28 April 2014
Project Officer –Assisted Reproductive Technology
Health & Research Ethics Section, NHMRC
GPO Box 1421, Canberra ACT 2601
Dear Sir/Madam,
Re: Review of Part B of the Ethical Guidelines for the Use of Assisted
Reproductive Technology in Clinical Practice and Research, 2007
Thank you for the opportunity to make a submission to the Review of Part B of
the Guidelines. A submission on behalf of Embryo Donation Network is attached.
Please contact me on [NHMRC has removed personal information]if you require
any additional information.
Regards,
Angela Ferguson
President
Embryo Donation Network
[NHMRC has removed personal information]
admin@embryodonation.org.au
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www.embryodonation.org.au
INC: 9897478
Name:
Organisation*:
Angela Ferguson & Marieke McPhail
Embryo Donation Network
*Please only include the name of the organisation here if the submission reflects the views of the organisation
About Embryo Donation Network
Embryo Donation Network is an independent not-for-profit organisation with a national
network. We provide information, support and advocacy around embryo donation. Our
volunteers have personal and professional experience relevant to embryo donation, and
are available to provide peer support and answer questions. Our comprehensive website
(embryodonation.org.au) provides easy to understand information about embryo donation
in Australia. Our online public classifieds provide a platform for clients to advertise for an
embryo donor or recipient. We also assist clients to find a suitable match by providing a
private forum where they can view more detailed profiles of donors or recipients, and help
clients to find out more about their potential match before they make direct contact.
Scope Of The Submission
This review of Part B of the Guidelines is an opportunity for Embryo Donation Network to
inform the Committee of the significant issues that those in our network experience.
Embryo Donation Network will address in this submission the areas of practice in which
we see inconsistency between clinical practice and the Guidelines or alternatively where
the issue is not adequately addressed in the Guidelines. We will draw from the research
that has informed our practice, as well as the feedback from, and personal experience of,
our members. The sections we will refer to are:
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Section 5.2
Section 6.1
Section 6.9
Section 7
Section 7.2
Section 8
Ethical Basis Of The Submission
Embryo Donation Network has based this submission primarily on the following ethical
principles, found in the Guidelines:
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‘Respect for all participants’ (Section 5.1)
‘Respect for human embryos’ (Section 5.2)
‘Use open and consistent decision making’ (Section 5.3),
‘Provide information and counselling’ (Section 5.4), as part of the duty of care that
clinics have to patients during their ART journey.
We have also made reference to ‘the autonomy and long-term welfare of individuals who
take part in ART or research’ (Section 2.6), and the need for ‘informed decision making’
(Section 2.6).
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5 Ethical principles for clinical practice of ART
Specific Questions
Section 5.2
Q7. Should there be a mandatory requirement for clinics to have policies and procedures
around embryos which are excess to the requirements of patients?
Policies and procedures around unused embryos
There should be a mandatory requirement for clinics to have policies and
procedures around unused embryos. It is widely accepted that decisions
about unused embryos can be very difficult for patients (Blyth, Frith, Paul &
Berger, 2011; McMahon & Saunders 2009). However, evidence from the
literature and our experience suggests that this decision is not always well
supported by clinics (see e.g. de Lacey, 2007; Fuscaldo, Russell, & Gillam,
2007; Nachtigall, MacDougall, Lee, Harrington, & Becker, 2010). Therefore
clinics should be required to have adequate policies and procedures around
embryo disposition and related decision-making.
Section 5.2 of the Guidelines should include a requirement for contact to be
made with patients by a clinical member of staff (e.g. a counsellor or nurse) a
year before the embryos reach the limit of their storage time. The aim of this
contact would provide support and information around embryo disposition
options, thereby reducing possible psychological distress (Fuscaldo et al.,
2007). We would maintain that mandating such contact is commensurate with
respecting the emotional, psychological and relational significance of this
decision for many patients, and is part of clinics’ duty of care for their patients.
Having this contact a full year prior to the storage time limit would allow
adequate time to pursue any of the options for disposition of embryos listed at
8.5.1 of the Guidelines, with embryo donation being the most time-sensitive
option.
In addition, the Guidelines should encourage clinics to provide as many
options as possible for patients with unused embryos, so that individuals can
find the one that is most closely aligned with their personal preferences.
Clinics should provide information on all possible embryo disposition options
(as stipulated at 8.5.1), even if not available at that particular clinic. This would
then allow patients to participate in informed decision making.
Recommendations:
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Section 5.2 should include a requirement that clinics have adequate policies
and procedures around unused embryos.
Section 5.2 should include a requirement that contact be made with patients by
a clinical member of staff a year prior to the embryos reaching the limit of their
storage time.
Section 5.2 should encourage clinics to provide information on all possible
embryo disposition options, even if not available at that clinic.
6 Use of gametes in reproductive treatment programs
Specific Questions
Section 6.1 (see also Section 7.1)
Q14. What assistance is required to support parents in telling their children about their
genetic origins?
o Should this guidance be included in the ART guidelines?
o How, and by whom, should this assistance be provided? e.g. Is there a role
for community practitioners such as GPs and maternal-child health nurses?
Disclosure
Guidance for parents about disclosure to children should be included in the
Guidelines, consistent with principles of ‘Respect for all participants’. It is now
well established that it is in the best interests of the donor conceived child to
be told about their genetic origins, and evidence suggests that there are
advantages to early disclosure (Blyth, 2002). Equally, research and
experience tells us that many in the wider community lack this understanding
(see e.g. Blyth, 2002). For these reasons, parents should receive information
and support about the importance of disclosure and how they might disclose.
The Guidelines should encourage clinics to put in place policies and
procedures around this.
It is our experience that community practitioners such as GPs and maternalchild health nurses are in an important position to provide ongoing support to
parents about the importance of disclosure. There is a need for training and
support for these professionals so that they can provide support in this
relatively new area of practice. There is a role here for collaboration between
professional associations, in order to integrate such training into continuing
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professional development.
Recommendation: Section 6.1 should stipulate that clinics should
provide parents with information about the importance of disclosure to
donor conceived children, and information to help them in this
disclosure.
Section 6.9 (see also Section 7.6)
Q23. Should conditional donation of sperm, eggs or embryos such as stipulating certain
race or social attributes be permitted? e.g. a sperm donor not wanting his sperm to
be used for a single woman, a lesbian couple, or a particular race?
Embryo Donation Network will address here conditional donation of embryos
only.
Embryo Donation Network would recommend that conditional donation of
embryos be permitted. Whilst it is clear from the literature that not all couples
are comfortable with or desire conditional embryo donation (Fuscaldo et al,
2007), it is also clear that for some, it would make it easier for them to donate
(Blyth et al, 2011; Millbank et al, 2013). In the interests of patient autonomy
and self-determination, individuals should be allowed to find the option that is
most aligned with their preferences, as long as it complies with all
requirements of legislation and the Guidelines. Therefore, we suggest that
conditional donation should be permitted, for those for whom it would be
helpful.
Recommendation: Section 6.9 should stipulate that conditional donation
of embryos should be permitted, as long as it complies with relevant
legislation and the Guidelines
7 Use of donated embryos
General Questions
Q34. Do you think that there are gaps in the current ethical guidance in Section 7?
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Single embryo donation
One gap in the current ethical guidance is around ensuring clinics will facilitate
donations of single embryos. There are wide variations in clinic practice when
potential donors only have a single embryo in storage. Some clinics will
facilitate single embryo donations. However it has been reported to us that
some clinics refuse to allow single embryo donations, apparently on the basis
that it is a significant investment of resources for the recipient, with potentially
lower chance of success.
It is the view of Embryo Donation Network that if a donor can find a known
recipient who is willing to receive a single embryo, clinic protocols should not
override the informed consent of these parties. Demand for donated embryos
continues to outstrip supply (Blyth et al, 2011; Hammarberg, Johnson &
Petrillo, 2011). In this situation, under principles of self-determination and
informed consent, recipients should be the ones to decide if a single embryo
donation is worthwhile in their case. This would also be consistent with the
principle of respect for human embryos. Section 7 should specifically mention
that clinic policy allow single embryo donations in situations of fully informed
consent.
Recommendation: Section 7 of the Guidelines should stipulate that
clinic policy should allow single embryo donations in situations of fully
informed consent.
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Embryo donation and genetic disease
Another gap in the ethical guidance in Section 7 is around embryos that may
carry genetic disease. Patients should not be arbitrarily prohibited from
donating embryos based on potential genetic disease of the embryos.
Practice that restricts such donation is inequitable and discriminatory, and can
cause psychological harm (de Lacey 2007; Millbank et al, 2013). The
Guidelines tend to conflate donor gametes and donor embryos at this point,
but we would argue that this is an area where there are distinct differences
between gamete donation and embryo donation (de Lacey & Norman, 2004;
Millbank et al, 2013). Clearly, in gamete donation, guidance about reducing
possible transmission of genetic disease is necessary and appropriate.
However in the case of unused embryos, these embryos that may carry
genetic disease already exist (de Lacey & Norman, 2004). Some in our
Network have wished to donate embryos rather than destroy them, but have
been prevented from doing so and suffered psychological harm as a result.
We would argue that practices around embryo donation should provide for
patient self-determination and for individual preferences, and allow as many
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choices as possible about embryo disposition.
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If donors can find a recipient for their embryos who is willing to receive
affected or potentially affected embryos, this donation should be facilitated by
the clinic as long as it complies with relevant legislation and the Guidelines.
Principles of informed consent should undergird decision-making in each of
these unique cases, and clinics should interfere only if there are ‘very strong
grounds’ (Millbank et al, 2013).
Recommendation: Section 7 should include guidance that donation of
embryos potentially affected by genetic disease should be facilitated in
situations where all parties give informed consent.
Specific Questions
Section 7.2
Q35. Paragraph 7.2.1 – Is the practice of on-donation of donated embryos acceptable if
all parties are involved in the counselling process?
On-donation
Embryo Donation Network recommends that the Guidelines be changed to
state that the practice of on-donation of donated embryos is acceptable if all
parties are involved in the counselling process. There is confusion and
misinformation evident amongst some patients about whether on-donation is
‘legal’, and this largely seems to stem from the contradiction between actual
clinic practice and the stipulations in 7.2.1 that on-donation should not occur.
There is much variation in practice between clinics, with some advising that it
is ‘illegal’, and others allowing it to go ahead on a case-by-case basis.
Our Network includes many who have conceived with donor sperm and/or
eggs, and would prefer to on-donate their unused embryos, often to a known
recipient. This cohort is often motivated to donate by a sense of gratitude for
the gift of donor gametes in enabling them to have children, and a wish to
reciprocate. Yet on the whole they are unable to do this.
In addition, we have some in our Network who have received a relatively
large number of donor embryos, and are unlikely to use all of these embryos.
These recipients are often concerned that they will not be permitted to ondonate these embryos. Others have had considerable difficulty finding a clinic
that will facilitate on-donation, if their own clinic does not.
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Donors of embryos have also commented that they are unsure of what would
happen if their recipients do not use all the embryos, and expressed concern
as to whether they as donors would be consulted before any action was
taken.
Donor identification procedures have improved throughout Australia since the
Guidelines were last reviewed, which reduces the need for restrictions on ondonation (Millbank et al., 2013). In addition, the fact that some clinics allow, or
are considering allowing, on-donation on a case-by-case basis indicates that
Paragraph 7.2.1 of the Guidelines does not align with practice in many clinics
and should be updated. Paragraph 7.2.1 should state that on-donation should
be possible where all parties give informed consent and where relevant
legislation and the Guidelines are complied with. Paragraph 7.2.1 would then
be consistent with principles of respect for all participants and human
embryos, and also the need for open and consistent decision making by
clinics.
Recommendation: Paragraph 7.2.1 should be updated to state that ondonation of embryos should be possible where all parties give informed
consent and where relevant legislation and the Guidelines are complied
with.
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8 Storage of gametes and embryos
Q37. Do you think that there are gaps in the current ethical guidance in Section 8?
Storage limits for donated embryos
There is a gap in current ethical guidance in Section 8, regarding storage
limits for donated embryos. There are members of our Network who have felt
rushed by storage time limits, or who have been unable to donate due to
time limitations. It is our view that the storage period for donated embryos
should be reset at the time of donation (Millbank et al, 2013). This would
avoid the difficult situation where donors have inadequate time in which to
work through the process of complex decision-making (Nachtigall, Becker,
Friese et al, 2005; de Lacey, 2007).
In addition, recipients of embryos sometimes have an unreasonably short
time span in which to use the embryos because of storage limits. For
example, they may be pressured by time constraints to attempt a second
pregnancy before it is medically or emotionally advisable; the alternative is
that they risk losing the embryos. Recipients of embryos are entitled to at
least the same period of time to utilise their embryos that the donors had.
Recommendation: Section 8 should state that the storage period for
donated embryos should be reset at the time of donation.
References:
Blyth, E. (2002). Information on genetic origins in donor-assisted conception: is knowing
who you are a human rights issue? Human Fertility, 5, 185-192.
Blyth, E., Frith, L., Paul, M., & Berger, R. (2011). Embryo relinquishment for family
building: How should it be conceptualized? . International Journal of Law, Policy
and the Family, 25(2), 260-285.
de Lacey, S. (2005). Parent identity and 'virtual' children: why patients discard rather than
donate unused embryos. Human Reproduction, 20(6), 1661-1669.
de Lacey, S. (2007a). Decisions for the fate of frozen embryos: Fresh insights into
patients' thinking and their rationales for donating or discarding embryos. Human
Reproduction, 22(6), 1751-1758.
de Lacey, S. & Norman, R. (2004). What should we do with donated embryos that may be
genetically affected? Human Reproduction, 19(5), 1065-1068.
Fuscaldo, G., Russell, S., & Gillam, L. (2007). How to facilitate decisions about surplus
embryos: patients' views. Human Reproduction, 22(12), 3129-3138.
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Hammarberg, K., Johnson, L., & Petrillo, T. (2011). Gamete and embryo donation and
surrogacy in Australia: The social context and regulatory framework. International
Journal of Fertility & Sterility, 4(4), 176-183.
McMahon, C., & Saunders, D. (2009). Attitudes of couples with stored frozen embryos
toward conditional embryo donation. Fertility and Sterility, 91, 140-147.
Millbank, J., Stuhmcke, A., Karpin, I. & Chandler, E. (2013). Enhancing reproductive
opportunity: a study of decision-making concerning stored embryos. University of
Technology Sydney: Sydney.
Nachtigall, R., Becker, G., Friese, C. et al. (2005). Parents’ conceptualization of their
frozen embryos complicates the disposition decision. Fertility and Sterility, 84, 431434.
Nachtigall, R., MacDougall, K., Lee, M., Harrington, J., & Becker, G. (2010). What do
patients want? Expectations and perceptions of IVF clinic information and support
regarding frozen embryo disposition. Fertility and Sterility, 94(6), 2069-2072.
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