LOWER SOUTH REGIONAL - DOC 1

Document Sample
LOWER SOUTH REGIONAL - DOC 1 Powered By Docstoc
					                                                                        Agenda – July meeting
                                                                               File RE08-04-6
                                                                                Page – - 1 -




             LOWER SOUTH REGIONAL
         ETHICS COMMITTEE MEETING
        TO BE HELD ON TUESDAY 7 OCTOBER 2008
                      MEETING ROOM L4.4
                         Level 4, Ministry of Health
             229 Moray Place, Dunedin at 1.15 p.m.


MEMBERS PRESENT:

        Dr. Phil White       Deputy Chair
        Mr. Kenneth Copland
        Associate Professor Alan Payne
        Mrs. Gwen Neave
        Dr. Rosemary Beresford
        Associate Professor Clare Robertson
        Karen Goffe
        Dr. Khyla Russell
        Mrs. Sandy Elkin
        Dr. Sarah Derrett

APOLOGIES:

        Dr. Nikki Kerruish   Leave
        Jenny Beck           Leave


IN ATTENDANCE:

        Riria Tautau-Grant                                               Administrator
        Rose Skerten, Rose Skerten, Lisa Houghton       LRS/08/10/054    1.30
        Dr Shyamala Nada-Raja, and others.              LRS/08/10/049    1.50
        Siti Zaleha Hamzah, Ms Eithne MacFadyen.        LRS/08/10/055    2.10
        Rebekah Scott, Associate Professor Greg Anson   LRS/08/10/050    2.30
        Mr Geoff Noller                                 LRS/08/10/048    3.40
                                                                               Agenda – July meeting
                                                                                      File RE08-04-6
                                                                                       Page – - 2 -



MINUTES OF THE PREVIOUS MEETING

   -   The minutes of the meeting held 2 September 2008, to be confirmed.

NEW PROTOCOLS



  1. Project Key: LRS/08/10/047
     Full Title:    Multicentre randomised controlled trial of pelvic floor muscle training to
                    prevent pelvic organ prolapse in women. (PREVPROL).
     Investigators: Professor Don Wilson, Gaye Ellis, Dr. Helen Paterson, Associate
                    Professor Peter Herbison, Jean Hay-Smith, Gail Hyland
     Localities:    ODHB, Physio Performance Ltd. Scotland and England

  2. Project Key: LRS/08/10/048
     Full Title:    An evaluation of the Moana House therapeutic community programme.
     Investigators: Dr. Simon Adamson, Dr. Daryle Deering, Mr Terry Huriwai, Ms Moana-O-
                    Hinerangi, Mr Geoff Noller.
     Localities:    Moana House, other localities.

  3. Project Key: LRS/08/10/049
     Full Title:    I-MEDIC: Internet Medical Education for Doctors to reduce Intimate
                    partner violence through Collaboration: A Feasibility Study
     Investigators: Dr Shyamala Nada-Raja, Dr Rob McGee, Associate Professor John D
                    Langley, Nandika Currey, Karen Knightbridge
     Localities:    Own Homes, , University of Otago

  4. Project Key: LRS/08/10/050
     Full Title:    Neural mechanisms underlying the cessation of voluntary movement in
                    Conversion Disorder with motor symptoms
     Investigators: Rebekah Scott, Associate Professor Greg Anson, Associate Professor
                    Brian I Hyland, Dr Elizabeth Franz, Dr Graeme Hammond-Tooke
     Localities:    Neuromotor control Lab, School of Physical Education

  5. Project Key: LRS/08/10/051
     Full Title:    An evaluation of bedside neurological tests in the diagnosis of motor
                    disorders.
     Investigators: Dr. Graeme Hammond-Tooke, Dr. Elizabeth Franz, Professor S. John
                    Sullivan, Mahmoud Amer.
     Localities:    Dunedin Hospital.

  6. Project Key: LRS/08/10/052
     Full Title:    Is Mullerian Inhibiting Substance (MIS) a risk factor for attention deficit
                    hyperactivity disorder (ADHD)?
     Investigators: Dr. Brent Alsop, Associate Professor Ian McLennan, Dr. Paula Sowerby,
                    Dr. Gail Tripp, Ms. Dianne Morrison.
     Localities:    ADHD Research Clinic, Southern Community Labs, MIS Neurology
                    Centre.
                                                                               Agenda – July meeting
                                                                                      File RE08-04-6
                                                                                       Page – - 3 -



  7. Project Key: LRS/08/10/053
     Full Title:    A comparison of two different methods of non-automated visual field
                    testing.
     Investigators: Mr. Gordon Sanderson, Dr. Graeme Hammond-Tooke, Jung-Ji Kim.
     Localities:    Ophthalmology Section, Dunedin School of Medicine.

  8. Project Key: LRS/08/10/054
     Full Title:    Serum 25-hydroxyvitamin D concentrations and its association with
                    parathyroid hormone concentrations in pregnant women in New Zealand.
     Investigators: Rose Skerten, Lisa Houghton, Professor Murray Skeaff, Associate
                    Professor Peter Herbison, Dr. Celia Devenish.
     Localities:    Southern Community Labs, Dept. of Human Nutrition.

  9. Project Key: LRS/08/10/055
     Full Title:    The development of special needs dentistry service in Malaysia - a
                    situational analysis (Based on New Zealand experience.)
     Investigators: Siti Zaleha Hamzah, Professor Robert Love, Ms Eithne MacFadyen, Dr.
                    Noraini Mohd Yunos.
     Localities:    Localities to be confirmed.



RE-APPROVALS

  1. Project Key: LRS/07/08/029
     Full Title:    Interventions for replacing missing teeth: oral implants in fresh extraction
                    sockets immediately loaded with all-ceramic prosthodontic components.
     Investigators: Mr Simon Brown, Associate Professor Alan Payne, Professor Michael
                    Swain, Professor Murray Thomson, Mr Rohana De Silva
     Localities:    School of Dentistry, University of Otago, Dunedin.

  2. Project Key: LRS/05/07/025
     Full Title:    Estimating the disease burden from diabetes using multiple lists of people
                    with diabetes
     Investigators: Claire Cameron, Associate Professor Richard Barker, Dr. Kirsten Coppell,
                    Dr Katrina Sharples, Dr. Fred Lam, Dr. Austina Clark
     Localities:    Dept. of Preventive and Social Medicine and Dept. of Maths & Statistics

  3. Project Key: LRS/06/06/029
     Full Title:    Validation of the disabilities of the arm, shoulder and hand (Dash)
                    questionnaire as an outcome measure for upper limb recovery following
                    stroke.
     Investigators: Bronagh Quinn, Sue Lord (Supervisor)
     Localities:    ISIS Rehabilitation Centre

  4. Project Key: LRS/06/09/040
     Full Title:    A prospective evaluation of matrix metalloproteinase-9 as a predictor of
                    coronary artery in-stent restenosis.
     Investigators: Dr. Michael Williams, Dr. Gregory Jones, Associate Professor Gerard
                    Wilkins.
                                                                              Agenda – July meeting
                                                                                     File RE08-04-6
                                                                                      Page – - 4 -



  5. Project Key: LRS/07/06/022
     Full Title:    Chylomicron associated paraoxanase activity in patients with type 2
                    diabetes and the effect of meals rich in saturated fat and oleic acid.
     Investigators: Assoc. Prof. Patrick Manning, Dr. Wayne Sutherland, Michelle
                    McGrath
     Localities:    Dept. of Medical and Surgical Sciences.

  6. Project Key: OTA/04/08/062
     Full Title:    Influence of bifidobactrerial species on human dendritic cell interactions
     with T         lymphocytes
     Investigators: Dr Margaret Baird, Prof Gerald W Tannock, Dr Sarah Young.
     Localities:    University of Otago.

  7. Project Key: LRS/06/09/037
     Full Title:    The clinical anatomy of the anterior neck muscles
     Investigators: Ewan Kennedy, Professor Helen Nicholson, Associate Professor Susan
                    Mercer, Lyndell Kelly
     Localities:    Dunedin Public Hospital, Oncology, Dept. of Anatomy and Structural
                    Biology, Dunedin

  8. Project Key: OTA/99/06/062
     Full Title:    MULTICENTRE: An Intergroup Phase III trial to evaluate the activity of
                    Docetaxel, given either sequentially or in combination with Doxorubicin,
                    followed by CMF, in comparison to Doxorubicin alone or in combination
                    with Cyclophosphamide, followed by DCMF, in the adjuvant treatment of
                    node positive breast cancer patients IBCSG TRIAL BIG 2-98
     Investigators: David Perez, Blair McLaren.
     Localities:    Oncology and Haemotology Unit, Dunedin

  9. Project Key: LRS/05/06/020
     Full Title:    Activity of bacteriocin-producing Micrococcus luteus Q24 on the
                    bacterial populations occupying human skin
     Investigators: Professor John Tagg, Dr Chris Chilcott, Dr Jeremy Burton
     Localities:    Dept of Microbiology and Immunology Centre for Innovation (BLIS
                    Technologies)

  10. Project Key: LRS/07/06/023
      Full Title:    Body temperature, cardiovascular function and exercise performance
                     following spinal cord injury.
      Investigators: Dr. Philip Ainslie, Dr. Jim Cotter, Associate Professor Greg Anson. Mr
                     Luke Wilson.
      Localities:    School of Physical Education




EXTENSIONS, AMENDMENTS & MODIFICATIONS



  1. Project Key: LRS/07/08/033
                                                                                 Agenda – July meeting
                                                                                        File RE08-04-6
                                                                                         Page – - 5 -



     Full Title:    Reinforcement mechanisms and attention deficit hyperactivity disorder
                    (ADHD)
     Investigators: Dr. Brent Alsop, Dr. Gail Tripp, Dr. Paula Sowerby, Dr. Dianne Morrison.
                    Mr Simon Seal.
     Localities:    Clinic Families: ADHD Research Clinic, Department of Psychology,
                    University of Otago, Dunedin. Control Families: At consenting
                    Dunedin based schools.

  2. Project Key: LRS/05/04/006
     Full Title:    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 treatnment within the BIG 1-98
                    Trial
     Investigators: Dr Blair McLaren, Dr David Perez
     Localities:    Dunedin Hospital

              Received copy of current insurance certificate.


SERIOUS ADVERSE EVENTS

  1. Project Key: OTA/04/11/086
     Full Title:    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
     Localities:    Dept. of Medical and Surgical Sciences

              Eye injury, unrelated.


CORRESPONDENCE

  1. From:         HRC
     Theme:        HRC News issue no. 61 September 2008.
     Action:       For your information.

  2. From:         Sally Cook
     Theme:        European paediatric clinical trials miss priority needs, warns review.
                   BMJ 2008;337:a1551
     Action:       For your information (emailed 11 September 2008)

  3. From:         Sally Cook
     Theme:        Various Items of interest from the September issue of BMJ.
     Action:       For your information (emailed 16 September 2008)
                                                                             Agenda – July meeting
                                                                                    File RE08-04-6
                                                                                     Page – - 6 -



  4. From:      June Chairs meeting minutes
     Theme:     For your information DRAFT
     Action:    For your information (emailed 16 September 2008)

  5. From:      Auckland DHB.
     Theme:     Auckland DHB 2007 Annual Research Report
     Action:    See administrator to review copy. (emailed 22 September 2008)

  6. From:      Sally Cook
     Theme:     Policy regarding retention of committee papers.
     Action:    For your information and action. (emailed 23 September 2008)

  7. From:      Sally Cook
     Theme:     Policy regarding Expert Advice
     Action:    For your information (emailed 29 September 2008)



CHAIRPERSONS DISCRETIONARY

  1. Project Key: LRS/08/07/027
     Full Title:    Influence of pedicle flap design on healing and post operative sequale
                    after lower third molar tooth removal
     Investigators: Samuel Mark Goldsmith, Professor Robert Love, Mr Rohana Kumara De
                    Silva, Mr. Darryl Tong
     Localities:    School of Dentistry

  2. Project Key: LRS/07/04/014
     Full Title:    Childhood obesity: respiratory sleep disturbance and its implications to
                    daytime functioning.
     Investigators: Dr. Barbara Galland, Professor Barry Taylor, Dr. Elizabeth Schaughnecy,
                    Mr. Evan Tan, Ms Carmen Lobb, Mr. Patrick Dawes.
     Localities:    Clinical Research Rooms, Respiratory laboratories, Radiology Dept. ,
                    Dunedin Public Hospital, Dept. of Medical & Surgical Sciences, University
                    of Otago

     As per amendment #1 confirmed at June meeting, these documents confirm that Carmen
     Lobb replaces Phoebe Cleland as Assistant

          Approved documents.
           Letter to parents/ guardians.
           PG infosheet & consent form
           ChildTeen infosheet & consent form
           Teacher infosheet & consent form

  3. Project Key: LRS/08/05/016
     Full Title:    The effect of mepilix lite dressings on the management of radiation-
     induced skin reactions in women with breast cancer.
     Investigators: Dr. Patries Herst, Lyndell Kelly, Noelle Bennett, Jo Tuaine, Katie
                                                                          Agenda – July meeting
                                                                                 File RE08-04-6
                                                                                  Page – - 7 -



                  Diggelmann.
   Localities:    Oncology Department, Dunedin Hospital.

   Amendment #2
       Request to gather more information from participants via questionnaires.
        Documents adjusted to reflect this.

4. Project Key: LRS/08/27/EXP
   Full Title:    Procera all ceramic crowns
   Investigators: Mr Danny Areai
   Localities:    Dental School
        Approved.

5. Project Key: LRS/08/28/EXP
   Full Title:    Closed tibialis anterior tendon rupture.
   Investigators: David Gwynne-Jones
   Localities:    Orthopaedics

          Approved.

6. Project Key: LRS/08/29/EXP
   Full Title:    PHTX 544 Foundations of Mechanical Diagnosis and Therapy
   Investigators: Professor S. John Sullivan.
   Localities:    School of Physiotherapy.

          Approved.

7. Project Key: LRS/08/06/021
   Full Title:    The experience of musculoskeletal disorders and related disability - a
                  qualitative study.
   Investigators: Ms. Helen Harcombe, Dr. David McBride, Dr. Sarah Derrett, Associate
                  Professor Peter Herbison.
   Localities:    Dept. of Preventive & Social Medicine, Participant’s home or other venue.

          Approved add on South Canterbury Site.

8. Project Key: LRS/08/03/007
   Full Title:    The effect of glucose on acute changes In circulating inflammatory
   markers in     overweight individuals.
   Investigators: Associate Professor Patrick Manning, Dr. Wayne Sutherland.
   Localities:    Endocrine Research Unit, Department of Medical and Surgical Sciences

          Changes to the original protocol approved subject to conditions.

9. Project Key: LRS/08/12/EXP
   Full Title:    Audit of Opioid prescribing practice amongst junior doctors working on the
                  orthopaedic ward of Dunedin Hospital.
   Investigators: Joseph McKerra
   Localities:    Dunedin Hospital.
                                                                               Agenda – July meeting
                                                                                      File RE08-04-6
                                                                                       Page – - 8 -




              Approved.

   10. Project Key: LRS/08/22/EXP
       Full Title:    First time birth experiences of Otago mothers.
       Investigators: Ms. Anne Howarth, Dr. Gareth Treharne, Dr. Nicola Swain-Campbell.

              Approved change of title.

   11. Project Key: LRS/06/07/030
       Full Title:    Experiencing palliative care in the community for those not enrolled in a
       hospice        programme
       Investigators: Roslyne McKechnie, Chrystal Jaye, Professor Rod McLeod
       Localities:    Various settings

              Approved change to recruitment.


FINAL REPORTS

The following final reports have been received.

   1. Project Key: LRS/05/07/027
      Full Title:    A randomised controlled trial of GPSI versus Usual Care in the treatment
                     of general practice patients with orthopaedic injuries
      Investigators: Professor Murray Tilyard, Associate Professor Susan Dovey, Associate
                     Professor Jean-Claude Theis, Petros Nitis
      Localities:    South Link Health Inc.

              The researchers report significant reductions in waiting time to first orthopaedic
               assessment suggests that GPSIs may successfully reduce Orthopaedic
               surgeons waiting lists by providing timely and adequate care for many non-
               urgent patients. The researchers intend to publish results in a peer reviewed
               international journal.



   2. Project Key: LRS/07/06/025
      Full Title:    Client initiated aggression against patient support workers in non
                     government organisations.
      Investigators: Chris Gale, Annette Hannah, Nicola Swain-Campbell.
      Localities:    At participants’ discretion

              Results presented as poster - attached - at the Mental Health Services
               Congress. Papers will follow when written.

   3. Project Key: LRS/07/16/EXP
      Full Title:    Survey and health needs assessment of the general health, access to
                     services and lifestyle of residents of Stewart Island (Rakiura), New
                     Zealand.
      Investigators: Jessica Haydon-Clarke, Eileen McKinlay and Helen Moriarty (Supervisors)
                                                                             Agenda – July meeting
                                                                                    File RE08-04-6
                                                                                     Page – - 9 -



   Localities:     Stewart Island.

4. Project Key: LRS/08/04/012
   Full Title:    An exploration of public knowledge about grief
   Investigators: Eunice Chapman
   Localities:    Wanaka.

5. Project Key: LRS/07/11/042
   Full Title:    Transforming notions of disability - a qualitative evaluation of the joint
                  IHC/CCS “Our stories” community education project.
   Investigators: Dr. Nancy Higgins, Dr. Jude MacArthur, Kelly Tikao, Ms Teresa Evans-
                  Turner.
   Localities:     Interviews at a place of the participant’s choosing. Donald Beasley
                   Institute.


6. Project Key: LRS/07/03/004
   Full Title:    Young children’s voices: obtaining information from young children about
                  their experience of illness and hospitalisation
   Investigators: Tess Patterson, Harlene Hayne, Emily Crawford, Ms Nicki Topliss.
   Localities:    Dunedin Public Hospital

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:11
posted:11/25/2011
language:English
pages:9