Research Involving Human Embryos Regulations 2003

Research Involving Human Embryos Regulations 2003

Statutory Rules 2003 No. 22 as amended

made under the

Research Involving Human Embryos Act 2002

This compilation was prepared on 17 May 2008
taking into account amendments up to SLI 2008 No. 80

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Contents

Part 1 Preliminary 

 1.1 Name of Regulations [see Note 1]

 1.2 Commencement [see Note 1]

 1.3 Definitions 

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

 2.1 Proper consent — prescribed guidelines 

 2.2 Unsuitable for implantation — prescribed guidelines 

 2.3 NHMRC Licensing Committee — prescribed bodies from which nominations must be sought (Act s 16)             

 2.4 Prescribed guidelines to which NHMRC Licensing Committee must have regard (Act s 21)             

Part 3 Miscellaneous 

 3.1 Form of identity card 

Schedule 1 Committee — prescribed bodies from which nominations must be sought             

Notes   

Part 1 Preliminary

1.1 Name of Regulations [see Note 1]

  These Regulations are the Research Involving Human Embryos Regulations 2003.

1.2 Commencement [see Note 1]

  These Regulations commence on gazettal.

1.3 Definitions

  In these Regulations:

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 in 2007 and as existing on 24 August 2007.

Note   The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research are available on the Internet — see http://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 in 2007 and as existing on 6 December 2007.

Note   The Objective Criteria for determining embryos that are
unsuitable for implantation are available on the Internet — see http://www.nhmrc.gov.au.

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

2.1 Proper consent — prescribed guidelines

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

2.2 Unsuitable for implantation — prescribed guidelines

  For paragraph (b) of the definition of unsuitable for implantation in section 7 of the Act, the Objective Criteria for Unsuitable Embryos are prescribed.

2.3 NHMRC Licensing Committee — prescribed bodies from which nominations must be sought (Act s 16)

  For paragraph 16 (3) (a) of the Act, each body mentioned in column 2 of an item in Schedule 1 is prescribed.

2.4 Prescribed guidelines to which NHMRC Licensing Committee must have regard (Act s 21)

  For paragraph 21 (4) (c) of the Act, the following guidelines are prescribed:

 (a) the ART Guidelines;

 (b) the National Statement on Ethical Conduct in Human Research, issued by the CEO of the NHMRC in 2007 and as existing on 24 August 2007.

Note   The National Statement on Ethical Conduct in Human Research is available on the Internet — see http://www.nhmrc.gov.au.

Part 3 Miscellaneous

3.1 Form of identity card

  For paragraph 34 (2) (a) of the Act:

 (a) an inspector’s identity card must state the date of issue and the period of validity; and

 (b) the card’s recent photograph of the inspector must be substantially a photograph of the inspector’s face.

Schedule 1 Committee — prescribed bodies from which nominations must be sought

(regulation 2.3)

Notes to the Research Involving Human Embryos Regulations 2003

Note 1

The Research Involving Human Embryos Regulations 2003 (in force under the Research Involving Human Embryos Act 2002) as shown in this compilation comprise Statutory Rules 2003 No. 22 amended as indicated in the Tables below.

Under the Legislative Instruments Act 2003, which came into force on 1 January 2005, it is a requirement for all non‑exempt legislative instruments to be registered on the Federal Register of Legislative Instruments.  From 1 January 2005 the Statutory Rules series ceased to exist and was replaced with Select Legislative Instruments (SLI series). Numbering conventions remain the same, ie Year and Number.

Table of Instruments

(a) Regulation 2 (2) of SLI 2008 No. 80 provides as follows:

(2) However, items [2] to [4] of Schedule 1 commence immediately after item [1] of that Schedule.

Item [1] of Schedule 1 commenced on 17 May 2008.

Table of Amendments