Docstoc

mec-minutes-22aug2006

Document Sample
mec-minutes-22aug2006 Powered By Docstoc
					                           MINUTES
          Multi – region Ethics Committee




                           22 August 2006




VENUE:
Royal New Zealand
Foundation of the Blind,
121 Adelaide Road
Newtown
Ph 04 380 2160
Wellington

Members of the public may attend the open section
of the meeting, which commences at 9.30 am.




Minutes of the OPEN MREC meeting on 22 August 2006   Page 1 of 17
Minutes of the Multi-region Ethics Committee open to the public held on Tuesday 22
August 2006 at the Royal NZ Foundation of the Blind, Newtown, Wellington
commencing at 9.30 am .

PRESENT:                          Dr. Martin Tolich (Chairperson)
                                  Assoc. Prof. Cynthia Darlington (Deputy Chairperson)
                                  Assoc. Prof. Jane Koziol-McLain
                                  Dr. Barry Smith
                                  Dr. Simon Jones
                                  Mrs. Georgina Johnson
                                  Mrs. Maliaga Erick
                                  Ms. Carolyn Weston
                                  Prof. Graham Mellsop

ATTENDED BY TELECONFERENCE:
                      Dr. Chris Wynne.
                      Dr Fiona McCrimmon

APOLOGIES:                        Assoc. Prof. Sheila Williams

ADMINISTRATORS:                   Sue Fish
                                  Michelle Judge

                      MINUTES OF THE PREVIOUS MEETING

The minutes of the open meeting held on 18 July 2006 were accepted as a true and correct
record of the meeting. (Barry Smith/Mali Erick)

The minutes of the closed meeting held on 18 July 2006 were accepted as a true and correct
record of the meeting. (Cynthia Darlington/ Georgina Johnson)

The committee expressed its gratitude to the Chairperson for his diplomatic representation on
its behalf in discussing the banking of human tissue with the Children‟s Oncology Group.

                                   NEW PROTOCOLS

1.     A comparison of birth outcomes for first time mothers between those who plan a
       home birth and those who plan to give birth in a secondary/tertiary hospital
       settings

        Lead Investigator: Suzanne Miller
        MEC Ref:           MEC/06/08/077

Suzanne Miller attended the discussion of this study.

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Dr Simon Jones will review the researchers’ responses prior to final ethical
approval by the Chairperson under delegated authority.




Minutes of the OPEN MREC meeting on 22 August 2006                              Page 2 of 17
 Requirements:

      (1) National               Obtain advice from a specialist statistician.
          Application Form,
          pg 5,
          A3.2.2:Specialist
          statistical advice
      (2) National               Provide evidence of consultation with an appropriate Maori
          Application Form,      group.
          pg 13, F3.1:Maori
          consultation
      (3) Consent form for       Make it explicit at the top of the survey form that completing
          midwives               the form implies consent to the use of their data.
      (4) National               Provide evidence of consultation with an appropriate Maori
          Application Form,      group for Victoria University.
          F3.2
      (5) Locality               Supply locality assessments by ethics committee for Victoria
          assessment             University.


2.      Baby Friendly Community Initiative (Retrospective Review)

         Lead Investigator: Geraldine Clemens
         MEC Ref:           MEC/06/08/078

 The Multi-region Ethics Committee deferred the above study because of concerns about
 the research method. (Refer to Operational standard for Ethics Committees, April 2006
 edition, paragraph 57(iii). This is not a retrospective review, as interviews will be held with
 mothers, and new data collected. A full resubmission using the National Application Form
 is needed.

 The following needs to be specifically addressed in the resubmission:

      Locality assessment        Please provide memoranda of understanding with the
                                 organisations where the research will be carried out, outlining
                                 the data that will be shared.


3.      Field testing of a quality of life questionnaire for patients receiving home
        parenteral nutrition (HPN)

        Lead Investigator:     Ms Lyn Gillanders
        MEC Ref:               MEC/06/08/079

 The Multi-region Ethics Committee deferred the above study because of concerns about
 the rationale for the research. (Refer to Operational Standard for Ethics Committees,
 April 2006 edition, paragraph 57(ii). A full resubmission is needed..

 The following need to be addressed in the resubmission:



 Minutes of the OPEN MREC meeting on 22 August 2006                               Page 3 of 17
      (1) National               Clarify who will make the initial approach to the participants.
          Application Form,      D4 is contradicted by E1. This person should be the one who
          pg 11, D4: Initial     compiles the register.
          approach
      (2) National               These references contradict each other. An interpreter must
          Application Form,      be made available, so that non-English-speakers are eligible
          A3.1, E3 and F3.2      to participate in the study.
      (3) Form I- eligibility    All patients who are able to understand the study should be
          checklist              eligible. Please explain in the Information Sheet, that to be
                                 consistent with the UK study, only participants over the age
                                 of 18 are eligible for this study.
      (4) Participant            Change this to include NZ patients.
          Information sheet,
          pg 1, last
          paragraph
      (5) Consent form,          Make it clear in the Participant Information sheet that
          item 3                 participants‟ answers will be sent to Scotland.
      (6) Form V – Socio-        This should be completed by the participants. It is not
          demographic data       acceptable for health professionals to supply this information
                                 on behalf of the participants.
      (7) Protocol , point       Please consult a specialist statistician regarding the statistical
          7.5.1                  analysis proposed.
      (8) National               Provide evidence of consultation with Mata Forbes at
          Application Form,      Auckland City Hospital.
          F3.2


4.      ‘Tangata Whaiora and Service Users’ Perspectives of Mental Health
        Classification (Diagnosis) Systems’ Focus Group Research Project.

        Lead Investigator:      Debra Wells
        MEC Ref:                MEC/06/08/080

The above study was approved subject to the following minor points being clarified and a
favourable locality assessment:

     (1) National Application    Clarify when the data will be destroyed.
         Form, D7: data
         storage
     (2) National Application    Comment on the contradiction between E3 and F4.1.
         Form, E3 and F4.1

     (3) National Application    Please provide evidence of consultation with an appropriate
         Form, F3.2              Maori group for Waikato Hospital
     (4) Locality assessment     Provide a locality assessment by locality organisation for
                                 Waikato Hospital




 Minutes of the OPEN MREC meeting on 22 August 2006                                  Page 4 of 17
5.       Diabetes excess weight loss (DEWL) trial: high protein vs low fat diets

         Lead Investigator: Dr Jeremy Krebs
         MEC Ref:           MEC/06/08/081

The Multi-region Ethics Committee approved the above study subject to the following
conditions. The Chairperson will give final ethical approval under delegated authority.

 Requirements:

     (1) National Application     Add a statement to the Consent form that participants agree
         Form, D9                 to their GP being informed of any abnormal personal results.
     (2) Locality assessment      Provide a locality assessment by locality organisation for
                                  Auckland DHB, Hutt Valley DHB, and Canterbury DHB


6.       HIV Futures New Zealand Survey 2: a National Survey of People Living With
         HIV/AIDS

         Lead Investigator:     Dr Jeffrey Grierson
         MEC Ref:               MEC/06/08/082

 The Multi-region Ethics Committee approved the above study subject to the following
 conditions. Dr Barry Smith will review the researchers’ responses prior to final ethical
 approval by the Chairperson under delegated authority.

 Requirements:

     (1) National Application    The committee was concerned at the idea of Maori power of
         Form, A6 and F3.4       veto over publication of results, and suggests changing this to
                                 a consultation process.
     (2) National Application    Explain what the “specific initiatives” are.
         Form, B5
     (3) HIV Futures 2 NZ        Add a statement in the grey box that participants should
         Survey, page 1          complete the survey only once.
     (4) HIV Futures 2 NZ        Provide contact details for the local New Zealand researchers.
         Survey, page 2
     (5) HIV Futures 2 NZ        Add a statement to the effect that completion of this form
         Survey, page 2          implies consent to take part in the study.
     (6) HIV Futures 2 NZ        Add NCEA options.
         Survey, page 3,
         question A8
     (7) HIV Futures 2 NZ        Add “AIDS neurological syndrome” to the list.
         Survey, page 8,
         Question C14
     (8) Locality assessment     Provide a locality assessment by ethics committee for the NZ
                                 AIDS Foundation




 Minutes of the OPEN MREC meeting on 22 August 2006                               Page 5 of 17
8.     Maternity Services Consumer Satisfaction

            Lead Investigator: Dr Julian King
            MEC Ref:           MEC/06/08/084

 The Multi-region Ethics Committee approved the above study subject to the following
 conditions. Dr Fiona McCrimmon will review the researchers’ responses prior to final
 ethical approval by the Chairperson under delegated authority.

 Requirements:

      (1) National              Provide details of the “Community-based groups” mentioned.
            Application Form,
            pg 11, D1
      (2) National              As focus groups will include Maori and Pacific Island
           Application Form,    participants, an interpreter should be made available. .
           A3.1 and E3
      (3) National              The provision of a koha of $40 needs to be put in the Participant
           Application Form,    Information sheet.
           pg 13, E10
       (4) Attachment D:        The LMC and the Participant Information Sheet‟s usual doctor
           Focus group          may be the same person. Change the wording to reflect this.
           outline, pg 24:
           communication, 2nd
           bullet point
       (5) Attachment F:        At least one of the focus group facilitators must be fully
           Focus group design   bilingual.
       (6) National             Please provide evidence of consultation with an appropriate
           Application Form,    Maori group for Health Outcomes International
           F3.2


 9.        Consumer Acceptability of Antenatal Screening for Down Syndrome

           Lead Investigator:   Dr Julian King
           MEC Ref:             MEC/06/08/092

 The Multi-region Ethics Committee deferred the above study because of concerns about
 the research method. (Refer to Operational standard for Ethics Committees, April 2006
 edition, paragraph 57(iii). The use of focus groups may not be an appropriate method for
 such a sensitive topic.

 The following need to be addressed in the resubmission:

     (1) National               The study should be more transparent about the fact that 90% of
         Application Form,      Down Syndrome diagnoses result in terminations, and the
         pg 6, A3, Study        survey is about the acceptability of termination. The focus
         design                 groups should discuss more than the cultural/ethnic issues of
                                screening. They should discuss the ethics of termination.


 Minutes of the OPEN MREC meeting on 22 August 2006                                 Page 6 of 17
 (2) National               The selection of participants biases the study outcome. The
     Application Form,      committee suggests the researchers include some people from a
     pg 6, A3, Study        Down Syndrome Support group in the focus groups. Parents of
     design                 children with Down Syndrome should also be included.
 (3) National               Clarify the aims and methodology of the study. Will the
     Application Form,      findings of this survey guide policy on termination? If so, the
     pg 6, A3: Study        data should be quantitative, so that decisions can be
     design                 quantitatively based.
 (4) National               Mention the koha of $40 - $50 in the Participant Information
     Application Form,      sheet. Specify what the exact amount will be - $40 or $50.
     pg 13, E10

10.    A Phase 3 randomized, double-blind, placebo-controlled, multi-center,
       parallel group study to evaluate the efficacy and safety of fixed doses of
       Darusentan in subjects with resistant systolic hypertension receiving
       combination therapy with four or more antihypertensive drugs, including a
       diuretic. (DORADO)

       Lead Investigator:    Prof Mark Richards
       MEC Ref:              MEC/06/08/085

The above study was approved by the Multi-region Ethics Committee


11.    A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of
       Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered
       Intravenously, in Subjects with Active Rheumatoid Arthritis Despite
       Methotrexate Therapy, Protocol number C0524T12. Protocol date: 05 June
       2006.

       Lead Investigator:    Dr Daniel Ching
       MEC Ref:              MEC/06/08/087

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Assoc Prof Cynthia Darlington and Prof Graham Mellsop will review the
researchers’ responses prior to final ethical approval by the Chairperson under delegated
authority.

Requirements:

 (1) National Application    Mention in the Participant Information sheet that these groups
     Form, pg 17, F3.5:      will only receive the results if they request them.
 (2) National Application    Please provide evidence of consultation with an appropriate
     Form, F3.2              Maori group for Dunedin Hospital, QE Hospital, and North
                             Shore Hospital
 (3) Protocol: pg 42:        No mention is made in either the protocol or the application
     concomitant             form of the dangers of mixing methotrexate with a monoclonal
     medications             antibody such as golimumab. We need a statement on the
                             safety of combining methotrexate with golimumab.
 (4) Safety data             Please specify the safety data for humans, as opposed to the


Minutes of the OPEN MREC meeting on 22 August 2006                             Page 7 of 17
                             safety data for monkeys.
 (5) Locality assessment     Provide a locality assessment by locality organisation for
                             Dunedin Hospital, Timaru Hospital, CGM Research, and North
                             Shore Hospital.

Comments:

 (1) National Application    Provide a copy of the results to the Committee when published.
     Form, pg 8, A6


12. A Phase IV, randomized, multicentre, efficacy and safety study examining the effect
    of induction dosing with the combination of Peginterferon alfa-2a and Ribavirin in
    patients with chronic hepatitis C infected with hepatitis C genotype 1.

       Lead Investigator:    Assoc Prof Ed Gane
       MEC Ref:              MEC/06/08/088

The Multi-region Ethics Committee approved the above study subject to the following
conditions. The Chairperson will review the researchers’ responses prior to final ethical
approval under delegated authority.

Requirements:

 (1) Participant             Change “…your partner cannot be pregnant or become
     Information sheet,      pregnant” to “…your partner should not be pregnant or become
     pg 3, 2nd paragraph     pregnant.”
 (2) Consent form            Include consent for sending blood samples to Sydney.
 (3) National Application    Please provide evidence of consultation with an appropriate
     Form, F3.2              Maori group for all sites
 (4) Locality assessment     Provide a locality assessment by locality organisation for all
                             sites.


13.    PROGRESS: Progesterone after previous preterm birth for the prevention of
       neonatal respiratory distress syndrome.

       Lead Investigator:    Prof Pippa Kyle
       MEC Ref:              MEC/06/08/089

The Multi-region Ethics Committee approved the above study subject to the following
conditions. The Chairperson will review the researchers’ responses prior to final ethical
approval under delegated authority.



Requirements:

 (1) Participant             Clarify the potential risk to participants who begin treatment,
     Information sheet       but withdraw early. Will this increase their risk of preterm


Minutes of the OPEN MREC meeting on 22 August 2006                              Page 8 of 17
                             labour?
 (2) Participant             Mention that women who have a history of preterm labour
     Information sheet       have a 15% risk of recurrence.
 (3) Participant             Provide site-specific information sheets, on each site‟s
     Information sheet       letterhead.
 (4) Participant             Paragraphs 4 and 7 are identical. Please edit.
     Information sheet,
     point 1
 (5) Participant             Make it clear that there is no cost to participants for the study
     Information sheet,      drug.
     point 12
 (6) National Application    Provide evidence of consultation with an appropriate Maori
     Form, F3.2              group for Auckland, Palmerston North and Wellington.
 (7) Locality assessment     Provide locality assessments by locality organisation for
                             Auckland, Palmerston North and Wellington.

Comments:

 (1) Participant             The Participant Information sheet refers to the “Research
      Information sheet      project” throughout. The term “Research” is more appropriate.


14.    An Open-Label Extension Study to Assess the Safety and Efficacy of Pazopanib
       in subjects with Renal Cell Carcinoma previously enrolled on Protocol
       VEG105192. Protocol:VEG107769

       Lead Investigator: Dr Chris Wynne
       MEC Ref:           MEC/06/08/090

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Assoc Prof Cynthia Darlington will review the researchers’ responses prior to
final ethical approval by the Chairperson under delegated authority.

Requirements:

  (1) Participant            Clarify who the business partners are.
      Information sheet,     Clarify the sentence which begins: “GSK may make your
      pg 4                   samples….” What exactly is the „consent‟ referred to?
  (2) Participant            Change the words “illegal drugs” to “recreational” or “non-
      Information sheet,     therapeutic drugs”.
      pg 5
  (3) Participant            Delete the words: “or item” .
      Information sheet,
      pg 7,
      Compensation, 1st
      sentence
  (4) National               Please provide evidence of consultation with an appropriate
      Application Form,      Maori group for Auckland City Hospital.
      F3.2
  (5) Locality assessment    Provide a locality assessment by locality organisation for


Minutes of the OPEN MREC meeting on 22 August 2006                                Page 9 of 17
                              Auckland City Hospital and Wellington Hospital


15.    A Phase II trial evaluating the efficacy and safety of epirubicin and
       cyclophosphamide (EC) followed by docetaxel with gemcitabine (DG)
       (+trastuzumab if HER2 positive) as neoadjuvant chemotherapy for women with
       large operable or locally advanced breast carcinoma

       Lead Investigator:     Assoc Prof Bridget Robinson
       MEC Ref:               MEC/06/08/091

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Assoc Prof Cynthia Darlington will review the researchers’ responses prior to
final ethical approval by the Chairperson under delegated authority.

Requirements:

 (1) National             The answer provided contradicts the answer given in A8.1. Clarify
      Application         whether participants will receive a payment or not.
      Form, A8.2
 (2) National             Please answer this more fully.
      Application
      Form, section C,
      Compensation
 (3) National             Please provide evidence of consultation with an appropriate Maori
      Application         group for Auckland City Hospital and Wellington Hospital.
      Form, F3.2
 (4) National             Clarify whether tissue will be disposed of or stored indefinitely.
      Application         The answer given does not agree with the answer in Point 1.13
      Form, Part 5,
      Point 1.9
 (5) National             Explain what ethical safeguards will be in place.
      Application
      Form, Part 5,
      Point 4.2
 (6) National             Specify that tissue which has already been used will not be able to
      Application         be returned.
      Form, Part 6,
      Point 5.3
 (7) I Information        Specify the name of the Ethics Committee i.e. the Multi-region
      Sheet, page 5       Ethics Committee
 (8) I Information        Clarify exactly what ACC will and will not pay for.
      Sheet, page 10
 (9) Generic Consent      Change the first point to read, „9th of July‟.
      Form
 (10) Generic Consent     Change the Niuean spelling to „Fia . . .”
      Form
 (11) Consent for         Specify that tissue is to be used for cancer research only.
      Tissue Collection
 (12) Consent for         The last bullet point: “I consent to researchers accessing my


Minutes of the OPEN MREC meeting on 22 August 2006                               Page 10 of 17
       Tissue Collection   medical records” should not be in this consent form but the Generic
                           Consent Form
  (13) Consent for         Change the sentence to, “ . . . all patients will immediately have a
       Sentinel Node       standard axillary lymph node dissection.”
       Substudy, 4th
       paragraph
  (14) Locality            Provide a locality assessment by locality organisation for Auckland
       assessment          City Hospital and Wellington Hospital

 Comments:

  (1) Participant          The Committee commends the researchers on providing a list of
       Information         common reversible side effects and what can be done to relieve
       Sheet               these.
  (2) Participant          Put the heading „Termination of the Study‟ in bold type.
      Information
      Sheet, page
      10
  (3) Consent for          Proof read the second line.
       Sentinel Node
       Substudy, 3rd
       paragraph


16.    A dose-blinded, long-term safety extension study of fixed doses of Darusentan
       in subjects with resistant systolic hypertension receiving combination therapy
       with four or more antihypertensive drugs, including a diuretic. (DORADO-EX)

       Lead Investigator:     Prof Mark Richards
       MEC Ref:               MEC/06/08/086

 The Multi-region Ethics Committee approved the above study subject to the following
 conditions. The Chairperson will review the researchers’ responses prior to final ethical
 approval under delegated authority.

 Requirements:

  (1) National              Provide evidence of consultation with Maori groups in Hawkes
      Application Form,     Bay and Christchurch School of Medicine & Health Sciences.
      F3.2, Maori
      consultation
  (2) Locality              Provide a locality assessment by locality organisation for
      assessment            Hawkes Bay and Christchurch School of Medicine & Health
                            Sciences.
  (3) SCOTT approval        Forward a copy of the SCOTT approval.




 17.    The PreCiSE Trial: Costar Paclotaxel-Eluting Coronary Stent Catheter


 Minutes of the OPEN MREC meeting on 22 August 2006                             Page 11 of 17
       System Evaluation

       Lead Investigator:     Dr Mark Webster
       MEC Ref:               MEC/06/08/093

 The Multi-region Ethics Committee approved the above study subject to the following
 conditions. Assoc Prof Cynthia Darlington will review the researchers’ responses prior to
 final ethical approval by the Chairperson under delegated authority.

 Requirements:

  (1) Participant           Write the full title of the „FDA‟.
      Information sheet,
      page 7
  (2) National              Complete this section more fully.
      Application Form,
      C
  (3) National              Please provide evidence of consultation with an appropriate
       Application Form,    Maori group for Auckland City Hospital, Christchurch Hospital,
       F3.2                 and Middlemore Hospital.
  (4) Locality              Provide a locality assessment by locality organisation for
       assessment           Christchurch Hospital and Middlemore Hospital.

Comments:

  (1) National              Insert the word „hours‟ after „8-12‟.
      Application Form,
      A3.1, Post-
      procedure



 18.        PATHS (Providing Access to Health Solutions) Evaluation

            Lead Investigator:        Dr Debbie McLeod
            MEC Ref:                  MEC/06/08/094

 The Multi-region Ethics Committee deferred the above application because it is not written
 as a research project and therefore the Committee could not review it as such. (Refer to
 Operational Standard for Ethics Committees, April 2006 edition, paragraph 57(iii).
 A full resubmission is required with a revision of the study design.

 The following need to be addressed in the resubmission:

 (1) National               Clarify whether GPs will receive written permission from
     Application Form,      patients to release their treatment history.
     A3.1
 (2) National               Clarify whether the results will be published on the MSD
     Application Form,      website.
     A6


 Minutes of the OPEN MREC meeting on 22 August 2006                          Page 12 of 17
  (3) National                A café may not be an appropriate setting to conduct a research
      Application Form,       interview.
      B4
  (4) National                Clarify the number of people in PATHS who will be
      Application Form,       interviewed.
      B5
  (5) National                Explain why no interpreter will be provided. This is inconsistent
      Application Form,       with F4.1. What provision will be made for potential participants
      E3                      on the Invalid‟s Benefit who are deaf?
  (6) National                Provide a copy of the letter described here.
      Application Form,       To make a follow-up phone call a week after sending a letter is
      E4                      too a short a time frame.
                              Provide a copy of the telephone script to be used.
  (7) National                This contradicts the Participant Information sheet. If participants
       Application Form,      are to be given a copy of their transcript, they should have the
       E6                     opportunity to edit it.
  (8) National                Provide evidence of consultation with an appropriate Maori
       Application Form,      group.
       F3.2
  (9) Participant             Add a statement that this study has been given ethical approval
       Information sheet      by the Multi-region Ethics Committee.
  (10) Locality assessment    Provide a locality assessment by locality organisation.

 Recommendation:

  (1) Draft Interview         Disability is not necessarily a health issue. Include a question
      Schedule                which asks, “Do you have a wellness plan or rehabilitation
                              plan?”

 Comments:

  (1) Interview               Some participants could find it intimidating to have one
                              interviewer taking notes and one conducting the interview.


19.            To produce an information resource for electroconvulsive therapy consumers
               and their family/whanau

               Lead Investigator:      Katrina Lenzie-Smith
               MEC Ref:                MEC/06/08/095

  The Multi-region Ethics Committee deferred the above application because it is not written
  as a research project and therefore the Committee could not review it as such. (Refer to
  Operational Standard for Ethics Committees, April 2006 edition, paragraph 57(iii).
  A full resubmission is required with a revision of the study design.

  Requirements:

      (1) National            Participant numbers are likely to be low because of the exclusion
          Application Form,   of patients with low mental function scores, ie. below 24


  Minutes of the OPEN MREC meeting on 22 August 2006                              Page 13 of 17
     A3                     It is also not likely that all DHBs will have an ECT nurse
                            available.
                            It is not acceptable for the treating psychiatrist to be held
                            responsible for any adverse events even though he or she will not
                            be consulted.
                            To access all 21 DHBs is not viable. The Committee suggests
                            that only the major DHBs are approached.
                            The Committee notes that the only DHB which has been
                            approached has deferred approval of this study.
 (2) National               Explain why only Maori participants may need to meet the
     Application Form,      project manager face to face.
     A3, page 5b
 (3) Participant         Provide a New Zealand specific Information Sheet
     Information sheet
 (4) Locality assessment Provide a locality assessment by locality organisation.

Comments:

    (1) General             The Committee queried why the researchers had not sought
                            expert advice on ECT within New Zealand.



                                     AMENDMENTS

Resubmission 1: Should we stay or should we go? A study looking at how women and
midwives make decisions around transfer from rural maternity facilities to secondary
care facilities in New Zealand Aotearoa.

           Lead Investigator:        Ms Jean Patterson
           MEC Ref:                  MEC/06/05/045

Dr Joan Skinner, one of the research supervisors, attended the discussion of this study.

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Georgina Johnson will review the researchers’ responses prior to final ethical
approval by the Chairperson under delegated authority.

Requirements:

 (1) National Application    Make it clear that this study is a mixed-method design.
     Form, A3.2: Study
     design
 (2) National Application    The Committee recommends communicating with a Maori
     Form, F3.1: Maori       research group at Victoria University to initiate Maori
     consultation            consultation.
                             Letters showing evidence of Maori support must be provided to
                             the Committee at each site where research is to be undertaken.
 (3) Locality assessment     A locality assessment is required for each site.


Minutes of the OPEN MREC meeting on 22 August 2006                            Page 14 of 17
                              The Committee recommends beginning this process at one of
                              the larger DHBs such as Auckland or Otago.
                              It is ideal for the locality assessment and Maori consultation
                              processes to be undertaken simultaneously.

Recommendation:

 (4) National Application     The researcher may wish to limit the number of DHBs she
     Form, A3.1               consults to just some of the larger DHBs, instead of all 21.


Resubmission 2: Whakanui Orana: Using the New Zealand Disability Strategy as a
framework for strategic policy development for U.S. indigenous peoples with disabilities

           Lead Investigator:        Ms Adrienne Wiley
           MEC Ref:                  MEC/06/06/063

The Multi-region Ethics Committee approved the above study subject to the following
conditions. The Chairperson will review the researchers’ responses prior to final ethical
approval under delegated authority.

Requirements:

  (1)   National              Confirm that the selection of participants will be randomised.
        Application Form,
        A4.2
  (2)   National              Initial approach to participants should be made by service
        Application Form      provider organisations, not the Lead Investigator.
        D2
  (3)   Patient Information   Describe briefly the qualitative outcomes of the interview data
        sheet, page 1         as well as the quantitative, in the third paragraph.


Resubmission 3: The Maori Community Heart Study

            Lead Investigator:       Suzanne Pitama
            MEC Ref:                 MEC/06/03/026

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Georgina Johnson and Dr Fiona McCrimmon will review the researchers’
responses prior to final ethical approval by the Chairperson under delegated authority.

Requirements:

   (1) National               Explain how the levels of previously undiagnosed disease will
       Application Form       be documented.
   (2) National               Provide a brief statistical report which describes how the
       Application            research is designed to meet its aims.
       Form, A3.2.2
   (3) National               Provide a statement in the Participant Information sheet and


Minutes of the OPEN MREC meeting on 22 August 2006                              Page 15 of 17
        Application            Consent Form that National Health Index (NHI) data will be
        Form, B11              accessed.
    (4) National               Describe the process by which participants are assigned to a
        Application            follow up clinic. Do they choose this clinic themselves or are
        Form, B9               they assigned by the researcher?
    (5) Participant            Proof read and edit this for typos and grammatical errors.
        Information sheet
    (6) Locality               Confirm that the localities where the study will be carried out
        assessment             are adequately resourced to support the research.


Resubmission 4: Prophylactic use of Kiwicrush for prevention of constipation in
orthopaedic elective surgery patients

           Lead Investigator:          Dr John Wyeth
           MEC Ref:                    MEC/06/07/068

The Multi-region Ethics Committee approved the above study subject to the following
conditions. Dr Barry Smith will review the researchers’ responses prior to final ethical
approval by the Chairperson under delegated authority.

Requirements:

    (1)   Study Title           Change the study title from „Kiwicrush‟ to „Kiwizyme‟
    (2)   Participant           Change „Kiwicrush‟ to „Kiwizyme‟ throughout this document
          Information Sheet
    (3)   Participant           Change „Central Region Ethics Committee‟ to „Multi-region
          Information Sheet,    Ethics Committee‟
          Compensation


                                   GENERAL BUSINESS

1. Schedule 1: Amendments reviewed by the Chairperson 28 June – 2 August
Confirmed by Cynthia Darlington/ Carolyn Weston
2. Schedule 2: Amendments reviewed by the Deputy-Chairperson 28 June – 12 July
Confirmed by Mali Erick/Barry Smith
3. Schedule 3: SAEs reviewed by the Deputy-Chairperson 14 June – 12 July
Confirmed by Barry Smith/Georgina Johnson
4. Studies approved 18 July – 22 August
Confirmed by Barry Smith/ Graham Mellsop
5. Letter from Therese Egan to Martin Tolich re: Tissue Banking Discussion
   Document
6. Letter inviting submissions to the Non-therapeutic use of Human Tissue Committee
7. Discussion of Tissue Banking issues
8. AKY/04/04/088 COG Study Amendment: Protocol amendment 2 and Information Sheet
 and Consent Form version 2 dated 3 July 2006 for Starship and Christchurch Hospitals.
 Approved by the Deputy-Chairperson and confirmed by the whole Committee.




Minutes of the OPEN MREC meeting on 22 August 2006                                Page 16 of 17
9. Discussion of the Guidelines on the Use of Human Tissue for Future Unspecified Research
Purposes: Discussion document. The Chairperson is to write a response on behalf of the
Committee.


                                  ADMINISTRATION

Claim forms.




Minutes of the OPEN MREC meeting on 22 August 2006                          Page 17 of 17

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:6
posted:6/7/2011
language:English
pages:17