Upper South B Regional Ethics Committee - Annual …...Gray Crawford NZ Dip Mgt, Cert.Pers., Cert...

Upper South B Regional Ethics Committee

Annual Report

January 2009 to December 2009

Published in June 2010 by the Ministry of Health

PO Box 5013, Wellington, New Zealand

ISBN 978-0-478-35988-6 (Website) HP 5129

This document is available on the New Zealand Health and Disability Ethics Committees website: http://www.ethicscommittee.health.govt.nz

Contents

Chairperson’s Report 1

Committee Membership 2

Response to Cultural Issues 8

Applications 9

Issues for the Committee 10

Guidelines for the Chairperson’s Delegation 10

Appendix 1: Upper South B Regional Ethics Committee Terms of Reference 12

Appendix 2: Upper South B Regional Ethics Committee Applications Listings 21

Upper South B Regional Ethics Committee Annual Report 2009 iii

Upper South B Regional Ethics Committee Annual Report 2009 1

This report provides an overview of the work of the Upper South B Regional Ethics Committee from January 2009 to December 2009. The report was presented to the Upper South B Regional Ethics Committee at its meeting on 1 February 2010. The report details applications received for ethical approval and other work undertaken by the committee.

Chairperson’s Report The Committee was initially established in December 2004. In its fifth year of operation (2009) the Committee met 10 times and processed 117 new applications: 69 full applications and 48 expedited review of observational studies. No meeting was held in April because insufficient applications were received. I was appointed to the role of Chairperson in December 2009 and Dr Melissa Copland was appointed to the role of Deputy Chair at the meeting held in December 2009. The committee would like to acknowledge the hard work and dedication to the committee over the past 5 years of Gray Crawford, former Chairperson, and Dr Mark Smith, former Deputy Chairperson, who both retired from the Committee in December 2009. They both contributed invaluable knowledge and expertise to the Committee. New members, Jan Marsh and Jo Gregan, who commenced their appointments in December 2009, were welcomed at the December meeting. The Committee has continued to actively encourage researcher/s to attend our monthly meetings in order to personally present their protocols to the Committee. This benefits both the researcher/s and the committee by speeding up the approval process and increasing the understanding of each other’s processes. It also results in improved relationships and co-operation. Sincerely Patricia Costigan Chairperson

Committee Membership

Appointments The following members were appointed by the Minister of Health, pursuant to section 11 of the New Zealand Health Public Health and Disability Act 2000. Chairperson December 2009 to present Patricia Costigan LLB (Hons) Representation Lay member Member category Community representative Gender Female Date of first appointment December 2006 Date of reappointment November 2009 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliations Iwi affiliations None Chairperson January 2009 to November 2009 Gray Crawford NZ Dip Mgt, Cert.Pers., Cert Rehab St (Massey), AFNZIM, JP Representation Lay member Member category Consumer representative Gender Male Date of first appointment November 2004 Date of reappointment February 2008 Term of appointment 1 year Six-year maximum term February 2009 Professional affiliations – Iwi affiliations None Deputy Chairperson December 2009 to present Melissa Copland PhD (Pharmaceutical Sciences and Immunology) Representation Non-lay member Member category Pharmacist/pharmacologist Gender Female Date of first appointment March 2008 Term of appointment 3 years Six-year maximum term February 2014 Professional affiliations - Iwi affiliations None

2 Upper South B Regional Ethics Committee Annual Report 2009

Deputy Chairperson January 2009 to November 2009 Mark Smith MBChB, PhD, FRACP Representation Non-lay member Member category Health practitioner Gender Male Date of first appointment November 2004 Date of reappointment February 2008 Term of appointment 1 year Six-year maximum term February 2009 Professional affiliations Canterbury District Health Board Iwi affiliations None Members Rosemary Carruthers LLB Representation Lay member Member category Lawyer Gender Female Date of first appointment December 2004 Date of reappointment December 2006 Term of appointment 3 years Six-year maximum term December 2009 Professional affiliations – Iwi affiliations None Brenda Moran BA Social Work Representation Lay member Member category Consumer representative Gender Female Date of first appointment November 2004 Date of reappointment December 2006 Term of appointment 3 years Six-year maximum term December 2009 Professional affiliations – Iwi affiliations None Annette Finlay Bachelor of Health Sciences, Dip Nursing Studies Representation Non-lay member Member category Health researcher Gender Female Date of first appointment December 2004 Date of reappointment February 2008 Term of appointment 3 years Six-year maximum term March 2011 Professional affiliations Iwi affiliations Tainui, Te Arawa


Magnus McGee MSc Medical Statistics and Information Technology Representation Non-lay member Member category Biostatistician Gender Male Date of first appointment March 2008 Term of appointment 3 years Six-year maximum term March 2014 Professional affiliations Christchurch School of Medicine and Health Sciences Iwi affiliations None Michael Gough Representation Lay member Member category Community representative Gender Male Date of first appointment November 2006 Date of reappointment December 2006 Term of appointment 3 years Six-year maximum term December 2009 Professional affiliations – Iwi affiliations Te Atiawa, Ngati Mutunga Jane Cooper PhD (Philosophy) Representation Lay member Member category Ethicist Gender Female Date of first appointment March 2008 Term of appointment 3 years Six-year maximum term March 2014 Professional affiliations Iwi affiliations None David McGregor MBChB, PhD, FRACP Representation Non-lay member Member category Health practitioner Gender Male Date of first appointment November 2004 Date of reappointment December 2006 Term of appointment 3 years Six-year maximum term December 2009 Professional affiliations Canterbury District Health Board Iwi affiliations None


Derelie Mangin MBChB, DPA (Distinction), PRIMEX (MRNZCGP) Representation Non-lay member Member category Health researcher Gender Female Date of first appointment December 2006 Term of appointment 3 years Six-year maximum term December 2012 Professional affiliations Iwi affiliations None Jo Gregan Representation Lay member Member category Community representative Gender Female Date of first appointment November 2009 Term of appointment 3 years Six-year maximum term November 2015 Professional affiliations Iwi affiliations None Jan Marsh M.A(Hons), Diploma in Clinical Psychology Representation Non-lay member Member category Psychologist Gender Female Date of first appointment November 2009 Term of appointment 3 years Six-year maximum term November 2015 Professional affiliations Iwi affiliations None

Retirements Gray Crawford, Mark Smith, David McGregor and Michael Gough retired in December 2009.

New Appointments Jan Marsh was appointed as a non-lay member, and Jo Gregan was appointed as a lay member in December 2009.


Members’ attendance Member M/F Lay/

non-Lay Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total

Gray Crawford Consumer Rep

M L Y Y Y Y Y Y Y A Y Retired 8/10

Mark Smith Health Practitioner

M NL Y A Y Y A Y Y A Y Retired 7/10

Rosemary Carruthers Lawyer

F L Y Y Y Y Y Y Y Y Y Y 10/10

Brenda Moran Consumer Rep

F L Y Y Y Y Y Y Y Y Y Y 10/10

Annette Finlay* Health Researcher

F NL Y Y Y Y Y Y Y Y Y Y 10/10

Michael Gough* Community Rep

M L Y Y A Y A Y Y A A Y 6/10

David McGregor Health practitioner

M NL Y A Y Y Y Y A A Y A 6/10

Derelie Mangin

Health Practitioner

F NL A Y Y Y A Y Y A Y Y 7/10

Patricia Costigan

Community Rep

F L Y Y Y Y A Y Y Y A Y 8/10

Magnus McGee

Biostatistician

M NL A Y Y Y A Y A Y Y Y 7/10

Jane Cooper

Ethicist

F L Y Y A Y Y Y Y Y Y Y 9/10

Melissa Copland

Pharmacist

F NL Y Y A Y Y Y Y Y Y Y 9/10

Jan Marsh

F NL Started November 2009 A 0/10

Jo Gregan

F L Started November 2009 Y 1/10

No. members present

10 10 9 12 7 12 10 7 10 10

No. of applications 5 9

6 6 8 7 4 5 8 11 69

* = Māori member Y = Present A = Apology

Expert Advisors Alison Luckey** F NL Y 1/10

Mark Smith M NL Y 1/10

Expert advisors attended to provide expert health practitioner opinion


Training New member training There was no new member training offered in 2009. Ongoing training Ongoing training for members was held in Wellington, 26 to 27 June 2009. Topics included:

Cancer Society Tissue Bank Future use of tissue DNA Testing from a Patient perspective Appeals Process Maori Ethical Framework Statistical aspects of ethics applications Phase I studies Consent in the Acute and Emergency setting

The following members attended:

Rosemary Carruthers Patricia Costigan Annette Finlay Brenda Moran Jane Cooper Magnus McGee Diana Whipp, Administrator also attended.

Chairpersons’ meetings Gray Crawford attended the chairpersons’ meetings on 21 May 2009 and Patricia Costigan attended the chairpersons’ meeting on 3 December 2009.

Approval by the Health Research Council The committee is approved by the Health Research Council (HRC) until December 2010.

United States Department of Health & Human Services Registration The Upper South B Regional Ethics Committee is registered with the United States Department of Health & Human Services. This enables the committee to review United States Government funded research. The registration number is: IRB00004668 – Upper South B Regional Ethics Committee.


Response to Cultural Issues

Number of applications deferred because Māori guidelines were not read

0

Number of applications for which consultation with Māori was considered appropriate

100%

Number of applications returned through insufficient consultation on cultural issues

Less than 10%

Process the committee has for following through on consultation

Feedback to researchers, offering advice for provision of Māori consultation groups for researchers. This is difficult as there are few places for researchers in the public arena who do not sit within an institution.

Cases of unsatisfactory reasons for not including Māori

None

Mechanisms in place to facilitate consultation with Māori by researchers

For comment on the cultural perspective for Māori the contacts are listed below: Canterbury District Health Board studies (CDHB): Tahu Stirling, Te Komiti Whakarite, Christchurch Hospital, Karen Keelan, Maori Komiti, The Princess Margaret Hospital, Te Korowai Atawhai, Mental Health, Hillmorton Hospital Christchurch School of Medicine and Health Sciences Elizabeth Cunningham For engagement with Māori at a community level, contact Dr. Matea Gillies, MIHI (Māori Indigenous Health Institute) at the Otago University And some private individuals who are willing to consult with researchers: Hector Matthews, Executive Director Māori Health CDHB email: Te Runanga o Nga Maata Waka

Te Runaka o Kai Tahu Ki Otautahi

Example of Māori not being included in research (a case of Māori excluded as the specific genetic mutation being studied is not found in Māori)


Applications The committee held 10 scheduled meetings from January 2009 to December 2009.

Ethics Committee statistics for January–December 2009

Applications reviewed by the full committee

Applications approved 2

Applications deferred as at time of report 3

Applications declined 1

Applications carried forward (approved subject to conditions) 62

Applications deferred and subsequently approved 1

Ethics committee approval not required

Studies withdrawn by researcher

Studies terminated by sponsor

Studies transferred to Multi-region Ethics Committee

Total number of applications considered by the full committee 69

Applications deferred and subsequently approved 1

Expedited review applications

Expedited review applications approved 27

Expedited review applications declined review – ethics committee approval not required 17

Expedited review applications declined review – full application required

Expedited review applications declined review – insufficient information provided 2

Expedited review applications carried forward (approved subject to conditions) 2

Total number of expedited review applications reviewed 48

Total number of applications received 117

Other committee statistics

Number of matters arising 11

Number of general business items 23

Number of amendments reviewed by committee 2

Number of amendments approved under Delegated Authority 96

Innovative practice No applications for innovative practice were received.

Second opinions None were sought in 2009.

Complaints There were no complaints made in 2009.


Issues for the Committee Closed Meetings The committee is concerned by requests for protocols to be heard in closed meetings. This occurs even when information on the proposed new medication to be tested is freely available on the internet.

The committee has previously agreed to a procedure in these circumstances. If a committee member considers that the researcher needs to explain, in more detail, their reasons for requesting the protocol to be heard in a closed meeting, then that member must communicate with the Chair, prior to the meeting. If it is considered appropriate, the Chair will then write to the researcher/s requesting further justification of their request for a closed meeting. The committee feels that it is important to continue to question the need for closed meetings to ensure they only occur for valid reasons.

Guidelines for the Chairperson’s Delegation At its meeting on 9 June 2008, the committee agreed to delegate the following authority to the Chairperson and Deputy Chairperson, taking into account the Ethical Guidelines for Observational Studies. The Chairperson and Deputy Chairperson may act with the delegated authority of the Upper South B Regional Ethics Committee between meetings. The Chairperson may approve the following: Minimal-risk observational research: case reports or case series; descriptive studies; and

questionnaires or surveys for research purposes that do not involve the collection of sensitive personal information.

Audit or related activity that requires ethics committee review. Observational studies that are undertaken as part of an educational qualification, which

require timely ethics committee review. Requests for the use of de-linked human tissue samples. Requests for the use of tissue/body parts that would normally be discarded and where

the consumer has given consent. Applications where an approval in principle (approved subject to conditions) has

previously been granted by the committee and the researcher has complied with the requests of the committee.

Amendments that require review and that should not impact adversely on participants. Extensions to existing protocols.


Annual Progress Reports & Final reports. These delegations are binding on the Deputy Chairperson where that person is required to act on behalf of the Chairperson.

Deputy Chairperson The Deputy Chairperson may approve the following: Amendments that require review and that should not impact adversely on participants Extensions to existing protocols Serious Adverse Events / Safety Reports Annual Progress Reports & Final reports Applications for expedited review, where the Chairperson has delegated review to the

Deputy Chairperson Applications where an approval in principle (approved subject to conditions) has

previously been granted by the committee and the researcher has complied with the requests of the committee

NB: EGOS refers to Ethical Guidelines for Observational Studies, 2006 OSEC refers to Operational Standards for Ethics Committees, 2006


Appendix 1: Upper South B Regional Ethics Committee Terms of Reference The new Terms of Reference for the Health and Disability Ethics Committees were updated in July 2008 and they are as follows.

Public Authority of the Upper South B Regional Ethics Committee (Upper South B REC) The Upper South B REC is established as a Ministerial committee under section 11 of the New Zealand Public Health and Disability Act 2000. These Terms of Reference outline the role and functions of the Upper South B REC.

Authority of the Upper South B Regional Ethics Committee The Upper South B REC (in conjunction with the Upper South A REC) shall have primary responsibility for ethics committee review of health and disability research and innovative practice occurring in the following District Health Board regions: Nelson/Marlborough West Coast Canterbury South Canterbury The Upper South B REC (in conjunction with the Upper South A REC) has primary responsibility for any health and disability research that is currently being undertaken in the above DHB regions, provided that such research has previously been given ethical approval by an approved regional ethics committee. Any other Regional Ethics Committee or the Multi-Region Ethics Committee may, if it has capacity, review health and disability research from the above regions. The Upper South B REC may, if it has additional capacity, review multi-region and national health and disability research or research from any other region.

Relation to the Operational Standard for Health and Disability Ethics Committees These Terms of Reference have precedence over the Operational Standard for Health and Disability Ethics Committees on any point of conflict, but otherwise, the Operational Standard applies to the Upper South B REC.


Relations with other public sector organisations The Upper South B REC shall liaise with other relevant ethics committees on matters of common interest, such as jurisdiction over borderline cases. The Upper South B REC shall inform the Ministry of Health and the National Ethics Advisory Committee of any matters that arise in its operation that potentially have policy significance.

Approval of the Upper South B Regional Ethics Committee The Upper South B REC has to be approved for the purposes outlined in the following enactments: - the Injury Prevention, Rehabilitation, and Compensation Act 2001 - the Health Research Council Act 1990 - the Health Information Privacy Code 1994.

Role of the Upper South B Regional Ethics Committee The primary role of the Upper South B REC is to provide independent ethical review of health research and innovative practice that will be conducted in its region of authority to safeguard the rights, health and wellbeing of consumers and research participants and, in particular, those persons with diminished autonomy. In order to do this, the Upper South B REC shall: i. foster an awareness of ethical principles and practices in the health and disability

sector and research community ii. facilitate excellence in health research and innovative practice for the wellbeing of

society iii. collaborate with researchers to ensure the interests, rights, dignity, welfare, health, and

wellbeing of participants and consumers are protected iv. give due consideration to community views v. consistent with section 4 of the New Zealand Public Health and Disability Act 2000 and

He Korowai Oranga, recognise and respect the principles of the Treaty of Waitangi vi. operate in accordance with the Operational Standard for Health and Disability Ethics

Committees vii. operate in accordance with any guidance issued or approved by the Minister of Health.

Composition and Membership Guiding principle The primary guiding principle for appointing members to the Upper South B REC is to ensure that the Upper South B REC has the appropriate expertise, skills, knowledge and perspectives to conduct ethical review of the best quality.


Member numbers The number of members of the Upper South B REC should be 12.

Lay/Non-lay membership One half of the total membership shall be lay members, including a lay Chairperson and a non-lay Deputy Chairperson. A lay person is a person who is not: currently, nor has recently been, a registered health practitioner (for example, a doctor,

nurse, midwife, dentist, pharmacist) involved in conducting health or disability research or who is employed by a health

agency and who is in a sector of that agency which undertakes health research construed by virtue of employment, profession or relationship to have a potential

conflict or professional bias in a majority of protocols reviewed.

Member categories The Upper South B REC’s lay membership shall include: an ethicist a lawyer consumer perspectives community perspectives

The Upper South B REC’s non-lay members shall include: two health researchers a pharmacist or pharmacologist a biostatistician two health practitioners

Whole committee requirements At any time, consistent with the requirements of the New Zealand Public Health and Disability Act requirements for District Health Boards, the Upper South B REC shall have at least two Mäori members. Mäori members should have a recognised awareness of te reo Mäori, and an understanding of tikanga Mäori. All members of the Upper South B REC are expected to have an understanding of how the health sector responds to Mäori issues and their application to ethical review. The Upper South B REC’s membership should include expertise in the main kinds of health and disability research (eg. interventional, observational, kaupapa Mäori, and social research), and in both quantitative and qualitative research methods. Members should possess an attitude that is accepting of the values of other professions and community perspectives, and it is important for committees to be comprised of people from a range of backgrounds and ethnicities.


Despite being drawn from groups identified with particular interests or responsibilities in connection with health and community issues, Upper South B REC members are not in any way the representatives of those groups. They are appointed in their own right, to participate in the work of the Upper South B REC as equal individuals of sound judgement, relevant experience and adequate training in ethical review.

Terms and Conditions of Appointment Members of the Upper South B REC are appointed by the Minister of Health, pursuant to section 11 of the New Zealand Public Health and Disability Act 2000, for a term of office of up to three years. The terms of office of members of the Upper South B REC shall be staggered to ensure continuity of membership. Members may be reappointed from time to time. No member may hold office for more than six consecutive years. After serving the maximum six-year term, members shall not be considered for reappointment until at least three years after their retirement from the Upper South B REC. Persons who have served six consecutive years on any Health Research Council (HRC)-approved ethics committee shall not be immediately eligible for appointment to the Upper South B REC. Those persons shall not be eligible for appointment to the Upper South B REC until at least three years after their retirement from any HRC-approved ethics committee. Persons who have served less than six years on any HRC-approved committee will be eligible to be appointed to the Upper South B REC for a term that is equal to the difference of six years and the term already served by that person on any HRC-approved ethics committee, or a shorter period. A person may not be a member of the Upper South B REC and National Ethics Advisory Committee or the Health Research Council Ethics Committee simultaneously. Unless a person sooner vacates their office, every appointed member of the Upper South B REC shall continue in office until their successor comes into office. Any member of the Upper South B REC may at any time resign as a member by advising the Minister of Health in writing. Any member of the Upper South B REC may at any time be removed from office by the Minister of Health for inability to perform the functions of office, bankruptcy, neglect of duty, or misconduct, proved to the satisfaction of the Minister. The Minister may from time to time alter or reconstitute the Upper South B REC, or discharge any member of the Upper South B REC, or appoint new members to the Upper South B REC for the purpose of decreasing or increasing the membership or filling any vacancies.


Chairperson and Deputy Chairperson The Minister shall appoint a lay member of the Upper South B REC to be its Chairperson. The terms and conditions of appointment for members of the Upper South B REC also apply to the person appointed as Chair. The Chairperson shall preside at every meeting of the Upper South B REC at which they are present. The Upper South B REC shall appoint a non-lay member as Deputy Chairperson and may appoint a second lay or non-lay Deputy Chairperson. The Chairperson and Deputy Chairperson/s may act with the delegated authority of the Upper South B REC between meetings.

Duties and responsibilities of a member This section sets out the duties and responsibilities generally expected of a person appointed as a member of the Upper South B REC. This is intended to aid Upper South B REC members by providing them with a common set of principles for appropriate conduct and behaviour.

General Upper South B REC members should have a commitment to protecting the interests of human participants while promoting and facilitating excellence in research and innovative practice. There is an expectation that Upper South B REC members will make every effort to attend all Upper South B REC meetings and devote sufficient time to become familiar with the affairs of the Upper South B REC and the wider environment within which it operates. Members have a duty to act responsibly with regard to the effective and efficient administration of the Upper South B REC and the use of Upper South B REC funds.

Conflicts of interest Upper South B REC members should perform their functions in good faith, honestly and impartially and avoid situations that might compromise their integrity or otherwise lead to conflicts of interest. Proper observation of these principles will protect the Upper South B REC and its members and will ensure it retains public confidence. Upper South B REC members attend meetings and undertake Upper South B REC activities as independent persons responsible to the Upper South B REC as a whole. Members are not appointed as representatives of professional organisations or particular community bodies. The Upper South B REC should not, therefore, assume that a particular group’s interests have been taken into account because a Upper South B REC member is associated with this group. Members should declare, and the committee regularly review their actual and potential conflicts of interest.


When Upper South B REC members believe they have a conflict of interest on a subject that will prevent them from reaching an impartial decision or from undertaking an activity consistent with the Upper South B REC’s functions, they should declare that conflict of interest and withdraw themselves from the discussion and/or activity. A member of the Upper South B REC who has a proposal before the Upper South B REC or who has an involvement in the proposal such as a supervisory role shall not take part in the Upper South B REC’s assessment of that proposal. The member may be present to answer questions about a proposal but should take no part in the discussion surrounding the consideration of the proposal or any decision relating to the proposal. This will allow proposals to be considered in a free and frank manner. The Upper South B REC must exhibit transparency in avoiding or managing any real or perceived conflict of interest.

Confidentiality and information sharing Agendas and minutes of all Upper South B REC meetings should be available to the public. Copies of proposals should be available to individuals outside the Upper South B REC, subject to deletions in accordance with the Official Information Act 1982, and any deletions necessary to protect the privacy of individual persons. If an applicant would like their proposal to remain confidential, they must give reasons, consistent with the Official Information Act, to satisfy the Upper South B REC that the proposal should remain confidential. The reasons for keeping a proposal confidential are subject to review by the Ombudsmen. It is desirable for the members of the Upper South B REC to have an opportunity to discuss issues arising from applications with key contacts and support people prior to the consideration of proposals. This process should be encouraged. However, due to the need to protect any personal information, names or identifying details should not be circulated or made known outside the Upper South B REC. The Upper South B REC will need to consider the Privacy Act 1993 and the Health Information Privacy Code 1994 in developing these processes. Within the Upper South B REC, members with particular community expertise should be consulted and provide advice on the appropriate consultative process for all ethical issues concerning particular communities of interest.

Committee meetings Meetings of the Upper South B REC shall be held monthly or less frequently, as determined by the workload. At any meeting, a quorum shall consist of at least seven members or the minimum number constituting a majority. The quorum must include a reasonable representation of members with health practitioner, research, ethical and community/consumer expertise, knowledge and perspectives.


As part of the accountability to the public they protect, it is desirable for the meetings of the Upper South B REC to be open to the public. Meetings of the Upper South B REC should therefore be: i. open meetings for the discussion of broad issues, particularly if the Upper South B

REC is reviewing health research ii. closed meetings when necessary to ensure the privacy and confidentiality of

participants iii. closed meetings when applicants provide good and sufficient reasons for this to occur,

and the minutes of the meeting should reflect these reasons. Information about the dates and times of committee meetings should be made available to the public. Applicants may attend meetings, in person or by teleconference, to talk to their proposal and answer any questions the Upper South B REC may have. Attendance is not mandatory. The Upper South B REC should advise applicants that they may be asked to leave the meeting while the Upper South B REC considers the proposal. Subject to the provisions set out in this document, the Upper South B REC may regulate its own procedures.

Decision-making process Wherever possible, the Upper South B REC should determine matters by consensus decision. Where a consensus cannot be reached, a vote shall apply, with a two-thirds majority of those voting required for any decisions, and the Chairperson having a casting vote. In relation to research involving Mäori, it is important that Mäori expertise be available to ensure that all issues are appropriately considered. Where it is not possible for Mäori members to attend an Upper South B REC meeting or for those members’ views to be sought and represented at the meeting, the matter should be deferred. On occasion, individual members may wish to abstain from some or all of the decision making process because of strong personal moral or religious reasons. Such abstentions shall not affect the approval process.

Ethics Committee Actions For each application it reviews, the Upper South B REC must state to its applicant whether its action is to Approve, Approve subject to conditions, Defer, or Decline that application. It must state its grounds for any action to Defer or Decline. For any action to Approve subject to conditions, it must specify the conditions, the grounds for these, and its process for assessing whether these conditions are subsequently met. In all cases, it must state which matters its action is based upon, and which are instead matters of comment, information, or advice to its applicant.


Expert advice and consultation Members may wish to consult on ethical issues with, for example, individuals, groups, iwi and hapü, and this should be encouraged and supported. Consultation should be carried out in a timely manner. Where the Chairperson or quorum of Upper South B REC members believes there is insufficient expertise on the Upper South B REC to assess an application or an issue, the committee should seek additional expert advice. Advice may be sought from recognised experts with: i. specialist knowledge in particular fields of science and medicine ii. knowledge of the experiences and perspectives of people with disabilities iii. awareness of gender health perspectives iv. consumer and/or research participant perspectives v. an understanding of community health issues vi. an understanding of relevant cultural perspectives vii. an understanding of developing Mäori research methodologies viii. expertise in te reo Mäori ix. expertise in ethical theory. It should be noted that the above list gives examples, without restricting the range, of external expertise that may be sought. Where external consultation has taken place or advice has been sought, this should be documented, and recorded where appropriate in the Upper South B REC’s decision on a proposal.

Review of Committee Decisions At any stage in its deliberations, the Upper South B REC may seek advice regarding procedures or proposals from another health and disability ethics committee. The decisions of the Upper South B REC may be reviewed by the Health Research Council Ethics Committee under the Health Research Council Act 1990.

Training for members Training should be provided for new members and chairpersons within six months of appointment to the Upper South B REC.

Reporting requirements The following provides a checklist of requirements for annual reporting. Annual reports should be submitted to the Minister of Health and will be tabled by the Minister of Health in the House of Representatives.


The annual report shall include information on the membership of the Upper South B REC, including any change in the Upper South B REC’s membership or other substantive changes the Upper South B REC or its chairperson feels should be noted. The annual report shall also include a list of the national and multi-region research and innovative treatment protocols reviewed in the preceding year outlining the following details: i. the research title ii. principal investigator iii. institutions where the research is to be/has been undertaken iv. date of first review v. date of final outcome vi. outcome (which will be one of: Approved, Approved with conditions, Deferred,

Declined) vii. for each protocol deferred or declined, the reason(s) for the decision

The annual report shall also include: i. A list of training undertaken by Upper South B REC members, and a statement on

processes for orientation and training of new Upper South B REC members should be included.

ii. A list of complaints received by the Upper South B REC (if any), the actions taken to resolve the complaint and a comment on the outcome of the complaint(s).

iii. Any areas of review that caused difficulty for the Upper South B REC in making a decision on any particular protocol(s), and any questions on policy or other matters the Upper South B REC referred to the National Ethics Advisory Committee or the Health Research Council Ethics Committee for comment or guidance.

In compiling their reports, the Upper South B REC should take care not to provide information that would involve a breach of the Privacy Act 1993 and/or the Health Information Privacy Code 1994.

Fees and Allowances Members of the Upper South B REC are entitled to be paid fees for attendance at meetings. The level of attendance fees are set in accordance with the State Services Commission’s framework for fees for statutory bodies. The Chairperson shall receive an attendance fee of $330 per day plus half a day’s preparation fee. The attendance fee for members is set at $250 per day plus half a day’s preparation fee. In the event that the Chairperson and/or Deputy Chairperson/s are required to undertake additional work under the delegated authority of the Upper South B REC, they will be remunerated for the additional work at the same rate of remuneration as their attendance fee, up to a maximum of 4 days per month. The Ministry of Health shall pay actual and reasonable travel and accommodation expenses of the Upper South B REC members.

Servicing of the Upper South B Regional Ethics Committee The Ministry of Health shall employ staff and provide resources to service, advise, and administer the Upper South B REC out of the allocated budget for ethics committees.



Appendix 2: Upper South B Regional Ethics Committee Applications Listings Appendix 1 details the applications considered by the committee from January 2009 to December 2009. Eight applications were considered in ‘closed’ meetings.

Project Key Full Title Primary Investigator

Date Received

Meeting Reviewed

Outcome Why deferred/declined

Staus at time of report

Date of approval

Locality Organisations

Form

Sponsor/Funder Consultation undertaken

URB/09/02/001 START Evaluation - Is Involving caregiver and family/whanau an effective treament strategy to reduce sexual abuse symptomology and what evidence exists of dissociative symptomology amongst START clients?

Mr Simon Panckhurst

13/01/2009

2/02/09 Approved Subject to Conditions

Approved 16/03/2009

START Nil START He Oranga Pounamu

URB/09/02/002 Reactions and responses to the diagnosis of a progressive hearing loss in adults

Katrina Light 16/01/2009


Approved 25/03/2009

Hearing Advantage Hearing Advantage Hearing Advantage Bay AudiologyBay Audiology

Nil University of Canterbury

Te Komiti Whakarite

URB/09/02/003 A comparison of music appreciation ratings for MED-EL cochlear implant users between the Fine Structure Processing and High Definition Continuous Interleaved Sampling processing strategies

Philip Winter 16/01/2009


Approved 16/03/2009

University of Canterbury

A MED-EL Corporation

Karuhiruhi

URB/09/02/004 Breath Analysis in High-Risk Haematology Patients for the Diagnosis of Invasive Aspergillosis

Prof. Stephen T Chambers

19/01/2009


Approved 2/03/2009 Christchurch Hospital

A HRC, Child Health Foundation

Ngai Tahu/Ngati Mutanga


Date Received

Meeting Reviewed



Date of approval


Form


URB/09/02/005 Behavioural and Physiological Dynamics of Lapses of Responsiveness and Errors after Sleep Deprivation

Associate Professor Richard Jones

19/01/2009


Approved 30/03/2009

Van der Veer Institute

A Marsden grant, CMRF grant and an ACC Career Development Award

Elizabeth Cunningham - Te Komiti Whakarite

URB/09/03/006 The spiritual well-being of patients with a life limiting illness in the acute care setting

Mr Willem Vink

17/02/2009


Closed 31/03/2009

Christchurch Hospital

Nil Elizabeth Cunningham

URB/09/03/007 Surgical menopause and hormone replacement therapy: Perceptions and experiences

Beverley Burrell

17/02/2009


Approved 30/03/2009

Private place Nil University of Otago Research Committee

Elizabeth Cunningham

URB/09/03/008 A Phase II study of Dasatinib Combined withInduction Chemotherapy in Previously Untreated de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia

Dr. Andrew Butler

17/02/2009


Approved 14/04/2009

Canterbury Health Laboratories

A Australasian Leukaemia & Lymphoma Group (ALLG)

Mr Peter Mason;Connections Nga Kete E Rua

URB/09/03/009 Getting better: Evaluating outcome measures for depression in older people in mental health services

Dr Matthew Croucher

17/02/2009


Approved 12/05/2009

Princess Margaret Hospital

Nil CDHB Te Komiti Whakarite

URB/09/03/010 The Canterbury Eating and Feeding Study: Survey of non-food factors affecting toddlers and preschoolers eating habits and weight

Ms Amy T Galloway

17/02/2009


Approved 11/05/2009

Royal New Zealand Plunket Society Canterbury Area Otautahi Maori Women's Welfare League

Nil CPIT, Appalachian State University

Royal New Zealand Plunket Society Canterbury Area;Otautahi Maori Women's Welfare League;Pacific Trust Canterbury

URB/09/03/011 Outcome Evaluation of Early Start (9 Year Follow-up)

Professor David Fergusson

18/02/2009


Approved 7/04/2009 In participant's homes

Nil HRC programme grant

Elizabeth Cunningham and Board ofEarly Start



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/03/012 Metacognitive Therapy and Cognitive Behaviour Therapy for Depression

Dr Jenny Jordan

18/02/2009


Approved 11/05/2009

Department of Psychological Medicine, Terrace House, nr Chch Hospital Van der Veer Institute

A Elizabeth Cunningham;Paul Roertson;Te Pora Ehau;Louise Tankersley;Wendy Dallas-Katoa

URB/09/03/013 Reform wound dressing: patient and nurse feedback study

Dr Martin Than

18/02/2009


Approved 6/07/2009 Nurse Maude Association

B Mesynthes Ltd Te Komiti Whakarite

URB/09/05/015 Citric-Acid Inhalation Cough Challenge – Establishing Normative Data

Margaret Monroe

20/04/2009


Approved 8/06/2009 Van der Veer Institute for Parkinson's and Brain Research

Nil Angelia Ria;He Oranga Pounamu

URB/09/05/016 The role of Magnetic Resonance Imaging in the Management of Perianal Crohn’s Disease

Mr Tim Eglinton

21/04/2009


Approved 10/08/2009


A No funding required

Te Komiti Whakarite

URB/09/05/017 Paediatric Haematology / Oncology Late Effects Assessment Programme (LEAP) study of the quality of life and wellbeing of survivors of childhood cancer in New Zealand

Ms Kathy Yallop

21/04/2009


Approved 10/08/2009

Starship Children's Health Christchurch Hospital Wellington Hospital

A Rotary Club of Newmarket Inc and CanTeen National Office

Mata Forbes - Maori Health Service Coordinator/Advisor;ADHB;Patrick Au - Asian Mental Health Coordinator;ADHB;Ilaisaane Langi - Team Leader;pacific Family support Unit. Starship ADHB

URB/09/05/018 A Dose-Blind Multicenter, extension study to determine the long term safety and efficacy of two doses of BG00012 Monotherapy in subjects with relapsing-remitting Multiple Sclerosis

Dr Deborah Mason

21/04/2009


Approved 10/06/2009

Christchurch Hospital Auckland Hospital Central Neurological Services Ltd (CNSL), Hamilton

B Biogen Idec Maori Advisory Group for each location

URB/09/06/021 Plasma CNP forms in adults with acquired thyroid disease: Corelation with thyroid status and bone turnover markers

Dr Belinda Schouten

19/05/2009


Approved 28/07/2009


Nil Departmental and research funds

Te Komiti Whakarite Christhchurch Hospital



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/06/022 The effect of bisphosphonates on plasma CNP forms

Dr Belinda Schouten

19/05/2009


Approved 3/08/2009 Christchurch Hospital Princess Margaret Hospital

Nil Departmental and research funds

Te Komiti Whakarite Christchurch Hospital

URB/09/06/023 The distribution of omeprazole into human breast milk: a single dose study

Ms Judith Dalrymple

19/05/2009


Approved 28/09/2009


Nil Existing Uni of Otago reseach funds

Te Komiti Whakarite Christchurch Hospital

URB/09/06/024 A Multi-center, Randomized, Double-blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail Protocol Number: 20062017

Dr. Nigel Gilchrist

19/05/2009


Approved 20/07/2009

Christchurch Hospital Leinster Orthopaedics Elmwood Orthopaedic Centre CGM Research Trust

B Amgen Inc. Mr Peter Mason

URB/09/06/025 A Phase 1B Open Label Study of The Safety, Tolerability and Pharmacodynamic Activity of 100mg Clemizole Hydrochloride Administered Orally Twice a Day for 28 days Immediately prior to Initiation of Treatment with HCV Standard of Care Therapy in Treatment Naive Subjects Chronically Infected with HCV. Protocol EIG-101

Dr Alison Luckey

19/05/2009


Approved 29/07/2009

Primorus Clinical Trials Ltd Christchurch Hospital

B Eiger BioPharmaceutical, Inc

Mr Peter Mason;Connections;Nga Kete E Rua;Christchurch

URB/09/06/026 Outcome effects of a Mentalization Based Treatment service (MindSight) for people with personality disorder in urban Christchurch: a clinical trial and evaluative study

Mr Dave Carlyle

19/05/2009


Approved 12/08/2009

Community Mental HEalth Services

A University of Otago Research Grant

Elizabeth Cunningham and Te Korowai Atawhai (Maori Mental Health Services)



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/07/027 Influence Of Inhaled Corticosteroids on Acoustic Features of Normal Voice Production in Adults

Prof. Mcihael Robb

22/06/2009


Approved 27/07/2009


Nil Discretionary account Dept of Health Sciences for Masters students

Na Theresa Rongonui, Maori Research and Innovation, University of Canterbury

URB/09/07/028 "How to respond to the role of alcohol and drugs in enabling violent behaviour: A "proof of concept" project using Service Science methods"

Dr Wendy Gregory

22/06/2009


Approved 10/08/2009

ESR Nil Capability Fund, Ministry of Research Science and Technology

Annabel Ahuriri-Driscoll and Maui Hudson;ESR Maori researchers;Daryl Gregory;founder of He Waka Tapu Trust;and;Wally Haumaha;(NZ Police.

URB/09/07/029 Assessment of changes to labyrinthine function following surgery on the middle ear

Dr Emily Macassey

22/06/2009


Approved Subject to Conditions

Christchurch Hospital St George's Hospital Southern Cross Hospital

Nil External funding to be applied for

Te Komiti Whakarite

URB/09/07/030 Impact of submaximal steady state exercise on arterial oxygen saturations of healthy volunteers at moderate altitude, compared to sea level values

Dr Rachel L Wiseman

23/06/2009


Approved 31/08/2009


Nil No direct funding Tahu Potiki Sitrling

URB/09/07/031 Impact of exercise on arterial oxygen saturations of healthy volunteers at moderate altitude

Dr Rachel L Wiseman

23/06/2009


Approved 31/08/2009

Christchurch Hospital Mount Hutt ski field

Nil No direct funding Tahu Potiki Sitrling

URB/09/07/032 Parkinson's disease dementia: brain imaging using saccades

Ms Sarah Wright

23/06/2009


Approved 29/07/2009

Van der Veer Institute for Parkinson's and Brain Research

A Project funding Neurological Foundation NZ and Canterbury Medical Research Foundation

Elizabeth Cunninham

URB/09/07/033 Characteristics of vocally disruptive behaviour in residents with dementia in private hospitals and

Ms Christine Wyles

23/06/2009


Approved 15/09/2009

Rosewood Rest Home

Nil Dept Communication Disorders Uni of Canterbury




Date Received

Meeting Reviewed



Date of approval


Form


possible interventions

URB/09/08/035 Role Development of Nurses Supervising Exercies Tolerance Tests

Ms Judith Ann Ward

21/07/2009


Approved 17/08/2009


Nil Volunteer Group Chch Hospital and Dept of Nursing Chch Hosptial and NZ Nurses Organisation

Te Komiti Whakarite (Tahu Stirling)

URB/09/08/036 An evaluation of the efficacy of Motivational Interviewing (MI) in increasing commitment language (CL) in interviews with clients with spinal cord injury (SCI)

Mr Michael Terrence Smith

21/07/2009

3/08/09 Deferred Approved 7/09/2009 Burwood Hospital

Nil costs covered by researcher and time contributions from Kaleidoscope and NZ Spinal Trust

Tim Reriti

URB/09/08/037 Cognitive Status, Everyday Functions, Eye Movements and Brain Imaging in Parkinson's Disease

Professor T Anderson

21/07/2009


Approved 9/09/2009 Van der Veer Institute for Parkinson's and Brain Research

Nil Canterbury Medical Research Foundation and HRC


URB/09/08/038 Cognitive and behavioural functioning in people withdrawn from long term SSRI antidepressant use

Dr Claire Dowson

21/07/2009

3/08/09 Approved Approved 10/08/2009

Department of Public Health

A Grant applications and iinternal funds

Dr Paul Robertson;MIHI;University of Otago;Christchurch (Ngai Tahu and a clinical psychologist)

URB/09/08/039 Improving diabetes self-management: A randomised controlled trial

Dr. Lisa Whitehead

21/07/2009


Approved 13/10/2009

Halls and Community Centres Centre for Postgraduate Nursing Studies

A Strategy to Advance Research in Nursing and Allied Heatlh Grant


URB/09/08/040 A randomized control trial to compare scarring in midline sternotomy wounds using a keratin gel dressing versus standard moisturizer therapy

Dr Hamesh Jina

21/07/2009

3/08/09 Declined operational standard 2.4 57 (ii) and (iii)

Declined Christchurch Hospital St George's Hospital Participant's homes

B RJK Developments Ltd

Te Komite Whakarite



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/08/041 The effect of intratympanic dexmethasone administration on hearing loss in patients receiving intermediate and high dose cisplatin

Mr P. A. Bird 21/07/2009


Approved 23/09/2009


A Head and Neck service at Christchurc Hospital. Data management paid by Christchurch Oncology Research Unit 704 account.

Karuhiruhi

URB/09/09/042 Rotating Platform Compared to Posterior Stabilised Low Contact Stress Total Knee Replacement: A Prospective Randomised Trial

James Taylor 12/08/2009


Approved 15/12/2009


A Unfunded Mere Hibbs;Kai Whakahaere;Ranga Hauora Maori Health Services

URB/09/09/043 A Computerized Pitch-Perception training Program for Hearing Impaired

Ms Donna M P Jayakody

25/08/2009


Approved 19/10/2009

Canterbury University St George's Hospital Van Asch Deaf Education Centre

Nil Uni of Canterbury PhD student fund, SCIP-Research Trust Fund and Phonak Fund

John Pirker - Maori Research Advisory Group

URB/09/09/044 Evaluation of the Presbyterian support Upper South Island (PSSUSI) integrated support service for older people living with cognitive impairment

Dr Diane Jorgensen

25/08/2009


Approved 5/10/2009 Participant's homes Canterbury DHB

Nil Canterbury DHB Karen Keelan, Kaitautoko Kaumatua

URB/09/10/046 An exploration of the Practice Nurse consultation and engagement with patients

Ms Elsa Lally 22/09/2009


Approved 4/11/2009 Tahuna Medical Centre Stoke Medical Centre Wakefield Health Centre Nelson Family Medicine Nelson East Medical Centre Drs Riley &

Nil University of Wellington post-gradue study grant

Ann Hampton;Te Amo Health;Motueka;Kaumatua Tahi Takao;Te Awhina Marae;Motueka;Mayanne Wilkki-Singh;Te Awhina Marae;Motueka;Trisha Falleni Ngati Rarua;Victory Community Centre;Nelson



Date Received

Meeting Reviewed



Date of approval


Form


Mawdsley Greenwood HEalth

URB/09/10/047 Genetic Analysis of Ovarian Granulosa Cell Tumours (TISSUE BANK)

Dr A Shelling 22/09/2009


Approved 9/11/2009 Nil

URB/09/10/048 Development of a diagnostic test for urinary tract infections

Associate Professor Tony Kettle

22/09/2009



University of Canterbury Canterbury DHB -select-

A Not currently funded


URB/09/10/049 Why are neutrophils unable to kill bacteria in the airways of children with cystic fibrosis?

Associate Professor Tony Kettle

22/09/2009



Canterbury DHB

A Free Radical Research Group


URB/09/10/050 Effect of vitamin D supplementation on upper respiratory infections in adults - a randomised controlled trial

Professor David Murdoch

22/09/2009

5/10/09 Approved Approved 12/10/2009

University of Otago Canterbury DHB

A HRC project grant (09-302)


URB/09/11/051 Validity of Renal Function Estimates in Persons with High Muscle Mass and Extreme Body Weight: suitability of eGFR estimates for screening Chronic Kidney Disease

Dr Chris Florkowski

13/10/2009



Canterbury DHB

A Canterbury Medical Research Foundation and the New Zealand Kidney Foundation


URB/09/11/052 The cost of paediatric and perianal Crohn's disease in New Zealand

Dr Richard Gearry

14/10/2009


Approved 2/12/2009 Canterbury DHB

A Bowel and Liver Trust




Date Received

Meeting Reviewed



Date of approval


Form


URB/09/11/053 ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the BVS Everolimus Elutiing Coronary Stent System in the Treatment of Subjects with de novo Native Coronary Artery Lesions CLINICAL INVESTIGATION PLAN 09-386

Dr Dougal McClean

20/10/2009


Approved 23/12/2009

Canterbury DHB

B Abbott Cardiovascular Systems, BVBA

Te Komite Whakarite

URB/09/11/054 Mapping the uptake, the process and the effectiveness of professional and clinical supervision, for nurses, in the Canterbury region

Ms Beverley Burrell

20/10/2009


Approved 2/12/2009 By Ethics Committee

A Student self funded

Elizabeth Cunningham;Annette Finlay

URB/09/11/055 A Phase 2 Randomized, Placebo-Controlled, Double-blind Study of Carboplatin/Placlitaxel in Combination with ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment

Dr Dean Harris

20/10/2009




B Abbott Laboratories

Te Komite Whakarite

URB/09/11/056 Epilepsy Phenome/Genome Project

Dr Lynette Sadleir

20/10/2009



Wellington Hospital

A EPGP Group Mark Brunton;Kaitakawaenga Rangahau Maori

URB/09/12/059 Quantification of serum vasopressin levels in patients following vomiting

Dr Emily Macassey

11/11/2009




A Applied for external funding

Te Komite Whakarite

URB/09/12/060 The effect of patient position on hepatic vein pressures in patients having a liver resection

Mr. Saxon Connor

11/11/2009




A Costs met by research team

Te Komiti Whakarite

URB/09/12/061 A comparison of CD-NP and BNP bioactivity in patients with stable Left Ventricular

Professor Mark Richards

24/11/2009




A HRC grant Elizabeth Cunningham



Date Received

Meeting Reviewed



Date of approval


Form


dysfunction/compensated heart failure

URB/09/12/062 The utility of the coagrasper in the management of acute non variceal upper gastrointestinal bleeding

Dr. Steven Ding

24/11/2009

7/12/09 Deferred operational standard 57 (iii)

Deferred Christchurch Hospital

A No funding required

Peter Mason;connections;Nga Kete E Rus

URB/09/12/063 Evaluation of maternity units (EMU): a prospective cohort study of primary level (free standing) maternity units

Professor Sally K Tracy

24/11/2009



Burwood Hospital Rangiora Hospital Lincoln Hospital Christchurch Women's Hospital St George's Hospital Maternity and Midwifery Provider Organisation

Nil Australian National Health & Medical Research Council

Tuhia ki te Rangi;Tuhia ki te Whenua;Tuhia ki te Ngakau;o nga Tangata;Ko te mea nui;Ko te Aroha;Tihei Mauri Ora;Tena Koutou Katoa;He Mihi kau atu ki a koutou katoa;Ko te Whenua Potiki O Tautahi taku paptuuwhenua;I raro I te maru o Aoraki;Ko Amber Clarke au;No reira;Tena koutou;tena koutou;Tena koutou katoa

URB/09/12/064 Do high flow nasal cannula aerosolise nasal mucus?

Dr Mark Jermy

24/11/2009




Nil University of Canterbury, Tertiary Education Commission and Fisher and paykel Healthcare


URB/09/12/065 Analysis of exhaled volatile compounds in phenotypes of airway inflammation using selected ion flow tube - mass spectrometry

Dr Michael Epton

24/11/2009




B SYFT Technologies Ltd

Te Komiti Whakarite

URB/09/12/066 Evaluation of the Hepatitis C Community Clinic Project

Loren Brener 24/11/2009

7/12/09 Deferred operational standard 57 (i)

Deferred Hepatitis C Community Clinic Rodger Wright Centre

Nil CDHB Elizabeth Cunningham;Angelia Ria;Duane Ngataieura;Bruce Hiku



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/12/067 Influence of age on protein-binding of highly protein-bound drugs measured through spiking the blood samples of healthy volunteers

Dr Paul KL Chin

24/11/2009




A CDHB, Dept of Clinical Pharmacology Trust Funds

Te Komiti Whakarite - pending

URB/09/12/069 Health benefits of high intensity exercise for populations at risk of diabetes and cardiovascular disease

Dr Helen Lunt 24/11/2009



Christchurch Diabetes Centre, Christchurch Hospital University of Canterbury

A 2009 Translational Research Funding, HRC of NZ District Health Board Research Fund.

Te Komiti Whakarite - pending

CLOSED MEETINGS

URB/09/03/014 A multi-center, observational, open-label study on peripheral blood biomarkers in subjects with Rheumatoid Arthritis (RA) Initiating Tumor Necrosis Factor a (TNFa) Antagonist Therapy

Associate Professor Richard Robson

18/02/2009


Closed 15/04/2009

Christchurch Clinical Studies Trust Department of Rheumatology, Christchurch Hospital

B Roche Products (New Zealand) Ltd

Mr and Mrs John McManus

URB/09/05/019 A Phase IIb, randomized, double blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNalfa-2a & RBV in treatment naïve genotype 1 Hep C infected pts Protocol Number: TMC435-TiDP16-C205 A substudy of TMC435-TiDP16-C205 to evaluate the pharmacokinetics of

Dr Frank Weilert

21/04/2009


Approved 29/06/2009

Auckland Hospital Auckland Clinical Studies Ltd Christchurch Hospital Waikato Hospital

B Janssen-Cilag Pty Ltd

ADHB Research Review Committee;Peter Mason - Connections Nga Kete E Rua



Date Received

Meeting Reviewed



Date of approval


Form


TMC435 as part of a treatment regimen including peginterferon alfa-2a and ribavirin in treatment-naive genotype 1 hepatitis C-infected subjects - AUCKLAND CLINICAL STUDIES only

URB/09/05/020 A Pilot study to evaluate the Single-dose pharmacokinetics of five investigational RO5190591 formulation prototypes in healthy subjects. Protocol Number: NP22580/A dated 6 April 2009


21/04/2009


Approved 19/05/2009

Christchurch Clinical Studies Trust


Mr And Mrs John McManus

URB/09/07/034 PHI112843: A Phase I, Single-Dose, Randomized and Single-Blind (Part 1), Fixed Sequence and Open-Label (Part 2), Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK1278863A in Subjects with Renal Impairment and Matched Healthy Volunteers. Protocol No. PHI112843, Amendment No 1


23/06/2009


Approved 5/08/2009 Christchurch Clinical Studies Trust Christchurch Hospital

B GlaxoSmith Kline John and Maureen McManus

URB/09/09/045 Cerebrospinal fluid C-type natriuretic peptide and activity; Correlation with plasma values and clinical status

Professor Gary Hooper

25/08/2009


Approved 13/10/2009

Burwood Hospital

A Chch Cardioendocrine Reseaarch Trust Funds




Date Received

Meeting Reviewed



Date of approval


Form


URB/09/11/057 A single oral ascending dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5267683 in healthy subjects, including the effect of food and formulation. Protocol number: BP22889


20/10/2009


Approved 25/11/2009



Mr and Mrs John McManus

URB/09/11/058 A Phase 11b, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral Bisphosphonate Protocol 012-00 dated 23 July 2009

Dr. Nigel Gilchrist

20/10/2009

2/11/09 Deferred operational standard 57 (iii)

Deferred University of Auckand By Ethics Committee

B Merck, Sharp and Dohme NZ Ltd

Mr Peter Mason

URB/09/12/068 Protocol PP22712: A randomized, observer-blind, single-ascending-dose, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5310074 following intravenous administration in healthy adults.

Dr. Chris Wynne

24/11/2009


Approved 22/12/2009



Mr & Mrs J McManus - pending

EXPEDITED REVIEWS

URB/09/01/EXP The effect of a unilateral scalp block on analgesia after supratentorial craniotomy - a retrospective audit.

Dr. Hamish Gray

16/01/2009

Closed 4/02/2009 Nil



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/02/EXP Case report and literature review on subject

Dr Erik Monasterio

9/02/2009 Approved 16/02/2009

Nil

URB/09/03/EXP Dietary Intervention in obese patients before elective joint replacement surgery

Ms Shelley Hargadon

16/02/2009

Approved 23/02/2009

Nil

URB/09/04/EXP Travel and Accommodation Impact for Cancer Patients

Ms Marinda Hawthorne

17/02/2009


URB/09/05/EXP The application of molecular epidemiology to campylobacteriosis in New Zealand

Dr Brent Gilpin

2/03/2009 Ethical approval not required

Nil

URB/09/06/EXP Early Mobilisation Study

Ms Jan Mehrtens

4/03/2009 Approved 9/03/2009 Nil

URB/09/07/EXP The Acute Demand (Hospital in the Home) Service: The Relationship between patterns of care and the outcomes for clients

Ms Sandi Evans

16/03/2009

Ethical approval not required

Nil

URB/09/08/EXP Falls in an inpatient stroke rehabilitation unit setting

Dr Carl Hanger

20/04/2009

Approved 28/04/2009

Nil

URB/09/09/EXP Assessment of the accuracy of predictions of inhaled anaesthetic levels during the elimination phase - an observational study

Associate Professor Ross Kennedy

21/04/2009


URB/09/10/EXP Oxygen Prescribing Dr Lutz Beckert

10/06/2009


Nil

URB/09/11/EXP Mental Health and Disability Support Services interface

Ms Leanne McTear

18/06/2009

Approved 23/06/2009

Nil

URB/09/12/EXP A review of Vital Capacity measurement protocol in acute spinal cord injury

Ms Tracey Croot

23/06/2009


Burwood Hospital

Nil



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/13/EXP Does measureable sensation and strength improve in people with median and ulnar nerve repairs after discharge from therapy,without formal sensory re-education

Ms Helen Hills

24/06/2009

Declined Nil

URB/09/14/EXP Changing treatment and outcomes in multiple myeloma over the last decade for patients in Christchurch

Dr Peter Ganly

30/06/2009


Nil

URB/09/15/EXP Family Centred Care - is this possible when a child is diagnosed with cancer?

Ms Jan Millar 6/07/2009 Closed 8/07/2009 Nil

URB/09/16/EXP Demographic and Psychosocial Predictors of Chronic Pain and Associated Disability in New Zealand Tertiary Care

Prof. Edward A Shipton


Nil

URB/09/17/EXP Outcomes after Fast Track Colorectal Surgery in Christchurch Hospital: Case-Control Study

Mr Tim Eglinton


Nil

URB/09/18/EXP Neonatal vancomycin study

Ms Tracey Borrie

13/07/2009


Nil

URB/09/19/EXP Clinical features and outcomes of legionellosis. A comparison of infections due to Legionella pneumophila and Legionella longbeachae

Matthew Amodeo

13/07/2009


Nil

URB/09/20/EXP CT Colonoscopy data collection study

Dr Adrian Balasingam

13/07/2009


Nil



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/21/EXP An epidemiological study assessing the number of cumulative CTU (computed tomography urography) scans performed on renal colic patients since 1999 in the Christchurch Hospital

Dr Martin Than

13/07/2009


Nil

URB/09/22/EXP An audit of direct investigation of suspected Deep Vein Thrombosis without initial D-Dimer blood testing through the Canterbury (CDHB) Acute Demand Program

Dr Martin Than

13/07/2009


Nil

URB/09/23/EXP Do customised fetal growth charts better predict fetal macrosomia than the standard population chart in women with diabetes in pregnancy?

Dr Ruth Hughes

14/07/2009


Nil

URB/09/24/EXP Expanded Access of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Dr Michael Sullivan

17/07/2009

Approved 17/07/2009

Canterbury DHB

A

URB/09/25/EXP The effectiveness of Peer Support in first episode psychosis

Mark Turner 20/07/2009


URB/09/26/EXP An evaluation of the cross-agency learning reource project

Brigit Mirfin-Veitch

11/08/2009

Approved 29/09/2009

Nil

URB/09/27/EXP Through the eyes of parents, children and friends: Exploring the resilience and success factors of parents with a disability

Ms Marilyn Raffensperger

12/08/2009

Declined A Na Theresa Rongonui;Research Consultand - Maori;Research and Innovation;University of Canterbury



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/28/EXP Normal Performance on Computerized Tests of Problem-Identification and Problem-Solving: Pilot Study

Dr. Carrie R.H. Innes

24/08/2009

Closed 1/09/2009 Nil

URB/09/29/EXP Family Members' experience of first episode psychosis

Mark Turner 31/08/2009

Approved 21/09/2009

Nil

URB/09/30/EXP Pilot study of Return to Work Attitudes and Behaviours Survey

Bronwyn Thompson

31/08/2009


URB/09/31/EXP Data Entry/Research Staff and Summer Research Studentship Candidate

Saul Gibney 9/09/2009 Approved 15/09/2009

Nil

URB/09/32/EXP Efficiency and reach of community dietician services within Partnership Health Canterbury

Mr Andrew Norriss

15/09/2009


URB/09/33/EXP Cachexia and Depression

Dr AD (Sandy) Macleod

15/09/2009


URB/09/34/EXP Day of surgery discharge for Acute Cholecystitis

Dr Sameer Memon

16/09/2009


Nil

URB/09/35/EXP Circumfrential margin positivity rates following Abdominoperineal Resection

Dr Sameer Memon

16/09/2009


Nil

URB/09/36/EXP The natural history of sleep disurbances in patients undergoing off-pump cardiac bypass grafting

Mr Richard Flint

21/09/2009

Request for information

Nil

URB/09/37/EXP Changes in sleep habits in obese patients following bariatric surgery

Mr Richard Flint

21/09/2009


URB/09/38/EXP Reducing the burden of Familial Hypercholesterolaemia: A mixed method approach

Dr Lauretta Muir

21/09/2009

Approved 29/09/2009

Nil Elizabeth Cunningham

URB/09/39/EXP Self-monitoring of blood glucose levels in Type 2 diabetes, is it valuable?

Ms Mary McLeod

6/10/2009 Approved 2/12/2009 Nil Elizabeth Cunningham



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/40/EXP Audit of Therapeutic Mild Hypothermia in Out-of-hospital Cardiac Arrest patients in Christchurch Hospital and a suggested guideline for cooling therapy

Mr Joseph Koh


Nil

URB/09/41/EXP Follow up audiological assessment of adult head and neck cancer patients treated with chemoradiation in the Christchurch area

Dr David Gibbs

27/10/2009

Approved 2/11/2009 A

URB/09/42/EXP Optimising Patient flow though the 24 Hour Surgery

Professor L Toop

27/10/2009


A

URB/09/43/EXP Serosurvey of the Cantebury primary care workforce following the A(H1N1)09 influenza pandemic

Professor Les Toop

3/11/2009 Approved 25/11/2009

A Elizabeth Cunningham

URB/09/44/EXP The effect of rehabilitation interventions on activity levels during inpatient stroke rehabilitation

Ms Haley Evans

17/11/2009

Approved 7/12/2009 A

URB/09/45/EXP Assessment of the ADVANCE group education course for patients with type 1 diabetes

Ms Mariam Parwaiz

23/11/2009

Approved 14/12/2009

A

URB/09/46/EXP Observational study on the natural history of type III actromioclavicularinjuries

Dr Andrew Matthews

23/11/2009


A

URB/09/47/EXP Implementation and audit of a Lymphoedema Management clinical pathway

Ms Mary Thomson

23/11/2009

Approved 22/12/2009

A



Date Received

Meeting Reviewed



Date of approval


Form


URB/09/48/EXP Evaluation of the pilot of the RAI 2.0 in Canterbury aged residential care facilities

Kaye Gilhooley

20/04/2009

Approved 24/06/2009

Rosecourt Life Care Bishops Park Churchill Complex Adriel Resthome Mef LifeCare Annaliese Haven Nurse Maude Hospital Rosewood Rest Home Elmswood Retirement Village Wesleycare

Nil


Upper South B Regional Ethics Committee - Annual …...Gray Crawford NZ Dip Mgt, Cert.Pers., Cert...

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Transcript of Upper South B Regional Ethics Committee - Annual …...Gray Crawford NZ Dip Mgt, Cert.Pers., Cert...