Research Involving Human Embryos Regulations 2003 (Cth)

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

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

Part 3 Miscellaneous

 

Part 1Preliminary

  1.1Name of Regulations [see Note 1]

These Regulations are the Research Involving Human Embryos Regulations 2003.

1.2Commencement [see Note 1]

These Regulations commence on gazettal.

1.3Definitions

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

  2.1Proper consent – prescribed guidelines

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

2.2Unsuitable 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.

2.3NHMRC 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.

2.4Prescribed 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:

1. (a)

   the ART Guidelines;

2. (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 3Miscellaneous

  3.1Form of identity card

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

1. (a)

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

2. (b)

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

Schedule 1 Committeeprescribed bodies from which nominations must be sought

(regulation 2.3)

  

Item	Body
1	Academy of Science
2	ACCESS Australia’s National Infertility Network Ltd
3	Australasian Bioethics Association Inc
4	Australian Biotechnology Advisory Council
5	Australian Consumers’ Association
6	Australian Research Council
7	Australian Vice‑Chancellors’ Committee
8	Consumers’ Health Forum of Australia
9	Law Council of Australia
10	Australian Federation of Disability Organisations
11	Royal College of Nursing, Australia
12	The Australian and New Zealand Infertility Counsellors Association Incorporated
13	The Australian Institute of Health, Law and Ethics Inc
14	The Australian Society for Medical Research
15	The Fertility Society of Australia
16	The Royal Australasian College of Physicians
17	The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
18	The Royal Australian College of General Practitioners

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

Year and number	Date of notification in Gazette or FRLI registration	Date of commencement	Application, saving or transitional provisions
2003 No. 22	27 Feb 2003	27 Feb 2003
2005 No. 206	19 Sept 2005 (see F2005L02562)	20 Sept 2005	—
2007 No. 255	22 Aug 2007 (see F2007L02261)	24 Aug 2007	—
2008 No. 80	16 May 2008 (see F2008L00983)	Schedule 1 (items 2–4): (a) Remainder: 17 May 2008	—

(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

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
Part 1
R. 1.3......................................	rs. 2007 No. 255
am. 2008 No. 80
Part 2
Heading to Part 2..................	rs. 2007 No. 255
R. 2.1A...................................	ad. 2005 No. 206
rs. 2007 No. 255
Renumbered 2.1................	2008 No. 80
R. 2.2......................................	ad. 2008 No. 80
R. 2.1
Renumbered 2.3................	2008 No. 80
R. 2.2......................................	am. 2005 No. 206; 2007 No. 255
Renumbered 2.4................	2008 No. 80
Schedule 1
Heading to Schedule 1........	rs. 2008 No. 80
Schedule 1.............................	am. 2005 No. 206