DOC

LOWER SOUTH REGIONAL

By Judith Ward,2014-01-10 22:30
6 views 0
LOWER SOUTH REGIONAL

    Minutes June Meeting

     File RE08-04-6

    Page - 1 -

    LOWER SOUTH REGIONAL

    ETHICS COMMITTEE MEETING

    HELD ON TUESDAY 10 JUNE 2008

    MEETING ROOM L4.4

    Level 4, Ministry of Health

    229 Moray Place, Dunedin at 1.15 p.m.

    MEMBERS PRESENT:

     Jenny Beck Chair

    Dr. Phil White Deputy Chair

    Mr. Kenneth Copland

    Associate Professor Alan Payne

    Mrs. Sandy Elkin

    Mrs. Gwen Neave

    Dr. Rosemary Beresford

    Associate Professor Clare Robertson

    Karen Goffe

    APOLOGIES:

    Dr. Nikki Kerruish Leave

    Dr. Khyla Russell

    Dr. Sarah Derrett

    IN ATTENDANCE:

    Riria Tautau-Grant Administrator

    Dr. Mohammed Alansari, Dr. Michael Schultz. 1.30 LRS/08/06/025

    Dr. Michael Schultz 1.50 LRS/08/06/026

    Ms. Helen Harcombe 3.00 LRS/08/06/021

    Dr. Emily Macassey, Mr. Patrick Dawes. 3.45 LRS/08/06/024

    MINUTES OF THE PREVIOUS MEETING

    - The minutes of the meeting held 1 April 2008, were confirmed.

    Minutes June Meeting

     File RE08-04-6

    Page - 2 -

    - The Committee ratified the decision to convene a sub-committee to review the protocols

    received in May.

    - Minutes of sub-committee meeting held 6 May 2008, were endorsed.

    NEW PROTOCOLS

Project Key: LRS/08/06/018 1.

    Full Title: The functional effect of the venous perforator in both normal & venous

     disease subjects.

    Investigators: Professor Andre van Rij, Gerry Hill, Dr. Greg Jones.

    Localities: Department of Surgery, Vascular Laboratory, Division of Medical Surgical

     Science.

    DEFERRED

Ethical approval is deferred In accordance with the Operational Standard for Ethics

    Committees, and pending substantial revision of the proposal.

    Invite the researcher to attend the meeting where this proposal will be reviewed.

    The Committee also comments that they had significant difficulty trying to understand what this ethics application seeks to achieve and that it reserves concerns for the safety

    of potential participants. The application was poorly put together and poorly proofread,

    which made reading it difficult.

Please consider the following comments when revising the proposal.

    Respect for Persons (Operational Standard Para 24-28)

    - Please refer to “…people with …” and “…participants…” rather than “subjects”

    - F3.1 Demonstrate that the researchers have given adequate consideration and

    the appropriate consultation has occurred with respect to the provisions of the

    Treaty of Waitangi.

Informed Consent

    - E2 Provide adequate time for people to consider their decision about participating.

Information Sheet Read NAF Guidelines

    - The Committee comments that the information sheet is inadequate. Please see

    the NAF Guidelines, and a copy of the top 10 tips enclosed with this document. Project Key: LRS/08/06/019 2.

    Full Title: The three dimensional anatomy of the human ileocaecal junction. Investigators: Mark Stringer, Matthew Pollard, Mark Thompson-Fawcett. Localities: Dept. of Surgery, Department of Anatomy and Structural

    APPROVED SUBJECT TO CONDITIONS.

D PRIVACY AND CONFIDENTIALITY

    - D7 Health information must be kept for 10 years. Please amend.

F CULTURAL AND SOCIAL RESPONSIBILITY

    - The Committee commends the thought given to your response in section F.

    - Please forward a copy of the letter from the Ngai Tahu Consultation Committee.

    Minutes June Meeting

     File RE08-04-6

    Page - 3 -

INFORMATION SHEET

    The Committee commends the researchers on the quality of the information

    sheet, and requests a few minor adjustments please.

    - Pg. 1 Sentence #5 - replace “Your surgeon has advised that you have…” with

    “Your surgeon has advised you that you need to …”

    - Pg. 1 Para 6. remove the last sentence beginning, “You will not need ...”

    - Please add a version no. and date in the footer.

CONSENT FORM

    - The Committee suggests a tick box/consent to allow the participant to identify

    whether they would like to receive a copy of the results.

    Project Key: LRS/08/06/020 3.

    Full Title: Effect of lower back pain on three dimensional lumbar and hip kinematics. Investigators: Pattariya Intolo, Professor David Baxter, Dr. Stephan Milosavljevic, Dr.

     Allan Carman, Dr. Melanie Bell.

    Localities: School of Physiotherapy.

    DEFERRED

Ethical approval is deferred in accordance with Section 2.2 of the Operational Standard

    for Ethics Committees which requires that adequate information is provided.

    Please consider the following comments when revising the proposal. Invite the researcher to attend the meeting where this proposal will be reviewed.

PART 1 : BASIC INFORMATION

    - Question 8.2 requires a signature.

B MINIMISATION OF HARM

    - B14 Change 5 years to 10 years.

E INFORMED CONSENT

    - Confirm when the information sheet will be given to the participant.

F CULTURAL AND SOCIAL RESPONSIBILITY

    - The Committee considers that the answer to question F.3 should be yes. Please

    respond.

INFORMATION SHEET

    - Rewrite the information sheet, as it is repetitious and contains superfluous

    information.

    - Ensure that information regarding what is being recorded on video is absolutely

    clear to the participant, e.g. that they are not going to be seen on video.

    - Make the timing of participants’ involvement clear; the advertisement says one

    hour.

    - Use the lay title from the application form.

    - Open the first paragraph with an invitation to participate.

    - Mention the vouchers from question E9 of the application form. (pg. 12)

    - Rewrite the document using lay language.

    - Para 3. Remove exclusion criteria.

    - Para 4. Use lay language.

    - Para 5. Replace male participants…” with men…”

    - Footer Apply a version number and date as a footer.

    Minutes June Meeting

     File RE08-04-6

    Page - 4 -

    - Include the standard, localised ACC statement as follows.

    - In the unlikely event of a physical injury as a result of your participation in

    this study, you will be covered by the accident compensation legislation

    with its limitations. If you have any questions about ACC please feel free

    to ask the researcher for more information before you agree to take part in

    this trial.

    - Include the standard H&D Advocacy statement as follows.

    - “If you have any queries or concerns about your rights as a participant in

    this study you may wish to contact a Health and Disability Services

    Consumer Advocate, telephone: (03) 479 0265 or freephone 0800 37 77

    66 or freefax 0800 2787 7678 (0800 2 SUPPORT) or email

    advocacy@hdc.org.nz If there is a specific Maori issue/concern please

    contact Linda Grennell at 0800 377 766”

    - Include the following approval statement.

    - “This Study has been approved by the Lower South Regional Ethics

    Committee”

CONSENT FORM

    - Use the lay title from the application form.

    - Remove consent no. 4.

    - Footer Apply a version number and date as a footer.

SF36 VERSION 2

    - Please reconsider question 12 wording as it does not appear to fit with the SF-36

    or this study .

    Project Key: LRS/08/06/021 4.

    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, Particpant’s home or other venue.

    APPROVED SUBJECT TO CONDITIONS.

F CULTURAL AND SOCIAL RESPONSIBILITY

    - Please forward a copy of the letter from the Ngai Tahu Research Consultation

    Committee.

CONSENT FORM

    - No. 4 As discussed, please indicate that every effort will be made to ensure

    confidentiality.

LOCALITY ASSESSMENT

    - Please provide a locality assessment from the Dept. of Preventive and Social

    Medicine.

PART 4 DECLARATIONS.

    - Dr. McBride is part of this study. Provide another copy signed by the appropriate

    HOD.

    Project Key: LRS/08/06/022 5.

    Minutes June Meeting

     File RE08-04-6

    Page - 5 -

Full Title: Tracheostomy geometry

    Investigators: Dr. Dean Ruske

    Localities: ENT Dept. Dunedin Public Hospital.

    APPROVED SUBJECT TO CONDITIONS.

PART 1 : BASIC INFORMATION

    - Please provide a simpler lay title, then apply that title to the information sheet and

    consent form.

C COMPENSATION FOR HARM

    - Please answer yes, this is a clinical trial

D PRIVACY AND CONFIDENTIALITY

    - Health information must be kept for 10 years.

INFORMATION SHEET

    - Simplify lay title as per request at Part 1

    - Do participants need to be advised of the collaboration with Groningen,

    Netherlands? If so, please include this information.

    - Para 3. Please change “If you have a chest infection of …” to “If you have

    a chest infection or …”

    - Para 3 also change “…you feel better before making…” to “…you feel

    better before taking…”

    - Add the preferred withdrawal statement as follows:

    - “If you do agree to take part, you are free to withdraw from the study at

    any time without having to give a reason, and this will in no way affect your

    future health care.”

CONSENT FORM

    - Simplify lay title as per request at Part 1.

    Project Key: LRS/08/06/023 6.

    Full Title: Group-based exercise and falls risk in elderly people: a pilot randomised

     controlled trial.

    Investigators: Dr. Stephanie Woodley, Associate Professor Clare Robertson, Professor

     A. John Campbell.

    Localities: Department of Anatomy and Structural Biology, School of Physiotherapy,

     Caversham Presbyterian Church Hall.

    APPROVED SUBJECT TO CONDITIONS.

    Associate Professor Clare Robertson vacated her position on the Committee to speak on behalf of this study.

B MINIMISATION OF HARM

    B4 It is noted that other venues may be used depending on responses.

INFORMATION SHEET

    - As discussed, please provide further information about clothing. Repeat under

    Assessment.

CONSENT FORM

    - Provide a consent to approach the GP

    Minutes June Meeting

     File RE08-04-6

    Page - 6 -

COMMUNICATION WITH GP.

    - As discussed, please develop a letter to the GP which advises them of the

    participant’s involvement in the study. The letter should invite the GP to notify the

    researchers immediately of any concerns. The letter should provide the GP with a

    copy of the signed consent.

OTHER COMMENTS.

    - The Committee commends the researchers’ initiative in offering the participants a

    cup of tea. The Committee agrees that socialisation is an important factor for the

    study cohort.

    Project Key: LRS/08/06/024 7.

    Full Title: Effect of a short post-operative course of oral prednisone on post-

     operative morbidity following tonsillectomy in children. Investigators: Dr. Emily Macassey, Mr. Patrick Dawes, Professor Barry Taylor. Localities: Day Surgery, Dunedin Public Hospital

    APPROVED SUBJECT TO CONDITIONS.

    Dr. Emily Macassey and Mr. Patrick Dawes attended the meeting.

D PRIVACY AND CONFIDENTIALITY

    - D7 This is health information, and records should be kept for 10 years. Please

     adjust the response here.

F CULTURAL AND SOCIAL RESPONSIBILITY

    - F3.1 As discussed, please rethink and rewrite the response here.

INFORMATION SHEET

    - Please present 3 new information sheets clearly headed:

    Young Children

    Teens

    Parent/ guardian.

    - Include a voluntariness statement in the parent/ guardian form.

    - Include the standard, localised ACC statement to all sheets as follows:

    - In the unlikely event of a physical injury as a result of your participation in

    this study, you will be covered by the accident compensation legislation

    with its limitations. If you have any questions about ACC please feel free

    to ask the researcher for more information before you agree to take part in

    this trial.

CONSENT FORM

    - As above, please present 3 new consent forms clearly headed:

    Young Children

    Teens

    Parent/ guardian.

LOCALITY ASSESSMENT

    - Please forward this document as soon as possible.

    Project Key: LRS/08/06/025 8.

    Full Title: The need for pethidine in needle liver biopsy: a double blinded,

     randomised controlled trial.

    Minutes June Meeting

     File RE08-04-6

    Page - 7 -

Investigators: Dr. Mohammed Alansari, Dr. Michael Schultz, Dr. Ralf Lubcke, Dr. Martin

     Schlup.

    Localities: Gastroentrology Dept. Dunedin Public Hospital.

    APPROVED SUBJECT TO CONDITIONS.

    Dr. Mohammed Alansari and Dr. Michael Schultz attended the meeting.

PART 1 : BASIC INFORMATION

    - As discussed, adjust the lay title to reconcile with that used in the information

    sheet.

B MINIMISATION OF HARM

    - B16 As discussed please confirm that there will be 100 participants.

D PRIVACY AND CONFIDENTIALITY

    - D7 Health information should be kept for at least 10 years, rather than “up to”.

     Please amend.

F CULTURAL AND SOCIAL RESPONSIBILITY

    - F.31 Please rephrase the intent of the approach to participants, as discussed.

INFORMATION SHEET

    - Use the lay title.

    - Remove the second line of the lay title.

    - Replace “Percutaneous…” with layperson’s terminology.

    - Para 4. Remove the second sentence.

    - As healthcare consumers are involved, please include the approved standard

    localised advocacy statement 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.

    Local (03) 479 0265; Telephone: (NZ wide) 0800 555 050; Free Fax (NZ wide):

    0800 2787 7678 (0800 2 SUPPORT); Email (NZ wide): advocacy@hdc.org.nzIf

    there is a specific Māori issue/concern please contact Linda Grennell at 0800 37

    77 66

CONSENT FORM

    - Remove the second line of the lay title.

LOCALITY ASSESSMENT

    - It is noted that the H&D Advocacy service is resident in Princes St. rather than

    Princess St.

OTHER DOCUMENTS

    - Please provide a copy of the HAMA questionnaire that will be used.

    - Part 4 declaration, provide a copy of this document signed by Rob Walker.

    - Part 7 complete and forward a registered drug form.

    Project Key: LRS/08/06/026 9.

    Full Title: Translocation of milk proteins

    Investigators: Dr. Michael Schultz, Dr. Bernard Venn, Dr. Grant Butt. Localities: Department of Biochemistry

    APPROVED SUBJECT TO CONDITIONS.

    Minutes June Meeting

     File RE08-04-6

    Page - 8 -

Dr. Michael Schultz attended the meeting.

PART 1 : BASIC INFORMATION

    - It is confirmed that the amount of milk will be 600 mls. (letter dated 6 June)

E INFORMED CONSENT

    - As blood will be taken from the participants, the Committee requires a consent

    form to be developed. As discussed, this may be styled on the standard consent

    form. The Committee accepts that in this instance, the participants will

    understand the study protocol. Therefore the consent should include the fact that

    the participants have had the chance to read, and understand, the protocol.

    - A signed consent also provides assurance against coercion to participate.

OTHER DOCUMENTS

    - Complete and forward Form A.

    RE-APPROVALS

Project Key: LRS/05/05/016 1.

    Full Title: Development of non-invasive, diagnostic and prognostic tests of

     prostate cancer

    Investigators: Dr J Stanton, Mr K Samalia, Dr Stephen Assinder,

    Localities: Dept. of Anatomy, University of Otago

    RECONFIRMED

    Further information requested regarding the nature of the larger study mentioned. . Project Key: LRS/07/04/010 2.

    Full Title: The experience of falls among community dwelling adults with physical

     disabilities.

    Investigators: Katrina Varian, Associate Professor Anne Bray (Supervisor) Dr. Leigh

     Hale, Dr. Brigit Mirfin-Veitch.

    Localities: Community setting of the participant’s choice. Participant’s home

    RECONFIRMED Project Key: LRS/06/11/056 3.

    Full Title: The management of non-eosinophilic asthma: a randomised controlled

     trial.

    Investigators: Professor Robin Taylor, Dr. Douglas Cowan, Mrs. Jan Cowan. Localities: Otago Respiratory Research Unit

    REQUEST FOR FURTHER INFORMATION. Reconfirmation pending receipt of the information sheet and consent form presently in

    use, as requested in the report form.

    Project Key: LRS/06/12/059 4.

    Full Title: The role of statin therapy in the management of persistent atopic asthma Investigators: Professor Robin D Taylor, Dr. Douglas Cowan, Mrs Jan Cowan

    Minutes June Meeting

     File RE08-04-6

    Page - 9 -

Localities: Respiratory Research Unit, Dunedin School of Medicine

    REQUEST FOR FURTHER INFORMATION. Reconfirmation pending receipt of the information sheet and consent form presently in use, as requested in the report form.

    Project Key: LRS/07/03/002 5.

    Full Title: Endothelial function and circulating endothelial microparticles in patients

     with rheumatoid arthritis.

    Investigators: Professor John Highton, Dr. Simon Stebbings, Dr. Jo Dockerty, Dr. Katey

     Meuli, Dr. Wayne Sutherland, Dr. Paul Hessian.

    Localities: Rheumatology Outpatients, Dunedin Hospital and Wellcome Buildings,

     University of Otago (FACS analysis)

    RECONFIRMED Project Key: LRS/07/03/EXP 6.

    Full Title: Synthesis and function of the human protein PEG10 in normal

     development and cancer

    Investigators: Dr. Warren Tate, Michael Clark, Dr. Ian Morison.

    Localities: Biochemistry Dept. University of Otago

    RECONFIRMED Project Key: OTA/04/11/086 7.

    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

    REQUEST FOR FURTHER INFORMATION

    - Invite researcher to specify why one participant withdrew, as is requested in the

    report form.

    Project Key: LRS/07/04/014 8.

    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. Phoebe Cleland, Mr. Patrick Dawes. Localities: Clinical Research Rooms, Respiratory laboratories, Radiology Dept. ,

     Dunedin Public Hospital, Dept. of Medical & Surgical Sciences, University

     of Otago

    RECONFIRMED Project Key: LRS/07/17/EXP 9.

    Full Title: European league against rheumatism scleroderma trials and research

     group - minimum essential data set international registry - EUSTAR Investigators: Dr Simon Stebbings, Professor John Highton, Dr. Jo Dockerty. Localities: Department of Medicine.

    RECONFIRMED

    Minutes June Meeting

     File RE08-04-6

    Page - 10 -

Project Key: LRS/06/02/008 10.

    Full Title: Loss of immune tolerance to the normal bowel microbiota as a potential

     factor in the pathogenesis of ankylosing spondylitis

    Investigators: Dr Simon Stebbings, Professor John Highton, Associate Professor

     Margaret Baird, Dr. Michael Schultz.

    Localities: Dept. of Rheumatology

    REQUEST FOR FURTHER INFORMATION. Reconfirmation pending receipt of the information sheet and consent form presently in

    use, as requested in the report form.

    Project Key: LRS/05/04/014 11.

    Full Title: Automatic and controlled memory in individuals with schizophrenia Investigators: Ms Daria Korobanova Dr Richard Linscott

    Localities: University of Otago

    RECONFIRMED Project Key: LRS/07/05/018 12.

    Full Title: Quality of life versus length of life: Are cancer patients’ preferences stable

     over time?

    Investigators: Claire C Paton, Associate Professor David Perez, Associate Professor

    Ken Buckingham, Mr Andrew Gray.

    Localities: Haematology/Oncology Dept. Dunedin Hospital

    RECONFIRMED

    EXTENSIONS, AMENDMENTS & MODIFICATIONS

Project Key: OTA/04/08/064 1.

    Full Title: Remineralisation of decalcified tooth enamel consequent to orthodontic

     treatment

    Investigators: Andrew Quick, Professor Michael Swain, Mr Peter Herbison, Emily Lam. Localities: School of Dentistry

    APPROVED Amendment # 2

    - Testing of IDD and comparison to use of fluoride rinse.

    - Addition of Emily Lam as a co-investigator.

    Project Key: LRS/07/06/024 2.

    Full Title: The effect of smoking on periodontal ligament fibroblasts and gingival

     fibroblasts: an in vitro wound model

    Investigators: Patty Chou, Ms Mary P Cullinan, Dr Warwick J Duncan, Professor

     Gregory J Seymour,

    Localities: School of Dentistry, University of Otago

    APPROVED

Amendment #2

    - Approved amendment to the recruitment protocol.

Report this document

For any questions or suggestions please email
cust-service@docsford.com