Submission to ACART on extended storage of gametes and embryos

NZORD supports proposals but seeks clarification on consent issues – March 2011

Assisted reproductive technologies contain important opportunities for people with fertility problems to have children and for at-risk families to avoid serious disorders from occurring in their children. They are also an area of health services that needs close scrutiny to ensure safety, consent and good ethical criteria in service delivery and decision making. A recent law change to the rules for storage of gametes and embryos led to new guidelines being developed by ACART, the Advisory Committee on Assisted Reproductive Technologies. Here is NZORDs submission in response to ACART’s discussion document.

NZORD takes an interest in a wide range of health policy and service issues that may impact on diagnosis, clinical care, or community support for those affected by rare disorders. We also work with a range of officials, clinicians and researchers to promote research into prevention, treatment and cure for rare disorders.

We have a network of 147 rare disease groups that we work closely with on a range of issues, in addition to our close connection with many of the major support groups for common disorders. A number of these groups have particular interests in fertility and research issues and we are informed by our dialogues with them.

NZORD supports the proposed guidelines on extended storage. They seem to provide a practical solution to the particular needs of people in certain circumstances. They also appear to provide realistic opportunities for approved research to continue. Additionally, they put a limit on the total time of storage in line with the intention of the HART Act.

One point we wish to raise about the detail of the draft guidelines is the references to research using gametes or non-viable embryos, in 2 c) iii) and 3 d).

  • These are very specific references to research that is currently permitted.
  • If there was future approval for research to occur on donated viable embryos, these guidelines would then need to be altered.
  • The process for altering guidelines can be complex and time-consuming.
  • It may be feasible for a consequential amendment to be made to these guidelines in the future associated with any guidelines that might be put in place to cover embryo research, but there may also be complexity with that process.

Alternatively, these guidelines could state a more general term about “ongoing or future research using gametes or embryos as may be permitted by law.”

Another comment we wish to make is about the discussion on informed consent in the consultation document. We support the statements made and conclusions reached. We believe these are correct and consistent with the rights of consumers under the HDC Code of Consumers Rights. There are two perspectives we offer on this:

  1. In the box on page 13 headed “ACART’s current thinking about informed consent” the first point could usefully have the phrase “or irretrievably used in research” added to the end of the statement. This would achieve consistency and completeness of coverage of issues related to changing or withdrawing consent.
  2. Question 4 is phrased in such a way that it could be interpreted as asking whether disagreement with the proposals for consent requirements, implies that consent of donors might not be required, or might be written into the guidelines in a significantly different way as a result of views raised in the consultation. That is, apparently consulting on whether a regulation actually applies, or should apply. We think it is important for ACART to note that if there is any significant move to change the views that ACART has currently formed in relation to informed consent, it would likely require a change of regulation to implement any different approach, rather than simply be incorporated in a guideline. The fact that ACART’s current thinking is based on application of the Code which has the status of a Regulation, reinforces our view on this.

Yours sincerely,

John Forman
Executive Director