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)
The continued development of new technologies in ART means that ART remains a complex area, scientifically and ethically, for both clinical practice and research.
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
- Part C provides ethical guidelines for research consistent with the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and the Research Involving Human Embryos Act 2002 (RIHE Act).
The current ART guidelines were issued in 2004 by the NHMRC and updated in 2007 to reflect amendments to the PHCR and RIHE Acts. Please note that Part B of the ART guidelines are currently under review and consequential changes have been required to Part A, the Introduction. Public consultation on draft revision to Part B commenced on 22 July 2015. Click here for further details.
The guidelines are primarily intended for ART practitioners, researchers, infertility clinic administrators, Human Research Ethics Committees, accreditation bodies and governments.
Use of Embryos in Research
The 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) (National Statement) 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 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.
Many aspects of clinical practice in ART raise ethical issues. The ART guidelines cover activities including:
- posthumous use of gametes
- donor conception
- sex selection
- pre-implantation genetic diagnosis (PGD).
The role of the ART guidelines in the regulation of ART
There is a robust framework for the conduct of ART in Australia. This framework consists of:
- Commonwealth legislation
- Prohibition of Human Cloning for Reproduction Act 2002
- Research Involving Human Embryos Act 2002
- State and territory legislation (see below)
- NHMRC guidelines
- The ART guidelines
- The National Statement
- The Australian code for the responsible conduct of research, 2007
- Accreditation of ART clinics by the Reproductive Technology Accreditation Committee (RTAC).
The ART guidelines underpin the regulation of ART practice within Australia. RTAC Accreditation 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.
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. When there are anomalies between the state acts and the guidelines, the legislation takes precedence.
Sex Selection through Pre-implantation Genetic Diagnosis (PGD)
The ART guidelines restrict the use of PGD for sex selection in Australia. The guidelines state that 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
Part B of the ART guidelines are currently under review. Public consultation on draft revisions commenced on 23 July 2015. Click here for further details.