Western Sydney LHD Institutional Biosafety Committee

Research using gene technology and genetically modified organisms (GMOs)

Research involving humans

You must get approval from a Human Research Ethics Committee (HREC) before starting research involving people.

The National Statement on Ethical Conduct in Human Research (2025) sets out the requirements. These guidelines are made under the National Health and Medical Research Council Act 1992.

Research involving animals

Research involving animals must be approved by an Animal Ethics Committee (AEC) in each state or territory.

Approvals are made under the:

• Australian Code of Practice for the Care and Use of Animals for Scientific Purposes
• Guidelines on the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes.

Research involving gene technology

If research involves genetic modification, you also need approval under the Gene Technology Act 2000.

The Act aims to protect people’s health and safety and the environment by:

• identifying risks from gene technology
• managing those risks through regulation of dealings with GMOs.

Approval process overview

Any dealings with genetically modified organisms (GMOs) needs approval under the Gene Technology Act 2000, these dealings include: 

• research
• manufacture
• production
• transport
• destruction
• commercial release
• importation.

Types of dealings requiring approval

The types of dealings are:

• exempt dealings
• notifiable low risk dealings (NLRD)
• dealings on the GMO Register
• emergency dealing determinations (EDD)
• licensed dealings.

Dealings that require a licence

Some dealings must be licensed by the Gene Technology Regulator. These include:

• dealings not involving intentional release (DNIR)
• dealings involving intentional release (DIR)
• inadvertent dealings.

The type of dealing determines whether the IBC grants approval to work with GMOs.