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Template for response
Part B of the Ethical Guidelines on the Use of Assisted
Reproductive Technology in Clinical Practice and Research, 2007
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process, please submit your comments as a Word document
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Name:
Antonia R Clissa & Iolanda Rodino – Approved
Infertility Counsellors under the WA Human
Reproductive Technology Act 1991
Organisation*:
*Please only include the name of the organisation here if the submission reflects the views of the organisation
5 Ethical principles for clinical practice of ART
General Questions
Q3. Should Section 5 recognise the significance of the ‘biological connection’
(e.g. between donor-conceived persons and the donors of gametes,
between donor-conceived persons and their siblings or half-siblings, or
between persons conceived from donated embryos and their genetic
parents) as an additional ethical principle for the clinical practice of ART?
(see also questions in relation to Paragraphs 6.1.1 and 6.1.2 and Section
9.2).
Yes we support the recognition of the significance of the ‘biological
connection’ as an additional ethical principle for the clinical practice of
ART. The importance of the right for a donor conceived person to have
access to and understand their biological connections was recognised in
WA when Registers of Identity were set up under 1991 legislation, the
Human Reproductive Technology Act (the HRT Act). The Registers
include the identity of the parents, the outcome of procedures as well as
the identity of the children born as a result of an artificial fertilisation
procedure, including the identity of each biological parent. It was
acknowledged that the circumstances of conception for donor conceived
persons should not disadvantage access to their genetic history. There
should be uniform collection and updates of data collected; as well
procedural and counselling policies on access to factual information and
donor linking processes.
Q4. Are there any further ethical principles for the clinical practice of ART
which should be included in Section 5?
Yes that patients undergoing fertility treatment are not coerced into
donating gametes and that patients are not approached to donate
gametes or embryos whilst undergoing their own fertility treatment.
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We also strongly recommend that patients complete their own treatment
before beginning any counselling or treatment associated with use of
donated gametes. This permits time to fully consider the implications of
using donor gametes for family formation and allows some time for
grieving the loss of the use of their own human reproductive material.
Often patients are sent for Donor Counselling so that they can have donor
gametes as a back up for their own treatment. Patients have reported the
distress of blurring the boundaries between the end of treatment using
their own gametes and beginning fertility treatment using donated
gametes.
Specific Questions
Section 5.1
Q5. Is more guidance needed on what constitutes the ‘welfare of those
involved’?
Yes there is more guidance required on what constitutes the ‘welfare of those
involved’ especially the interests of children to be born. In the UK the Human
Fertilisation & Embryology Authority (HFEA) has developed Welfare of the
Child Assessment see www.hfea.gov.uk/1414.html Clinics are required to ask
patients questions relating to the following; previous convictions relating to
harming children, contact with child protection agencies concerning the care
of existing children; serious violence in the family; serious drug or alcohol
abuse; serious mental or physical condition and risk to the child of a serious
medical condition.
Section 5.2
Q6. Paragraph 5.2.1 – Should there be exceptions to the
restrictions/limitations on accumulating gametes/embryos in some
situations? e.g. for fertility preservation in children, young people and
adults undergoing chemotherapy, for the purposes of preimplantation
genetic diagnosis, and/or for women with reduced ovarian reserve.
Yes in our clinical experience we believe it is essential to allow exceptions
especially in the situations outlined above.
Q7. Should there be a mandatory requirement for clinics to have policies and
procedures around embryos which are excess to the requirements of
patients?
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Yes this is essential as it provides guidance for parties to navigate complex
life situations such as in the case of posthumous use or relationship
breakdowns on resolving matters relating to surplus embryos.
Section 5.3
Q8. Paragraph 5.3.1 – Should financial transparency be included in this list of
protocols?
Yes protocols should include financial transparency. Commercial
inducements should not be permitted in relation to the supply of a human egg,
human sperm or a human embryo by a person. This includes any inducement,
discount or priority in the provision of a service to the person, valuable
consideration but does not include the payment of reasonable expenses
incurred by the person in connection with the supply. (Section 53Q of the WA
Human Reproductive Technology Act 1991)
Reasonable expenses should include reasonable medical, travel or
accommodation costs and any legal advice associated with the donation of
human reproductive material.
General Comments on Section 5
Psycho-social counselling in the area of ART should be carried out by
ANZICA Counsellors who are qualified professional counsellors specialising in
the range of Infertility issues and associated complex ethical dilemmas.
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6 Use of gametes in reproductive treatment programs
Questions 11 – 17 & 22 - 23 also relate to Section 7 - Use of donated
embryos.
General Questions
Q10. Do you think that there are gaps in the current ethical guidance in
Section 6?
Yes we believe there are gaps concerning the following: 1) recruitment and
use of gamete donors from outside Australia. We believe that there should be
explicit ethical guidance provided which matches the recruitment and use of
gamete donation within Australia such as reimbursement for reasonable
expenses, the availability of identifying and non-identifying information, the
right of donors to withdraw or vary the terms of their consent, implications
counselling of donors and their partners, retention of records and outcomes of
donation and maximum number of offspring per donor worldwide.
2) policies and protocols for counselling for the release of donor identity
information. ANZICA has developed donor linking guidelines based on good
praxis. See http://www.fertilitysociety.com.au/anzica/policy-documents/
Specific Questions
Section 6.1 (see also Section 7.1)
Q11. Should there be a standard way that data is collected and stored to
facilitate linkage?
o If so, how?
o Should this guidance be included in the ART guidelines?
Yes we believe that there should be a standardised data collection and
storage to facilitate linkage. The expertise of the ANZARD database systems
and protocols which has been in operation since 2004 could provide this
guidance.
Q12. What is best-practice to facilitate a first contact between donor/s and the
donor-conceived person?
o Should this guidance be included in the ART guidelines?
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Donor linkage guidance should be included in the guidance to assist those
who providing the service. Counselling must
- Be provided by an ANZICA counsellor who is experienced in
psychosocial implications of donor-assisted conception including
developmental lifespan issues, identity and research outcomes
- Provision of counselling must be face-to-face
- Provision for follow-up review to gauge outcome of first contact
- ANZICA Donor-Linking guidelines maybe considered a as a useful
framework
We strongly recommend referring to the ANZICA donor linking guidelines –
http://www.fertilitysociety.com.au/anzica/policy-documents/. These best
practice guidelines have been developed by experienced ANZICA counsellors
who have undertaken this mediator-counsellor role in donor linking.
Q13. Does the statement in Paragraph 6.1.2 need to be strengthened? (see
also questions in relation to Section 5 and Section 9.2)
o If so, in what ways?
Yes this statement needs to be strengthened to state that an ANZICA
Counsellor must provide the Counselling to prospective recipients which must
include reference to research and evidence based practice concerning the
importance of the biological connection for donor conceived offspring.
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?
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-
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Counselling should be provided by professional ANZICA counsellors as
this is a specialised area of knowledge. ANZICA counsellors are the
most experienced with issues relating to donor conception and through
professional development have access to the most up-to-date research
outcomes.
We consider that all health professionals should support the rights of a
child to know their genetic origin. This means being knowledgeable
about referrals to counsellors and support groups where the parent/s
can find the help and resources they need for the on-going process of
‘telling’.
Our experience of non-professional counsellors in addressing these
matters is that personal opinions and judgements can cloud appropriate
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support of parents and their donor-conceived offspring,
Q15. Paragraph 6.1.3
o Who should be involved in the dissemination of information to
gamete donors (or gamete providers for donated embryos)
about children born as a result of their donation? (see also
questions in relation to Section 6.12)
o How can gamete donors and donor-conceived persons be
encouraged to register their consent to being contacted?
 Should this guidance be included in the ART guidelines?
We support non-identifying information may be provided by clinic staff, unless
there is information that may be highly sensitive, in which case, the advice and
guidance of an ANZICA counsellor should be sought.
Release of identifying information should be facilitated through ANZICA
counsellors, who are experienced in donor-conception issues. This should be
mandated in the ART guidelines.
Gamete donors can be encouraged to register their consent at the time they
undergo their mandatory implications counselling session. In our experience
gamete donors are open to what is in the best interests of donor conceived
persons and their families. This can be achieved through broader discussions
about offspring-centric needs including the importance of knowledge of
biological heritage. We support this guidance being included in the ART
guidelines.
Public consultation programmes and Time-to-Tell programmes as that
provided by VARTA may also serve as a framework to enhance disclosure
practices amongst all stakeholders.
Section 6.2 (also relevant to donated embryos)
Q16. In the best interest of the child, should there be an age limit for:
o male gamete donors?
o female gamete donors?
o Male and female gamete providers for donated embryos?
If so, what do you think the age limit(s) should be?
We believe that in the best interest of the child and as a duty of care to male
and female gamete donors the age limit for donation should be raised to 25
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years. Increasing evidence in neuroscience is showing that emotional
maturity, self-image and judgement is affected until the prefrontal cortex of the
brain has fully developed. Longitudinal neuroimaging studies demonstrate that
the adolescent brain continues to mature well into the 20s ( The Journal of
Adolescent Health; official publication of the society for Adolescent Medicine –
www.ncbi.nim.nih.gov/pmc/articles)
In terms of setting upper age limits for male gamete donation there is
increasing but not conclusive evidence that sperm donation beyond 45 years
of age may affect fertility and rates of sperm abnormalities, congenital
malformations, miscarriage, adverse birth outcomes (HFEA
www.hfea.gov.uk/docs). In terms of setting upper age limits for female gamete
donation accepting donors 35 years and under increases chances of success.
However we would advocate that the female gamete donor has had at least
one child before becoming a gamete donor.
Q17. Should there be an age limit for female recipients of gamete or embryo
donation?
o If so, what do you think this age limit should be?
We strongly recommend that the age limit for female recipients is based on
menopause occurring within the normal age range as determined by clinical
parameters on a case by case basis.
Section 6.3
Q18. Is more guidance required to enable clinics to take all reasonable steps
to reduce the numbers of genetic relatives created through donor
gamete programs? What guidance do you recommend?
In the best interests of the donor conceived person we strongly advocate that
more guidance is provided to clinics in terms of limiting numbers created
through donor gamete programs. In WA there is a legislated 5 family limit
world wide which we support until further evidence is available on ideal
number of donor half siblings that is not psychologically bewildering for donor
conceived persons.
The 2010 Human Reproduction article “Sperm donor limits that control for the
‘relative’ risk associated with the use of open-identity donors by Neroli
Sawyer* summarises the literature to date on this issue. The article discusses
why donor limits are crucial for open-identity donors and how they need to be
lower than the existing limits that are intended to control for the genetic
concerns associated with anonymous donors. The author’s first
recommendation is:
 In jurisdictions which support or mandate the use of open-identity
donors that conservative provisional limits be placed on the use of
open-identity donors while the full psychosocial impact of the
revocation of anonymity is investigated and evidence-based limits are
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determined.
*Human Reproduction, Vol.00, No.0 pp. 1–8, 2010
Section 6.4
Section 6.5
Q20. In view of developments in other countries allowing women to receive
compensation above medical and travelling expenses for donating eggs,
should it be permissible for Australian women to also be compensated
for the reproductive effort and risks associated with donating their eggs?
(See also Section 13 Surrogacy)
We do not support financial compensation for reproductive effort however do
support reasonable and legitimate expenses associated with donation as
outlined earlier.
Q21. Should more guidance be given about the reimbursement of legitimate
expenses? What guidance would you recommend?
We support greater guidance for the reimbursement of legitimate expenses
and suggest Part 2 Section6 (2) WA Surrogacy Act 2008 for guidance.
Section 6.7 (see also Section 7.5)
Q22. Are there any specific relationships that give rise to particular concerns
between donor and recipient that should be included in the guidelines?
e.g. egg or embryo donation from a daughter to her mother.
Yes the element of coercion is always a concern between donor and recipient
and we highly recommend a complete independent psychological assessment
by a Psychologist not associated with the ART clinic treating the participants
especially in cases of daughter to mother donation. We also advise that the
recipients complete their own treatment before beginning any counselling or
treatment associated with donation. This permits time to fully consider the
implications of using donor gametes for family formation and allows some
time for grieving the loss of the use of their own human reproductive material.
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?
Yes we support the position permitted in WA where donations are deemed a
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personal gift and as a gift the donor has the right to place reasonable
conditions upon his/her donations (culture/ religion). In terms of best interests
of donor conceived persons in the long term this may facilitate greater comfort
in future contact between all stakeholders.
Section 6.10 – 6.11
Q24. Do you think that the current ethical guidance is adequate?
o Should information about the number and sex of half-siblings be
available to donor-conceived persons?
o Do you think that more information about half-siblings should be
available to donor-conceived persons? e.g. identifying
information.
Yes we support non-identifying information about number of half-genetic
children and gender of half-siblings being made available to donor conceived
persons. However identifying information should only be made available
through the voluntary consent of all adult parties involved. We support the
Voluntary Register model developed in WA by the Department of Health.
Q25. Do you consider 18 years of age too late to have access to this
information?
o Should earlier access to the information be possible?
We agree access to identifying information at 18 years is an appropriate age.
There may be grounds for early disclosure, with donor consent, for example
on the basis of medical or serious psychological grounds on a case by case
basis.
Q26. What is best-practice to facilitate a first contact between the half
siblings?
o Should this guidance be included in the ART guidelines?
We highly recommend donor linkage guidance between half siblings be
included in the ART guidelines.
This best practice will provide guidance to assist those who providing the
service. Counselling must
- Be provided by an ANZICA counsellor who is experienced in
psychosocial implications of donor-assisted conception including
developmental lifespan issues, identity and research outcomes
- Provision of counselling must be face-to-face
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-
Provision for follow-up review to gauge outcome of first contact
ANZICA Donor-Linking guidelines may be considered a valuable
framework
We strongly recommend referring to the ANZICA donor linking guidelines –
http://www.fertilitysociety.com.au/anzica/policy-documents/. These best
practice guidelines have been developed by experienced ANZICA
counsellors who have undertaken this mediator-counsellor role in donor
linking.
Section 6.12
Q27. Should the donor be able to receive identifying information with the
consent of the donor-conceived person?
We support the exchange of information is permissible with appropriate
consent provided all are adult stakeholders. We would not support consent
from a young child as being full informed and effective consent.
Q28. Should donor and recipient information be completely confidential or do
you think that this information should be available to all individuals involved?
We support that information exchange remain confidential between
consenting adults parties and pertaining only to them.
Section 6.14
Q29. Is it reasonable for a sperm donor to be able to vary or withdraw their
consent for donation at any time before insemination or fertilisation? Is
the point of treatment commencement or ovarian stimulation a more
reasonable point at which a sperm donor can vary or withdraw their
consent for donation? (see also Sections 7.3 & 9.6)
o Should the right of gamete donors (or gamete providers for
donated embryos) be restricted to the time before a woman
begins treatment in anticipation of using specific gametes or
receiving specific embryos?
Yes we agree it is reasonable for a sperm donor to be able to vary or withdraw
consent until the point of insemination or fertilisation of oocytes or embryos
transferred.
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Section 6.15 (see also Section 8.4)
Q30. Should restrictions on posthumous donation require written expressed
direction from the donor or should the requirements allow less explicit
and/or implied expressions?
Yes we agree that restrictions on posthumous donation must require the
written expressed direction from the donor.
Q31. Is it acceptable to take donations from dying or deceased persons?
o If so, under what circumstances?
o Should this rely on prior consent?
We maintain that it is not acceptable to take gametes from a deceased person
even with their prior explicit written consent. Posthumous conception fails to
take into account a child’s perspective on being conceived from gametes of an
individual who is no longer physically living. There is no research outcomes on
the psychological wellbeing of children conceived as a result of posthumous
conception.
We support taking donations of gametes from dying/terminally ill patients, for
the specific use of a named person/partner/spouse; provided they have given
full and effective written consent and received counselling concerning the full
ramifications of a child being created and raised without that parent and never
having the opportunity to meet that parent; that the recipient should also
receive counselling – concerning grief and telling the child about its conception
- and adequate time should be allowed for the grieving process before the
gametes are used; that in the event of the recipient not proceeding to use the
gametes these should be destroyed within a prescribed period of time.
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7 Use of donated embryos
In addition to questions 11 – 17 & 22 – 23.
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?
We support on donation where embryos have been created with donor
gametes provided the 5 family limit is maintained as well as any conditions
placed by the original donors. Counselling by ANZICA counsellors is essential
in discussing the potential complexity and implications of family formation
using on-donated embryos.
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8 Storage of gametes and embryos
Specific Questions
Section 8.7
Q39. Paragraph 8.7.1 – In the case of stored embryos where the couple is in
dispute, should embryos be kept in storage until the dispute is resolved
or should there be time-limited storage?
o What do you think the maximum duration should be for timelimited storage?
o Should advance directives about the future of any excess ART
embryos be obtained prior to the embryo being formed, so that
in the event of a dispute a process for either disposal or donation
is known?
Yes we support advance directives in the event of a dispute and or death.
We also support having a time limit on embryo storage of 10 years – 15
years based on family formation within the normal life cycle
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9
Information giving, counselling and consent
General Questions
Q40. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 9?
We support the definition of a professional, accredited infertility counsellor.
We would welcome the use of ANZICA Counsellor to recognise the national
counselling body most qualified to provide ART psychosocial counselling.
The complexity of counselling in ART is not always fully appreciated. There
is a tendency to believe that anyone can provide ART Psycho-social
Counselling. We consider it a duty of care to provide the best psycho-social
care for ART participants by ensuring that Counselling is delivered by
qualified and highly experienced ANZICA Counsellors. ART participants still
report receiving counselling that is well intentioned but not grounded in ART
psycho-social expertise.
Q41. Do you think that there are gaps in the current ethical guidance in
Section 9?
Yes we see that there are gaps in the provision of Counselling availability in
ART units across Australia. We would support ART participants having
access to Implications and Supportive Counselling at the beginning and
throughout their treatment. The impact of treatment on individuals and
relationships is very significant especially if outcomes are poor. We observe
participants are more likely to access Counselling throughout treatment if
they have already met the Counsellor. Furthermore Counselling should be
promoted by the Clinic as an integral part of treatment just as it is important
to see the Doctor or Nurse. We understand that implications’ counselling for
ART treatment involving donors is mandatory across Australia. However the
number of sessions is determined on a clinic by clinic basis. In some clinics
only one session of counselling is offered for all participants in cases of
known donation. This is definitely not best practice or in the interests of all
parties. As we have been working within the WA legislation since the 1990s
we would strongly recommend the following for cases of known donation.
Initial Counselling should include a minimum of 3 hours counselling in 3
individual sessions; it is mandatory that the partner of the donor and recipient
are included in the counselling and consenting process; a minimum of 3
months cooling off period for egg/embryo donation and 6 months for sperm
donation; an exit interview for those not proceeding.
(Refer to HRT Act 1991 Directions Part 2 – Psycho-Social Preparation for
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Participants prior to Known Donation.)
Specific Questions
Section 9.2
Q42. Among the information which should be discussed, should there be
specific reference to the significance of biological connection between
donor-conceived persons and the donors of gametes, and to the right of
these donor-conceived persons to knowledge of their genetic parents
and siblings? (see also questions in relation to Section 5 and
Paragraphs 6.1.1 and 6.1.2)
Yes we absolutely support this and consider it a duty of care and in the best
interests of all parties including the donor conceived persons born as a result
of these arrangements. Please see our response above.
Section 9.8
Q43. When a child or young person with stored gonadal tissue or gametes
reaches adulthood, how should the ongoing consent arrangements be
managed? i.e. the transition from parental consent to the consent of the
individual.
Yes we agree that consent should cease with the parents and should be
transferred to the young person (18+) for ongoing decision making and
consent about storage and use.
Section 9.9
Q44. Do you think that the guidance in Section 9.9 is appropriate?
Yes we support the inclusion of independent judgement as a safeguard for
the interests of child or young person concerning the consent for the retrieval
of gonadal tissue or gametes.
General Comments on Section 9
We would support uniform practices across ART clinics in the following areas
- Identity confirmation given the increase of identity fraud; effective consent
giving procedures when participants change partners or when relationships
have ended; the application of latest technology or methodology to reduce
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identity fraud.
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10
Record keeping and data reporting
General Comments on Section 10
We believe that record keeping and data reporting is an integral part of the
ART treatment. There is a duty of care to ART participants and children born
of ART treatment to ensure that there is appropriate maintenance of records
and data; that accuracy of data collections is of a high standard, that there is
national uniformity in data collection, storage, and adequate financial
resourcing.
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11 Sex selection
Specific Questions
Section 11.1
Q49. Are there any circumstances under which it is appropriate to allow sex
selection for non-medical purposes? e.g. for family balancing, to replace
a lost child, for cultural purposes?
We do not support sex selection for non-medical purposes.
Q50. Do you think that it is ethically acceptable for ART to be available to
individuals solely for non-medical sex selection purposes, e.g. for family
balancing, to replace a lost child, for cultural purposes, when the
individuals are neither infertile (physically or socially), nor have reduced
fertility?
No we do not think it is ethically acceptable to use ART for non-medical
purposes. Just because ART makes this possible does not mean we should
be using it in this way.
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13 Surrogacy
Specific Questions
Section 13.2
Q57. In view of developments in other countries, should there be
compensation, more than expenses, for gestational mothers congruent
with the reproductive effort contributed?
No we are not in support of the commercialisation of surrogacy in Australia.
We believe that any payment may act as enticement for those who would
otherwise not engage in this arrangement. Australia has historically been
opposed to payment for any human tissue and agreeing to any form of
compensation could be opening the floodgates to non favourable practices.
Q58. Paragraph 13.2.1 – Is this guidance still appropriate?
Yes we agree that this guidance is still appropriate and embedded in WA
legislation, the Surrogacy Act, 2008.
General Comments on Section 13
We advocate that the Counselling in this section be undertaken by
Counsellors who are members of ANZICA as the body with specialist and
expert knowledge in this complex area of Surrogacy.
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