Ethics clearance for research
The University of Melbourne requires that prior to being commenced, research by staff or students which involves any degree of risk to participants must have obtained ethics approval. The body coordinating such approvals is the University's Human Research Ethics Committee (HREC). HREC committees meet once a month during semester, and applicants are advised to allow a minimum of four to six weeks for HREC approval. To streamline the process, and in particular to help students and other researchers undertaking comparatively low-risk research avoid unnecessarily long delays, HREC has authorised some schools to establish their own Human Ethics Advisory Groups (HEAGs). These Advisory Groups have delegated authority to grant immediate approval to research assessed as low-risk. The HEAGs are also required to provide researchers contemplating higher-risk research with a preliminary review and assessment of their ethics applications, before such applications are forwarded to the HREC for a final decision.
Please note: All Human Ethics applications are to be submitted electronically via Themis and, specifically, the Human Ethics Workbench. In addition one signed single sided copy of all applications for ethics approval must also be submitted to the Research Support Officer before the deadline for the next School HEAG meeting (see below for deadlines).
All University of Melbourne researchers including Research Higher Degree students have ready access to Themis, however other students requiring access may need to arrange this through the Research Support Officer.
Please note: Research must not commence until all required ethical or other approvals have been obtained.
The type of application form to be used by school researchers and students will depend on:
a) The type of project for which they are seeking ethics approval (ie. whether it is a large-scale program of research; a specific project within a large-scale program that has previously been approved, or a one-off research project)
b) Whether the research is considered low-risk
University policy is to encourage honours, Postgraduate Diploma and other students compiling theses of 15,000 words or less to ensure that their research is low-risk. A quick way to make a preliminary assessment as to whether your research is low risk is to fill out the Minimal Risk Checklist form available on the Offcie for Research Ethics and Integrity Forms, samples and links web page.
There are four broad types of ethics applications. Most research applications received by the HEAG are in the category of "one-off project, low-risk".
1. Application for expedited review of a one-off, low-risk project involving humans
The HEAG will consider applications in this category at its next meeting. If your application is approved outright, it will be signed by the chair of HEAG and returned to you, and you can commence research immediately. In most instances, however, the HEAG will require some amendments. A HEAG member will be delegated to give the applicant feedback on the changes required. Once these changes have been made, the amended application form should be re-lodged. Your research can commence as soon as the HEAG has signed off on your application.
On rare occasions the HEAG will not agree that your research is low-risk. In such cases it will suggest that you resubmit on a different application form. If your application is resubmitted to the School promptly, the HEAG will give priority to ensuring that it is checked and forwarded to the HREC in time for consideration at its next meeting.
2. Application for approval of a one-off project involving humans that is not low-risk
Applications in this category must first be submitted to the HEAG before the School deadline for the next HEAG meeting (see below for deadlines). The HEAG's role is to "vet" ethical aspects of the study before forwarding the application, together with its recommendations, to the University's HREC for final approval.
The School's policy is to subject all applications to rigorous internal assessment. As a result, very few applications forwarded with a supportive recommendation from the HEAG have been subsequently rejected or amended by the HREC. One consequence of this rigorous approach, however, is that a significant proportion of applications tend not to be approved on first consideration by the HEAG, but are returned to the researcher with amendments suggested.
3. Application for ethics approval for a program of research involving more than one individual project
If the HEAG considers all of the components of your program of research to be low risk, it can approve it without referring the application to the HREC. However a copy of the approved application still must be sent to the HREC for filing and audit purposes. Please note, also, that a research program or project has only been approved by the HEAG when the Chairperson has signed off on the application form. The Chair will only sign off on the application when satisfied that the applicant has made all project amendments required by the HEAG.
If one or more components in the overall program of research exceed the low-risk threshold, the application will initially be 'vetted' by the HEAG but must also be referred to the HREC for final assessment. The HEAG may, of course, suggest that some changes be made, prior to the referral of the application to the HREC. Once the overall program of research has been approved by the HREC, individual projects within the program (see below) can be submitted to, and approved by, the HEAG even if they exceed the low-risk threshold.
4. Application for ethics approval of a project to be undertaken as part of an already approved program of research
The HEAG will consider applications in this category at its next meeting. If the application is consistent with the ethics approval previously received for the overall research program, it can be approved and signed by the chair of HEAG forthwith. Once this HEAG approval has been received you can commence research on the project immediately - regardless of whether or not it exceeds the low-risk threshold.
If the application requires some amendments, a HEAG member will be delegated to give feedback on the changes required. Once these changes have been made, the amended application form should be re-lodged. Research can commence as soon as the HEAG has signed off on the application.
Please note that applicants are not obliged to accept HEAG decisions. If you do not agree with the Advisory Group's recommendations in relation to your application, you can ask for it, and the HEAG comments, to be forwarded to the HREC for a decision at its next meeting.
Commencement of research
Low-risk research projects cannot commence until all changes suggested by the HEAG have been made and 'signed off' by the chair. Unless part of a previously approved program of research (see 3 and 4 above), research projects not satisfying the Expedited Review Checklist criteria cannot commence until considered and approved by the HREC, with any changes requested by that Committee made and signed off by the executive officer of that Committee. Research projects which commence without approval from a relevant ethics committee or advisory group are likely to be terminated.
External ethics applications
If a research project is to be conducted in an external institution, then ethics clearance may also need to be obtained within that institution. Once ethics approval has been obtained a copy of the ethics application made to, and the approval correspondence received from, the relevant institution must be forwarded for HEAG endorsement. Once endorsed, the project can commence (provided, of course, that it already has University ethics approval), and a copy of the relevant paperwork will be forwarded to the HREC for noting.
2013 School application deadlines and meeting schedules
|1/12||30 January||13 February|
|2/12||27 February||13 March|
|6/12||24 July||7 August|
|7/12||28 August||11 September|
|8/12||25 September||9 October|
|9/12||23 October||6 November|
|10/12||20 November||4 December|
University application deadlines and meeting dates
Please note: applications that are for approval of a one-off project involving humans that is not low-risk or for ethics approval for a program of research involving more than one individual project (i.e. under 2. or 3. above) will need to go on to the Humanities and Applied Sciences Human Ethics Sub Committee.
The deadlines for these applications are as follows:
Please Note: these deadlines are quite tight from the time you may receive feedback from the School HEAG. Please ensure your application is submitted on time so it reaches the HESC by the deadline.
Office administration procedures
One signed original single-sided copy of the ethics application should be submitted to the Research Support Officer, Level 4, West tower, John Medley (Building 191), after submitting the application online. Please only upload word documents to Themis, not pdf.
All researchers, whether staff or student, must ensure their data is stored appropriately. Researchers are permitted to make a copy of their data to keep at another location, provided the originals remain in the School and that the data stored off site is kept in accordance with storage guidelines. At the completion of the project, a complete set of data is to be stored in the School for a minimum of 5 years (see the University guidelines).
School HEAG membership
- Dr Pradeep Taneja (Chair)
- Dr Damon Alexander
- Dr Emma Kowal
- Dr Siobhan O'Sullivan
- Dr Scott Flower
- Dr Samantha Balaton-Chrimes
- Dr Buck Rosenberg
- Dr Giordano Nanni