MINUTES OF MEETING OF THE CENTRAL REGIONAL ETHICS COMMITTEE
OF 12 DECEMBER 2006 HELD IN MEETING ROOM C06, LEVEL 2, 1-3 THE
TERRACE WELLINGTON COMMENCING AT 4.30 PM.
PRESENT:
Trevor James (Chair), John Kleinsman, Jane Herschell (legal
expert), Anne Tuffin, Dianne Wepa, Jacqui Virtue, Guy Taylor, Joe
Asghar, Matire Harwood, Jacky Renouf, Claire Yendoll & Jan
Ostnes co-administrators.
APOLOGIES
Maureen Holdaway
KARAKIA
Jacqui Virtue offered the Karakia
MINUTES:
The minutes of the meeting of 13 November 2006 having been
circulated were confirmed:
Moved:
Trevor James
Seconded:
Jacky Renouf
Progress and Final Reports
A list of progress and final reports received during November 2006 was tabled at the
meeting for the Committee’s information.
Studies approved by the Chair under delegated authority in November 2006 were
confirmed.
Serious Adverse Events – A list of Serious Adverse Events received during November
2006 was circulated to the Committee. These had been reviewed by the Deputy Chair.
She drew the Committee’s attention to a large number of reports received for study
MWH/99/08/039 but as this study was now closed no action was considered necessary.
She also drew the Committee’s attention to a letter from Novartis concerning the
Gleevac/Glivac study which has been the subject of a journal article relating to the cardiac
side effects.
Protocol Amendments A report of 1 protocol amendment approved by the Chair/Deputy
Chair in November 2006 was confirmed.
(A copy of these reports is filed with the minutes).
MATTERS ARISING FROM NOVEMBER MINUTES
(CEN/05/12/095 – Safety assessment of two popular legal party drugs: BZP+BZP
and TFMPP)
The Committee noted that a copy of the final report submitted to the Ministry of Health had
now been received.
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CEN/06/11/097 - Collection of pre-screening data for use in future clinical trials
Principal Investigator – Dr Dean Quinn
Dr Dean Quinn attended the meeting. The Chair thanked Dr Quinn for seeking the
Committees advice before implementing this pre-screening process. The Committee
agreed that, although this proposal did not constitute research as such, it should be
reviewed by an ethics committee under the provisions of the Operational Standard for
Ethics Committee 3.1, 99ii. It was agreed that the review highlighted the following
issues to be addressed:
1. Amended information sheet and consent form should be submitted to the Committee
removing any reference to the process being “research” or a “study”
2. All references to “patients” should be changed to “participants”.
3. Participants to be advised that they may receive their tests results if they wish or
these may be forwarded to their GP with their consent (make provision for this in the
consent form).
4. The approval statement should read “This screening process has been reviewed by
the Central Regional Ethics Committee”.
5. The information sheet should contain a clear indication of the time commitment
required from the participants.
6. The Consent Form should contain a statement “I understand that I can request that
my name and screening information be removed from the P3 database at anytime”.
7. Committee to sight proposed advertisement.
8. Researcher to confirm that there is no inducement to participants in this process.
GENERAL BUSINESS
Date of meeting April 2007
The Committee agreed to keep the date unchanged at 10 April 2007.
Invitation for coroner to attend March meeting.
The Committee reaffirmed that it would extend an invitation to the Wellington Coroner to
attend the March meeting of the Committee.
Jane Herschell’s last meeting
The Committee expressed its thanks to Jane for providing legal advice to the
Committee during Helen Colebrook’s absence overseas. The Committee particularly
noted the hard work she put in to the submission to the ombudsmen regarding the
Paritutu study.
Annual Report
The Chair advised that prior to publication of the Committee’s December 2004 –
December 2005 annual report the Ministry and ESR commented on the “Complaints”
section of the report relating to the study “TRK/03/05/014 The collection and analysis of
blood serum in a selected population to investigate serum dioxin levels in residents who
live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New
Plymouth”. ESR had asked that it be revised. The Committee agreed with the Chair’s
proposal to add the following sentence to the relevant section:
“However the Committee is pleased to report that ESR has now acknowledged
that it has erred and has advised the Committee that it has taken remedial action
for the future”.
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The Committee wished it to be minuted that the independence of Ethics Committees
needs to be maintained in all activities, including the annual report, while valuing any
comments made by the Ministry of Health or other parties.
RESEARCH PROTOCOLS
(OSEC refers to Operational Standard for Ethics Committees April 2006)
CEN/06/12/109 - Implications for treatment: Methadone maintenance treatment
(MMT) clients who concurrently take Benzodiazepine (BZD) medication
Principal Investigator – Katherine Clarke
The study was approved subject to the following issues being addressed:
1. The researcher to confirm in writing that she will not be including the focus group
component of the research, as discussed with John Kleinsman.
2. Page 5, A3.1, researcher to provide further information, as raised by the University
of Otago Health Sciences Board of Studies (letter dated 16 October 2006),
concerning the justification of phenomenology as an appropriate methodology as an
also the analytical process used in phenomenology.(OSEC 2.4, 57)
3. Page 8, B10 researcher to justify why she is excluding those who are taking
prescribed BZD’s. (OSEC 2.5)
4. Page 9, B12, researcher to consider how she will manage the possible stress to
participants of disclosure of illicit use of BZD or other illegal activities. (OSEC 2.5,
65)
5. Page 12, D5 participant’s transcripts of interviews should be de-identified once they
have been corrected by the participant so that they are truly anonymous.(OSEC 2.3,
49)
6. Page 14, F3.4 consultation with Mr Riki Nia Nia suggested collection of ethnicity
data. Researcher to advise if she plans to do this. (OSEC 2.7, 83)
7. Page 17, Part 4 declaration needs to be signed by the principal investigator.
8. Information Sheet (OSEC 2.2, 29)
 Add statement concerning the confidentiality of the information gathered in view of
the illicit activity involved.
 Add statement regarding the confidentiality and security of stored data.
 Add statement concerning how confidentiality of audio-tapes will be ensured.
 Add statement that CADS supports the research.
 Amend title of committee in approval statement to read “Central Regional Ethics
Committee”.
9. Consent Form (OSEC 2.2)
 Add provision for participant to consent to audio-taping and revising transcripts.
 Amend withdrawal statement to include that participant may withdraw “without
having to give a reason”.
CEN/06/12/110 - Safety and efficacy of pentoxifylline in the treatment of
necrostising enterocolitis in preterm neonates. A randomised, placebo controlled
pilot trial
Principal Investigator – Dr Sanjay Patole
The study was approved subject to the following issues being addressed:
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1. Page 7, B1 minimisation of harm; Clarify the mode of preparation and administration
of the drug pentoxifylline given the blinding and preparation of the drug appear to
occur in Australia. Is there a role for the local hospital pharmacist to oversee/ensure
this drug administration to this vulnerable population? (OSEC 2.5, 64)
2. Page 10, B19 evidence of SCOTT approval to be provided. (OSEC 2.4, 58)
3. Page 11, D7 data for infants needs to be stored for 10 years after participants have
turned 16 years of age.
4. Page 13, F3.2 researcher to provide written evidence of Maori consultation with Mr
Riki Nia Nia at Maori Health Development Unit C&CDHB. (OSEC 2.7, 83)
5. Information Sheet (OSEC 2.2, 29)
 Needs appropriate letterhead.
 Language is too technical. Needs to be rewritten. Researcher to liaise with Dr
Jacqui Virtue and John Kleinsman regarding required changes.
 Needs Health Advocates Trust Statement (refer guidelines, page 17, item 8 General,
para 9).
 Add statement that study has been approved by the “Central Regional Ethics
Committee”.
 Add compensation statement for declaration A trial (refer guidelines page 21).
 Need to provide local contact telephone number for participants.
6. Consent Form (OSEC 2.2)
 To be amended in consultation with Dr Jacqui Virtue
7. Suggestion/Comments
 Exclusion criteria (page 5 of protocol) suggest use laboratory levels comparable to
those commonly used in local laboratory for clarity.
CEN/06/12/111 - A qualitative exploration of the person living with Type 2
Diabetes in Wanganui, their understanding, perception and ability to self manage
their condition
Principal Investigator – Janice Handley
The study was approved subject to the following issues being addressed:
1. Page 4, A1.2 more specific information is required on the study aims. (OSEC 2.4,
57)
2. Page 4, A2 researcher to provide scientific background information. (OSEC 2.4, 59)
3. Page 5, A3.1 and A3.3 information on methodologies to be used appears to be
contradictory and requires clarification. Researcher to state how the methods
analysis will include cultural processes. (OSEC 2.4, 57)
4. Page 7, A8.1 researcher to confirm answer should be “no”.
5. Page 10, B20 answer should be “yes” as PHO resources and time for staff to do
recruitment is involved.
6. Page 11, D1 researcher to clarify which specific “clinicians” will be outlining the
project to potential participants. (OSEC 2.3, 52)
7. Information Sheet (OSEC 2.2, 29)
 Change statement to read that study has been approved by the “Central Regional
Ethics Committee”.
 Needs Health Advocates Trust Statement (refer guidelines, page 17, item 8 General,
para 9)
CEN/06/12/112 - Service Research and Improvement Project: Midcentral Health’s
After Hours Emergency Mental Health Services
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Principal Investigator – Jo Innes
Following discussion with the reviewer, the researcher had provided an amended
application form.
The study was approved subject to the following issues being addressed:
1. The Committee expressed its reservation about the lack of robustness around the
information to be collected and how it will be used and whether the questionnaire
would generate any results of value. Researcher invited to comment on this.
Committee suggested help in addressing this issue could be obtained by
consultation with the relevant consumer advocacy group. (OSEC 2.4)
2. Page 9, B10, service users who are not stabilised should be excluded from the
research. (OSEC 2.5, 65)
3. Page 11, D5/D6 the Committee noted that confidentiality issues had been addressed
in the relevant section of the amended application.
4. Page 11, D1 researcher to give more detail on recruitment process, eg, whether this
will be verbally, by letter, by notice in clinic and provide copy of relevant documents
to be used. (OSEC 2.3, 52)
5. Page 13, F3.2 written evidence of specific consultation with regard to this project is
required as outlined in the amended section F3.2. (OSEC 2.7, 83)
6. Page 15, part 3, General: researcher to elaborate further on how privacy issues will
be addressed. OSEC 2.3)
7. Information Sheet (OSEC 2.2, 29)
 Needs Health Advocates Trust Statement (refer guidelines, page 17, item 8 General,
para 9)
 Amend statement to read that this study has been approved by the “Central
Regional Ethics Committee”.
 Needs to include statement that participant may have a support person as well as a
family person if they so wish.
 Add information concerning the fact that participants may withdraw from the study.
 Needs to include information on storage of data.
8. Consent Form (OSEC 2.2)
 Seventh statement amend to read “I understand that the investigation will be
stopped if it should appear stressful to me”.
9. Confidentiality Agreement – Focus Group
 Researcher to provide two separate versions, one appropriate to clinicians and one
for service users omitting references to future health care, compensation, side
effects and other irrelevant information where appropriate.
10. Suggestions/Comments
 Suggest information sheet could include examples of the type of topics to be
discussed with participant.
CEN/06/12/113 - A randomised, double blind, two-way crossover study, to
examine the safety, tolerability, pharmaco-kinetics and pharmaco-dynamics of a
single inhaled administration of GW685698X (800 g) with and without magnesium
stearate, in mild/moderate asthmatic patients
Principal Investigator – Dr Dean Quinn
The study was approved subject to the following issues being addressed:
1. Page 10, B19 Evidence of SCOTT approval is required (since received).
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2. Page 11, C2 (f) compensation provision should replace “deviation” with “significant
departure” as per RMI guidelines. Researcher to be advised that new compensation
provisions are proposed and this will impact on future applications for ethical
approval. (OSEC 2.8)
3. Page 13, F3.3, written evidence of Maori consultation is required. (OSEC 2.7, 83)
4. Information Sheet (OSEC 2.2, 29)
 Change all references from “patient” to “participant”.
 Page 4 of 9, “Contraceptive” section, this section needs to be highlighted and the
researcher needs to stress this requirement to potential participants.
 Page 5 of 9, final paragraph, reference to 13 clinical studies would be expressed
better in numbers of participants.
5. Consent Form (OSEC 2.2)
 14th statement should be separated into two separate points. One for compensation
provisions and the other for the reimbursement amount.
CEN/06/12/114 - Assessment of Bone Mineral Density around a Femoral Revision
Stem using Dual-energy X-ray Absorptiometry (DEXA)
Principal Investigator – Prof Geoffrey Horne
The study was approved subject to the following issues being addressed:
1. Page 5, A3.1, potential participants may be taking bone active agents. How will
researcher factor this into results? (OSEC 2.4, 57)
2. Page 5, A3.3.2 researcher to provide evidence of statistical advice from Gordon
Purdie. (OSEC 2.4, 57iii)
3. Page 8, B5 power calculations are vital to provide the justification for undertaking the
research. Researcher to address this issue. (OSEC 2.4, 57iii)
4. Page 11, D1, initial approach should be made by the clinic nurse who can provide
potential participants with the information sheet so that they are in a position to ask
the surgeon relevant questions at the time of the consultation. (OSEC 2.3, 52)
5. Page 11, D6/7 data to be stored for 10 years.
6. Page 13, F3.2 researcher to confirm that Mr Riki Nia Nia of the Maori Health Unit at
C&CDHB has seen the letter from Laurayne Mariu Peck and agrees with its advice.
(OSEC 2.7, 83)
7. Information Sheet (OSEC 2.2, 29)
 Should be on letterhead
 Page 3, Ethics Committees correct title in all 3 instances should be amended to
Central Regional Ethics Committee and the telephone number changed to 04 4962405.
 Amend telephone for Health and Disability Health Advocates to 0800 423638. Omit
4 ADNET.
8. Consent Form (OSEC 2.2)
 Delete point 9.
 Point 5, last sentence amend “effect” to “affect”.
CEN/06/12/115 - The use of Exhaled Nitric Oxide in the practical management of
childhood asthma: Pilot study
Principal Investigator – Dr Thorsten Stanley
The study was approved subject to the following issues being addressed:
Children’s Information Sheet (OSEC 2.2, 29)
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

Under section “What do I have to do”, point 3, change “dairy” to “diary”.
Page 12, D6/7 data to be stored for 10 years after participant turns 16 years of age.
Meeting Closed at 8.00pm
Date of the next meeting is 13 February 2007
Maureen Holdaway to do the Karakia for the February meeting