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Ethical guidelines on the use of assisted reproductive technology in clinical practice and research: information issues

Ethical guidelines on the use of assisted reproductive technology in clinical practice and research: information issues

Published on November 13, 2017 by Bill Madden

As first published in the Australian Health Law Bulletin, October 2017, p 156 – 158

Abstract

2017 saw the release of revised Australian ethical guidelines on the use of assisted reproductive technology (ART) in both clinical practice and in research. This article focuses on some information provision issues addressed in the guidelines, which appear far wider than the expectations of the common law.

Through the work of the Australian Health Ethics Committee (AHEC), the National Health and Medical Research Council (NHMRC) develops health advice and provides a framework for ethical behaviour in health care and in the conduct of medical research. Earlier in 2017, the NHMRC released the revised Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research[1] (the ART Ethical Guide­ lines), having first issued ethical guidelines some 35 years ago in 1982. The increasing significance of such guidelines is highlighted by the introductory observation that “1 in 25 individuals who gave birth in Australia in 2012 [used] some form of ART to do so”.[2]

The NHMRC observes that many aspects of clinical practice in ART raise ethical issues. Accordingly, the new ART Ethical Guidelines cover activities including:

  • fertility preservation;
  • the posthumous use of gametes;
  • surrogacy;
  • donor conception; sex selection; and
  • pre-implantation genetic diagnosis.

The ART Ethical Guidelines exists against a legislative framework at the Commonwealth level[3] and in some Australian states.[4] It was at around the same time as the release of the ART Ethical Guidelines that a report on the South Australian legislative regime was released, entitled the Report on the Review of the Assisted Reproductive Treatment Act 1988 (SA) by Dr Sonia Allan.[5]

This article focuses on some of the consent/information provision requirements addressed in Pt B (Ch 4) of the guidelines, which appear far wider than the expectations of the common law.

Consent elements

In the introductory part of the ART Ethical Guide­ lines,[6] consent issues are described in a level of detail going well beyond the traditional legal expectations of material risk and information disclosure in Rogers v Whitaker.[7] The ART Ethical Guidelines expects much more than appears to have been expected by the courts, in cases such as Morocz v Marshman [8] where Harrison J addressed the surgeon’s own history and experience[9] and the concept of a therapeutic veto.[10]

Matters required by the ART Ethical Guidelines to be addressed extend far beyond material risks. They include:

  • the options for the use or discard of gametes or embryos (including options that are legal but may not be offered at the particular clinic);
  • whether the proposed procedure or treatment is accepted practice or an innovative practice;[11]
  • the experience of the clinic and the clinician with the procedure, including any clinically relevant outcomes and success rates;[12]
  • an explanation that certain procedures may be undertaken by persons other than the individual’s or couple’s treating clinician; [13] and
  • whether any training activities are intended to be conducted in the course of the treatment.

Explanation is required of all costs involved for relevant parties along with the clinic’s privacy and record keeping policies, including an explanation of any mandatory uses or reporting of data and options for participation in a current research study or any possibility of future requests for participation in research studies.

Donor information

The ART Ethical Guidelines require[14] recipients of donated gametes or embryos to be allowed access to information about gamete donors including medical history, family history and any existing genetic test results that are relevant to the future health of the person who would be born. They also require details of the physical characteristics of the gamete donor and the number, age and sex of persons already born from the gametes provided by the same gamete donor and the number of families involved.

Conflicts of interest

It is noteworthy that the ART Ethical Guidelines emphasise that the safety and wellbeing of patients should take priority over the commercial, financial, personal or other interests of the clinic or clinician. With that in mind, an obligation is placed on clinics to ensure (and to document) that the clinical team discloses any interests, including any commercial, financial or personal interests relating to the services provided or any treatment or procedure recommended by the treating clinicians.[15]

Risks of treatment overseas

Clinics approached by an individual or a couple for advice on undertaking ART overseas have an ethical obligation under the ART Ethical Guidelines to advise of any concerns about the standard of care in the overseas clinic.[16] Where an individual or couple has made an autonomous decision to seek ART overseas, a clinician may feel they have an ethical obligation to participate in elements of the treatment of the individual or couple in order to minimise potential harms, however clinicians have no obligation to participate in such treatment.[17] The ART Ethical Guidelines expressly address conscientious objection. The passage is succinct and self-explanatory:

A member of staff or a student who expresses a conscientious objection to the treatment of an individual patient or to an ART procedure is not obliged to be involved in that treatment or procedure, so long as the objection does not contravene relevant anti-discrimination laws and does not compromise the clinical care of the patient (e.g. the patient is referred to someone without a conscientious objection and is willing to accept their care). The clinic must allow a member of staff or a student who expresses a lawful conscientious objection to withdraw from involvement and ensure that the member of staff or student is not disadvantaged because of their lawful conscientious objection.[18]

Counselling services

The ART Ethical Guidelines provide that individuals and couples involved in a donor conception program must undergo counselling because of the complex nature of the issues involved.[19] Counselling must include a detailed discussion of the potential long-term psychosocial implications for each individual and each family involved, including the person who would be born and any other child within the family units who may be affected by that birth.[20]

Conclusion

The author is not aware of any medical negligence compensation claims which have, thus far, grappled with the legal implications of the much wider consent frame­ work required by the ART Ethical Guidelines in ART settings.[21] Such claims will probably arise in due course and it will be of interest to see what impact is placed by the courts on the obligations and standards set out in the ART Ethical Guidelines. Even without that challenge, ongoing development of assisted reproduction technologies has the potential to raise new ethical issues. This is recognised in the revised 2017 ART Ethical Guidelines, which makes reference to research occurring internationally that might raise additional ethical issues such as:[22]

  • editing of the embryonic genome;
  • mitochondrial donation to prevent of the transmission of mitochondrial disease; and
  • prolonged culture of embryos.

No doubt further revised guidelines will follow as the technologies develop, with accompanying needs for more complex consent discussions with prospective patients.


[1] NHMRC Ethical Guidelines on the Use of Assisted  Reproduc­ tive Technology in Clinical Practice and Research(2017)https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/ethics/16506_nhmrc_-_ethical_guidelines_on_the_use_of_assisted_reproductive_technology-web.pdf.

[2] Above n 1, p 13.

[3] Research Involving Human Embryos Act 2002 (Cth); Prohibition of Human Cloning for Reproduction Act 2002 (Cth).

[4] Assisted Reproductive Technology Act 2007 (NSW); Assisted Reproductive Treatment Act 1988 (SA); Assisted Reproductive Treatment Act 2008 (Vic); Human Reproductive Technology Act 1991 (WA) and Surrogacy Act 2008 (WA).

[5] S Allan Report on the Review of the Assisted Reproductive Treatment Act 1988 (SA) (2017) http://assels.yoursay.sa.gov.au/s3.amazonaws.com/production/2017/04/12/03/32/44/2b7ffad1-7400-4d0c-aca3-77d7c790f337/ARTReview_AllanReport 2017.pdf.

[6] Above n 1, p 30.

[7] Rogers  v Whitaker (1992) 175 CLR 479; (1992) 109 ALR (1992) 67 ALJR 47; BC9202689.

[8] Morocz v Marshman [2015] NSWSC 325; BC201502687.

[9] Above n 8, at [192].

[10] Above n 8, at [182].

[11] Compare with Hall v Petros [2004] WADC 87; Health Care Complaints Commission v Bours (No J) [2014] NSWCATOD 113.

[12] Compare with G & C v Down (2008) 258 LSJS 150; [2008] SADC 135.

[13] Compare with Tinnock v Murrumbidgee Local Health District (No 6) [2017] NSWSC 1003; BC201706305.

[14] Above n l, p 32.

[15] Above n 1, p 28.

[16] Above n 1, p 33.

[17] Above n 1, p 34.

[18] Above n l, p 26

[19] Above n l, p 35

[20] Judicial mention has been made of circumstances in which a claimant has been sent for assessment by a psychiatrist before treatment See Hanis v Bellemore [2010] NSWSC 176; BC201001710 at [62].

[21] Cases have arisen in the context of ART errors. See ACB v Thomson Medical Pty Ltd [2017] SGCA 20; G & M v Armellin [2009] ACTCA 6; BC200903375.

[22] Above n 1, p 134.

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