Southern Health and Disability Ethics Committee Annual Report 2013

Southern Health and Disability Ethics Committee
Annual Report
2013

Published in October2014

by the Ministry of Health
PO Box 5013, Wellington, New Zealand

ISBN: 978-0-478-39332-3 (online) HP5489

This document is available on the New Zealand Health and Disability Ethics Committees’ website:

Contents

Contents

About the Committee

Membership and attendance

Membership

Training and conferences

Chairpersons’ meetings

Applications reviewed

Applications processed by Secretariat

Average review time

Post approval items reviewed

Reasons for declining

Issues and complaints

Action taken

Complaints received

Overdue review

Appendix 1: Details of applications reviewed

Applications reviewed by full committee

Applications reviewed by expedited review

Minimal dataset form applications

Overdue full applications

Overdue expedited applications

About the Committee

The Southern Health and Disability Ethics Committee (HDEC) is a Ministerial committee established under section 11 of the New Zealand Public Health and Disability Act 2000. Its members are appointed by the Minister of Health through the public appointments process.

The primary function of the Committee is to provide independent ethical review of health research and innovative practice in order to safeguard the rights, health and wellbeing of consumers and research participants and, in particular, those persons with diminished autonomy.

The Committee is required by its Terms of Reference to submit an Annual Report to the Minister of Health. The Annual Report must include information on the membership of the Committee, a summary of the applications reviewed during the year, details of any complaints received (and how they were resolved), and areas of review that caused difficulty when making decisions, among other matters.

Approvals and registrations

The Southern HDECis approved by the Health Research Council Ethics Committee for the purposes of section 25(1)(c) of the Health Research Council Act 1990.

The Southern HDECis registered (number IRB00008713) with the United States’ Office for Human Research Protections. This registration enables the committee to review research conducted or supported by the US Department of Health and Human Services.

On behalf of the Southern HDEC, I am pleased to present this report which provides a summary of the work and other activities undertaken by the committee.

2013 was another challenging year for Christchurch and it marked a full year since the introduction of the new online system.

The Southern HDEC has functioned very well with the new system and continuous IT improvements will ensure it continues to meet our needs. We are particularly pleased with the changes in Head Office functions with the appointment of Helen Colebrook and our team of advisors. The new role certainly provides us with an excellent level of support.

The Southern HDEC received 139 applications in 2013. 89 applications were reviewed by the full committee and 50 were reviewed through the expedited pathway.

The Southern HDEC has an outstanding group of people with a wide variety of professional expertise and I am grateful for the significant work undertaken by them. Ethical review is often challenging and the sincerity and integrity with which each member has applied themselves has been greatly appreciated.

The Committee thanks Mr Doug Bailey for his time on the Committee and welcomed Dr Devonie Waaka who joined mid-2013.

Raewyn Idoine

Chairperson

Southern Heath and Disability Ethics Committee

Membership and attendance

No meetings were postponed or cancelled due to inability to make quorum.One member was appointed during 2013.One member resigned during 2013.

Membership

Lay members

Ms Raewyn Idoine (Chair)

Membership category: / Consumer representative
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2015
Ms Raewyn Idoine is the director of the NZ Blood Service. Her recent roles include Stakeholder Engagement Manager for the Tertiary Education Commission (2007-2009) and Owner/Manager of a number of large private Tertiary institutions. Ms Idoine was registered as a Nurse at Auckland Public Hospital (1976). Other positions she has undertaken include: Judge of the New Zealand Hospitality Awards (2004-2007), Head Assessor of the New Zealand Tourism Awards (1999-2006) and member of the Ministry of Education Tertiary Advisory Group (1996-2004)

Ms Gwen Neave

Membership category: / Consumer/Community Perspectives
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2014

Gwen is a Marriage, Funeral and Civil Union Celebrant. She was made a Director of Sister Cities New Zealand earlier this year and is a long serving member of the Southland District Council Friendship Committee. Gwen chairs Toi Rakiura Arts Trust Stewart Island, and is the local Victim Support Co-ordinator. She serves on the Southland Museum and Art Gallery Board and the Venture Southland Trust.

Mrs Angelika Frank-Alexander
Membership category: / Community representative
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2014
Mrs Angelika Frank-Alexander is currently an Upper School Manager with the Christchurch Rudolph Steiner School (2006-present). Prior to this she was the Owner/Manager of La Bamba American Restaurant, Christchurch (1994-2002). Mrs Frank-Alexander completed a Candidatus Jurisprudenses at the Ludwig Maximilian University of Munich, Germany (1981). She is currently the President of the German Society of Canterbury (2003 to present) and a member of the Canterbury Business Association (2006-present) to name a few. She was previously a School Trustee (2004 to 2007) and a Board member of the Canterbury Playcentre Association (2000 to 2002). Mrs Frank-Alexander was appointed a Justice of the Peace in 2006. She stood for the 2007 local body election.

Non-Lay members

Dr Nicola Swain

Membership category: / Health researcher
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2014

Dr Nicola Swainis currently a Senior Lecturer at the University of Otago (2007-present). Prior to this she was a Research Fellow with the Christchurch Health and Development Study. She has completed a Doctor of Philosophy (1998) and a Bachelor of Science, with honours (1994) at the University of Otago. Dr Swain holds professional memberships with the Centre for Applied Positive Psychology, the International Positive Psychology Association and the New Zealand Pain Society. Dr Swain specialises in Health Psychology and pain research. She has published over 20 refereed journal articles and regularly contributes to conferences. She teaches Health Psychology and Pain to medical students at the Dunedin School of Medicine. She also supervises students studying for PhDs, Masters and summer research projects in fields such as dr-patient communication, child well-being, child-birth satisfaction and on-line interventions for pain.

Dr Mathew Zacharias

Membership category: / Health/disability service provision
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2015
Dr Mathew Zacharias is currently a Specialist Anaesthetist at Southern District Health Board (1989-present) and is also a Clinical Senior Lecturer at the University of Otago (1989-present). Prior to this he was a Specialist Anaesthetist at Southland District Health Board (1985-1989). Dr Zacharias completed a Postgraduate Diploma in Public Health at the University of Otago (2005) and was made a Fellow of the Australian and New Zealand College of Anaesthetists (1992) and a Fellow of the Faculty of Anaesthetists, Royal Australasian College of Surgeons (1991). He was also made a Fellow of the Royal College of Anaesthetists (1991), completed a Doctor of Philosophy at Queen’s University of Belfast (1979) and was made a Fellow of the Faculty of Anaesthetists of the Royal College of Surgeons (1976). Dr Zacharias also completed a Master of Surgery (Anaesthesia) at Guru Nanak University (1971) and a Bachelor of Medicine and Bachelor of Surgery at the University of Kerala (1968). He is in the Editorial Board of the Cochrane Anaesthesia Review Group (2001 – present). Dr Zacharias has published over 20 refereed journal articles and four book chapters.
Dr Martin Than
Membership category: / Intervention Studies
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2014
Dr Martin Than is currently a Consultant Specialist in Emergency Medicine at Christchurch Public Hospital and a Senior Clinical Lecturer at the University of Otago (2001-present). Prior to this he was the Co-Director of the Clinical Decision Support Unit (2003-2006). Dr Than was made a Fellow of the Royal College of Surgeons of Edinburgh in Accident and Emergency, the Faculty of Accident and Emergency Medicine United Kingdom and the Australasian College of Emergency Medicine. He completed a Post Graduate Certificate in Research Methods in Health Care at the University of Exeter (2003) and a Bachelor of Medicine and Surgery at the University of London (1991). In 2010 the Health Research Council awarded Dr Than the inaugural Beaven Medal for excellence in translational research.

Dr Sarah Gunningham

Membership category: / Intervention Studies
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2015
Dr Sarah Gunningham is currently a Postdoctoral Fellow at the University of Otago (2008-present). Prior to this she was an Assistant Research Fellow and PhD student at the University of Otago (1996-2008). Dr Gunningham completed a PhD at the University of Otago (2008), a Master of Science at the University of Otago (2003) and a Bachelor of Science at the University of West of England (1995). She was registered as a General Nurse at Royal United Hospital (1982) and worked as a nurse 1982-1996 completing a Diploma of Nursing at London University (1986) and Certificates of Teaching and Assessing in Clinical Practice (1989), and General Intensive Care (1987) at the Bristol and Weston School of Nursing. Dr Gunningham has published one book, 15 refereed journal articles and presented papers at six conference proceedings.
Dr Devonie Waaka
Membership category: / Health researcher
Date of appointment: / 1 July 2013
Current term expires: / 1 July 2016
Dr Waaka graduated in medicine from the University of Otago in 1996. She worked as a medical registrar for a number of years, developing an interest in nephrology and rheumatology, before joining an early phase clinical trials unit as a research physician in 2004. Over the past decade she has been involved in the planning and implementation of numerous early phase trials in New Zealand and Australia.
In 2011 Devonie completed a Master of Medical Science in Drug Development from the University of New South Wales, achieved with high distinction, and was the recipient of the ARCS award for Highest Aggregate Score in the MMedSc Drug Development Program. In addition to her clinical duties, Dr Waaka has been on the teaching staff for the Pharmaceutical Medicine and Drug Development Master Program, University of New South Wales (2012 – present).

Former Members

Mr Doug Bailey (resigned 1 March 2013)

Membership category: / The Law
Date of appointment: / 1 July 2012
Current term expires: / 1 July 2015

Attendance

The SouthernHDECheld 10meetings in 2013.

Members / Meetings / Total
Jan / Feb / Mar / Apr / May / Jun / Jul / Aug / Sep / Oct / Nov / Dec
Lay members / Cn / Ms Raewyn Idoine /  /  /  /  /  /  /  /  /  /  / 10/10
L / Mr Doug Bailey /  / A / A / A / A / 1/5
Cn / Mrs Angelika Frank-Alexander /  /  / A /  /  / A /  / A /  / A / 6/10
Cn / Ms Gwen Neave / A /  / A /  /  /  /  / A /  /  / 7/10
Cn / Mrs Helen Walker
Co-opted from Central Committee /  / 1/1
Cn / Dr Brian Fergus
Co-opted from Northern A Committee /  / 1/1
Cm / Mrs Sandy Gill
Co-opted from Central Committee /  / 1/1
Non-Lay / HR / Dr Nicola Swain /  / A /  /  /  /  /  /  /  /  / 9/10
HR / Dr Martin Than /  /  /  /  /  / A /  / A / A /  / 7/10
HP / Dr Mathew Zacharias /  /  /  / A /  /  /  / A /  /  / 8/10
HR / Dr Sarah Gunningham /  / A / A /  / A / A / A /  /  /  / 5/10
HR / Dr Devonie Waaka /  /  /  /  / 4/4
Key: / L / Lawyer / P / Pharmacist/pharmacologist /  / present
E / Ethicist / B / Biostatistician / A / apologies
Cm / Community representative / HP / Health practitioner / X / absent
Cn / Consumer representative / HR / Health researcher / not applicable

Training and conferences

The Southern Committee did not have training during 2013.

Committee members were invited to attend the Cartwright Conference held in Auckland. Ms Raewyn Idoine attended.

Chairpersons’ meetings

Ms Raewyn Idoine attended two Chairs day meetings in 2013. Both meetings were held in Wellington in the Medsafe Boardroom.

The first meeting was held on 5 April. The Chairs were updated by the Secretariat about:

• appointments of new members
• annual reports to the Minister
• preliminary trends and measuring quality
• upcoming changes to the online system.

The Chairs and Secretariat identified seven key issues that were discussed.

• Bio-banking.
• Peer review.
• Restrictions on publication.
• Remuneration.
• Data safety monitoring.
• Examples of good practice.
• The possibility of a protocol template.

The Chairs spent the afternoon participating in a training session on ‘Managing Meetings’.

The second meeting was held on 23 August. The Chairs were updated by the Secretariat about:

• annual reports to the Minister
• further improvements planned for the online system.

The Chairs and Secretariat identified four key issues that were discussed.

• Peer review.
• Conflicts of interests.
• Restrictions on publication.
• Data safety monitoring.

Mr John Hancock, a legal adviser for the Office of the Commissioner for Children, gave a videoconference presentation to the Chairs about children’s consent in health research. The Chairs had a presentation and discussion with Associate Professor Martin Tolich on his recent academic work and practical observations of HDECs.

Applications reviewed

The Southern HDEC reviewed139 applicationsin 2013. From the 157 application 89 applications were reviewed by the full committee and 50were reviewed through the expedited pathway.

At each of its meetings in 2013 the Committee reviewed an average of nineapplications.

Full / Approved / 79
Declined / 1
Provisional Approval (as at 31 December 2013) / 9
Total (with a decision at 31 December 2013) / 89
Expedited / Approved / 46
Declined / 0
Provisional Approval (as at 31 December 2013) / 4
Total (with a decision at 31 December 2013) / 50
Total applications reviewed / 139

A summary of these applications can be found in Appendix A.

Applications processed by Secretariat

The Southern HDEC received 31 applications that were screened by the HDEC Secretariat and were deemed out of scope for HDEC review.

The Southern HDEC received 196 Minimal Dataset Forms (MDF). These forms are used to broker applications from the previous HREC Lotus Notes database to the new HDEC database.

Average review time

Average review times take into account the time taken for the Secretariat to process applications and the time taken for the Committee to review applications. The clock is stopped when a decision letter is emailed to applicants. The average time excludes time taken for researchers to respond to requests for further information.

The average review timefor full applications was 22 days compared to a target timeframe of 35 calendar days.

The average review timefor expedited applicationswas 17 days compared to a target timeframe of 15 calendar days.

Post approval items reviewed

The Southern HDEC reviewed a total of 835 post approval items. A graph of the different types reviewed is below.

Post approval items reviewed during 2013

Reasons for declining

The SouthernHDEC is required to clearly identify the ethical standard(s) that it considers not to be met by an application. These ethical standards are contained in the Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (GFUR), Ethical Guidelines for Observational Studies (EGOS) and Ethical Guidelines for Intervention Studies (EGIS). The references in the tables below are to paragraph numbers in these documents.

Reference:13/STH/44
Review Type: Observational

Short title:Assessment of Tumour Mitotic Rate in Primary Cutaneous Malignant Melanomas ≤1mm in Thickness

Co-ordinating Investigator:Dr Ben Tallon

Reference / Reason
6.43 EGOS / The main ethical issue discussed by the Committee is the use of stored human tissue for a purpose for which it was not initially submitted, without obtaining informed consent for this particular use. The Committee was concerned that informed consent would not be obtained from the patients, especially as this study may detect new or different information to what was initially reported to the patient. The Committee does not believe that the use of human tissue without consent has been adequately justified for this study and considers this does not align with the ethical guidelines.
6.42EGOS / The consent of participants should generally be obtained for using identified or potentially identifiable data for research.

Issues and complaints

This section outlines issues faced by the Committee during 2013.

Issues causing difficulty in review

• Online system issues.
• Lack of appropriate peer review.
• Provisional responses not being submitted in tracked changes format.

Action Taken

• New online system updates have been drafted, tested and implemented.
• Peer review template developed and published on HDEC website.
• Newsletter containing reminder to track changes was published on HDEC website.

Issues referred to NEAC and/or the HRC Ethics Committee

NIL

Complaints received

None cited by the Chair.

Overdue review

During 2013 there were seven instances where the review time was over 35 days for full applications and 23where the review time was over 15 days for expedited applications.

See Appendix 1 for more information.

Issues causing delays in reported review times

• Online system issues prevented Committee members from reviewing effectively.
• The online system clock that records time taken to receive a decision includes all calendar days which results in public holidays and weekends being included in the timeframes.
• The standard operating procedures state that the HDEC review should be paused over the period 25 December to 15 January the following year. This does not occur automatically and as a result, any applications awaiting review during this period have been identified and are not considered overdue.

Action taken

• The online system issues have been addressed with the latest system update.
• Any applications that were running over the public holidays have been identified in Appendix 1.

1

Southern Health and Disability Ethics Committee – 2013 Annual Report

Appendix 1: Details of applications reviewed

Applications reviewed by full committee

Study reference / Study status / Short title / Co-ordinating Investigator / Other Investigators / Locality/ies / Application type
13/STH/10 / Approve / A study to evaluate Vx135 and GSK2336805 in Chronic HCV patients. / Prof Ed Gane / Auckland Clinical Studies Ltd,Chris Taylor, CCST / Intervention
13/STH/100 / Approve / NORIBOGAINE THERAPY FOR RELIEF OF OPIOID WITHDRAWAL, PHASE IB (NITROW PIB) / Professor Paul Glue / Health Research South,Zenith Technology Corporation Limited / Intervention
13/STH/107 / Approve / Media, advertising and other influences on decisions to enter aged care / Ms Robyn Henderson / Intervention