1. The purpose of our procedure
This procedure outlines the management systems and compliance mechanisms in place to ensure Adelaide University research or teaching activities involving biological materials are conducted in accordance with the Gene Technology Act 2000 (Cth) (Gene Technology Act), Gene Technology Regulations 2001 (Cth) (Gene Technology.
Regulations), Biosecurity Act 2015 (Cth) (Biosecurity Act), Australian/New Zealand
Standard 2243.3:2022 (‘AS/NZS 2243.3 Standard’), Gene Technology Act 2001 (SA)
(SA Gene Technology Act), the Gene Technology Regulations 2017 (SA) (SA Gene Technology Regulations), as well as associated legislation, guidelines and standards.
This procedure gives effect to our Research Integrity Policy.
Please read this procedure in conjunction with:
- Wellbeing and Safety Policy
- Risk Management and Legal Compliance Policy.
2. Who our procedure applies to
This procedure applies to all members of the Adelaide University community involved in research or teaching activities that involve biological materials.
This procedure authorises the Director Research Compliance, Ethics and Integrity to maintain associated protocols, including [Release of non-GMOs derived from GMOs Protocol], [Assessment of Excluded Technologies Protocol], and [Importing Research Materials Protocol].
3. Our biosafety and compliance procedure
This procedure outlines the processes for ensuring compliance with biosafety requirements for research and teaching activities involving gene technology, genetically modified organisms, imported biological goods, or Risk Group 2 or higher microorganisms and other infectious material.
3.1 Gene technology and genetically modiied organisms
The Gene Technology Act 2000 (Cth) defines a genetically modified organism as:
- an organism that has been modified by gene technology
- an organism that has inherited particular traits from an organism (the initial organism), where those traits occurred because of gene technology.
- any organism declared by the Gene Technology Regulations 2001 (Cth) or Gene Technology Regulations 2017 (SA) (collectively, 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.
A genetically modified organism does not include:
- a human being, if they are only covered by the first point above (modified gene therapy) because they have undergone somatic cell gene therapy
- 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.
The Adelaide University Institutional Biosafety Committee (IBC) administers gene technology regulatory compliance and serves as the primary liaison with the Australian Government Office of the Gene Technology Regulator (OGTR).
Adelaide University personnel proposing to use any technique for the modification or synthesis of genes or other genetic material in an organism must consult the IBC before commencing work.
3.2 Microbiological safety
AS/NZS 2243.3:2022 outlines key principles of microbiological biosafety. It establishes a core set of requirements and practices for the safe handling and containment of microorganisms, including bacteria, viruses, parasites, fungi and prions that are hazardous to humans, animals, plants, aquatic organisms or carried by invertebrates.
These requirements apply across research, teaching, clinical and industry settings, and extend to areas where specimens that may contain pathogenic microorganisms and prions are handled (such as biochemistry or soil laboratories).
Adelaide University expects that all research and teaching activities undertaken with pathogenic microorganisms adhere to the requirements of the Standard.
3.2.2 Microbiological risk groups
AS/NZS 2243.3:2022 (and equivalent international standards and regulations) uses a risk group classification system to categorise microorganisms according to the level of risk that they pose, and the containment measure required.
Four risk groups are defined:
- Risk Group 1 – the lowest level of risk, requiring physical containment level 1
- Risk Group 2 – moderate level of risk, requiring physical containment level 2
- Risk Group 3 - high level of risk, requiring physical containment level 3
- Risk Group 4 – very high level of risk, requiring physical containment level 4.
Risk group ratings apply to bacteria, viruses, parasites, fungi, and prions. The Standard defines different risk group criteria based on their hazard to humans, animals, plants, aquatic organisms, and for microorganisms carried by invertebrate vectors.
3.2.3 Microbiological risk assessments and IBC approvals
All work involving microorganisms, human or animal samples, or biological materials of unknown microbiological content must undergo a risk assessment.
A risk assessment must be completed before commencing any work involving:
- Risk Group 2 or higher microorganisms
- infectious or potentially infectious samples.
The IBC acts as a Biosafety Committee as defined within AS/NZS 2243.3:2022. It is responsible for:
- Providing advice, guidance and training materials for personnel in relation to microbiological biosafety.
- Overall monitoring and surveillance of the continuing implementation of standards and guidelines.
- Review of risk assessments before work commences and considering the implications of microbiological components of research proposals.
- Inspections of microbiological containment facilities and any licencing of laboratories for microbiological work.
3.2.4 Microbiological risk applications
Research and teaching involving non-genetically modified microorganisms that meet any of the following criteria must be submitted to the IBC for review:
- storage of, or work with, Risk Group 2 microorganisms including bacteria, viruses, parasites, fungi, or prions that may cause disease in, or are pathogenic, allergenic or toxic to humans, animals, plants or aquatic organisms
- isolation or culture of microorganisms from human or animal bodily fluids or tissues
- handling of plants or animals knowingly infected with a microorganism capable of causing disease – for example, infected as part of the research, or obtained to investigate a known disease agent
- storage of, or work with, primary cells or cell lines that are known or reasonably suspected to contain Risk Group 2 microorganisms (excluding Mycoplasma contaminants)
- isolation, culture or enrichment of unknown microorganisms from environmental samples using methods intended to isolate Risk Group 2 (or higher) microorganisms.
For the following high-risk categories, researchers must consult the Research Compliance Officer before starting work or preparing an application:
- storage of, or work with, Security Sensitive Biological Agents or samples believed to contain these
- storage of, or work with, viable or non-viable Risk Group 3 or 4 microorganisms or samples believed to contain these.
Microbiological project research risk assessment must be submitted via the [Adelaide Compliance and Ethics System (ACES)] to be approved by the IBC. For associated tasks within the project, risk assessments must be submitted via the Unisafe BioSafety/Chemical/Radiation (BCR) risk assessment module.
3.3 Biosecurity
Adelaide University personnel must comply with the Biosecurity Act 2015 (Cth) and the requirements of other relevant regulatory bodies when dealing with goods subject to biosecurity control, both before and after importation of materials.
Adelaide University personnel wanting to import material from overseas should first determine whether they require an Import Permit from the Commonwealth Department of Agriculture, Fisheries and Forestry (DAFF). In addition, some goods subject to biosecurity control must be stored or dealt with under an Approved Arrangement.
3.3.1 Biosecurity Import Permits
The DAFF Biosecurity Import Conditions (BICON) system outlines the specific biosecurity conditions under which various commodities may be imported into Australia. If an Import Permit is required, or if any other specific conditions apply, BICON will specify these.
Personnel must confirm whether a permit is required before importing any goods. For advice, or to apply for an Import Permit, contact the Manager, Research Compliance.
3.4 Institutional Biosafety Committee
The IBC reviews applications for gene technology and microbiological activities in accordance with the Gene Technology Act 2000 (Cth), Gene Technology Regulations 2001 (Cth), Gene Technology Regulations 2017 (SA), the guidelines issued by the Office of the Gene Technology Regulator (OGTR), and the AS/NZS 2243.3:2022 Standard.
3.4.1 IBC Membership
Under the OGTR conditions of accreditation, the IBC must maintain a minimum membership that collectively demonstrates the technical and scientific expertise required to review and assess all the matters likely to be presented to it by the organisation. At least one member of the IBC must be independent.
As per AS/NZS 2243.3:2022, the IBC must also include an expert member able to provide advice and guidance on microbiological safety.
Further information on the IBC’s responsibilities, functions and membership is available in the Terms of Reference.
3.4.2 Cessation and termination of membership
The IBC Chair may recommend the early conclusion of a member’s term to the Deputy Vice Chancellor – Research and Innovation (DVCRI). The DVCRI is responsible for making the final decision.
Where practicable, any concerns will be addressed in a supportive and proportionate manner before a recommendation is made. The objective is to maintain a constructive and effective environment, recognising that personal or professional circumstances may change over time.
Membership lapses if a member fails to:
- attend three consecutive meetings without reasonable justification or in exceptional circumstances
- attend at least two thirds of all scheduled IBC meetings in each year, barring exceptional circumstances
- complete any required training or professional development for their role as an IBC member, as directed by the IBC Chairperson or Adelaide University.
The DVCRI may terminate the appointment of any IBC member if:
- it is necessary for the proper and effective functioning of the IBC
- the person is not a fit and proper person to serve on an IBC
- the person has failed to carry out their duties as an IBC member.
Members who intend to resign or take a planned leave of absence for an extended period from the IBC must provide at least four weeks’ written notice to the Chairperson and IBC Coordinator, to allow time to fill the vacancy.
The DVCRI will issue written notification of any membership termination. The Director, Research Compliance, Ethics and Integrity (or delegate) will issue written notification of membership lapses.
3.4.3 Conflict of interest
IBC members must declare all actual, potential, or perceived conflicts of interest upon identification that a conflict exists and excuse themselves from participation in Committee decision-making.
The IBC must deal with conflicts of interest in accordance with the requirements of the OGTR’s guidelines for Accreditation of Organisations, including: that an IBC member who has a conflict of interest must declare the conflict of interest prior to the commencement of any meeting to consider that matter. If the IBC member does not have notice of the matter prior to the meeting, the member must declare the conflict of interest immediately upon becoming aware of it. Minutes of IBC meetings contain records of all declared conflicts of interest and of any measures taken to address the conflicts of interest.
3.5 IBC applications
Applications for gene technology teaching or research, or microbiological research must be submitted to, and approval or endorsement must be received from, the IBC prior to a project commencing.
3.5.1 Gene technology applications
Applications must be submitted to the IBC for any research or teaching activity involving the following categories of dealings, as defined in the Gene Technology Act 2000 (Cth):
- exempt dealings
- notifiable low risk dealings
- dealings not involving intentional release (DNIR) licences
- dealings involving intentional release (DIR) licences.
Applications must be submitted via the Adelaide Compliance and Ethics System (ACES).
3.6 Recognition of prior approvals from foundation universities
Adelaide University IBC recognises the activities undertaken, advice provided, and approvals or authorisations granted by the IBCs of the University of Adelaide and University of South Australia (foundation universities) before 1 January 2026 (Prior Approvals).
Recognition of Prior Approvals does not prevent the Adelaide University IBC from exercising its responsibilities under these Terms or Reference, the Gene Technology Acts and associated regulations, or AS/NZS 2243.3:2022.
3.7 Complaints and appeals
Complaints relating to activities that would typically require IBC approval must be referred to the IBC Chair, who will determine the level of investigation in accordance with relevant legislation and guidelines.
Depending on the nature and severity of the complaint, the IBC Chair may investigate the matter in consultation with the appropriate parties or forward the complaint to the Deputy Vice Chancellor - Research & Innovation for further investigation.
Where the review or investigation finds that the breach of the relevant ethical guidelines may also represent a breach of the Australian Code for the Responsible Conduct of Research (2018), the matter will be handled in accordance with the [Adelaide University Investigation and Management of Research Conduct Procedure]
Complaints about Adelaide University’s IBC or its decisions must be directed to the [Research Compliance Officer], who will refer them to the Chair or the Director, Research Compliance, Ethics and Integrity, as appropriate.
4. Definitions used in our procedure
Please refer to our Adelaide University glossary for a full list of our definitions. Other definitions used in this procedure may be defined in relevant legislation and regulations.
Adelaide University community means a broad range of stakeholders who engage with Adelaide University and includes (but is not limited to) all students, staff, and nonstaff members of Adelaide University including alumni, honorary titleholders, adjuncts, visiting academics, guest lecturers, volunteers, suppliers and partners who are engaging with and contributing to the work of Adelaide University.
Foundation universities means the University of South Australia and The University of Adelaide.
5. How our procedure is governed
This procedure is categorised, approved and owned in line with the governance structure of Adelaide University and the offices and officers listed below.
| Parent policy | Research Integrity Policy |
|---|---|
| Policy category | Academic |
| Policy owner | Deputy Vice Chancellor - Research and Innovation |
| Procedure owner | Pro Vice Chancellor, Research Services and Infrastructure |
| Approving authority | co-Vice Chancellors/Vice Chancellor and President |
| Responsible officer | Director, Research Compliance, Ethics and Integrity |
| Effective from | 19 December 2025 |
| Review date | 5 years after the date this version is approved |
| Enquiries | Interim Central Policy Unit |
| Replaced documents | None |
6. Legislation and other documents related to our procedure
Refer to the Delegation Policy for all delegations at Adelaide University.
| Category | Documents |
|---|---|
| Related policy documents |
[Records Management Procedure] |
| Referenced legislation |
Higher Education Standards Framework (Threshold Standards) 2021 Gene Technology Act 2000 (Cth) Commonwealth Gene Technology Regulations 2001 (Cth) Australian/New Zealand Standard 2243.3:2022(‘AS/NZS 2243.3 Standard’) Gene Technology Regulations 2017 (SA) Australian Code for the Responsible Conduct of Research 2018 |
7. History of changes
| Date approved | To section/clauses | Description of change |
|---|---|---|
| DD Month Year | N/A | New procedure |
At the time of writing, Adelaide University’s organisational structure, position titles, and committee names have not been confirmed. Square brackets [ ] indicate placeholders for these details. Brackets are also used to identify policy elements that are subject to further decision-making or confirmation. These will be updated once final decisions are made.