Research involving biohazardous materials and genetically modified organisms (GMOs) must comply with relevant legislation and guidelines. This legislation includes and and corresponding state and territory legislation.
What does this mean for me?
The ºìõ¹åÉçÇø Biosafety Committee (SBC) oversees compliance to The Gene Technology Act (2000) and the Gene Technology Regulations (2001) as well as assesses, approves, inspects and monitors research facilities to ensure that potential biological hazardous materials cause no harm to human, animal and environmental health.
If you are working with biohazards such as GMOs, blood products or venoms, you will need to apply to the SBC to ensure that any risks posed by your research are appropriately managed and contained.
What biosafety matters require approval or notification?
The ºìõ¹åÉçÇø Biosafety Committee (SBC) requires approval or notification for:
- Genetically modified organisms (GMO) and certification of physical containment facilities in which GMO dealings will be conducted
- Security Sensitive Biological Agents (SSBAs)
- Organisms in Risk Group 2‌ in the or procedures that may result in the isolation or enrichment of such organisms — ºìõ¹åÉçÇø is not equipped to work with Risk Group 3 and 4 organisms
- All human tissue and/or blood products
- High risk cell lines
- Material of biological origin that may be or contain a hazard to humans such as toxins, allergens or prions
- Quarantine materials in any of these categories
Note: SBC responsibility does not extend to general laboratory risks and procedures involving the use of chemicals that are otherwise covered by ºìõ¹åÉçÇø Health, Safety and Wellbeing Procedures.
How do I submit an application for approval?
- Go to the Ìý·É±ð²ú²õ¾±³Ù±ð.
- Click ‘Log in’ in the top right-hand corner of the menu bar and enter your ºìõ¹åÉçÇø email address and password.Â
- Select ‘Create project’ from the left-hand sidebar, add in the Project Title and select ‘Biosafety Clearance’ from the drop-down menu, then click ‘Create’.
- Complete the application — you can invite your ºìõ¹åÉçÇø collaborators to review and work on the form too.
- Create and attach relevant additional documents as requested in the form.
- Obtain the sign-offs requested in the form.
- Submit the form.
- Respond to any queries posed by the committee.
- Approval will be granted once all outstanding queries are satisfied. You will receive formal notification of this approval.
- To modify your existing biosafety application, refer to the ERM applicant guide.
Note: Work cannot commence until written approval has been received. Please contact resethics@swinburne.edu.au for more information.
Further information about biosafety matters
The ºìõ¹åÉçÇø Biosafety Committee has approved a number of generic risk assessments and standard operating procedures that are available for use across ºìõ¹åÉçÇø:
- Standard operating procedure and risk assessment — working with human blood, plasma, tissue and other body fluids
- General risk assessment for working with Risk Level 2 Bacteria in all ºìõ¹åÉçÇø PC2 laboratories (according to Australian and New Zealand Standard AS 2243.3)
- Use and propagation of Risk Level 2 human and animal cells in all ºìõ¹åÉçÇø PC2 laboratories (according to Australian and New Zealand Standard AS 2243.3)
Please contact the Research Ethics Office if you would like copies or more information about these documents.
GMOs refers to organisms that have been altered using gene technology. In 2001, a national regulatory scheme was introduced to monitor all work involving GMOs. This regulatory system is administered by the (OGTR).
Organisations dealing with GMOs must be accredited and must have an Institutional Biosafety Committee, or access to an IBC, that reviews research applications and monitors certified facilities.
The IBC for ºìõ¹åÉçÇø is the ºìõ¹åÉçÇø Biosafety Committee (SBC). The SBC provides a quality assurance or risk management mechanism with respect to ºìõ¹åÉçÇø activity (research and teaching) or facilities involving GMOs and biohazardous materials.
Exempt dealings are a category of dealings with genetically modified organisms (GMOs) that have been assessed over time as posing a very low risk, such as contained research involving very well understood organisms and processes for creating and studying GMOs.
More information about exempt dealings can be found on the website.
Notifiable Low Risk Dealings (NLRDs) are dealings with genetically modified organisms that have been assessed as posing a low risk to the health and safety of people and the environment provided certain risk management conditions are met.
NLRDs must be:
- conducted by persons with appropriate training and experience within a facility certified for Physical Containment level 2 (PC2)
- assessed by the ºìõ¹åÉçÇø Biosafety Committee and lodged by the SBC with the OGTR
- transported in accordance with the Regulator's
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Contact us for more information
If you would like to know more about our biosafety compliance, please contact the Research Ethics, Integrity and Biosafety team via resethics@swinburne.edu.au.