Document ID: chunk:federal_register_of_legislation:C2024C00449:section:8:p2
Version: federal_register_of_legislation:C2024C00449
Segment Type: section
Provision Reference: s 8 (pt 2/2)
Character Range: 16828–19067

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 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.
Note: 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:
 (a) for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and
 (b) 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:
 (a) for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and
 (b) 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.
Note: 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).