Minutes – April Meeting File RE08 04 4 by hdj16238

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									                                                                         Minutes – April Meeting
                                                                                 File RE08-04-4
                                                                                       Page – 1




              LOWER SOUTH REGIONAL
          ETHICS COMMITTEE MEETING
             TO BE HELD ON TUESDAY 4 APRIL 2006
           MEETING ROOMS GF7 and GF 8
           GROUND FLOOR, MINISTRY OF HEALTH
             229 Moray Place, Dunedin at 1.15 p.m.


MEMBERS PRESENT:

         Mrs. Jenny Beck     (Chair)
         Dr. Phil White      (Deputy Chair)
         Mrs. Fay McDonald
         Mr. Kenneth Copland
         Dr. Alan Payne
         Dr. Clare Robertson
         Dr. Rosemary Beresford
         Dr. Nikki Kerruish
         Dr. Gail Tripp
         Dr. Khyla Russell
         Mrs. Gwen Neave
         Mrs. Sandra Elkin




IN ATTENDANCE:

         Riria Tautau-Grant                                           Administrator
         LRS/06/04/016 Dr. Nigel Harnett                              Researcher 1.30 p.m.
         LRS/06/04/017 Dr. Barbara Galland & Mr Patrick Dawes         Researcher 2.30 p.m.


MINUTES OF THE PREVIOUS MEETING

   -   The minutes of the meeting held 7 March 2006 were confirmed.
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NEW PROTOCOLS

  1. Project Key: LRS/06/04/016
     Full Title:    Post-operative pain management following arthroscopic rotator cuff repair.
                    A comparison of inter-scalene block with subacromial bursal infusion
     Investigators: Dr. Nigel Hartnett, Simon McMahon, John Hyndman, Michael Chin.
     Localities:    Mercy Hospital, Dunedin Hospital, University of Otago.

                                                                                   DEFERRED
     Dr. Nigel Harnett attended the meeting at 1.30

     Application Form
        1. 8.2    Supervisor’s signature is required
        2. 10     Amend, the correct answer to this is yes,
        3. D2     State that the participants will be approached by the Clinician.
        4. D7     The data is health information, so must be kept for 10 years,
        5. F3.1 As the discussions revealed that there would be some impact on Mäori
                  Health, the researcher is asked to give some thought as to how to address
                  the issue of Mäori participating
        6. C      Amend the application. This is a Clinical trial. The Committee notes that
                  the incorrect box has been ticked, but that it has also received Form A.

     Information sheet
         7. Separate the information sheet and consent form. Administrator to forward
             website details
         8. Use a shorter title. The example discussed suggested ending the present title at
             “shoulder surgery”
         9. Add a footer, with the version number and date
         10. Place information sheet on a letterhead
         11. Include the correct local advocacy statement
         12. Use the correct approval statement
         13. Pg. 1 remove the word introduction
         14. Pg. 1 Para 1 change “… affect your levels of pain…” to “… affect levels of pain
             …”
         15. Pg. 1 Para 2 change “… anaesthetics. Either …you as you are …” to “…
             anaesthetics in patients having an …”
         16. Explain the term randomised
         17. Simplify the language used
         18. Keep the tenor of language used consistently direct
         19. Pg. 2 Para 2 remove numbering, and keep explanation flowing. Eg. Instead of “…
             are 1. Patients will have …”use “… are that patients will have …”
         20. Pg. 2 Para 3 as above. remove the numbering, and keep the information flowing.
         21. Pg. 2 Para 6, modify the participation paragraph
         22. Pg. 2 Para 11, add that data will be kept for 10 years

     Locality assessments
        23. These should be signed by appropriate signatories, and returned

     The committee made the following suggested amendments, which do not affect the
     applications approval status.
        24. The committee suggest that the randomisation schedule is held by someone who
            is not associated with the actual research
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       25. Caution regarding potential for biasing the research
       - Make it clear that this study is a comparison
       - Be careful not to inform participants which group you think will do better

2. Project Key: LRS/06/04/017
   Full Title:    The use of Pulse Transit Time (PTT) in the detection of sleep disruption
                  and respiratory events in children with habitual snoring
   Investigators: Dr. Barbara Galland, Professor Barry Taylor, Mr Patrick Dawes, Mrs
                  Rachel Sayers, Ms Jessie P Bennison
   Localities:    Paediatrics Outpatients, Dunedin Hospital, Unviersity of Otago,
                  Paediatrics clinical research rooms.

                                                  APPROVED SUBJECT TO CONDITIONS
   Application
      1. Pt 4     This should be signed by a signatory who is not also involved in the study
      2. C1.      Keep the language consistent
      3. F3.1     The Committee notes that the recommendations from the consultation
                  process have been taken on board
       4. F3.1    Provide a copy of the consultation undertaken with Christine Rimene.

   All attachments
       5. Provide copies containing a footer with a version no. and footer

   Advertisements
      6. Provide a “remove by” date

   Information sheets
       7. Use the standard localised advocacy statement so as to ensure notification of
          contact for Mäori issues

   Parent information sheet
      8. Pg. 1 Para 1 Explain what pulse transit time involves
      9. If this is research for an academic qualification, then state this in the information
          sheet
      10. Tell parents that travel and parking costs will be reimbursed

   Consent form
     11. Provide a consent form for children

   Locality assessment
      12. Provide signed copies of the locality assessment

   The committee made the following suggested amendments, which do not affect the
   applications approval status.
      13. Regarding No. 3 above, the Committee advises that if recruitment occurs at Te
          Kura Kaupapa Mäori, then the children’s information and consent forms will need
          to be translated into te reo Mäori, which is the language of instruction
      14. Grammatical corrections;
      - Attachment A; Thank you is two words
      - Attachment D; Provide a date by which the advertisement should be removed
      - Attachment E; Provide a date by which the advertisement should be removed
      - Attachment F; Paragraph 4, remove the apostrophe from the word its
      - Attachment G; Change “4 small leads will be place…” to “… 4 small leads will be
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             placed …”
         -   Attachment H; Keep the language consistent



REAPPROVAL



  1. Project Key: OTA/04/06/052
     Full Title:    Impact of parent behaviour management training on the quality and nature
                    of parent-child interactions
     Investigators: Holly Fentiman, Dr E Gail Tripp, Ms Adell Cox
     Localities:    Paediatric Outpatients and CAFS

                                                                              REAPPROVED



EXTENSIONS, AMENDMENTS & MODIFICATIONS



  1. Project Key: OTA/04/06/052
     Full Title:    Impact of parent behaviour management training on the quality and nature
                    of parent-child interactions
     Investigators: Holly Fentiman, Dr E Gail Tripp, Ms Adell Cox
     Localities:    Paediatric Outpatients and CAFS
                  See also reapprovals no.1
                  Ms Jo Prince and Ms Jenny Long will be responsible for coding the parent
                    child interactions.
                  Confidentiality statements received

                                                   APPROVED SUBJECT TO CONDITIONS
         -   Confidentiality statement should be phrased in such a manner that it remains
             binding. The suggested wording to add is “… now and at any time in the future”
         -   Use the standard localised advocacy statement so as to ensure notification of
             contact for Mäori issues
         -   Adjust the approval statement to reflect approval by the Lower South Regional
             Ethics Committee

  2. Project Key: OTA/03/02/006
     Full Title:      Reward dysfunction: a putative model for attention deficit hyperactivity
                      disorder (ADHD)
     Investigators: Dr. Gail Tripp, Dr. Brent Alsop, Mr. Ben McEachen, Ms Dianne Morrision,
                      Ms. Holly       Fentiman, Dr. Paula Sowerby, Katrina Sugre, Brigette
     Gorman,          Simon Seal.
     Localities:      ADHD Research Clinic, Dept Psychology, University of Otago
                                                                                    APPROVED
         - Change to control and clinic demographic questionnaires designed to clarify the
              situation with regard to household income.
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MATTERS ARISING



  1. Project Key: LRS/06/02/003
     Full Title:    Effect of meals rich in thermally oxidised polyunsaturated fat and saturated
                    fat on circulating numbers of endotelial microparticles.
     Investigators: Dr Wayne Sutherland, Dr Michael Williams, Dr Paul A Hessian.
     Localities:    Department of Medical and Surgical Sciences, Dunedin Hospital.
                                                                                    APPROVED
         - The Committee has taken on board the situation.

  2. Project Key: LRS/06/03/11
     Full Title:    Factors affecting the perception of Dyspnoea in obese subjects
     Investigators: Professor Robin Taylor, Dr. Tim Sutherland, Mrs Jan Cowan.
     Localities:    Otago Respiratory Unit, and Cardiology Dept. Dunedin Hospital.

                                               APPROVED SUBJECT TO CONDITIONS
     Information sheet
         - Use the standard localised advocacy statement so as to ensure notification of
            contact for Mäori issues

  3. Project Key: LRS/06/03/13
     Full Title:    What is it like for older women to live with depression? A hermeneutic
                    phenomenological study.
     Investigators: Jeanette Allen
     Localities:    Various

         -    Advise researcher to refer to the Otago Polytechnic’s policies



GENERAL BUSINESS

  1. From            Dr. Phil White
     Theme           Privacy of lab test results (DHB’s and Labs)
     Action          Discussion re progressing this issue

         -    Noted that the original letter was not circulated.



CHAIRPERSONS DISCRETIONARY

  1. Project Key: OTA/00/07/045
     Full Title:    Randomised phase III trial to compare radiation therapy alone with
                    radiation therapy and concomitant anti-EGFr antibody (Cetuximab) for
                    locally advanced squamous cell carcinomas of the head and neck
     Investigators: North, Dr C J, Various
     Localities:    Oncology.
     Outcome:       RE-APPROVED
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FINAL REPORTS

The following final reports have been received, and may be requested from the administrator.
   1. Project Key: STH/03/02/002
      Full Title:    A community based primary prevention programme in New Zealand for
                     children and adolescents at risk of non insulin dependant diabetes mellitus
                     (NIDDM) by modifying some associated risk factors
      Investigators: Amanda Benson
      Localities:    Human Performance Laboratory, Southland Institute of Technology
                                                                            NOTED, ARCHIVE

   2. Project Key: LRS/06/001/CPD
      Full Title:    Influenza Pandemic - Community preparedness and ethical considerations
      Investigators: Mr. Richard Walsh, Kati Taghavi, Claus Bader, Gloria Dainty, Liz Briggs,
                     Kynana Bazley, Ross Scott-Weekley, Mel Lauiti, Rebecca Thomas.
      Localities:    University of Otago. Dept. of Social & Preventive Mediciine
                                                                            NOTED, ARCHIVE
          - Summary of findings provided



                                     MEETING ENDED

								
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