Human Research Ethics Committee

• Applications must be presented using the Human Research Ethics Application (HREA) along with the Victorian Specific Module.
• Proposals are to be submitted to the Executive officer at least two weeks before the scheduled date of the meeting.
• Discuss your application with the committee Executive Officer research.ethics@health.vic.gov.au prior to lodgement.

Researchers should consider the Criteria for Referral of Research to the Committee to determine whether their project should be submitted for ethical review. Those seeking to lodge an application must discuss their application with the committee Executive Officer research.ethics@health.vic.gov.au​​​​​​.

Researchers should note the following in preparing and submitting their application to the DH and DFFH HREC:

1. Completing the HREC application form

The Human Research Ethics Application (HREA) is a standard form developed by the National Health and Medical Research Council (NHMRC). The Victorian Specific Module (VSM) addresses Victorian legislative requirements; it must be submitted as part of an ethics application when the HREA is used.

For a low and negligible risk (LNR) research project taking place in Victoria only, the LNR VIC application form may be used instead of the HREA. The applicant must discuss the project with the HREC Executive Officer research.ethics@health.vic.gov.au before completing the LNR VIC. A Victorian Specific Module is not required for projects using the LNR VIC.

2. Submitting the ethics application

Your application must include:

• a cover letter stating the meeting at which review is sought
• a completed HREA or LNR VIC
• a completed Victorian specific Module (not required with LNR VIC)
• any other relevant attachments, such as protocol, survey instruments, copies of questions, data variables sought from databases, recruitment materials, plain language statements of the project, consent forms
• Curriculum vitae. Researchers are asked to please provide no more than a BRIEF 2 PAGE CVS of the lead investigator and primary person doing the work of the project (if not the lead investigator).

These application documents should be enumerated in the cover letter in the order in which they appear in the application, so it is apparent that the submission is complete.
 
The HREC considers proposals for approval at its monthly meetings. In cases of extreme urgency, for instance a proposal addressing a current epidemic, it will consider a proposal out of session. In some instances, the HREC finds it useful to talk to the researcher/s in person and will make arrangements to do so at a monthly meeting. The result of the review process is communicated to researchers as soon as possible after the meeting at which the proposal was considered. In those instances where the HREC requests clarifications, modifications or additional information, responses to these requests are considered either out of session or at the earliest available meeting - the mode depends upon the deliberations of the meeting at which the proposal was considered.

The HREC does not consider draft, ‘in principle’ or otherwise incomplete proposals. It does, however, consider proposals in respect to studies to be completed in stages, provided the proposal in relation to the first stage is complete.

• Checklist – Determining Review Pathway (LNR or Full HREC Review) (Word)

For guidance on data linkage projects please review the information provided and contact the Centre for Victorian Data Linkage.

As a general rule, if the proposed research involves personnel, resources, data or clients of a particular program area within the department, researchers should seek program area management support for their project before submitting it to the HREC for ethical review.

Although support within the relevant program area may be conditional upon receiving HREC approval, program managers may refuse permission to carry out a project on grounds unrelated to ethical issues.

The granting of approval by the HREC does not take precedence over the authority of program managers to determine the priority of activities within their area and researchers should be aware that HREC approval does not guarantee program support for their project.

See the Ethical considerations in Quality Assurance and Evaluation Activities on the NHMRC website.

In addition, chapters from the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) that are relevant when determining whether or not an activity ought be characterised as one of research or quality assurance are: Chapter 2.1 Low risk and negligible risk research and:

• Oversight and review of ethical procedures (5.1.10–5.1.17)
• Research involving no more than low risk (5.1.18–5.1.21)
• Research that can be exempted from ethical review (5.122–5.1.23).

Researchers must ensure that proposals conform to all relevant privacy legislation, including the Privacy Act 1988 (Commonwealth), the Privacy and Data Protection Act 2014 (Vic) and the Health Records Act 2001 (Vic).

Where researchers are seeking to obtain information from Commonwealth agencies or from private health service providers, they should consult the Guidelines Under Section 95 of the Privacy Act 1988 and/or the Guidelines Approved Under Section 95A of the Privacy Act 1988. The Privacy and Data Protection Act 2014 (Vic) regulates the responsible collection and handling of personal information (excluding health information) by organisations in the Victorian public sector and replaces the Information Privacy Act 2000 (Vic). The Health Records Act 2001 (Vic) applies to all health information held in Victoria in the public or private sectors. The Health Privacy Principles became legally binding on 1 July 2002. Victoria has statutory guidelines for the purposes of Health Privacy Principles 1.1 (e) paragraph (iii) and 2.2 (g) paragraph (iii). The guidelines can be obtained from the Office of the Health Complaints Commissioner.

Researchers are responsible for providing sufficient information in the HREA to enable the HREC to determine whether the research represents any breach of the various Privacy Principles and, if so, whether the public interest in the research substantially outweighs the public interest in respecting privacy.

Researchers wishing to conduct medical research involving patients under a legal incapacity to consent must consult the relevant provisions of the Victorian Guardianship and Administration Act 1986 especially Division Six ss(42)P–ss(42)Z. There are certain preconditions that must be met before a HREC can approve such research.

Guidance, frequently asked questions (FAQs) and information documents are available in ERM – go to the 'Help' area.

Contact the Coordinating Office for Clinical Trial Research

Phone: 0408 274 054 – General enquiries and ERM application advice
Phone: 0408 410 938 – Enquiries and ERM for Research Office administrators
Email: multisite.ethics@health.vic.gov.au
9am to 5pm AET, Monday to Friday

ERM technical support

Infonetica Helpdesk
02 9037 8404
helpdesk@infonetica.net 
9am to 5pm AET, Monday to Friday

Dr Philomena Horsley - Chair

Dr Philomena Horsley has been a Chair of HRECs for over 20 years in the fields of health, disability and the justice system. She also served on the NHMRC’s National Statement Section 4 Review Working Committee from 2018-2020.

Since 2005, Philomena has been engaged in teaching ethical thinking to HREC members and researchers. She was a content creator and workshop facilitator for PRAXIS Australia, including its accreditation course, HREC Essentials and its HREC Evaluation Guide and Toolkit. She regularly presents at conferences and courses on research ethics. She is particularly focussed on the inclusion of diverse and marginalised populations, and the importance of engaging relevant communities in the design of research.

Philomena is a Medical Anthropologist with additional qualifications in education, gender studies and professional writing and editing. She is an independent consultant to government, academic, health and community organisations, and holds a position as Honorary Senior Research Fellow at the University of Melbourne where she also lectures. Her expertise includes gender and health, family and sexual violence, disability services, LGBTQ health and wellbeing, genetics and cancer, medical autopsies, and death and dying. She was an expert witness to the Commonwealth Royal Commission into Institutional Responses to Child Sexual Abuse and the Victorian Royal Commission on Family Violence.

She has served on a range of NFP Boards for many years and is currently the Chair of Abound Communities (retirement villages, residential aged care) and an Independent Member of Scope Australia’s Customer Experience & Outcomes Board Committee. In her private life, Philomena is an award-winning fiction writer and past Judge on the national literary awards, the Davitts.

In 2001, Philomena was inducted into the Victorian Honour Roll for Women and awarded a Centenary Medal for her work in women's health, disability and HIV/AIDS.

Dr Lowen Clarke – Community Member

Dr Lowen Clarke is a writer who holds a doctorate in Therapeutic Arts Practice, as well as qualifications in Professional Writing, Divinity, and Applied Science in Organisation Dynamics. Dr Clarke is a current member of the Department of Health Human Research Ethics Committee (HREC) as a layperson and has also served on several committees and community groups. Dr Clarke has the ability to look at situations and information from many disciplines and points of view, whether being creative writing, theology, psycho-traumatology. Dr Clarke’s strong literary background, as well as his strength, keen interest and commitment to logical thinking, formal structure, Philosophy and ethical discipline enables him to provide a valuable contribution to the DH ethics committee.

Professor Victoria White – Researcher

Victoria White (PhD) is Professor Psycho-oncology in the School of Psychology at Deakin University and Principal Research Fellow in the Centre for Behavioural Research in Cancer (CBRC) at Cancer Council Victoria. Taking up the role at Deakin University in 2017, Victoria has spent most of her research career with the Cancer Council Victoria where she gained substantial experience in cancer control and oncology research. Over her research career, Prof White has had two main research areas: understanding the prevalence of tobacco and alcohol use in adolescents and identifying ways to improve the care of people with cancer. Professor White has a long involvement with the national study of tobacco, alcohol and illicit substance use in Australian secondary students (ASSAD) and was the principal investigator for this project between 2002 and 2018. This work involved collaboration with state and territory partners to undertake surveys of over 20,000 secondary school students across Australia every three years. Professor White has produced major reports for the Australian Government’s Department of Health and Ageing and the Victorian Department of Health relating to the findings from this study. Her work in the area of cancer patients has involved the development of surveys to assess patients experience of care, surveys assessing the management of different adult and adolescents/young adult cancers and testing interventions to determine their ability to reduce distress in people affected by cancer including those diagnosed with a BRCA1/2 mutation. Professor White’s research has been funded by a range of Australia’s key research funding bodies including NHMRC, Cancer Australia, National Breast Cancer Foundation and the Victorian Cancer Agency. She has published over 170 peer-refereed papers with high impact (h-Index: Google Scholar 50) and has authored over 200 reports to governments at the state and federal level and state-based cancer societies and consumer advocacy organisations. She has published in Journal of Clinical Oncology, Psychoncology, Supportive Care in Cancer, Addiction and Tobacco Control. She currently serves on Cancer Council Victoria’s Medical and Scientific Standing Research Sub-Committee (2004-ongoing) and is on the access committee for Register4 (a register of people interested in taking part in research projects) and has participated in National Breast Cancer Foundation and Cancer Australia grant review panels. She was a member of Cancer Australia’s Data Advisory Committee (2012-2017). She received the Nigel Gray Award for Achievement in Tobacco Control in the Oceania Region in 2013.

Dr Rachel Earl – Knowledge and Expertise (Care and Counselling)

Dr Rachel Earl is a public health practitioner who lives and works on the lands of the Boon Wurrung and Wurundjeri People in the South East of Melbourne. Rachel holds a combined Master of Psychology (Clinical)/PhD from the University of Adelaide and a Master of Public Health (Health Management) from Harvard T.H Chan School of Public Health. Rachel is passionate about the intersection of psychology and public health and has built experience across spheres of government in Australia, University teaching and research, the United Nations, and International Non-Government Organisations. Rachel’s current role is as Manager of Youth Mental Health and Suicide Prevention at South Eastern Melbourne Primary Health Network (SEMPHN). At SEMPHN, Rachel, and her team, work with those with lived experience of suicide and other partners to implement place-based approaches to suicide prevention. In addition, the Youth Mental Health and Suicide Prevention team contribute to the commissioning and contract management of a range of clinical and non-clinical services that support the mental health and wellbeing needs of the local community.

Adjunct Professor (Practice) Nicholas Coppel – Community member

Nicholas Coppel CSI is an Adjunct Associate Professor (Practice) at Monash University, and a former career diplomat and Ambassador. He was Australia’s Ambassador to Myanmar from 2015–2018 leading a team of 18 diplomatic staff and 80 local staff and managing a $42million aid program. Between 2011 and 2013 Nicholas headed the 500+ person Regional Assistance Mission to Solomon Islands in restoring law and order and governance in Solomon Islands after a period of ethnic tensions. Overseas, Nicholas has also served as Australia’s Deputy High Commissioner in Port Moresby and Deputy Head of Mission in Manila, with an earlier posting in Washington DC. Nicholas holds a Bachelor of Economics degree from the Australian National University and a Master of Business Administration degree from London Business School. He was awarded the Cross of Solomon Islands in 2017.

Mary Rydberg – Community member

Mary Rydberg is a senior leader with experience in diverse administration and management roles within the health and community services sectors in Victoria.  The roles have been within the State government, hospital, not-for-profit sector, and local government.  I have extensive experience in strategic management, restructuring and business improvement with firsthand experience with culturally diverse and rural and remote organisations.  I am an experienced non-executive board member with a strong commitment to good governance. I have a particular interest and experience in advocating for the local communities and community members through my board roles and past contributions as a lay member to the PeterMac Human Research Ethics Committee.

Nina Ellis – Community member

Nina Ellis is a senior research management professional with extensive experience and expertise in the design, commissioning and strategic management of research and evaluation. Nina is passionate about well-designed and executed research, and the important intersect between research, insight, strategy and policy. She is particularly interested in health and vocational outcomes, customer experience and insight, behaviour change, and the strategies and policies that help people and organisations achieve outcomes and enhance quality of life. Nina’s technical research expertise covers academic and commercial sectors, qualitative and quantitative methodologies, cross-sectional and longitudinal studies, monitoring and evaluation. She also has extensive experience in KPI development and tracking, program logic mapping, project management, research with general and vulnerable populations, data management, analysis and reporting, translation and strategy development. Nina is currently taking a career break and studying a Master of Evaluation at Melbourne University. Nina’s most recent former role was Senior Manager, Health, Disability and Compensation Research with the Transport Accident Commission (TAC), Victoria, Australia where she led a small team of research professionals focused on strategic research investment and governance, and the translation of evidence to inform strategy and operational performance.

Rabbi Ralph Genende – Pastoral

Born in Zimbabwe, raised in South Africa, Rabbi Ralph Genende is a well-known and popular Modern Orthodox Rabbi. Ralph was Senior Rabbi to the Auckland, New Zealand Jewish community for ten years. He then became College Rabbi at Mount Scopus College, member of its Executive Team and Rabbi of Beit Aharon congregation. Currently Rabbi Genende is Senior Rabbi of Caulfield Hebrew Congregation, one of Melbourne’s largest congregations. He was a senior Reserve Chaplain in the South African Defence Force and is now Principal Rabbi to the Australian Defence Force, Member of the Religious Advisory Council to the Minister of Defence (RACS), board member of AIJAC (Australian Israel Jewish Affairs Council) and member of the Premier's Multifaith Advisory Group. He was President of JCMA (Jewish Christian Muslim Association) and long-time executive member of the Rabbinical Association of Victoria. He also oversees Yad BeYad a premarital relationship program, is a member of Swinburne University’s Research Ethics Committee and on the Glen Eira City Council’s Committee responsible for its Reconciliation Action Plan for recognition and integration of our first peoples. Ralph has a passion for social justice and creating bridges between different cultures and faiths. For him the purpose of religion is to create a better society for all people and to engage with the critical issues facing Australian society. The role of the rabbi is, in his words, to challenge the comfortable and comfort the challenged. In 2018 Rabbi Genende was awarded an OAM for his services to multi-faith relations, and to the Jewish community of Victoria. Rabbi Genende is a trained counsellor with a Masters degree from Auckland University. He is married to Caron, a psychologist and they have three children and two grandchildren.

Associate Professor Daniel Halliday – Philosopher

Daniel Halliday teaches ethics and political philosophy at the University of Melbourne. His teaching and research focus on matters of justice in relation to the regulation of employment, education, taxation, and other aspects of contemporary market societies. In addition to various journal articles, he is the author of two books, The Inheritance of Wealth (2018), and The Ethics of Capitalism: An Introduction (2020), both with Oxford University Press. He is also part of an international group of researchers studying ethically significant issues emerging from the current pandemic, including the question of how much pharmaceutical companies should be allowed to charge for vaccines (and therapeutics), and the adequacy of current efforts to safeguard vaccine supply for low-income countries. He holds a PhD in philosophy from Stanford University.

Dr Dru Marsh – Legal

Dr Marsh has practiced in health, safety, environment and community law for more than 10 years, variously as a private solicitor, government legal policy officer and volunteer lawyer. He also has experience in technical health and safety consulting and is a casual researcher with the University of NSW (Canberra). Dru sits on the boards of a number of non-government organisations, including a disability support services provider, and holds a PhD in Environmental Science.

Rena Ou Yang – Legal

Rena has a background in health, science, and law and currently practices as a lawyer for a large healthcare provider. She previously worked in private practice, providing trusted advice to a wide range of clients in health care, aged care, disability, education, and family violence. Her areas of practice include employment, privacy, technology, research,
intellectual property, clinical governance, risk, and regulation. She has a degree in Bachelor of Biomedical Science / Laws (Honours) and studied health law at Sheffield University in the UK.
In addition to her expertise in health law, Rena has worked and volunteered in child safety and sexual violence prevention. She co-founded and was director of Empowered Together, a youth led not-for-profit which runs workshops in secondary schools on the primary prevention of sexual violence. She is the author of a textbook chapter on Respectful Relationships which is used in secondary schools across Australia.
Rena previously served as the director of a health journalism not-for-profit. Her governance experience was strengthened as a recipient of the Women’s Board Leadership Program Scholarship and subsequent studies with the Australian Institute of Company Directions. As a young woman of colour, she is passionate about diversity and representation.

Dr Stefanie Vaccher – Researcher

Dr Stefanie Vaccher is a Senior Research Fellow at the Burnet Institute, where her work focuses on immunisation and health system strengthening. She brings a decade of experience in health research in Australia and across the Asia-Pacific region to the committee. As an epidemiologist, Stefanie works with local communities to respond to infectious disease outbreaks, uses data to drive evidence-based responses and shape policy, and enhance surveillance systems to detect and prevent future illness. Overall, Stefanie is driven to improve the health of vulnerable and marginalised populations through meaningful engagement and a comprehensive understanding of community needs. She has a PhD in Public Health from UNSW Sydney and has recently relocated to Australia after living in Papua New Guinea.

Associate Professor Chris Maylea – Researcher

Associate Professor Chris Maylea is a social worker, lawyer, and Associate Professor of law at La Trobe University. He has practice experience in mental health services as a social worker and manager, provides advice to government and policy reform bodies. Associate Professor Maylea’s work sits at the intersections of health, welfare and the law, and is underpinned by human rights and social justice. He is the author of over 70 peer-reviewed publications and commissioned reports, and is the author of 'Social work and the Law: a guide for ethical practice'. He has conducted evaluations of health and advocacy services, empirical research on interdisciplinary practice advance statements, gender-based violence in mental health inpatient units, child protection, elder abuse, and doctrinal and human rights analyses. His work uses codesign approaches, with a focus on promoting the voice of people who use health and welfare services. Associate Professor Maylea has extensive experience before the Victorian Mental Health Tribunal as a legal representative. He previously managed and evaluated mainstream Aboriginal and child and family community mental health services, rehabilitation units and assertive outreach and support services in regional areas. He has served as Chair and Deputy Chair of the Victorian Mental Illness Awareness Council (VMIAC).

In the context of research with humans, a dual relationship can exist when the researcher has another (or several) significant relationship(s) with the research participant other than that which is the subject of the research protocol. An example of a dual relationship is when, for example, the researcher is also responsible for project, program or administrative oversight within the organisation where it is proposed to implement an approved research protocol, when participants in such a research program are also under the administrative care of the researcher. Such secondary relationships can create inappropriate power relationships between researchers and participants, with consequent ethical difficulties, when for instance the research participant may reasonably perceive:

• actual or potential conflicts of interest for the researcher ‘as researcher’ and ‘as administrator or manager in the secondary relationship’ in addressing for example such issues as security of information and the handling of complaints
• the likelihood of potential compromises concerning the confidentiality and anonymity being assured to research participants in the research protocol.

The securing of genuine voluntary informed consent from research participants may also be compromised when it may be perceived by potential participants at recruitment stage that it may be prejudicial to their interests should they decline participation in the research.

In submitting research protocols for consideration by the department HREC, researchers should:

1. Disclose in the protocol any actual or potential dual relationships with the research participants and notify the Committee should such a situation arise during the implementation of an approved research protocol
2. Advise how the dual relationship can be managed so that the interests of the research participant are fully protected on the one hand, and the integrity of the research program is not compromised on the other
3. Address any possible perceptions by research participants that confidentiality and anonymity may be compromised
4. Establish appropriate processes within the protocol for complaints procedures that involve notification to other persons or authorities in addition to, or instead of, the researcher in the first instance
5. Ensure that, as much as is practically possible, an appropriate power distance is maintained by the researcher (or actively and effectively monitored by a person independent of the researcher) during the implementation of any approved research protocol
6. Ensure that procedures are followed that prevent information collected for the purposes of an approved research program are not used for any other purpose with which the researcher may be associated in the secondary or dual relationship.

In considering applications for ethical review of research into illegal behaviour, the Department of Health and the Department of Families, Fairness and Housing Human Research Ethics Committee (HREC) takes into account the following factors:

• The importance of the participant not being misled as to the possible legal consequences of responding to questions about his or her illegal behaviour, particularly the risk of self-incrimination
• Whether any legal proceedings, such as summary hearings, trials, fitness to stand trial, or proceedings for breach of a sentencing order are still pending
• Whether the participants of the research are juveniles
• Any existing obligations the researchers may have under mandatory reporting legislation in relation to their knowledge of illegal activity
• The discretionary nature of the legal powers to prosecute those who are alleged to be involved in criminal activity
• The fact that the law cannot be relied upon to protect the confidentiality of information if the researchers are subject to a subpoena to produce documents to a court, or to appear in person to give evidence.

In dealing with research into illegal behaviour, the Committee will not accept wording in Participant Information and Consent Forms that ‘absolute’ confidentiality can be guaranteed. This is because researchers may be obliged under mandatory reporting legislation to supply information to authorities, or under subpoena to testify in court or to produce documents in relation to information supplied to them in the course of their research.

However, it's not necessary to spell out in precise detail the nature of the circumstances in which a legal obligation may arise to reveal information to police, prosecuting authorities, or to a court. The Committee will accept statements in the Participant Information and Consent Form to the effect:

“You are not obliged to disclose information about illegal behaviours. The researchers cannot guarantee absolute confidentiality with respect to illegal behaviour of which they are made aware.”

A warning to this effect should be followed by a brief description of the steps proposed by the researchers to maintain the confidentiality of the information supplied to them by participants, as far as is legally possible.

Where it is known that the researchers are subject to the requirements of mandatory reporting legislation if the research participants disclose certain matters, for example sexual abuse, the Committee will require an explanation in the research protocol of how these situations will be handled if they arise. A similar (briefer) explanation should also appear in the Participant Information and Consent Form.

In all questionnaires, focus group schedules or similar instruments used in research, it must be made clear that the research participants are not obliged to answer questions. Where only part of the questionnaire deals with illegal behaviour, that warning should normally be repeated prior to that group of questions.

Where the researchers intend to question a research participant about criminal matters that are still before the courts (whether the participant is involved as offender or victim), researchers must exercise extreme caution. The consent of the participant may not be sufficiently informed if the person has not obtained legal advice regarding the possible consequences for his or her defence (in the case of an offender), or for the success of the prosecution case (where the participant is a victim of crime).

Data collected in the course of research approved by the department HREC must be retained for a period of at least 7 years in accordance with the Public Records Act 1973. However, the data retention period may be longer for certain types of research. For example, clinical trial data should be retained for a period of at least 15 years (Guidelines for Good Clinical Practice in Australia (1991)), while health data collected in relation to minors must be retained until the individual attains the age of 25 [Health Records Act 2001 (Vic)].

It's the responsibility of the Principal Researcher to ensure that all data collected during the project are stored and disposed of securely following the seven-year data retention period.

Researchers are required to inform the Committee about the location where data will be stored and who will have access to the data. They must also provide a detailed account of the security arrangements in place to protect individuals’ privacy and confidentiality. In addition, a clear statement of the method of destruction must be provided.

Researchers must bear in mind that data cannot be retained indefinitely for use in future research unless participants have been advised of this and have consented to the use of their data in additional research. It's important to consider the need to use data collected in future research and make the necessary arrangements with the Ethics Committee when initially submitting the application, as well as with participants when recruiting them.