Research Integrity and Compliance

Ethical Conduct of Research Policy

Policy code: RS1921
Policy owner: Director, Research Innovation and Enterprise
Approval authority: Deputy Vice-Chancellor (Research and Innovation)
Approval date: 25 November 2015
Next review date: 19 July 2027

Purpose

The purpose of this document is to outline the Federation University policy on Human and Animal Research Ethics, and Institutional Biosafety.

This policy will inform members of the University community of their obligations to conduct ethical research in accordance with the National Statement on Ethical Conduct in Human Research (2007), the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition, 2013), and the Gene Technology Regulations (2001).

Scope

This policy applies to:

  • All staff, including sessional staff, employed by the University or any controlled entity;
  • All members of University ethics committees, including the Human Research Ethics Committee, the Animal Ethics Committee and the Institutional Biosafety Committee;
  • All persons, including adjunct staff and honorary staff engaged in research under the auspices of the University or any controlled entity;
  • All students of the University who engage in research and/or research related activities while enrolled at the University.

Definitions

TERM DEFINITION
Animal Ethics Committee (AEC) A University Committee established in accordance with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 8th edition, to oversee and approve animal use in research.
Approval Withheld A review outcome for a project application which requires that ethical issues be satisfactorily addressed and the application resubmitted to the relevant Committee before the project can commence.
Approved A review outcome for a project approved to commence.
Approved with comment A review outcome for a project that has been approved to commence, but with comment from the relevant Committee.
Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition (2013) Provides guidelines for the ethical use of animals in research and teaching, and outlines the requirements for the function of an institutional Animal Ethics Committee.
Compliance Acting in accordance with the relevant Code, National Statement and/or Regulation.
Co-Researcher/s One or more participants (or a particular sub-group of participants) who make/s a significant contribution to the planning, design implementation or outputs of a research projects, including collection, analysis or interpretation of data.
Gene Technology

Any technique for the modification of genes or other genetic material, but does not include:

  • sexual reproduction; or

  • homologous recombination; or

  • any other technique specified in the Gene Technology Regulations.

Genetically Modified Organism (GMO)
  • An organism that has been modified by gene technology; or
  • An organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
  • Anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

  • A human being, if the human being is covered only because the human being has undergone somatic cell gene therapy; or
  • An organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms

Please Note: If any GMOs will be involved in the project, the researcher(s) must ALSO submit an application to the IBC.

Human Participants Research participants who are personally interacting with the investigator, subject to observation, completing online surveys etc and/or those whose personal and/or confidential records are being accessed.
Human Research Ethics Committee (HREC) A University Committee established in accordance with the National Health and Medical Research Council requirements to oversee and approve research involving humans.
Incident/Adverse/Unexpected event Any outcome that may have a negative impact on a participant, the welfare of animals, or the researcher, and was not foreseen in the approved project.
Institutional Biosafety Committee (IBC) A University Committee established in accordance with the Gene Technology Regulations 2001 to assess, review, monitor and approve certain kinds of research involving genetically modified organisms.
Low Risk A category of risk determined according to the National Statement definitions of risk, that would permit an application to be reviewed by the Low Risk Human Ethics Committee (as outlined in the HREC Procedure).
Low Risk Human Research Ethics Committee A sub-committee of the University Human Research Ethics Committee. This Committee assesses and approves low risk human research applications in accordance with the National Statement.
Monitoring The process of verifying that the conduct of research conforms to the approved proposal.
National Statement National Statement on Ethical Conduct in Human Research (2007) and updates.
NHMRC National Health and Medical Research Council.
Not Approved A review outcome for a project where the research must not progress.
Participant Anyone who has given informed consent to participate in a research project.
Project Any activity or group of activities that form a discrete piece of work that aims to achieve a scientific purpose.
Provisional Approval A category review outcome for a project approved subject to particular issues being satisfactorily addressed as directed by the relevant Committee.
Risk The function of the magnitude of harm and the probability that it will occur.
Terms of Reference Terms of Reference show how the scope of the Committees will be defined, developed, and verified.
The Code The Australian Code for the Responsible Conduct of Research.
Variation Any proposed amendment or modifications researchers might wish to make to an approved project. All variations require approval from the Committee.

Policy Statement

In accordance with the Australian Code for the Responsible Conduct of Research, the University is obligated to provide a research governance framework through which research is assessed for ethical acceptability. This research governance framework is designed to ensure that research undertaken by the University is ethically designed, reviewed and conducted. The University's research governance framework demands that its researchers comply with laws, regulations, guidelines and codes of practice governing the conduct of research.

The responsibilities of researchers under the various regulations and codes of practice include compliance with ethical principles, and:

  • respect for, and protection of, human participants in research; and/or
  • ethical and humane use and care of animals used in research.

Federation University adheres to and promotes the principles of ethical research as outlined in the National Statement on Ethical Conduct in Human Research (2007), the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition, 2013) and the Gene Technology Regulations (2001).

Under these policy statements no research involving human participants, use of animals or genetically modified organisms can be undertaken without approval by the appropriate University Committee:

  • Animal Ethics Committee (AEC)
  • Human Research Ethic Committee (HREC)
  • Institutional Biosafety Committee (IBC) 

Training

As part of its obligations, the University will provide induction, formal training and appropriate continuing education covering ethics to all staff and research students.

All Federation University staff or students who submit an application to the Human Research Ethics Committee or the Animal Ethics Committee are required to complete Research Integrity training.  This training is provided online and the details can be found by following this link.

Mentoring of Students

In accordance with their role as the Principal Researcher on relevant ethics applications, supervisors of Higher Degree by Research candidates and Honours students are responsible for mentoring their students and providing guidance throughout the relevant ethics application process. This includes the assessment of the approval type required, the development of an application, monitoring of work undertaken following approval, and submission of required reports.

Principal Researchers are also responsible for the long term storage of relevant research data and materials, including for student projects they oversee. Researchers should refer to the Research Data Management Policy and Procedure.

Human Research Ethics

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:

  • has merit;
  • is conducted with integrity;
  • is just;
  • has beneficence; and
  • is conducted with respect.

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 National Statement and other regulations and codes of practice relating to human research, written approval from the Human Research Ethics Committee must be obtained prior to the commencement of research involving human data.

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; and
  • AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research 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, and research which draws on their traditional knowledge, follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.

Requirements for Human Research Ethics Approval

A project requires Human Research Ethics approval prior to commencement if it involves the collection or use of human data, i.e. human participation.  As per the National Statement Human participation may include:

  • taking part in surveys, interviews or focus groups;
  • undergoing psychological, physiological or medical testing or treatment;
  • being observed by researchers;
  • researchers having access to their personal documents or other materials;
  • the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
  • access to their information (in individually identifiable, re-identifiable or nonidentifiable form) as part of an existing published or unpublished source or database.

Projects Approved by Another Australian Human Research Ethics Committee (HREC)

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 Human Research Ethics Committee (HREC)

The HREC is appointed by the Deputy Vice-Chancellor (Research & Innovation) 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, but is not limited to, all projects which include 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 (in accordance with the Research Data Management Procedure). 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).

HREC Membership

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

External HREC members, that is, members who are not paid employees of Federation University, will receive an allowance in accordance with the Research Compliance Committees External Members Allowance Procedure.

HREC Applications

Standard Review

An application considered above low risk, using the definition of risk outlined in the National Statement (i.e one which for which there is potential for harm), is considered by the full HREC Committee as a standard review, as outlined in the Human Research Ethics Procedure.

Low Risk Review

Where a project is assessed by the applicant to be low or negligible risk using the definition of risk outlined in the National Statement (i.e. one for which potential risks involve no more than discomfort or inconvenience), the application may be reviewed by the Low Risk Human Ethics Committee in accordance with the process 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 students researching under the supervision of a Principal Researcher. The student projects are incorporated under the umbrella of a single application and are approved as amendments to the application where the students nominate which of the approved methodologies they will use.

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.

HREC Monitoring and Auditing

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.

HREC Complaints and Appeals

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.   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).

Animal Research Ethics

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 emphasises the responsibilities of researchers and the University to:

  • ensure that animal use is justified;
  • ensure that the welfare of animals is always considered;
  • promote the use of techniques that replace animal use;
  • minimise the number of animals used;
  • refine methods to avoid pain and distress in animals.

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 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.

Requirements for Animal Ethics Committee (AEC) Approval

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.

Projects Approved by Another Australian 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 Animal Ethics Committee

The Animal Ethics Committee is appointed by the Deputy Vice-Chancellor (Research & Innovation). The Committee’s primary responsibility is to ensure that all staff and students involved in the care and use of animals are compliant with current legislative requirements. 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:

  • ensure that the use of animals is justified;
  • provide for the welfare of those animals;
  • incorporate the principles of Replacement, Reduction and Refinement (Three R's);
  • review and approve new and ongoing activities;
  • monitor the housing, care and use of animals;
  • take action regarding unexpected adverse events;
  • take action regarding non-compliance;
  • approve guidelines for the care and use of animals;
  • provide advice and recommendations to the institution;
  • report to the institution.

AEC Membership

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

External AEC members, that is, members who are not paid employees of Federation University, will receive an allowance in accordance with the Research Compliance Committees External Members Allowance Procedure.

AEC Applications

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.

AEC Monitoring and Auditing

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.

AEC Complaints and Appeals

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).

Institutional Biosafety

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.

Institutional Biosafety Committee (IBC)

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:
    • May result in the liberation or creation of novel types of nucleic acid with the capacity to multiply or spread to involve humans, animals, or plants; or
    • Involves hazardous micro-organisms or potentially tumorigenic viruses; or
    • Involves the use of known or suspected teratogens and carcinogens.
  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.

IBC Membership

Membership of the IBC is established as per the Gene Technology Regulations 2001.

External IBC members, that is, members who are not paid employees of Federation University, will receive an allowance in accordance with the Research Compliance Committees External Members Allowance Procedure.

IBC Monitoring

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.

IBC Complaints and Appeals

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 Institutional Biosafety Procedure (Policy Code: RS1927).

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).

Responsibility

  • Deputy Vice-Chancellor (Research & Innovation) (as the Approval Authority) is responsible for monitoring the implementation, outcomes and scheduled review of this policy and its accompanying procedure(s).
  • Director, Research Innovation and Enterprise (as the Policy Sponsor) is responsible for maintaining the content of this policy as delegated by the DVC (R&I).
  • Research Services is responsible for the administration support for the maintenance of this policy as directed by the DVC (R&I).

Promulgation

The Ethical Conduct of Research Policy will be communicated throughout the University community in the form of:

1.      an Announcement Notice via FedNews website and on the ‘Recently Approved Documents’ page on the ‘Policies, Procedures and Forms @ the University’ website to alert the University-wide community of the approved Policy.

Implementation

The Ethical Conduct of Research Policy will be implemented throughout the University via:

1.     an Announcement Notice via FedNews website and on the ‘Recently Approved Documents’ page on the ‘Policies, Procedures and Forms @ the University’ website to alert the University-wide community of the approved Policy.

Records Management

TITLE LOCATION RESPONSIBLE OFFICER MINIMUM RETENTION PERIOD

HREC Application Form

Research Services Director, Research Services 7 years
HREC Approval Notification Form Research Services Director, Research Services 7 years
HREC Amendment Request Form, including change of personnel and project extension requests Research Services Director, Research Services 7 years
AEC Application Form Research Services Director, Research Services 7 years
AEC Approval Notification Form Research Services Director, Research Services 7 years
AEC Amendment Request Form, including change of personnel and project extension requests Research Services Director, Research Services 7 years
Annual Project Report Form Research Services Director, Research Services 7 years
Final Project Report Form Research Services Director, Research Services 7 years
Project Incident Report Form Research Services Director, Research Services 7 years
Complaints/Misconduct Report Form Research Services Director, Research Services 7 years
Exempt Dealing Application Research Services Director, Research Services 7 years
Proposal for Notifiable Low Risk Dealings (NLRDs)
Research Services Director, Research Services 7 years