General information regarding submissions to DHHS HREC
Researchers should consider the Criteria for Referral of Research to the DHHS HREC to determine whether their project should be submitted for ethical review. Those seeking to lodge an application must discuss their application with the HREC secretary, on 9096 5239 prior to submission.
Researchers should note the following in preparing and submitting their application to the DHHS 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 utilised instead of the HREA. The applicant must discuss the project with the HREC secretary, on 9096 1149 before completing the LNR VIC. A Victorian Specific Module is not required for projects utilising 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 survey instruments, copies of questions, data variables sought from databases, recruitment materials, plain language statements of the project, consent forms.
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.
Research requiring access to data held by the DHHS
For guidance on data linkage projects please contact the Centre for Victorian Data Linkage.
Research requiring DHHS Programme area approval
As a general rule, if the proposed research involves personnel, resources, data or clients of a particular programme area within the Department, researchers should seek programme area management support for their project before submitting it to the HREC for ethical review.
Although support within the relevant programme area may be conditional upon receiving HREC approval, programme 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 programme managers to determine the priority of activities within their area and researchers should be aware that HREC approval does not guarantee programme support for their project.
Ethical considerations in Quality Assurance and Evaluation Activities
Ethical considerations in Quality Assurance and Evaluation
In addition, chapters from the National Statement on Ethical Conduct in Human Research 2007 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.
Medical research involving patients under a legal incapacity
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.
Submission and meeting dates for the Human Research Ethics Committee 2021
There are eight (8) meetings of the Committee scheduled for 2021. A limit of (5) five applications per meeting applies. It is imperative that those seeking to lodge an application for ethical review discuss their application with the Ethics Committee Secretary, prior to lodgement – on 0452 381 948.
Applications to the Committee are lodged via the ERM (Ethics Review Manager) on- line portal. Researchers will need to set up an account on ERM in order to lodge their submissions.
ERM - setting up an account
ERM - technical support
02 9037 8404
Further information on how to make a HREC application and ERM can be found on the Clinical trial research website.
The Committee meets the first Wednesday of the month in the second two months of each quarter. Submissions should be submitted by 2.00pm the day they are due
2021 HREC Submission and meeting dates - 2.00pm deadline
|Submission closes (Thursday)
||Meeting dates (Wednesday)
|14 January 2021
|3 February 2021
|11 February 2021
|3 March 2021
|15 April 2021
|5 May 2021
|13 May 2021
|2 June 2021
|15 July 2021
|4 August 2021
|12 August 2021
|1 September 2021
|14 October 2021
|3 November 2021
|11 November 2021
|1 December 2021
Membership of the DHHS HREC 2020
Dr Sandra Hacker - Chairperson
Sandra is a psychiatrist in private practice whose prime area of clinical interest is severe psychological trauma. Her medico-legal interests are in Crimes Compensation, WorkCover and medical negligence. She is a Fellow of the Australian Institute of Company Directors.
Sandra is Deputy Chair of the Lord Mayor’s Charitable Foundation Board and a Director of Entertainment Assist (HPC). She was Liaison Psychiatrist to the Heart Lung Transplant Unit, Alfred Hospital for nearly 30 years.
Sandra was appointed an Officer of the Order of Australia (AO) in the Australia Day Honours in 2005 and received a Doctor of Medical Science (honoris causa) from the University of Melbourne in 2012.
Rev Fr Michael Elligate - Pastoral Care
Michael Elligate has been Parish Priest at St Carthages University Parish Parkville, and works and chairs Human Ethics Committees at The University of Melbourne. He is a graduate in Social Sciences, Arts and Education.
Rabbi Aviva Kipen - Pastoral Care
Aviva has held HREC appointments and served on the Victorian Bio-Ethics Advisory Committee. She returned to serve a second term on the Australian Health Ethics Committee of NHMRC in 2019. She is fascinated by the proposition that clergy and pastoral carers of all faiths work alongside each other and interchangeably succeed each other to committees on behalf of people of all faiths and none, for the care of all involved in research involving humans.
Ms Judy Chambers - Philosopher
Judy has over 10 years’ experience promoting ethical standards in human research. Her educational background is in Philosophy. She has a BA in Philosophy from the University of Toronto, a first class (honours) degree in Philosophy from the University of Sydney, a Masters of Bioethics from Monash University and a Masters in Philosophy from Melbourne University. She is currently the Philosopher member of the Victorian Department of Health and Human Services HREC and an Ethicist member of the Western Health Clinical Ethics Committee. In the past she has served on the Deakin University HREC and the Victorian Association for Philosophy in Schools Committee. She has been involved in developing and co-facilitating ethics classes for primary school children. Her research interests include altruism and the psychology of moral motivation, reproductive ethics and clinical ethics.
Dr Owen Bradfield - Lawyer
Owen is a Lawyer member of the Committee. He is also a qualified medical practitioner, having graduated from Monash University’s unique combined Bachelor of Medicine/Bachelor of Surgery and Bachelor of Laws degree with First Class Honours in 2003. He has extensive experience in primary care as a GP and in medical indemnity insurance as a specialist health lawyer. Owen sits on a number of other government boards and panels, including the Australian Institute of Health and Welfare Ethics Committee, the Suitability Panel and the Patient Review Panel. Owen is also a 2020 Fulbright Scholar and will be undertaking part of his PhD at Stanford Law School in the United States.
Dr Dru Marsh - Lawyer
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.
Dr Lisa Chaffey - Researcher
Lisa is an occupational therapist, academic and researcher. Her qualitative research is in the fields of disability, health services, and education. She also brings her lived experience of being a wheelchair user to her academic field.
Dr Stella Koritsas - Researcher
Stella is a researcher with expertise in developmental disability, particularly in relation to inclusion, health, mental health, behaviour, and outcomes measurement. She is the Manager of Strategic Research at Scope, one of the largest disability service providers in Victoria, and has an honorary position at the University of Melbourne. In the past, she has held research positions in both University and community services settings.
Dr Karen Willis - Researcher
Karen Willis is a qualitative researcher and health sociologist. Her research focuses on health choices, health behaviours and the healthcare system. She is editor of Health Sociology Review, and is an active user of Twitter (@kwillis19) to disseminate her research findings and contribute to current debates about health and healthcare.
Dr Jacky Hewitt - Researcher
Jacky is a paediatric endocrinologist and clinician-scientist with clinical and research expertise in the development of sex and gender. She has published original research, treatment guidelines, and a number of textbook chapters within the field. She sits on a number of health advisory committees and consults for government bodies on issues relating to sex and gender.
Dr Sarah Kennedy - Experienced in Care/ counselling
Ms Maureen MacPhail - Experienced in Care/ counselling
Maureen MacPhail who is from Ballarat is a community member. She worked as an occupational therapist in health and rehabilitation programs until her recent retirement. Maureen’s research focused on health changes associated with client-centred practice and the complexities associated with goal setting for patients with cognitive impairments. Maureen has participated in community-based committees and in volunteer activities in Australia and in India.
Mr Lowen Clarke - Layperson
Lowen is a 'professional lay person', with diverse studies in classics, divinity, group dynamics, coaching and is currently completing his doctorate in art therapy with a focus on autoethnography and narrative. Lowen is the author of Sam the Tram, a series of children’s books. His latest work is the creation of 'Empowerment Script', an EMDR replicating form of reading, to be published in the U.S.
Pst Peter Keeley - Layperson
Peter has extensive expertise evaluating ethical aspects in human research in serving on Human Reach Committees and as an Ordained Minister in Pastoral Care & Counselling. This is combined with his academic studies in Research Methodology at Monash University. He holds a Masters Degree in Applied Linguistics and has several Diplomas in Leadership and Ethical Decision making.
Ms Liesl McKay - Layperson
Liesl is an experienced Senior Executive, with a strong background in public sector corporate regulation and change management, including leading the implementation of policy reforms into complex technology and service environments.
She holds a Bachelor of Business degree, a Graduate Diploma in Organisation Behaviour, is a graduate member of the Australian Institute of Company Directors and currently serves on the Boards of an independent school and regional health service.
Ms Vivienne Moyle - Layperson
Mr Jeff Chapman - Secretary
Members are appointed for three years.
Vacancies in all memnbership categories arise from time to time. The department welcomes expressions of interest for appointment for all membership categories. These categories are:
- Lay member
- Research member
- Lawyer member
- Pastoral care member
- Professional care member
- Koori representative member.