National Health and Medical Research Council

This page contains frequently asked questions relating to the issuing of Licences to use excess assisted reproductive technology embryos.

What is the NHMRC Licensing Committee?

The NHMRC Embryo Research Licensing Committee is a Principal Committee of the National Health and Medical Research Council. It was established by the Research Involving Human Embryos Act 2002 passed by the Australian Parliament in December 2002.

The Committee is responsible for administering the national regulatory system prescribed by the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.

What qualifications and expertise do committee members hold?

The NHMRC Embryo Research Licensing Committee comprises 9 members as follows:

• a member of the Australian Health Ethics Committee (AHEC);
• a person with expertise in research ethics;
• a person with expertise in a relevant area of research;
• a person with expertise in assisted reproductive technology;
• a person with expertise in a relevant area of law;
• a person with expertise in consumer health issues relating to disability and disease;
• a person with expertise in consumer issues relating to assisted reproductive technology;
• a person with expertise in the regulation of assisted reproductive technology; and
• a person with expertise in embryology.

Members were appointed following extensive consultation with relevant State and Territory Ministers.

• Membership details

What does the committee do?

The Committee:

• considers applications for licences to use excess assisted reproductive technology embryos or human eggs and the creation and/or use of human embryos created other than by fertilisation;
• grants (subject to conditions) or refuses licences;
• maintains a publicly available database containing information about licences issued;
• monitors activities and ensures compliance with the legislation through appointment of inspectors, and takes necessary enforcement action, such as cancelling or suspending licences; and
• reports to the Australian Parliament on the operation of the Research Involving Human Embryos Act 2002 and the licences issued under the Act.

What is an excess assisted reproductive technology (ART) embryo?

An excess ART embryo is a human embryo created by ART for use in the ART treatment of a woman that is no longer required for IVF procedures.

An example may be where the individuals have embryos in storage from a previous ART treatment cycle, but do not want to pursue further ART treatment.

Embryos which are considered to be unsuitable for implantation according to the objective criteria may also be declared to be excess.

What criteria are used to determine whether a licence should be issued?

The legislation sets out strict criteria that the NHMRC Embryo Research Licensing Committee must consider before it issues a licence authorising the use of excess ART embryos or the creation and/or use of other embryos.

According to these criteria, the Committee must be satisfied that:

• appropriate protocols are in place to enable proper consent to be obtained before an excess ART embryo or human egg is used or other embryos are created or used and to ensure adherence to any restrictions specified by the persons for who gave consent to the use; and
• the proposed project has been considered and approved by a Human Research Ethics Committee that is constituted in accordance with, and acting in compliance with, the NHMRC's National Statement on Ethical Conduct in Human Research 2007.

The NHMRC Embryo Research Licensing Committee must also have regard to:

• restricting the number of excess ART embryos, other embryos or human eggs to that likely to be necessary to achieve the goals of the research or activity proposed in the application;
• the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means;
• any relevant guidelines, or parts of guidelines, issued by the NHMRC, as prescribed in the Regulations. Currently the relevant Guidelines are the National Statement on Ethical Conduct in Human Research (2007) and the Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research (2007); and
• the Human Research Ethics Committee's assessment of the application.
• National Statement on Ethical Conduct in Human Research (2007)
• Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research 2007

How does the legislation ensure that proper consent is obtained for the use of excess ART embryos and human eggs and the creation and/or use of other embryos?

The legislation makes it illegal to use an excess ART embryo or human egg or to create or use an embryo for licensed research without consent having been provided, in writing, by all responsible persons.

Before consenting, all responsible persons must have been provided with written information describing the proposed research.

Before issuing a licence, the NHMRC Embryo Research Licensing Committee must be satisfied that the consent protocols are appropriate and that the donors will receive appropriate information to enable them to make an informed decision about whether to donate the embryo or egg to research.

Guidelines also require that counselling is offered and an oral explanation about the proposed research is given.

What are the licence holders hoping to achieve through the use of human embryos for research?

Melbourne IVF is licensed to develop tests to improve IVF success rates for couples with specific types of infertility.

The licences issued to Genea Limited will enable them to undertake research leading to improved IVF success rates; a better understanding of embryo metabolism; and undertake specialised work to derive embryonic stem cells and to attempt to create embryos by somatic cell nuclear transfer and then, if successful, to attempt to derive embryonic stem cells from the embryos.

Monash Institute of Medical Research and Fertility Australia (trading as Fertility East Assisted Conception Clinic) have been issued with a joint licence to create parthenogenetic embryos and to attempt to derive embryonic stem cells from these embryos.

How many excess ART embryos or eggs will be used in the licensed activities?

There are currently 10 active licences issued by the NHMRC Embryo Research Licensing Committee:

• Database of Licences

Does the NHMRC Embryo Research Licensing Committee have to make information about licences issued public?

Yes. The NHMRC Embryo Research Licensing Committee will maintain a publicly available database
containing the following information in relation to each licence:

• the name of the organisation to whom the licence was issued;
• a short statement about the nature of the uses of excess ART embryos that are authorised by the licence;
• any conditions to which the licence is subject;
• the number of excess ART embryos or human eggs authorised to be used and the number of other embryos authorised ot be created or used under the licence;
• the date on which the licence was issued; and
• the date on which the licence will expire.

The database is available from the Databse of licenses.

How will the committee ensure that legislative requirements are complied with?

Section 33 of the Research Involving Human Embryos Act 2002 authorises the Chair of the NHMRC Embryo Research Licensing Committee to appoint inspectors.

NHMRC inspectors attend the premises of licence holders for the purpose of monitoring compliance with licence conditions, the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.

The inspectors are also responsible for providing information on, and monitoring compliance with the requirements of the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 more generally across all organisations undertaking activities affected by the legislation.

How many inspectors have been appointed?

The Chair of the NHMRC Embryo Research Licensing Committee appoints inspectors in accordance with the requirements of the legislation and to meet operational requirements. Between three and five inspectors' appointments are current at any one time.