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) were issued in 2004 by the NHMRC and updated in 2007 to reflect amendments to the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act).
The process of preparation of the 2007 ART Guidelines included a full and comprehensive public consultation, where 93 interested parties provided submissions.
The ART Guidelines address both clinical and research aspects of assisted reproductive technology. 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 Reproductive Technology 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. 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
NHMRC, through the Australian Health Ethics Committee (AHEC), has issued ethical guidance under the National Health and Medical Research Council Act 1992. The ART Guidelines have been adopted through legislation in Victoria, New South Wales, South Australia and Western Australia. Accreditation of IVF clinics, which is administered by the Fertility Society of Australia, also requires adherence to the ART Guidelines.
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
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.