The University adheres to the National Statement on Ethical Conduct in Human Research (2007) which requires that researchers comply with ethical principles to ensure that research:

The University's Human Research Ethics Committee applies a set of principles outlined in the National Statement that govern the ethical conduct of research involving human participants. To ensure compliance with the various regulations and codes of practice relating to human research, the University requires that written approval from the Human Research Ethics Committee must be obtained when required so as to protect human participants in research.

Ethical considerations in the Design, Development, Review and Conduct of Research

Chapter 3.1 of the National Statement on Ethical Conduct in Human Research outlines seven elements that provide guidance on the ethical considerations that are relevant to the way that research is designed, reviewed and conducted.

These Elements are:

Element 1 – Research Scope, Aims, Themes, Questions and Methods

Element 2 – Recruitment

Element 3 – Consent

Element 4 – Collection, Use and Management of Data and Information

Element 5 – Communication of Research Findings or Results to Participants

Element 6 – Dissemination of Research Outputs and Outcomes

Element 7 – After the Project

The University acknowledges that research with Aboriginal and Torres Strait Islander peoples spans many methodologies and disciplines, and that there are wide variations in the ways in which Aboriginal and Torres Strait Islander individuals, communities and groups are involved in, or are affected by, research. Relevant research ethics applications must demonstrate compliance with the most contemporary versions of Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders and Keeping research on track 11 as well as the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies. These guidelines embody the best standards of ethical research and human rights and seek to ensure that research with and about Aboriginal and Torres Strait Islander peoples follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.

The University will ensure that all staff and students who undertake research involving humans have access to the appropriate training required and that they are aware of their responsibilities.

A project requires Human Research Ethics approval if one or more of the following apply:

Federation University Australia Human Research Ethics Committee recognises approvals from other Australian Human Research Ethics Committees and may endorse such approval upon provision of the appropriate information.

The HREC is established in accordance with National Health and Medical Research Council (NHMRC) requirements to oversee, approve and monitor research involving humans.

The Committee considers the ethical implications of proposed research involving human participants.  This includes all research and teaching projects, including surveys, interviews, experiments, analysis of databases, and examination of documents, where the interests of human participants require consideration.

The Committee ensures ethical standards are addressed in research projects involving human subjects, in order to protect the interests of the research subjects, the investigator, the University and the general community, in accordance with the NHMRC’s National Statement.

The Committee acts to protect the confidentiality and privacy of individuals by ensuring the security, storage and disposal of confidential data collected during the conduct of research involving human subjects. The Committee acts to promote understanding within the University and the broader community of the ethical issues raised by research, teaching and related academic activities.

The Committee acts to inform and work with the Research Committee to ensure the adoption of, and compliance with, appropriate codes of practice for the conduct of research involving human subjects.

The Committee establishes, implements and reviews procedures for evaluating, certifying and monitoring the acceptable ethical conduct of research involving human subjects and conducted by:

1.     staff and/or students of Federation University Australia on a campus, using Federation University Australia premises, equipment, name or resources (human and physical);

2.     staff and/or students of Federation University Australia outside a campus using Federation University Australia equipment, name or resources (human and physical);

3.     other persons, who are not staff and/or students of Federation University Australia, using Federation University Australia premises, equipment, name or resources (human and physical)

HREC Membership

Membership of the University HREC is in accordance with the National Statement.

Standard Review

An application not considered to be in the low risk category, (which is a project presenting minimal ethical risk or less to participants - as outlined in the HREC Procedure), is considered by the full HREC Committee as a standard review, as outlined in the Human Research Ethics Procedure.

Bulk Review

An application can be considered under bulk review when the project is low risk, and involves multiple student researchers studying the same course. The student projects are incorporated under the umbrella of a standard application and are approved as amendments to the standard application where the students nominate which of the approved methodologies etc they will use. The umbrella standard application is considered by the full HREC Committee as a bulk standard review.

Expedited Review

Where a project is assessed by the applicant (using the Risk Assessment Checklist) to be in the low risk category, an application can be approved outside of the full Committee meeting schedule. Assessment of risk and completion of the appropriate form is in accordance with the process outlined in the Human Research Ethics Procedure.

Out of Session Application Review

An application with an urgent deadline may be considered by the HREC in an Out of Session review only under exceptional circumstances. This will be at the discretion of the Chair of the Human Research Ethics Committee and may involve additional costs to the applicant.

Request for Approval to use Existing Data

In some circumstances, such as but not limited to, seeking to use existing data for a purpose other than that for which it was collected, or where required by the custodial body, the use of existing data may require HREC approval. Researchers are advised to consult Research Services to determine whether an application should be submitted.

The National Statement requires the HREC to monitor research projects for which they have given ethical approval in order to ensure that they confirm to the protocol approved.

The principal reason for monitoring research projects is to ensure that their conduct does not jeopardise the rights and interests of those who have consented to participate and/or approved use of their personal information.

Monitoring involves the completion of an annual/final report form. Random audits of approved research activities may be undertaken by the University. In accordance with the National Statement, all approved projects may be subject to auditing by the HREC.

1.   Complaints concerning the HREC process of review of an application or report, including resolution of disagreements between HREC members, between the HREC and investigators, and between the HREC and the institution

Complaints will be dealt with in accordance with the University’s Applying for Human Research Ethics Procedure (Policy Code: RS1922).

2.   Complaints concerning the HREC process of review of an application or report, including resolution of disagreements between HREC members, between the HREC and investigators, and between the HREC and the institution

Complaints will be dealt with in accordance with the University’s Research Integrity and Misconduct Procedure (Policy Code: RS1502).

All those people involved in the care and use of animals for scientific purposes must be aware of the relevant Commonwealth, state and territory legislation, including the Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition 2013.

The purpose of the University's policy and procedure on ethics in research is to ensure the ethical conduct of good animal (non-human) research, in which animal care and use is ethical and humane. The University adheres to the Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition 2013 which requires that researchers respect the animals they use in research. The code emphasizes the responsibilities of researchers and the University to:

The University's Animal Ethics Committee (AEC) applies a set of principles outlined in the Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition (2013) that govern the ethical conduct of research involving the use of animals. To ensure compliance with the various regulations and codes of practice relating to animal research, the University requires that written approval from the Animal Ethics Committee must be obtained when required so as to protect animals used in research.

The University is responsible for ensuring that all persons involved in animal care and use are appropriately trained and competent, and that they maintain adequate records of animal usage.

All activities that involve the care and use of animals for scientific purposes must be subject to ethical review, approval and monitoring by the AEC.

Federation University AEC does not recognise approvals from other Australian AECs. Any projects that are transferred from another institution must apply for and receive approval from the Federation University AEC, although prior approval from another institution will be taken into consideration

The primary function of the AEC is to consider the ethical implication of proposed research and teaching projects involving animals, conducted by staff and/or students of Federation University Australia. The Committee reviews all projects with activities involving animals, including acquisition, transport, breeding, housing, husbandry, trapping, observations, fieldwork, the use of the animal, and the provisions for the animal at the completion of their use.

The role of the AEC is to:

AEC Membership

The AEC is established as per the Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition 2013.

Standard Review

An application for ethical approval for a project involving animals is considered by the AEC as a Standard Review, as outlined in the Animal Ethics Procedure.

Urgent Application Review

An application with an urgent deadline may be considered by the AEC in an extraordinary meeting under exceptional circumstances. This will be at the discretion of the Chair of the AEC.

The conduct of approved activities is monitored by the AEC. This includes the monitoring of the care and use of animals by inspecting animals and animal housing, as well as regular assessment of acquisition, transport, breeding and husbandry of animals. The AEC is required to monitor any activities that are likely to cause distress to animals. The AEC is able to delegate authority to a suitably qualified member of staff, to monitor a project where appropriate, for example during fieldwork.

The AEC is required to maintain records of all inspections and monitoring of activities and report these to Government, as outlined in the Code. Random audits of approved activities may be undertaken by the University. In line with the National Statement, all approved projects may be subject to internal and external auditing.

1.   Complaints concerning the care and use of animals by the institution, including conscientious objection in the case of teaching activities

Complaints will be dealt with in accordance with the University’s Applying for Animal Research Ethics Procedure (Policy Code: RS1923).

2.   Complaints concerning the AEC process of review of an application or report, including resolution of disagreements between AEC members, between the AEC and investigators, and between the AEC and the institution

Complaints will be dealt with in accordance with the University’s Applying for Animal Research Ethics Procedure (Policy Code: RS1923).

3.   Complaints concerning the process for independent external review

Complaints will be dealt with in accordance with the University’s Applying for Animal Research Ethics Procedure (Policy Code: RS1923).

4.   Non-Compliance with the relevant Codes (Research Misconduct)

Complaints will be dealt with in accordance with the University’s Research Integrity and Misconduct Procedure (Policy Code: RS1502).

The University adheres to the Gene Technology Act 2000 and the corresponding Gene Technology Regulations 2001. The purpose of the Act and corresponding Regulation is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs. The Act regulates all dealings (e.g. research, manufacture, production, commercial release and import) with live, viable organisms that have been modified by techniques of gene technology, including the progeny (or descendants) of such GMOs which also share a genetically modified trait. The legislation will also regulate some GM products, but only where the products are not regulated by an existing agency.

The purpose of the Institutional Biosafety Committee (IBC) is to assess, review and approve certain kinds of research related to Genetically Modified Organisms (GMOs). The Committee advises on the identification and management of the risks associated with dealings with GMOs undertaken by the organisation, including the containment of GMOs. The Committee also provides an interface with the Office of the Gene Technology Regulator (OGTR).

The IBC is responsible for conducting inspections of OGTR-certified facilities to ensure that they adhere to the Act and licensing agreements. Membership of the IBC is established as per the Gene Technology Regulations 2001.

The role of the IBC is to:

1.      Undertake assessment, review and approval of research proposals, to identify any potential biohazard which may arise in the course of research as a consequence of any type of experiment or manipulation which:

2.      Assess the actual and potential risks involved in the light of the intrinsic nature of the experiments, the competence of the personnel and the security of the laboratory facilities.

3.      Determine containment and procedures for experimental work under its purview, and for the housing, storage and transportation of genetically manipulated organisms;

4.      Inspect and certify relevant facilities as specified in the Act, before they are used for genetic manipulation work (at least annually);

5.      To advise researchers on matters related to GMOs.

An appropriately qualified member of the IBC shall, on behalf of the University, inspect all of the University's relevant research facilities, against the Regulator's requirements for containment, at least once per year.

The Regulator may undertake monitoring, including auditing of written reports or unannounced site visits, at their discretion.

1.   Complaints concerning the IBC process of review of an application or report, including resolution of disagreements between IBC members, between the IBC and researchers, and between the IBC and the institution

Complaints will be dealt with in accordance with the University’s (to be developed) Institutional Biosafety Approval Procedure (Policy Code: RS….).

2.   Non-Compliance with the relevant Codes (Research Misconduct)

Complaints will be dealt with in accordance with the University’s Research Integrity and Misconduct Procedure (Policy Code: RS1502).