On 23 July 2015, the National Health and Medical Research Council (NHMRC), issued a Media Release opening public consultation on proposed draft revisions to the clinical practice section of: Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research, 2007 (‘ART Guideline’).11

Assisted Reproductive Technology (ART) is the application of laboratory or clinical techniques to human eggs, sperm or embryos for the purposes of reproduction. Compliance with these guidelines is a key part of accreditation for all Australian ART clinics.

Part B of the ART Guideline (Ethical Guidelines for the Clinical Practice of ART) is the main section under review by the NHMRC, with some amendments to Part A (Introduction), however Part C (Ethical Guidelines for Research involving ART and other practices) is not part of the current review.

The main purpose of the ART Guideline is to assist clinicians with developing appropriate operating procedures in ART clinics utilising the ethical principles which are illustrated. “The Ethical Guidelines provide an overarching framework for the conduct of ART in both clinical practice and research”. 

In essence, the ART Guidelines should be adhered to “unless there is an effective alternative option that is consistent with the relevant ethical principle.”

It is the expectation of the NHMRC that the ART Guidelines will form part of the standard operating procedures utilised by ART clinicians and researchers.

The review process will be coordinated by the Australian Health Ethics Committee (‘AHEC’) and assisted by the Assisted Reproductive Technology Working Committee. Public submissions close on Thursday 17th September 2015 at 5.00pm AEST. The ART Working Committee includes experts in the field of ethics, law, religion, reproductive technology and consumer issues.

The revised ART Guideline is to operate within a framework of existing Australian State and Territory legislation, covering certain quality assurance and accreditation standards.

Some of the proposed changes to the draft ART Guidelines cover topic areas concerning the following issues:

• The use and storage of human eggs, sperm and embryos;
• Specific situations such as fertility preservation, surrogacy, preimplantation genetic testing, 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 the person;
• The provision of counselling, information, and consent requirements.

Some of the other considerations factored into the draft ART Guidelines include:

• A clearer identification of ethical principles which are relevant to ART clinical practice (and associated guidance to apply these principles);
• Changes in technology and community sentiment to be reflected; and
• Making the document more “user friendly”.

The Ethical Principles in the Clinical Practice of ART adopts a ‘rights-based’ framework, and in particular, respect for human rights is relevant to the development and implementation of health polices, laws and practices, including those that relate to assisted reproduction.

The principles and valued are defined as follows:

Respect – the right for individuals to be treated with dignity and to have their autonomy respected;

Justice – which is concerned with equality and fairness;

Solidarity – ‘standing together’ as a group, community or nation;

Altruism – seeking the welfare of others, with no expectation of personal reward or gain;

Transparency – the disclosure of clear and accurate information about activities and decision-making processes; and

Effectiveness and Efficiency of practices and resources.

The draft ethical principles include:

• ART activities must be conducted in a way that shows respect to all involved;
• Decision-making in the clinical practice of ART must be undertaken in a manner that protects from harm each individual or couple involved in ART activities and any persons who would be born;
• Decision-making in the clinical practice of ART must recognise and take into account the biological connections and social relationships that exist or may be formed;
• Decision-making about ART activities must recognise and respect the autonomy of each individual or couple involved;
• Processes and policies for determining an individual’s or couple’s eligibility to access ART services must be just, equitable and respectful of the inherent dignity and of the equal and inalienable rights of all persons;
• Donation of gametes or embryos or the provision of surrogacy services is an act of altruism and solidarity that provides significant benefits to those requiring assisted conception; and
• The provision of ART must be transparent and open to scrutiny, while ensuring the protection of the privacy of all individuals or couples involved in ART and persons born.

The NHMRC has stated that it is extremely interested in receiving comments in connection with the following subject areas:

• The establishment of an Australian donor egg bank;
• Sex-selection for non-medical purposes; and
• Monetary compensation for the reproductive effort/risks in connection with egg donation for Australian women.

This article was included in the recent Holman Webb Health Law Bulletin.  To read other articles in the September edition of the bulletin, please click here.

11 Australian Government – National Health and Medical Research Council Media Release“Feedback Sought on Draft Revisions to Ethical Guidelines for Assisted Technology” (23 July 2015). Australian Government – National Health and Medical Research Council - Public Consultation Paper: Draft Ethical Guidelines on the Use of for Assisted Reproductive Technology in Clinical Practice and Research” (15 July 2015).