Federal Register of Legislation - Australian Government

Primary content

Research Involving Human Embryos Regulations 2017

Authoritative Version
Regulations as made
These regulations remake the Principal Regulations to update the references to guidance material and to the list of prescribed bodies by which nominations to Licencing Committee are to be sought.
Administered by: Health
Registered 19 Sep 2017
Tabling HistoryDate
Tabled HR16-Oct-2017
Tabled Senate16-Oct-2017

 

Research Involving Human Embryos Regulations 2017

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 18 September 2017

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

 

  

  


Contents

Part 1—Preliminary                                                                                                                                        1

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

2............ Commencement............................................................................................................. 1

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

4............ Schedules...................................................................................................................... 1

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

Part 2—Regulation of the use of excess ART embryos, other embryos and human eggs             3

6............ Definition of unsuitable for implantation—prescribed guidelines................................. 3

7............ Definition of proper consent—prescribed guidelines.................................................... 3

8............ Membership of NHMRC Licensing Committee—prescribed bodies from which nominations must be sought      3

9............ Determination by NHMRC Licensing Committee of licence applications—prescribed guidelines           4

Part 3—Miscellaneous                                                                                                                                   5

10.......... Form of identity card..................................................................................................... 5

Part 4—Transitional, savings and application provisions                                                       6

11.......... Licence applications....................................................................................................... 6

Schedule 1—Repeals                                                                                                                                       7

Research Involving Human Embryos Regulations 2003                                                                7

 


Part 1Preliminary

  

1  Name

                   This instrument is the Research Involving Human Embryos Regulations 2017.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

20 September 2017

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

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

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

5  Definitions

                   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 2017, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing at the time when this instrument commences.

Note:          The ART Guidelines could in 2017 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).

National Statement means the National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015), issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing at the time when this instrument commences.

Note:          The National Statement could in 2017 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).

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 at the time when this instrument commences.

Note:          The Objective Criteria for Unsuitable Embryos could in 2017 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).

Part 2Regulation of the use of excess ART embryos, other embryos and human eggs

  

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.

7  Definition of proper consent—prescribed guidelines

                   For the purposes of the definition of proper consent in section 8 of the Act, the ART Guidelines are prescribed.

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.

 

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

 

9  Determination by NHMRC Licensing Committee of 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.

Part 3Miscellaneous

  

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.

Part 4Transitional, savings and application provisions

  

11  Licence applications

             (1)  This section applies in relation to an application for a licence made, but not finally determined, before the repeal of the Research Involving Human Embryos Regulations 2003 (the old regulations).

             (2)  The following provisions of this instrument do not apply to the application:

                     (a)  the definition of ART Guidelines in section 5;

                     (b)  section 7;

                     (c)  section 9.

             (3)  Despite the repeal of the old regulations, the following provisions, as in force immediately before the repeal of the old regulations, continue to apply, on and after the commencement of this instrument, in relation to the application as if the repeal had not happened:

                     (a)  the definition of ART Guidelines in regulation 1.3;

                     (b)  regulation 2.1;

                     (c)  regulation 2.4.


Schedule 1Repeals

  

Research Involving Human Embryos Regulations 2003

1  The whole of the regulations

Repeal the regulations.