Ethical Guidelines for Assisted Reproductive Technology (ART)

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.

NHMRC ethical guidelines on ART

Through the work of the Australian Health Ethics Committee (AHEC), NHMRC develops health advice and provides a framework for ethical behaviour in health care and in the conduct of medical research. AHEC’s advice is used by policy makers, clinicians, researchers, human research ethics committees and members of research institutions to guide decision-making on human research and matters of human health. AHEC periodically reviews human ethics guidelines for currency in the Australian context.

AHEC first issued ethical guidelines on ART in 1982 as Supplementary Note 4 (In Vitro Fertilisation and Embryo Transfer) to the then Statement on Human Experimentation (NHMRC 1966). These guidelines were rescinded when the National Health and Medical Research Council Act 1992 came into force.

Since 1992, AHEC has developed and revised the following ethical guidelines:

Information about the development of the 2017 ART guidelines is available here

Overview of the ART guidelines

The ART guidelines are divided into three parts:

The ART guidelines are used by professional organisations to set standards for the practice of ART. The ART guidelines are primarily intended for ART clinicians, clinic nurses, embryologists, counsellors and administrators, researchers, Human Research Ethics Committees, 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.

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
  • pre-implantation genetic diagnosis (PGD).

The role of the ART guidelines in the regulation of ART

In Australia there is a robust framework for the conduct of ART(in both clinical practice and in research). This framework consists of:

Commonwealth legislation

State and territory legislation

NHMRC guidelines

Accreditation 

  • Accreditation of ART clinics is the responsibility of the Reproductive Technology Accreditation Committee (RTAC), established by the Fertility Society of Australia (FSA).
    • RTAC accreditation requires ART clinics to comply with government laws and guidelines concerning the practice of ART, including NHMRC’s ART guidelines.
    • RTAC accreditation is required for services provided by clinics to be eligible for Medicare funding.