Human research ethics
Research Ethics refers to ethical conduct in research, as well as the protection of research participants. Ethics approval is required for all research involving people, personal data, and human tissue. We are committed to the highest standards of ethical research, through promotion of the values outlined in the National Statement on Ethical Conduct in Human Research.
When is Human Research Ethics approval required?
All Federation University staff and students (including undergraduate and postgraduate students) who intend to conduct research involving human participants and/or their data or tissue must apply for approval from the Federation University Human Research Ethics Committee (HREC) prior to commencing their research.
'Human research' has a broad definition that includes:
- humans taking part in surveys, interviews or focus groups
- humans undergoing psychological, physiological or medical testing or treatment
- humans being observed by researchers
- researchers having access to participants’ personal documents or other materials
- the collection and use of participants’ body organs, tissues or fluids (such as skin, blood, urine, saliva, hair, bones, tumours and other biopsy specimens, or exhaled breath)
- accessing participants’ information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database
- accessing health information, personal information, and sensitive information for research purposes.
Ethical clearance must be sought and notification of approval received prior to commencing any research project involving human participants. Please see the resources below for detailed information.
How to apply for Human Research Ethics approval
Step 3: Submit the application
When your application is complete; has all the required signatures and supporting documents are attached, successful submission of your application requires attention to the following details:
- Establish the submission date and closing time deadline by reviewing the list of HREC meeting dates and note the due date and time for agenda items.
- Submit one Electronic copy of the complete and authorised application with all supporting documents to research.ethics@federation.edu.au
- Note: Researchers are to ensure they receive an email from the ethics office acknowledging receipt of their application. They will be provided with a unique identifier code, and advised of the meeting date their application will be assessed.
- Caution: Responsibility lies with the principal researcher to ensure the application has been received and scheduled for assessment. Contact the Ethics office 24hrs prior to the Agenda items due date if you have not received an email confirming receipt of your application.
- Late submission will result in the application being held over until the following meeting.
- The committee reserve the right to not assess an application submitted on a superseded form, and / or with superseded attachments. Superseded templates may no longer meet current legislative requirements.
Research must not commence until the lead researcher nominated in your application form has received written notification of ethics approval from the Coordinator, Research Ethics.
Step 2: Complete the application form
- Always download required forms from the Ethics website (refer to below section - Forms/New applications), rather than use a copy previously saved to your computer to ensure you are using the most up to date form.
- Refer to the National Statement (PDF 600kb) and the Australian Code for the Responsible Conduct of Research (PDF 829kb) for guidance when preparing your application, as well as University policy and procedure documents.
- Read the preamble in each section of the selected application form, and diligently follow the directions as given.
- Application forms must be completed on your computer. Handwritten applications will not be accepted.
- Special consideration must be given to the following sections - read and understand the requirements as listed in the preamble in each section:
- lay description;
- research methodology;
- risk and risk management versus benefits of proposed research;
- recruitment strategies;
- consent.
- Answer all sections with sufficient information, in lay terms, so the committee are able to make an informed decision regarding your project.
- Prepare all required supporting documentation. These may include but are not limited to:
- Recruitment advertisements
- Plain Language Information Statement (PLIS)
- Consent form(s)
- Questionnaire(s)
- Interview guide(s), and
- Letters of support
- Review spelling and grammar on material prepared for the general public, and ensure it is written appropriately for the intended audience. It must represent the University in a professional manner.
- Obtain all required signatures before submitting your application:
- Chief Investigator, and other researchers,
- Approval for submission must then be obtained by the relevant Director/Research Advisor/Ethics Advisor/Line Manager.
- Incomplete applications and/or superseded forms will be returned to the researcher.
- Ensure all recruitment documents include the FedUni logo
- Use FedUni email details at all times - no personal email contact details should be distributed
- Use FedUni phone details whenever possible - only use personal mobile when necessary
- Remember to prepare documents with the intended audience in mind
- Ensure spelling and grammar are correct for all participant documents
- Include interview schedule information in the Plain Language Information Statement (PLIS) for participants to keep
- Use FedUni templates whenever possible - consent form & PLIS
- Refer back to relevant sections of your application to ensure you have prepared all necessary supplementary documents
- Where supporting documentation is submitted in draft form, the final version must be submitted to the HREC for assessment as soon as it is available. Full approval will not be given until the final version is submitted.
- Final approval cannot be given by the HREC for any project with outstanding documentation.
Many research projects involve or will impact on participants within other agencies or organisations. In such instances, researchers must supply the HREC with documented approval from the authorised officer or committee of the relevant agency or organisation for the specified project: e.g., Department of Education, School Principal, companies, Elders (Aboriginal communities); or representative bodies for collectives.
When applying for HREC approval, you must supply all approval letters obtained from the external agencies or organisations. If you are in the process of, but have not yet obtained this approval, you must include with your application the following information:
- Names of external agencies or organisations you are applying to for
- Copies of all relevant correspondence with these external agencies to date.
Some institutions/authorities may decline to provide permission letters until ethics approval has been granted. In such cases, you should submit your HREC application, to obtain 'Provisional Approval - pending receipt of the documentation from the external body'. HREC approval will be granted on receipt of all outstanding documents.
Step 1: Assess the project's ethical risk
For any human research project you consider may be low risk, you will need to assess the ethical risk this project presents to its participants by reviewing Section 2 of the National Statement
Once you have reviewed this Section and you believe that your project is low risk, you are able to submit your application to the Low Risk committee for review.
Researchers should note that timing constraints are not an acceptable reason for seeking low risk review where projects are of more than low risk.
Forms
Application Form and templates
APPLICATION FOR HUMAN RESEARCH ETHICS APPROVAL
To apply for approval from the HREC, please download and complete: Application for Human Research Ethics Approval (docx, 150kb)
PLAIN LANGUAGE INFORMATION STATEMENT AND INFORMED CONSENT FORM
It is the responsibility of the Chief Investigator to ensure the Ethics Office is contacted immediately regarding any proposed change.
If you need to make any changes to your project after approval, you will first need to submit an Amendment Request. Amendments may include:
- Request to extend the approval end date. Apply at least one month prior to the anticipated completion date for an extension to ensure ongoing approval is obtained, as retrospective approval will not be granted.
- Changes to project personnel.
- Changes to project detail including, but not limited to:
- recruitment methods
- data collection
- participants cohorts(s) or numbers
- location of interviews
- dissemination of results
To submit a request for amendments:
- Download and complete the Amendment request (docx. 99kb) form
- Make the requested amendments to all relevant documents (e.g. PLIS, questionnaires etc)
- Send the completed Amendment request form along with any and all amended documentation to the Ethics Office at research.ethics@federation.edu.au
Notes:
- Amendment requests may be submitted at any time and will be reviewed outside of the meetings schedule.
- All amendments MUST be approved by the relevant Committee prior to being actioned.
- When requesting approval for amendments, researchers should read through the original approved application to ensure that the proposed amendments will not affect responses given in the original application.
- If possible, the amended documentation to support your request should be submitted as a single pdf in the following order:
- Recruitment material
- Plain Language Information Statement
- Consent form
- Data collection tools
- Other supporting documentation
- Changes to research personnel may require updates to recruitment or other participant materials to reflect changes in the research team.
- Documents which remain unchanged by the Amendment Request do not need to be resubmitted.
Annual and final reports
It is a condition of approval that progress reports are submitted annually on the anniversary of the approval date. It is the responsibility of researchers to take note of the report dates on the approval notification, and submit as due. Failure to submit reports is a breach of compliance and project approval, which may result in ethics approval lapsing.
Amendment requests will not be considered if annual reporting requirements are not met.
A final report must be submitted within one month of completion of the project. If the project does not proceed or is discontinued, for any reason, please advise the Committee by completing the final report form.
- Download and complete the Annual/Final Project Report Form (docx. 104kb)
- Send completed report to research.ethics@federation.edu.au
Notes:
- The HREC may conduct random audits and /or require additional reports concerning the research project as part of the requirements for monitoring, as set out in the National Statement on Ethical Conduct in Human Research.
Incident and adverse events
It is the responsibility of the Chief Investigator to ensure the Ethics Office is contacted immediately regarding any incident, serious or unexpected adverse event. This may include adverse effects of the research on participants or problems relating to the conduct of the project. Failure to do so may result in discontinuation of approval and/or disciplinary action.
- Download and complete the Incident Report Form (docx. 92kb)
- Send the completed report to research.ethics@federation.edu.au
Notes:
- You may be required to submit an amendment request alongside or shortly after your incident report.
- In most cases, recruitment and data collection should be paused while an incident report is under review.
- If you have any queries about whether or not you are required to submit an incident report, please contact the Ethics Team to discuss at research.ethics@federation.edu.au
Federation University adopts the recommendation of the National Statement, Chapter 5.3, to eliminate unnecessary duplication of ethical review. As such, projects approved by another NHMRC registered Human Research Ethics Committee or delegated negligible/low risk review body are recognised by Federation University Australia HREC. This may include:
- Collaborative projects hosted by another institution with Federation University researcher(s); and
- Projects transferred from another institution by a new staff member.
However, for insurance purposes, any projects involving Federation University staff and research students must be registered as an Externally Approved Project.
- Download and complete the Externally Approved Project Form
- Collate supporting documentation, including at a minimum:
- Evidence of HREC approval including reference number and approval date; and
- Approved application in full, along with all recruitment and participant materials, and data collection tools.
- Send the completed application form along with all supporting documentation to the Ethics Office at research.ethics@federation.edu.au.
Note:
- Externally Approved Project Requests may be submitted at any time and will be reviewed outside of the meetings schedule above.
- If possible, the approved application and all supporting documentation should be submitted as a single pdf file in the following order:
- HREC approval
- Approved application form
- Recruitment material
- Plain Language Information Statement
- Consent Form
- Data collection tools
- Other supporting documentation
Policies & Guidelines
Australian Code for the Responsible Conduct of Research 2018 - For all research projects, refer to the this Code for guidance in:
- General principles of responsible research
- Management of research data and primary materials
- Supervision of research trainees
- Publication and dissemination of research findings
- Authorship
- Peer review
- Conflicts of interest
- Collaborative research across institutions
Guidelines Approved under Section 95A of the Privacy Act 1988
Statutory Guidelines on Research Issued for the Purposes of Health Privacy Principles
Australian Research Data Commons (ARDC)
Including Trans People in Research - A practical guide to collecting data on gender and sex
Internet Research: Ethical Guidelines 3.0
Mental health support
- In Australia: https://www.healthdirect.gov.au/mental-health-helplines
- International: https://www.wearespur.com/org/mentalhealthhub
Committee meeting dates
HREC meeting dates
Low Risk Meetings 2024
Low risk meetings are held twice monthly. Only low and negligible risk applications can be considered at these meetings. Above low risk applications must be considered at a full meeting.
Late applications will be held over until the following meeting.
Application Deadline (12pm, Midday) | Meeting Date |
---|---|
Wednesday 8 May | Wednesday 22 May |
Wednesday 29 May | Wednesday 12 June |
Wednesday 12 June | Wednesday 26 June |
Wednesday 26 June | Wednesday 10 July |
Wednesday 10 July | Wednesday 24 July |
Wednesday 31 July | Wednesday 14 August |
Wednesday 14 August | Wednesday 28 August |
Wednesday 28 August | Wednesday 11 September |
Wednesday 11 September | Wednesday 25 September |
Wednesday 25 September | Wednesday 9 October |
Wednesday 9 October | Wednesday 23 October |
Wednesday 30 October | Wednesday 13 November |
Wednesday 13 November | Wednesday 27 November |
Wednesday 27 November | Wednesday 11 December |
Full Meetings 2024
Full Committee meetings are held each month. Only above low risk applications are considered at these meetings. Low risk applications are considered at low risk meetings.
Late applications will be held over until the following meeting.
Application Deadline (12.00pm, Midday) | Meeting Date |
---|---|
Wednesday 29 May | Wednesday 12 June |
Wednesday 26 June | Wednesday 10 July |
Wednesday 31 July | Wednesday 14 August |
Wednesday 28 August | Wednesday 11 September |
Wednesday 25 September | Wednesday 9 October |
Wednesday 30 October | Wednesday 13 November |
Wednesday 27 November | Wednesday 11 December |
Become a Committee member
Join the Committee
The Federation University Human Research Ethics Committee (HREC) is currently seeking expressions of interest for the following membership categories:
(b) lay people who have no affiliation with Federation University and do not currently engage in medical, scientific, legal or academic work;
(c) person or people with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, an allied health professional;
(d) person or people who perform a pastoral care role in the community; and
(e) lawyers, not otherwise engaged to advise the institution.
The Federation University Low Risk Human Research Ethics Committee is currently seeking expressions of interest from:
(f) current researchers.
Benefits include continued professional development. Induction training is provided to all new members, and the Committee is supported by professional staff who are available to answer both researcher and Committee member queries.
If you would like further information, please do not hesitate to contact us at research.ethics@federation.edu.au or phone (03) 5327 9765 / 5327 9353.
Expressions of interest can be submitted to the Manager, Research Ethics at research.ethics@federation.edu.au.
Expressions of interest should include a current resume and brief statement outlining interest in joining the Committee and any relevant experience.
Contact Us
Please visit our Research Services Contact us webpage for further information on how to get in touch.
All correspondence or queries should be directed to the Coordinator Research Ethics, please visit our Research Services Team webpage for contact details.
For academic or discipline specific assistance with human ethics applications, please contact your Centre Director or equivalent.