| Legal status |
PERMISSIVE WITH RESTRICTIONS |
| Key organization |
National Health and Medical Research Council (NHMRC) |
| Policy |
Research use of human pluripotent stem cell lines must comply with requirements for human biospecimens under the National Statement on Ethical Conduct in Human Research [https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018]. Specifically, derivation of any pluripotent stem cell line requires ethics review and approval by a Human Research Ethics Committee (HREC). This process involves considerations around consent, collection, storage and distribution of cell lines. For the derivation of human embryonic stem cell lines, researchers must also obtain a licence from the NHMRC Embryo Research Licensing Committee (ERLC) where consideration is given to the number of assisted reproductive technology (ART) embryos, other embryos or human eggs to be used; and the likelihood of significant advances in knowledge which could not be achieved by other means. Reproductive cloning is prohibited under Australian law, but human embryos created by SCNT can be used for research including stem cell derivation provided a licence is granted by ERLC. Subsequent use of derived pluripotent stem cell lines does not require an ERLC licence but may require review and approval by HREC under certain circumstances. |
| Legislation |
National Statement on Ethical Conduct in Human Research [https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018]
There are two Commonwealth Acts providing a regulatory framework to prohibit certain unacceptable practices including human cloning, and to regulate uses of excess human embryos created through assisted reproductive technology, and the use of human embryos in research created through other means:
Research Involving Human Embryos Act 2002 (Cth)
Prohibition of Human Cloning for Reproduction Act 2002 (Cth)
Additional information about Australian regulations, such as state and territory legislation and regulation pertaining to the import or export of stem cells derived from human SCNT embryos can be found here [https://www.nhmrc.gov.au/research-policy/embryo-research-licensing/commonwealth-and-state-legislation legislation]
|
| Legislation Link |
https://www.legislation.gov.au/Details/C2016C00968 ; https://www.legislation.gov.au/Details/C2017C00306 |
| Embryonic stem cell research policy |
The NHMRC ERLC regulates the use of human embryos in research through a licensing process, including for the derivation of human embryonic stem cells. This includes the use of donated, excess ART embryos; SCNT embryo, and embryos created by other means. Ethics approval by a HREC is also required for embryonic stem cell derivation. Subsequent use of derived human embryonic stem cell lines does not require an ERLC licence but may require review and approval by HREC under certain circumstances. The import or export of human embryonic stem cell lines derived from SCNT embryos is subject to Customs regulations and is only allowed if the cell lines have been derived using practices consistent with Australian law. |
| Research with embryo |
Research with human embryos is allowed only if the project has HREC ethics approval and has been granted a licence by the NHMRC ERLC. Human embryos that may be used for research are limited to: donated, excess ART embryos; ART embryos not suitable for transplantation; SCNT embryo and embryos created by other means. Creating human embryos by sperm-egg fertilisation for research is prohibited by law, as is creating embryos by SCNT or other means without a licence. It is also explicitly prohibited to: create human embryos using genetic material from more than two people; culture human embryos for more than 14 days; add animal cells to human embryos; create hybrids; import or export prohibited human embryos; commercially trade in human embryos or gametes; or make heritable changes to the human genome of human embryos, gametes and precursor cells. |
| Embryo donation and cryopreservation |
Embryos can be cryopreserved and donation of excess ART embryos is allowed for reproductive purposes and for ERLC licensed research projects. |
| Somatic cell nuclear transfer |
SCNT is allowed in research that has HREC ethics approval and a licence from the ERLC. |
