Document ID: chunk:federal_register_of_legislation:C2024C00449:section:8:p1
Version: federal_register_of_legislation:C2024C00449
Segment Type: section
Provision Reference: s 8 (pt 1/2)
Character Range: 14226–17064

8  Definitions
  In this Part:
accredited ART centre means a person or body accredited to carry out assisted reproductive technology by:
 (a) the Reproductive Technology Accreditation Committee of the Fertility Society of Australia; or
 (b) 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:
 (a) do an act; or
 (b) 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) a pre‑clinical research and training licence; or
 (b) a clinical trial research and training licence; or
 (c) a clinical trial licence; or
 (d) a clinical practice research and training licence; or
 (e) a clinical practice licence.
mitochondrial donation technique means a technique, prescribed by the regulations for the purposes of this definition, that:
 (a) 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
 (b) involves using assisted reproductive technology to create a zygote that:
 (i) has nuclear DNA from the woman and a man; and
 (ii) contains mitochondria from a human egg of a different woman; and
 (c) does not involve:
 (i) intentionally modifying nuclear DNA or mitochondrial DNA; or
 (ii) using any cell, or any component part of a cell, of an animal; or
 (iii) 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.
Note: The National Statement could in 2021 be viewed