The NHMRC Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research (2007) (ART guidelines) deal with the ethical aspects of research and clinical practice of assisted reproductive technology. The guidelines are primarily intended for ART practitioners, researchers, infertility clinic administrators, Human Research Ethics Committees, accrediting bodies and Governments.
The document is divided into three parts:
- Part A provides background and introductory material
- Part B provides ethical guidelines for the clinical practice of ART and
- Part C provides ethical guidelines for research consistent with the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and the Research Involving Human Embryos Act 2002 (RIHE Act).
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 in relation to human research and matters of human health. AHEC periodically reviews human ethics guidelines for currency in the Australian context.
With regard to assisted reproductive technology (ART), AHEC develops the ART guidelines. Adherence to the ART guidelines is a requirement for the accreditation of ART clinics by the Reproductive Technology Accreditation Committee, established by the Fertility Society of Australia.
The current ART guidelines were issued in 2004, with only the research guidelines updated in 2007. NHMRC recognises that ART is an important issue for the Australian community. AHEC is currently reviewing the clinical practice guidelines to ensure their ongoing relevance. A number of issues are being considered as part of this review, including:
- the use and storage of human eggs, sperm and embryos
- situations such as fertility preservation, surrogacy, pre-implantation genetic testing, sex selection, the collection and use of eggs and sperm from persons who are deceased or dying, and the use of stored eggs, sperm and embryos after the death of a person
- information giving, counselling and consent.
See ‘The Review so Far' below for further information.
The ART Working Committee
Under Section 39 of the National Health and Medical Research Council Act 1992 the CEO (or CEO approved delegate) is authorised to establish any working committee deemed necessary to assist the functions of the CEO, Council, or a Principal Committee.
The CEO establishes working committees when required to seek advice, support, research or expertise from outside NHMRC in order to achieve a specific NHMRC outcome.
Members of Council or the Principal Committees may at times be invited to participate on a working committee in their area of expertise.
The Assisted Reproductive Technology (ART) Working Committee was established on 16 April 2013 to advise the Australian Health Ethics Committee (AHEC) on the review of Part B of the ART guidelines. Appointments to the ART Working Committee conclude on 31 December 2017.
The review so far
The ART Working Committee has held six face-to-face meetings and met a further four times by teleconference.
To inform the development of revised ethical guidance in Part B of the ART guidelines, public consultation on the current ethical guidance was conducted over the period 11 March – 30 April 2014. Sixty-five submissions were received. Where NHMRC has the permission of the author, submissions are available from the NHMRC Public Consultation website.
All submissions received were considered by the ART Working Committee to inform the development of DRAFT ethical guidelines which underwent public consultation during 23 July – 17 September 2015. One hundred and eighty-seven submissions were received. Where permission has been granted, submissions to the 2015 public consultation will be available from the NHMRC Public Consultation website, once the review has been completed.
The Working Committee has considered the complex issues raised during public consultation and has finalised its advice to AHEC.
The review of Part B of the ART guidelines has also necessitated changes to Part A (the introduction). Part C (the ethical guidelines for research) is not currently under review. **Notice to dispense with public consultation on editorial changes to Part C of the ART guidelines**
Under the NHMRC Act draft ethical guidelines must be approved by AHEC and the Council of NHMRC before being issued by the NHMRC CEO.
AHEC considered the advice of the ART Working Committee at its meetings in June and August 2016. On the advice of AHEC, the draft guidelines were considered by the Council of NHMRC in November 2016. Council has sought further advice from AHEC, which will occur in early 2017.
It is anticipated the review will be finalised in 2017, however NHMRC is currently unable to provide a definitive timeframe for completion. NHMRC is unable to pre-empt the outcomes of the review until the draft ethical guidelines have gone through the relevant approvals process.
All respondents to the public consultations will be notified of the release of the final guidelines.
For further information please contact NHMRC at email@example.com.
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