
      replaced.
     P.3: ‘What are the costs involved….’: Amount needs to be removed and
      replaced with ‘You will be compensated for your time.

Consent Form
   Date in first line must match footer in PIS/Cons

Committee Suggestions:
   PIS: Review for more appropriate and simpler lay language.

                                                            Chair/Deputy Chair



11. NTX/09/07/065
The ISAR-SAFE Trial: prospective, randomised, double-blind, placebo-
controlled trial of six months versus twelve months clopidogrel therapy after
implantation of a drug-eluting stent: Protocol V#8, 4/09
Principal investigator:     Dr Mark Webster, ADHB
Co-Investigators:           Dr John Ormiston, Dr Peter Ruygrok, Dr Jim Stewart,
                            Dr William Harrison

Mark Webster and Jan Burd attended

Approved subject to conditions below.

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

                                                                            13
The Researcher is requested to please provide/amend:

Application
   International study
   ADHB MRRC letter of support (pending)
   ADHB Locality Assessment (pending)
   P.1: Expand lay title to be more explanatory
   B8: Clarify the inclusion criteria further
   B13: A competent DSMB is required. Researchers to supply information on
      experience of people on DSMB. Will standard methods for sequentially
      monitoring adverse events of studies be used?
   A5.2: Invalid to statistically test baseline measures. Will a statistician be
      involved with the analysis of this study?

Information Sheet
     Insert that blood will be taken and what happens to it.
     Include commonly interacting medications with clopidogrel, e.g. NSAIDS etc
     Explain more fully the verbal consent process
     Expand the side effects

Consent Form
   Insert ‘I consent to my excess blood sample being destroyed after analysis’

                                                                 Chair/Dep Chair




12. NTX/09/07/066
Enzogenol supplementation for improving cognitive function in post-TBI
subjects: a pilot study: Protocol V#3, 23/06/09
Principal investigator:     Prof Valery Feigin, AUT
Co-Investigators:           Dr Suzanne Barker-Collo, Ms Alice Theadom, Prof
                            Kathryn McPherson, Prof Elaine Rush

Valery Feigin and Alice Theadom attended

Approved subject to conditions below.

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

The Researcher is requested to please provide/amend:

Application
   Provide Locality Assessment Form through Concussion Clinic of the Cavit
      Group, Remuera
   A5.2: This section needs to reflect the aims of a pilot study. As this is an
      unpowered pilot study, hypothesis testing should not be conducted.


                                                                              14
      B14: Clarify any serious unexpected adverse events or will these be
       assessed?
      B18: First approach needs to be by clinical nurse not physicians

Information Sheet
     Supply the cost of the supplement should participants want to continue with
      it after the study ends, or say that participants can be supplied with the cost.
     P.2: ‘Randomisation’: Taking supplement 15 minutes to one hour before
      breakfast may have an effect on absorption. Researchers may want to
      tighten this.
     ‘Randomisation’ Clarify the study groups – make it plainer that everyone will
      receive the active treatment for part of the time and a placebo for the
      remainder of the time: but that these times will be different in the two study
      groups.
     Insert information on withdrawal.
     Insert information regarding any interactions that may occur with this
      supplement.
     Under ‘Purpose of research’ make it clear that this is a pilot to gather
      information to design a study to see if there are improvements, rather than
      that this study is doing this.
     Compensation: Remove present statement and replace with the statement
      from Guidelines 2009 P. 28/29 for Dec B
     Edit the ethical approval statement to……Northern X Regional Ethics
      Committee’

Consent Form
   Invitation needs only to be in the PIS.
   First para to be ‘I have read and I understand the Information Sheet
     dated…….
   Correct wording of third dot point to different times on active and placebo as
     everyone receives both.
   Remove dot point compelling participants to continue follow-up.

Committee Suggestions:
   Place a poster in the clinic
   PIS: A diagram could be of benefit.

                                                                  Chair/Deputy Chair




13. NTX/09/07/067
Feasibility of implementing a sleep education programme amongst New
Zealand youth
Principal investigator:   Dr Ralph Maddison (supervisor), School of Population
                          Health
Co-Investigators:         Ms Michelle Hull, Mr Geoff Kira, Mr Yannan Jiang

Michelle Hull and Geoff Kira attended via teleconference


                                                                                   15
    Approved subject to conditions below.

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

    The Researcher is requested to please provide/amend:

    Application
       Masters study
       Letter of support from UoA Maori Advisory Committee
       Provide Locality Assessment through University – head of dept

    Letter of invitation to School principals:
        Provide copies of signed letters of consent from each school.

    Information Sheets
         P. 2: ‘Who can be in the study?’ Remove that parents or guardians need to
          be under 80.
         As no Declaration A completed, Compensation statement is not required just
          the first sentence re contacting ACC is necessary.
         Footer with version # and date need to be the same in PIS/Consent and
          Assent.
         Explain that those that only some of those who consent will be asked to take
          part in the study.
         Describe how the 20 participants will be chosen from those that consent.

    Consent Form
       Date in first para required to be the date of the updated information sheet
       PIS P. 2 states ‘need to be able to understand and speak English’ therefore
         remove interpreter box.
       Insert a statement that the participants understand that they may not be
         asked to participate in the study.
       Describe how the 20 participants will be chosen from those that consent.

    Questionnaires:
       Language needs to be edited to ensure terminology is understandable by NZ
          children, i.e. ‘sinch’

                                                                   Chair/Deputy Chair



EXPEDITED APPLICATION REVIEWED BY FULL COMMITTEE:

    NTX/09/90/EXP
    The Centre for Brain Research Volunteer Register
    Principal Investigator:   Dr Richard Faull

    Approved subject to conditions

    Application:

                                                                                   16
          On line questionnaire to set up registry

    Information Sheet:
         Researchers will need to address the demographics by way in which the
          registry was set up.
         and be aware that the demographic of volunteers via the internet may not be
          a representative sample.
         State that any research studies relating to this registry will require ethical
          approval.


    Consent Form:
       Not required as on line questionnaire completion is sufficient

    Questionnaire:
       Include ‘ethnicity’
                                                                          Deputy Chair




AMENDMENTS:

    1.     NTX/08/07/062
    An investigation of the relationship between emotional awareness and eating
    disorder illness severity over 18 weeks of treatment: PIS/Cons V#3, 23/11/08
    Principal Investigator:
    Principal Investigator:    Dr Roger Mysliwiec
    Co-Investigator:          Ms Kara Woodward
    Co-investigator Sydney: Natalie Mirabito

       Protocol Amendment dated 19 June 2009 (letter) which included:.
        Removal of Kara Woodward as co-investigator.
        Addition of Chie Yumoto and Christine Murphy (clinical psychologists at
          Greenlane Clinical Centre) as co-investigators
        Extension of completion date to 31/8/2010 (however subject to annual
          reports).
        Two letters for participants, one after completing 1st batch of questionnaires;
          and the 2nd to be sent with the week 18 questionnaire batch V#1 dated 19
          June 2009.
        Application of exclusion criteria for those with psychosis, mania, serious
          medical or neurological illness, or alcohol/substance abuse
        Demographic and illness duration information V#3 dated 19 June 2009
        Treatment history V#1 dated 19 June 2009 Treatment over 18 weeks V#1
          dated 19 June 2009
        Participant Information Sheet/Consent Form V#4 dated 19 June 2009-07-01

       Approved

       The Committee has the following queries:


                                                                                     17
         1.     Explain why Wesley Private Hospital in Australia withdrew
         2.     Letter states pursuing three other possible sites. Committee request the
                names of these sites when they consent.




    2.     NTX/07/06/064 IN COMMITTEE
    A Phase I/IIa, open-label investigation of the safety and effectiveness of
    DIABCELL (R) {immunoprotected (alginate-encapsulated) porcine islets for
    xenotransplantation} in patients with type 1 diabetes mellitus: Protocol #
    LCT/DIA-06, 8/06 Prot/amend 1. 20/11/08: Prot/amend 2, 21/01/09, Principal
    Investigator:           Dr John Baker, CMDHB
    Co-Investigators:       Prof Robert B. Elliott, Dr Paul Tan, Dr Olga
                            Garkavenko, Dr Michelle Tatnell, Dr Alexander
                            Ferguson

             Amendments

         Approved



    3.        NTX/09/02/009
    International study to predict optimised treatment in depression: Protocol 12/6/08:
    PIS/Cons V#2, 23/03/09
    Principal Investigator:    Dr Bruce Russell
    Co-Investigators:          Prof Rob Kydd, Prof Jim Wright, Ms Louise Curley, Ms Dr
                               Mirjana Stojkovic, Ms Hee Sueng Lee
    Sites:                     ADHB and WDHB


             Protocol iSPOT-D Amendment 2 dated 19 January 2009 incorporating
              Amendments 1 and 2 + Summary of Changes (letter 17/6/09)
             Protocol Amendment 2 dated 19 January 2009
             Protocol incorporating Amendment 1 and Amendment 2 dated 19 January 2009
             Participant Information Summary Sheet – Controls, dated 14 June 2009
             Participant Information Sheet/Consent Form– Controls V#3 dated 14 June 2009
             Participant Information Summary Sheet – Subjects , dated 14 June 2009
             Participant Information Sheet/Consent Form – Subjects V#3 dated 14 June 2009
             Brain Resource Web Questionnaire Week dated 27 January 2009
             Addition of Dr Mirjana Stojkovic as co-investigator; deletion of Michelle Gordon as
              co-investigator

         Received: Participating sites, locations and contact details

         Not received: advertisement.

         Approved

AMENDMENTS    REVIEWED   UNDER   CHAIRPERSON’S                            AND/OR        DEPUTY
CHAIRPERSON’S DELEGATED AUTHORITY:



                                                                                               18
1.     AKY/04/12/342
Assessment of everolimus in addition to calcineurin inhibitors reduction in
maintenance       renal transplant     recipients    (ASCERTAIN):       Protocol
RAD001A)Kidney # CRAD001A2413, 8/09/04:              Prot/amend #1, 2/11/04:
Prot/amend 2, 1/02/05 Prot/amend 3, 31/3/06: PIS/Cons V#9, 10/08/06: plus
substudy Protocol CRAD001A2401, 28/04/06, Prot/amend V#4, 15/02/07: IB Ed
9, 27/08/07: PIS/Cons V#3, 27/05/09
Principal Investigator:  Dr Helen Pilmore
Co-investigators:        Dr Ian Dittmer, A/Prof John Collins, Dr Laurie Williams,
                         Dr Michael Collins

     Substudy extension for at least 72 months.
     Participant Information Sheet/Consent Form V#3 dated 12 June 2009



1.     AKY/04/12/338
Early prediction of brain damage after heart surgery in infants: Substudy:
Cardiac scan trial: PIS/Cons V#8, 9/06/09
Principal Investigator:   Dr John Becca

     To increase the size of the study to 90 infants, mainly to obtain a complete
      set of data for both the cardiac imaging and neurological components of the
      trial on at least 50 infants.
     Participant Information Sheet/Consent Form V#8 dated 9 June 2009



2.     NTX/05/11/142
A 24-month, multicentre, randomised, open-label, non-inferiority study of
efficacy and safety comparing concentration-controlled Certican(r) in two
doses (1.5 and 3.0 mg/day starting dose) with reduced Neoral versus 1.44 g
Myfortic(r) with standard dose Neoral in de novo renal transplant recipients:
Protocol # CRAD001A2309, 17/06/05, Prot/amend #1 22/11/05 & #2 30/12/05:
IProt/amend #3, 2/01/01/08: IB Ed.10, 27/08/08
Compassionate Substudy: Prot/Amends 1&2, 28/04/06: PIS/Cons V#3,
12/06/09
Principal Investigator:      Dr Helen Pilmore
Co-investigators:            Dr Ian Dittmer, A/Prof John Collins, Dr Paul Manley,
                             Dr Michael Collins

     Substudy extension for at least 72 months.
     Participant Information Sheet/Consent Form V#3 dated 12 June 2009



3.     NTX/09/04/026
Randomised trial of doppler-optimised fluid balance in elective colectomy:
PIS/Cons V#4, 30/04/09
Principal Investigator: A/Prof Andrew Hill

     Addition of another similar measure using a different device

                                                                               19
    .
PROGRESS REPORTS:

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


   AKY/03/11/294
   Case-controlled study of stillbirths at Middlemore Hospital from 1990 to 2000:
   Prot/amend 7/07/06
   Principal Investigator:   Dr Alec J Ekeroma


   AKX/04/03/063
   The oncological consequences of hepatic mobilization: detections of tumour
   cells in blood in patients undergoing hepatic resection for colorectal cancer
   metastases: PIS/Cons V. 14/04/04
   Principal Investigator:    A/Prof Jonathan Koea


   AKX/04/03/072
   A children’s oncology group protocol for collecting and banking paediatric
   research including rare paediatric tumours (COG: ABTRO1B1); PIS/Cons V#3,
   11/02/09
   Principal Investigator:   Dr Lochie Teague

   + Abstract


   AKY/04/12/338
   Early prediction of brain damage after heart surgery in infants:     Substudy:
   Cardiac scan trial: PIS/Cons V#8, 9/06/09
   Principal Investigator:     Dr John Becca


   NTX/05/02/004
   An open-label trial of telbivudine (LdT) in adults with chronic hepatitis B
   previously treated in Idenix-sponsored telbivudine studies: Protocol # NV-02B-
   022. 21/10/04: Prot/amend 1, V. 3.0, 18/05/05: Prot/amenend 02 V#2.0, 24/08/06:
   Prot/amend 4, 7/12/07: PIS/Cons V#6, 28/04/08: IB Ed 10, 14/7/08
   Principal Investigator:     A/Prof Ed Gane


   NTX/05/07/088
   A 3-year double blind extension to CZOL446H23021 to evaluate the long-term
   safety and efficacy of zoledronic acid in the treatment of osteoporosis in post-
   menopausal women taking calcium and vitamin D: CZOL446H2301E1, 6/04/05:
   PIS/Cons V#2, 20/06/05: Prot/amend #1, 4/11/05: Prot/amend 3 8/10/07,

                                                                                20
Prot/amend #4, 25/06/08: PIS Adden 2 15/01/08: IB Ed. 13, 17/11/08
 Substudy: Prot/amend V#1.07/04/08 2nd 3-yr Ext study PIS/Cons V#1
17/07/08: Substudy PIS/Cons V#1, 8/10/08.
Principal Investigator:    Prof Ian Reid


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


NTX/06/11/136
A prospective study to evaluate quality of life (QOL) for patients with cerebral
metastases with and without whole brain radiation therapy (WBRT): PIS/Cons
V#5, 10/09/08
Principal Investigator:   Dr Gillian Campbell


NTX/07/04/030
A pilot double blind randomised trial of indomethacin for closure of patent
ductus arteriosus in very preterm infants. The Iindomethacin ductus closure
effect trial: The INDUCE trial: Protocol 14/03/07: PIS/Cons V#3, 3/06/08
Principal Investigator:     Dr Mariam Buksh


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


NTX/07/06/057        Prevalence of pulmonary hypertension in sarcoidosis:
PIS/Cons V#2, 10/07/07
Principal Investigator:       Dr Sally de Boer


NTX/07/07/059
Epidemiology of severe lower respiratory illness in the paediatric population in
Counties Manukau: Prot/amend V#2.l0, 3/08: Prot/amend V#3, 12/08: PIS/Cons
C V#3, 12/08:
Principal Investigator:     Dr Adrian Trenholme


NTX/07/11/118
A prospective, multi-centre, double-blind, randomised, placebo-controlled,
parallel-group study to assess the efficacy and safety of clazosentan in
reducing vasospasm-related morbidity and all-cause mortality in adult patients
with ancurysmal subarachnoid hemorrhage treated by surgical clipping:

                                                                             21
Protocol AC-054-301/CONSCIOUS-2, 7/08/07: Prot/amend V#2, 13/05/08: Global
Amend 1, PIS/Cons V#4, 18/07/08: IBV#8, 12/08:
Principal Investigator:   Dr Edward Mee


NTX/07/31/CPD
Can we reduce episodes of haemoglobin desaturation in full term babies
restrained in infant car seats? PIS/Cons V#3, 20/08/08
Principal Investigator:      Dr Shirley Tonkin


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

NTX/07/136/EXP
A case-control study of the health benefits of participating in sponsored
clinical trials.
Principal Investigator:  Dr John Baker


NTX/08/03/017
Engagement pathways for Maori in mental health services at Auckland District
Health Board: PIS/Cons V#2, 25/03/08
Principal Investigator:   Mr Tom Ruakere


NTX/08/04/029
Falls Prevention in residential care: a pilot study of a multifactorial and an
activity programme: PIS/Cons V#3, 15/05/08: Q’aire V#1 4/9/08
Principal Investigator:   Dr Ngaire Kerse


NTX/08/04/030
CoreValve International ReValving™ Registry: Percutaneous Aortic Valve
Replacement (PAVR) with the CoreValve ReValving™ System (CRS): Protocol
CV-PAVR-R2007-V2, 1/08/07: Prot/amend V#4, 21/11/08, IB Rev. 2, 19/01/09,
PIS/Cons V#4, 12/02/09:
  (Waikato, Prot CV-PAVR-R2007-V2, 1/08/07, IB Rev. 1, 25/03/08, PIS/Cons V#3,
23/07/08)
Principal Investigator:  Dr John Ormiston


NTX/08/04/036
Screening trials to assess the effects of lipid emulsions on satiety, energy
intake and serum markers of appetite regulation & body weight control:
preliminary studies in a group of lean, healthy men: Protocol 10/03/08:
PIS/Cons V#2, 19/06/08: Prot/amend 18/06/08 Prot/amend 19/6/08: Prot/amend
V#3, 17/12/08: PIS/Cons V#3, 17/12/08
Principal Investigator:   Dr Sally Poppitt


                                                                            22
Co-Investigators:           Dr Anne Thea McGill, Mr Kai Chan


NTX/08/05/042
An investigation into the impact of a mindfulness group on clinical functioning
for people experiencing psychosis: PIS/Cons/Q’aire V#2 16/06/08
Principal Investigator:     Ms Janette Symes


NTX/08/05/043
A randomised, controlled trial measuring the effect of subjects taking
metaclopramide on gastric and small bowel transit time as measured by
capsule endoscopy vs subjects not taking metraclopramide; PIS/Cons V#4,
28/05/08
Principal Investigator: Dr Alasdair Patrick


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


NTX/08/06/050
A randomized double blind placebo controlled trial of zoledronate in the
treatment of bone erosions in gout: Protocol V#5, 8/05/08: PIS/Cons V#2,
18/06/08
Principal Investigator:  Dr. Nicola Dalbeth


NTX/08/06/054
A Phase I randomised, prospective, within-subject, double-blind, vehicle-
controlled, dose-escalation study to evaluate the safety, tolerability and clinical
effect of Nexagon ™ in full-thickness punch wounds: Protocol NEX-SKI-001
V#1, 22/05/08: IB V#2, 4/08: PIS/Cons V#2, 3/7/08: Prot/amend 1, V#2, 24/7/08:
PIS/Cons V#8, 19/09/08
Principal Investigator:       Dr Rod Ellis-Pegler


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


NTX/08/08/075
Evaluation of Whitiora Diabetes Services: PIS/Cons V#4, 23/09/08
Principal Investigator:    A/Prof Tim Kenealy




                                                                                23
NTX/08/10/097
Does CPAP pressure affect apnoea, bradycardia and desaturation episodes
andoOxygen requirement in preterm infants on CPAP for respiratory distress
syndrome? A double-blinded, randomised, cross-over pilot trial: Protocol
V#1.0, 1/09/08: PIS/Cons V#2. 15/12/08
Principal Investigator:    Dr Anna Tottman


NTX/08/11/105
The quest for meaning in chronic progressive disease: PIS/Cons V#2, 21/12/08
Principal Investigator:    Rev Susan Irene Jacobi


NTX/08/50/EXP
Survey assessing the health care and health care needs of young people with
bronchiectasisPIS/Cons V#2, 5/08
Principal Investigator:   Dr Timothy Hill

+Abstract


NTX/08/17/EXP
Adherence to medication in a Pacific general practice: qualitative review and
nurse led intervention
Principal Investigator:   Dr Kuinileti Chang Wai

+Abstract


NTX/08/56/EXP
Research into elderly patient anaesthesia and surgery outcome numbers: an
audit of post operative complications in Australia and New Zealand hospitals:
Protocol V.2, 8.04/08: Prot/amend 1.4, 17/06/08
Principal Investigator:      Dr Vanessa Beavis


NTX/08/66/EXP
Audit of Gastrointestinal stenting at Middlemore Hospital
Principal Investigator:     Mr Ravinder Ogra


NTX/08/67/EXP
Management of large colorectal polyps at Middlemore Hospital
Principal Investigator:   Mr Ravinder Ogra

+Abstract


NTX/08/68/EXP
Audit of Triamcinolone Injection & Dilatation for oesophageal strictures
Principal Investigator:    Mr Ravinder Ogra


                                                                           24
     NTX/08/69/EXP
     Endoscopic management of gastrointestinal malignancy at Middlemore
     Hospital
     Principal Investigator: Mr Ravinder Ogra

     +Abstract


     NTX/08/77/EXP
     Adherence with secondary prevention medications in ischaemic stroke
     patients from Auckland City Hospital
     Principal Investigator:    Dr Cheryl Johnson


END OF STUDY REPORTS:

.

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


     NTX/07/82/EXP
     Exploring the perioperative nurse practitioner position, PIS/Cons V#1, 23/09/07
     Principal Investigator:    Ms Joanne Knapp


     NTX/08/02/007
     Auckland District Health Board palliative care services: views of service users
     and providers: PIS/Cons V#2 29/02/08
     Principal Investigator:    Dr Elizabeth Bennett

     +Abstract


     NTX/08/04/028
     Comparison of Vehicle Delivery Depth using the NovoFine® 5mm needle with
     or without a skin fold and inserted at either 45 or 90 degrees: PIS/Cons V#2,
     15/5/08
     Principal Investigator:    Dr Paul Hofman

     +Abstract


     NTX/08/05/040
     The Impact of Point of Care Testing on patients presenting with acute illness at
     a small rural hospital in New Zealand: PIS V#2, 5/08
     Principal Investigator:      Dr Kattarina Blattner

                                                                                  25
+Abstract


NTX/08/06/052
Sustaining Community Midwifery Services: An appreciative inquiry of services
provided by Warkworth Birthing Centre: PIS/Cons V#2, 24/06/08
Principal Investigator:   A/Prof Liz Smythe

+Abstract


NTX/08/06/055
The effects of single sessions of music therapy on the level of anxiety in older
persons with psychiatric disorders: PIS/Cons V#2, 24/06/08
Principal Investigator:     Mr Ajay Castelino

+Abstract


NTX/08/06/057
‘Journey back into Body and Soul’ - Exploring the experiences of yoga practice
in people with Psychosis: PIS/Cons V#3, 9/10/08: Q’aire V#3, 9/10/08:
Principal Investigator:     Ms Brigitte Sistig

+Abstract


NTX/08/07/066
Validation of sarcoidosis health questionnaire, a disease-specific health
related quality of life measure for patients with sarcoidosis: PIS/Cons Q’ires
V#2, 18/07/08
Principal Investigator:     Dr Salley de Boer

+Abstract


NTX/08/53/EXP
Prospective audit of transversus abdominus plane block after elective lower
segment caesarean section
Principal Investigator:    Dr Calum Grant

+Abstract


NTX/08/75/EXP
Analysis of outcomes in patients treated with Biologics
Principal Investigator:     Ms Julia Martin




                                                                             26
+Abstract


NTX/08/82/EXP
The mortality of diabetics under 31 years of age in the Auckland region, 2000 -
2008
Principal Investigator:      Dr Daniel Garofalo

+Abstract


NTX/08/101/EXP
Study of carbohydrate intolerance in patients with acute coronary syndrome
(ACS) admitted to Middlemore Hospital coronary care unit (CCU)
Principal Investigator:   Dr Ajith Dissanayake

+Abstract


NTX/08/132/EXP
Audit for the use of surgisis anorectal plugs for treatment of anorectal fistulae
Principal Investigator:       Dr Todd Hore

+Abstract




                                                                                27

				
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