Human Ethics FAQs

Human Research Ethics Approval Requirements

If you are planning to conduct research with or about people, you will require ethics approval.

It is important for you to read the National Statement on Ethical Conduct in Human Research (‘National Statement’) and other relevant guidelines early in the planning stages of your research.  Adhering to the principles of ethical research conduct outlined in the National Statement not only ensures your research is conducted responsibly but also enhances the quality and credibility of your outcomes.  Proper planning and ethical conduct will ultimately improve your research and its impact.

Make sure to allow for the time and administrative effort that will be required to obtain ethics approval before commencing your research.

Human research is conducted with or about people, their data, and/or their tissue/fluids.  Data may have been collected previously for another research project or purpose (for example, it may be stored and obtained from a database or another source), but that does not necessarily mean that you don’t need ethics approval to conduct your project.

Please submit an application for ethical review, or contact the Ethics Office for further advice.

You must not commence your research until you have received ethics approval or confirmation that the project does not require ethical review.

If you are collecting data online – for example, from social media sites – you may or may not require ethics approval, depending on the specific details of your project.

Not all information online is necessarily public.  People associated with data available online may not have granted permission for its use in research or be aware that it may be.  Therefore there may be cause for researchers to request consent from participants or a waiver of consent from the relevant review committee to use this data for research purposes.  Please refer to the ‘Secondary use of data or information’ section (Chapter 3.1) of the National Statement on Ethical Conduct in Human Research.  In any case, you must comply with the terms and conditions of any website or social media platform from which you are collecting data.

You are encouraged to seek advice from the Ethics Team if you have any queries about this.

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 HREC.  These 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, 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, available from the website.
  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.

Note: Externally Approved Project Requests may be submitted at any time and will be reviewed outside of the meetings schedule.

The HREC may grant ethics approvals for courses in which a cohort of students undertake short-term research projects. This option is only available where there is one cohesive research project with consolidated aims and objectives.  The project may have multiple research outputs (each students’ paper).  The application needs to include research project aims and significance (not teaching project aims and significance), research project methodology (not teaching methodology, etc).

Course approval applications are subject to the same process (including risk assessment) as other applications. It is recommended that course coordinators design projects that are low risk for this purpose.

To apply for course approval, the course coordinator should submit an ethics application prior to the commencement of the course. The application should cover the component of the course requiring ethics approval (e.g., the research project that students will undertake).

Human Research is conducted with or about people, their data, and/or their tissue/fluids. The term ‘participants’ is used very broadly to include those who may not even know they are the subjects of research.

Some examples of activities that count as human research:

  • Surveys
  • Interviews
  • Focus Groups
  • Observations
  • Testing
  • Access to:
    • Personal information
    • Documents
    • Data sets
    • Social Media
  • Collection and use of:
    • Bodily organs
    • Cell lines
    • Tissues
    • Fluids
    • Exhaled breath

The Human Research Ethics Application and Review Process

Research involving the use of human data will be assessed for risk prior to review.

Low risk research

Research projects in which the only foreseeable risk is of minor burden/inconvenience or discomfort. These projects will be reviewed by the Low Risk Committee.

Higher risk research

All other research projects, those that involve risk of harm, i.e., more than low risk. These projects will be reviewed by the full Human Research Ethics Committee.

Note, use of the word ‘distress’ implies potential for harm (N.S. p. 13).  Therefore stating that your project may cause distress to participants will likely result in your project being assessed to be of higher risk.

Please refer to Chapter 2.1 of the National Statement on Ethical Conduct in Human Research for a detailed discussion of risk and benefit.

Participant Considerations

For permission to recruit/access Federation University staff, students or data for research purposes, including permission to send emails and/or display flyers/posters, please seek permission from the Dean/Director/Senior Manager or delegate of the relevant Academic Unit.

For recruitment within Administrative Units of the University, permission must be sought from the relevant Director/delegate.

Please contact the Facilities Management Unit and/or the Federation University Students Association (where relevant) for requirements in relation to permissions to post flyers or posters on campus.

Recruitment permission should ideally occur before applying for ethics approval.

Please be advised that the onus of acquiring and maintaining the records of these requisite approvals and permissions lies solely with researchers.

Researchers are required to obtain written permission from any organisation to access their employees or clients, data associated with these people or other organisational data for research purposes.

Similarly, where you wish to post material on an organisation’s website or social media account, or where you plan to promote your project in private/closed social media groups, you will need to investigate and (if applicable) seek approval to post this recruitment material from the relevant senior manager and/or moderator for those organisations or sites.

Ethics approval does not mean that permission to access staff, clients, students, data or other information is guaranteed. This permission is separate from the ethics approval process and is usually required from the Chief Executive Officer or another authorised person. The decision to grant researchers permission to access staff, clients, students, data or other information is entirely up to the authorised person in the organisation.

Please be advised that the onus of acquiring and maintaining the records of these requisite approvals and permissions lies solely with researchers.

Relevant Commonwealth Acts:

Researchers who intend to undertake research with minors or to enter a school, pre-school, childcare centre or other educational facilities in any capacity are required to obtain a Working with Children Check.

Researchers who undertake research with vulnerable adults or aged care services are also required to obtain an appropriate clearance before undertaking the relevant research. Individuals can only obtain a clearance via their organisation.

Please refer to the relevant chapter of Section 4 of the National Statement, ‘Ethical considerations specific to participants.’

Note, the National Statement (p. 67) states that when working with minors,

  • Researchers must respect the developing capacity of children and young people to be involved in decisions about participation in research. The child or young person’s particular level of maturity has implications for whether his or her consent is necessary and/or sufficient to authorise participation.

Please note that researchers who intend to undertake research in Victoria with minors or to enter a school, pre-school, childcare centre or other educational facilities in any capacity are required to obtain a Working with Children Check.

Further information is available at https://www.vic.gov.au/working-with-children-check.

Public Schools

Any researchers planning to conduct research and/or evaluation activities involving Department of Education sites, children, young people, staff and carers must submit a Research in Schools and Early Childhood Settings (RISEC) application to the Department of Education for review.

Note, ethics approval from Federation University, or collaborating research institution if appropriate, should be obtained first.

It is the researcher's responsibility to ensure that all necessary Department of Education approvals and permissions are in place before commencing research.

For more information, please see https://www.vic.gov.au/conduct-research-department-education

Catholic Schools

If you intend to conduct research in Catholic Schools, you will need to seek approval from the relevant archdiocese.

For more information, please see the relevant archdiocese website. For example:

Independent Schools

If you intend to conduct research in another independent school, please seek approval directly from the school or relevant authority prior to submitting your ethics application.

Ethics applications with significant or targeted participation of First Nations Peoples and communities will be reviewed by the HREC.

Where appropriate, researchers may consider inviting First Nations researchers to the study team in order to ensure that the study places the needs, priorities and wellbeing of First Nations Peoples and communities first, and presents a partnership approach.  It is expected that the researchers have involved local First Nations Peoples and/or communities in the research design and methodology.

It is very important that appropriate acknowledgements and recognitions are extended to all participants of the research project, and opportunities to co-author publications are established.

Researchers must offer appropriate remuneration for First Nations community members for their time and sharing their knowledges for the research project.

Researchers are required to become familiar with Chapter 4.7 of the National Statement, and are expected to submit an application that demonstrates how they have addressed:

  • Research merit and integrity (4.7.1 to 4.7.4)
  • Justice (4.7.5 to 4.7.6)
  • Beneficence (4.7.7 to 4.7.9); and
  • Respect (4.7.10 to 4.7.12).

Careful consideration must also be given to cultural and intellectual property. Aboriginal and Torres Strait Islander Peoples have the right to assert and retain ownership of the cultural and intellectual property related to the information that is provided to a research project and it is important that these rights are respected. Ownership may take many forms, including as rights recognised under Australian and international intellectual property laws. However, cultural and intellectual property is not limited to only those forms of knowledges.

Please see the NHMRC’s guide on Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities for further information.

Researchers need to show how each phase of the research process is ethically defensible, based on the NHMRC guidelines relating to ethical research with Aboriginal and Torres Strait Islander peoples.

Researchers must develop an understanding of:

Research claiming an Indigenous approach, methodology and/or research practice must include citations of Indigenous scholars in the Reference List accompanying their application.

For further information please refer to the following documents and websites:

If you plan to conduct research in a hospital or local health network, you may need ethics approval from a certified HREC.  Please will need to first seek ethics approval from the relevant local HREC, identified via this list.

You may then submit an Externally Approved Project Application to the Federation University HREC.  Please refer to the FAQ on Externally Approved Project Applications, above.

This process may also apply for research with employees or clients of some government departments (e.g. Department of Justice).

Please contact the the Ethics Office, if you have any queries about this process.

Consent

Data Types and Management

The NHMRC defines data as either:

  • Non-identifiable: Data which have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known that they are about the same data subject, although the person’s identity remains unknown.
  • Re-identifiable: Data from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets.
  • Identifiable: Data where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual’s name, image, date of birth or address

Research data created by Federation University staff or students during the course of their employment or study is owned by the University, subject to any relevant third-party agreements, or licences.

Intellectual property rights in research data created by Federation University students are retained by the University, while the student retains copyright in any thesis produced.

Where research is conducted with Indigenous peoples, a research agreement should assign ownership of data to the Indigenous research partners/participants.  Please refer to the AIATSIS Code, of Ethics, he NHMRC’s guide on Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities, and the international CARE Principles for Indigenous Data Governance.

For more information, please see:

As outlined in the Australian Code for the Responsible Conduct of Research (the Code), researchers (including student researchers and their Supervisor) are obligated to ensure that the integrity and security of their research data, primary materials and research records are maintained, and that this material is stored in an identifiable and retrievable way.

Please see the Federation University Research Data Management Procedure, and LibGuides on research data management.

Please refer to the Public Record Office Victoria Retention and Disposal Authority for Records of the Higher and Further Education Functions (PROS16/07 VAR 1 3-3.45) for minimum data retention periods, typically:

  • 5 years post publication for research data
  • 7 years post publication for research data with health information
  • 15 years post publication for drug/device clinical trials
  • After the last participant turns 25, or 15 years post publication, whichever is longest for drug/device clinical trials where participants are under 18 years old at the time of data collection.

However, the FAIR data Principles are intended to foster collaboration, data sharing, promote transparency and advance the integrity of research by making research data:

  • Findable: Research data should be easy to find and discover.
  • Accessible: Data should be openly available and accessible to researchers and interested parties.
  • Interoperable: The data should be structured in a way that allows seamless integration with other datasets and tools.
  • Reusable: Data should be presented in a manner that enables researchers to reuse it for various purposes.

If possible, it is therefore expected that data will be made available for use in future projects by the researchers who collected the data and other researchers.  Participants should be informed of this possibility and provided opportunity to consent or not to extended or unspecified use of their data.  Refer to FAQ above on consent .

Please also refer to the Federation University Research Data Management Procedure, LibGuides on research data management for advice on data storage, security and retention, and the Australian Research Data Commons (ARDC) advice on FAIR data principles.

Risks and Benefits

Chapter 2.1 of the National Statement on Ethical Conduct on Human Research provides the following (non-exhaustive) list of potential harms for research participants:

  • physical harms: including injury, illness, pain
  • psychological harms: including feelings of worthlessness, distress, guilt, anger or fear related, for example, to disclosure of sensitive or embarrassing information, or learning about a genetic possibility of developing an untreatable disease
  • devaluation of personal worth: including being humiliated, manipulated or in other ways treated disrespectfully or unjustly
  • social harms: including damage to social networks or relationships with others; discrimination in access to benefits, services, employment or insurance; social stigmatisation
  • findings of previously unknown paternity status
  • economic harms: including the imposition of direct or indirect costs on participants
  • legal harms: including discovery and prosecution of criminal conduct.

Discomfort is less serious than harm. Examples may include minor side-effects of medication, the discomforts related to measuring blood pressure, and anxiety induced by an interview. Where a person's reactions exceed discomfort and become distress, they should be viewed as harms.

Inconvenience is considered less serious again. Examples may include filling in a form, participating in a street survey, or giving up time to participate in research.

Please refer to the above FAQ on the different levels of risk and review to understand how potential for harm, discomfort or inconvenience may impact the review of your project.

If your research carries any risk of psychological or emotional stress for participants, your Plain Language Information Statement should include:

Prior warning of this risk (in plain language)

Information about any measures which may be taken if the participant suffers an adverse event as a result of participating in the research

Details of relevant mental health support services such as:

Important: Support services suggested or offered to participants should be appropriate to the participants and the research project/topic.  For example, providing the details of Lifeline, a crisis hotline, may not be appropriate for a project of minimal risk.  In fact, doing so may in fact create risk.

It is generally appropriate to reimburse the costs to participants of taking part in research, including costs such as travel, accommodation and parking. Sometimes participants may also be paid for time involved. However, payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable.

Decisions about payment or reimbursement in kind, whether to participants or their community, should take into account the customs and practices of the community in which the research is to be conducted.

Where you plan to offer a reimbursement or honorarium to research participants, please include full details in your ethics application so that the HREC can determine whether it is appropriate and proportionate.

Refer to Chapter 2.2 of the National Statement on Ethical Conduct in Human Research, for further information.

Other Approvals

Research conducted in another country is defined as when you are travelling to that country, and not when you are simply collecting data from an online survey. Overseas research might have legal, social or cultural implications which would not be an issue if the research was carried out in Australia.

Researchers are responsible for ensuring that research conducted offshore is culturally appropriate and complies with the legal requirements of the other country, as well as complying with Australian ethical standards.

It is the responsibility of the researcher (and the research supervisor) to thoroughly investigate any legal, governmental, visa, ethical, cultural or research approval requirements when conducting research in another country. If applicable, final ethics approval may not be granted until written evidence of having met those requirements has been provided. Please be advised that the onus of acquiring and maintaining the records of these requisite approvals and permissions lies solely with researchers.

Overseas research might involve Indigenous people. As with research involving Australian Aboriginal and Torres Strait Islander people, you should ensure that your proposed research is culturally appropriate by consulting with relevant representative bodies.

Post-Approval Requirements

Human Research Ethics Committee approval is always based on the standard conditions outlined in your approval notification.  Researchers must be familiar with, and abide by, these conditions.

Your research must not commence until the Federation University HREC has granted full and final ethics approval. However, you may also be required to gain approvals and permissions through other HRECs or committees external to Federation University, or other Federation University internal approvals relevant to your research and activities. The onus of acquiring and maintaining the records of the requisite approvals and permissions lies with researchers.

These may include, but are not limited to, the following examples:

  • Federation University Animal Ethics Committee approval if your research also involves animals.
  • Federation University Institutional Biosafety Committee approval if using GMOs.
  • Other institutions’ Ethics Committees (please see the FAQ above, Externally Approved Applications).
  • Permission to recruit Federation University staff and students and/or for the use of Federation University data.
  • Permission to interact with and/or recruit from external organisations.
  • Internal and/or external written agreements, or contracts for collaborative research projects.
  • Relevant screening checks for research work involving children, aged care or vulnerable groups.
  • Relevant external HRECs and committees (including research involving Aboriginal communities, research in education, defence or child protection requiring relevant departmental clearances, research in a hospital or local health network).
  • Any legal, governmental, visa, ethical, cultural or research approval requirements when conducting research in another country or with a foreign entity, including assessment for foreign interactions.

Reports on the progress and completion of the project must be provided annually to the Human Research Ethics Committee. Ethics approval is granted for five years (unless otherwise stated) contingent upon annual review.

  • An Annual Report is to be provided annually on the anniversary of HREC approval for the duration of the project. Ethical approval will lapse if an Annual Report is not submitted.
  • A Final Report is to be submitted within three months of the project’s completion.
  • An Extension Request is to be submitted if you require more than 5 years in which to complete the research. This form must be submitted at least 1 month prior to the final expiration of the ethics approval for the project.  Expired ethics approval cannot be renewed, and a new application must be submitted for the continuation of the project.

These forms can be downloaded from the Ethics website.

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 request a variation, the Amendment Request (available from the Ethics website) must be submitted to the Human Research Ethics Office (research.ethics@federation.edu.au) along with copies of any relevant documents (e.g., Plain Language Information Statements, research tools, recruitment materials) affected by the variation. Variations must be justified and be consistent with the original research aims and research questions.

Feedback from the Federation University HREC should occur within 5 working days of receipt of your Amendment Request.

Formal notification of approval from Federation University HREC must be received prior to implementing the change(s).

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 available from the Ethics website.
  2. Send the completed report to research.ethics@federation.edu.au

Please note:

  • 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

Any complaints relating to research projects approved by Federation University's HREC should be directed to:

Coordinator, Research Ethics
Research Services
Tel: 03 5327 9795

The Coordinator, Research Ethics will ensure the information is handled in a confidential manner and discussed with the HREC Chair/Deputy Chair as soon as possible. Depending on the nature of the issue identified, an investigation will be undertaken in consultation with the appropriate parties.

The Complaints and Appeals process is detailed in the Research Ethics and Institutional Biosafety Procedure.