Do I need approval?

All projects involving a "dealing" with a Genetically Modified Organism (GMO) require written approval before work can start.

In addition to project approval, the facility (room) where the dealing is to be conducted may need to be certified by the Office of the Gene Technology Regulator (OGTR).

Project approvals from other organisations are not recognised by the Austin Health IBC. The IBC of Austin Health can review and approve projects for investigators from organisations located at the Austin Health precinct (Olivia Newton-John Cancer Research Institute, Institute for Breathing and Sleep, The University of Melbourne’s Departments of Medicine and Surgery, Florey Neuroscience Institutes -  Heidelberg Campus).

Austin Health approval is required before GMOs are transported from another organisation.

Work with a genetically modified vertebrate animal requires: 

(1) approval for GMO work; and
(2) animal ethics approval (this component will require separate approval)

How do I get approval?

You will need to complete the appropriate application form and submit it to the Austin Health IBC for review and approval. For Dealings Not involving Intentional Release (DNIR) and Dealings involving Intentional Release (DIR) applications, the Austin Health IBC must first review your application before it is forwarded to the OGTR for final approval.

Who approves my application?

While the Gene Technology Act 2000 enables Institutional Biosafety Committees (IBCs) to assess and approve certain kinds of GMO dealings, other types will require a licence from the OGTR before work can start. The Austin Health Institutional Biosafety Committee conducts the initial review of all GMO project applications at regular out-of-session meetings throughout the year.

Does the work need to be conducted in an OGTR certified facility?

In summary, dealings with GMOs that are classified as Notifiable Low Risk Dealings (NLRD), Dealings Not involving Intentional Release (DNIR) or Dealings involving Intentional Release (DIR) must be conducted in facilities that are OGTR certified. The certified facility type and the level of containment must be suited to the type of GMO and the activities being conducted (refer to OGTR Guide to Physical Containment Levels and Facility Types).

See Certification of Facilities (OGTR) for more details