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. The VSM is available below.
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 5239 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 application must be emailed in ONE pdf document to the committee by 12.00pm on the submission due date - multiple attachments will not be accepted.
In addition, three hard copies (one an original signed document) must be delivered by 12.00pm on the same due date. Hard copies can be delivered to 50 Lonsdale Street by arrangement with the Secretary, Human Research Ethics Committee on 9096 5239. Alternatively, applications can be posted to:
Secretary, Human Research Ethics Committee
Department of Health and Human Services
Level 15/50 Lonsdale St Melbourne 3000
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
All researchers wishing to access data held by DHHS will need to seek departmental support prior to the submission of their proposal to HREC. Researchers must comply with the standard release conditions imposed by Heads of the relevant DHHS programme areas, who have ultimate responsibility for the appropriate storage, handling of, access to and use of the data of which they are custodians (3.1 National Statement).
Research that involves the use of data held by DHHS does not require ethical consideration by the DHHS HREC in the following circumstances:
- The principal researcher is external to the DHHS and will be seeking approval from the HREC of the organisation of which they are a member of staff. External researchers are required to submit to their organisational ethics committee and will therefore not have access to the DHHS HREC;
- The principal researcher is a DHHS member of staff but has already been granted approval for the conduct of the research by another HREC; or
- The data are non-identifiable as determined by the Head of the relevant DHHS programme area.
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.
Participant information and consent forms
Template Participant Information and Consent Forms are available at Health and medical research – How to make an HREC application.
Submission and meeting dates for the Human Research Ethics Committee 2019
There are eight (8) meetings of the Committee scheduled for 2019. A limit of 5 applications per meeting applies: it is imperative that those seeking to lodge an application for ethical review discuss their application with the Committee secretary, on 9096 5239 prior to lodgment.
2019 HREC Submission and meeting dates - 2.00pm deadline