Submission on Using Stem Cell Lines for Research - March 2006

In November 2005 the Ministry of Health published a document on this topic and called for public submissions on a draft set of guidelines to manage the use of these cells in research. The discussion document is published at this link on the Ministry of Health website [discussion document no longer available; a summary of the submissions is available].

This submission is from NZORD, the New Zealand Organisation for Rare Disorders. We are an umbrella group set up to assist patients and their families improve access to knowledge about the disease that affects them, to assist contacts with and development of support groups for rare disorders, and to work in partnership with clinicians, researchers and policy agencies to improve clinical care and research into treatments, prevention and cures.

Context of our submission

  1. Our wide support of research into treatments and cures for rare diseases is in the context of a group that also has a very keen interest in protection of the rights and interests of patients and their families in clinical treatment and in research. A robust ethical framework is essential for our interests and wellbeing in the broadest possible sense. In the context of this particular consultation that means we do not subscribe to research gains at any price. All systems and research projects must conform to the high ethical standards appropriate to our culture and social norms.
  2. This submission has not been the subject of specific detailed consultation within NZORD’s wider network of more than 120 rare disease support groups and 70 groups for more common diseases. We have simply referred to it in a recent newsletter to alert groups to the consultation and encouraged their participation. However over the past six years we have engaged in many discussions and consultations with a wide range of individual patients and families, support group leaders, focus groups and workshops, with some professionals often included, to discuss topics like genetic modification, xenotransplantation, pre-implantation genetic diagnosis, genetic testing and screening, transgenics, and other topics where there are strong elements of leading edge science coupled with significant social and ethical issues to be considered. The basis for the opinions in this submission is the collected wisdom of our stakeholders, consistently expressed through all of those consultations and discussions over those years.

We would like to receive a summary of the reviews and we give permission for personal details to be released under the Official Information Act.

Part one - Ethical review

We support the draft section on ethical review. We understand that such review is currently standard in all institutions, even if not required at every level of research. In the case of research involving existing stem cell lines derived from human embryos, it seems appropriate to ensure this practice is maintained in all cases, and that the existing health and disability ethics committees are the appropriate bodies to review the proposals.

Part two - the way in which the cell lines have been established

  1. This part suitably focuses on use of existing cell lines from embryos surplus to IVF procedures. This fits with the limits in the HART Act 2004 which requires public consultation and advice to the Minister before generation of cell lines from human embryos and other human reproductive research could be considered here. The limited range of cell lines that could be considered under these guidelines strike a good balance between the need to enable important research to take place in new Zealand, and the fact that advice is yet to come on the question of generating them here from human embryos. It enables yet does not pre-empt.
  2. Importantly, this part establishes procedures to ensure the cell lines were obtained and generated in an ethical way, including informed consent, confirmation of surplus status, absence of pressure or payment, and freedom to withdraw. These issues are very important protections that are the ethical foundation of the research and an important protection for the original donors as well as, indirectly, for all the potential beneficiaries of the research efforts. It harms all of us and undermines our confidence in health research, if the core of the work does not have an ethical validity to it, and this part ensures the foundation is solid.

Part three - the use of the cell lines

We support the general thrust of this part in ensuring valid research purposes, but query the provision in paragraph 10 that appears to exclude use of the cell lines when the objective may be able to be addressed by other means. This imposes a further layer of restriction over the establishment of ethical approval in part two, and we question whether this additional rule is required once part two has been complied with. At that stage they are cell lines only, and have long since ceased to be part of an embryo, suggesting that extra hurdles may be inappropriate and excessive. We also suggest there will be occasions where other types of research may achieve certain objectives, but leave questions unanswered about the comparative advantages of using these cell lines. That could lead to contradictory situations that are difficult to resolve under the current wording - for example, there cannot be certainty about alternative methods or the comparative value of other methods until the research is actually done on both to determine their relative merit.

Part four - Duty of ethics committees

We strongly support this part which has the effect of stating that each cell line in question gets one approval in relation to its origin that is valid for all future considerations, and does not require reconsideration on that point.

Publicity

We support this part.

Yours sincerely,

John Forman
Executive Director