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Frequently asked questions (FAQs)
on this page
- » What is the NHMRC Licensing Committee?
- » What qualifications and expertise do committee members hold?
- » What does the committee do?
- » What is an excess assisted reproductive technology (ART) embryo?
- » What criteria are used to determine whether a licence should be issued?
- » How does the legislation ensure that proper consent is obtained for the use of excess ART embryos?
- » What are the licence holders hoping to achieve through the use of human embryos for research?
- » How many excess ART embryos will be used in the licensed activities?
- » Does the NHMRC Embryo Research Licensing Committee have to makes information about licences issued public?
- » How will the committee ensure that legislative requirements are complied with?
- » How many inspectors have been appointed?
What is the NHMRC Licensing Committee?
The NHMRC Embryo Research Licensing Committee is a Principal Committee of the National Heath and Medical Research Council. It was established by the Research Involving Human Embryos Act 2002 passed by Federal Parliament in December 2002.
The Committee is responsible for administering the national regulatory system described by the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.
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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 as they relate 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. Details of membership is available from: www.nhmrc.gov.au/about/committees/lc/index.htm
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What does the committee do?
The Committee:
- considers applications for licences to use excess assisted reproductive technology embryos;
- 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 canceling or suspending licences; and
- reports to the Commonwealth Parliament on the operation of the Research Involving Human Embryos Act 2002 and the licences issued under the Research Involving Human Embryos Act 2002.
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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 and 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.
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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.
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 is used and to ensure adherence to any restrictions specified by the persons for whom the embryo was created; and
- the proposed project has been considered and approved by the Human Research Ethics Committee that is constituted in accordance with, and acting in compliance with, the NHMRC's National Statement on Ethical Conduct in Research Involving Humans.
The NHMRC Embryo Research Licensing Committee must also have regard to:
- restricting the number of excess ART embryos that are 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 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 Research Involving Humans (1999) and the Ethical Guidelines on Assisted Reproductive Technology (1996). The NHMRC has recently published new Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2004) and these are being incorporated into the Regulations; and
- the Human Research Ethics Committee's assessment of the application.
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How does the legislation ensure that proper consent is obtained for the use of excess ART embryos?
The legislation makes it illegal to use an excess ART 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 use of the excess ART embryos.
Before issuing a licence, the NHMRC Embryo Research Licensing Committee must be satisfied that the consent protocols are appropriate and that the donors have appropriate information before them to enable them to make an informed decision about whether to donate the embryo to research.
Guidelines also require that counselling is offered and an oral explanation about the proposed use of the excess ART embryos is given.
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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.
In collaboration with Stem Cell Sciences Pty Ltd, Melbourne IVF is licensed to develop improved and defined culture conditions for establishing embryonic stem cell lines.
The licences issued to Sydney IVF 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.
There is a collaborative project between IVF Australia and the Diabetes Transplant Unit, Prince of Wales Hospital, authorising work aimed at establishing six human embryonic stem cell lines for research in the treatment of diabetes.
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How many excess ART embryos or eggs will be used in the licensed activities?
There are currently 11 active licences issued by the NHMRC Embryo Research Licensing Committee:
Sydney IVF: |
|
| Licence 309701 | up to 670 embryos |
| Licence 309702A | up to 170 embryos |
| Licence 309702B | 220 embryos (170 of these must have been used in 309701 first and then transferred to 309702B) *. |
| Licence 309703 | 50 embryos |
| Licence 309710 | 100 embryos |
| Licence 309712 | 2400 eggs |
| Licence 309713 | 2400 eggs |
| Licence 309714 | 2400 eggs |
Note: (*) These Licences were granted on the condition that suitable embryos used in 309701 must then be used for 309702B. This is to ensure a minimum number of embryos are used in the research authorised in these Licences. |
|
Melbourne IVF: |
|
Licence 309704 |
up to 120 embryos |
Licence 309709 |
up to 200 embryos |
IVF Australia: |
|
Licence 309708 |
up to 100 embryos |
These details are included in the information on each licence that is provided on the NHMRC website : www.nhmrc.gov.au/embryo/monitor/database/index.htm
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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 authorised to be 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 embryo research page of the NHMRC website: www.nhmrc.gov.au/embryos/monitor/database/index.htm
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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.
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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.
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