Definitions
8 Definitions
In this Part:
accredited ART centre means a person or body accredited to carry out assisted reproductive technology by:
the Reproductive Technology Accreditation Committee of the Fertility Society of Australia; or
if the regulations prescribe another body or other bodies in addition to, or instead of, the body mentioned in paragraph (a)—that other body or any of those other bodies, as the case requires.
AHEC means the Australian Health Ethics Committee established by the National Health and Medical Research Council Act 1992.
clinical practice licence means a licence referred to in section 28G.
clinical practice research and training licence means a licence referred to in section 28F.
clinical trial licence means a licence referred to in section 28E.
clinical trial research and training licence means a licence referred to in section 28D.
confidential commercial information means information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.
disclose, in relation to information, means give or communicate in any way.
donor, in relation to a particular use of a mitochondrial donation technique, has the meaning given by subsection 28R(2).
engage in conduct means:
do an act; or
omit to perform an act.
excess ART embryo has the meaning given by section 9.
general licence means a licence issued under section 21.
HREC means a Human Research Ethics Committee.
mitochondrial donation licence means:
a pre‑clinical research and training licence; or
a clinical trial research and training licence; or
a clinical trial licence; or
a clinical practice research and training licence; or
a clinical practice licence.
mitochondrial donation technique means a technique, prescribed by the regulations for the purposes of this definition, that:
can be used to minimise the risk of a woman’s offspring inheriting mitochondria from that woman that would predispose the offspring to mitochondrial disease; and
involves using assisted reproductive technology to create a zygote that:
has nuclear DNA from the woman and a man; and
contains mitochondria from a human egg of a different woman; and
does not involve:
intentionally modifying nuclear DNA or mitochondrial DNA; or
using any cell, or any component part of a cell, of an animal; or
creating a chimeric embryo (within the meaning of the Prohibition of Human Cloning for Reproduction Act 2002) or a hybrid embryo.
National Statement means the National Statement on Ethical Conduct in Human Research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing from time to time.
The National Statement could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
patient means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical practice licence.
For a human embryo to be created for, or placed in the body of, a woman under a clinical practice licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see paragraph 28P(4)(a).
permitted technique for a mitochondrial donation licence of a particular kind means a mitochondrial donation technique that is declared by the regulations to be a permitted technique for a mitochondrial donation licence of that kind.
pre‑clinical research and training licence means a licence referred to in section 28C.
proper consent:
for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and
for the purposes of Division 4A (mitochondrial donation licences) of Part 2—has the meaning given by subsection 28N(8).
relevant State body means a person or body notified by a State to the Chairperson of the NHMRC Licensing Committee for the purposes of this Part.
responsible person:
for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and
for the purposes of Division 4A (mitochondrial donation licences) of Part 2—has the meaning given by subsection 28N(8).
trial participant means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical trial licence.
For a human embryo to be created for, or placed in the body of, a woman under a clinical trial licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see paragraph 28P(4)(a).
This provision refers to the regulations (the regulations
, prescribed by the regulations
, declared by the regulations
). Made under this Act:
- Research Involving Human Embryos (Corresponding State Law—ACT) Declaration 2018 · Legislative Instrument · under s 7(1)
- Research Involving Human Embryos (Corresponding State Law—NSW) Declaration 2018 · Legislative Instrument · under s 7(1)
- Research Involving Human Embryos (Corresponding State Law—TAS) Declaration 2018 · Legislative Instrument · under s 7(1)
1 more instrument made under this Act are listed on the Act’s overview.
This Act’s bill:Explanatory memorandumSecond reading speech
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