AUSTRALIAN DEFENCE Human Research Ethics Committee ...crl.defence.gov.au/Health/HBP/DDHRC/Docs/HREC_Annual_Report_2016.pdf · Ms Vivienne Moyle, Director Defence Health Research provided

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AUSTRALIAN DEFENCEHuman Research Ethics Committee

Annual Report 2016

2 Australian Defence Human Research Ethics Committee

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INTRODUCTION1. In accordance with the ‘National Statement on Ethical Conduct in Human Research’ (the

National Statement) and Defence Health Manual Volume 1 Part 18 Chapter 1 ‘Conduct of human research in Defence’ (DHM Vol 1 Pt 18 Ch 1), the Australian Defence Human Research Ethics Committee (ADHREC) reports annually to the Chief of the Defence Force on research during the previous year involving humans. This 25th Annual Report provides a summary of ADHREC’s activities from 1 January 2016 to 31 December 2016.

MEMBERSHIP2. The composition of the committee is in accordance with National Statement 5.1.30.

Additionally, two Defence Health Graduates are appointed as members in accordance with Health Manual Volume 23 ‘Human Research in Defence – Instructions for Researchers’.

3. The following appointments to the committee were made in the reporting period:

a. Mr Bronson Horan – layperson

b. Ms Margaret Proctor – layperson

c. Ms Vivienne Moyle – layperson

d. Dr Maxwell Fraser – current experience in the professional care, counselling or treatment of people

e. Chaplain Robert Sutherland – pastoral care

f. Mr Chris Gunson – lawyer

g. Dr Susannah Whitney – researcher

h. Rev Nikki Coleman – researcher.


4. Committee membership for the reporting period is provided at Table 1.

Table 1: Australian Defence Human Research Ethics Committee Members

Position Name

Chair Mr Ian Tindall

A laywoman not associated with Defence Ms Margaret Proctor (appointed March 2016)Ms Vivienne Moyle (appointed April 2016)

A layman not associated with Defence Mr Lindsay RoeMr Bronson Horan (appointed April 2016)

A member with knowledge of , and current experience in, the professional care, counseling or treatment of people

Dr Jodi BaileyDr Maxwell Fraser (appointed July 2016)

A minister of religion Mr Robert (Doug) HutchinsonCHAP Robert Sutherland (appointed October 2016)

A lawyer Dr Wendy BonythonMr Chris Gunson (appointed August 2016)

A member with knowledge of , and current experience in, the areas of research that are regularly considered by ADHREC

Dr Mark Jaffrey Dr Stephen ColemanMr Tony CottonDr Susannah Whitney (appointed October 2016)REV Nikki Coleman (appointed October 2016)Dr Keith Horsley

A health graduate from Defence (one of two, one of whom is to be a medical graduate)

Dr Victoria Ross CAPT Nicole Curtis, RAN

5. Dr Keith Horsley resigned from the committee in June 2016.

6. A brief biography of members and the administrative support staff is provided at Annex A.

Annual Report 2016 5

TRAINING7. In accordance with the National Statement section 5.2.3 (c), members are required

to attend continuing education or training programs in research ethics at least every three years. This was accomplished through distribution of human research ethics articles and publications on an ad hoc basis.

8. Additionally, one member completed the Praxis Australia online Ethics Training course, another attended two ethics related conferences and the Chair presented at the Forum for Ethical Review Committees in the Asian & Western Pacific Region in Thailand in November 2016.

MEETINGS 9. The Committee met seven times during the reporting period. Meeting dates and the

member attendance record is at Annex B.

10. Due to member availability there was a gender imbalance of members at the 12 September meeting. Additional members were appointed in October 2016 in order to ensure requirements under the National Statement relating to gender balance could be met in subsequent meetings throughout the year and into 2017.

EXECUTIVE SUPPORT11. Ms Vivienne Moyle, Director Defence Health Research provided organisational

oversight for the day-to-day functions of the ADHREC and supervision for the ADHREC Secretariat from 1 January – 19 February 2016. Ms Terri Davis was appointed as the A/Director on 22 February 2016.

12. ADHREC Secretariat support was provided by:

• Ms Terri Davis – Acting Executive Officer (1 January 2016 – 21 February 2016), Acting Director Defence Health Research (A/DDHR) (22 February 2016 – 31 December 2016).

• Ms Georgina Gill – Research Administration Officer.

13. Ms Davis attended the ‘Preparing for your data future’ seminar at the Australian National University on 22 July 2016, as part of her ongoing training and development.

COMMITTEE EXPENDITURE14. The Committee’s expenditure for the 2016 period was $40,806.70 made up of:

a. Sitting fees $35,600

b. Travel/accommodation $4,514.95

c. Catering $693.75.


REVIEW OF RESEARCH PROJECTS

Overview of ADHREC activities15. During 2016, 36 new protocols were reviewed by ADHREC. The outcome of the review of

the protocols is as follows:

a. one was deemed to be a quality assurance activity

b. four were withdrawn by the relevant principal investigator

c. one was closed due to the time that had elapsed since the outcome of the ethical review was provided

d. 20 were granted ethical approval

e. as at 31 December 2016, ten require additional information prior to ethical approval being granted.

16. A list of the new research projects approved by ADHREC in 2016 is at Annex C.

17. In addition to considering new applications ADHREC considered the following:

a. 33 resubmissions

b. 30 amendments

c. 26 requests for extensions of ethical approval.

Quality Assurance and Evaluation Activities18. As indicated above, ADHREC deemed one proposal to be a quality assurance activity

during the reporting period. Although quality assurance activities do not require formal ethical approval under the national guidelines, the activity must be conducted in a way that is ethical. This includes considering risk or harm, ensuring an informed consent process is adhered to, and relevant privacy, legislative, national and professional standards are adhered to in accordance with the guidance issues by the National Health and Medical Research Council’s ‘Ethical Considerations in Quality Assurance and Evaluation Activities’. To this end during their deliberations the ADHREC made a number of recommendations to the applicant on amendments that needed to be considered in order to ensure the ethical robustness of the activity.

Waivers of consent (National Statement 2.3.12)19. Occasionally ADHREC will receive requests for waivers of consent for research

activities. These requests are considered in accordance with the National Statement, the Privacy Act 1988 and other relevant guidance and/or legislation. A list of the research projects that were completed during the reporting period where a waiver of consent was granted is provided in Annex D.

https://www.nhmrc.gov.au/guidelines-publications/e111

https://www.nhmrc.gov.au/guidelines-publications/e111


RESEARCH MONITORING20. In accordance with Chapter 5.5 of the National Statement, Defence has a

responsibility for ensuring that research approved by their institutional ethical review body (ADHREC) is monitored.

Progress Reports21. As a condition of approval, researchers are required to submit six monthly progress

reports to ADHREC. These reports are due by 1 June and 1 December of each calendar year for the life span of the project. The Secretariat provides a compliance register to ADHREC that lists all active research projects and indicates what progress reports were received, what reports are outstanding and where further information is required. Following the ADHREC meeting, non-compliance letters from the Chair are sent to researchers who have not submitted a progress report during the corresponding period.

22. Due to failure to submit consecutive progress reports, ethical approval was withdrawn for one protocol in June 2016. Both the principal investigator and the head of organisation were advised of the matter of non-compliance and the subsequent withdrawal of ethical approval.

Serious Adverse and Adverse Events23. Researchers are required to report serious adverse events within 72 hours and adverse

events within 30 days.

24. During 2016, one adverse event for ADHREC approved research was reported. This event did not raise any concerns about the ethical validity of the research. The risks had been identified in the relevant research protocols and participants were advised of these risks. The event resulted in a civilian participant withdrawing from the study, a referral being made to a specialist and advice that medical clearance would be required prior to the individual recommencing participation in the research.

Complaints25. The Directorate of Health Research Coordination received a complaint in July 2016

which raised concerns that the conduct of a protocol was not in accordance with the approved protocol. The A/DDHR and the ADHREC Chair liaised with the Principal Investigator and the complainant to address the concerns. These conversations resulted in a number of minor amendments being made to the protocol which addressed the concerns that were raised.


Completed Research Projects26. In accordance with the National Statement section 5.5.5, researchers are required to

submit a final report at the completion of their research. A list of the research projects that were finalised and reported to ADHREC in the reporting period is at Annex D.

MINIMISING DUPLICATION OF ETHICAL REVIEW27. In accordance with National Statement Chapter 5.3 ‘Minimising duplication of ethical

review’, CJHLTH provided the authority for the Directorate Defence Health Research to conduct an administrative review and where appropriate accept the outcome of an ethical review conducted by the Department of Veterans’ Affairs Human Research Ethics Committee for joint DVA and JHC research, effective 1 July 2014.

28. Subject to minor amendments, the outcome of the review conducted by DVA HREC on E016/025 ‘Evaluation of online video counselling’ was accepted under the mutual recognition processes.

29. Additionally, A/DDHR considered four amendments under mutual recognition for studies conducted under the Transition and Wellbeing Research Programme.

LOW RISK ETHICAL REVIEW30. In accordance with National Statement section 5.1.18 – 5.1.23, Defence has

established mechanisms for the review of low and negligible risk research. They include the Joint Health Command Low Risk Ethics Panel (JHC-LREP), the Defence People Research Low Risk Ethics Panel (DPR-LREP) and the Defence Science and Technology Low Risk Ethics Panel (DST-LREP).

31. During the 2016 calendar year the JHC-LREP reviewed 23 applications. Of these, 16 were approved, one was withdrawn, four were referred to ADHREC and two were still under review as at 31 December 2016.

32. The DPR-LREP reviewed 55 low or negligible risk applications. Of these, 25 were approved, 28 were exempt as quality assurance/evaluation activities and two were rejected for resubmission. There were no outstanding registered applications as at 23 December 2016

33. The DST-LREP received 32 low or negligible risk applications for review and/or for record keeping purposes. Of these, 11 were submitted for DSTG LREP review, all of which were subsequently approved as low risk protocols. The other 21 applications were approved by a DSTG Chief of Division or his/her Delegate (a Research Leader) as either low or negligible risk protocols.


REVIEW OF EXTANT DEFENCE RESEARCH POLICY34. DHM Vol 1 Pt 18 Ch 1 replaced Defence Instruction (General) Administrative 24-3

‘Conduct of human research in Defence’ in late 2016. Defence People Intelligence and Research are currently reviewing and seeking stakeholder feedback on the replacement policy, which is intended to be a stand alone research manual. The establishment of the research manual will ensure that Defence policy reflects current standards and practices and reflects the implementation of non-HREC review level mechanisms for the review of low and negligible risk research as described in paragraphs 30-33. ADHREC provided feedback, via Joint Health Command, on the draft policy in July 2016. It is anticipated that ADHREC will provide further stakeholder feedback on the draft policy when it is submitted into the Directorate of Administrative Policy review system in February 2017.

ESTABLISHMENT OF THE DEPARTMENTS OF DEFENCE AND VETERANS’ AFFAIRS HUMAN RESEARCH ETHICS COMMITTEE35. The December 2014 Ministerial Paper ‘Smaller Government – Towards a Sustainable

Future’ recommended that ADHREC and the Department of Veterans’ Affairs Human Research Ethics Committee (DVA HREC) merge by 1 July 2017. A number of meetings were held between institutional representatives during the reporting period with agreement on a proposed model reached in August 2016. Approval of the model has been obtained from the Defence Human Research Advisory Board, the Vice Chief of the Defence Forces and the Commissions. Final approval from the Chief of Defence Force is anticipated early in 2017.

36. Drafting of Terms of Reference and a joint institutional policy has commenced. It is anticipated that an advertisement seeking expressions of interest for the joint HREC will proceed in the first quarter of 2017, following institutional approval of the Joint Committee. Various other bodies of work will be progressed in the first quarter of 2017 to ensure establishment of the joint HREC by 1 July 2017.

CONCLUSION37. The reporting period saw a change in membership in a number of categories, a change

in the staff providing organisational oversight of the committee, and a significant amount of work being undertaken to address the recommendation to merge ADHREC and the DVA HREC. In addition to providing secretariat support to ADHREC, the Directorate will continue to undertake a large body of administrative work to ensure that the relevant bodies of work are completed in a timely manner to facilitate transition to a joint HREC for Defence and the Department of Veterans’ Affairs.


BIOGRAPHIES FOR ADHREC MEMBERS AND EXECUTIVE SUPPORT

ANNEX A

Category (a) Chair – Mr Ian Tindall (April 2015 – current)

Mr Tindall is currently serving as an active reservist within the Royal Australian Air Force. Ian is an inaugural Committee member and deputy chair of the Bellberry Human Research Ethics Committee, and a previous member of the Ashford Community Hospital Human Research Ethics committee. Mr Tindall is currently a Consultant Pharmacist working in a variety of roles.

Category (b) Layperson – Mr Lindsay Roe (June 2010 – current)

Mr Roe has worked for over thirty years in the Australian Public Service, initially in the field of design and development of administrative computer systems. He was also involved in the introduction of computing to a number of areas within commonwealth departments and the training of staff in computing skills. He subsequently moved on to project management and IT audit and eventually performance audit with the Australian National Audit Office.

Mr Roe received a Bachelor of Science degree from the University of Queensland in 1974 and a Master of Arts from the University of Western Sydney in 2004.

He now is a freelance consultant in the areas of Quality Assurance and workplace interactive skills.

Category (b) Layperson – Mr Bronson Horan (April 2016 – current)

Bronson Horan has been a commissioned officer in both the United States and Australian Army for over 15 years. He initially served with the US Army 10th Mountain Division and then 1st Special Forces Groups. Later he gained a commission in the Australian Army where Bronson served five years as a Commando Officer in 1 Commando Regiment. Bronson has been on active service in both armies in places such as Bosnia, Sinai, Philippines, Iraq and Afghanistan.

Bronson is also a member of the Department of Veterans’ Affairs Human Research Ethics Committee and holds a number of positions on veteran related bodies. Bronson is currently the Managing Director for Ludus Training International (LTI).

Category (b) Layperson – Ms Margaret Proctor (March 2016 – current)

Margaret is an Educational consultant who has expertise in International Education and qualification recognition in particular. She holds undergraduate and graduate qualifications from the University of Toronto Canada. Margaret has over fourteen years’ experience on Human Ethics Committees at Academic institutions in both Australia and Canada.


Category (b) Layperson – Ms Vivienne Moyle (April 2016 – current)

Ms Moyle has extensive experience in health research, administration and ethics. She has worked in the university and public service research arena in Australia and the United States including roles with Northeastern University (Boston USA), the National Health and Medical Research Council, the Department of Defence, the University of Melbourne and the Australian National University. She is currently Manager, Business Development, for Newcastle Innovation with the University of Newcastle.

Category (c) Professional care/counselling – Dr Jodi Bailey (December 2012 – current)

Dr Bailey joined the Royal Australian Navy as an Undergraduate and completed 15 years of full time Navy Service before transferring to the Reserves and the public service in 2007. Dr Bailey completed her Masters of Public Health in 2013 which included core subjects on critical evaluation of research, epidemiology and biostatistics. Dr Bailey is a University of Queensland medical graduate (1995), working in Ipswich Hospital for two years post graduation and most states of Australia during her career.

Dr Bailey obtained her FRACGP in 2003 and has continued to work in private civilian practice since 2007 (part time). Dr Bailey is currently the Chief Medical Officer for Defence Force Recruiting and is currently working one session a week in private general practice (Deakin, ACT). Dr Bailey has been the Chief Medical Officer for Defence Force Recruiting since November 2008.

Category (c) Professional care/counselling – Dr Maxwell Fraser (July 2016 – current)

Dr Maxwell Fraser is a clinical psychologist who works for Monash Health, in Melbourne's eastern suburbs. He completed a Doctorate of Psychology (Clinical) with a specialisation in working with children, adolescents, and their families and is a registered member of the Australian Psychological Society. During his studies, Max received training in both research and professional ethics and was involved in human research relating to sleep and emotional expression. He is passionate about improving mental health outcomes for young people, ethically and scientifically sound research, and the treatment of trauma related conditions such as Post Traumatic Stress Disorder. Max also has a particular interest in the Australian Defence Force as his father was an officer in the Australian Army.

ANNEX A


Category (d) Pastoral Care – Mr Robert (Doug) Hutchinson(November 2012 – current)

After completing his undergraduate studies, Mr Hutchinson worked in laboratory medicine for 25 years. During that time he was a multidisciplinary Scientist and shared that experience as a part time seasonal lecturer for Darwin and Hobart TAFE colleges in laboratory methods and biochemistry. In 1997 Doug worked full time as a pastoral assistant and was ordained as an Anglican Deacon in 1999. In 2001 Doug began working in New Zealand as a medical scientist where he was also appointed a Deacon with the Maori Tikanga. As part of the discernment process of the Church he was asked to serve the church as a Bioethicist and was asked to study to fulfil that role and so between 2003 and 2008 he obtained Masters Degrees in Bioethics and Applied Ethics. In 2008 he was selected to attend the Faraday Institute for Science and religion at Westminster College, Cambridge University.

Doug has experience on a number of human research ethics committee, in addition to ADHREC.

Category (d) Pastoral Care – CHAP Robert Sutherland (October 2016 – current)

Rob served as an Infantry Officer for 20 years before training as an Anglican minister. Since ordination he has been a prison chaplain, parish priest and has spent 18 years as an Army Chaplain both in the Army Reserve and the Australian Regular Army. Rob is currently an Assistant Minister in a parish in Sydney working with veterans and their families and chaplain to Headquarters 6th Combat Support Brigade.

Category (e) Lawyer – Dr Wendy Bonython (November 2012 – current)

Dr Bonython is an Assistant Professor at the School of Law & Justice at University of Canberra. Previously, Dr Bonython worked in health administration, project management, education, and clinical research.

Dr Bonython is an admitted Legal Practitioner of the Supreme Court of the Australian Capital Territory. She holds a PhD in Medical Research and a Juris Doctor, amongst other qualifications. Her research interests include genetic privacy, medicolegal issues, torts law, capacity and consent, and research ethics and governance.

Category (e) Lawyer – Mr Chris Gunson (August 2016 – current)

Mr Gunson is a Barrister and has been admitted to the Victorian Bar, the Supreme Court of Tasmania and the High Court of Australia. Mr Gunson has been a member of the Army Reserve since 1994 and an Army Reserve legal officer since 2001. Mr Gunson is also currently a member of the Tasmanian Human Research Ethics Committee.


Category (f) Researcher – Dr Mark Jaffrey (September 2013 – current)Dr Jaffrey has been a research scientist with the Defence Science and Technology Group (DSTG) since 2001. Dr Jaffrey conducts research and provides scientific support for Defence in the areas of injury prevention, injury biomechanics and human factors/ergonomics. He has a PhD in the field of Biomechanics, and has been involved with the ethical review of human research within DST and the Department of Defence since 2013.

Category (f) Researcher – Dr Stephen Coleman (November 2012 – current)

Dr Coleman is Associate Professor of Ethics and Leadership at UNSW Canberra. He works in a diverse range of areas in applied ethics, including military ethics, police ethics, medical ethics, and the practical applications of human rights. He has held a Research Fellowship at the Stockdale Center for Ethical Leadership at the U.S. Naval Academy and worked as a consultant for the Australian Defence Force, Food Standards Australia, the Victorian Police and DSTG. In addition to his academic duties he also works to increase understanding of ethical issues in less traditionally academic has, giving talks and presentations in schools and public venues.

Category (f) Researcher – Mr Tony Cotton AM (June 2006 – current)

Mr Cotton is an industrial psychologist with nearly thirty years experience providing and managing a broad range of psychological services in large and complex workplaces.

He was Director of Psychology for the Australian Defence Force and served on a number of international collaborative research panels. He was also the inaugural Director of Mental Health for the ADF where he was responsible for developing and implementing the ADF Mental Health Strategy.

After leaving the ADF he spent five years as the senior psychologist for the Australian Federal Police before moving into his current role as Director of Workforce Research and Analysis at the Australian Public Service Commission where he oversees a broad range of workplace and organisational psychology research supporting the APS workforce including developing the APS Human Capital Framework and the APS Employee Engagement model.

He is currently completing his PhD studying employee engagement in the Australian Public Service.

Category (f) Researcher – Dr Keith Horsley (June 2006 – June 2016)

Dr Horsley has worked as a Medical Advisor (Defence Recruitment) Corporate Health Group. Keith tutored at the Australian National University Medical School, and was a senior Medical Officer HAS Group. Keith has a Master of Public Administration, University of Queensland and a MB, BS also University of Queensland.


Category (f) Researcher – Dr Susannah Whitney(October 2016 – current)Dr Susannah Whitney is a Senior Human Cognition & Behaviour Scientist in DSTG. She has been employed in DSTG since 2007, where her research examines the training implications of new military technologies, and the role that simulation can play in supporting training. She holds a PhD and Honours degree in Psychology. She has been involved in DST Group’s low risk ethical review panel since 2007.

Category (f) Researcher – REVD Nikki Coleman (October 2016 – current)

Revd Coleman is a Uniting Church minister who teaches military ethics at the Australian Defence Force Academy (University of New South Wales) and bioethics at the Australian National University. Her research work focuses on the question of obedience in the military, moral injury of soldiers, the use of military personnel in medical experimentation, the rights of individuals and the role of the citizen soldier. She is currently the Commissioner for Spiritual Development for Scouts ACT, and has previously worked as a multi-faith chaplain at ANU, emergency services chaplain and a congregational minister.

Revd Coleman was previously a member of the Greater Southern Area Health Service Human Research Ethics Committee.

Defence Health Graduate – Dr Victoria (Vicki) Ross (September 2002 – current)

Dr Ross joined the Army undergraduate scheme in 1985 while completing her medical training at the University of Melbourne and the Royal Melbourne Hospital. After two years working as a medical resident at the Geelong Hospital, Dr Ross joined the Army on a full time basis.

Dr Ross has had postings to the 1st Field Hospital, Duntroon Medical Centre, Headquarters Logistic Command (Army) and various positions within Joint Health Command. Colonel Ross became a Fellow of the Royal Australian College of General Practitioners (FRACGP) in 1997, completed a Masters of Public Health (MPH) in 2003 and became a Fellow of the Australasian Faculty of Public Health Medicine (FAFPHM) in 2006. In 2008, Dr Ross transitioned out of the full time Army to take up a public service position as a Senior Medical Advisor within Joint Health Command. She remains in the active Army Reserve.

Dr Ross was Executive Secretary of ADHREC from July 1998 to June 2000 and was appointed a member of ADHREC in 2002.


Defence Health Graduate – Captain Nicole Curtis, RAN (February 2015 – current)

CAPT Curtis joined the Royal Australian Navy as a final year medical student at Monash University in 1995. She completed her intern year at Dandenong Hospital and a resident year at Geelong hospital before commencing her Navy officer training. Nicole’s recent shore posting include Fleet Medical Officer and Director Health at Headquarters Joint Operations Command. Her sea service has included deployments in South East Asia, North East Asia and operational deployments to East Timor, and the Middle East region.

Nicole is a graduate of the Australian Command and Staff Course. She is a registered medical practitioner with specialist registration in General Practice and Medical Administration. Nicole is a Fellow of the Royal Australian College of General Practitioners and a Fellow of the Royal Australasian College of Medical Administrators. Her academic qualifications include MBBS, MA, MHM, and a Grad Cert Maritime Studies.

A/Director Defence Health Research –(February 2016 – 31 December 2016)

Executive Officer –(April 2014 – February 2016)

Ms Terri Davis Ms Davis has previously worked at the National Health and Medical Research Council where she was an integral part of the administration of the National Certification Scheme (for institutional ethical review processes, as administered by their Human Research Ethics Committees) and was also trained and participated as both a lead and co-assessor under the Scheme. Ms Davis has experience as a research assistant in the Aged Care Evaluation Unit at Greater Southern Area Health Service and was co-author to two published articles.

Research Administration Officer – Ms Georgina Gill (2003 – current)

Ms Gill joined the Department of Defence in 2001 as an Administration Officer for the Directorate of Clinical Policy. In 2003 Ms Gill was promoted to Research Officer in the Directorate of Clinical Policy. In May 2006 Ms Gill joined ADHREC on a contract and was made permanent in October 2006.


MEMBER ATTENDANCE RECORD1. Table B1 provides a summary of member meeting attendance for the reporting period.

Table B1: Meeting Attendance Record

Name 21 March 16 2 May 16 20 June 16 1 August 16 12 September 16 31 October 16 5 December 16

Mr Ian Tindall x x x x x x x

Mr Lindsay Roe x x x x

Mr Bronson Horan x x x

Ms Margaret Proctor x x x x x

Ms Vivienne Moyle x x

Dr Jodi Bailey x x x x

Dr Maxwell Fraser x x x

Mr Robert (Doug) Hutchinson x x x x x x

CHAP Robert Sutherland x

Dr Wendy Bonython x x x x x

Mr Chris Gunson x x

Dr Mark Jaffrey x x

Dr Stephen Coleman x x x x

Mr Tony Cotton x x x x x

Dr Keith Horsley

Dr Susannah Whitney x

REV Nikki Coleman x x

Dr Victoria Ross x x x x x x x

CAPT Nicole Curtis x x x x x

ANNEX B

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AUSTRALIAN DEFENCE HUMAN RESEARCH ETHICS COMMITTEE APPROVED RESEARCH1. Table C1 provides a summary of the ADHREC approved research protocols during the reporting period.

Table C1: Australian Defence Human Research Ethics Committee Approved Research

Principal Investigator and Institution

Protocol number and Title Description

CHAP Timothy HodgsonUniversity of Queensland

801-15 Moral Injury within the Royal Australian Air Force

This project aims to explore and seek to address moral injury in the Royal Australian Air Force. The research involves quantitative and qualitative methods with long term goal to provide evidence to facilitate a restoration/rehabilitation program.

Prof Mark MoranAustralian Civil Military Centre

808-15 Deployed Women: Australian uniformed and civilian female personnel in peace and security operations

This project explores the skills and contributions of women to Australian peace and security operations overseas. It focuses on women deployed by the Department of Defence (Defence), including Australian Defence Force (ADF) personnel and public servants (APS), the Australian Federal Police (AFP), and the Department of Foreign Affairs and Trade (DFAT) between 1988 and 2014. It is to be undertaken by the Institute for Social Science (ISSR) within the University of Queensland (UQ).The project aims to:• develop an evidence base documenting the experiences of women during their deployment;• contribute to the wider, ongoing discussions about whether – and, if so, what – benefits accrue by

deploying female personnel in peace and security operations; and• contribute to the development of Australian government policy and training guidance.

Dr Alicia EvansAustralian Catholic University

810-15 A theory of modern Australian Army nursing in armed conflict

This research study is being undertaken to investigate the contemporary experiences of Australian Army registered nurses (RN) deployed to and practicing in an armed conflict (AC) zone. The aim of this study is to:• explore the modern experience of Army RN deployed to AC; • develop an understanding of how the Army and conflict influence nursing practice;• identify strategies RN use in order to prepare for their experience of deploying to and practicing in

AC zone; and • identify strategies used to deliver care in an AC zone and outline the effect on practice after

returning home.

ANNEX C




Ms Martine CosgroveAustralian National University

811-15 A qualitative study of flourishing in the Australian Army

The study explores the experience of maintaining high levels of wellbeing in the Army from four key perspectives: • members (focusing on experience of 18–26 year olds in lower and other ranks); • Command;• health and medical practitioners; and • senior leadership. The aim of the research is to better understand from the members’ perspective how the Army supports them to maintain high levels of wellbeing.

WGCDR Jarrod PendleburyUniversity of Sydney

812-15 The Dawn Horizon: Constructing an Air Force Identity at The Australian Defence Force Academy

This project aims to answer is how the formation of military identities in early Officer training contributes to construction of ‘ideal’ military identities. The project compares and contrasts the approaches to military identity construction in three air forces (Royal Air Force, United States Air Force and the Royal Australian Air Force) in order to develop a deeper understanding of the underlying philosophical approaches to identity construction in each organisation.

Ms Jemma KingUniversity of Queensland

813-15 Psychological Edge Training

The research aims to investigate the effectiveness of psychological training designed as a pre-emptive approach to stress, burnout avoidance, emotional and interpersonal skills development in Army soldiers.

Dr Phil AndersonAustralian Institute of Health and Welfare

815-16 Estimation of Incidence of suicide in Ex-serving Australian Defence Force members

The aims of the project are to estimate the incidence of suicide in ex-serving members of the ADF, undertake a comparison with general community, and identify significant factors and relationships that may influence the number of suicides.

Prof David ForbesPhoenix Australia

818-16 Rapid Exposure Supporting Trauma Recovery – the RESTORE Trial

This clinical trial seeks to test whether the intensive approach to prolonged exposure is as effective as the existing 10 week model.

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Dr Melinda JacksonRoyal Melbourne Institute of Technology University

820-16 Improving Complex Decision Making in Army Personnel Under Conditions of Fatigue and Sleep Deprivation During Simulated Prolonged Field Operations

This pilot study will provide initial evidence regarding the effectiveness of countermeasures for sleep loss for improving or maintaining complex decision –making in healthy young males. Participants will be randomised to one of three conditions (napping, Modafinil or placebo) and will be required to complete a battery of neuropsychological tests throughout the night to assess decision making and planning under conditions of fatigue and extended wakefulness.

Dr Melanie WhiteQueensland University of Technology

821-16 Testing a novel psychological treatment to reduce chronic pain, depression, anxiety, and associated health outcomes in Defence personnel.

The project will investigate whether a technique known as attention bias modification (ABM) (completed on a computer with specialist software once a week for five consecutive weeks) can modify this largely unconscious, automated and implicit allocation of attention to pain cues. Additionally, it will examine whether this treatment method will subsequently reduce negative pain-related outcomes (e.g., pain severity, reduced activities) and improve individuals’ mental health and wellbeing (e.g., anxiety and depression symptoms) during the training period, at the end of the five weeks of training, and one month later.

Mr Matthew StevensThe George Institute of Global Health

822-16 Trial of Prevention Strategies for Low Back Pain

This project aims to establish the effectiveness and cost-effectiveness of a group-based exercise and education program in preventing recurrence of lower back pain.Defence members who have recently recovered from an episode of lower back pain will be randomised into either a 12 week comprehensive, individualised group exercise and education program or a receive minimal intervention program.

A/Prof Richard FletcherUniversity of Newcastle

823-16 SMS4dads Multi-Centre wait list randomised control trial

This multi-centre randomised controlled trial (RCT) aims to test the efficacy of SMS4dads. In this study the investigators will assess, using validated scales, the influence that SMS4dads has on key indicators of how well a father is coping with the transition to parenthood. These indicators include paternal depression, anxiety and distress, a sense of co-parenting quality, perceptions of parenting confidence, and reported alcohol consumption. Fathers will complete surveys at entry to the study, at six months after entry and at completion of the study.




Dr Darren HedleyOlga Tennison Autism Research Centre

825-16 Successful employment outcomes for people with autism spectrum disorder: The Dandelion Program

The aims of this project are to:• understand the social impact of participation in employment on adults with ASD and their families,

as well as the support staff and organization; and • determine key criteria for measuring success, and identify potential barriers to success to enable

continuous improvements of the program. The research is mixed method employing both longitudinal quantitative and qualitative methodology. Longitudinal data will be collected for the length of the program (three years) at Baseline (when applicants apply for positions in the program), at commencement of employment, and at four month intervals following commencement.

Dr Daniel BillingDefence Science Technology Group

827-16 Real-Time physiological status monitoring

This project aims to:• evaluate the acceptability and usability of the real-time physiological status monitoring systems

for dismounted personnel; • perform retrospective data analysis of the physiological strain experienced during military

activities for the identification of physiological indicators of work performance and tolerance; and • compare performance of military activities with feedback of individualised physiological strain

indicators with the guidance provided by the normative physiological strain anticipated for that activity.

Dr Andrea PhelpsPhoenix Australia

828-16 Evaluation of PTSD treatment programs funded by DVA

The primary aim of this project is to analyse to evaluate the effectiveness of the Trauma Recovery Programs for Defence members diagnosed with Posttraumatic Stress Disorder. The secondary aim is to analyse the data to gain an understanding of the patterns and predictors of recovery to better inform future treatments.

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Prof Deborah BlackmoreUniversity of New South Wales

829-16 Understanding contexts for developing future leaders

This study seeks to:• determine the range of contextual interpretations and understanding of the CRISP values

(Courage, Respect, Integrity, Service and Professionalism) to be found among Australian Defence Force (ADFA) cadets and those charged with training ADFA cadets;

• the degree to which CRISP values can be said to be embedded in ADFA culture through the values and behaviours of it cadets and trainers; and

• how well Q methodology supports the evaluation of culture.

Mr James HayesUniversity of New South Wales

830-16 Effect of Workload on human swarm interaction

The aim of this research is to investigate future modes of interaction between a human operator and a team of robots.

Mr Thomas DebenedictisUniversity of South Australia

831-16 The effects of the mechanical whole body vibrational forces experienced during military land transit on dismounted combatant physical performance

The purpose of this study is to explore the impact of military land transit on physical performance.

Prof Patrick O’LearyGriffith University

833-16 The experience of male sexual assault survivors within the Australian Defence Forces (ADF)

This project aims to examine male sexual assault in the Australian Defence Force.

Ms Tracey McLaughlinDefence Science Technology Group

834-16 Field use evaluation of a prototype mission adaptive, modular design of combat rations

This project aims to assess the prototype Mission Adaptive Combat Ration Pack (MA CR1M) including consumption patterns, packaging, product design, jack ration use, efficacy and convenience, constraints associated, food preparation, energy expenditure of users, and nutritional intake.




Prof Alexander McFarlaneUniversity of Adelaide

836-16 Evaluation of Biological markers of traumatic stress risk and resilience

The aim of this project is to investigate and characterise risk and resilience profiles in combat deployed troops.

Dr Reece ClothierRoyal Melbourne Institute of Technology University

837-16 Assessing the suitability of DAHRTS for UAV accident/incident occurrences

The aim of this research is to assess the suitability of DAHRTS (as an accident/incident database) for UAV specific events.

Dr Monique CraneMacquarie University

839-16 A mechanism for enhancing mental fitness as a consequence of stressor exposure: Exploring the role of systematic reflection

This research aims to evaluate the mental fitness training program which is designed to encourage systematic self reflection on coping approaches when exposed to stressor events.

Prof James McCarthyArmy Malaria Institute

840-16 A Phase IB experimental study to assess the in vivo Safety and response to Chloroquine of Plasmodium Vivax isolate HMPBS02-Pv in healthy participants with induced blood stage malaria infection

This research aims to further assess the safety of Plasmodium vivax isolate HMPBS02Pv in healthy participants using the induced blood stage malaria model and to investigate the effectiveness of chloroquine in reducing parasitaemia.

Dr Michael Edstein Army Malaria Institute

841-16 Efficacy and tolerability of pyronaridine-artesunate in treating uncomplicated mono-infections of falciparum, vivax and malaria or mixed infections in Vietnam

The primary aim of this research is to assess the therapeutic efficacy of pyronaridineartesunate for the treatment of uncomplicated monoinfections of Plasmodium falciparum and Plasmodium vivax malaria.

23

COMPLETED RESEARCH PROJECTS1. Table D1 provides a list of research protocols that ADHREC have been advised were completed in the reporting period.

Table D1: Completed Research Protocols

Principal Investigator and Institution Protocol number and title

LTCOL Alison KaineArmy, Army Logistics Training Centre, Army School of Health

538-08 Mental Health Outcomes Following Deployment: Investigation into coping as a result of operational deployment.

Dr Bhupi SinghRoyal Australian Air Force Institute of Aviation Medicine

541-09 Alveolar equivalence for three techniques of hypoxia awareness training: hypobaric hypoxia, combined altitude and depleted oxygen (CADO), and normobaric hypoxia.

Major Ray HingstCivil Military Cooperation

602-10 The influence of the military posting cycle on group formation and team development in the ADF.

Mr David ShackletonUniversity of New South Wales

630-11 Impact of Charles F. Adams Class Guided Missile Destroyers on the Royal Australian Navy 1959-1999.

Ms Angeline WilsonDefence Intelligence and Security Group

637-11 The Defence Intelligence and Security (I&S) Group psychological research project.

Dr Michael EdsteinArmy Malaria Institute

649-11 Pharmacokinetics and ex vivo antimalarial activity of methylene blue combined with artesunate and amodiaquine in healthy Vietnamese volunteers.

Dr Jodie VaileDefence People Intelligence and Research

651-12 An exploratory study into the relationship between blast dose and mild traumatic brain injury.

Dr Vandra HarrisRoyal Melbourne Institute of Technology

652-12 The NGO-military interface in post-conflict and post-disaster contexts.

ANNEX D



Major Emma Grigson-GairArmy

659-12 The impact of 'emerging' training methods on battle readiness in Australian Defence Force members.

Dr Jace DrainDefence Science Technology Group

695-13 Australian load effects assessment program.

Ms Gail MacDonaldDefence Community Organisation

705-13 Student support during parental deployment.

Ms Kyleigh HeggieDepartment of Veterans Affairs

707-13 Fourth study of mortality and cancer incidence in aircraft maintenance personnel.

Ms Annette SummersDirectorate of Occupational Psychology & Health Analysis

708-13 Operational mental health screening in the Australian Defence Force: Evaluating the psychometric properties of the Kessler 10 using Rasch analysis.

Dr Jodie VaileDefence People Intelligence and Research

722-13 Australian Defence Force Academy and Defence initial training establishments Unacceptable Behaviour Survey 2014.

Major David OrmrodDefence Material Organisation

731-13 Managing the risks of information deception upon tactical C41SR systems used for land combat.

Mr Zhiyong (Darran) FooUniversity of New South Wales

755-14 The influence of nitrogen narcosis on emotional processing.

Ms Kelly HandAustralian Institute of Family Studies

760-14 The role of the family in Australian Defence Force members rehabilitation.

Ms Kelly HandAustralian Institute of Family Studies

766-14 The Role of the Family in Australian Defence Force Member Rehabilitation. Study Two: Perspectives of Defence member families.

25


Mr Phillip TembyDefence Science Technology Group

785-15 Evaluation of the Australian Defence Force Arts for Recovery, Resilience, Teamwork and Skills (ARRTS) Program.

Dr Mark PageHMAS Kuttabul

786-15 HMAS Sydney II – Dental Health Then and Now.

CAPT Melanie FreemanHuman Capital Revolution

790-15 Examining the level of perceived support and other issues faced by military families, including perceived level of support from the organisation.

Dr Janis Wilton University of New England

792-15 Oral History: Interviewing Soldier Sons.

Dr Michael EdsteinArmy Malaria Institute

803-15 Chemical fingerprinting investigation into relapsing Plasmodium vivax malaria in ADF personnel.

Dr Janette RoseAppleton Institute for behavioural science

804-15 Evaluation of level-crossing road user behaviour.

Dr Daniel GucciardiCurtin University

806-15 Stress-related growth: The role of stressor appraisals, mental toughness and proactive goal regulation.

2. Of the completed research projects, ADHREC granted a waiver of consent for the following protocols: a. 707-13 Fourth study of mortality and cancer incidence in aircraft maintenance personnel b. 803-15 Chemical fingerprinting investigation into relapsing Plasmodium vivax malaria in ADF personnel.

3. A summary description of the protocols is provided in the 2013 and 2015 ADHREC Annual Reports respectively.


4. Table D2 provides a list of research protocols that ADHREC have been advised where research was closed due to inactivity in the reporting period.

Table D2: Closed Research Protocols


Mr Ross CoadDefence Science Technology Group

412-05 Fatigue, Nutrition and Fitness on Hydrographic Vessels.

Ms Sheena DavisDefence Science Technology Group

684-12 General Anthropometry: Generic Protocol for Manual Measures.

Ms Sheena DavisDefence Science Technology Group

685-12 General Anthropometry: Generic Protocol for Manual measurements and 3D body scanning.

27

DPS: FEB016-17

Documents

AUSTRALIAN DEFENCE Human Research Ethics Committee ...crl.defence.gov.au/Health/HBP/DDHRC/Docs/HREC_Annual_Report_2016.pdf · Ms Vivienne Moyle, Director Defence Health Research provided