LOWER SOUTH REGIONAL by mikeholy

VIEWS: 7 PAGES: 8

									                                                                          Minutes – May Meeting
                                                                                 File RE08-04-3
                                                                                    Page – - 1 -




             LOWER SOUTH REGIONAL
         ETHICS COMMITTEE MEETING
                 HELD ON TUESDAY 3 MAY 2005
                     IN THE EDINBURGH ROOM
                 1ST FLOOR, KINGSGATE HOTEL
                             10 Smith St, Dunedin
                                       at 1.15 p.m.




MEMBERS PRESENT:

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

APOLOGIES:

        Dr. Nikki Kerruish - Leave of Absence

IN ATTENDANCE:

        Riria Tautau-Grant                      Administrator

        LRS/05/05/016    Dr. Stephen Assinder & Dr. Joanne Stanton                1.30 p.m.
        LRS/05/05/017    Dr. Niamh Conlon & Dr. Richard Sullivan                  2.30 p.m.
        LRS/05/05/015    Rachael Schembri, Robert G Knight & Dr. Nikolai Titov    3.30 p.m.
                                                                                Minutes – May Meeting
                                                                                       File RE08-04-3
                                                                                          Page – - 2 -

MINUTES OF THE PREVIOUS MEETING

   -   The minutes of the meetings held 5 April were confirmed with the following exception. It
       was noted that Professor Rod McLeod did not attend the meeting as stated.
   -   The minutes of the meetings held 7 April were confirmed

NEW PROTOCOLS



  1. Initial evaluation of an awareness training programme using virtual environments
     following traumatic brain injury
     Investigators: Rachael Schembri, Robert G Knight, Dr. Nikolai Titov
     Ethics Ref:      LRS/05/05/015

       Rachael Schembri, Robert G Knight, Dr. Nikolai Titov attended the meeting at 3.30 p.m.
       Approved in Principle, the committee made the following comments.

       Application:
                 - Pg. 13 Q 12.3 and Pg 14 Q 14.3. As discussed, the committee felt that the
                    responses to these two questions directly contradict each other.
                 - The researchers are asked to consider a contingency that allows inclusion
                    of Maori in the research

       Information:
                 - Advise participants, that this is a Pilot study, and that it is being done as a
                    part of the requirements for a Masters study
                 - Use correct approval statement.
                 - Reward for participants

       Part V:
                   -   Please ensure that the Part V has been completed. Eg. is signatory is
                       required from ISIS or Wakari Hospital.

       The committee forward the following suggested amendments, which do not affect the
       applications ethical approval status.

                   -   The committee suggests that the researchers keep Ngai Tahu Research
                       Committee informed of the study and subsequent sub-studies.
                   -   The committee requests a copy of all correspondence with the research
                       committee for our records.

       To Check:
                   -   Clinical psychologists are not listed under the ACC Act. Therefore cannot
                       technically perform clinical trials. May perform research, but not clinical
                       trials.

  2. Development of non-invasive, diagnostic and prognostic tests of prostate cancer
     Investigators: Dr. Stephen Assinder, Mr K Samalia, Dr. J Stanton
     Ethics Ref:    LRS/05/05/016

       CLOSED MEETING
                                                                           Minutes – May Meeting
                                                                                  File RE08-04-3
                                                                                     Page – - 3 -


3. The VALID Trial: is ventilation affected by leaving in dentures
   Investigators: Dr. Niamh Conlon, Dr. Richard Sullivan
   Ethics Ref:    LRS/05/05/017

   Dr. Niamh Conlon and Dr. Richard Sullivan attended the meeting at 2.30 p.m.
   Approved in Principle, the committee made the following comments

   Application
             -    Locality Assessment is required.

   Information sheet
             - Advocacy statement
             - Approval statement
             - ACC statement
             - Para 3.       Expand on the information provided, giving a reassurance
                             that dentures will be returned.
             - Place Information sheet and consent form on a letterhead


   The committee forward the following advice, which does not affect the application‟s final
   ethical approval status
              - It is suggested that the study is limited to those people who have full upper
                  and lower dentures.

4. Experiences of interdisciplinary team members involved in the rehabilitation of
   clients with somatoform disorder
   Investigators: Bridget Dickson, Dr. Jean Hay-Smith, Dr. Sarah Dean
   Ethics ref:     LRS/05/

   Deferred, the committee made the following comments.

   The committee has taken on board the fact, that the researcher is anxious to begin this
   study. The committee has serious reservations about the implications of this study for the
   emotional safety of the researcher and her colleagues, and the potential damage to
   interpersonal relationships.

   The committee suggests that the researcher contact the Chairperson to discuss this.

   Other comments of the committee include;

   Application
             -    Locality assessment form is required.

   Information sheet
             - Correct approval statement (as it appears twice in the information sheet)

   The committee forward the following advice, which does not affect the application‟s final
   ethical approval status

              -   Consider building in some form of „Supervision‟ for both the researcher
                  and researched.
                                                                               Minutes – May Meeting
                                                                                      File RE08-04-3
                                                                                         Page – - 4 -




RE-APPROVAL REQUESTS


A progress report has been received and continued approval is requested for the following study:


   1. MULTICENTRE: Investigation of a major new prognostic factor for brain tumours
      (gliomas)
      Investigators: Janice Royds, Prof A Braithwaite, Ms S Jackson, Mr E Mee, Mr J
                     Bonkowski, Mr V Balakrishnan
      Ethics Ref:    OTA/01/11/107

       Approved


EXTENSIONS, AMENDMENTS & MODIFICATIONS



   1. Decision making and response action
      Investigators: Dr Elizabeth Franz
      Ethics Ref:    OTA/04/09/074

       The committee request the researchers comments on the following matters;

                  -   The committee wanted to know the name of the mood questionnaire
                      and requested information on its reliability and validity.

                  -   The committee wanted to know how the scale fits in in terms of the original
                      study - ie what are participants being asked to do with respect to the
                      original study and this questionnaire.

                  -   The committee questions if the original information sheets and consent
                      form need to be altered to include the fact participants will be asked to
                      complete this measure. Copies of the amended information and consent
                      forms need to be forwarded to the committee.

                  -   The committee thought it important that the participants were aware that
                      their responses to the mood scale would be scored. The Committee also
                      questioned what the researchers were planning to do if they identified
                      participants with high levels of depression.

   2. The effect of selenium supplementation on clinical outcome in high risk cardiac
      patients with coronary artery disease
      Investigators: Dr Nathalie van Havre
      Ethics Ref:     OTA/04/04/035

       The committee would like to see this request to amend, placed in the context of the
       previous study.
                  - Provide more information about the process of accessing names from the
                                                                          Minutes – May Meeting
                                                                                 File RE08-04-3
                                                                                    Page – - 5 -


                 logbook. What gives the right to do this, eg. Is the clinician a member of
                 the Dept?
             -   Would like to see this placed in the context of the previous study
             -   This is a new source of participants, how many people have already
                 participated, and how many more are required ?

3. Oxidative stress and the effects of antioxidant therapy in people with the metabolic
   syndrome
   Investigators: Dr Patrick Manning, Dr Wayne Sutherland, Professor Robert Walker,
                   Mrs Sheila Williams, Ms Eleanor Murphy
   Ethics Ref:     OTA/04/11/086

   Approved.
            -    Please ensure correct formatting of page breaks on the Information sheet,
                 and forward a revised copy to the committee, for our records.

4. Reward dysfunction: A putative model for attention deficit hyperactivity disorder
   (ADHD)
   Investigators: Dr. Gail Tripp, Dr Brent Alsop, Mr Ben McEachen, Ms Dianne Morrison,
                  Ms Holly     Fentiman, Dr. Paula Sowerby, Ms Sasha Gold, Ms Brigette
                  Gorman, Simon Seal
   Ethics Ref:    OTA/03/02/006

   Approved with thanks.
   The committee is highly impressed with the calibre of the documentation received in
   these requests for modifications.

   Two proposals of amendment were submitted and approved as below.
   Request one to add Simon Seal to this study
   Request two some minor grammatical changes are requested to Page 2 of the
   information sheet. These were noted by Dr. Gail Tripp.

5. Effect of BLIS-producing Streptococcus salivarius K12 on the incidence of
   recurrent tonsillitis in children
   Investigators: Mr Patrick Dawes, Professor John Tagg, Dr Chris Chilcott, Dr Jeremy
                    Burton
   Ethics Ref:      OTA/04/06/047

   Approved subject to the following conditions being met;
             - children‟s consent is required. Please include a children‟s consent form.
             - Explain how the tonsils going to be disposed of or destroyed.
             - Is additional consultation required?
             - It is recommended that the researchers read the ODHB Maori protocols
                and tikanga best practice, to consider whether this amendment constitutes
                an issue for Maori participants
                                                                              Minutes – May Meeting
                                                                                     File RE08-04-3
                                                                                        Page – - 6 -


  6. BIG 2-98/IBCSG Trial 20-98 Adjuvant Taxotere Trial
     Investigators: David Perez, Blair McLaren
     Ethics Ref:    99/06/062

     These amendments were forwarded to Professor Laverty and Dr. Phil White. The
     committee received Prof. Laverty‟s report, and accepted the recommendations.
        - Protocol Amendment 4 dated 18 November 2004 with a document
            detailing content and rationale for amendment changes
        - A copy of a file note acknowledging a discrepancy within Amendment
            4 dated 18 November 2004
        - Letter from the Breast International Group that provides an overview
            to the changes made to the protocol.



MATTERS ARISING-



  1. Breast International Group (BIG) Trial 1-98/IBCSG Trial 18-98 Bone Sub Study
     investigating bone density and bone loss without baseline information for
     postmenopausal women with operated breast cancer, randomized and receiving
     adjuvant Letrozole Vs Tamoxifen treatment within the BIG 1-98 Trial
     Investigators: Dr Blair McLaren, Dr David Perez
     Ethics Ref:     LRS/05/04/006

     Noted

  2. Optimising the procdures for the isolation proliferation, characterisation and
     differentiation of the mesechymal stem cells (MSCs) from adult human bone
     Marrow
     Investigators: Dr Deborah Stuart, Dr Faed.
     Ethics ref:      LRS/05/04/

     At the request of the researcher, the committee reviewed its comments. The committee
     deferred this study on the basis that the committee felt strongly that information to the
     participant needs to be full and clear, and that these were essential, rather than
     cosmetic points.

     The following points were reiterated
         - Patients having HIV testing need to have counselling. Is this being
             provided?

     Application
        - F3.2       The committee recommends that researchers contact Christine
            Rimene, to ensure that appropriate parties are consulted, and that research is
            undertaken in an appropriate manner.
        - Ensure that the choice of the manner of disposal be the right of the donor or
            individual to decide what happens, and that this needs to be built into the
            protocol; eg. Information sheet might suggest as follows “We are going to give
            you (the participant) the ability to decide … ”

     Information Sheet
                                                                              Minutes – May Meeting
                                                                                     File RE08-04-3
                                                                                        Page – - 7 -


         -   Provide information about bone marrow aspirations and the discomfort it entails.
         -   Provide information about the implications of the tests for the individual, rather
             than just what the tests are.
         -   Acknowledge that this is an invasive procedure.



CORRESPONDENCE



  1. Update Xenotransplantation                                          Noted

  2. Clinical Research Conference – Information                          Noted
     May 27 & 28, Waipuna Hotel & Conference Centre

  3. Ministry of Health Newhealth                                        Noted
     Volume 6 No.7 15 April 2005

  4. NEAC 3rd Annual Report                                              Noted

  5. Ethics Review Issue 4                                               Noted


  6. Newsletter HRC                                                      Noted
     Issue No. 47, March 2005



GENERAL BUSINESS



  1. Annual Report 2004

  2. Consultation with Maori
        - Discussion regarding stating that we required evidence of consultation with Maori



CHAIRPERSONS DISCRETIONARY APPROVALS



  1. The Contribution of family and school factors to the academic functioning of
     children with ADHD
     Investigators: Sarah Fahey
     Ethics Ref:     LRS/05/04/CPD

  2. The contribution of family factors to the childrens emotional functioning
                                                                          Minutes – May Meeting
                                                                                 File RE08-04-3
                                                                                    Page – - 8 -


       Investigators: Ms Amy Smith
       Ethics Ref:    LRS/05/05/CPD

   3. Retrospective Review Of A Patients Neurorehabilitation Treatment - A Student
      Study
      Investigators: Justine Grieve
      Ethics Ref:    LRS/05/06/CPD

   4. Gout in the Community
      Investigators: Carl Harmer, Sanjeeva Herath, Louisa Metcalf, Bridget Watson, Nusrat
                     Zahan, Tim Medlicott
      Ethics Ref:    LRS/05/06/CPD



FINAL REPORTS

The following final reports were received.

   1. Active movement programme for special focus kindergartens
      Investigators: Allison Brown, Et al
      Ethics Ref:    STH/04/09/15

   2. Neuropsychological assessment of prospective memory and complete attentional
      ability using virtual environment with participants with brain injury
      Investigators: Dr. Nick Titov, Professor R Knight
      Ethics Ref:       OTA/04/04/028

   3. A study to assess risk factors that may affect a choice to suicide in rural Southland
      Investigators: Dr Keri Fitch
      Ethics Ref:    STH/03/12/22

                                             Meeting Ends

								
To top