Research Involving Human Embryos Regulations 2017

Contents

Part 1 · Preliminary

1Name#

This instrument is the Research Involving Human Embryos Regulations 2017.

3Authority#

This instrument is made under the Research Involving Human Embryos Act 2002.

5Definitions#

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

6Definition 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.

6ADetermination 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.

7Definition 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

7ADefinition 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.

7BDefinition 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.

Definition of permitted technique
Item	For this kind of mitochondrial donation licence …	the permitted techniques are …
1	a pre-clinical research and training licence	the following:(a) maternal spindle transfer;(b) pronuclear transfer;(c) germinal vesicle transfer;(d) first polar body transfer;(e) second polar body transfer
2	a clinical trial research and training licence or a clinical trial licence	the following:(a) maternal spindle transfer;(b) pronuclear transfer

7CDefinition 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.

7DDefinition 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.

7EDefinition 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.

7FDefinition 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.

7GDefinition 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.

7HDetermination 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.

7JDefinition 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.

7KKeeping 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.

7LNotifying 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.

7MDefinition 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

8Membership 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.

Prescribed bodies
Item	Body
1	Access Australia’s National Infertility Network Limited
2	Association of Australian Medical Research Institutes Limited
3	Australasian Association of Bioethics and Health Law
4	Australian Academy of Health and Medical Sciences Limited
5	Australian Academy of Science
6	Australian College of Nursing Ltd
7	Australian College of Rural and Remote Medicine
8	Australian Consumers’ Association
9	Australian Federation of Disability Organisations (AFDO) Ltd
10	Australian Research Council
11	The Australian Society for Medical Research
12	Consumers Health Forum of Australia Ltd
13	The Fertility Society of Australia
14	Human Genetics Society of Australasia
15	Law Council of Australia Ltd
16	National Association of Specialist Obstetricians and Gynaecologists
17	National Stem Cell Foundation of Australia
18	Rare Voices Australia Ltd
19	The Royal Australasian College of Physicians
20	The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
21	The Royal Australian College of General Practitioners
22	Society for Reproductive Biology Incorporated
23	Universities Australia

Part 3 · Miscellaneous

10Form 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.

Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.