The National Framework 2012 provides a national reference point to promote the ethical conduct of dealings with gene technology consistent with the national regulatory system.

Organisations accredited under the Act, researchers and IBCs are encouraged to take account of the principles presented here although they are not a requirement under the legislation (See Section 6).

Australian scientists and researchers are encouraged to abide by these principles when dealing with gene technology and genetically modified organisms (GMOs) at all times. Researchers should provide evidence that they have considered these principles when seeking approval for their research projects.

The National Framework 2012 provides guidance to IBCs. These review committees should include the ethical aspects of any dealings with gene technology in their review work.

The National Framework 2012 also provides guidance to HRECs. Research on humans requires ethical approval from HRECs before the research can be undertaken (National Statement on Ethical Conduct in Research Involving Humans, NHMRC 2007). Where this work involves genetic modification, approval under the GT Act is also required.

Similarly, the National Framework 2012 will guide research involving animals. This research requires AEC approval in each jurisdiction under the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes and the Guidelines on the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes (NHMRC 2004 and 2006, respectively). Where the work involves genetic modification, additional approval under the Act is required
(as well as any other required approvals).

The National Framework 2012 will fill the current gap where gene modification research does not involve humans and animals – not only will approval be required and risk assessment carried out by the OGTR, but also the ethical aspects of the work should be considered by the institution’s IBC and researchers.