UPPER SOUTH REGIONAL ETHICS COMMITTEE

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					UPPER SOUTH A REGIONAL ETHICS COMMITTEE
Minutes of the meeting of 28 May 2007, 16:00hrs

Meeting held in the Boardroom on level 4, Charles Luney House, 250
Oxford Terrace, Christchurch


APOLOGIES
Ellen McCrae, Jane Kerr, Liz Richards

PRESENT
Carolyn Mason (Chair), Alison Luckey (Deputy Chair), Carolynn Bull, John Horwood,
Tom Marshall, Edie Moke, Nicky Murray, Russell Scott, Alieke Dierckx (Administrator)

Sharon English attended as expert advisor.

Meeting commenced at 16:10hrs.

NEW PROTOCOLS
1. Investigating cortical contribution to pre-motor planning of volitional and naive
   swallows using the Bereitschafspotential
   Investigators: P Macrae, Dr ML Huckabee (Supervisor), Prof R Jones
   Ethics ref: URA/07/05/035
   Spokesperson: Edie Moke

    Approved subject to amendments
    Edie Moke to review.

    Requests
    - The application form indicates consultation has taken place with Dr Gail Gillon.
    Information sheet
    - P2 paragraph 2: Please explain or re-word “the influence of arousal and attention
        on swallowing”.
    - Clarify how many visits are involved, and the duration of the visits. The
        information given in response to question B1 of the application form does not
        correlate with what is stated in the information sheet.
    - P3 section 7. What is the likelihood of further data being required? If participants
        are required to return for a second visit, how long will this visit be? Will
        participants then receive extra reimbursements?
    - P3 Risks and benefits: Please rewrite the second sentence to read, “There are
        no direct benefits to you as an individual. You will be paid $150 to reimburse your
        time and travel expenses.
    - In other studies offering payments to participants, the Committee has noted that
        participants’ benefits have been affected. WINZ has regarded the entire time of
        participant involvement in the study (even for example one visit per week over 6
        weeks) as being a period of paid employment, and benefits have been stopped


URA Minutes 28 May 2007                                                                  1
       over this period of time. It is suggested to investigate whether participants in this
       study will be affected in this way, and if so, the Information Sheet should state
       that benefits may be affected by the reimbursements paid for participation.
       Please contact the Administrator for details.
    - State that this is student research.
    Questionnaire
    - Please reword the first question to read, “Which ethnic groups do you belong
       to?”
    - Reword the first sentence to read, “Please complete the following questionnaire
       by ticking the boxes that are most applicable to you.”
    - Please remove the phrase ‘suffer from’. Does this question refer to current or
       past problems, or both? Clarify.
    - Clarify how much detail is required about current medications (eg name/dosage
       etc).
    Advertisement
    - Paragraph 1: Please reword the last sentence to read, “There are no known risks
       associated with any procedures used in this study.”
    - Is it expected that participants will experience any discomfort during the study? If
       so, this should be stated.
    General
    - The committee wishes to compliment the researcher on their clear application
       and information sheet.


2. Coming to terms with serious mental illness
   Investigator: Dr A Scott
   Ethics ref: URA/07/05/036
   Spokesperson: Tom Marshall

    Dr Scott attended the meeting.

    Approved subject to amendments
    Tom Marshall and Edie Moke to review

    Requests
    - Written evidence of Maori consultation is required.
    - A locality assessment is required from MHERC, Pacific Trust and Te Awa o te
        Ora
    Information sheet
    - The information sheet and consent form must be printed on letterhead.
    - P1 What research?: Clarify ‘living process’.
    - P1 Who may take part?: State that participants over the age of 18 are sought.
    - Some participants may become distressed and/or unwell during the interviews.
        Explain how this will be dealt with and include this information in the information
        sheet.
    - State in the information sheet what topics will be covered in the interview.
    - State that a person who is happy to have the interview audiotaped may be
        chosen to participate in preference over someone who is not.
    - The footers of the information sheet and consent form must contain the full study
        title, a version number and/or date.



URA Minutes 28 May 2007                                                                    2
    -  Include the following information: If you have any questions or concerns about
       your rights as a participant in this research study you can contact an independent
       health and disability advocate. This is a free service provided under the Health
       and Disability Commissioner Act.
       Telephone: (NZ wide) 0800 555 050
       Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT)
       Email (NZ wide): advocacy@hdc.org.nz
    - Include the following statement: “This study has received ethical approval from
       the Upper South A Regional Ethics Committee.”
    - P1 Risks and benefits: Please find an alternative for ‘sufferers’.
    - P2 Confidentiality: Please amend the last sentence to read, “You may choose to
       have the tapes either returned to you or destroyed at the end of the study, and
       transcripts will be deleted.”
    - P2 Who am I?: Please reverse the order of the two sentences in this section.
    Consent form
    - How will transcripts and audiotapes be returned to participants? It may be
       necessary to make an arrangement with the participant individually. This should
       be registered on the consent form.
    - If anyone other than the researcher transcribes the interview tapes, the
       transcriber will need to sign a confidentiality agreement. State in the information
       sheet who will transcribe the tapes.
    General
    - With regard to offering karakia before/during the interviews, further discussion
       with the Maori advisor is recommended. Clarify how this will be made available
       (ie who will carry this out), and explain this in the information sheet and consent
       form.
    Suggestions
    - It is suggested to focus on thoughts rather than feelings, because people
       generally find it easier to put their thoughts into words.
    - Questionnaire: The questions about support groups and resources could be
       extended to include family/friends/whanau.
    - Information sheet: It is suggested to put the text of the ‘results’ section under
       ‘what research’ on page 1.


3. Why are skin cancers more aggressive in renal transplant patients?
   Investigators: Dr K Mackenzie, Prof J Roake (Supervisor), A/Prof B Robinson, Dr M
   Currie, Dr G Dachs, Dr S Langley, A/Prof J Stanek
   Ethics ref: URA/07/05/037
   Spokesperson: John Horwood

    Approved subject to amendments
    John Horwood to review

    Requests
    - A locality assessment from the School of Medicine is required.
    General
    - Are these tissues being tissue-banked? If so, a consent process should be put
       into place.
    - Where possible, consent for the use of the tissue samples for this study should
       be obtained.


URA Minutes 28 May 2007                                                                 3
    -   The data must be kept for 10 years.


4. Differences in patient's results and perception of the effort required while performing
   spirometry using different manoeuvres
   Investigators: Dr M Swanney, LE Beckert, C Frampton, J Stanton, K Wilson
   Ethics ref: URA/07/05/038
   Spokesperson: Nicky Murray

    Approved subject to amendments
    Nicky Murray to review

    Application form
    - For future reference, it should be noted that the summary of page 3 (section 17)
        must be in lay language.
    Information sheet
    - In order to allow ample time to consider whether to take part, the information
        sheet should be sent with a covering letter at the same time as appointment
        confirmation letters are sent.
    - Consider a lay alternative for ‘vital capacity measurements’ in the title.
    - P2 Compensation: The updated text for this section is as follows: “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. ACC cover is not automatic and your case will need to be
        assessed by ACC according to the provisions of the 2002 Injury Prevention
        Rehabilitation and Compensation Act. If your claim is accepted by ACC, you still
        might not get any compensation. This depends on a number of factors such as
        whether you are an earner or non-earner. ACC usually provides only partial
        reimbursement of costs and expenses and there may be no lump sum
        compensation payable. There is no cover for mental injury unless it is a result of
        physical injury. If you have ACC cover, generally this will affect your right to sue
        the investigators. If you have any questions about ACC, contact your nearest
        ACC office or the investigator.”
    - P3 Advocacy: The updated text for this section is as follows: ”If you have any
        questions or concerns about your rights as a participant in this research study
        you can contact an independent health and disability advocate. This is a free
        service provided under the Health and Disability Commissioner Act.
        Telephone: (NZ wide) 0800 555 050
        Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT)
        Email (NZ wide): advocacy@hdc.org.nz
    - Please remove the section “I understand that if I have any complaints or
        concerns about this research” (including the administrator’s contact details) from
        both the information sheet and consent form. It is more appropriate for
        participants to contact researchers.
    - Please refer to the committee as the Upper South A Regional Ethics Committee.
    - The footers of the information sheet and consent form should contain the full
        study title, a version number and/or date.
    General
    - Will the 192 participants include the 10 control group participants?




URA Minutes 28 May 2007                                                                      4
5. PROTECT-PACE STUDY - The protection of the left ventricular function during right
   ventricular placing. Does right ventricular high-septal pacing improve outcome
   compared with right ventricular apical pacing. Protocol version 1.10 dated
   25/11/2006
   Investigators: Dr I Crozier, Dr I Melton, Dr R Park, Dr R Troughton
   Ethics ref: URA/07/05/039
   Spokesperson: Russell Scott

    Approved subject to conditions
    Russell Scott to review

    Requests
    - Please forward the NRL certificate as soon as it is available.
    - A Part 5 Human Tissue declaration is required.
    - The committee would like to view the standard pacemaking information pamphlet
        that is handed out to these patients.
    Application form
    - P7 QA8.1: It is noted that this section has not been completed accurately.
    - P10 QB16: Please complete this section.
    - P11 QC3: The compensation offered must be at least equal to what ACC would
        offer.
    Information sheet
    - Provide a meaningful lay title
    - The information sheet and consent form must be written in lay language. Please
        check both documents.
    - State that this is a sponsored trial and identify the sponsor.
    - P2 Procedure: The second paragraph mentions that data will be saved on a
        diskette. Please clarify what will happen to this diskette.
    - Include a ‘confidentiality’ paragraph that explains whether data will be
        anonymised, how it will be stored and destroyed etc.
    - Specify where the blood samples will be sent for analysis, and explain how they
        will be disposed of.
    - P2 Purpose: Please amend the first sentence to read, “You are invited to
        participate in a clinical study comparing…”.
    - P4 General Information: Please provide the departmental telephone number
        rather than the main switchboard number.
    - P4 General Information: Please update the Advocacy Service information as
        follows: If you have any questions or concerns about your rights as a participant
        in this research study you can contact an independent health and disability
        advocate. This is a free service provided under the Health and Disability
        Commissioner Act.
        Telephone: (NZ wide) 0800 555 050
        Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT)
        Email (NZ wide): advocacy@hdc.org.nz
    - Please refer to the committee as the Upper South A Regional Ethics Committee
    Suggestions
    - To clarify the procedure, it is suggested to include a diagram in the information
        sheet.



URA Minutes 28 May 2007                                                                 5
    Consent form
    - P6: Please provide the departmental telephone number rather than the main
      switchboard number.

6. SPIRIT V - A clinical evaluation of the XIENCE V Everolimus Eluting Coronary Stent
   System in the treatment of patients with de novo coronary artery lesions - protocol
   05-369, version 6.0 dated 22/11/2006
   Investigators: Dr D McClean, Dr D Smyth, A/Prof J Elliot, Prof M Richards, Dr A
   Moynagh
   Ethics ref: URA/07/05/040
   Spokesperson: Alison Luckey

    Approved subject to amendments
    Alison Luckey to review

    Requests
    - Form B: The sixth bullet point (“Relationship of proposed research…”) has not
        been answered fully.
    - As extra blood will be taken for CK and CK-MB analysis, a Part 5 Human Tissue
        declaration is required.
    - Please forward written evidence of Maori consultation as soon as it is available.
    Application form
    - P8 QA8.1: It is noted that this section has not been completed accurately.
    - P11 QC3: The compensation offered must be at least equal to what ACC would
        offer.
    Information Sheet
    - Provide a more meaningful lay title.
    - Pease ensure lay language is used throughout the information sheet and consent
        form.
    - P1 Introduction: State that 50 participants are sought in Christchurch.
    - P5: The information about Advocacy services should read, “If you have any
        questions or concerns about your rights as a participant in this research study
        you can contact an independent health and disability advocate. This is a free
        service provided under the Health and Disability Commissioner Act.
        Telephone: (NZ wide) 0800 555 050
        Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT)
        Email (NZ wide): advocacy@hdc.org.nz
    Consent form
    - P7 3rd statement: Please change ‘NZ Multi-Region Ethics Committee’ to ‘Upper
        South A Regional Ethics Committee’.
    General
    - Clarify who is paying for the stents.
    Suggestions
    - P5, first statement: It is suggested to remove ‘unbiased’.




URA Minutes 28 May 2007                                                              6
7. Residual hearing levels post-surgery for the Southern Cochlear Implant Program -
   baseline levels
   Investigators: G Vraich, Dr V Looi (Supervisor), P Bird
   Ethics ref: URA/07/05/041
   Spokesperson: Edie Moke

    G Vraich and Dr V Looi attended the meeting

    Approved subject to amendments
    Edie Moke, Carolynn Bull, John Horwood to review

    Requests
    - A locality assessment is required from the University of Canterbury.
    Application form
    - P13 QF3.1: The committee is unsure what the answer to this question means.
        The researcher is encouraged to discuss further with their Maori advisor and
        forward a comment to the committee.
    Information sheet
    - Please provide a clearer lay title.
    - The committee should be referred to as the ‘Upper South A Regional Ethics
        Committee’.
    - The footers of the information sheet and consent form should contain the full
        study title, a version number and/or date.
    - Please avoid the use of abbreviations such as CI.
    - Please simplify the language of the information sheet and introduction letter.
    General
    - The study data must be stored for 10 years


8. A multicenter, randomised, double-blind, placebo-controlled, parallel-group study of
   intravenous Methylnaltrexone (MOA-728) for the treatment of post operative Ileus.
   Protocol 6.0 01/03/2007
   Investigators: Prof F Frizelle, Dr G Robertson, Dr J Frye
   Ethics ref: URA/07/05/042
   Spokesperson: Sharon English

    Approved subject to amendments
    Nicky Murray, Alison Luckey and Sharon English to review

    Requests
    - Please forward a Part 4 declaration signed by Professor Frizelle as soon as it is
        available.
    - A Form B is required.
    Application form
    - P12 Section C: This study is a clinical trial. Please complete section C.
    Information sheet
    - Provide a meaningful lay title.
    - Please ensure lay language is used throughout the information sheet and
        consent form.
    - Ensure the information is appropriate for New Zealand – for instance, attention is
        required where drugs are mentioned that are not available in New Zealand.


URA Minutes 28 May 2007                                                                   7
    -  The information sheet refers to the ‘study doctor’s office’. This is generally known
       as the ‘research office’.
    - P1 Introduction: Please remove the third paragraph in this section.
    - P1 Introduction: State how many participants are sought in Christchurch.
    - P2 first paragraph: This information may be better placed at the beginning of the
       first paragraph in the introduction section.
    - P2 second paragraph: This information is repeated elsewhere in the information
       sheet.
    - P2 Test article: Please amend the first sentence of the second paragraph to
       read, “The medication will be given to you through a vein in your arm…).
    - P6 Risks to unborn children: The committee raised a query regarding the period
       of time that a male participant in the study should continue to use birth control
       after completing the study. It is thought that this may be 72 days rather than 15
       days.
    - Include the information that 50% of people taking the study drug experience
       abdominal pain.
    - Please provide the contact details of the Principal Investigator rather than Dr
       Dobbs on the information sheet.
    General
    - Please clarify why epidural pain relief is not available to participants post surgery.
       Explain what the standard practice is.
    - Please clarify why participants taking placebo are not permitted to take laxatives.
    - Explain how screening for Hepatitis and HIV will be carried out.
    Suggestions
    - It is suggested to use ‘medication’ rather than ‘test article’.
    - It is not necessary to state in the information sheet that a mobile or home phone
       is required as this can be determined at screening.


9. Pre-to-post cochlear implant surgery comparisons for speech and environmental
   sound perception
   Investigators: J Arnephy, Dr V Looi (Supervisor)
   Ethics ref: URA/07/05/043
   Spokesperson: John Horwood

    J Arnephy and Dr V Looi attended the meeting.

    Approved subject to amendments
    John Horwood, Edie Moke and Carolynn Bull to review

    Requests
    - Please submit the invitation letter for ethical approval.
    - P12 QE2: The ‘statement of rights’ was not included in the application. Please
       submit this document.
    - A locality assessment from the University of Canterbury is required.
    Application form
    - P13 QF3.1: The committee is unsure what the answer to this question means.
       The researcher is encouraged to discuss further with their Maori advisor and
       forward a comment to the committee.




URA Minutes 28 May 2007                                                                   8
    Information sheet
    - The information sheet is not appropriate for the control group. Please submit a
        suitable sheet for review.
    - Please simplify the language of the information sheet.
    - The term ‘participants’ is preferred to ‘subjects’.
    - The footers of the information sheet and consent form must contain the full study
        title, a version number and/or date.
    - Please refer to the committee as the ‘Upper South A Regional Ethics Committee’.
    Consent form
    - The consent form should be rewritten according to the guidelines.
    General
    - Please clarify how the control group will be recruited.

MATTERS ARISING
1. Is CNP/NTproCNP better than PSA as a marker of prostate cancer?
   Investigators: Prof G Nicholls, Prof T Yandle, Dr T Prickett, Mr F Kueppers, Mr P
   Davidson
   Ethics ref: URA/07/04/028
   Spokesperson: Sharon English

    Approved subject to conditions
    Sharon English, Alison Luckey and Edie Moke to review

    Requests
    - A locality assessment from the Christchurch School of Medicine is required.
    - A Part 5 Human Tissue declaration is required.
    - Please provide evidence of Maori consultation.
    Information sheet
    - If it is intended to use the data from this study in future research, this must be
        included in the information sheet and consent form.
    - Repeat the departmental telephone number at the end of the information sheet.
    - Include the full study title, a version number and/or date in the footer of the
        information sheet and consent form.
    General
    - Please explain whether in going through medical records, cardiovascular
        information will be used and linked to cardioendocrine information, for additional
        studies. If so, this must be included in the information sheet.


CORRESPONDENCE

1. Letter from G Witte, Secretary of the Human Ethics Committee, University of Otago

    The committee is unsure what Mr Witte means. Please clarify.




URA Minutes 28 May 2007                                                                      9
MINUTES OF LAST MEETING
Minutes of meeting 28 April 2007

Approved.

PROTOCOLS GIVEN FINAL ETHICAL APPROVAL UNDER
DELEGATED AUTHORITY
1. Comparison of late-night salivary cortisol levels with standard screening tests
   for Cushing’s Syndrome in obese patients with type 2 Diabetes
   Investigators: Dr E Ellis, Dr S Soule, Dr P Hunt, Dr H Lunt
   Locality: Christchurch Hospital
   Ethics ref: URA/07/03/018
   The Committee is satisfied that this study is not being conducted principally for the
   benefit of the manufacturer or distributor of the medicine or item in respect of which
   the trial is being carried out.

2. Endometrial sampling and receptivity study
   Investigators: G Evans, Mr G Phillipson, Dr P Benny
   Localities: Christchurch Women’s Hospital, St George’s Hospital
   Ethics ref: URA/07/03/021
   The Committee is satisfied that this study is not being conducted principally for the
   benefit of the manufacturer or distributor of the medicine or item in respect of which
   the trial is being carried out.

PROGRESS REPORTS SUBMITTED
1. Genes, Behaviour, Personality and Anorexia Nervosa
   Investigator: Prof P Joyce
   Ethics ref: CTY/02/10/158
   Allocated to: Tom Marshall

2. Low-dose Cytotoxics as “Anti-angiogenesis Treatment” following Adjuvant Induction
   Chemotherapy for Patients with ER-negative and PgR-negative
   Investigator: Prof B Robinson
   Ethics ref: CTY/02/10/163
   Allocated to: Alison Luckey

FINAL REPORTS SUBMITTED

1. Neurodevelopmental outcomes of Very Low Birth Weight Infants at Age 4 years:
   Role of Neuroanatomical and Socio-Environmental Factors
   Investigator: Dr L Woodward
   Ethics ref: CTY/02/10/174
   Allocated to: Nicky Murray




URA Minutes 28 May 2007                                                                 10
2. Quality of drinking-water and its relation to gastrointestinal disease in children
   Investigator: A Ball
   Ethics ref: CTY/01/03/026
   Allocated to: Sharon English


SUMMARIES OF RESULTS RECEIVED
1.   Neurodevelopmental outcomes of Very Low Birth Weight Infants at Age 4 years: Role of
     Neuroanatomical and Socio-Environmental Factors
     Investigator: Dr L Woodward


SERIOUS ADVERSE EVENTS
SAEs 16 April 2007 – 14 May 2007 (see separate listing)

Meeting concluded at 19:50hrs




URA Minutes 28 May 2007                                                                     11

				
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