Research Involving Human Embryos Regulations 2017

made under the

Research Involving Human Embryos Act 2002

Compilation No. 1

Compilation date:                              1 October 2022

Includes amendments up to:            Act No. 26, 2022

Registered:                                         10 October 2022

About this compilation

This compilation

This is a compilation of the Research Involving Human Embryos Regulations 2017 that shows the text of the law as amended and in force on 1 October 2022 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1—Preliminary                                                                                                                                        1

1............ Name............................................................................................................................. 1

3............ Authority....................................................................................................................... 1

5............ Definitions..................................................................................................................... 1

Part 2—Regulation of the use of excess ART embryos and other material                 2

Division 1—Provisions relating to general licences                                                                2

6............ Definition of unsuitable for implantation—prescribed guidelines................................. 2

6A......... Determination by NHMRC Licensing Committee of general licence applications—prescribed guidelines              2

7............ Definition of proper consent—prescribed guidelines.................................................... 2

Division 2—Provisions relating to mitochondrial donation licences                             3

7A......... Definition of mitochondrial donation technique............................................................. 3

7B......... Definition of permitted technique.................................................................................. 3

7C......... Definition of maternal spindle transfer.......................................................................... 3

7D......... Definition of pronuclear transfer................................................................................... 4

7E.......... Definition of germinal vesicle transfer........................................................................... 4

7F.......... Definition of first polar body transfer............................................................................ 4

7G......... Definition of second polar body transfer....................................................................... 4

7H......... Determination by NHMRC Licensing Committee of mitochondrial donation licence applications—prescribed guidelines...................................................................................................................................... 5

7J.......... Definition of proper consent—prescribed guidelines.................................................... 5

7K......... Keeping records—prescribed period............................................................................. 5

7L.......... Notifying adverse events—form of notification............................................................ 5

7M........ Definition of adverse event............................................................................................ 5

Division 3—Other provisions                                                                                                             6

8............ Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought      6

Part 3—Miscellaneous                                                                                                                                   7

10.......... Form of identity card..................................................................................................... 7

Endnotes                                                                                                                                                                 8

Endnote 1—About the endnotes                                                                                                        8

Endnote 2—Abbreviation key                                                                                                            9

Endnote 3—Legislation history                                                                                                       10

Endnote 4—Amendment history                                                                                                     11

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.

7C  Definition of maternal spindle transfer

                   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.

Part 3—Miscellaneous

10  Form of identity card

                   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.

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history