MEETING MINUTES
Committee: Upper South B Regional Ethics Committee
Meeting date: 7 November 2011
Meeting venue: Sudima Hotel, cnr Memorial Avenue and Orchard Road, Christchurch
Dakota Room
Time Item of business
4.00pm 1. Welcome
2. Confirmation of minutes of meeting of 29 August 2011
3. Resubmissions of previously deferred applications (see over for details)
Nil
4. New applications for review (see over for details)
i. URB/11/11/039 – Magnus McGee
ii. URB/11/11/040– Raewyn Idoine
iii. URB/11/11/041– Dr Mary Livingston
iv. URB/11/11/042– Annette Finlay
v. URB/11/11/043 – Dr Melissa Copland
vi. URB/11/11/044 – Dr Sarah Gunningham
vii. URB/11/11/045 – Judene Edgar
viii. URB/11/11/046 – Selma Scott
5. General business
6. Amendments to approved applications
Nil
Meeting closes
Committee members: Patricia Costigan, Chair
Annette Finlay
Sarah Gunningham
Selma Scott
Judene Edgar
Magnus McGee
Raewyn Idoine
Mary Livingston
Melissa Copland
Apologies: None
Administrator(s): Diana Whipp
URB Minutes 7 November 2011
1. Welcome
The Chair opened the meeting at 4.05pm and welcomed the Committee members.
The Chair noted that the meeting was quorate, with 9 members present, and there was a
balanced representation of lay and non-lay members.
The Committee noted and agreed the agenda for the meeting.
Potential conflicts of interest declared:
Dr Sarah Gunningham is the Principal Investigator for the submitted Tissue Bank study
URB/11/11/040.
2. Confirmation of previous minutes
The minutes of the meeting of 29 August 2011 were confirmed subject to one amendment on
page 9: Dr Paparangi Reed is female and therefore reference to her needs to be changed to
‘she’.
3. Resubmissions of previously deferred applications
Nil
4. New applications for review
1. Ethics ref: URB/11/11/039
Title: A prospective randomised trial of Niti-S full covered vs double
layered oesophageal stents for malignant dysphagia
Principal Investigator: Dr Gary Lim
Main Site: Christchurch Hospital
Reviewer(s): Magnus McGee
locality Māori
Locality documentation received? assessment consultation
Part 4
Canterbury District Health Board Yes Yes Yes
Potential conflicts of interest
- No potential conflicts of interest were declared.
Discussion
The main points discussed by the Committee were as follows.
- The Committee is concerned about the efficacy of the use of stents. It appears that the
researcher has some prior knowledge on the efficacy of stents. The Committee notes that a 5
year retrospective study of oesophageal stent insertion for malignant dysphagia in Christchurch,
NZ. is in progress. The results to date of this study need to be provided to the Committee. The
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Committee also requires clarification about the current criteria for deciding which stent is selected
at Christchurch Hospital.
- The Committee found the description of the sample size calculation to be inadequate. A detailed
description of the sample size calculation including a justification the expected design affect and
its standard deviation is required.
- On this basis, the Committee found that the application failed to meet the requirements for ethical
research as found in the Operational Standards for Ethics Committees, 2006. In particular the
relevant provisions found in section 2.4 Validity of Research Proposal number 57 (ii) and (iii).
Decision
Following this discussion, the Upper South B Regional Ethics Committee deferred the above study.
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
2. Ethics ref: URB/11/11/040
Title: Ang – 1/IL-29 as markers of cancer in patients with venous
thromboembolism
Principal Investigator: Dr Sarah Gunningham
Main Site: Christchurch Tissue Bank
Reviewer(s): Raewyn Idoine
locality Māori
Locality documentation received? assessment consultation
Part 4
Not applicable No No No
Potential conflicts of interest
Dr Sarah Gunningham is the Principal Investigator for the submitted Tissue Bank study
URB/11/11/040. Dr Gunningham left the room whilst the study was being considered.
Discussion
The main points discussed by the Committee were as follows.
- This is a straightforward and well written application.
Decision
Following this discussion, the Committee decided to approve the above study.
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
3. Ethics ref: URB/11/11/041
Title: Colorectal cancer (CRC) and chronic kidney disease − CRC
screening and early detection
Principal Investigator: Dr Nicholas B Cross
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Main Site: Christchurch Hospital
Reviewer(s): Dr Mary Livingston
locality Māori
Locality documentation received? assessment consultation
Part 4
Christchurch Hospital Pending Pending Yes
Potential conflicts of interest
- No potential conflicts of interest were declared.
Discussion
The main points discussed by the Committee were as follows.
- The Committee is concerned that because of differences in health provisions the New Zealand
arm of the study will be quite different from the Australian arm and that combining the two data
sets might not be valid. The researcher needs to explain and justify why combining the two arms
would be appropriate.
- On this basis, the Committee found that the application failed to meet the requirements for ethical
research as found in the Operational Standards for Ethics Committees, 2006. In particular the
relevant provisions found in section 2.4 Validity of Research Proposal number 57 (iii).
- The Committee strongly encourages the researcher to attend the meeting if and when this
application is resubmitted.
Decision
Following this discussion, the Upper South B Regional Ethics Committee deferred the above study.
Other requests for the researcher to note for any future resubmission of the application
Application Form
- Please clarify the funding for the colonoscopies.
- The flow diagram stating 268 patients is inconsistent with the application form which refers to 100
patients.
- Please clarify whether this is a 5 or 7 year study.
- Please confirm whether the screening test laboratory is in New Zealand or Australia and the
reasons for this choice.
Information sheet
- An Information Sheet is required for the 60 people on the sub study.
- Health data must be stored for 10 years. This must be stated in the Information Sheet. For
studies that involve children, health data must be stored for 10 years after the youngest
participant has turned 16 years of age.
- Please amend your Statement of approval to read as follows:
This study has received ethical approval from the Upper South B Regional Ethics Committee,
ethics reference number URB/11/11/041.
Consent Form
- A Consent Form is required for the 60 people on the sub study.
- A number of co-investigators are mentioned in the Consent Form but they are not included on the
application form. Please include them in the application form.
- Please remove the declaration about being over 16 years of age as this is not relevant to this
study.
Locality Assessment Form
A locality assessment form is required for this study for each site.
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Maori consultation
Written evidence of Maori consultation is required for this study.
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
4. Ethics ref: URB/11/11/042
Title: Efficacy and acceptability of chewing gum to reduce postoperative ileus, pain and
nausea after elective open abdominal surgery in a New Zealand context
Principal Investigator: Dr Katherine Hulme
Main Site: Wairau Hospital, NMDHB
Reviewer(s): Annette Finlay
locality Māori
Locality documentation received? assessment consultation
Part 4
Wairau Hospital, NMDHB
Yes Pending Yes
Potential conflicts of interest
- No potential conflicts of interest were declared.
Discussion
The main points discussed by the Committee were as follows.
- It appears that this study is similar to the work of the systematic review of the ‘Fitzgerald Review’.
The Committee did not find the application provided sufficient information to understand why this
additional study needed to be carried out.
- The requirement for a full power calculation for this study.
- The study cannot provide a New Zealand context if it is conducted in only one location.
- The definition of ileus versus post operative paralytic ileus was discussed.
Decision
Following this discussion, the Committee decided to approve this application subject to the
following conditions, which are to be checked by the Chairperson and Spokesperson.
Requirements
Application Form
It appears that this study is similar to the work of the systematic review of the ‘Fitzgerald Review’.
Therefore, please justify why this additional study is being done.
Please provide a full power calculation for this study explaining where the data has been taken from.
Please clarify whether the participant is chewing gum for 10 minutes 3 times a day or for 30 minutes
once per day and ensure that this information is consistent with the Information Sheet.
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Short project title (lay title): use language that is readily understandable by laypersons. This title is
also to be used on the consent form and information sheet.
Information sheet
- For administrative clarity please include a footer on the Information Sheet with the full study title,
version number, and/or date (dd/mm/yy).
- Please amend your Statement of approval to read as follows:
This study has received ethical approval from the Upper South B Regional Ethics Committee,
ethics reference number URB/11/11/042.
Consent Form
For administrative clarity please include a footer on the Consent Form with the full study title, version
number, and/or date (dd/mm/yy).
Locality Assessment Form
- The first page of the Locality Assessment Form needs to be completed.
Maori consultation
- Written evidence of Maori consultation is required for this study.
Suggestion
Please consider asking the placebo group if they used chewing gum as part of the exit survey.
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
5. Ethics ref: URB/11/11/043 – CLOSED MEETING
Title: Protocol NP27945: A Two part Relative bioavailability Study
Between the Danoprevir Tablet Formulation 1, Danoprevir Tablet
Formulation 2, and the reference Phase 2 Tablet Formulation (Part
1) and Between the Ritonavir Test formulation 1, Ritonavir Test
Formulation 2, and the Reference Ritonavir Formulation Norvir ®
(Part 2) following Oral Administration to Healthy Subjects
Principal Investigator: Dr Richard Robson
Main Site: Christchurch Clinical Studies Trust
Reviewer(s): Dr Melissa Copland
locality Māori
Locality documentation received? assessment consultation
Part 4
Christchurch Clinical Studies Trust Yes Yes Yes
Potential conflicts of interest
- No potential conflicts of interest were declared.
Decision
In a closed meeting the Upper South B Regional Ethics Committee approved this application
subject to conditions.
Point of contact for applicant
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The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
6. Ethics ref: URB/11/11/044
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group Study to Assess the Safety and Efficacy of Two
Different Regimens of Mipomersen in Patients with Familial
Hypercholesterolemia and Inadequately Controlled Low-Density
Lipoprotein Cholesterol. Protocol Number: MIP03801011
Principal Investigator: Professor Russell Scott
Main Site: Diabetes Research Institute, 40 Stewart Street
Reviewer(s): Dr Sarah Gunningham
locality Māori
Locality documentation received? assessment consultation
Part 4
Diabetes Research Institute, 40 Stewart Street Yes Pending Yes
16 St Asaph Street Yes Pending Yes
Potential conflicts of interest
- No potential conflicts of interest were declared.
Discussion
The main points discussed by the Committee were as follows.
- Reimbursement for participants is unclear and may be insufficient.
- Additional information about blood samples, and withdrawal protocol from study needs to be
included in the Information Sheet and Consent Form.
Decision
Following this discussion, the Committee decided to approve this application subject to the
following conditions, which are to be checked by the Chairperson and Spokesperson.
Requirements
Application Form
A.9.2 Please clarify what reimbursement will be given to participants and include this information in
the Information Sheet.
Invitation Letter
- The invitation letter needs to include an explanation about how the participant has been
identified.
- The invitation letter should be prepared on the appropriate letterhead of the principal
investigator’s institution and the full address of the ‘Hagley Building’ given.
Information sheet
- No mention is made in the Information Sheet of the blood samples being sent to the USA for
analysis, the storage time for samples and the protocol for withdrawal from the study. Please
include this information in the Information Sheet and Consent Form.
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- Please include another contact on the Information Sheet so that if Professor Scott is unavailable
there is an alternative contact for participants.
- Please amend your Statement of approval to read as follows:
This study has received ethical approval from the Upper South B Regional Ethics Committee,
ethics reference number URB/11/11/044.
Insurance Certificate
Please provide the Committee with amended insurance certificates which covers the full period of the
study.
Suggestion
The Committee recommends that an appropriate reimbursement be made to participants for this
study.
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
7. Ethics ref: URB/11/11/045
Title: WHY ARE NEUTROPHILS UNABLE TO KILL BACTERIA IN THE
AIRWAYS OF CHILDREN WITH CYSTIC FIBROSIS?
Principal Investigator: Dr Anthony J Kettle
Main Site: Christchurch Hospital, CDHB
Reviewer(s): Judene Edgar
locality Māori
Locality documentation received? assessment consultation
Part 4
Christchurch Hospital, CDHB Yes Yes Yes
Department of Pathology, University of Otago, No Yes Yes
Christchurch
Canterbury Scientific, Christchurch No Yes Yes
Dr Anthony Kettle attended the meeting.
Potential conflicts of interest
- No potential conflicts of interest were declared.
Discussion
The main points discussed by the Committee were as follows.
- This is a worthwhile study but some amendments are required on the Information Sheet and
Consent Form to make them age appropriate and easy to understand.
Decision
Following this discussion, the Committee decided to approve this application subject to the
following conditions, which are to be checked by the Chairperson and Spokesperson.
Requirements
Application Form
- No. 16 Consent: this should be answered with ‘No’ and not ‘Yes’. Please amend.
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- Part 8: Please refer to the requirements for ‘Research with children’ on page 33 of the
Guidelines for the Completion of the National Application Form for Ethical Approval of a
Research Project (NAFG), and ‘Appendix 1: Guidelines for Health Research with Children’ on
pages 51 – 55 of the Operational Standard for Ethics Committees in particular the section on
‘Consent’ in paragraph 263, pages 53 - 54. In the event the child is competent to consent,
the form submitted with the application is appropriate. However, in the event that the
child is deemed not competent to consent, then parent/caregiver consent will be
necessary which should also include the child’s assent. The wording or clauses in pages 21
– 29 of the NAFG, ‘Pro forma for Consent Form’ may be helpful for use or adaption.
Information sheet
- Short project title (lay title): use language that is readily understandable by laypersons. This title
is also to be used on the consent form.
- The wording in the Information Sheet needs to be reviewed to ensure that technical terms and
words are written in lay language eg on page 2 replace the word ‘neutrophils’ with ’white blood
cells’.
- Please rewrite the Information Sheet in more age appropriate language.
- Page 1: Please remove the reference to chlorine bleach.
- Page 3: Please remove the first sentence at the top of page 3 ‘If students or health
……organisation’.
- All references to 50mls blood need to be changed to 20mls.
- Please amend your Statement of approval to read as follows:
This study has received ethical approval from the Upper South B Regional Ethics Committee,
ethics reference number URB/11/11/045.
Consent Form
- Please ensure that the Consent Form is age appropriate and the Consent Form needs to follow
the format of the pro forma template as found on page 20 of the guidelines for completion of the
National Application Form, found using the following link:
http://www.ethicscommittees.health.govt.nz/moh.nsf/pagescm/6771/$File/naf-guidelines-2009-v1-
3.doc
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
8. Ethics ref: URB/11/11/046
Title: Insomnia and Melatonin: A Polar Exploration
Principal Investigator: Wells Weymouth
Main Site: Gateway Antarctica
Reviewer(s): Selma Scott
locality Māori
Locality documentation received? assessment consultation
Part 4
Gateway Antarctica Yes No Yes
Wells Weymouth and Dr Gary Steel attended the meeting.
Potential conflicts of interest
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- No potential conflicts of interest were declared.
Discussion
The main points discussed by the Committee were as follows.
- This study needs to meet the prescribing process in New Zealand.
- The Information Sheet and Consent Forms need to be reviewed.
- Maori consultation is required for this study.
Decision
Following this discussion, the Committee decided to approve this application subject to the
following conditions, which are to be checked by the Chairperson and Spokesperson.
Requirements
Application Form
Form A: the statutory declaration needs to be signed by the most senior registered health
professional ie prescribing physician.
Information sheet
- The Information Sheet needs to include that the drug taken is a prescription medicine and
confirm the process that will be used for this medicine to be prescribed for participants ie which
medical practitioner they will visit.
- Please combine the invitation sheet and the information sheet to avoid confusion.
- Please use wording appropriate for New Zealand.
- Please highlight, embolden or move the ‘Participants’ Rights’ statement to the first page of the
Information Sheet.
- “Compensation”: Please include with the appropriate ACC wording (as per the recommended
Guidelines) as follows:
‘In the unlikely event of a physical injury as a result of your participation in this study, you may
be covered by ACC under the Injury Prevention, Rehabilitation and Compensation Act. ACC
cover is not automatic and your case will need to be assessed by ACC according to the
provisions of the 2002 Injury Prevention Rehabilitation and Compensation Act. If your claim
is accepted by ACC, you still might not get any compensation. This depends on a number of
factors such as whether you are an earner or non-earner. ACC usually provides only partial
reimbursement of costs and expenses and there may be no lump sum compensation
payable. There is no cover for mental injury unless it is a result of physical injury. If you have
ACC cover, generally this will affect your right to sue the investigators.
If you have any questions about ACC, contact your nearest ACC office or the investigator.’
‘You are also advised to check whether participation in this study would affect any indemnity
cover you have or are considering, such as medical insurance, life insurance and
superannuation.’
- Please amend your Statement of approval to read as follows:
This study has received ethical approval from the Upper South B Regional Ethics Committee,
ethics reference number URB/11/11/046.For administrative clarity please include a footer on the
Information Sheet with the full study title, version number, and/or date (dd/mm/yy).
- Information sheets should be prepared on the appropriate letterhead of the principal
investigator’s institution.
Consent Form
- The authorisation needs to be become the Consent Form and the Consent Form needs to follow
the format of the pro forma template as found on page 20 of the guidelines for completion of the
National Application Form, found using the following link:
http://www.ethicscommittees.health.govt.nz/moh.nsf/pagescm/6771/$File/naf-guidelines-2009-v1-
3.doc
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- Please include a statement about the recording of the actigraph during sleep.
- Please include the statement ‘I confirm that I am not pregnant’.
- Consent Forms should be prepared on the appropriate letterhead of the principal investigator’s
institution.
- For administrative clarity please include a footer on the Consent Form with the full study title,
version number, and/or date (dd/mm/yy).
Maori consultation
Written evidence of Maori consultation is required for this study.
Suggestion
You may wish to consider collecting data on people on medications that may affect sleep eg
sedatives, contraceptives,
Point of contact for applicant
The Committee decided that the Administrator be available to be contacted by the applicant with any
questions arising from its decision on this application.
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5. General business
1. Dr Martin Than joined the meeting by phone to say thank you and farewell to committee
members, and the committee thanked Dr Martin Than for his contribution and work for the
committee and wished him well for the future. Dr Than has now transferred to the Upper
South A Regional Ethics Committee.
2. Upcoming changes to health and disability ethics committees: the Chairperson gave the
committee an update of the changes announced by the Government in September as part of
its recent response to an inquiry into New Zealand’s clinical trial environment undertaken by
Parliament’s Health Committee.
New SOPs and shorter, simpler application forms
The Government has directed the Ministry of Health to lead work on developing standard
operating procedures (SOPs) for HDECs. These SOPs will replace the current procedural
rules for HDECs, which are fragmented across a number of documents (including the
Operational Standard).
Consistent with the Government’s decisions, the SOPs will:
clarify and reduce the scope of HDEC review expand access to the expedited review
pathway to include some clinical trials
introduce timelines for full review (35 days) and expedited review (15 days)
clarify when amendments to approved studies themselves require HDEC review
reduce duplication by clarifying the role of HDECs with regard to peer review and local
governance issues.
These SOPs will be finalised by mid-January 2012, by which time shorter, simpler application
forms will also be developed. They will take effect from 1 July 2012.
The Ministry of Health has worked with HDEC Chairs to develop draft SOPs and application
forms. These are likely to be released to stakeholders for comment from December 2011.
Online applications
The Government has directed that applications for HDEC review be able to be made
electronically through the web by 1 July 2012. This will require that the Ministry purchase an
electronic information management system.
The Ministry of Health has released a Request for Proposal (RFP) to give effect to this
Government decision. This RFP, which has been posted on the Government Electronic
Tender Service, closes on Monday 10 October 2011.
Structural changes to HDECs
The number of HDECs will be reduced from seven to four, and their size from twelve to eight
members, as of 1 July 2012. The seven current HDECs will continue to operate normally until
this date.
The Ministry expects to make a call for applications for membership of the four HDECs in late
2011. This call will be publicised on the HDECs’ website.
3. A new member’s training and orientation day is being held in Wellington on 14 November
2011. Judene Edgar is attending.
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6. Amendments to approved applications
Nil
Meeting closed: 6.55 pm.
Signed:……………………………………..Date………………………………
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