These regulations set out detailed rules under the Research Involving Human Embryos Act 2002: they define and classify five mitochondrial donation techniques, declare which techniques each licence type may use, and prescribe procedural requirements such as proper consent, 25‑year recordkeeping, adverse‑event notifications and inspector identity cards. They affect researchers, ART clinics, licence applicants, the NHMRC Licensing Committee and trial participants: compliance requires following the ART Guidelines and National Statement and using NHMRC‑approved forms, with administrative discretion exercised by the NHMRC and its CEO.
The Research Involving Human Embryos Regulations 2017 (the Regulations) supplies technical, definitional and procedural detail required to operate parts of the Research Involving Human Embryos Act 2002 (the Act). The Regulations do not create stand‑alone offences; instead they prescribe what the Act refers to, and set out how certain statutory duties are to be met. Key mechanical effects in the text provided are:
Prescribes external documents and guidelines as the authoritative standards to be applied in specified contexts under the Act: the Objective Criteria for Unsuitable Embryos, the ART Guidelines (Ethical guidelines on the use of assisted reproductive technology in clinical practice and research), and the National Statement. These are prescribed for purposes including the definition of "unsuitable for implantation" (reg 6), decision‑making by the NHMRC Licensing Committee on general licence and mitochondrial donation licence applications (regs 6A and 7H), and what constitutes "proper consent" (regs 7 and 7J).
Defines the set of mitochondrial donation techniques that fall within the meaning of "mitochondrial donation technique" in the Act: maternal spindle transfer, pronuclear transfer, germinal vesicle transfer, first polar body transfer, and second polar body transfer (reg 7A). Each sub‑technique is then carefully described, with consistent language that the steps must be taken "without intentionally modifying any nuclear DNA or mitochondrial DNA" and that the operator must "seek to minimise carryover of mitochondria" from donor material (regs 7C-7G).
Declares which of those techniques are "permitted techniques" for particular types of mitochondrial donation licences. The Regulations split licences into two items: (1) a pre‑clinical research and training licence, for which all five named techniques are declared permitted; and (2) a clinical trial research and training licence or a clinical trial licence, for which only maternal spindle transfer and pronuclear transfer are declared permitted (reg 7B and the accompanying table).
Current sections
Direct links to the current provisions in Research Involving Human Embryos Regulations 2017.
26
Part 1
Preliminary
Part 1—Preliminary
1
Name
1 Name
This instrument is the Research Involving Human Embryos Regulations 2017.
3
Authority
3 Authority
This instrument is made under the Research Involving Human Embryos Act 2002.
5
Definitions
5 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) National Statement;
(b) the NHMRC.
In this instrument:
Act means the Research Involving Human Embryos Act 2002.
ART Guidelines means the Ethical guidelines on the use of assisted reproductive technology in clinical practice and 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 ART Guidelines could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
first polar body transfer has the meaning given by section 7F.
germinal vesicle transfer has the meaning given by section 7E.
maternal spindle transfer has the meaning given by section 7C.
Objective Criteria for Unsuitable Embryos means the Objective Criteria for determining embryos that are unsuitable for implantation, 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 Objective Criteria for Unsuitable Embryos could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
pronuclear transfer has the meaning given by section 7D.
second polar body transfer has the meaning given by section 7G.
Part 2
Regulation of the use of excess ART embryos and other material
Part 1—Preliminary
1 Name
This instrument is the Research Involving Human Embryos Regulations 2017.
3 Authority
This instrument is made under the Research Involving Human Embryos Act 2002.
5 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) National Statement;
(b) the NHMRC.
In this instrument:
Act means the Research Involving Human Embryos Act 2002.
ART Guidelines means the Ethical guidelines on the use of assisted reproductive technology in clinical practice and 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 ART Guidelines could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
first polar body transfer has the meaning given by section 7F.
germinal vesicle transfer has the meaning given by section 7E.
maternal spindle transfer has the meaning given by section 7C.
Objective Criteria for Unsuitable Embryos means the Objective Criteria for determining embryos that are unsuitable for implantation, 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 Objective Criteria for Unsuitable Embryos could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
pronuclear transfer has the meaning given by section 7D.
second polar body transfer has the meaning given by section 7G.
Part 2—Regulation of the use of excess ART embryos and other material
Division 1—Provisions relating to general licences
6 Definition of unsuitable for implantation—prescribed guidelines
For the purposes of paragraph (b) of the definition of unsuitable for implantation in subsection 7(1) of the Act, the Objective Criteria for Unsuitable Embryos are prescribed.
6A Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines
For the purposes of paragraph 21(4)(c) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7 Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 24(9) of the Act, the ART Guidelines are prescribed.
Division 2—Provisions relating to mitochondrial donation licences
7A Definition of mitochondrial donation technique
For the purposes of the definition of mitochondrial donation technique in section 8 of the Act, the following are mitochondrial donation techniques:
(a) maternal spindle transfer;
(b) pronuclear transfer;
(c) germinal vesicle transfer;
(d) first polar body transfer;
(e) second polar body transfer.
7B Definition of permitted technique
For the purposes of the definition of permitted technique in section 8 of the Act, a mitochondrial donation technique mentioned in an item in the following table is declared to be a permitted technique for a mitochondrial donation licence mentioned in that item.
Maternal spindle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the maternal spindle from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7D Definition of pronuclear transfer
Pronuclear transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) removing the pronuclei from zygote A;
(c) fertilising, with a human sperm, a human egg of a different woman to create another zygote (zygote B);
(d) removing the pronuclei from zygote B;
(e) implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.
7E Definition of germinal vesicle transfer
Germinal vesicle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the germinal vesicle from a maturing human egg (egg A) of a woman;
(b) removing the germinal vesicle from a maturing human egg (egg B) of a different woman;
(c) implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) maturing egg B in vitro to the stage ready for fertilisation;
(e) fertilising egg B with a human sperm to create a zygote.
7F Definition of first polar body transfer
First polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the first polar body from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) fusing the first polar body to, or implanting the first polar body into, egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7G Definition of second polar body transfer
Second polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) fertilising, with a human sperm, a human egg of a different woman to produce another zygote (zygote B);
(c) removing the second polar body from zygote A;
(d) removing the female pronucleus from zygote B;
(e) transferring the second polar body from zygote A to zygote B.
7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines
For the purposes of paragraph 28J(3)(b) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7J Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 28N(8) of the Act, the ART Guidelines are prescribed.
7K Keeping records—prescribed period
For the purposes of subsection 28R(4) of the Act, the period for which a record must be kept is 25 years after the creation of the record.
7L Notifying adverse events—form of notification
For the purposes of subsection 28S(4) of the Act, a notification for the purposes of subsection 28S(3) of the Act must:
(a) be in the form approved by the CEO of the NHMRC; and
(b) contain any information required by the form.
7M Definition of adverse event
For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:
(a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:
(i) a failed embryo development;
(ii) a miscarriage;
(iii) a premature birth of a child;
(iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and
(b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.
Division 3—Other provisions
8 Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought
For the purposes of paragraph 16(3)(a) of the Act, the bodies mentioned in the following table are prescribed.
For the purposes of paragraph 34(2)(a) of the Act:
(a) an inspector’s identity card must state the date of issue of the card and the period of validity of the card; and
(b) the card’s recent photograph of the inspector must be substantially a photograph of the inspector’s face.
Division 1
Provisions relating to general licences
Division 1—Provisions relating to general licences
6
Definition of unsuitable for implantation—prescribed guidelines
6 Definition of unsuitable for implantation—prescribed guidelines
For the purposes of paragraph (b) of the definition of unsuitable for implantation in subsection 7(1) of the Act, the Objective Criteria for Unsuitable Embryos are prescribed.
6A
Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines
6A Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines
For the purposes of paragraph 21(4)(c) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7
Definition of proper consent—prescribed guidelines
7 Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 24(9) of the Act, the ART Guidelines are prescribed.
Division 2
Provisions relating to mitochondrial donation licences
Part 1—Preliminary
1 Name
This instrument is the Research Involving Human Embryos Regulations 2017.
3 Authority
This instrument is made under the Research Involving Human Embryos Act 2002.
5 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) National Statement;
(b) the NHMRC.
In this instrument:
Act means the Research Involving Human Embryos Act 2002.
ART Guidelines means the Ethical guidelines on the use of assisted reproductive technology in clinical practice and 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 ART Guidelines could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
first polar body transfer has the meaning given by section 7F.
germinal vesicle transfer has the meaning given by section 7E.
maternal spindle transfer has the meaning given by section 7C.
Objective Criteria for Unsuitable Embryos means the Objective Criteria for determining embryos that are unsuitable for implantation, 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 Objective Criteria for Unsuitable Embryos could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
pronuclear transfer has the meaning given by section 7D.
second polar body transfer has the meaning given by section 7G.
Part 2—Regulation of the use of excess ART embryos and other material
Division 1—Provisions relating to general licences
6 Definition of unsuitable for implantation—prescribed guidelines
For the purposes of paragraph (b) of the definition of unsuitable for implantation in subsection 7(1) of the Act, the Objective Criteria for Unsuitable Embryos are prescribed.
6A Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines
For the purposes of paragraph 21(4)(c) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7 Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 24(9) of the Act, the ART Guidelines are prescribed.
Division 2—Provisions relating to mitochondrial donation licences
7A Definition of mitochondrial donation technique
For the purposes of the definition of mitochondrial donation technique in section 8 of the Act, the following are mitochondrial donation techniques:
(a) maternal spindle transfer;
(b) pronuclear transfer;
(c) germinal vesicle transfer;
(d) first polar body transfer;
(e) second polar body transfer.
7B Definition of permitted technique
For the purposes of the definition of permitted technique in section 8 of the Act, a mitochondrial donation technique mentioned in an item in the following table is declared to be a permitted technique for a mitochondrial donation licence mentioned in that item.
Maternal spindle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the maternal spindle from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7D Definition of pronuclear transfer
Pronuclear transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) removing the pronuclei from zygote A;
(c) fertilising, with a human sperm, a human egg of a different woman to create another zygote (zygote B);
(d) removing the pronuclei from zygote B;
(e) implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.
7E Definition of germinal vesicle transfer
Germinal vesicle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the germinal vesicle from a maturing human egg (egg A) of a woman;
(b) removing the germinal vesicle from a maturing human egg (egg B) of a different woman;
(c) implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) maturing egg B in vitro to the stage ready for fertilisation;
(e) fertilising egg B with a human sperm to create a zygote.
7F Definition of first polar body transfer
First polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the first polar body from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) fusing the first polar body to, or implanting the first polar body into, egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7G Definition of second polar body transfer
Second polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) fertilising, with a human sperm, a human egg of a different woman to produce another zygote (zygote B);
(c) removing the second polar body from zygote A;
(d) removing the female pronucleus from zygote B;
(e) transferring the second polar body from zygote A to zygote B.
7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines
For the purposes of paragraph 28J(3)(b) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7J Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 28N(8) of the Act, the ART Guidelines are prescribed.
7K Keeping records—prescribed period
For the purposes of subsection 28R(4) of the Act, the period for which a record must be kept is 25 years after the creation of the record.
7L Notifying adverse events—form of notification
For the purposes of subsection 28S(4) of the Act, a notification for the purposes of subsection 28S(3) of the Act must:
(a) be in the form approved by the CEO of the NHMRC; and
(b) contain any information required by the form.
7M Definition of adverse event
For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:
(a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:
(i) a failed embryo development;
(ii) a miscarriage;
(iii) a premature birth of a child;
(iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and
(b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.
Division 3—Other provisions
8 Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought
For the purposes of paragraph 16(3)(a) of the Act, the bodies mentioned in the following table are prescribed.
For the purposes of paragraph 34(2)(a) of the Act:
(a) an inspector’s identity card must state the date of issue of the card and the period of validity of the card; and
(b) the card’s recent photograph of the inspector must be substantially a photograph of the inspector’s face.
7A
Definition of mitochondrial donation technique
7A Definition of mitochondrial donation technique
For the purposes of the definition of mitochondrial donation technique in section 8 of the Act, the following are mitochondrial donation techniques:
(a) maternal spindle transfer;
(b) pronuclear transfer;
(c) germinal vesicle transfer;
(d) first polar body transfer;
(e) second polar body transfer.
7B
Definition of permitted technique
7B Definition of permitted technique
For the purposes of the definition of permitted technique in section 8 of the Act, a mitochondrial donation technique mentioned in an item in the following table is declared to be a permitted technique for a mitochondrial donation licence mentioned in that item.
Maternal spindle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the maternal spindle from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7D
Definition of pronuclear transfer
7D Definition of pronuclear transfer
Pronuclear transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) removing the pronuclei from zygote A;
(c) fertilising, with a human sperm, a human egg of a different woman to create another zygote (zygote B);
(d) removing the pronuclei from zygote B;
(e) implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.
7E
Definition of germinal vesicle transfer
7E Definition of germinal vesicle transfer
Germinal vesicle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the germinal vesicle from a maturing human egg (egg A) of a woman;
(b) removing the germinal vesicle from a maturing human egg (egg B) of a different woman;
(c) implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) maturing egg B in vitro to the stage ready for fertilisation;
(e) fertilising egg B with a human sperm to create a zygote.
7F
Definition of first polar body transfer
7F Definition of first polar body transfer
First polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the first polar body from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) fusing the first polar body to, or implanting the first polar body into, egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7G
Definition of second polar body transfer
7G Definition of second polar body transfer
Second polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) fertilising, with a human sperm, a human egg of a different woman to produce another zygote (zygote B);
(c) removing the second polar body from zygote A;
(d) removing the female pronucleus from zygote B;
(e) transferring the second polar body from zygote A to zygote B.
7H
Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines
7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines
For the purposes of paragraph 28J(3)(b) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7J
Definition of proper consent—prescribed guidelines
7J Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 28N(8) of the Act, the ART Guidelines are prescribed.
7K
Keeping records—prescribed period
7K Keeping records—prescribed period
For the purposes of subsection 28R(4) of the Act, the period for which a record must be kept is 25 years after the creation of the record.
7L
Notifying adverse events—form of notification
7L Notifying adverse events—form of notification
For the purposes of subsection 28S(4) of the Act, a notification for the purposes of subsection 28S(3) of the Act must:
(a) be in the form approved by the CEO of the NHMRC; and
(b) contain any information required by the form.
7M
Definition of adverse event
7M Definition of adverse event
For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:
(a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:
(i) a failed embryo development;
(ii) a miscarriage;
(iii) a premature birth of a child;
(iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and
(b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.
Division 3
Other provisions
Part 1—Preliminary
1 Name
This instrument is the Research Involving Human Embryos Regulations 2017.
3 Authority
This instrument is made under the Research Involving Human Embryos Act 2002.
5 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) National Statement;
(b) the NHMRC.
In this instrument:
Act means the Research Involving Human Embryos Act 2002.
ART Guidelines means the Ethical guidelines on the use of assisted reproductive technology in clinical practice and 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 ART Guidelines could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
first polar body transfer has the meaning given by section 7F.
germinal vesicle transfer has the meaning given by section 7E.
maternal spindle transfer has the meaning given by section 7C.
Objective Criteria for Unsuitable Embryos means the Objective Criteria for determining embryos that are unsuitable for implantation, 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 Objective Criteria for Unsuitable Embryos could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
pronuclear transfer has the meaning given by section 7D.
second polar body transfer has the meaning given by section 7G.
Part 2—Regulation of the use of excess ART embryos and other material
Division 1—Provisions relating to general licences
6 Definition of unsuitable for implantation—prescribed guidelines
For the purposes of paragraph (b) of the definition of unsuitable for implantation in subsection 7(1) of the Act, the Objective Criteria for Unsuitable Embryos are prescribed.
6A Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines
For the purposes of paragraph 21(4)(c) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7 Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 24(9) of the Act, the ART Guidelines are prescribed.
Division 2—Provisions relating to mitochondrial donation licences
7A Definition of mitochondrial donation technique
For the purposes of the definition of mitochondrial donation technique in section 8 of the Act, the following are mitochondrial donation techniques:
(a) maternal spindle transfer;
(b) pronuclear transfer;
(c) germinal vesicle transfer;
(d) first polar body transfer;
(e) second polar body transfer.
7B Definition of permitted technique
For the purposes of the definition of permitted technique in section 8 of the Act, a mitochondrial donation technique mentioned in an item in the following table is declared to be a permitted technique for a mitochondrial donation licence mentioned in that item.
Maternal spindle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the maternal spindle from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7D Definition of pronuclear transfer
Pronuclear transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) removing the pronuclei from zygote A;
(c) fertilising, with a human sperm, a human egg of a different woman to create another zygote (zygote B);
(d) removing the pronuclei from zygote B;
(e) implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.
7E Definition of germinal vesicle transfer
Germinal vesicle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the germinal vesicle from a maturing human egg (egg A) of a woman;
(b) removing the germinal vesicle from a maturing human egg (egg B) of a different woman;
(c) implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) maturing egg B in vitro to the stage ready for fertilisation;
(e) fertilising egg B with a human sperm to create a zygote.
7F Definition of first polar body transfer
First polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the first polar body from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) fusing the first polar body to, or implanting the first polar body into, egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7G Definition of second polar body transfer
Second polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) fertilising, with a human sperm, a human egg of a different woman to produce another zygote (zygote B);
(c) removing the second polar body from zygote A;
(d) removing the female pronucleus from zygote B;
(e) transferring the second polar body from zygote A to zygote B.
7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines
For the purposes of paragraph 28J(3)(b) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7J Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 28N(8) of the Act, the ART Guidelines are prescribed.
7K Keeping records—prescribed period
For the purposes of subsection 28R(4) of the Act, the period for which a record must be kept is 25 years after the creation of the record.
7L Notifying adverse events—form of notification
For the purposes of subsection 28S(4) of the Act, a notification for the purposes of subsection 28S(3) of the Act must:
(a) be in the form approved by the CEO of the NHMRC; and
(b) contain any information required by the form.
7M Definition of adverse event
For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:
(a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:
(i) a failed embryo development;
(ii) a miscarriage;
(iii) a premature birth of a child;
(iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and
(b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.
Division 3—Other provisions
8 Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought
For the purposes of paragraph 16(3)(a) of the Act, the bodies mentioned in the following table are prescribed.
For the purposes of paragraph 34(2)(a) of the Act:
(a) an inspector’s identity card must state the date of issue of the card and the period of validity of the card; and
(b) the card’s recent photograph of the inspector must be substantially a photograph of the inspector’s face.
8
Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought
8 Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought
For the purposes of paragraph 16(3)(a) of the Act, the bodies mentioned in the following table are prescribed.
For the purposes of paragraph 34(2)(a) of the Act:
(a) an inspector’s identity card must state the date of issue of the card and the period of validity of the card; and
(b) the card’s recent photograph of the inspector must be substantially a photograph of the inspector’s face.
Source text: opening excerpt
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
Part 1 Preliminary
Part 1—Preliminary
1 Name
1 Name
This instrument is the Research Involving Human Embryos Regulations 2017.
3 Authority
3 Authority
This instrument is made under the Research Involving Human Embryos Act 2002.
5 Definitions
5 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) National Statement;
(b) the NHMRC.
In this instrument:
Act means the Research Involving Human Embryos Act 2002.
ART Guidelines means the Ethical guidelines on the use of assisted reproductive technology in clinical practice and 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 ART Guidelines could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
first polar body transfer has the meaning given by section 7F.
germinal vesicle transfer has the meaning given by section 7E.
maternal spindle transfer has the meaning given by section 7C.
Objective Criteria for Unsuitable Embryos means the Objective Criteria for determining embryos that are unsuitable for implantation, 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 Objective Criteria for Unsuitable Embryos could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
pronuclear transfer has the meaning given by section 7D.
second polar body transfer has the meaning given by section 7G.
Part 2 Regulation of the use of excess ART embryos and other material
Part 1—Preliminary
1 Name
This instrument is the Research Involving Human Embryos Regulations 2017.
Sets record‑keeping and reporting form requirements tied to specific Act provisions: records required under subsection 28R(4) must be kept for 25 years after creation (reg 7K); adverse event notifications under subsection 28S(3) must be in a form approved by the CEO of the NHMRC and contain any information required by that form (reg 7L); and the Regulations prescribe a working definition of "adverse event" for purposes of subsection 28S(8) that includes specific outcomes for trial participants, patients and children (reg 7M).
Prescribes the bodies from which nominations must be sought when appointing members to the NHMRC Licensing Committee, for the purposes of paragraph 16(3)(a) of the Act, by listing 23 named organisations (reg 8 and its table).
Sets minimum identity card content for inspectors exercising powers under the Act: the card must state the date of issue and the period of validity, and include a recent photograph that is "substantially a photograph of the inspector’s face" (reg 10).
Mechanically, the Regulations therefore translate several open or delegated powers in the Act into concrete standards: what external guidance must be applied, which techniques are allowed in which regulatory contexts, how long and in what form records and notifications must be kept and made, who must be consulted in committee appointments, and what minimal identity verification inspectors must carry. The Regulations also create regulatory asymmetries between research stages: pre‑clinical licences can authorise a wider set of mitochondrial donation techniques than clinical licences (reg 7B).
All cross‑references in this summary are to the regulation numbers and to the sections of the Act that the Regulations themselves cite (for example, reg 6 refers to subsection 7(1) of the Act; regs 6A and 7H refer to paragraph 21(4)(c) and paragraph 28J(3)(b) of the Act respectively).
Main concepts
The Regulations centre on a handful of interlocking concepts that operationalise the Act. Those concepts, as they appear in the Regulations, are:
Prescribed guidance documents. The Regulations repeatedly reference three external instruments: the ART Guidelines, the Objective Criteria for Unsuitable Embryos, and the National Statement. Each is prescribed for particular functions under the Act: determining whether an embryo is "unsuitable for implantation" (reg 6), framing proper consent (regs 7 and 7J), and guiding licensing committee determinations (regs 6A and 7H). The Regulations state that these documents operate "as existing from time to time", which means compliance obligations point to the current versions of those documents rather than to fixed text contained in the Regulations (regs 5, 6, 6A, 7, 7H, 7J).
Definitions of techniques. The Regulations define "mitochondrial donation technique" broadly (reg 7A) and then specify each technique through stepwise process descriptions in regs 7C-7G. Each definition follows a consistent template: a sequence of steps to be undertaken, plus two interacting constraints , do not "intentionally modify" nuclear or mitochondrial DNA, and "seek to minimise carryover of mitochondria" from source material. Those constraints frame the technical boundaries of practice: deliberate editing of nuclear or mitochondrial genomes is excluded; incidental carryover is permissible but minimisation is required (regs 7C-7G).
Permitted techniques mapped to licence types. Reg 7B declares which of the defined techniques are permitted under the Act’s definition of permitted technique for different categories of mitochondrial donation licences. The table distinguishes pre‑clinical licences (allowing all five techniques) from clinical licences (allowing only maternal spindle transfer and pronuclear transfer), creating a regulatory gate between laboratory research/training and clinical trial work (reg 7B table).
Procedural requirements for records and adverse event reporting. The Regulations identify the retention period for records under subsection 28R(4) (25 years, reg 7K). They make notification of adverse events subject to a CEO‑approved form and its content requirements (reg 7L). They also provide a prescriptive definition of "adverse event" for the Act’s monitoring framework, enumerating failed embryo development, miscarriage, premature birth, birth with defects or genetic abnormalities, diagnosis at birth of mitochondrial disease, and, for children, diagnosis at any time of mitochondrial disease (reg 7M).
Institutional nomination list. Reg 8 lists specific organisations from which nominations must be sought for NHMRC Licensing Committee membership for paragraph 16(3)(a) of the Act. The list includes professional colleges, research bodies, consumer organisations and universities, which concretely shapes whose nominations the responsible Minister or appointing authority must seek.
Inspector identity card requirements. Reg 10 sets two minimum content elements for an inspector’s identity card referenced in paragraph 34(2)(a) of the Act: date of issue and period of validity, and a recent photograph substantially of the inspector’s face.
Together, these concepts convert high‑level statutory terms in the Act into operational obligations and limits: which documents must be applied, how various mitochondrial donation techniques are to be understood and restricted, how safety monitoring is to be recorded and reported, who is to be consulted in committee appointments, and what minimal identification inspectors must carry.
The Regulations also embed particular normative choices into technical language. For example, the twin phrases "without intentionally modifying any nuclear DNA or mitochondrial DNA" and "seeking to minimise carryover of mitochondria" place emphasis on intent and mitigation rather than absolute prohibition of all transfer of mitochondrial material. The phrase "as existing from time to time" when prescribing external guidance makes the Regulations dependent on documents that can change outside the Regulations themselves.
Who it affects
The Regulations create obligations or constraints that map to discrete stakeholder groups. The text provided identifies the following primary affected parties:
Researchers and laboratory personnel engaged in pre‑clinical and clinical trial work involving mitochondrial donation. The Regulations define the scope of techniques that can be performed under particular licence categories (reg 7B). Those conducting research must ensure the technique applied is one declared permitted for the licence type (reg 7B table) and must follow the stepwise method descriptions and constraints for each defined technique (regs 7C-7G).
Assisted reproductive technology clinics and clinicians using excess ART embryos, and parties dealing with embryos and other ART material. The Regulations prescribe that the Objective Criteria for Unsuitable Embryos are to be used for the Act’s definition of "unsuitable for implantation" (reg 6), and that proper consent is to be determined by the ART Guidelines (reg 7). These requirements affect clinicians’ decisions on embryo disposition and consent processes.
Licence applicants and holders under the Act, especially those seeking mitochondrial donation licences. Regulatory constraints on which techniques are permitted for pre‑clinical versus clinical licences (reg 7B) directly affect what research or clinical protocols can be authorised.
The NHMRC Licensing Committee and the NHMRC CEO. The Regulations prescribe that the ART Guidelines and the National Statement must be used by the Licensing Committee in determining general licence and mitochondrial licence applications (regs 6A and 7H). The CEO of the NHMRC has delegated functions in practice because the Regulations require the CEO to approve the form for adverse event notifications (reg 7L) and the ART Guidelines and Objective Criteria are to be those issued by the CEO under the NHMRC Act (reg 5 definitions note).
Trial participants, patients and children who are the subject of mitochondrial donation trials. The Regulations define "adverse event" to include several pregnancy and birth outcomes related to mitochondrial donation trials and make child diagnoses at any time an adverse event for monitoring purposes (reg 7M). That definition shapes reporting obligations and monitoring regimes that concern participants and their offspring.
Inspectors operating under the Act. The Regulations prescribe the minimum content of inspector identity cards (reg 10), which affects how inspectors identify themselves in the field.
Organisations involved in nominating candidates for the NHMRC Licensing Committee. Reg 8 lists 23 specific bodies from which nominations must be sought for paragraph 16(3)(a) of the Act; those bodies therefore have a statutory role in the composition process for the Licensing Committee and can influence committee membership nominations.
Institutional records custodians and administrators responsible for compliance. The Regulations require retention of records for 25 years (reg 7K), which places a long‑term storage and access obligation on licence holders, research institutions and clinics.
Secondary effects flow to entities such as institutional ethics committees and legal/compliance advisers, who will need to align consent processes with the ART Guidelines, and information technology and records management teams, who must implement 25‑year retention policies for specified records (reg 7K).
The Regulations channel decision‑making through a limited set of external instruments and named bodies. Where the Regulations require the use of documents "as existing from time to time" (regs 5, 6, 6A, 7, 7H, 7J), operators and compliance officers must monitor changes to those external instruments and adapt procedures accordingly. The split in permitted techniques between pre‑clinical and clinical licences (reg 7B) creates a clear regulatory boundary that affects whether certain techniques can move from laboratory research into clinical application.
Key duties and rights
The Regulations articulate a network of duties (things regulated parties must do) and rights (authorisations and permitted practices) that operationalise the Act. The principal duties and rights in the text provided are:
Duties
Apply prescribed external guidance where the Act requires it. Where the Act references proper consent or the criteria for unsuitable embryos, parties must use the ART Guidelines and the Objective Criteria for Unsuitable Embryos respectively (regs 6 and 7). The NHMRC Licensing Committee must use the ART Guidelines and the National Statement in making determinations (regs 6A and 7H).
Obtain "proper consent" in accordance with the ART Guidelines. The Regulations expressly prescribe the ART Guidelines for the definition of proper consent in both general licence and mitochondrial donation licence contexts (regs 7 and 7J). This creates a statutory duty to implement consent processes consistent with the CEO‑issued ART Guidelines.
Limit practice to permitted techniques for the licence held. The Regulations declare which mitochondrial donation techniques are permitted for specified licence types (reg 7B). Licence holders and researchers must ensure the techniques used are those authorised.
Observe process constraints for the defined techniques. Each named technique in regs 7C-7G is defined by discrete steps and the dual constraints of not intentionally modifying nuclear or mitochondrial DNA and of seeking to minimise mitochondrial carryover. Practitioners therefore have a procedural duty to follow the defined steps and constraints.
Keep records for the prescribed period. Records referred to in subsection 28R(4) of the Act must be retained for 25 years after creation (reg 7K). This places a clear archival duty on licence holders and institutions.
Notify adverse events in the form approved by the CEO of the NHMRC and include required information. The Regulations require notifications under subsection 28S(3) to be in the CEO‑approved form and to contain any information required by the form (reg 7L).
Monitor and report on the enumerated adverse events. The Regulations define adverse events for monitoring purposes and so impose an obligation to identify and report those enumerated outcomes (reg 7M).
Rights and authorisations
Licence‑based authorisation to perform specified mitochondrial donation techniques. Reg 7B declares that particular techniques are permitted techniques for particular types of mitochondrial donation licences; being granted the relevant licence therefore confers the right to perform those declared techniques within the bounds of the Act and the Regulations.
Use of external guidance as the statutory standard. Where the Act requires application of the ART Guidelines or the National Statement, licence applicants and the Licensing Committee are directed to those texts (regs 6A, 7H, 7, 7J). This grants a predictable standard for consent and ethical review, but ties parties to the current versions of those documents.
Inspector identification. Inspectors authorised under the Act have a right to carry a state‑issued identity card conforming to the minimum content set out in reg 10 when exercising their functions.
Interacting constraints and areas of discretion
The "without intentionally modifying" clause (regs 7C-7G) distinguishes conduct that intentionally edits nuclear or mitochondrial DNA from permitted techniques. That introduces an element of intent into regulatory assessment , an action that unintentionally modifies DNA may fall into a different regulatory category, but the Regulations do not specify enforcement mechanics for unintentional modifications.
The "seek to minimise carryover of mitochondria" requirement (regs 7C-7G) is a mitigation duty rather than a strict quantitative limit. The Regulations do not define an acceptable carryover threshold; that discretion will fall to regulators, licensing processes and possibly the ART Guidelines and National Statement to interpret and operationalise.
Use of documents "as existing from time to time" creates an ongoing duty to monitor and apply updated external guidance rather than a static duty to comply with a single text.
Rights and duties in the Regulations are deliberately structured around licence types, external standards and procedural forms, so parties must align technical laboratory practice, consent processes and record/notification systems with both the Act and the prescribed instruments cited in the Regulations.
Penalties and enforcement
The Regulations supplied do not themselves set out penalties or criminal offences. Instead, they define standards, prescribe guidance and allocate procedural requirements that operate under the Act. The text of the Regulations refers to specific provisions of the Act where enforcement and offences are likely set out (for example, paragraph 34(2)(a) concerning inspector identity cards is referenced in reg 10). Because the Regulations are limited to prescriptive and definitional measures, the following points are drawn directly from the Regulations and their relationship to the Act:
Enforcement mechanisms and penalties applicable for non‑compliance are not defined in the Regulations. The Regulations repeatedly reference and operate for purposes of particular subsections and paragraphs of the Act (for example, subsection 7(1), paragraph 21(4)(c), subsection 24(9), section 8, paragraph 28J(3)(b), subsection 28N(8), subsection 28R(4), subsection 28S(4) and paragraph 16(3)(a), and paragraph 34(2)(a)). Any offences, penalties, injunctive powers, licence suspension or cancellation procedures are matters for the Act itself and are not restated in the Regulations provided.
Administrative enforcement follows from regulatory duties. The Regulations impose substantive compliance requirements , such as retention of records for 25 years (reg 7K), reporting adverse events in CEO‑approved form (reg 7L), and using specified external guidance (regs 6, 6A, 7, 7H, 7J). Failure to comply with those duties is likely to be actionable under the Act’s enforcement regime; the Regulations do not supply an independent sanctions regime.
Identification and inspection. Reg 10 prescribes minimum identity card content for inspectors authorised under paragraph 34(2)(a) of the Act. Inspectors must carry cards that state the date of issue and period of validity and include a recent photograph substantially of the inspector’s face. That requirement conditions the legitimacy of inspections and will be relevant to procedural challenges and evidentiary issues where inspection powers are exercised.
Regulatory discretion embedded in forms and CEO approvals. The requirement that adverse event notifications be in a form approved by the CEO of the NHMRC (reg 7L) means the CEO controls the information flow for monitoring and enforcement. The Regulations give effect to the CEO’s administrative role but do not prescribe the specific entries, thresholds or processing timelines for those forms; regulatory enforcement will therefore depend on how the CEO designs and uses the form.
Monitoring and ongoing obligations. The definition of adverse event in reg 7M includes a child's diagnosis of mitochondrial disease "at any time", which creates an indefinite reporting horizon for certain monitoring duties connected to clinical trials. That extended window can have enforcement implications because it keeps trial participants and researchers subject to reporting obligations long after initial treatment.
In short, the Regulations specify compliance obligations and procedural mechanisms; the Act should be consulted for the precise enforcement and penalty regime that attaches to breaches of those obligations. The Regulations’ recurring cross‑references to the Act (for example, subsection 28S(3) for adverse event notifications and subsection 28R(4) for record keeping) indicate the channel through which enforcement and penalties, if any, will be applied.
How it interacts with other laws
The Regulations explicitly cross‑link to the Research Involving Human Embryos Act 2002 and to instruments issued under the National Health and Medical Research Council Act 1992. Key statutory interactions in the Regulations are:
The Regulations are made under the authority of the Act. The instrument states at reg 3 that it is "made under the Research Involving Human Embryos Act 2002" (reg 3 Authority). Consequently, the Regulations operate as delegated legislation, giving effect to delegated powers and filling in statutory definitions and procedures the Act leaves to subordinate instrument.
The Regulations prescribe documents issued by the NHMRC CEO under the National Health and Medical Research Council Act 1992. The ART Guidelines and the Objective Criteria for Unsuitable Embryos are defined in reg 5 as documents "issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing from time to time." The Regulations therefore make the content of those CEO‑issued instruments legally operative for specific definitions and decisions under the Act (regs 5, 6, 6A, 7, 7H, 7J). This links the Act’s licensing and consent obligations to NHMRC policy and ethical guidance.
The Regulations reference and give effect to specific subsections and paragraphs of the Act. For example:
Reg 6 prescribes the Objective Criteria for Unsuitable Embryos for purposes of paragraph (b) of the definition of unsuitable for implantation in subsection 7(1) of the Act.
Reg 6A prescribes the ART Guidelines and the National Statement for the purpose of paragraph 21(4)(c) of the Act, which concerns determination of general licence applications by the NHMRC Licensing Committee.
Reg 7 prescribes the ART Guidelines for the purposes of the definition of proper consent in subsection 24(9) of the Act.
Reg 7A, 7B and 7C-7G operate for the purposes of the definition of "mitochondrial donation technique" and "permitted technique" in section 8 of the Act and the regulation of mitochondrial donation licences under Part 2 (regs 7A-7G, 7B).
Reg 7H prescribes the ART Guidelines and the National Statement for paragraph 28J(3)(b) of the Act in relation to the NHMRC Licensing Committee’s determination of mitochondrial donation licence applications.
Reg 7J prescribes the ART Guidelines for the purposes of the definition of proper consent in subsection 28N(8) of the Act.
Reg 7K relates to subsection 28R(4) of the Act on record keeping.
Reg 7L and 7M relate to subsection 28S(4) and subsection 28S(8) of the Act on adverse event notification and definition.
Reg 8 prescribes bodies for paragraph 16(3)(a) of the Act (nominations to Licensing Committee).
Reg 10 sets identity card content for paragraph 34(2)(a) of the Act.
The Regulations thus embed cross‑institutional governance: the NHMRC CEO’s guidelines, the NHMRC Licensing Committee’s decisions, and the Act’s statutory licensing and inspection powers are all mutually interdependent. For example, the Licensing Committee is required to use the ART Guidelines and the National Statement (regs 6A and 7H) when exercising statutory decision‑making powers under the Act. Similarly, consent standards under the Act are tethered to ART Guidelines (regs 7 and 7J), which are issued under a separate statutory scheme.
The Regulations do not restate or alter state or territory laws governing ART clinics or clinical practice. They operate at Commonwealth level and primarily concern regulation under the Act. The text does not claim to displace other legal obligations clinics and researchers may have under health practitioner registration, state‑based licensing or human tissue laws. Users should therefore treat the Regulations as one part of a multi‑layered regulatory environment: the Regulations link the Act to NHMRC instruments, but they do not purport to reconcile conflicts with other Commonwealth, state or territory law.
The "as existing from time to time" formulation (regs 5, 6, 6A, 7, 7H, 7J) creates an ongoing external link. The Regulations make compliance dependent on documents outside the Regulations. That means a change to the ART Guidelines, the National Statement or the Objective Criteria (each issued under the NHMRC Act) will change a regulated party’s obligations under the Act without the Regulations themselves being amended.
Practitioners, licence applicants and institutional counsel therefore need to manage multi‑instrument compliance: statutory obligations from the Act and Regulations; NHMRC CEO‑issued guidance instruments that the Regulations prescribe; and other applicable legal regimes (clinical, professional, and state-based) that the Regulations do not cover.
Amendment history
The text presented identifies the instrument by name as the Research Involving Human Embryos Regulations 2017 (see reg 1 Name). The Regulations repeatedly state they are made under the Research Involving Human Embryos Act 2002 (reg 3 Authority) and repeatedly reference CEO‑issued instruments as "as existing from time to time" (reg 5 and other cross‑references). The document itself, as provided, does not include any schedules or editorial notes that record subsequent amendments, commencement details beyond the instrument name, or variations.
What is present in the provided text:
Title and authority: the instrument title is given (reg 1) and the statutory head of power is recorded (reg 3).
Repetitive structure: several provisions appear duplicated in the supplied text, but they are the same substantive regulations (for example, reg 6 and reg 6A appear multiple times in the extracted material). Those duplications do not indicate amendments; they are repetitions in the material supplied.
No explicit amendment clauses: the text does not contain a history note, amendment list, or "made/registered" dates beyond the instrument name. The Regulations as quoted do not show any later amending instruments, nor do they include marginal notes identifying changes.
Given the absence of an amendment record within the provided text, a reader relying on this document should treat it as the base instrument text and consult the Federal Register of Legislation, the Commonwealth Consolidated Acts and Regulations, or other official legislative tracking services for any subsequent amendments, revocations or commencement instruments. The Regulations themselves require that external documents prescribed by reference (the ART Guidelines, Objective Criteria for Unsuitable Embryos, National Statement) operate "as existing from time to time", so in practice compliance obligations evolve with those external instruments irrespective of whether the Regulations themselves have been amended.
If the user requires a formal amendment history (dates, amendment instruments, or textual change log), that information is not contained in the provided Regulations text and must be obtained from the official legislative register or from parliamentary records.
Litigation history
The provided Regulations text contains no references to litigation, judicial decisions, or case law. There are no annotated judicial notes, reported cases, or references to determinations of courts or tribunals in the material supplied. The Regulations are a statutory instrument that prescribes operational detail under the Act; any litigation related to these Regulations , for example, challenges to licence decisions, disputes over the meaning of "seek to minimise carryover", or enforcement actions under the Act , is not recorded in the Regulations themselves.
If a practitioner needs to know whether these Regulations have been the subject of judicial review, statutory interpretation in litigation, or have played a role in authoritative tribunal decisions, that information must be sought outside the Regulations text. Sources to consult would include:
Judicial databases and law reports for decisions referencing the Research Involving Human Embryos Act 2002 or the Regulations 2017.
Administrative law decisions that consider the Licensing Committee’s use of the ART Guidelines or the National Statement in decisions (regs 6A, 7H).
Any cases involving the meaning or application of the procedural obligations set out in the Regulations, such as the interpretation of "proper consent" as prescribed by the ART Guidelines (regs 7 and 7J), or the operational requirement to "seek to minimise carryover" (regs 7C-7G).
Because the Regulations themselves do not record litigation history, and because this instrument operates closely with the Act and NHMRC instruments, researching both statutory materials and administrative decisions is necessary to build a litigation profile. That work is outside the scope of the Regulation text provided.
Gotchas
The Regulations embed a number of technical features and delegated choices that create practical compliance risks and interpretive uncertainties. The following are concrete pitfalls and attention points drawn from the Regulations themselves, together with their operational mechanisms:
Reliance on external documents that change over time
Mechanism: The ART Guidelines, Objective Criteria for Unsuitable Embryos and the National Statement are prescribed "as existing from time to time" (reg 5 definitions and regs 6, 6A, 7, 7H, 7J).
Practical effect: Compliance obligations will shift when those external instruments are updated. Licence applicants and holders must monitor those instruments continually and update consent forms, ethical protocols and committee submissions accordingly.
"Seek to minimise carryover" is not quantitatively defined
Mechanism: Each mitochondrial donation technique definition (regs 7C-7G) requires seeking to minimise carryover of mitochondria from the source material.
Practical effect: The absence of a numerical threshold or testing standard creates uncertainty about what level of carryover is acceptable. Operational interpretation will likely depend on licensing conditions, the ART Guidelines, the National Statement, and the Licensing Committee’s practices. Documentation showing steps taken to minimise carryover will be important.
Intent‑based constraint on DNA modification
Mechanism: Technique definitions state they must be carried out "without intentionally modifying any nuclear DNA or mitochondrial DNA" (regs 7C-7G).
Practical effect: The focus on intent raises questions about unintentional modification and its regulatory consequences. Parties must demonstrate practices that avoid intentional editing, and there may be ambiguity about liability or regulatory status where unintentional modifications are detected.
Divergent technique permissions across licence stages
Mechanism: Reg 7B permits all five techniques for pre‑clinical licences but restricts clinical licences to maternal spindle and pronuclear transfer.
Practical effect: Transitioning from pre‑clinical to clinical phases will require adjusting protocols and possibly re‑applying for different licence authorisations. Applicants must plan studies and technology development paths with that restriction in mind.
Long record retention period
Mechanism: Reg 7K requires records to be kept for 25 years after creation for the purposes of subsection 28R(4) of the Act.
Practical effect: This is a substantial retention burden for clinics and research institutions. Records management systems, data security, and privacy compliance frameworks must accommodate 25‑year retention periods, with implications for cost and IT architecture.
Adverse event reporting horizon and scope
Mechanism: Reg 7M defines adverse events to include a child’s diagnosis of mitochondrial disease "at any time".
Practical effect: Trial sponsors and researchers retain an open‑ended reporting obligation regarding offspring. This creates potential long‑term monitoring and reporting duties, and raises questions about ongoing contact with families, data governance and the mechanics of long‑term follow up.
Regulatory discretion held by the NHMRC CEO
Mechanism: Reg 7L requires adverse event notifications to be in a form approved by the CEO of the NHMRC; the ART Guidelines and Objective Criteria are CEO‑issued instruments (reg 5).
Practical effect: The CEO controls the content and form of key reports and the standards used to measure consent and embryo suitability. That central administrative discretion will influence enforcement and licensing outcomes.
Prescribed nomination list shapes committee composition
Mechanism: Reg 8 names 23 bodies from which nominations must be sought for the NHMRC Licensing Committee.
Practical effect: The Licensing Committee’s composition is shaped institutionally; applicants should expect that particular professional and consumer groups will have formal nomination standing. This affects the committee’s perspectives and potentially the pathway for stakeholder engagement.
No penalty language in the Regulations themselves
Mechanism: The Regulations do not set out sanctions or offences.
Practical effect: Determining the consequences of non‑compliance requires consulting the Act. Enforcement and penalties therefore inherit the Act’s structure, which practitioners must check for procedural protections and remedies.
Inspector identity card minimal requirements
Mechanism: Reg 10 prescribes only date of issue, period of validity and a recent facial photograph for inspector identity cards.
Practical effect: While minimal, these content requirements may become focal in disputes about inspection authority or admissibility of inspection evidence; inspectors and regulated parties should ensure identity card issuance and presentation conform precisely to reg 10.
Each of these "gotchas" follows directly from the text of the Regulations. Many of them concern ambiguity left to external documents or to administrative discretion (CEO‑approved forms, the ART Guidelines and National Statement). Practitioners should treat these as concrete points to interrogate in licence applications, institutional policies, consent documentation, lab standard operating procedures and recordkeeping systems.
How to comply
This section summarises practical, source‑grounded steps for compliance mapped to the specific regulatory provisions cited in the Regulations. All steps refer to the regulation numbers in the text provided.
Link internal policies to the prescribed external guidance (regs 5, 6, 6A, 7, 7H, 7J)
Ensure institutional consent templates, ethics committee guidance and licence application materials explicitly reference and track the ART Guidelines and the National Statement where those are prescribed (regs 6A, 7, 7H, 7J).
Implement a monitoring process for updates to the ART Guidelines, the Objective Criteria for Unsuitable Embryos and the National Statement because the Regulations prescribe them "as existing from time to time" (reg 5 definitions note). Assign responsibility (for example, NHMRC liaison or compliance manager) to check for updates and to log versioning.
Match licence applications and activity to permitted techniques (reg 7B)
Before applying, determine whether the work is pre‑clinical research and training or a clinical trial. For pre‑clinical licences, all five techniques in reg 7A are declared permitted (reg 7B item 1). For clinical trials or clinical trial research and training licences, only maternal spindle transfer and pronuclear transfer are permitted (reg 7B item 2).
In protocols and SOPs, identify the technique(s) intended and align the licence application to the declared permitted techniques. If a technique is not listed for the licence category, do not include it in the protocol.
Document technique steps and mitigation for mitochondrial carryover (regs 7C-7G)
For each mitochondrial donation technique used, maintain SOPs that reflect the stepwise sequence described in regs 7C-7G. Document how the "seek to minimise carryover of mitochondria" requirement is operationalised: laboratory methods, validation studies, measurement/assay processes, and training protocols.
Capture evidence in logs, validation reports and quality assurance records showing steps taken to reduce carryover. Given the lack of a numerical carryover threshold in the Regulations, demonstrate a reasonable, documented approach tied to scientific best practice and relevant ART Guidelines.
Avoid intentional modification of nuclear or mitochondrial DNA (regs 7C-7G)
Ensure research governance explicitly forbids intentional editing of nuclear or mitochondrial DNA within the defined technique procedures. Institute oversight (e.g., institutional biosafety committee or equivalent) to review protocols that might risk intentional modification and to sign off prior to practice.
Implement and maintain long‑term records retention systems (reg 7K)
Establish records management policies ensuring specified records required under subsection 28R(4) of the Act are preserved for 25 years from their creation (reg 7K). Identify which documents fall within subsection 28R(4) and classify them.
Ensure secure archiving, access controls, and data breach responses are configured for a 25‑year retention envelope. Budget and technical planning should reflect the long timeline for physical or electronic storage, and consider migration strategies to maintain readability over time.
Prepare for adverse event reporting in CEO‑approved form (regs 7L and 7M)
Expect and plan to use an adverse event notification form approved by the CEO of the NHMRC (reg 7L). Establish internal procedures for rapid filling of that form when an event occurs and for ensuring the form contains any information required by the CEO‑approved version.
Map the defined adverse events in reg 7M into clinical safety monitoring plans: failed embryo development; miscarriage; premature birth; birth with a birth defect, genetic abnormality or diagnosis at birth of mitochondrial disease; and for children, a diagnosis at any time of mitochondrial disease. Create triggers, timelines and designated responsible persons for notification.
Design consent processes in line with the ART Guidelines (regs 7 and 7J)
Review and adopt the ART Guidelines’ consent requirements into clinic consent forms and information sheets because the Regulations prescribe the ART Guidelines for the Act’s "proper consent" definition (regs 7 and 7J).
Train clinicians and research staff on the ART Guidelines’ content and evidence required to meet the prescribed definition of consent.
Engage with the NHMRC Licensing Committee and prescribed nomination bodies (regs 6A, 7H, 8)
When preparing licence applications, ensure submissions explicitly reference compliance with the ART Guidelines and the National Statement, as the Licensing Committee must use those guidelines in determinations (regs 6A and 7H).
Be aware of the list of prescribed bodies in reg 8; these organisations are formally prescribed as sources of nominations for the Licensing Committee. If stakeholder engagement or endorsements are required, target the organisations on that list where appropriate.
Prepare identity and inspection facilitation (reg 10)
Where inspections are expected, ensure inspectors present identity cards that state the date of issue, the period of validity and include a recent photograph substantially of the inspector’s face (reg 10). For institutions, establish a procedure to verify such credentials prior to granting access.
Institutional whistleblowing and ongoing obligations
Implement follow‑up processes for monitoring children born as a result of mitochondrial donation trials because reg 7M requires reporting of a child’s diagnosis of mitochondrial disease "at any time". Maintain accurate contact and follow‑up mechanisms consistent with privacy law and ethical standards.
Compliance documentation and audit trail
Keep a compliance binder for each licence and project that includes: licence terms, SOPs mapped to regs 7C-7G, consent templates tied to ART Guidelines, adverse event reporting processes and records, records retention logs demonstrating 25‑year archiving, and documentation of steps taken to minimise mitochondrial carryover.
Ensure internal audits periodically verify that the ART Guidelines and National Statement have been reviewed and that any changes to those documents have been implemented in internal policies.
Seek clarification when the Regulations are silent or ambiguous
For interpretive gaps in the Regulations , for example, acceptable carryover levels, or the operational meaning of "without intentionally modifying" , seek guidance from the NHMRC or the Licensing Committee, and record any such guidance as part of the project file.
These measures are practical steps directly traceable to the Regulations. They require institutions to integrate scientific protocols, ethical consent standards prescribed by the NHMRC CEO, long‑term recordkeeping systems and reporting frameworks that satisfy CEO‑approved forms and the Monitoring regime defined in the Act and the Regulations.
This instrument is made under the Research Involving Human Embryos Act 2002.
5 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) National Statement;
(b) the NHMRC.
In this instrument:
Act means the Research Involving Human Embryos Act 2002.
ART Guidelines means the Ethical guidelines on the use of assisted reproductive technology in clinical practice and 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 ART Guidelines could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
first polar body transfer has the meaning given by section 7F.
germinal vesicle transfer has the meaning given by section 7E.
maternal spindle transfer has the meaning given by section 7C.
Objective Criteria for Unsuitable Embryos means the Objective Criteria for determining embryos that are unsuitable for implantation, 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 Objective Criteria for Unsuitable Embryos could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
pronuclear transfer has the meaning given by section 7D.
second polar body transfer has the meaning given by section 7G.
Part 2—Regulation of the use of excess ART embryos and other material
Division 1—Provisions relating to general licences
6 Definition of unsuitable for implantation—prescribed guidelines
For the purposes of paragraph (b) of the definition of unsuitable for implantation in subsection 7(1) of the Act, the Objective Criteria for Unsuitable Embryos are prescribed.
6A Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines
For the purposes of paragraph 21(4)(c) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7 Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 24(9) of the Act, the ART Guidelines are prescribed.
Division 2—Provisions relating to mitochondrial donation licences
7A Definition of mitochondrial donation technique
For the purposes of the definition of mitochondrial donation technique in section 8 of the Act, the following are mitochondrial donation techniques:
(a) maternal spindle transfer;
(b) pronuclear transfer;
(c) germinal vesicle transfer;
(d) first polar body transfer;
(e) second polar body transfer.
7B Definition of permitted technique
For the purposes of the definition of permitted technique in section 8 of the Act, a mitochondrial donation technique mentioned in an item in the following table is declared to be a permitted technique for a mitochondrial donation licence mentioned in that item.
Maternal spindle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the maternal spindle from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7D Definition of pronuclear transfer
Pronuclear transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) removing the pronuclei from zygote A;
(c) fertilising, with a human sperm, a human egg of a different woman to create another zygote (zygote B);
(d) removing the pronuclei from zygote B;
(e) implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.
7E Definition of germinal vesicle transfer
Germinal vesicle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the germinal vesicle from a maturing human egg (egg A) of a woman;
(b) removing the germinal vesicle from a maturing human egg (egg B) of a different woman;
(c) implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;
(d) maturing egg B in vitro to the stage ready for fertilisation;
(e) fertilising egg B with a human sperm to create a zygote.
7F Definition of first polar body transfer
First polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) removing the first polar body from a human egg (egg A) of a woman;
(b) removing the maternal spindle from a human egg (egg B) of a different woman;
(c) fusing the first polar body to, or implanting the first polar body into, egg B;
(d) fertilising egg B with a human sperm to create a zygote.
7G Definition of second polar body transfer
Second polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:
(a) fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
(b) fertilising, with a human sperm, a human egg of a different woman to produce another zygote (zygote B);
(c) removing the second polar body from zygote A;
(d) removing the female pronucleus from zygote B;
(e) transferring the second polar body from zygote A to zygote B.
7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines
For the purposes of paragraph 28J(3)(b) of the Act, the following guidelines are prescribed:
(a) the ART Guidelines;
(b) the National Statement.
7J Definition of proper consent—prescribed guidelines
For the purposes of the definition of proper consent in subsection 28N(8) of the Act, the ART Guidelines are prescribed.
7K Keeping records—prescribed period
For the purposes of subsection 28R(4) of the Act, the period for which a record must be kept is 25 years after the creation of the record.
7L Notifying adverse events—form of notification
For the purposes of subsection 28S(4) of the Act, a notification for the purposes of subsection 28S(3) of the Act must:
(a) be in the form approved by the CEO of the NHMRC; and
(b) contain any information required by the form.
7M Definition of adverse event
For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:
(a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:
(i) a failed embryo development;
(ii) a miscarriage;
(iii) a premature birth of a child;
(iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and
(b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.
Division 3—Other provisions
8 Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought
For the purposes of paragraph 16(3)(a) of the Act, the bodies mentioned in the following table are prescribed.