Application and Approval Process

Preparation

Prior to applying for Institutional Biosafety Committee (IBC) approval you will need to develop a well considered research proposal/protocol. You may need to:

• Seek review of the academic merit of your project
• Complete all required risk assessments and safe work procedures
• Consult with co-researchers/supervisors
• Obtain necessary institutional approvals, including sign off from your Supervisor if necessary
• Procure any necessary external documentation such as details of the organisms and vectors
• Determine a timeline for the commencement of your research after approval. Refer to the meeting schedule

Applications to work with Genetically Modified Organisms (GMOs)

Work involving genetic manipulation or the use of genetically modified organisms (GMOs) is regulated by the Gene Technology Act 2000 and the Gene Technology Regulations 2001 and amendments through the national Office of the Gene Technology Regulator (OGTR). The legislative mandate of theOGTRis to “prevent harm to human health and safety and the environment by regulating use of GMOs in Australia’.

A GMO is defined as:

• 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 entities declared by the regulations to be genetically modified organisms

Dealings with, in relation to a GMO, means the following:

• Conduct experiments with the GMO
• Make, develop, produce or manufacture the GMO
• Breed the GMO
• Propagate the GMO
• Use the GMO in the course of manufacture of an entity that is not the GMO
• Grow, raise or culture the GMO
• Import, transport or dispose of a GMO

The Charles Sturt University IBC is accredited by the OGTR to provide on-site monitoring of all teaching and research proposals of work involving the use of GMOs, and to act on behalf of the OGTR and the University to ensure that the Act, Regulations and guidelines are followed. All work with GMOs must:

• Have written approval from the IBC before commencement
• If the GMO is a vertebrate animal or cephalopod, then an Animal Care and Ethics application is also required
• Comply with the Gene technology Act 2000, Gene technology Regulations 2001 and OGTR guidelines and any subsequent amendments to the act and regulations.

Application forms for Exempt and Notifiable Low Risk Dealings working are available in the 'Forms & Resources' section. For further clarification of dealing classes please consult the OGTR website or follow this link to a summary.

Application to work with unscreened Human Biological Specimens

Applications for an exemption to the Human Biological specimen's policy may be made to the IBC at any time via the Governance Officer biosafety@csu.edu.au

The definition of a screened donor is that they show negative serology/virology for syphilis, Hepatitis B and C, and HIV.

The application form can be found in the 'Forms & Resources' page.

Confirmation of approvals from other compliance committees (for example, the Human Research Ethics Committee) must accompany the application. Names and contact details of all involved on the project together with confirmation that required vaccination/serological testing for those workers has been cited and recorded.

Applicants must provide sufficient information to enable the committee to make an informed decision.

If the applicant is applying for an ongoing exemption (for example, for some undergraduate practical classes), they shall nominate the time period (Session times) for such exemptions (for a maximum of three years).

Risk Groups

The Australian Standard AS/NZS 2243.3:2010 classifies infectious microorganisms into risk groups by microorganism type (e.g. viruses, bacteria, parasites, fungi) and further divides the lists into human/animal, plant and invertebrate infectious microorganisms. Safe work practices and physical containment levels for each group are also detailed within the standard. For a list of risk group 2, 3 and 4 organisms click here.  Note that risk grouping is not an exact science and risk groups can vary for some organisms between countries. When the grouping is ambiguous the definition of the risk group helps to determine. If in doubt then assume a higher risk grouping rather than a lower one.

Note: Some organisms which are risk group 2 can be particularly hazardous to certain individuals and so a thorough understanding of the routes/ risk of infection, diseases caused is essential before any work is conducted with any microorganism. For example Rubella, Toxoplasma gondii and cytomegalovirus are all RG2 but are known to be teratogenic, so pregnant women or women that may be pregnant should not work with or be exposed to these organisms. Careful consideration of whether individuals that are immunosuppressed or on chemotherapy and or radiotherapy should be undertaken as these individuals may be at increased risk of infection.

When planning to purchase or acquire Micro-organisms of Risk Group 2 and above you need to submit the application form to the Institutional Biosafety Committee for approval, the form can be found in the 'Forms & Resources' section.

Submission

Applications and supporting documentation should be e-mail to biosafety@csu.edu.au ensuring all necessary signatures have been included.