The Australian Health Ethics Committee (AHEC) is conducting a limited review of the Ethical guidelines on the use of Assisted Reproductive Technology in clinical practice and research (ART Guidelines) in response to the introduction of legislation to permit mitochondrial donation in Australia.

Public consultation on Mitochondrial Donation Supplementary Section

The Mitochondrial Donation Law Reform (Maeve's Law) Act 2022 came into effect on 2 October 2022 and amended the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) to facilitate the staged introduction of mitochondrial donation into Australian clinical IVF practice. To support the ethical implementation of this technology, AHEC has developed the 'Mitochondrial Donation Supplementary Section to the Ethical guidelines on the use of Assisted Reproductive Technology in clinical practice and research' (the Supplementary Section). Respectful contributions to this consultation process from the Australian community are encouraged, including those from individuals or on behalf of groups or organisations. The Supplementary Section is included below under 'Consultation documents'.

To make a submission to the public consultation, complete the online survey. Submissions close at 5:00 pm (AEDT) Monday 19 December 2022.

Consultation documents

The following consultation documents are available in the Downloads section at the bottom of this page:

Contact for further information

Email
mito.consultation@nhmrc.gov.au

Minor administrative amendments to ART Guidelines

Alongside the public consultation on the Supplementary Section, AHEC is making some minor administrative changes to the main body of the ART Guidelines. The changes will update the process narrative in the introduction, provide information about the updated mitochondrial donation legislation, and update the terminology used in the pre-implantation genetic testing section so that it reflects contemporary ART practice. As the changes are statements of fact and raise issues that are of minor significance only, AHEC is not required to seek public consultation (National Health and Medical Research Council Act 1992 sub section 14B(1)(b)).

A summary of proposed changes is available in the downloads section, to fulfill notification requirements in accordance with section 9 of the National Health and Medical Research Council Regulation 2016:

Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2017

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 (HREC), and governments. A history of NHMRC's involvement in developing ethical guidelines for ART is provided in Appendix 1 of the ART guidelines.

Overview of the ART Guidelines

The ART guidelines are divided into 3 parts:

Clinical practice of ART

Many aspects of clinical practice in ART raise ethical issues. The ART guidelines cover activities including:

  • the use of sperm and eggs after death (posthumous use)
  • surrogacy
  • donor conception
  • sex selection
  • pre-implantation genetic diagnosis (PGD).

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 Research Licensing Committee. The Licensing Committee must be satisfied that the research proposal has been assessed and approved by an HREC acting in accordance with the National Statement on Ethical Conduct in Human Research, 2007 (National Statement) and the ART guidelines.

Mitochondrial Donation Licensing Scheme

Eligible Australian women with a diagnosis of mitochondrial disease may have access to mitochondrial donation under amendments to the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 which took effect on 2 October 2022. The amendments allow for the introduction of this ART technique in Australia under a new licensing scheme. NHMRC's Embryo Research Licensing Committee (ERLC) is the responsible authority for the new licensing framework.

More information on the mitochondrial donation licensing scheme and ERLC's responsibilities in administering these licences, including information for licence applicants is found on mitochondrial donation licensing scheme.

Regulation of ART in Australia

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

Legislation to regulate ART exists for the following 4 states:

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.