Details regarding biosafety-related activities, approval requirements, and all related matters, are contained within the biosafety manual. The information provided on these biosafety webpages is a summary only, and the manual must be consulted for complete details.
If you are planning to conduct research or teaching activities involving:
You must seek and receive biosafety approval before commencing.
Gene technology activities are referred to as 'dealings'. There are several classes of dealings, which are fully described on the Office of the Gene Technology Regulator (OGTR) website, and in the biosafety manual. The major classes are:
You must understand these classes of dealings, and decide which dealing is appropriate for the activity that you are undertaking.
The Gene Technology Regulations 2001 were substantially amended in October 2020, with changes to the regulation of gene editing technologies and RNA technologies in particular. To assist researchers to assess their dealings against these changes, a self-assessment form is available on this website under Resources > Application forms - internal. A summary of the changes is also provided in the training section of this website.
Microorganisms
In Australia and New Zealand, microorganisms are classified into Risk Groups 1 to 4, based on the pathogenicity of the agent, the mode of transmission, and the availability of preventative measures and treatment.
Research or teaching activities involving the use of Risk Group 2 microorganisms or higher must be approved by the Institutional Biosafety Committee (IBC) before commencement.
Please note that facilities within Flinders University are not currently equipped for work with Risk Group 3 and 4 microorganisms.
The University's Institutional Biosafety Committee (IBC) approves applications to conduct research and teaching activities with gene technology and Risk Group 2 or higher microorganisms.
For work involving gene technology, the IBC operates under the Commonwealth Gene Technology Act 2000 and the associated Gene Technology Regulations 2001, overseen by the Office of the Gene Technology Regulator (OGTR), as well as corresponding State-based legislation. A full listing of relevant legislation and regulations can be found at legislation and guidelines.
The Institutional Biosafety Committee (IBC) also has responsibility for overseeing the following biosafety-related activities:
The University must notify the Australian Government Department of Health regarding all research involving the use of Security Sensitive Biological Agents (SSBAs).
Therefore, all use of SSBAs must be notified to the IBC, via the IBC Executive Officer.
Information relating to SSBAs can be found on the Department of Health's SSBA website.
There are four types of physical containment (PC) facilities: PC1, PC2, PC3 and PC4.
At Flinders, certified PC facilities include: laboratory, animal and plant. PC2 microbiology and biosecurity facilities are also available.
All work performed in a certified facility of a specific PC level must follow the procedures set out for that level of containment. PC facilities used for gene technology work must be certified by the Office of the Gene Technology Regulator (OGTR).
Internal inspections of PC facilities are regularly conducted to ensure compliance.
To request a PC facility certification, or to discuss renewal, variation or suspension of an existing certification, please contact the IBC Executive Officer, Dr Jess Hall.
Please note that the IBC is unable to provide financial assistance for PC facility maintenance or for equipment and reagent purchases. Facility supervisors are expected to maintain PC facilities in a compliant status as a requirement of retaining facility certification. The IBC’s role is to oversee compliance of the facilities by performing inspections, assisting with training, and providing advice about PC facility and biosafety requirements to facility operators.
The IBC is subject to the following legislation, regulations and amendments governing the practices and procedures involving GMOs:
The following legislation and regulations are also relevant to work with biohazardous materials, including GMOs:
In Australia, safety and containment aspects of work with microorganisms are governed by Australian and New Zealand Standard 2243.3 ‘Safety in Laboratories - Part 3: Microbiological Safety and Containment'. The Standard may be accessed via the SAI Global website, Standards Online (access is available on campus).
If you are working with clinical or environmental samples, remember that any specimen has the potential to be infectious, and precautions should be taken when handling these samples.
In the Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010), the National Health and Medical Research Council (NHMRC) adopts the term ‘standard precautions’ as the basic risk minimisation strategy for handling human “blood (including dried blood); all other body substances, secretions and excretions (excluding sweat), regardless of whether they contain visible blood; non-intact skin; and mucous membranes”. These precautions should also be followed when working with potentially infectious environmental samples, such as untreated water, sewerage samples, animal faecal matter, soil, etc.
‘Standard precautions’ are the work practices required for basic infection control and include:
A risk assessment must always be performed before beginning any work with these types of samples.
If you are unsure if you require Institutional Biosafety Committee (IBC) approval, or if you are unsure what type of application you need to submit, please refer to the decision flowchart above.
The following four forms can be downloaded from the Office of the Gene Technology Regulator (OGTR) website:
These external forms are to be submitted to the Institutional Biosafety Committee (IBC), who will forward to the OGTR as required.
A Microsoft Word version of these documents is available upon request should you wish to modify the SOP to suit your lab/project specific requirements.
Please contact the IBC Executive Officer to obtain a copy.
These documents provide guidance and examples on preparing Standard Operating Procedures for work with lentiviral vectors. The documents are a guide only, and should be modified for your own project.
The Office of the Gene Technology Regulator (OGTR) have prepared a guidance document on classification of contained dealings with viral vectors. This document may be helpful when trying to determine which classification your viral vector dealings fall under within the Gene Technology Regulations 2001.
On 8 October 2020, technical revisions to the Gene Technology Regulations 2001 came into force. These included changes to the regulation of:
The Institutional Biosafety Committee (IBC) prepared a short video outlining the changes, available at ResearchLink.
Further information about the technical review of the Regulations is available on the Office of the Gene Technology Regulator’s website.
Please do not hesitate to contact the IBC if you have any questions about the session or the changes to the Regulations.
All personnel working in a certified facility must undergo training specific to that class of certification. The PC facility induction checklists in the Resources section should be used to undertake facility induction.
Staff and students who use the PC2 Microbiological Laboratory in Teaching Lab 5, Biological Sciences, are invited to watch a short video of the induction session for this facility. This video provides training for students undertaking practical sessions in the facility.
Flinders University Biosafety Training is now available as a self-paced online course via Flinders Learn Online (FLO).
The training provides an overview of what biosafety is, how it is regulated in Australia, and how we manage risks associated with research projects involving regulated samples and organisms. The training also provides information about physical containment (PC) and the conditions for working in PC laboratories, greenhouses and animal facilities at Flinders University.
All students and staff working on a project involving gene technology, genetically modified organisms, pathogenic microorganisms, and those who will access or work within physical containment facilities on Flinders’ campus and within Flinders Medical Centre are required to complete this training at commencement of their research and once every three years thereafter.
Access to the training is available via FLO. Please log in to FLO via Okta, and then click this link to access the Biosafety Training: https://flo.flinders.edu.au/enrol/index.php?id=68991
Any questions about the training or any other biosafety matter should be directed to the Institutional Biosafety Committee – ibcadmin@flinders.edu.au.
The Victorian Infectious Diseases Reference Laboratory (VIDRL) has produced a valuable introductory training video demonstrating the basic principles of biosafety cabinets and their safe use.
The Office of the Gene Technology Regulator (OGTR) is an Australian Government department that oversees the Commonwealth Gene Technology Act, 2000 and the associated Gene Technology Regulations, 2001. The OGTR website provides a range of important and useful information in this area.
Download a copy of the OGTR’s Guidance flowchart for the classification of contained dealings with viral vectors.
For an indicative listing of microbiological organisms in each of the risk groups, refer to AS/NZS 2243.3 ‘Safety in Laboratories: Part 3: Microbiological Safety and Containment’. The standard may be accessed via the SAI Global website, standards online (access is available on campus)”
Where researchers wish to send or receive materials to or from external organisations for use in their research, a Material Transfer Agreement (MTA), will often be required. MTAs are appropriate where the owner of the material wishes to formalise the permitted uses of the material, the ownership or sharing of ownership of the material, (and any research outputs arising from the use of the material), and also where it is desirable to clearly establish with which party the risk and liability in relation to the use of the material will lie.
At Flinders, MTAs are overseen by Research Development and Support - please refer to the contracts section for more information.
The names and contact information for staff involved in the operation of IBC are detailed below. For general advice regarding the submission of applications to the IBC, please contact the IBC Executive Officer.
IBC Chair
Professor Melissa Brown
College of Science and Engineering
IBC Executive Officer
Hendryk Flaegel
Manager, Research Ethics and Compliance, Research Development and Support
Sturt Rd, Bedford Park
South Australia 5042
CRICOS Provider: 00114A
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