Assisted reproductive technology (ART) is the application of laboratory or clinical technology to gametes (human egg or sperm) and/or embryos for the purposes of reproduction. All reproductive medicine units offering ART services should comply with the NHMRC Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research (2007) (ART Guidelines).
The continued development of new technologies in ART means that ART remains a complex area, scientifically and ethically, for both clinical practice and research.
Overview
The NHMRC Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research (2007) (ART Guidelines) deal with the ethical aspects of research and clinical practice of assisted reproductive technology. The document is divided into three parts. Part A provides background and introductory material. Part B provides ethical guidelines for the clinical practice of ART and Part C provides ethical guidelines for research. Part C of the guidelines is consistent with the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and the Research Involving Human Embryos Act 2002 (RIHE Act) (collectively ‘the Acts’)
The ART Guidelines were issued in 2004 by the NHMRC and updated in 2007 to reflect amendments to the Acts.
The process of preparing the changes to the ART Guidelines in 2007 included comprehensive public consultation on part C of the guidelines, where 93 interested parties provided submissions.
The guidelines are primarily intended for ART practitioners, researchers, infertility clinic administrators, Human Research Ethics Committees and governments.
Use of Embryos in Research
The Research Involving Human Embryos Act 2002 (RIHE Act) requires that research on certain human embryos may only be conducted under a licence issued by the NHMRC Embryo Licensing Committee. The Licensing Committee must be satisfied that the research proposal has been assessed and approved by a Human Research Ethics Committee acting in compliance with the National Statement on Ethical Conduct in Human Research (2007) and the ART guidelines.
The RIHE Act distinguishes between embryos intended for transfer to a woman to achieve a pregnancy and embryos that have been deemed to be no longer needed in an ART program (‘excess ART embryos’). The Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and RIHE Act permit research on excess ART embryos, including those that are unsuitable for implantation, and embryos created by means other than by fertilisation of a human egg and human sperm. Consent from the donor must also be sought prior to use of excess ART embryos for research.
For any licensable activity the number of excess ART embryos, other embryos or human eggs should be restricted to that likely to be necessary to achieve the goals of the activity. Research proposals involving human embryos must not include any practices prohibited by the legislation.
Clinical Practice
Many aspects of clinical practice in ART raise ethical issues. The ART Guidelines cover activities including:
- posthumous use of gametes
- surrogacy
- donor conception
- sex selection; and
- pre-implantation genetic diagnosis (PGD).
The role of the ART ethical guidelines in the regulation of ART
The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2007 underpin the regulation of ART practice within Australia. Accreditation of ART treatment centres by the Reproductive Technology Accreditation Committee (RTAC) is the basis of a nationally consistent approach for overseeing ART clinical practice. RTAC accreditation requires ART treatment centres to comply with government laws and guidelines concerning the practice of ART. The ART Guidelines are included in this requirement. RTAC was established by the Fertility Society of Australia.
State and Territory ART legislation
Legislation in four states regulates ART - the Victorian Assisted Reproductive Treatment Act (2008), the New South Wales Assisted Reproductive Technology Act (2007), the South Australian Assisted Reproductive Treatment Act (1988) and the Western Australian Human Reproductive Technology Act (1991). Each of these pieces of legislation established a state regulatory body which issues licences to clinics that provide ART services. The ART Guidelines have been adopted through these pieces of legislation. When there are anomalies between the state acts and the guidelines, the state acts have precedence.
The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 (Heerey Review)
The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2007 are consistent with the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). The Guidelines are also prescribed in the regulations under the RIHE Act.
The NHMRC Licensing Committee oversees the RIHE Act and the PHCR Act.
An independent committee was established by the Australian Government to review this legislation on cloning and research involving human embryos in Australia and was chaired by the Hon. Justice Peter Heerey QC.
The review of this legislation commenced in late December 2010 and the independent committee released its report in July 2011.
The Australian Government is currently considering the recommendations in the Heerey Report.
There are important links between the human embryo research legislation and the ART Guidelines. Accordingly NHMRC is preparing for a review of the guidelines, subject to the response from Government to the Heerey Report.
Further information regarding the Heerey Review is available from the Legislation Review website.
Sex Selection through Pre-implantation Genetic Diagnosis
The ART Guidelines restrict the use of PGD for sex selection in Australia. These Guidelines reflect the sentiment of the community that admission to life should not be conditional upon a child being of a particular sex. Therefore, sex selection (by whatever means) should not be undertaken except to reduce the risk of transmission of a serious genetic condition (see sections 11 and 12 of the ART Guidelines).
Review of the ART Guidelines
The ART guidelines are not currently under review; however, a review of Part B (ethical guidelines for the clinical practice of ART) will take place during the NHMRC’s current triennium (2012 – 2015). A review of Part C will occur after the Australian Government has considered the Heerey Report and passed any necessary legislative changes.
NHMRC recognises and appreciates that ART is an important issue for the Australian community and is committed to ensuring that the review is well planned and allows for meaningful consultation and debate. As this review is only in the planning stages, there are currently no confirmed timelines to report. This page will be updated with details as they become available.
In reviewing its guidelines, the NHMRC undertakes a period of public consultation and calls for submissions in the national press and on its Public Consultation website. All interested persons will be encouraged to participate in the public consultation processes.