THE UPDATED ETHICAL GUIDELINES ON THE USE OF ASSISTED REPRODUCTIVE TECHNIQUES (ART) IN CLINICAL PRACTICE AND

RESEARCH 2007 89

In 2007, revisions were made to the ART Guidelines. The changes are only to the extent made necessary by the amendments made by the Amendment Act 2006. Making such revisions ensure consistency between guidelines and legislation and also maintain regulatory connection. As the Amendment Act 2006 now permits SCNT activity, it is important that the interests of egg donors for this activity are fully protected.

Ethical issues surrounding exploitation of women in egg donation for SCNT purposes were fully explored in the Lockhart Report. The Hwang scandal raised some serious concerns about exploitation of women in research.90 It was therefore crucial that the guidelines pertaining to egg donation are updated and comprehensive in order to protect the interests of egg donors.

Recommendations 32 and 33 in the report are reflected in the revised ART Guidelines.91 They incorporated detailed guidelines for egg donation to protect the interests of egg donors.

It is noted that the guidelines were updated by AHEC and they were released for public consultation. 93 submissions were received and these were analysed by a sub-group of AHEC. The NHMRC considered the revised draft.92

The revised guidelines do not adopt phrase SCNT, for instance, ‗... created by means other than by fertilisation of a human egg by human sperm‘.93 In addition, there is no reference to egg or occyte. A more generic term is adopted, that is gamete, as the guidelines are intended to cover sperm donors as well.

89 _{The website is http://www.nhmrc.gov.au/publications/synopses/_files/e78.pdf. It was issued}

on June 2007

90 _{The Hwang scandal was explored in Chapter 1.4.2 of this thesis} 91

Recommendation 31 is on the current principles of consent for participation in medical research to continue, Recommendation 32 is on the development of guidelines on egg donation and Recommendation 33 is on the reimbursement to egg donors

92

See Appendix B of the ART Guidelines 2007 at 87

93

Section 17.21 provides that a person who agrees to her eggs being used in research is a research participant for the purposes of the National Statement.94 Consent to the use of stem cells developed from donated eggs must meet the requirements of the section on human stem cells in the National Statement.95 Any research involving procedures that carry significant risk of harm must be reviewed by HREC,96 for instance, the risks of long term consequences of fertility must be disclosed to potential donors.97 The HREC and the Licensing Committee must have regard to whether the donors have been fully informed about the risks to fertility and have given consent.98 The HREC must be satisfied that the potential benefits are sufficient to justify the risks associated with the donation process. In deciding whether there is sufficient benefit, HRECs must apply the guidelines on risk and benefit in the National Statement.99 Clinicians and clinical centres should encourage studies on the medical and psychological effects on the donors with a view to achieving more accurate evaluation of risk and benefit.100

The revisions made to the revised ART Guidelines 2004 comprise three areas of importance. First, on the issue of consent, the revised guidelines emphasise that donation of eggs must be voluntary and free from exploitation or coercion.101 To ensure the protection of egg donors, the guidelines provide comprehensive provisions. The potential donor should be provided with the following information both in oral and written form:

 A brief description of the project in lay language;

 A clear statement that the provision of her eggs is voluntary;

 A description of the intended use of her eggs;

 That any value for the eggs may only be realised in the long term;

 A description of the retrieval process of eggs including what will be done; where the procedure will be done and by whom;

 A statement of the potential risks of retrieving and donation of eggs;

94 _{Section 17.21 of ART Guidelines 2007} 95 _{Section 17.21.7 of ART Guidelines 2007} 96 _{Section 17.21.10 of ART Guidelines 2007} 97 _{Section 17.21.11 of ART Guidelines 2007} 98

Section 17.21.12 of ART Guidelines 2007

99 _{Section 17.21.13 of ART Guidelines 2007} 100 _{Section 17.21.17 of ART Guidelines 2007} 101

 A description of how to withdraw from egg donation;

 Her right to refuse donation for a specific project but agree to donation for another;

 A statement about the availability of counselling resources;

 How privacy will be protected;

 A statement of the potential financial and on financial interest of researchers;

 A statement that the donor will receive no financial benefits;

 A statement that the donation will not be used for any other purpose;

 A statement of any future financial gains that the researcher may receive if the research gives rise to a commercial product; and

 Any other information required by the National Statement 2007.102

Counselling on the risks and the psychological and ethical implications of donation must be offered to the donors, and the counsellors should be available at any time from before the procedures for retrieval of eggs are commenced to the time they are used in research.103 The number of cycles and intensity of ovarian stimulation should be limited.104 An egg donor may withdraw consent105 and is entitled to know the outcome of the research.106

Secondly, women who are in dependent relationships should not be permitted to be egg donors. These include relationships between researchers and students or other junior staff employed at a research institute.107 Thirdly, the statutory prohibition on selling eggs108 is reiterated in the updated guidelines.109 However, reimbursement of reasonable out-of-pocket expenses associated with the procedures is permitted for

102 _{Section 17.21.6 of ART Guidelines 2007} 103

Section 17.21.15 of ART Guidelines 2007

104 _{RTAC Code of Practice, code of practice for assisted reproductive technology units (RTAC}

2005), which is developed by the profession for the accreditation of the ART centres in Australia

105 _{Section 17.21.8 of ART Guideline s2007} 106

Section 17.21.9 of ART Guidelines 2007

107 _{Section 17.21.5 of ART Guidelines 2007. There are explanations of ‗dependent relationship‘}

at 59 of the National Statement 2007

108

Section 23 of PHC Act 2002

109

egg donorsfor the discomfort, inconvenience and risks associated with the surgical removal of eggs.110

The updated guidelines pertaining to egg donation as explored above are comprehensive and adequately protect the interests of egg donors. Had similar stringent and comprehensive regulation existed in South Korea, the Hwang scandal might have been prevented.

It is noted that the Lockhart committee conducted the law review in 2005 which was at the same time when the Hwang scandal was exposed. Thus, there were concerns raised about exploitation of women in SCNT research in the submissions made to the committee. These concerns were taken into consideration when the recommendations were made and they in turn have led to the revisions of the ART Guidelines 2004 which currently provides adequate protection to egg donors as discussed above. This provides evidence that the conduct of law reviews periodically are crucial as they would assist in ensuring regulatory connection.