A presentation to the AABHL Conference

Auckland

14 July 2012

Dr John Angus PhD and Alison Douglass LLB, MBHL

Informed Consent and Assisted Reproductive Technology

• Assisted reproductive technologies – clinical interventions to achieve reproduction.

• They include:• Collection of gametes (eggs/sperm)• Cryopreservation • Treatment or modification• Use for treatment or research• Donation of eggs, sperm or embryos• Fertilisation (including IVF) and implantation• Surrogacy

Assisted reproductive technology

• The Human Assisted Reproductive Technology (HART) Act regulates the provision of ART services and human reproductive research

• Section 76 HART Act enables regulations to be made on requirements for informed consent

• ACART is a committee under the HART Act with the responsibility to issue guidelines in some areas of service and to provide advice to the Minister of Health

• Guidelines often include specific requirements for informed consent

The HART Act and the role of ACART

• The principles of the HART Act include a requirement for informed consent and informed choice (includes withdrawal of consent)

• Other principles are:• Consideration of the health and well being of children born as a

result• Preserving and promoting health, safety and dignity of present

and future generations• Protection of the health and wellbeing of women• Information of genetic origins available to donor offspring• Respect for needs, values and beliefs of Maori• Respect for diverse ethical, spiritual and cultural perspectives

Principles of the HART Act

• All steps in the process of ART require consent - raising issue of point at which consent might be withdrawn or varied

• There are multiple parties involved and different interests - raising issue of the weight to be given different interests

• Episodes of treatment or other action occur over long periods of time - raising issue of duration of consent and any conditions set

• Embryos are created from the gametes of two people – raising issue of what to do when they do not agree about usage or disposal

Informed consent in the ART context

ART processes and points of consent for the example of a couple using IVF

Couple Seeking IVF

Ovulation induction Donated sperm

Spare sperm

Discard Freeze Freeze Discard

Gamete collection

Spare oocytesIVF – fresh oocytes and

sperm

Spare embryos

Discard Freeze

Storage

Future use by couple Donation Research

Discard

Red indicates possible points of consent

• Who needs to consent?

• For how long does the consent remain valid?

• When can consent be withdrawn?

• Can a donor put conditions on use?

Four matters not set out in legislation and subject to debate:

Circumstances in which consent might be varied or withdrawn include:•By a partner or ex partner in the case of embryo from own gametes•By donor in the case of embryos created using donated sperm or donated eggs•By one or other donor in case of embryos created using donated eggs and sperm•By either party in a couple donating embryos

Who, how long and what about withdrawal: the example of consent related to embryos

• Gamete/embryo donors?

• Intending parents/recipients?

• And/or surrogates?

• Offspring born as a result of ART?

• The embryo itself?

Who are the interested parties?

• At the time of donation, or at the time it is used?

• At the creation of the embryo?

• Upon placement of the embryo in the womb?

• Or should there be no ‘point of no return’?

When is the ‘point of no return’?

• Informed consent requires competence and voluntariness

• Right 7, Code of Rights provides limited guidance for donation situation

• US case law – in the absence of an express agreement of the parties intention the courts will protect the right not to procreate.

• This raises the legal issue of the extent to which donors may assert rights to control the destiny of embryos using their donated gametes

What does the law say?

• What conditions can be placed by donors on the use of their gametes and embryos?

Should conditions be allowed?

1. Conditions on Donations• What conditions can be placed by donors on the use

of their gametes and embryos?

2. Varying or withdrawing consent to the use of gametes and embryos• Should the creation of an embryo be the “point of no

return” after which the gamete provider cannot vary or withdraw consent?

Two issues for discussion