INFORMED CONSENT SUB-PROJECT:
CLINIC POLICIES, RULES AND PROCESSES
EXECUTIVE SUMMARY
1.
The purpose of this study was to obtain robust descriptive information on clinics’
informed consent policies, rules and processes, and any challenges with informed
consent raised by clinics. Semi-structured interviews were conducted at three
Auckland fertility clinics with separate groups of doctors, embryologists,
managements, nurses and counsellors.
2.
Information on the policies and rules followed by the clinics focussed on those
followed where donated gametes or embryos were use. These are summarised in
the tables in part 1 of the report.
3.
The process of obtaining informed consent is a multidisciplinary effort by clinic staff.
Clinic staff work together to provide support for their patients. Nurses are the primary
point of contact for patients, and hold an overarching responsibility for ensuring all
required consents are in place. Immediately prior to starting a procedure, consents
are checked again by embryologists. These consents provide assurance for
embryologists that they are doing exactly what has been authorised by the patient.
Counsellors discuss future eventualities and potential long term issues with patients
and work more closely with donors.
4.
Language was the most commonly identified challenge across clinics. Clinics have
discretion to recommend or require an interpreter for explaining medical terminology
and discussing consents. Understanding information is a further challenge, but
clinics agree a team approach is useful because it provides multiple opportunities to
clear up any misunderstandings and communicate information. To reduce the risk of
coercion in family donors or partners, clinics can insist on counselling.
5.
Clinics reported that the point of no return (where consent can be no longer amended
or withdrawn) is a fundamental and well-established concept in donation that is
clearly understood by donors.
6.
All consent forms have been developed with a focus on the patient. They have been
written in plain English, and aim to maximise a patient’s understanding of what they
are consenting to.
7.
Clinics also have mechanisms in place to ensure review of the consent forms. This
can be triggered by incident reporting, patient suggestions, developments in medical
techniques or technology, or legislative change. All staff have the opportunity to
provide feedback or input into the review.
1
INTRODUCTION
Purpose
1.
The focus of this study was to get an accurate picture of the policies, rules and
processes that clinics have established to give effect to the requirements and
management of informed consent.
2.
The study aimed to:

obtain robust descriptive information on clinics’ policies, rules, and processes
when obtaining and managing informed consent
identify any issues with current informed consent processes raised by clinics

3.
The study was not aimed at getting a thorough understanding of every situation where
consent is required or is an issue, and the methods associated with every situation.
Scope
4.
The scope of this study included all consent processes associated with assisted
reproductive technology procedures relating to use of gametes, and embryos,
including PGD. The scope excluded informed consent for human reproductive
research.
METHOD
5.
Semi-structured interviews were held on 6 to 8 May 2014 at the three Auckland fertility
clinics - Fertility Associates, Fertility Plus and Repromed. After the interviews, emails
were sent seeking additional information on several occasions.
6.
The interviews were conducted at each clinic by Secretariat staff members, with
separate groups of doctors, embryologists, management, nurses and counsellors.
Separate groups were indicated to ensure free and frank discussions as different
groups may have differing views on informed consent. Not all groups were interviewed
at each clinic according to availability; however, doctors, nurses and counsellors were
always interviewed.
7.
This report is in four sections:





Information on the policies, rules and processes followed by clinics about who
is asked to consent, when, and over what matters; about withdrawing or
changing consent, and about the provision of information to donors and
recipients
Information on the processes followed by clinics in obtaining informed consent
Information on the processes followed by clinics in managing informed consent
responsibilities
Information clinics’ views of the issues that arise in taking and managing
informed consent
Clinic views on the policies and rules they follow are set out in an appendix.
2
THE POLICIES AND RULES FOLLOWED BY CLINICS AROUND INFORMED CONSENT
8.
This section reports on information obtained on the policies, rules and processes
followed by clinics. It covers who is asked to consent, when, and over what matters;
withdrawing or changing consent, and the provision of information to donors and
recipients. The report focusses on the practices around informed consent in
circumstance when treatments and actions involve the use of donated gametes and
embryos. The note considers the range of circumstances that are possible. It does not
take account of the frequency with which such circumstances might arise eg, a wish to
withdraw consent.
9.
It covers the following issues around informed consent in such circumstances: Who is
involved in giving consent? Over what actions, when and with what power to withdraw
or change consent? What information is provided to donors about recipients and vice
versa? What information is provided at point of use of donated gametes or embryos
about actions? What information is provided about outcomes?
10.
The findings are summarised below in tables covering:










Who is asked to give consent, or involved in the decision in some way?
When consent is first sought?
What is sought – consent covering what actions/uses/treatments?
What information is provided to donors about recipients and vice versa?
When can consent be amended and/or withdrawn?
Do any consents ‘run out’, requiring new consents?
Are there any practices to confirm consents before actions/use?
Do consents become in practice ‘unable’ to be withdrawn – at what point?
Is information provided to donors by clinics when actions or use of donated
gametes or embryos occurs?
What information is provided to donors about outcomes?
3
Sperm donation
Who is asked to give consent, or
involved in the decision in some
way?
When is consent sought?
What is sought – consent covering
what actions/use/treatments?
What information is provided to
donors about recipients and vice
versa?
When can consent be amended
and/or withdrawn?
Do any consents ‘run out’ requiring
new consents?
Are there any practices to reconfirm consents with donors
before actions/use?
Do consents become in practice
‘unable’ to be withdrawn or
amended – at what point?
Is information provided to donors
by clinics about actions/ use of
donated gametes or embryos when
it occurs?
What information is provided to
donors about outcomes?

Sperm donor
Sperm donor
Consent is sought before donation
 Pre-treatment screening
 HART Act requirements eg, donor information
 Setting conditions for the donation
 Medical history disclosure
 Maintaining contact information
N/A
Usually at point of donation the future recipient cannot be identified
Limited donor information provided to recipients at time of use but not
vice versa except under embryo donation and surrogacy guidelines.
At any time up to the point of insemination, or creation of an embryo
– this is commonly known as the ‘point of no return’
Donors are being asked to re-consent to the extension of storage for
their own gametes and embryos created from their gametes
Partner of donor
Where relevant, a
partner will be
asked to consent
Consent is sought
before donation
N/A
Notes
Based on requirements in Fertility
Standards documents
In one clinic partners did not have
automatic ‘veto rights’
One clinic seeks to frontload as many
consents possible eg, export. Now
seeking approval to seek consent for
extension of storage after 10 years.
N/A
N/A
Changes do not occur often and are
usually a result of changes in donor
relationships. In circumstance where
other stakeholders would be affected
clinics seek unanimous approval
N/A
N/A
No
See above re ‘point of no return’
N/A
 Proactive provision practices vary. Sperm donors not usually
informed
 Information as required is available to the donor at any time after
donation.
 Information as required is available to the donor at any time after
donation on number and gender of any children born
N/A
The point of no return is a well-established concept that gamete donors lose consent once insemination has occurred or embryos have been created.
4
Egg donation
Egg donor
Partner of donor
Notes
Who is asked to give consent, or
involved in the decision in some
way?
Egg donor
Where relevant a
partner will be
asked to consent
Based on requirements in Fertility
Standards documents
When is consent sought?
Consent is sought before donation.
Further consent is sought prior to egg collection
 Pre-treatment screening
 HART Act requirements eg, donor information
 Medical history disclosure
 Maintaining contact information
 Drugs and medicines
 Setting conditions for the donation
Consent is sought
before donation
N/A
.
What information is provided to
donors about recipients and vice
versa?
Limited donor information provided to recipients at time of use.
Intending parents may be told when their profile is being shown to
an egg donor.
Recipient information provided in embryo donation and surrogacy.
N/A
In many cases (more than 50% in
one clinic) donors and recipients are
well known to each other and share
information directly
When can consent be amended
and/or withdrawn?
At any time up until creation of an embryo
N/A
Do any consents ‘run out’ requiring
new consents?
Donors are being asked to re-consent to the extension of storage
for their gametes and for embryos created from their gametes
N/A
Are there any practices to reconfirm consents before
actions/use?
No
What is sought – consent covering
what actions/use/treatments?
Do consents become in practice
‘unable’ to be withdrawn or
amended – at what point?
See above re ‘point of no return’
Is information provided to donors
by clinics about actions/ use of
donated gametes or embryos when
it occurs?
 Proactive provision practices vary. Egg donors often are
informed.
 Information as required is available to the donor at any time after
donation.
What information is provided to
donors about outcomes?
 Varies. Information as required is available to the donor at any
time after donation on number and gender of any children born
N/A
N/A
N/A
Some practice occurs of informing
egg donors when eggs are used. This
arises because treatment cycles are
usually close to donation being made.
5
Donation of embryos created by couple from own gametes (each gamete provider treated individually)
Egg provider
Sperm provider
Who is asked to give consent, or involved in the
decision in some way?
Egg provider
Sperm provider
When is consent sought?
Post-embryo creation and freezing – when making
decisions about storage at any point – potentially some
years after embryos stored
 Number of embryos to donate
 Screening and medical history
 Legal status of the resultant child
 Any other conditions set by the donors
Post-embryo creation and freezing – when making
decisions about storage at any point – potentially some
years after embryos stored
 Number of embryos to donate
 Screening and medical history
 Legal status of the resultant child
 Any other conditions set by the donors
When can consent be amended and/or
withdrawn?
Up to the point of transfer into the recipient woman
Up to the point of transfer into the recipient woman
Do any consents ‘run out’ requiring new
consents?
Upon reading the extending storage guidelines, it may be
that embryo donors are re-contacted to give consent to
the extension of storage because they are the “gamete
providers”.1
Upon reading the extending storage guidelines, it may be
that embryo donors are re-contacted to give consent to the
extension of storage because they are the “gamete
providers”.
Do consents become in practice ‘unable’ to be
withdrawn – at what point?
Up to the point of transfer into the recipient woman.
Up to the point of transfer into the recipient woman.
Is information provided to donors by clinics about
actions/ use of donated gametes or embryos
when it occurs?
 There is continued information available to the donor
during the donation process.
 Information as required is available to the donor at any
time after donation
 There is continued information available to the donor
during the donation process
Proactive provision practices vary.
Information as required is available to the donor at any
time after donation on number and gender of any children
born
Proactive provision practices vary.
Information as required is available to the donor at any
time after donation on number and gender of any children
born
What is sought – consent covering what
actions/use/treatments?
Are there any practices to re-confirm consents
before actions/use?
What information is provided to donors about
outcomes?

1
The Guidelines only allow for donation of embryos created from the donors’ own gametes.
Section 5(a) Guidelines on Extending the Storage Period of Gametes and Embryos
6
Posthumous use of sperm
Sperm provider
Potential recipient
Who is asked to give consent, or involved in the
decision in some way?
Sperm provider
N/A
When is consent sought?
At the point of storage
Renewing consent for storage
N/A
What is sought – consent covering what
actions/use/treatments?
To specify what should happen to the sperm if the donor dies
while the sperm is in storage
Stored sperm (donors)
 Sperm be available for use by a person/couple who have
already produced a child/children by donor insemination,
or
 Disposal
Stored sperm (personal use)
 Sperm be available for use by a specified person with a
specified time frame
 Disposal
Must demonstrate written consent to collect sperm from a
comatose or recently deceased person.
N/A
When can consent be amended and/or withdrawn?
Any time prior to death
N/A
Do any consents ‘run out’ requiring new consents?
May be asked to renew consent for posthumous use when
extending storage
N/A
Are there any practices to re-confirm consents before
actions/use?
No
N/A
Do consents become in practice ‘unable’ to be
withdrawn – at what point?
If there is no written consent in place prior to a person
becoming comatose or upon their death, then no collection is
allowed. The exception is if a Court Order is obtained.
N/A
Is information provided to donors by clinics about
actions/ use of donated gametes or embryos?
N/A
7
Extended storage gamete providers
Gamete provider
Partner
Who is asked to give consent, or involved in the decision in some way?
Sperm provider
No?
When is consent sought?
At the point of consent for storage
Renewing consent for storage
N/A
What is sought – consent covering what actions/use/treatments?
Extension and purposes for it
N/A
When can consent be amended and/or withdrawn?
At any application
N/A
Do any consents ‘run out’ requiring new consents?
Yes since approvals are time limited
N/A
Are there any practices to re-confirm consents before actions/use?
N/A
N/A
Do consents become in practice ‘unable’ to be withdrawn – at what point?
N/A
N/A
Is information provided to donors by clinics about actions/ use of donated gametes or embryos?
N/A
N/A
Gamete provider
Partner
Who is asked to give consent, or involved in the decision in some way?
Intended parents, gamete providers
Involved as IP
When is consent sought?
At the point of storage
Renewing consent for storage
N/A
What is sought – consent covering what actions/use/treatments?
Extension and purposes for it
N/A
When can consent be amended and/or withdrawn?
At any application
N/A
Do any consents ‘run out’ requiring new consents?
Yes since approvals are time limited
N/A
Are there any practices to re-confirm consents before actions/use?
N/A
N/A
Do consents become in practice ‘unable’ to be withdrawn – at what point?
N/A
N/A
Is information provided to donors by clinics about actions/ use of donated gametes or embryos?
N/A
N/A
Extended storage embryos
8
11.
The discussion that follows is a summary of information from discussions during the
clinic visits, and subsequent emails.
Obtaining consent from donors
12.
Prior to the donation itself, donors will provide consents for pre-treatment screening,
providing donor information to fulfil HART Act requirements and setting conditions on
their donation if they wish (eg, a donor can specify their consent for donation to go to
heterosexual couple only).
13.
Once the donation is made, donors are not contacted for further consent if the clinic
intends to use the donated material (with the exception of the extension of storage, this
is further discussed in the appendix).
Obtaining consent from donors’ partners
14.
The Fertility Services Standard 1.10.3 states that clinics shall obtain consent for
donation from the donor’s partner if they are married, in a civil union or in a de facto
relationship with the donor.
15.
As discussed above, the importance of informed consent is about providing people
with information. Partners undergo the same informed consent process as the
donating partner. They are also provided with the relevant information and the
opportunity to ask questions.
Counselling can also be useful for facilitating
discussions between a donor and their partner.
16.
One clinic advised that where a partner does not give consent, the donation should not
take place while the potential donor is still in the relationship. However, should the
donor insist on proceeding, even without the support and consent of their partner, the
clinic could consider the donor’s request through a case conference.
Information sharing between donors and recipients
17.
There are no guidelines on what (medical) information about the donor should be
provided to the potential recipient. Most of the information provided to donor recipients
is what the donor tells about himself in his profile, rather than anything extracted from
medical history.
18.
Donors also fill out a full medical questionnaire that is only seen by doctors. On
occasion, a doctor will consult with a nurse about aspects of the medical
questionnaire. This comprehensive medical information is not available to recipients. It
is at the doctor’s clinical discretion as to whether further medical information is shared
with the recipient. There are some questions around what particular health issues
should be disclosed if identified, for example, mental health issues.
19.
A donor must consent to any further information that is shared with the recipient.
20.
In some instances, the donor will request a recipient’s profile. There is currently no
obligation on the recipient to provide any information, and responses to such requests
are be arranged by clinic staff.
9
Expiry and changes to consents
21.
The length of time before consents expire of varies between clinics. Generally, a new
consent will be required before each procedure (eg, egg collection). This means there
is no expiry date, for as soon as the procedure is over, that consent ceases. Clinics
may have an overarching consent in place for IVF that may last years, with additional
consents required for each cycle.
22.
The overall feedback from discussions is that people do not often make changes to
their consents. This would only be likely to occur if there had been a change in
relationship status.
23.
There is some variation between clinics about the process used when a patient wishes
to make changes to their existing consent form. The process also depends on the
nature of the change requested. Some clinic policies insist on a newly signed consent
form no matter the nature of the change. Other clinics will accept verbal confirmation
for a minor change, and annotate the change on the existing consent form. This may
be followed up with patients required to sign the amended consent form to verify the
change.
24.
However for any variation to consent involving multiple parties, all parties must agree
to the proposed amendment. As a risk management exercise, signatures may be
checked, or the clinic can request identification or written evidence (ie, a letter) that the
amendment is mutually agreed.
25.
One participant saw consent forms as a “statement of intent” and that these are not set
in stone. Changes can always be made, and more often than not, changes will be
required if there is some change to a patient’s treatment plan.
Withdrawal of consent
26.
The informed consent process is very clear in covering at what point any party is
entitled to withdraw consent. Every consent form is labelled clearly that consent may
be withdrawn.
27.
Overall, it was reported that donors rarely withdraw consent. On the rare occasion
consent has been withdrawn, it has been in relation to donors withdrawing consent for
further use of their gametes following a live birth.
28.
When multiple parties are involved, the party withdrawing consent usually contacts the
clinic. If there is any disagreement between the parties, for example where one party
withdraws consent to use surplus frozen embryos, then a counsellor may be involved
to work with the parties to decide what would happen to the surplus frozen embryos.
Point of no return
29.
Clinics reported that the point of no return (where consent can be no longer amended
or withdrawn) is a fundamental and well-established concept in donation. It is also a
useful tool for managing relationships and expectations between donors and
recipients.
30.
Clinic practice for gamete donors is that once insemination has occurred or embryos
have been created, a new entity exists, that the donor has a biological link to, but
which is no longer within their control.
10
31.
The point of no return for embryo donors is different, in accord with the embryo
donation guidelines. They can withdraw consent up to the point before an embryo is
transferred into a woman. This means that if a child is born from an embryo donation,
the embryo donor can withdraw consent if the recipients wish to use another donated
embryo in hopes of providing a full genetic sibling.
Information shared with donors about outcomes of their donation
32.
One clinic’s policy is that donors will not be informed of whether a recipient has started
or completed a treatment cycle, if there has been a positive pregnancy test, or if there
has been a live birth. This clinic has an exception for egg donors, who will be
contacted and informed of the outcome of their fresh treatment cycle and whether any
embryos have been frozen from their donation. The clinic also adopted an internal
policy for embryo donors that allow recipients to decide whether their embryo donor is
informed if a treatment cycle has happened.
33.
However, a donor is not precluded from accessing information about their donation.
As per section 60 of the HART Act, if a donor contacts their clinic and requests
information from the clinic, the donor will be told if any children have been born from
their donation, the gender of the children. One clinic will also tell a donor if there is a
recipient currently pregnant.
34.
It appears that the responsibility is on donors to actively seek information about the
outcomes of their donation. One clinic takes the view that this respects donors, as not
all will be interested in the outcomes of their donation.
35.
Notably, one clinic reported 50% of donors being family or friends of the recipients. It
is likely there will be communication and information shared, external to the clinic.
THE PROCESS OF OBTAINING INFORMED CONSENT
Overall approach
36.
Clinics share the view that informed consent is about providing people with
information. The act of signing consent forms is a formal recognition that people have
received information, had an opportunity to ask questions and understand what they
are consenting to. The consent forms are useful for capturing the culmination of
interactions between the patient and the different people involved in their care.
37.
The process of informed consent is a multidisciplinary effort between nurses, doctors,
counsellors, embryologists/laboratory staff and patients. Clinic staff work together to
ensure informed consent has been obtained.
38.
Obtaining informed consent from a patient is tailored to the individual. Clinic staff
providing information to patients noted the importance of working with the individual in
accord with their circumstances. A person’s physical or emotional response is a useful
indicator when assessing how much information to give them and whether it is being
understood. For example, one person may want all the information available, while
another would be overwhelmed if the same amount of information was given to them.
11
39.
Clinics noted the usefulness of having a broad and knowledgeable support
infrastructure for their patients. When a patient has a query, it will be forwarded on to
the most appropriate clinic staff, if the person who takes the query (most likely, a
nurse) cannot answer it. For example, specific medical questions could be directed to
a doctor or embryologist. This structure ensures that the patients are well-informed.
40.
All parties involved in the process are required to give their consent for any treatment
that uses gametes or embryos outside the body, any operative procedures, and
medication regimes. For example, in the case of IVF using donor sperm, consent prior
to treatment commencing is required from the intending mother, the donor and the
partner – despite the fact that the partner is not contributing sperm to the process.
41.
All clinics require consent forms to be signed-off or witnessed by a clinic staff member.
Depending on clinic policy, this is usually done by a nurse, although some clinic
policies require it to be done by a doctor.
42.
Clinical sign-off and witnessing acts as an accountability mechanism for staff. One
clinic staff member considered their signature as a declaration that they are satisfied
the patient has understood what they signing and consenting to. This instils a sense of
responsibility to ensure information has been given and understood.
43.
Different roles have developed in-house checklists that are used to ensure that
important issues have been covered off with patients, and to make sure that all
required consents have been obtained. With IVF procedures, clinics will commonly use
egg collection as a checkpoint to ensure all require consents are in place.
Roles in the clinic
Role of doctors
44.
Doctors have a clear role as the initial information provider. All patients will have a first
consultation with a doctor. At this consultation, a doctor will talk about what a
procedure or treatment will be like in relation to a patient’s individual circumstances.
The doctor will also discuss the risks and side effects, and answer any questions the
patient may have at this point.
45.
Some doctors will provide patients with the appropriate consent forms and take them
through the consent forms, but this is not always the case. Where the patient has any
specific medical follow-up queries these will be answered by a doctor.
Role of nurses
46.
Nurses share the role of providing information to patients. Patients will usually see a
nurse following their doctor’s consultation. Nurses will go over baseline information
about assisted reproduction, as well as discussing the specific procedure or treatment
will involve. Nurses may also go through any in-house patient information.
47.
Nurses work with an individual to assess what level of information should be provided,
whether it is being understood, and if not, ways to facilitate their understanding. The
type of treatment, whether they are a donor or IVF patient, a first-time or repeat clinic
patient, and personal needs, will affect the amount of time a nurse spends with the
patient.
12
48.
If a patient has not been given the appropriate consent forms, the nurse will provide
the forms. Nurses will also go through the informed consents required for a procedure
and explain what the consents cover.
49.
Some nurses encourage patients to take the information and consent forms away
before signing. In most cases there is a time lapse from the patient receiving
information, signing consent forms and beginning treatment. This length of time varies
between patients (some will choose to sign quickly while others will take a long time)
and the nature of the consent forms (patients may be at different points of their
treatment, for example, considering general consents for IVF versus consents specific
to an IVF cycle).
50.
In some cases, the nurse will organise a follow-up appointment prior to patients
signing consents. This latter appointment is an opportunity to ensure patients
understand what is being, or has been signed, and to clarify any information or
concerns.
51.
Over the course of a patient’s treatment, nurses have the greatest amount of patient
interaction compared to other professional roles in clinics. Often strong, open and
honest relationships develop between patient and nurse.
52.
Nurses are the primary point of contact for patients during the course of their
treatment, and act as a liaison for patients and staff. Patients are most likely to contact
their nurse in the first instance if they have a particular question or query. If the nature
of the query is outside a nurse’s scope of practice, it will be forwarded on to the
appropriate party.
53.
Nurses tend to have an overarching responsibility for ensuring all required consents
are in place and coded to the relevant cycle or procedure before it begins. They check
consents have not expired, and if they discover an expired consent they will ensure a
new consent form is signed before the treatment begins.
Role of the counsellor
54.
A counsellor will work with patients primarily to identify and explore the potential issues
and circumstances that may arise during and after their treatment. In particular, a
counsellor will discuss with patients the future eventualities and potential long-term
implications, and explore ways to manage these should they occur. Counsellors also
provide a non-medical perspective on any issues and concerns someone might have.
55.
Counsellors predominantly work with donors; they will not see all IVF patients. The
consent process for IVF patients is generally covered by doctors, nurses and
embryologists. However one clinic gives all its IVF patients the option to meet with a
counsellor.
56.
Given the multidisciplinary nature of the informed consent process, it is not uncommon
for a doctor or nurse to refer an IVF patient to counselling if they think the patient could
benefit from further support, or have a discussion about any issues or concerns, from a
non-medical perspective. Alternatively some IVF patients choose to speak with the
counsellor and can always do so.
13
57.
Counsellors also have a role managing donor and recipient relationships and
expectations. Implications counselling is particularly important for donors, with the aim
of exploring the social, ethical and legal implications of their donation. Sometimes this
means raising scenarios a donor may not have considered.

One example is a sperm donor setting conditions on the use of his sperm. He
may agree to donate to heterosexual couples but not to single women. The clinic
would find it difficult if they were presented with a heterosexual couple, but the
male partner is very old or terminally ill. This would conflict with the donor’s
condition because there is potential for the woman to become a single parent.
58.
An important aspect of counselling for donors and recipients is the possibility of
withdrawal of consent. This involves talking to recipients about a donor’s ability to
withdraw consent and talking to donors about the “point of no return” (see ‘challenges’
section).
59.
Depending on the clinic, a counsellor may co-sign or witness the signing of a consent
form to ensure a donor has understood what they are consenting to, been given the
opportunity to discuss their concerns, and feel supported in making a decision that is
the best for them.
Role of embryologists
60.
Embryologists are primarily involved in the informed consent process after a patient
meets with a doctor, nurse, and in some cases, a counsellor. On occasion, the
embryologist will meet face-to-face with a patient prior to treatment, to discuss their
role, but usually this has been covered by a nurse or doctor. Embryologists are always
available to speak with patients when required or requested.
61.
As mentioned earlier, nurses have an overarching responsibility for checking all
required consents are in place. However, embryologists perform an important
secondary check. Immediately prior to starting a procedure, embryologists will check
to ensure all consents are present. Processes involving the laboratory will not proceed
without the required consents.
62.
Clinics often use the signed consent forms as instructions to be followed by the
laboratory. The consent forms provide assurance for the embryologists that they are
doing exactly what has been authorised by the patient. For example, an IVF patient will
provide the laboratory with the cycle-specific consent form that details the number of
eggs they wish to inseminate, identifies the gamete providers, and the number of
embryos for transfer.
THE MANAGEMENT OF INFORMED CONSENT RESPONSIBILITIES
Consent forms
Development
63.
Existing consent forms have been developed from a range of resources including:
 the Fertility Services Standard that outlines the required components of a consent
form
 overseas consent forms and sources that been adapted for the New Zealand
framework, for example the HFEA and the RTAC Code of Practice.
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64.
However all clinics’ consent forms are developed with a focus on the patient
perspective. This means including information that is relevant and sufficient for
maximising a patient’s understanding of what they are consenting to. There is a
shared view that it is possible to undermine a patient’s understanding with information
overload.
65.
Furthermore, consent forms have been written in plain and simple language to make
clear what the issues are, and people know what they are consenting to.
66.
Consent forms primarily focus on medical risks, issues and topics to be discussed
between patients and those involved in their care. The broader social risks and future
eventualities are sometimes overlooked.
67.
However, consent forms are not necessarily appropriate for capturing these nonmedical risks, and it would be impossible to cover every possible circumstance. This
is when patient-staff interaction when discussing consents is key, ensuring that these
matters are covered in another way.
Review
68.
69.
The most common trigger for reviewing consent forms is if there has been an incident
reported either by patients or staff. Other triggers for consent form review include:

recurring situations or circumstances that would warrant permanent capture in a
consent form

developments in medical techniques, technology or code of practice

legislative changes.
Consent forms require continuous review: when risks change, consent forms will
change. Across the clinics, staff have an opportunity to provide feedback, or provide
direct input into reviewing a consent form.
Standardisation
70.
There are variations between consent forms and the way in which informed consent is
obtained between clinics. Clinics had differing views on whether standardised consent
forms for some procedures, such as IVF, would be helpful.
71.
One perspective was that consistency would help minimise any patient confusion in
the operation of the different clinics and also be helpful with auditing. It would also be
useful to ensure the content in the consent forms are consistent, so all patients are
being given the same information. More specifically, there was feedback that it would
be useful to have clear and consistent forms for some niche areas of fertility treatment.
72.
It was suggested that an external body such as RTAC or Standards New Zealand
could produce standardised consent forms.
73.
Another perspective was that, standardised consent forms may not be useful because
consent forms require continuous review. There will always be some issue or scenario
that has not been considered in the consent form.
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Audit
74.
Auditing processes are useful for identifying where there may be weaknesses in the
clinics’ processes and practice. In particular, audits can capture deficiencies or risk
can be useful for feeding into the development or review of consent forms.
75.
Each clinic is accredited against the Fertility Services Standard (NZS 8181) and has
auditing responsibilities to an external certification body. Internal audits are also
carried out and are useful for determining the frequency of issues, and to capture and
manage risks.
Training
76.
A large component of training and orientation of new staff involves informed consent.
Across the clinics the policies and procedures are very clear to all staff regarding
consent requirements for each treatment.
77.
However most people acknowledged that informed consent processes are best learnt
on the job. For nurses, it was agreed that informed consent is hardwired into them
from start of their training.
78.
New staff may be paired with a ‘buddy’ who is responsible for teaching them the
specific policies and practices of the clinic.
CHALLENGES OF THE INFORMED CONSENT PROCESS
Language
79.
This was the most commonly identified challenge across clinics. Clinics find it difficult
to ascertain whether informed consent has been obtained when there is uncertainty
around whether someone has actually understood the information and consent forms.
80.
Clinics and staff members have discretion recommend or require an interpreter. An
interpreter is useful for explaining medical terminology, discussing consents and
communicating a patient’s concerns.
81.
Some patients will refuse an interpreter because they do not trust them, or think they
do not need one.
82.
Patients will often want to use family or friends as an interpreter, but all clinics insist on
using an externally-sourced medical interpreter. Clinic staff need assurance the
interpreter is communicating complete, accurate and unbiased information. A patient’s
choice of interpreter may not understand or be familiar with the medical terminology.
83.
An interpreter may not be required at every stage of treatment. The staff may insist on
an interpreter at particular points, for example during the signing of consent. The use
of an interpreter also useful where there are multiple parties involved. One party may
not require an interpreter, but another might. The interpreter would therefore only be
present when needed.
84.
English as a second language is not the only language challenge. A fluent English
speaker could struggle with the medical terminology used. It would be a matter of
spending more time with these patients to ensure that they understand all the
information given.
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Disability
85.
Patients with disabilities are treated on a case by case basis – it may be someone with
a physical disability, eg, sight or hearing impairment, or other types of disability eg,
someone with limited literacy.
86.
If a person’s disability creates a challenge to obtaining their informed consent, clinics
adopt different approaches to overcome this. For example, if a blind person or couple
were seeking treatment, the clinics can provide the relevant consent forms in Braille, or
a person with a hearing impairment can have a hearing interpreter present. One clinic
suggested that they could do a verbal reading of the consent forms, and record the
discussions. This could be used for patients with a visual impairment, or those with
limited literacy.
Understanding information
87.
It is a judgement call from clinic staff as to whether or not a patient has understood the
information given and what they have consented to. This is particularly challenging
when someone has already signed a consent form, and think they can do something
they cannot, or have misconstrued the information they have been given.
88.
A team approach is useful for mitigating this particular challenge, because there are
multiple opportunities to clear up any misunderstandings before starting treatment.
89.
An added complexity with obtaining informed consent for fertility treatment is that it
requires people to provide consent for a highly variable and uncertain future. Some
participants questioned whether someone so preoccupied with having a child and
under a lot of stress can fully comprehend the information and properly consider future
uncertainties and implications.
90.
For example, some consent forms require people to think about what happens to their
frozen surplus embryos if there is a relationship breakdown. Often couples will find it
difficult to comprehend this situation, even though this is a realistic question. One
case discussed was a married couple who struggled to make this decision because
their cultural and religious views did not contemplate the possibility of a relationship
breakdown.
91.
It is important to acknowledge that fertility patients are a unique patient pool because
they are generally well-informed and prepared. These patients have made a
significant financial and emotional investment that makes them very motivated to seek
and understand information.
Coercion
92.
There were few reports of coercion. However, there are two specific groups at the risk
of greater exposure to coercion:

Young family donors: There is particular concern about young family donors who
may be restricted in their ability to make independent decisions. Counselling is
the most useful way for ensuring a donor is making the best decision for
themselves, and not for the recipient. However, this can be difficult to ascertain
in light of the weight of familial obligations.
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For example, there may be pressure from the wider family who are supportive of
the donation or have been actively involved in recruiting the donor for the
recipient. It can be difficult for the donor or other family members to speak out
against the donation because it is regarded as “such a wonderful thing”. One
counsellor in particular was uncomfortable with young family donors who had not
yet had their own family.

Between partners: Although this was uncommon, there were a few cases where
coercion of one partner has been identified, with some pressure on one of the
parties to participate.
Where this situation is identified, counselling is
recommended.
93.
To minimise the risk of coercion, counsellors will attempt to see the parties alone, or
seek input from other clinic staff involved in their care to assess whether consent has
in fact been provided. The ECART application process is also considered an
additional safeguard against coercion.
94.
Linked to the challenge of coercion, there are a number of patients who may feel
pressure to make decisions they are not entirely comfortable with when facing funding
restrictions. One example discussed was where people are uncomfortable about
creating surplus embryos, on the grounds that the surplus embryos may have to be
disposed of. However patients may feel compelled to create surplus embryos if they
are receiving public funding and wish to capitalise on the opportunity for a future
pregnancy.
CONCLUSIONS
95.
Clinics treat informed consent as an integral part of the fertility treatment process. The
informed consent process is about providing enough information to the patients to
enable them to make fully informed decisions.
96.
Clinics recognise that individuals require different amounts of information, and adjust
their approach accordingly. However, clinics questioned whether a patient can really
be fully informed. Given that the patient’s mind is often on the present, are they able to
fully comprehend how the decisions they make now will affect them in the future?
97.
All parties involved must give their consent, even if they are not providing gametes (eg,
the partner of a female undergoing IVF with donor sperm). Procedures will not go
ahead without the correct consents in place, and there are multiple checkpoints to
ensure this.
98.
Clinics consider the point of no return as a well-established and well-understood
concept in donation. However this is being challenged with the extending storage of
embryos created from donated gametes. Donors are being contacted and asked to reconsent, which is inconsistent with their understanding from the time of donation that
they will have no further contact if embryos are created.
99.
Clinics recognise consent forms require continuous review. Triggers for review include
incident reporting by staff or patients; a recurring situation to warrant permanent
capture in a consent form; developments in medical techniques, technology or code of
practice; and legislative change. Clinic staff provide feedback and input into the
review.
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APPENDIX: CLINIC PERSPECTIVES
The donation as a gift
Clinic often expressed the view that donors view their donation a gift, and understand it as
completed without the need to have it re confirmed. Once the donation is made, donors are
not contacted for further consent if the clinic intends to use the donated The clinics consider
this position well-aligned with how the concept of donation is understood by donors – that it
is a gift. Clinics say that donors’ expectations from the time of donation are that they will
have no further contact if embryos are created. Donors who have been contacted have
reacted with surprise.
This is a firmly held view in respect of sperm donors, but practices allow of more proactive
approach to egg donors.
Change to conditions or withdrawal of consent
Clinics are of the view that the point of no return (where consent can be no longer amended
or withdrawn) is a fundamental and well-established concept in donation. It is also a useful
tool for managing relationships and expectations between donors and recipients.
The point of no return has never been reported as complex or challenging for donors to
understand. Furthermore, donors are all clear that their donation is a gift.
Both gamete and embryo donors are able to withdraw consent. For example, if a gamete or
embryo donor withdraws consent to use their gametes or embryos after a recipient has
already used them to have a child; the recipient cannot try for another child by the same
donor.
However, the point of no return where the consent can no longer be amended or withdrawn
is different for gamete and embryo donors.
Gamete donors
The point of no return for gamete donors is up until the point of sperm meeting egg (ie, at the
point of insemination or creation of embryos). Once insemination has occurred or embryos
have been created, a new entity exists, that the donor has a biological link to, but which is no
longer within their control.
However, this concept is currently being challenged. Gamete donors are being contacted
and asked to re-consent to the extension of storage for embryos created from their gametes.
Clinics consider this policy to be inconsistent with donor consents at the time of donation.
The shift in the point of no return can be problematic if a donor refuses to consent to an
extension of storage. The decision then must be made as to who has the overriding rights,
the donor or the recipient.
Embryo donors
The point of no return for embryo donors, in accord with the embryo donation guidelines, is
up to the point of transfer into the recipient woman.
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