Monash IVF Group
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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Name:
Monash IVF Group, Repromed, Reproductive Medicine
Organisation*: Albury (RMA)
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5 Ethical principles for clinical practice of ART
General Questions
Q1. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 5?
Difficulty has been encountered in enforcing counselling requirements and
who should participate in the counselling and consenting process.
Q2. Do you think that there are gaps in the current ethical guidance in Section
5?
Section 5.4. Does not clarify who can provide professional counselling. It
is recommended that specific criteria are listed such as the counsellor
must be a registered psychologist or social worker and must be a member
of ANZICA and employed by an IVF unit. It is of concern that 5.4 could be
interpreted that anyone could provide this service and therefore not have
the necessary skills and qualifications to adequately consider the long
term psychological and psychosocial implications of treatment procedures
and treatment types (e.g. donor treatment). Hence someone with tertiary
counselling qualifications who is either employed by or affiliated with a
clinic will have insight and experience into the issues.
Another concern with Section 5.4 is that it states” Clinicians must strive to
ensure that all participants (and where relevant their spouses or partners)
in ART must be informed about all aspects of the procedures and receive
professional counselling” It does not specify when partners should attend
counselling. Since IVF treatment impacts on both parties in the
relationship and decision making has psychological and legal implications
for both parties as well as any children born, it is strongly recommended
that the guidelines specify that partners attend and participate in the
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counselling, consenting and decision making process. This should also
include the partners of any donors, as the act and outcome of donation
will have future implications also for the donors’ partners and their
children. People are not able to give informed consent if they haven’t
been counselled about implications of decisions.
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).
Whilst there is mention throughout the document acknowledging that
donor conceived people should have the right to information about their
biological heritage, inclusion of this as a guiding principle under section 5
will assist in highlighting the importance of the matter and add weight to
the necessity of the other principles such as record keeping, consent and
counselling.
Q4. Are there any further ethical principles for the clinical practice of ART
which should be included in Section 5?
Recognition of the significance of the biological connection; such as the
right of donor-conceived people to information about their donor of the
gametes, and genetic half-siblings, and the rights of persons conceived
from donated embryos to information about their genetic parents and full
siblings.
Specific Questions
Section 5.1
Q5. Is more guidance needed on what constitutes the ‘welfare of those
involved’?
It would be useful to have clarity on what constitutes the welfare of those
involved and how this should be assessed or defined. And this section should
also include more clarity about how to evaluate the welfare of the unborn or
future child. At present this definition is vague and clinics do not have any
direction about how to implement this guiding principle.
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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.
As it is not possible for a clinician to predict the number of eggs that will be
collected, the number of eggs that will be fertilised, the number of embryos
that will meet the criteria for transfer or cryo preservation for a particular
patient, clinicians can only ensure best practice.
There are some instances where exceptions to Section 5.2.1 should occur
and they include cases where fertility preservation is required via the freezing
of gametes or formation of embryos due to medical conditions. For example,
people who are about to undergo cancer treatment, women with premature
ovarian failure, women with low ovarian reserve and children with medical
conditions that will require treatment that will cause damage to their future
fertility. Fertility preservation of their own gametes will provide them with the
possibility of having their own genetic child in the future. Also those who have
gametes or embryos stored because of medical conditions should be granted
permission for extended storage of those gametes or embryos. Exceptions
should also be granted to women of advanced maternal age
Q7. Should there be a mandatory requirement for clinics to have policies and
procedures around embryos which are excess to the requirements of
patients?
The Monash IVF Group supports a mandatory requirement for clinics to have
policies in place around embryos which are in excess to the requirements of
patients including provision of education to patients about implications of
decisions. In Victoria, clinics must provide counselling to all people seeking
ART treatment whereas in other states counselling is only mandated for donor
treatment procedures or surrogacy. The Victorian experience has been that
people are keen to maximise their chances of pregnancy from the outset and
generally do not give a great deal of consideration to the future where there
may in fact be surplus embryos. Counselling around those issues prior to
commencing treatment would be helpful as well as provision of information
and education in those states where counselling isn’t mandated. Consent
forms should clearly state what the options are at that clinic regarding the fate
of surplus embryos e.g. donation to another couple or on-donate to a third
party to achieve pregnancy, donation to research, or disposal. The information
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should include what counselling and consenting requirements are necessary
and also provision of information around what is and isn’t permissible in the
event of separation, divorce or death. If the clinic in question has ethical or
legislative restrictions around options then this should be documented also.
E.g. if the clinic does not support on-donation of embryos for third party
reproduction.
Section 5.3
Q8. Paragraph 5.3.1 – Should financial transparency be included in this list of
protocols?
The break down of costs should be transparent to patients so that they are
fully informed prior to commencing treatment. Treatment success rates should
also be included so that patients are informed of reasonable expectations.
6 Use of gametes in reproductive treatment programs
Questions 11 – 17 & 22 - 23 also relate to Section 7 - Use of donated
embryos.
General Questions
Q9. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 6?
Some challenges have been experienced in the application and interpretation
of Section 6, and what is required is more clarity. For example in 6.2 it should
state that clinicians have the right to refuse or decline or possibly delay
treatment if they have concern about the physical or psychological wellbeing
of a person, and Section 6.5 needs to be more explicit (i.e. it is illegal to trade
in human gametes) and discuss consequences. E.g. if it becomes known that
a financial transaction has occurred, over and above reasonable expenses,
then the clinic will not be able to treat the patient.
Q10. Do you think that there are gaps in the current ethical guidance in
Section 6?
Section 6.1 is an area that may require review and enforcement. Monash IVF
and Repromed provide a donor-linking service at all clinics and therefore
maintains consistent practices across all sites.
There is a view amongst other clinics that if a person donated under
“anonymous” conditions then this should be respected and maintained.
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However current research and practice in Victoria has shown that if
approached sensitively and given the opportunity for counselling and
consideration of any requested information, donors are often open to
providing some kind of information. Whilst this may not necessarily include
identifying information it may be enough to satisfy the curiosity of the donor
conceived off-spring. It also provides the beginning of discussions that with
time and consideration opens up the possibility for further discussion and
contact in the future.
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?
There should be consistency in how data is collected and stored to facilitate
linkage. Guidelines on how to collect and manage information should be
published in the ART guidelines so that all clinics follow the same process and
there is consistency within all clinics across Australia.
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?
The NHMRC guidelines should contain some information about what is best
practice in relation to first contact between donor/s and the donor-conceived
person. There are already guidelines set out by ANZICA however these are
only accessible by counsellors. It would be very useful to have clear guidelines
(adopted from ANZICA best practice) for clinics to follow and adopt so that
there are uniform practices and transparency across all clinics.
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?
Whilst the subject matter in section 6.1.2 is addressed in donor counselling
with recipients, there are cases where recipients express anxiety or resistance
to the concept of informing donor conceived children about their biological
origins. Typically people present for counselling at a time when treatment is
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imminent and their judgement is influenced by the urgency of proceeding with
treatment. So while all the issues are addressed in counselling there is
concern that they may not really have absorbed the implications of these
decisions or really considered the future impact on any off-spring. The
statement in section 6.1.2 needs to be strengthened so that there are uniform
efforts across all clinics to provide education and resources to prospective
patients and donors before they are engaged in treatment and before
counselling. This also correlates with the principle of the welfare and
wellbeing of the unborn child, if children are not told of their donor origins and
find out from other means than their parents in the future, there will be
psychological distress as well as repercussions for the family system. If they
are informed by their parents when they are older because the parents
believe they will have the maturity to understand there will be psychological
consequences as by that stage the children have already developed their
sense of identity and integrated what they believe to be the story of their birth.
Clinics should continue to provide education and support via counselling
services. This is imperative to demystify the stigma of infertility and in
particular donor treatment. This support should be provided before treatment
and be available during and post treatment, as well as during pregnancy and
after a child is born. Sometimes the complexities and implications of
undergoing donor treatment don’t really sink in until the pregnancy or birth has
actually occurred and become a reality rather than an abstract fantasy. Also
how people think they are going to react and how they actually react can be
quite different and hence distressing and destabilising.
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?
Assistance to support parents should be available in various mediums including
counselling services provided by the clinics, literature and resources made
available to patients on how to tell children about their donor origins. Clinics
should provide a list of resources such as books and where they can be
purchased, online resources, support groups.
In addition general resources can be provided by local GPs and also maternal
health nurses. The more information that is disseminated within the community
the more it normalise the anxieties these parents experience and will enable
them to seek out support.
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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?
Information should be provided to donors from experienced infertility
counsellors or experienced donor program coordinators who are able to
assess whether any additional support and interventions are required for the
donor (e.g. referral to a counsellor). Donor program coordinators are
frequently in contact with donors and would be in a position to provide initial
information, however encouraging donors to register their consent to be
contacted will require ongoing education, counselling and support in order to
address any anxieties they may have as well as education and counselling
them about the needs of the off-spring. This could be managed through written
information sent to donors, clinics providing obligation free education seminars
that are run and advertised regularly, links to other networks and resources,
e.g. the Donor Conception Support Group, ACCESS, VARTA and counselling.
Guidelines and recommendations for clinics would be useful to be included in
the ART Guidelines.
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?
In the best interests of all parties including the future child, the donor and the
recipient parents there should be clear age guidelines regarding when a
person can donate. The minimum age for gamete donors should be 21 years
as by that life stage they will have developed some maturity and experience
and will have greater insight regarding the implications of donating. Typically
cases where treatment is requested with a younger donor (e.g. 19) they
involve a known donor arrangement and there is concern that there may be
emotional coercion for the young person to donate. While clinics are able to
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set their own policies and limits, it would be extremely useful to have
consistent practices in place and written guidelines about age restrictions.
This will make it easier for clinics to enforce and to better manage patients’
expectations.
There should also be clear guidelines about upper limits for gamete donations
to minimise risks to the pregnancy and future child as well as reduced
success rates for the recipients. Monash IVF and Repromed recommend that
the ideal age range of 21-37 years for egg donors and 21-45 years for semen
donors. It is usually cases of known donor arrangements that recipients will
present with a known donor who may be out the recommended age bracket
and it is important to manage people’s expectations so that they are realistic
regarding outcomes regarding success and potential risks. The age limit for
known male and female gamete donors should be at the clinicians’ discretion,
however, risks associated with advanced ages must be discussed and
information included in consent forms
Similarly, the age limit for male and female gamete providers for donated
embryos should be at the clinicians discretion, however, risks associated with
advanced ages must be discussed and information included in consent forms
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?
Current practice at Monash IVF and Repromed is that a woman is not treated
after her 53rd birthday, and this seems to be consistent with industry practice
as this is the age when a woman experiences menopause and therefore
naturally wouldn’t be able to conceive.
There is not an upper age limit for men seeking fertility treatment. Information
about the risks should be provided as research has shown there are
increased risks to children born from older fathers including autism and
schizophrenia.
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?
The current guidelines which recommend a 10 family limit are reasonable.
Whilst some states recommend less (WA & NSW have a 5 family limit) and
some agencies suggest that the limit should apply worldwide rather than in
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Australia only, in reality this is not practical. Firstly, it would be difficult to
monitor and police worldwide and virtually impossible to control what other
agencies do overseas. Secondly reducing the family limit even more than the
current recommendation will significantly reduce the amount of people who
would be able to access donor treatment services and encourage people to
travel overseas for third party reproduction. This means they won’t be privy to
the counselling support they would receive in Australia nor would the offspring
have access to donors identifying information. Also there are other risks
associated with the relaxed practices of some overseas clinics for example,
around the number of embryos transferred at any given time, increasing risks
for the patients.
There needs to be clarity around the definition of a family i.e. does a female
couple constitute one family or two if both females have a child using the
same sperm donor. In Victoria, a family is counted for each woman having a
child. However, in South Australia a female partner of a woman being treated
can now be listed as a co-parent on the birth certificate. For this reason, it
appears more reasonable for a female couple to be considered as one family
(see Q34 for further details).
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)
The internet and access to services worldwide has made the world a smaller
place. People are able to access treatment anywhere in the world and many
overseas clinics offer commercialised third party reproduction. This raises a
number of ethical concerns about the potential exploitation of donors and their
capacity to give informed consent if there is financial coercion/incentive that
may cloud their judgement to the medical risks and psychosocial implications.
Furthermore there is the interest of the future child, and what would it mean for
them to know that they were conceived as a result of an act of commercial
benefit?
Monash IVF and Repromed support the notion that gamete donation should
be motivated by altruism but at the same time the current guidelines (or lack
thereof) for what constitutes fair and reasonable expenses need a lot more
clarity. Templates or examples should be provided for clinics and prospective
patients. This would provide consistency across all states and reduce the risk
of recipients being exploited and extorted for money.
Patients are already traumatised and psychologically vulnerable and therefore
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at risk themselves of being exploited. There should be reasonable financial
acknowledgment for the donor’s time which would also make it viable for them
to commit to becoming a donor and compensate for their time for going
through the rigorous assessment and counselling process. This would also
encourage more people to donate and thereby enable patients to have their
medical care in Australia by their own doctor within the protection of Australian
regulations.
Q21. Should more guidance be given about the reimbursement of legitimate
expenses? What guidance would you recommend?
A list of what constitutes fair and reasonable expenses and a range of costs
depending on factors such as travel. E.g. is air fare for donor only acceptable
or air fare for donor, donor’s partner and donor’s children acceptable?
Boundaries around how travel costs are calculated, economy versus business
versus first class. Perhaps an hourly rate average for time off work for the
donor, and include lost time due to side effects of IVF treatment to also be
reimbursed? Other considerations to include babysitting costs,
accommodation, car hire, calculation of mileage for reimbursement of fuel and
depreciation costs, etc.
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.
There are particular types of case presentations and relationships that are of
concern and these include situations where one party could be considered
vulnerable and in a disempowered position. Examples of this include cross
generational donations especially where the donors are under 25 and in a
diminished position of power in the relationship, e.g. daughter donating to
mother, niece donating to aunt; where donors have not had any children of
their own; or where the donor is dependent on the recipient in some way, e.g.
an overseas student living with a host family (i.e. the donor feels obligated or
beholden to the recipients and may fear repercussions if they do not donate).
Also situations where blood relationships with a person would be considered
incestuous in other circumstances should also be avoided. E.g. daughter
donating eggs to mother where her biological father is also the sperm
provider. Whilst it is important to consider the welfare of all the parties and
implications to their lives in engaging in the act of donation, the welfare of the
children created from these procedures should be of paramount importance.
What will it mean for the child when their “sister” is also their biological
mother? Or their ‘biological mother (egg donor)” is also the step daughter of
their biological father (recipient male)?
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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?
Donors should have the right to direct their donations and specify any groups
to whom they do or do not wish to donate to. In matching donors and
recipients it is important to have compatibility. Matching is not only about
physical characteristics but also values. It is important to consider the
wellbeing of the future child and what impact it would have for that person to
have contact with a donor in future, for example, meeting a donor who was
homophobic (and the child was born to a lesbian couple).
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.
6.10 should also include other non-identifying information such as the donor’s
educational history, personal interests, and the donor’s reasons for donating.
6.11 should include information that could be made available to donor
conceived persons about the number and sex of half siblings. Half siblings
should have the right to register their interest in meeting/contacting other half
siblings on the proviso that all parties are fully consenting to this. This would
mean that the respective clinics or state should keep a Voluntary Register
where parties can register their details and if a match is noted then contact is
facilitated only after all parties have undergone counselling with an
appropriately qualified counsellor (ANZICA approved). Victoria has a
Voluntary Register run separately from the BDM Central Register for this very
purpose which could be used as a model.
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?
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Donor conceived people should be given the opportunity of accessing
identifying information before the age of 18 providing that they have
undergone counselling with an appropriately qualified counsellor, who can
assess the nature of the request and is able to assess the person’s maturity in
being able to process the information. In Victoria under the ART Act 2008 a
donor conceived person can apply for identifying information from the age of
16 providing the above criteria have been met. This could serve as a model
for minimum age.
It is becoming increasingly more common that parents are approaching
clinics or in Victoria the BDM Central Register requesting information about
the donor when the child is still quite young (e.g. under the age of 5 years).
These parents are preparing to tell their children and want to have as much
information on hand as possible for their child throughout their life cycle,
rather than putting their child through an arduous process of applying for
information once they turn 18. There may also be some circumstances where
the child may not live with the parents due to challenging family
circumstances and hence not have the parents’ permission. Applications for
information should be reviewed on a case by case situation taking into
consideration all the relevant issues.
Q26. What is best-practice to facilitate a first contact between the half
siblings?
o Should this guidance be included in the ART guidelines?
First contact between half siblings should follow the same best practice
guidelines that are outlined in the ANZICA guidelines for donor-linking. Either
the NHMRC guidelines set out the same guidelines or makes reference to
ANZICA guidelines to be followed.
Section 6.12
Q27. Should the donor be able to receive identifying information with the
consent of the donor-conceived person?
In principle the donor should have the same rights of access to information as
the parents and donor conceived people. This is a matter that should be
handled with the utmost sensitivity as clinical practice shows that not
everyone tells their children about their donor origins, even those undergoing
treatment in 2014. If a donor was to make an application for information there
should be some steps in place to manage the situation ethically and
sensitively.
1. Assess reason for request (via counselling for the donor and managing
his/her expectations);
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2. The parents of the donor conceived child notified that a request has been
made so that they can address issue of disclosure if it hasn’t already been
done (and have the opportunity for counselling and assistance);
3. Liaison between the parties by an appropriately qualified person such as an
ANZICA approved donor linking counsellor, who can manage the situation
over a period of time at a pace that is comfortable for all parties (perhaps
starting with exchange of letters to eventually meeting face to face if
consented to).
There are numerous donor linking cases that have been matched in Victoria
and South Australia, which have followed VARTA and ANZICA models. These
models would be useful for other clinics to follow.
Q28. Should donor and recipient information be completely confidential or do
you think that this information should be available to all individuals involved?
A very clear process needs to be outlined for donor linking. Counselling
provided for all relevant parties and identifying information should not be
released without written consent (especially for donors and recipients). Nonidentifying information should be made available to all parties involved. Donor
conceived people in Victoria can access identifying information once they turn
18 without the donors consent, and all other states should include in the
donors consent forms information about future contact and provisions for
advance consent. Clinics should also check in with donors periodically to
advice them of any legal changes and to check whether they wish to update
their consent.
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?
Donors should have the right to withdraw consent of the use of their gametes
up to the point of insemination (of eggs and sperm) as is the case in most
states of Australia at present. Donors should set conditions for their donation
well BEFORE insemination. The recipient/s then can make an informed
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decision about whether or not to proceed with that particular donor.
Once an embryo is formed then that embryo should remain the property of the
recipient/couple and the recipient/s is responsible for decision making around
the fate of the embryo.
Under Victorian legislation donors have the right to withdraw consent at ANY
time, meaning even after the embryo is formed and even after some years
have passed where there may be embryos frozen and a child is born from that
donation. This has been a right that some known donors have exercised when
their relationship with the recipient has broken down. Whilst this protects the
donors rights, it completely renders the recipients powerless and at the mercy
of the donor. The rights of the other gamete provider (the recipient) are
completely overridden and this is unjust and completely unfair and cruel.
Monash IVF strongly believes that the Victorian legislation should be changed
so that gamete donors are only able to withdraw consent up to insemination of
sperm into an egg NOT once an embryo has formed (as is currently the case).
Many patients are currently electing to have all their embryos frozen after a
stimulated cycle and then have an embryo thawed and transferred in a natural
cycle a month or so later. Under the current Victorian legislation, the patient
will not be able to use the embryos formed from her eggs if the sperm donor
withdraws consent for whatever reason.
Pre-treatment donor/recipient counselling should consider all the implications
of the donation including any feelings of ambivalence, and in such cases
where participants are uncertain additional counselling should be offered and
a cooling off period instituted so that all parties can have adequate time to
consider all the issues.
There should be more support and stricter guidelines about pre-treatment
donor counselling such as multiple sessions to cover the donor/recipient
counselling. A minimum of 2 counselling sessions for donors and 2 for
recipients is strongly recommended. In cases of known donations, a 3rd
session in addition to their 2 individual sessions should include a group
session with all parties present. Clinics should be given the right to implement
cooling off periods where particularly complex matters arise so that all parties
have time to fully consider the longer term implications of entering such an
arrangement. A minimum standard should be 2 weeks between each
counselling appointment.
Embryo donors should be able to direct their donations and the clinics should
honour their wishes to ensure an appropriate match occurs between donors
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and recipients.
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?
Restrictions should be made on the use of gametes or embryos from
deceased people. In South Australia there is a requirement that donors are reconsented annually to the use of their stored gametes. In the case of a death,
the sperm from that donor can no longer be used.
However in cases where a couple already have embryos formed from donor
gametes and they already have a child conceived from that donor, then those
people should be given permission to use the embryos to have a sibling for
their child. If gametes or embryos are in storage, the donor is deceased and
no children are born then gametes should not be used. In the situation where
one party in a couple dies, then either frozen gametes or embryos formed
from those gametes should only be used for the surviving partner where there
has been clearly witnessed written consent before that person’s death. The
surviving partner should go through a period of mourning for example1 year,
and undergo counselling before being allowed to access treatment with those
gametes or embryos. The survivors are traumatised and grieving and not in a
psychological position to adequately consider the implications of having a child
using gametes or embryos from their deceased partner.
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?
Only if there has been prior written consent from the dying or deceased
person. This could be in a consent form from an ART clinic or an explicit
directive in a person’s will.
Section 6.17
Q32. Do you think that Section 6.17 is still relevant to the clinical practice of
ART?
Yes
7 Use of donated embryos
In addition to questions 11 – 17 & 22 – 23.
General Questions
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Q34. Do you think that there are gaps in the current ethical guidance in
Section 7?
There are contradictions across state legislations regarding family limits when
using a donor, e.g. Most states follow NHMRC Guidelines of 10 family limit,
Victorian legislation restricts the family limit to 10 women, and WA & NSW
legislation 5 families. There should be consistent practices across all states
and they should be fair and equal and not discriminate. Victoria’s legislation of
10 women discriminates against lesbian couples who are in a committed
relationship and intend on raising the children together as a family. It is quite
common that 2 women will wish to use the same semen donor so that their
children will have shared genetics, and this should be treated as one family
not 2 separate entities.
More thought and direction should be given to managing the number of
families formed from on-donated embryos that are originally formed from
gamete donation. There should be a clear and easily traceable chain of
information that will be accessible should a donor conceived person seek
information in the future about his/her biological origins and about full or half
siblings. Clinics should be made accountable for this record keeping and
audited accordingly under RTAC. It is also quite common that people may
donate gametes or embryos interstate, which means that the chain of
information needs to be carefully documented and clinics need to have the
capacity to be able to communicate with one another regarding the number of
families already formed so that they can comply with the regulatory
requirements. A national donor register may assist with this problem and
significantly reduce the risk of donors donating in excess of their family limit.
Whilst family limits are in place, it is difficult to police when gametes and
embryos are being donate outside of the state they were created.
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?
This should only be permitted if the original gametes donors have been
appropriately counselled by an ANZICA approved counsellor and if the
original gametes donors have provided written consent that is current and
relates specifically to the current on-donation situation not just general donor
counselling. All parties to the arrangement even the non-biological parents
who are seeking to on-donate the donated embryos should be counselled
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about the implications for themselves and their children.
8 Storage of gametes and embryos
General Questions
Q37. Do you think that there are gaps in the current ethical guidance in
Section 8?
Section 8.3 Limit of storage of gametes is vague and places onus of setting
limits back on the clinics. This will result in disparity between clinics and it
recommended that uniform processes exist across all states and clinics.
Currently in Victoria the ART Act 2008 sets legislative limits on the storage of
gametes and embryos. The guidelines set out in the ART Act could be
applied by NHMRC (see section 31 of the ART Act 2008).
Specific Questions
Section 8.3
Q38. Should limits apply to the duration of storage of gametes - recognising
that if stored for fertility preservation purposes, they may not be used for
decades?
o If yes, what do you think the maximum duration should be?
o If no, what difficulties do you perceive and how should the
storage of gametes be managed?
Whilst limits and boundaries should be placed on the storage of embryos and
gametes they should not be punitive or onerous on the patient, particularly
where the material has been stored for fertility preservation. There should be
processes in place to ensure that clinics are accountable for maintaining
ongoing communication with the patients who have stored material and
ensure that information is kept up to date. Having limits on the storage
periods with potential for review and extension of storage will ensure that
there is continued communication between clinic and patient.
The Victorian ART Act 2008 provides a good model for gamete storage for
fertility preservation for medical reasons. The statutory limit for gamete
storage is 10 years at which time a request for an extensions for a further 10
year period can be submitted to the Victorian Patient Review Panel (PRP)
who will take into account exceptional circumstances. Young patients storing
gametes for fertility preservation can keep gametes in storage for 20 years
with a written request from the oncologist / specialist before applying to the
Victorian PRP for an extension of storage time
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In South Australia, a condition of registration is that any donated gametes
are destroyed after 15 years from the time of donation unless approval from
the Minister (of health) is obtained for the ongoing storage and use. This
stipulation was instigated in recent years and has assisted Repromed in
managing long term storage issues of donor gametes.
There is another group of patients who would keep material in storage
indefinitely if possible because they find the responsibility of making a
decision about the fate of their stored embryos emotionally and
psychologically traumatising. Whilst this is difficult for this group, having
specific limits placed by a regulatory body may take the onus of responsibility
away from the patient. It is recommended that very clear consenting
processes and accountabilities need to be in place, for example,
documentation (to be signed off by the patient and a copy given to them)
about the consequences of failure to maintain contact with the clinic could
result in the disposal of the material after the specified storage period.
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?
Clinics do encounter difficult situations whereby couples may be in dispute
about the fate of their stored embryos. This is an extremely distressing time
for people. Allowances should be made where storage can be extended for a
specified period of time to allow the parties to resolve their dispute and/or
undergo counselling to assist them in coming to a decision. In Victoria the
Patient Review Panel will review cases where the statutory limit of storage is
about to expire and has in some cases given a brief extension period to allow
the mediation process to occur. For many separated couples where one
party will not sign a disposal form, the final expiry date is used as closure for
the separated couple and the clinic can then dispose to meet the statuary
requirements as set out in the legislation.
Having very clear consenting processes in place such as advance directive
in consent forms may be helpful in some cases such as in the event of death
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or permanent physical or mental incapacity. However these advance
directives are not particularly helpful in the event of a relationship breakdown
or once a child has been born from that cohort of embryos. People find it
very hard to conceptualise at the beginning of their IVF journey what the
embryos may mean to them once they have children. They are usually
focussed at that stage on doing whatever they can to maximise their chances
of having a baby. And for many patients the emotional attachment becomes
quite profound once they can identify their own child with the cohort of
embryos it came from. That frozen embryo represents another child. In these
types of cases advance directives might only be useful to have a starting
point for discussion even if the person has since changed their mind.
Allowing time for people to process their options and receive counselling to
adjust to the psychological implications is important in managing cases like
this.
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?
In order to maintain professionalism and quality standards the term
accredited counsellor needs to be more specific to include a counsellor with
graduate tertiary qualifications in either psychology or social work and must
be registered with their professional body AHPRA or AASW and be a
member of ANZICA. At present the term “counsellor” means nothing.
ANYONE can call themselves a counsellor including someone who has done
a 6 week online course. This is inappropriate and creates risk for the patients
and the clinics. Replace the term “accredited counsellors” to “ANZICA
approved registered psychologists or social workers”.
Q41. Do you think that there are gaps in the current ethical guidance in
Section 9?
The gap in section 9 is around specifications around what constitutes an
accredited counsellor. As mentioned above applying ANZICA standards is
recommended and should include a graduate tertiary qualified registered
psychologist or social worker. Psychologists and social workers are also
required by their professional bodies to maintain ongoing professional
development as conditions for their registration.
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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)
Among the information that should be discussed under section 9.2 specific
references should be made 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. The distribution of this information should be done consistently
across all health practitioners including doctors, nurses and counsellors, not
just in counselling; although counselling would be the most appropriate
setting to explore and address issues of concern in greater depth regarding
this subject. The dissemination of information on the subject from other
health practitioners will also set up a positive culture of acceptance and
normality and will assist in de-stigmatising an already sensitive area. In
addition it is strongly recommended that the NHMRC guidelines clearly state
that the donor’s partners must be provided with information and attend and
participate in the counselling process. The current statement doesn’t refer to
the donor’s partner just donors and recipients and is easily interpreted that
donor’s partners are not required to consent or undergo counselling. The
donor’s partners also have a right to consider the longer term implications of
the donation on the children they may with the gamete donor.
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.
This is a difficult issue. In principle it should be a requirement that clinics add
a statement to the original consent form that the parents sign on behalf of the
child, that when that person reaches the age of 21 they are responsible for
decision making around the fate of their biological material. However in
practice there have been cases where upon reaching 18 (the current age of
consent) the young adult has requested that the frozen material be disposed
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of. At 18 years of age a person does not have the maturity to fully appreciate
the future implications to one’s own fertility, and may very well make
decisions at 18 that they will regret when they are 28. There should also be
provisions for the parents of the young person to be able to continue to
request and pay for storage on behalf of their child even after the age of 18.
Section 9.9
Q44. Do you think that the guidance in Section 9.9 is appropriate?
Section 9.9 should be more specific, and make reference to what type of
circumstances a person with impaired cognitive functioning; intellectual
disability and mental illness are able to have material collected on their
behalf. For example, if the person is unlikely to ever regain full cognitive
functioning is it appropriate to retrieve gonadal tissue or gametes from them,
even for fertility preservation?
10
Record keeping and data reporting
General Questions
Q46. Do you think that there are gaps in the current ethical guidance in
Section 10?
One of the practical complications of maintaining long term contact with
participants e.g. donors and recipients, is that contact information can easily
become outdated, and therefore make it very difficult to contact people years
down the track. The guidelines could specify a broad range of contact
information to include names, addresses dates of birth, but also mobile
telephone numbers, work telephone numbers, email addresses and social
media where appropriate. Clinics should be required to maintain regular and
ongoing contact with their donors and patients to ensure contact information
is up to date and also enable the opportunity to update any medical records.
11 Sex selection
General Questions
Q47. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 11?
No
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Q48. Do you think that there are gaps in the current ethical guidance in
Section 11?
No
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?
No
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
Q51. Is it possible to define a “serious genetic condition” for the purposes of
allowing sex selection? If so, please provide a suitable definition.
Very difficult to define “serious genetic condition”. If further clarification is
required, point 11 could be expanded to say that this will be determined at
the discretion of a qualified Clinical Geneticist.
12 Preimplantation genetic diagnosis
General Questions
Q52. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 12?
Section 12.3 on Preimplantation Genetic Diagnosis in reference to HLA
matching (using PGD to select an embryo with compatible tissue for sibling).
The guidelines state that clinics must seek advice from a clinical ethics
committee (or relevant state or territory regulatory agency) to ascertain that
the points in 12.3.1 are met. However Monash IVF believes that it is more
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appropriate for qualified individuals to make this decision and propose that a
clinical geneticist together with a genetic counsellor meet to ascertain and
report whether the points mentioned in section 12.3.1 are applicable and
therefore whether HLA matching should proceed
Q53. Do you think that there are gaps in the current ethical guidance in
Section 12?
No
Specific Questions
Section 12.1 – 12.2
Q.3 Under what situations do you think the use of preimplantation genetic
diagnosis is ethically acceptable?
In cases in which PGD is being performed to prevent the transmission of a
serious genetic condition to the child (eg: single gene condition, unbalanced
chromosome rearrangement, chromosome aneuploidy).
13 Surrogacy
General Questions
Q55. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 13?
Section 13 requires revision and is out of date
Q56. Do you think that there are gaps in the current ethical guidance in
Section 13?
There are considerable gaps in section 13 and since surrogacy is now legal
in most states in Australia this section should contain clear guidelines about
practices, counselling and assessment that are far more detailed than the
current guidelines. ANZICA has guidelines for counselling and assessment
which could be applied so that there is consistency with all states and clinics
and to ensure best practice amongst counsellors. Section 13.2.1 should also
be amended since it is now legal to provide altruistic surrogacy services and
clinicians and clinics should be allowed to convey that information to their
patients.
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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?
There needs to be a careful balance between a woman acting as a surrogate
altruistically and compensating her for time and expenses. At present only
altruistic surrogacy is legal in Australia and only reasonable out of pocket
expenses related specifically to the surrogacy arrangement can be
reimbursed. There have been some cases where dispute has occurred
between the parties to a surrogacy arrangement about this very matter. Very
clear guidelines should be given about what reasonable expenses constitute
and how these can be defined, so that all clinics can follow the same
template. If surrogates were to be financially compensated for being a
surrogate then the amount should be commensurate with reasonable
compensation for their time and expenses. There should not be a financial
inducement to become a surrogate which might therefore cloud a surrogate’s
judgement about the potential risks involved.
Q58. Paragraph 13.2.1 – Is this guidance still appropriate?
No see above question 56
14
Innovations, training and quality assurance
General Questions
Q59. Have you encountered any difficulties in the interpretation and/or
application of the current ethical guidance in Section 14?
No
Q60. Do you think that there are gaps in the current ethical guidance in
Section 14?
no
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General Comments on Section 14
No further comments
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