RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - made under the Research Involving Human Embryos Act 2002 - TABLE OF PROVISIONS 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 RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 1.1 Name of Regulations [see Note 1] These Regulations are the Research Involving Human Embryos Regulations 2003. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 1.2 Commencement [see Note 1] These Regulations commence on gazettal. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 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. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 2.1 Proper consent -- prescribed guidelines For the definition of proper consent in section 8 of the Act, the ART Guidelines are prescribed. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 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. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 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. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 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. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - REG 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. RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - SCHEDULE 1 Committee -- prescribed 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 RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - NOTES Statutory Rules 2003 No. 22 as amended 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] 3 1.2 Commencement [see Note 1] 3 1.3 Definitions 3 Part 2 Regulation of the use of excess ART embryos, other embryos and human eggs 2.1 Proper consent -- prescribed guidelines 4 2.2 Unsuitable for implantation -- prescribed guidelines 4 2.3 NHMRC Licensing Committee -- prescribed bodies from which nominations must be sought (Act s 16) 4 2.4 Prescribed guidelines to which NHMRC Licensing Committee must have regard (Act s 21) 4 Part 3 Miscellaneous 3.1 Form of identity card 5 Schedule 1 Committee -- prescribed bodies from which nominations must be sought 6 Notes 7 RESEARCH INVOLVING HUMAN EMBRYOS REGULATIONS 2003 - NOTES 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