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Research Involving Human Embryos Act 2002—Report on the operation of the Act for the period 1 September 2017 to 28 February 2018


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NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 MARCH 2015 TO 31 AUGUST 2015

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NHMRC Embryo Research Licensing Committee

Report to the Parliament of Australia For the period 1 September 2017 to 28 February 2018

NHMRC Embryo Research Licensing Committee

Report to the Parliament of Australia For the period 1 September 2017 to 28 February 2018

Publication Details

Publication title: NHMRC Embryo Research Licensing Committee: Report to the Parliament of Australia for the period 1 September 2017 to 28 February 2018

Published: June 2018

Publisher: National Health and Medical Research Council

NHMRC Publication reference: HC53

Online version: www.nhmrc.gov.au/guidelines/publications/hc5 3

IISBN Online: 978-1-86496-021-1

Suggested citation: National Health and Medical Research Council (2018)

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© Commonwealth of Australia 2018

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www.nhmrc.gov.au

The Hon Greg Hunt MP Minister for Health Parliament House Canberra ACT 2600

Dear Minister Hunt

I am pleased to present to you the thirty-first biannual report from the NHMRC Embryo Research Licensing Committee (the NHMRC Licensing Committee), which, in accordance with section 19(3) of Research Involving Human Embryos Act 2002 (the Act), reports on the operation of the Act and the licences issued under it.

This report is for the period 1 September 2017 to 28 February 2018 and describes the activities the NHMRC Licensing Committee has undertaken during this reporting period, including associated monitoring and compliance activities.

The NHMRC Licensing Committee met twice during this reporting period, and has considered one licence application and eight applications seeking to vary previously issued licences for the use of excess assisted reproductive technology embryos and human eggs. In total twenty-one licences have been issued under the Act since the legislation commenced, of which eight were current at 28 February 2018.

Yours sincerely

Professor Constantine (Con) Michael AO Chairperson NHMRC Embryo Research Licensing Committee April 2018

Contents

Introduction 1

Legislative framework 1

Reporting to Parliament 1

Further information 2

Membership of the NHMRC Licensing Committee 3

Functions 3

Operation of the NHMRC Licensing Committee 4

Committee meetings 4

Consideration of licence applications 4

New licences issued 4

Variations to existing licences 4

Progress of licensed activities 6

Licence holder reports 6

Licensed use of excess ART embryos 8

Licensed use of human eggs or creation of other embryos 9

Monitoring compliance with the legislation 10

Monitoring activities 10

Communication and awareness 11

Information exchange visits 11

Appendix A: Current membership of the NHMRC Licensing Committee 12

Appendix B: Variations to licences 13

Appendix C: Corresponding State and Territory legislation 14

Appendix D: Glossary of Common Terms 15

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

INTRODUCTION

1

Introduction

Legislative framework

The Commonwealth Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and Research Involving Human Embryos Act 2002 (RIHE Act) were developed to address community concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos in research activities. The legislation prohibits human cloning for reproductive purposes and a range of other practices relating to reproductive technology. It also regulates research activities that involve the use of human embryos created by assisted reproductive technology (ART) or by other means. There are strong penalties for non-compliance with the legislation.

The RIHE Act established the Embryo Research Licensing Committee of the National Health and Medical Research Council (the NHMRC Licensing Committee) as a Principal Committee of the NHMRC. One of the functions of the NHMRC Licensing Committee is to consider applications for licences to conduct research involving human embryos. As required under section 29 of the RIHE Act, the NHMRC Licensing Committee maintains a publicly available database containing information about licences issued. This database can be accessed on the NHMRC website at www.nhmrc.gov.au.

In April 2002 and again in April 2007, the Council of Australian Governments agreed to introduce nationally consistent legislation to support the regulatory framework. Information about the implementation of complementary State and Territory legislation is included at Appendix C to this report.

Reporting to Parliament

Section 19(3) of the RIHE Act requires the NHMRC Licensing Committee to table six-monthly reports in either House of Parliament on or before 30 June and 31 December each year, and at any other time as required by either House of Parliament. The reports must include information about the operation of the RIHE Act and about licences issued under this Act.

This is the thirty-first Parliamentary Report of the NHMRC Licensing Committee, which covers the period 1 September 2017 to 28 February 2018.

INTRODUCTION

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 2

Further information

Further information about this report and the issue of licences can be obtained by contacting:

The Director, Strategic Projects and Support Research Quality and Priorities NHMRC GPO Box 1421 CANBERRA ACT 2601 Telephone: 02 6217 9000 Website: www.nhmrc.gov.au

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

MEMBERSHIP OF THE NHMRC LICENSING COMMITTEE

3

Membership of the NHMRC Licensing Committee

The NHMRC Licensing Committee was established in May 2003 under the Research Involving Human Embryos Act 2002 (RIHE Act) which was passed by Federal Parliament in December 2002.

NHMRC Licensing Committee appointments for the 2015-2018 NHMRC triennium commenced on 13 August 2015. The current NHMRC Licensing Committee was appointed by the Minister for Health following consultation with relevant State and Territory Ministers and other bodies prescribed in the regulations under the RIHE Act.

Members are appointed on a part-time basis for a period not exceeding three years, as specified in the instrument of appointment, and are eligible for reappointment. The nine-member NHMRC Licensing Committee is responsible for making statutory decisions as outlined in the RIHE Act.

The membership of the NHMRC Licensing Committee is detailed at Appendix A.

Functions

Established as a Principal Committee of the NHMRC, the functions of the NHMRC Licensing Committee are to:

• consider applications for licences to conduct research involving human embryos

• issue (subject to conditions) or not issue such licences

• maintain a publicly available database containing information about licences issued

• monitor licensed activities and ensure compliance with the legislation through the appointment of inspectors and take necessary enforcement action, such as cancelling or suspending licences

• report to the Parliament of Australia on the operation of the RIHE Act and the licences issued under this Act

• perform such other functions as are conferred on it by the RIHE Act or any other relevant law.

OPERATION OF THE NHMRC LICENSING COMMITTEE

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 4

Operation of the NHMRC Licensing Committee

Committee meetings

During the reporting period the NHMRC Licensing Committee met on 5 October 2017 and 13 February 2018.

Consideration of licence applications

One new licence application was received during the reporting period and the NHMRC Licensing Committee completed its assessment of the application received during the previous reporting period.

New licences issued

One licence was issued during the reporting period. On 1 September 2017, the NHMRC Licensing Committee issued Licence 309725 to TasIVF Pty Ltd. The licence permits TasIVF Pty Ltd to use excess ART embryos to train embryologists in the technique of blastocyst stage embryo biopsy.

Variations to existing licences

The RIHE Act empowers the NHMRC Licensing Committee to vary a licence. Variations to licences may either be requested by the licence holder or initiated by the committee. Variations may be of an administrative nature (e.g. change to site address) or may relate to aspects of the authorised activities (e.g. number of embryos used).

During the reporting period the NHMRC Licensing Committee approved eight variations to licences.

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

OPERATION OF THE NHMRC LICENSING COMMITTEE

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Seven variations were initiated by licence holders as follows:

• one variation related to the extension of a licence

• one variation related to changes to reporting requirements

• five variations involved changes to the lists of persons authorised to conduct the licensed activities.

One variation was initiated by the NHMRC Licensing Committee. It involved changes to reporting requirements.

Further information about variations to existing licences approved during the reporting period is at Appendix B.

PROGRESS OF LICENSED ACTIVITIES

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 6

Progress of licensed activities

Licence holder reports

Licence holders are required to report every six months on the progress of their licensed activities. The following reports on the outcomes are provided here as received from the licence holders.

Current licences

Licence number 309702B

Licence holder Genea Limited

Licence title Development of methods for pre-implantation genetic and metabolic evaluation of human embryos

Progress of licensed activity to date No work has been carried out in this reporting period.

Licence number 309703

Licence holder Genea Limited

Licence title Development of human embryonic stem (ES) cells

Progress of licensed activity to date Under this licence we have derived a total of thirty (30) cell lines, four of which are karyotypically abnormal.

Cell lines from this licence have been registered at the NIH registry and have been approved by the Steering Committee of the UK Stem Cell Bank for research use in the UK.

Cell lines are available to researchers worldwide for basic disease research and drug development projects. Various distribution services aid in this process.

Licence number 309710

Licence holder Genea Limited

Licence title Derivation of human embryonic stem cells from embryos identified through preimplantation genetic diagnosis to be affected by known serious monogenic conditions

Progress of licensed activity to date Under this licence, a total of forty-six (46) affected stem cell lines have been derived, four of which are karyotypically abnormal.

Cell lines from this licence have been registered at the NIH registry and have been approved by the Steering Committee of the UK Stem Cell Bank for research use in the UK.

Cell lines are available to researchers worldwide for basic disease research and drug development projects. Various distribution services aid in this process.

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

PROGRESS OF LICENSED ACTIVITIES

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Licence number 309718

Licence holder Genea Limited

Licence title Use of excess ART embryos and clinically unusable eggs for validation of an IVF device

Progress of licensed activity to date Over the lifetime of the project, clinically unsuitable abnormally fertilised eggs and excess-declared ART blastocysts have been used to develop an automated vitrification instrument

(Gavi) for freezing of zygotes, day 3 and blastocyst stage embryos. After several protocol optimisations and development of consumables, the instrument and consumables are now in their final version and manufacturing is taking place. The instrument and media are CE marked products and are commercially distributed. The Gavi system now has approved protocols for freezing of blastocyst stage, zygotes and cleavage stage embryos. Further optimisations for the different developmental stages may be required depending on market feedback.

Licence number 309719

Licence holder Genea Limited

Licence title Use of excess ART embryos for the development of improved IVF culture media

Progress of licensed activity to date The research activities which are currently being conducted involve the assessment of the viability of an alternate mineral oil product. Future work may involve further advances

to the Gems Media Suite, ultimately leading to improved clinical outcomes.

Licence number 309723

Licence holder Melbourne IVF Pty Ltd

Licence title Use of excess ART embryos for blastocyst-stage biopsy training

Progress of licensed activity to date Licence Number 309723 involves the use of excess ART embryos to train scientists in the technique of embryo biopsy at the blastocyst stage of development. This technique

involves removal of a small piece of tissue (trophectoderm) from the embryo and the processing of this tissue in a way that allows it to be subjected to genetic testing. The licence was renewed for the next three years.

Licence number 309724

Licence holder IVFAustralia Pty Ltd

Licence title Use of excess ART embryos for blastocyst-stage biopsy training

Progress of licensed activity to date Licence Number 309724 involves the use of excess ART embryos in the final step of their blastocyst biopsy training. This technique involves removal of a small piece of tissue

(trophectoderm) from the blastocyst and the processing of this tissue in a way that allows it to be subjected to genetic testing.

In the last six months activities under this licence have resulted in one scientist demonstrating proficiency in this technique to a level required for clinical application.

Licence number 309725

Licence holder TasIVF Pty Ltd

Licence title Use of excess ART embryos for blastocyst-stage embryo biopsy training

Progress of licensed activity to date This reporting period involved obtaining patient consent to use excess embryos for training and observing the cooling off period.

Training is just about to commence as the required minimum of 25 embryos has been obtained (condition number 9105).

PROGRESS OF LICENSED ACTIVITIES

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 8

Licensed use of excess ART embryos

The following table shows the use of excess ART embryos under licence, as at 28 February 2018.

Current licences

Licence number Licence holder Licence title Embryos

authorised to be used under licence

Embryos used in licensed activity up to 28 February 2018

Embryos used during the reporting period

309702B Genea Limited Development of methods for pre-implantation genetic and metabolic evaluation of human embryos

220 58 0

309703 Genea Limited Development of human embryonic stem (ES) cells

300

(plus up to 20 inner cell masses which may be transferred from

309702A or 309702B)

249

(plus 12 embryos first used in 309702A and then transferred

to 309703)

0

309710 Genea Limited Derivation of human embryonic stem cells from embryos identified through preimplantation genetic diagnosis to be affected by known genetic conditions

500 304 0

309718 Genea Limited Use of excess ART embryos and clinically unusable eggs for validation of an IVF device

345 259 0

309719 Genea Limited Use of excess ART embryos for the development of improved IVF culture media

640 58 20

309723 Melbourne IVF Pty Ltd Use of excess ART embryos for

blastocyst-stage biopsy training

2501 142 0

1 Melbourne IVF is permitted to thaw 50 embryos for each authorised trainee. The total number of embryos authorised to be used under this licence is determined from the total number of authorised trainees.

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

PROGRESS OF LICENSED ACTIVITIES

9

Licence number Licence holder Licence title Embryos

authorised to be used under licence

Embryos used in licensed activity up to 28 February 2018

Embryos used during the reporting period

309724 IVFAustralia Pty Ltd Use of excess ART embryos for

blastocyst-stage biopsy training

120 2 13 9

309725 TasIVF Pty Ltd Use of excess ART embryos for blastocyst-stage embryo biopsy training

104 3 0 0

Total for current licences 2479 1083 29

Licensed use of human eggs or creation of other embryos

The following tables show the use of human eggs or creation of other embryos under licence, as at 28 February 2018. “Other embryos” is the term used in the RIHE Act to refer to human embryos created by processes other than fertilisation of a human egg by a human sperm.

Current licences

Licence number Licence holder

Licence title Eggs authorised

to be used under licence

Eggs used in licensed activity up to 28 February 2018

Eggs used during the

reporting period

309718 Genea Limited Use of excess ART embryos and

clinically unusable eggs for validation of an IVF device

1000 407 0

Total 1000 407 0

2 IVFAustralia is permitted to thaw 24 embryos for each authorised trainee. The total number of embryos authorised to be used under this licence is determined from the total number of authorised trainees.

3 TasIVF is permitted to thaw up to 52 embryos for each authorised trainee. The total number of embryos authorised to be used under this licence is determined from the total number of authorised trainees.

MONITORING COMPLIANCE wITH THE LEGISLATION

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Monitoring compliance with the legislation

The NHMRC is committed to ensuring that individuals and licence holder organisations comply with both the RIHE Act and the PHCR Act. The legislation establishes a Monitoring and Compliance Framework, which involves the appointment of inspectors and the conduct of a range of monitoring and compliance activities. Further information about the Monitoring and Compliance Framework can be found on the NHMRC website at www.nhmrc.gov.au.

Monitoring activities

NHMRC inspectors did not conduct any monitoring activities during the reporting period.

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

COMMUNICATION AND AwARENESS

11

Communication and awareness

The NHMRC Licensing Committee has published an information kit that can be accessed on the NHMRC website at: www.nhmrc.gov.au. Researchers and other interested people can contact the committee by e-mail or telephone. The committee responds to all queries received.

Information exchange visits

No information exchange visits were conducted during this reporting period.

APPENDIx A: CURRENT MEMBERSHIP OF THE NHMRC LICENSING COMMITTEE

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 12

Appendix A: Current membership of the NHMRC Licensing Committee

Members of the NHMRC Licensing Committee for the 2015-2018 triennium are:

Professor Constantine (Con) Michael AO, Western Australia (Chairperson) A person with expertise in the regulation of assisted reproductive technology

Professor Dianne Nicol, Tasmania A member of the Australian Health Ethics Committee (AHEC)

Professor Sheryl de Lacey, South Australia A person with expertise in research ethics

Professor Martin Pera, USA (formerly Victoria) A person with expertise in a relevant area of research

Dr Anne Clark, New South Wales A person with expertise in assisted reproductive technology

Associate Professor Bernadette Richards, South Australia A person with expertise in a relevant area of law

Mr Robert Pask, Victoria A person with expertise in consumer health issues relating to disability and disease

Professor Patrick Tam, New South Wales A person with expertise in embryology

Ms Kay Oke OAM, Victoria A person with expertise in consumer issues relating to assisted reproductive technology

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

APPENDIx B: VARIATIONS TO LICENCES

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Appendix B: Variations to licences

During the reporting period, the NHMRC Licensing Committee approved the following variations to existing licences:

Licence No. Organisation Date of variation Brief description of variation

309702B Genea Limited 6 November 2017 Addition of new authorised persons

309718 Genea Limited 6 November 2017 Variation to reporting conditions

309723 Melbourne IVF 28 November 2017 Extension of licence

Variation to reporting conditions

309719 Genea Limited 6 December 2017 Addition of new authorised persons

309703 309710 309718

Genea Limited 28 February 2018 Departure of authorised persons

APPENDIx C: CORRESPONDING STATE AND TERRITORY LEGISLATION

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 14

Appendix C: Corresponding State and Territory legislation

Following the passage of the Prohibition of Human Cloning and the Regulation of Human Embryo Research Amendment Act 2006, embryo research in Australia must comply with both Commonwealth and corresponding State and Territory legislation. At the 13 April 2007 Council of Australian Governments (COAG) meeting, all jurisdictions (except the Northern Territory) restated their commitment to introduce nationally consistent legislation.

Victoria, New South Wales, Tasmania, Queensland, the Australian Capital Territory and South Australia have all passed amending complementary legislation.

Queensland, Tasmania, South Australia and the Australian Capital Territory have had their legislation declared as a corresponding law by the Minister responsible for the Research Involving Human Embryos Act 2002.

The relevant State and Territory legislation is as follows:

Victoria Research Involving Human Embryos Act 2008 Prohibition of Human Cloning for Reproduction Act 2008

New South Wales Human Cloning for Reproduction and Other Prohibited Practices Act 2003 Research Involving Human Embryos (New South Wales) Act 2003

Tasmania Human Embryonic Research Regulation Act 2003 Human Cloning for Reproduction and Other Prohibited Practices Act 2003

Queensland Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003

South Australia Prohibition of Human Cloning for Reproduction Act 2003 Research Involving Human Embryos Act 2003

Australian Capital Territory Human Cloning and Embryo Research Act 2004

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

APPENDIx D: GLOSSARY OF COMMON TERMS

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Appendix D: Glossary of Common Terms

Term Description

AHEC Australian Health Ethics Committee (a Principal Committee of the National Health and Medical Research Council).

Application for a licence Application form for a licence to conduct research activities permitted under section 20(1) of the Research Involving

Human Embryos Act 2002.

ART Assisted reproductive technology.

ART embryo A human embryo that was created by assisted reproductive technology for use in the assisted reproductive technology treatment of a woman.

Blastocyst A 5 to 7 day-old embryo that has an outer layer of cells and a fluid filled cavity in which there is a cluster of cells called the inner cell mass.

COAG The Council of Australian Governments is the peak intergovernmental forum in Australia. The members of COAG are the Prime Minister, State and Territory Premiers and Chief Ministers and the President of the Australian Local Government Association.

Compliance Ensuring that the requirements of the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 are met.

Embryonic Stem Cell An undifferentiated cell that is a precursor to many different cell types, obtained from a preimplantation

embryo, usually at blastocyst stage.

APPENDIx D: GLOSSARY OF COMMON TERMS

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018 16

Term Description

Excess ART embryo

An ART embryo that is excess to the needs of the woman for whom it was created and her spouse (if any) at the time the embryo was created, as determined in writing by section 9 of the Research Involving Human Embryos Act 2002.

Gamete A human sperm or egg (ovum or oocyte).

HREC A human research ethics committee.

Human Embryo Clone A human embryo that is a genetic copy of another living or dead human.

Information Exchange Visit A pre-arranged visit by NHMRC inspectors to provide information about the legislation to interested stakeholders.

Inspection An inspection of records, documents and premises to ensure compliance with licence conditions and the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.

Investigation An inquiry into a suspected breach of the legislation with the aim of gathering evidence. An investigation may be initiated as a consequence of monitoring by NHMRC inspectors, self-reporting or third party reporting.

IVF In vitro fertilisation.

Monitoring Activities conducted to assess the level of compliance with licence conditions, the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.

NHMRC National Health and Medical Research Council.

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 SEPTEMBER 2017 TO 28 FEBRUARY 2018

APPENDIx D: GLOSSARY OF COMMON TERMS

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Term Description

NHMRC Licensing Committee The Embryo Research Licensing Committee of the National Health and Medical Research Council.

“Other embryos” “Other embryos” is the term used in the Research Involving Human Embryos Act 2002 to refer to human embryos created by processes other than fertilisation of a human egg by a human sperm.

Parthenogenetic A process in which an unfertilised egg can be induced to develop like an embryo.

Preimplantation Genetic Diagnosis A procedure used prior to implantation to detect serious genetic conditions, diseases or abnormalities, to which the

gamete providers are known to be at risk, to carry or to be predisposed.

Proper Consent Consent obtained in accordance with the Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research 2017, issued by the NHMRC.

Somatic Cell Nuclear Transfer (SCNT)

A laboratory technique used to create a human embryo clone involving removing the nucleus of a human egg and replacing it with the genetic material from a somatic cell (such as a skin cell or fibroblast) or stem cell line.

SCNT Construct An entity created by the process of SCNT, which may or may not divide to become an “other embryo”.

NHMRC EMBRYO RESEARCH LICENSING COMMITTEE: REPORT TO THE PARLIAMENT OF AUSTRALIA FOR THE PERIOD 1 MARCH 2015 TO 31 AUGUST 2015 A

www.nhmrc.gov.au GPO Box 1421, Canberra ACT 2601 16 Marcus Clarke Street, Canberra City ACT

T. 13 000 NHMRC (13 000 64672) or +61 2 6217 9000 F. 61 2 6217 9100 E. nhmrc@nhmrc.gov.au