Minutes – November Meeting
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LOWER SOUTH REGIONAL
ETHICS COMMITTEE MEETING
HELD ON TUESDAY 7 NOVEMBER 2006
MEETING ROOM L4.4
FOURTH 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. Gail Tripp
Mrs. Gwen Neave
Dr. Rosemary Beresford
Dr. Nikki Kerruish
Mrs. Sandra Elkin
Dr. Alan Payne
Dr. Khyla Russell
APOLOGIES:
Dr. Clare Robertson
IN ATTENDANCE:
Riria Tautau-Grant
Carolyn Mason
LRS/06/11/050
LRS/06/11/051
LRS/06/11/052
LRS/06/11/057
LRS/06/11/054
LRS/06/11/055
LRS/06/11/056
Dr. Rob MacGinley, Dr. John
Schollum, Professor Stephen Duffill
and Alwyn Todd
Rajiv Verma and Dr Warwick Duncan
Professor Robin Taylor
Dr. Douglas Cowan
Administrator
Chairperson Upper South A
Co-Researchers 1.45 p.m.
Co-Researchers
Co-Researchers
2.30 p.m.
3.45 p.m.
MINUTES OF THE PREVIOUS MEETING
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The minutes of the closed meeting and open meeting held 3 October 2006 were
confirmed.
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NEW PROTOCOLS
1. PROJECT KEY: LRS/06/11/049
Full Title:
What is the incidence and awareness of Asthma in the Southland Region
Investigators: Jill Parsons, Lesley Watson, Ed Flagg, Cara Agnew
Localities:
Participant's homes, Southern Institute of Technology
DEFERRED
Ethical approval was deferred pending substantial revision of the proposal and
satisfactory answers to the questions being asked.
Note: Provide a copy of the Top Ten Tips
A VALIDITY OF RESEARCH
- Different people are likely to be home at different times of the day, is the timing of
the calls being made to participants, going to bias the sample?
B MINIMISATION OF HARM
- B 13 Please clarify whether the researchers will be present when all the calls
are made
- What is the process if additional health professionals input is required?
- It is noted that the Bachelor of Nursing students participation in this research is
significant. Please provide a description of what educational value will be gained
by participating nursing students. The Committee would prefer that:
(a) no coercion is involved in having the nursing students participate
(b) that they are remunerated appropriately
D PRIVACY AND CONFIDENTIALITY
- D6
Raw data needs to be kept for 10 years if it includes health information
and according to Institute’s policies if it does not include health information
- D7
This is health information and must be kept for 10 years. Please ensure
uniformity throughout the documentation
E INFORMED CONSENT
- Please describe how you plan to manage the issue of consent for and access to
those under 16 years old:
- Please note that:
(a)
Some of those under 16years old will be able to give consent and
take part in the survey; and
(b)
Those who are not taking part in the survey but about whom
information is being sought should be allowed to assent or not.
See Operational Standards for Ethics Committees, Appendix 1, Pg. 54 Para. 263.
F CULTURAL AND SOCIAL RESPONSIBILITY
- F3.1 – please revisit this question as the answer is likely to be “Yes”
- Consultation with Māori is required. Please forward evidence of consultation.
LOCALITY ASSESSMENT
- A locality assessment is required from the Southern Institute of Technology
APPENDIX 1 NEWSPAPER ADVERTISEMENT / INFORMATION SHEET
- Pg. 13 Para 4
Please use the full name of the Committee as follows: the
Lower South Regional Ethics Committee
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Pg. 13 Para 5
Please replace the last four words of this paragraph with a
full stop after the word team
Pg. 14 sect 6
The last paragraph mentions a follow up study. The
Committee needs to know what is involved in the follow up
study, and wishes it noted that full approval of this study
does not establish ethical approval for the follow up study.
Pg. 14 sect 6
Please change the last sentence to read as follows: “ If you
supply your name and contact details for the follow up
study, that information will be kept by the research team
only, then destroyed at the completion of that study”
More details regarding the “further study” should also be provided in the
information sheet.
Please provide a copy of the approval given by the Southern Institute of
Technology Research Committee
APPENDIX 2 QUESTIONNAIRE
- The ethnicity question is not appropriate. Please use the ethnicity question from
the census
- Q 14 Add “other” as a choice
- Q 15 Please explain what is meant by an Asthma management plan. The
terminology may not be familiar to everyone.
- Q 25 As stated above, the Committee needs to see information about a follow
up study
APPENDIX 4 LETTER FROM SOUTHLAND ASTHMA SOCIETY INC.
- See also A7.1. The Committee has chosen to defer this study. Will the funding
for the project be still available post ethical approval?
APPENDIX 5 PROCEDURAL STEPS
- Add an instruction to ask “Is this a good time to call?”
- No. 4 Is it appropriate to include a question about whether another member of
the household has asthma? so that they can be interviewed about their
asthma.
2. PROJECT KEY: LRS/06/11/050
Full Title:
An audit of prescribing patterns in patients who are obese
Investigators: Professor Stephen Duffull, Dr. Ruth Ferguson, Dr. John Schollum
Localities:
School of Pharmacy, University of Otago, Otago District Health Board
APPROVED SUBJECT TO CONDITIONS
Note: Provide a copy of the Top Ten Tips
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Dr. Rob MacGinley, Alwyn Todd, Dr. John Schollum and Professor. Stephen
Duffill attended the meeting.
PART 1 : BASIC INFORMATION
- No. 6 Please provide information about the summer student. Include their
background and training. What will they do if they know the participant?
D PRIVACY AND CONFIDENTIALITY
- Please provide information regarding the procedures under which the student will
safeguard the privacy of participants and of health and personal information.
F CULTURAL AND SOCIAL RESPONSIBILITY
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Please provide a copy of the letter evidencing that consultation has been
completed.
CONSENT FORM
- It is noted that If the height and weight is recorded on the form that there will be
no need to gather consent
LOCALITY ASSESSMENT
- A locality assessment from is required for the ODHB
3. PROJECT KEY: LRS/06/11/051
Full Title:
Enoxaparin and the risk of bleeding - an impact study
Investigators: Professor Stephen Duffill, Hesham Al-Sallami, Ruth Ferguson, Natalie
Medlicot, Dr. John Schollum
Localities:
Dunedin Hospital, School of Pharmacy
APPROVED SUBJECT TO CONDITIONS
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Dr. Rob MacGinley, Alwyn Todd, Dr. John Schollum and Professor. Stephen
Duffill attended the meeting.
BASIC INFORMATION
- 18-21 – Please clarify timeline specifically in relation to A4.1
B MINIMISATION OF HARM
- B10 Explain why patients less than 18 years old are being excluded
C COMPENSATION FOR HARM
- C
As health professionals are involved in the assessment of participants,
ACC would regard this as a clinical trial. The answer should be “Yes”
Please forward a signed copy of the Form A
F CULTURAL AND SOCIAL RESPONSIBILITY
- F3.2 Please forward a copy of the letter from Ngai Tahu once that is received
- F3.3 Please modify the response here as it contradicts the response at F3.2.
- F3.4 Explain why it was decided that ongoing involvement with groups
consulted is not applicable. The Committee notes that there are a number
of issues involving blood that raise cultural considerations for Maori.
INFORMATION SHEET
- Provide information sheet on a letterhead
- The Committee commends the good use of language
- Increase the font size for the name and number for the Principal investigator, and
place into the body of the information sheet.
- Please place all investigators names on this sheet
- Pg. 2 Para 10
Omit the words ‘for New Zealand’
- Pg. 2 Para 11
Please add the word “be” between “…individual…” and
“…released…”
- ACC is mentioned on pg.1 ‘what are side effects’ and pg. 2 ‘Compensation.’ The
second mention is sufficient
- Please use preferred abbreviated ACC statement. Refer to Top 10 Tips
document appended.
- The Health and Disability advocacy statement has been recently updated. The
new statement is included in the Top 10 Tips document appended.
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CONSENT FORM
- No. 6 Remove the question to notify GP’s of adverse events
LOCALITY ASSESSMENT
- Please provide locality assessment forms for the ODHB and the School of
Pharmacy
HUMAN TISSUE
- 1.7
Describe the protocol for transferring blood from the Hospital to the School
of Pharmacy
FORM A
- Please provide a copy of the Form A
4. PROJECT KEY: LRS/06/11/052
Full Title:
A randomised single blind study to improve health related quality of life as
measured by the SF-36 vitality score by correcting anaemia of chronic
kidney related disease with Aranesp® (darbepoetin alfa) in the elderly
(STIMULATE)
Investigators: Dr. John Schollum, Professor Rob.Walker, Dr. Rob. MacGinley, Gaye
Ellis
Localities:
Department of Medical and Surgical Sciences
APPROVED SUBJECT TO CONDITIONS
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Dr. Rob MacGinley, Alwyn Todd, Dr. John Schollum and Professor. Stephen
Duffill attended the meeting.
C COMPENSATION FOR HARM
- Please complete a Form B
- ACC compensation provisions are baseline. The Company appear to be offering
less than that which ACC would usually provide. Please discuss with the
company the need to provide at least what is covered by ACC. A copy of the
Health and Disability Ethics Committees guidelines are appended.
F CULTURAL AND SOCIAL RESPONSIBILITY
- F4
Please revisit this question acknowledging the comments of the Ngai Tahu
Research Committee
INFORMATION SHEET
- The Committee notes that there are imposed restrictions on investigator’s ability
to reconfigure the information sheet:
(a) Where possible please make the following changes to the information
sheet.
(b) Where it is not possible, then the Committee request that the
information be provided in a summary/ guide:
2. Pg. 5 Para 5 Link paragraphs 3(a) and 3(b) to make it clearer that the
second paragraph describes the ‘associated side effects’
3. Simplify the language
4. Use the term participants rather than subjects
5. Provide more information about the background drug and how long it has
been available
6. Pg. 3 Q 3b
Make it clearer that if people in the placebo group really
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need the drug, that they will get it.
7. Add the right to withdraw earlier in the information sheet, with the
background information
8. Make it clear that Amgen makes and owns the license for the drug
REGISTERED DRUG FORM
- The committee would like to know the chemical constituents of the clear
colourless fluid being used as placebo
LOCALITY ASSESSMENT
- Please forward a copy of this as soon as possible
5. Project Key: LRS/06/11/053
Full Title:
Double blind randomised controlled trial of an orally administered
probiotic in the treatment of spondylo arthritis
Investigators: Dr. Simon Stebbings, Dr. Michael Schultz, Professor John Highton
Localities:
Rheumatology Outpatient Dept., Microbiology Dept, Chemistry Dept.
APPROVED SUBJECT TO CONDITIONS
A VALIDITY OF RESEARCH
- A3.1 Clarify whether you will require presence of HLA-B27 gene as a gateway
onto the study
B MINIMISATION OF HARM
- B10 What is the reason for excluding persons with major depressive illnesses?
If there is a likelihood of psychiatric distress, then this should be advised in
the information sheet
C COMPENSATION FOR HARM
- Please complete and forward the Form A document
F CULTURAL AND SOCIAL RESPONSIBILITY
- F3.1 Please provide a copy of the letter form NTRCC as evidence of
consultation
- F3.3 Please clarify the consultation process undertaken, the Committee is
aware that Christine Rimene has not held the liaison role for some time
now.
INFORMATION SHEET
- Please apply a footer with a version no. and date
- Number the pages
- Pg. 3 Para 3 Simplify the language used, clearly explaining the implications
- Pg. 3 Para 7 An “or” is missing. Please insert “or” in the second line,
between “…group…” and “…the placebo…”
- Please explain where the analysis of the samples will take place, at the Dept of
Pharmacology as per the information sheet or at the Dept of Chemistry as per the
response at Basic Information no. 10
- Counselling needs to be mentioned, as it is offered at B12 of the application form
- Pg. 3 Para 4 Replace ‘tests’ with ‘test’
- Pg. 3 Para 5 Replace ‘he’ with ‘the’
- Pg. 2 Para 6 Remove the word ‘an’
- Pg. 2 Para 6 Replace the first instance of ‘these’ with ‘this’
- Pg. 3 Para 6 ‘labelled’ is spelt incorrectly
- Pg. 3 Para 6 Use ‘number’ instead of no
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The Health and Disability statement has been updated. Please refer to Top 10
Tips appended
CONSENT FORM
- Add a consent question for genetic testing
LOCALITY ASSESSMENT
- Please forward completed locality assessment forms from the ODHB and the
University of Otago
6. PROJECT KEY: LRS/06/11/054
Full Title:
Retrospective analysis of dental implant treatment provided at the School
of Dentistry since 1989
Investigators: Rajiv Verma, Dr. Warwick Duncan, Ms. Mary Cullinan, Professor Gregory
Seymour
Localities:
School of Dentistry, University of Otago
APPROVED SUBJECT TO CONDITIONS
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Rajiv Verma and Dr. Warwick Duncan attended the meeting
B MINIMISATION OF HARM
- The committee is concerned that every possible measure should be taken to
avoid contact with the families of people who have died since their original
treatment.
C COMPENSATION FOR HARM
- C
Please answer yes. ACC would regard this as a clinical trial as
assessment and treatment is being undertaken by a health professional.
Form A is required
F CULTURAL AND SOCIAL RESPONSIBILITY
- F3
This needs to be answered in the affirmative
- F3.1 Bullet point 3 Please revisit the response. The head is tapū, and this has
some cultural considerations
- F3.1 Bullet point 5 Please change “Whānau members are…” to “A whānau
member is …”
- Please take into account Mark Brunton’s recommendations
INFORMATION SHEET
- Pg.1 Para 1 Add that the two appointments will be for one hour each
- This sheet contains two advocacy statements, only the first of which is correct.
Replace the 2nd one on Pg.2 with the first one on page one.
- Add the standard abbreviated ACC statement. This is appended in the Top 10
Tips sheet
- It is understood that the exams and x-rays will be at no cost. Please make it
clearer on pg. 3 para. 2 that treatments thereafter will be at usual costs
CONSENT FORM
- Add a consent for later use of plaque samples and add that later use will only
occur providing ethical approval to do so is granted.
RADIATION FORM
- Please urgently complete a radiation form
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7. PROJECT KEY: LRS/06/11/055
Full Title:
Does obesity influence the pattern of lung function during acute
bronchoconstriction? (the INCA study - Investigating broncho-constriction
in asthma)
Investigators: Professor Robin Taylor, Dr. Tim Sutherland, Mrs. Jan Cowan.
Localities:
Otago Respiratory Research Unit
APPROVED SUBJECT TO CONDITIONS
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Professor Robin Taylor and Dr. Douglas Cowan attended the meeting
F CULTURAL AND SOCIAL RESPONSIBILITY
- Please provide letter and feedback from Māori consultation
INCA STUDY INFORMATION SHEET
- Pg. 1 Para 4 Under Visit 1, bullet point 2 please remove the word ‘to’
- The H&D advocacy statement has recently been updated to reflect the additional
contact services that they provide. A copy of that statement may be found in the
appended Top 10 Tips.
LOCALITY ASSESSMENT
- Please provide a signed copy of the locality assessment forms for the University
of Otago and the ODHB.
REGISTERED DRUG FORMS
- Please provide registered drug forms for methacholine and Ventolin
8. PROJECT KEY: LRS/06/11/056
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
APPROVED SUBJECT TO CONDITIONS
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Professor Robin Taylor and Dr. Douglas Cowan attended the meeting
F CULTURAL AND SOCIAL RESPONSIBILITY
- F3.1 Please provide the response from the Ngai Tahu Research
Consultation Committee
- F3.5 Make the results known to Ngai Tahu Research Consultation Committee
INFORMATION SHEET / CONSENT FORM
- Use the term participants rather than subjects
- The H&D advocacy statement has recently been updated to reflect the additional
contact services that they provide. A copy of that statement may be found in the
appended Top 10 Tips.
AMP INFORMATION SHEET
- Para 3
Please update this with correct details for researchers/respiratory
dept.
LOCALITY ASSESSMENT
- Please provide completed locality assessment forms for the University of Otago
and the ODHB
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9. PROJECT KEY: LRS/06/11/057
Full Title:
The impact of dietary salt (NaC1) intake on arterial wall function in
hypertensive subjects: a randomised controlled cross-over study
Investigators: Dr. Rob MacGinley, Professor Robert Walker, Dr. Wayne Sutherland,
Alwyn Todd, Professor Jim Mann, Dr. John Schollum
Localities:
Dept. of Medical and Surgical Sciences Clinic, Endolab, Chch and Royal
Perth Hospital
APPROVED SUBJECT TO CONDITIONS
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Dr. Rob MacGinley, Alwyn Todd and Dr. John Schollum attended the meeting.
GENERAL
- The Committee notes that the researcher has taken on board previous
comments from the Committee
BASIC INFO
- 4.1
Please confirm that this study is recruiting people with Essential
Hypertension only and not normal healthy volunteers
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B10
Please confirm that inclusion criteria should read BMI <30 not >30
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D
Privacy and Confidentiality – please confirm that potential participants will
be made aware by the GP’s of the nature of the personal information that
the GP’s are sending to the researchers prior to them consenting to be
part of the study and please provide the committee with a copy of the
referral form
F CULTURAL AND SOCIAL RESPONSIBILITY
- F3.1 Please write to Mark Brunton again, in particular with a view to bringing
him up to date with the status of the study. Please forward a copy of any
response that is received from this communication.
DECLARATION FORM
- The declaration form needs to be signed by Professor John Highton and a copy
forwarded for the Committee’s records
INFORMATION SHEET
- The committee is aware that some GPs have been approached to facilitate
recruiting already and have been provided with an information sheet that is dated
June 2006. It is important to note that the study may not begin until full approval
has been granted and that potential participants should be provided with the
most recent information sheet
- Use the preferred ACC statement. See Top ten tips sheet appended.
- Pg. 2 Para 3 The second sentence states that the participant should drink 500
mls. of juice for four weeks. Please clarify what is intended.
- Include information about parking, taxis and breakfast.
- Dr. John Schollum’s name is misspelt in the opening paragraph of the info sheet.
Also in the letter to potential participants
LOCALITY ASSESSMENT
- Please forward copies of the locality assessments as they are received from the
University and the ODHB
ADVERTISEMENT
- Please provide better spacing for the tear of strips. In particular for tearing.
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RE-APPROVALS
1. PROJECT KEY: OTA/03/02/009
Full Title:
Prospective memory in schizophrenia and related disorders
Investigators: Dr Richard Linscott, Associate Professor Robert G Knight, Dr Nick Titov,
Mr Mark
Lewis
Localities:
Department of Physiology, University of Otago
REAPPROVED
2. PROJECT KEY: LRS/05/17/CPD
Full Title:
Professional development and recognition programme: portfolio
development, is it more than a means to an end?
Investigators: Miss Deborah Ashworth
Localities:
Southland District Health Board
REAPPROVED
3. PROJECT KEY: LRS/04/12/005
Full Title:
Respiratory and Cardiovascular effects of a bronchodilator drug (200 ug
salbutamol) in medicine, pharmacy and pharmacology students.
Investigators: Martin J Le Nedelec, Associate Professor Darlington.
Localities:
School of Medicines.
REAPPROVED
MATTERS ARISING
1.
PROJECT KEY: OTA/02/17/CPD
Full Title:
Giving asthma and COPD medicines to the residents of Dunedin rest
homes
Investigators: Gayan Samarakoon, Nerida Smith
Localities:
Dept of Pharmacology and Toxicology
STUDY CLOSED
2.
From
Theme
Action
Dr. Khyla Russell
Meeting of Māori Members, Ethics Committees, 18 Oct 2006
For your information
NOTED
CHAIRPERSONS DISCRETIONARY
1.
From:
Theme:
Action:
Anthony Molteno
The Otago Glaucoma Surgery Outcome Study
Ethical approval not required
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2.
Project Key: LRS/06/08/CPD
Full Title:
Follow-Up of patients with rheumatoid arthritis
Investigators: Deborah Johnstone, Georgina Chan
Localities:
Department of Rheumatology
APPROVED
CORRESPONDENCE
1.
From:
Theme:
Action:
Health Research Council
HRC News Issue No. 53, October 2006
For your information
NOTED
PROTOCOLS GIVEN FINAL APPROVAL UNDER DELEGATED AUTHORITY
1. PROJECT KEY: LRS/06/09/037
Full Title:
The clinical anatomy of the anterior neck muscles
Investigators: Ewan Kennedy, Professor Helen Nicholson, Associate Profesor Susan
Mercer, Lyndell Kelly
Localities:
Dunedin Public Hospital, Oncology, Dept. of Anatomy and Structural
Biology, Dunedin
2. PROJECT KEY: LRS/06/10/043
Full Title:
The geometry of the solid hypophraryngeal walls
Investigators: Dr. Ming Zhang, Dr. Amy Fong, Professor Terence Doyle, Dr. Albert
Chong
Localities:
Depts. Anatomy and Structural Biology, Radiology, School of Surveying,
University of Otago
3. Project Key: LRS/06/09/038
Full Title:
Measurement of quality of life of New Zealand adults and adolescents with
cystic fibrosis.
Investigators: Malcolm Neall, Dr. Margot Skinner (Supervisor)
Localities:
Participant’s homes, PI’s home.
4. Project Key: LRS/06/10/045
Full Title:
Course and prognosis following first time lateral ankle sprain
Investigators: Dr. Joanne Munn, Dr Haxby Abbott
Localities:
School of Physiotherapy
FINAL REPORTS
The following final reports have been received.
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1. Project Key: LRS/06/05/019
Full Title:
A clinical audit of dental implant treatment at the School of Dentistry, 20012005
Investigators: Dr. Warwick Duncan, Ms Angela Ross, Ms Saana Tutbury
Localities:
University of Otago School of Dentistry
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The study is complete however a masters student will be using results from this
study for his research. The study was presented at the final year students
colloquium day. Smaller samples than originally intended. 117/250
Meeting Ends