In order to protect the health and safety of Australia and the Australian environment, The Gene Technology Act 2001, regulates the use of genetically modified organisms in Australia by identifying risks posed by or as a result of gene technology, and to manage those risks by regulating certain dealings with genetically modified organisms (GMOs).
Amongst other things, this national Act "prohibits persons from dealing with GMOs (e.g. research, manufacture, production, commercial release and import) unless the dealing is authorised in accordance with the Act". This covers any experiment involving the construction and/or propagation of viruses, prokaryotic or eukaryotic cells or organisms of novel genotype as a result of genetic manipulation which are either unlikely to occur in nature or likely to pose biosafety risks to the environment or human health and safety.
Any researcher planning work in this area MUST submit an application describing the project, regardless of whether he/she personally considers the work safe and/or exempt, to the Royal North Shore Hospital Institutional Biosafety Committee (RNSH IBC). The RNSH IBC is answerable to the Office of the Gene Technology Regulator, Canberra, and is empowered to recommend exemption from the guidelines.
Work must not commence without IBC approval. There are significant sanctions imposed on non-compliance including the thre at of fines and/or imprisonment for the individual researcher.
Standard Forms for IBC submissions:
Please note the use of these forms is mandatory for all submissions to the Committee.
IBC Application Form Notifiable Low Risk Dealing (NLRD) for Dealings with GMOs
IBC Application for Exemption Status for Dealing with GMOs
IBC Amendment to an Approved Research Project
IBC Notification of Change in Personnel
IBC Annual Report Template for Dealings with GMOs - Please note that your application MUST specify the agent which will be used for decontamination, including concentration and duration of exposure.
NRLD Information Sheet for Dealings with GMOs
Gene Technology Act 2000
GMO Storage Policy
Guideline for Certification of PC2 Facility & Physical Containment Requirements
Lab Procedures Manual for Handling GMOs
Flowchart for the classification of contained dealings with viral vectors
Office of the Gene Technology Regulator
Australian Code for the Responsible Conduct of Research 2018
National Framework of Ethical Principles in Gene Technology 2012
Office of the Gene Technology Regulator (OGTR) Guidelines for the Transport, Storage and Disposal of GMOs
OGTR Guidelines for Physical Containment level 2 facilities:
Constant Temperature Room
Lab Procedures Manual for handling of GMOs
Useful fact sheets relating to the use of GMOs published by OGTR
Please contact the Research Office, if you require further information regarding a submission to the IBC.