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• The committee reserve the right to not assess an application submitted on a superseded form, and / or with superseded attachments. Superseded templates may no longer meet current legislative requirements.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.

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

• Download Plain Language Information Statement (docx, 105kb)
• Download Informed Consent Form (docx, 95kb)

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:

1. 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.
2. Changes to project personnel.
3. Changes to project detail including, but not limited to:
   1. recruitment methods
   2. data collection
   3. participants cohorts(s) or numbers
   4. location of interviews
   5. dissemination of results

To submit a request for amendments:

1. Download and complete the Amendment request (docx. 99kb) form
2. Make the requested amendments to all relevant documents (e.g. PLIS, questionnaires etc)
3. Send the completed Amendment request form along with any and all amended documentation to the Ethics Office at research.ethics@federation.edu.au

Notes:

1. Amendment requests may be submitted at any time and will be reviewed outside of the meetings schedule.
2. All amendments MUST be approved by the relevant Committee prior to being actioned.
3. 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.
4. If possible, the amended documentation to support your request should be submitted as a single pdf in the following order:
   1. Recruitment material
   2. Plain Language Information Statement
   3. Consent form
   4. Data collection tools
   5. Other supporting documentation
5. Changes to research personnel may require updates to recruitment or other participant materials to reflect changes in the research team.
6. 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.

1. Download and complete the Annual/Final Project Report Form (docx. 104kb)
2. 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.

1. Download and complete the Incident Report Form (docx. 92kb)
2. 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.

1. Download and complete the Externally Approved Project Form
2. Collate supporting documentation, including at a minimum:
   1. Evidence of HREC approval including reference number and approval date; and
   2. Approved application in full, along with all recruitment and participant materials, and data collection tools.
3. 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.

National Statement on Ethical Conduct in Human Research (2023)

AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

Ethical conduct of research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders

Research and Research Training Policy

Research Ethics and Institutional Biosafety Procedure

Research Integrity & Misconduct Procedure

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

Keeping research on track II

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

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.

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.

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.

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.