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Comment from Toi te taiao: the Bioethics Council to the Ministry of Health on the discussion document and guidelines “Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research”Toi te Taiao: the Bioethics Council ("the Council") welcomes the opportunity to comment on the Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research. The Council’s Terms of Reference places strong emphasis on public engagement in its work, and the Council is very aware of the need to understand public attitudes. The issue of stem cell lines and their derivation has not been the subject of formal public debate to date, so for this reason the Council commissioned a series of focus groups to inform its thinking on the proposed guidelines. General points1. Toi te Taiao: the Bioethics Council was established by the New Zealand Government in 2002 as a ministerial advisory committee. The Council’s Terms of Reference are based on recommendations made by the Royal Commission on Genetic Modification in 2001. The key responsibilities of the Council are to:
2. The Council views the term “cultural” in its widest sense as embracing all the people of New Zealand and their diverse cultures. 3. Part 4 of “Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research” (the discussion document) refers to “ethical issues”. The report of the Royal Commission on Genetic Modification established the need to include ethical, cultural and spiritual aspects in any decisions about biotechnology, not just ethical effects. The Council’s own Terms of Reference refers repeatedly to “cultural, ethical and spiritual” aspects of biotechnology, reflecting the views of the Royal Commission and many New Zealanders. 4. The Council believes that the use of human embryos to create embryonic stem cells lines for research raises cultural, ethical and spiritual questions, which are of significant interest to the public. The limited dialogue work undertaken with members of the public to date (see paragraph 6), indicates that while there is acceptance of the fact that embryonic stem cell lines are not embryos, this does not separate them in people’s minds from the ethical issues associated with their creation from embryos. The Discussion Document itself explicitly recognises this linkage in dealing with the use of embryos in research and cell lines together throughout the document. 5. The Council is aware that the proposed guidelines will not have the force of law. However it is concerned that if they are accepted as binding by ethics committees, this is de facto regulation without the safeguards inherent in the legislative process. By contrast, the Human Assisted Reproductive Technology Act 2004 prescribes the process by which guidelines may be made under that Act and requires that they be published and notified, prior their being issued. Focus groups6. In order to inform its views the Council contracted with the Centre for Research Evaluation and Social Assessment (CRESA) to conduct eight focus groups involving a total of 54 people, with the intention of scoping out the views of the participants towards stem cell research in New Zealand and the importation of human embryonic stem cell lines. The groups included young parents, retirees, Māori, Pacific people, young people, rural residents and mixed groups. The views of the participants as set out below are not necessarily those of the Council, but point to a need for further dialogue with the public in these areas. 7. Many of the participants in the focus groups expressed a lack of knowledge about stem cell research and wished to know more. This indicates a need to undertake public education about stem cell research, its ethical implications and its potential applications. Although the discussion document contains information, many members of the public would find it difficult to easily understand this information, because the discussion document assumes familiarity with and expertise in the subject matter. In addition, the timing of the consultation over the holiday season is unlikely to elicit a wide response from the general public on this important matter. 8. The focus group participants expressed an underlying mistrust of scientists and their motives, which is consistent with the findings of the Council’s previous public dialogues on the use of human genes and xenotransplantation. Many participants in the focus groups appear to have been influenced by the Greenlane Hospital heart collection issue. They tended to see science and technology in a deterministic way with scientific progress shaped by the interests of drug companies and the scientists themselves. Concerns expressed relating to distributive justice included:
9. In the focus groups, opinions were divided, with some people favouring the use of embryos created for IVF because they would otherwise be “wasted”, and others favouring the creation of embryos using donor gametes on the grounds that the intention behind the production of embryos should define their use. There were a small number of participants in each focus group who felt that the extraction of stem cells from human embryos was always unacceptable because life begins at conception. 10. The focus groups expressed support for adult stem cell research because it involves less ethical complexity than embryonic stem cell research and might avoid rejection problems. 11. About half of the participants were influenced by a need to maintain science expertise in New Zealand. Apart from concerns about loss of expertise, people also valued the ability to control more effectively the ethical and risk management issues potentially associated with the research. 12. The most consistent response from the focus groups was opposition to the importation of cell lines, preferring that, if they are to be used, they should be created in New Zealand. The reasons for this were concerns about the standards in other countries and the reliability of documentation. In addition, there were concerns about biosecurity and the health and/or genetic characteristics of overseas donors. Discussion Document13. The Council agrees that public consensus as to whether an embryo is a person or has the status of a person is unlikely, but firmly believes that all the issues associated with embryos need public dialogue and discussion. It is important that the many perspectives in the community are understood by all, and that the public is well-informed. 14. The Council recognises that a practical consequence of the provisions of the Human Assisted Reproductive Technology Act 2004 (HART Act) and the acceptance of PGD as an established procedure under the HART Act is that some embryos created using IVF, but not implanted, will be destroyed. It also recognises that abortions are legal under some circumstances and that, in general, the unborn child is not treated as a person in the law until “born alive”. [Discussion document p19.] However, the Council considers that the laws referred to in the discussion document are context specific, rather than indicating an accepted public view. 15. The Council does not accept that this regulatory framework necessarily implies that “it can be ethically acceptable to destroy embryos for research purposes.” [Discussion document p20.] The laws concerned have arisen in light of particular circumstances or concerns and cannot be interpreted as providing an overarching view about the destruction of embryos for research. 16. During the dialogue processes it has conducted [Such as the projects relating to Human Genes and Other Organisms and Xenotransplantation. These reports are available at: http://www.bioethics.org.nz.] the Council has found a public willingness to weigh cultural, ethical and spiritual factors with potential benefits, such as the alleviation of human suffering. As such, the public may view the destruction of embryos for research as acceptable in some circumstances. However, insufficient dialogue with the public has been undertaken to ascertain the intensity or malleability of these viewpoints. The Council notes that the guidelines propose to limit the use of imported cell lines to those derived from embryos initially created for IVF treatment because such public participation has not taken place. The Council strongly believes that there are also cultural ethical and spiritual issues relating to the destruction of IVF embryos and that this is an area where a public dialogue process is also essential. 17. The Council notes the emphasis in the discussion document on the potential clinical applications arising from the research. The Council is very concerned that in this regard the discussion document is misleading, as the public may have unrealistic expectations about the likelihood of treatments being available in the short term or being derived from research in New Zealand. This is particularly important as the discussion document specifies the type of research being undertaken in New Zealand relates to understanding the basic processes, rather than clinical applications. 18. The Council believes that the use of the expression “informed consent” is inappropriate in this context. The expression is commonly used with reference to medical treatment, as is demonstrated by Right 6 of the The Code of Health and Disability Services Consumers' Rights. [http://www.hdc.org.nz. The Code does also apply to research but provides “Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, needs to make an informed choice or give informed consent.’ Right 6(2).] The Council notes that it is not possible for the gamete providers to give informed consent. This is because the future research uses of the cell lines are not yet known, so the providers cannot be fully informed. Effectively they are giving “authorisation” for the embryos to be used for the creation of cell lines to be used for, as yet, unknown purposes. [It is noted that UK Biobank has recognised this difficulty. See http://www.ukbiobank.ac.uk/ethics/efg.php. The expression “consent” is used and participants are advised that as it is impossible to foresee future research uses the donors will be protected by a strong governance structure.] The Council considers that rather than using the misleading term “informed consent” in this context, the donors should at least be made aware that the cell lines may be used for many years in the future and that the future uses are not yet known and cannot be controlled by the donors. Additionally, they should know that they are unconditionally giving up any rights over their embryos and that the cell lines may distributed globally. The Council believes that the people who donate embryos retain an interest in their use and in the genetic information obtainable from them and may have cultural or personal preferences about the type of research to be undertaken. [For example, research on cures for illnesses may be viewed differently than cosmetic treatments or enhancements.] However if valid consent has been given, waiving such interest, ethically approved research is acceptable. 19. This issue of consent was raised by focus group participants who were concerned about the information that would, or could, be provided to donors. The discussion document states that the issues are the same as in other research on human subjects. [Discussion document p.22.]The Council believes that the issues arising from competent persons consenting to research on themselves are different from the issues involved in research using embryos. 20. The Council recognises that some established cell lines may have been created some time ago and their provenance may be unclear. Use of these cell lines for research purposes is of limited ethical concern, other than the ongoing interest that the gamete providers may have in the types of research undertaken. However, if they gave "blanket" or generic consent, the Council recognises that the gamete providers consented to a broad research use of the resultant cell lines. 21. It is recommended that cell lines created before March 2006 should be able to be used for research with less restrictive requirements as to consent of the gamete providers and that the more onerous requirements in the guidelines and those suggested in this submission should only apply to those created after this date. 22. The discussion document states that the provisions in the HART Act are an expression of the values of New Zealanders about the commodification of the early forms of life. [Discussion document p.21.] However, no dialogue has been undertaken to tease out the nature or extent of such values, for example, whether the payment of expenses to donors is acceptable and, if there are such concerns as expressed in the discussion document, whether these can be extrapolated to an unwillingness to allow the providers of the embryos to negotiate a share of any potential commercial profits arising from a lucrative invention using the cell line derived from the embryos they have donated. 23. In general, the focus groups stipulated that there should be no financial incentive for donating embryos for use in research, although one participant was concerned about the need to protect the rights of donors in the event that corporations made significant economic gains from some application of the research. 24. The Council has been advised that should clinical applications result from stem cell research it is likely that, at least initially, it would be necessary to genetically modify the cells to enable them to be tracked in the body and destroyed if deleterious consequences arose. The Council considers that the need to genetically modify the cell lines may lead to further cultural, ethical and spiritual concerns for some members of the public. This is another area requiring public dialogue. 25. In general, the focus groups were concerned about genetic modification. This was particularly so with Māori participants. 26. The Council agrees that the standards of the country of source and any other country in which the cells are processed, as well as New Zealand standards, must be complied with. This may limit the availability of such cell lines, as a thorough “paper trail” will need to be maintained and be able to be checked for veracity. As mentioned above, if applied to older established cell lines, this may result in them not being able to be used in New Zealand. Guidelines27. The Council considers that a fundamental issue is whether New Zealand researchers should be able to benefit from lower standards in other countries or whether we are concerned to ensure that New Zealand standards are met. The Council commends the approach in the guidelines to require the compliance with New Zealand values in addition to the requirements of the country of source and any country where the embryos are used. The Council strongly believes that there must be a dialogue process to determine the nature of these standards and values. The Council is of the opinion that the discussion document makes unsupported assumptions in this area. [Discussion document p.20, 21.] 28. The Council also believes that the relevance of the comparison with other jurisdictions [Discussion document p. 25.] would be enhanced by dialogue designed to tease out whether the values of New Zealanders differ from those of the countries whose policies are outlined in the discussion document. 29. As the discussion document guidelines require the researcher to certify a range of matters, there is a need for an audit requirement- such as that a certain percentage of projects will be independently audited. The Council considers that the requirement for the lead researcher to provide documentation relating to the source of the embryos is commendable, as the effect is likely to be to exclude less reputable providers. However, the Council shares the concerns expressed in the focus groups- that neither the researcher nor the ethics committee may be in a position to personally certify the conditions as to acquisition have been met, as they will be reliant on information from overseas. 30. The Council notes that the guidelines are confined to IVF embryos initially created for reproductive purposes and so embryos created for research purposes from donated gametes or by SCNT (cloning) are excluded. The Council believes that dialogue should be undertaken to determine whether the public accept that there is a moral difference between the use of embryos created for IVF and those created for research. 31. The Council recommends that reference to “excess” or “surplus” embryos be avoided, because of the potential for offence from such expressions. The use of a phrase such as “embryos that will not be implanted” is preferable. 32. The Council considers that the proposed guidelines do not address the xenotransplantation issues arising if the cell lines have been created using feeder cells from mice or other non-human animals. It is necessary to ensure the protection of researchers and consequently, the guidelines should require the ethics committee considering an application to ensure that there are no issues arising regarding xenotransplantation. 33. It is unclear what is meant by “used” in clause 6. If the embryos were sourced in one country, the cell line was created in another country, then provided to New Zealand researchers, it is unclear at what point they are “used”. 34. The Council believes the guidelines should clearly require “consent” or “authorisation” from both gamete providers, not just the woman. 35 The Council believes that if cell lines have been created following valid consent or authorisation by the gamete providers the cell lines themselves do not have interests. As such, the restrictions in guidelines 9 and 10 are unnecessary 36. Some focus group participants felt that consent for subsequent research use must be obtained at the time the IVF process is commenced, rather than at its conclusion. The reasoning of the participants related to the purposes of the embryo creation. They saw a distinction between requesting research use of embryos that were created for reproduction, as contrasted with those created for reproduction and research. However, the Council is concerned that such an approach could encourage providers of fertility services to create extra embryos in order to ensure there were embryos available for research. 37. The Council believes the guidelines should include a requirement that the lead researcher must provide evidence (not just “assurance”) that additional embryos were not created at the time of the IVF treatment with a view to their later availability for research purposes. 38. In order to avoid conflicts of interest there should be a clear separation between the processes of IVF and the collection of embryos for use in research. Different medical professionals should advise the embryo donors at each stage of the process to ensure that there is no implication that agreement to donate is a part of the IVF process and to ensure that there is no pressure on donors. 39. Guideline 9 refers to “serious disease”. The Council is concerned about the ambiguity of the expression “serious disease”, as it could mean serious from the point of view of the patient, or has potentially serious effects on the community, or is serious because there are no existing effective treatments. The guidelines should specify who decides the limits of “serious disease”. 40. The Council considers that the effectiveness of the guidelines needs to be adequately assessed by an appropriate body. The proposed human tissue legislation could provide for adequate monitoring through the establishment of a Human Tissue Authority (which would have a larger brief than just stem cell lines) or the establishment of a monitoring committee specifically to deal with stem cell matters. For this reason the Council believes these guidelines should be deferred until after the human tissue legislation has become law. 41. The Council notes that, at present, ethical issues to do with human health are dealt with by a number of committees whereas, by comparison, environmental matters fall under ERMA [With delegation to Institutional Biological Safety Committees.] which is a better resourced statutory authority. The Council suggests that the human health ethics area also requires a similar level of status and resourcing. 42. The Council notes that the submission booklet largely focuses on the procedural aspects of the guidelines. It does not invite consideration of the wider cultural, ethical and spiritual issues arising from the use of embryos for research. The voices the Council has heard have stated forcefully that such issues are of importance to the public, who need the opportunity to address them. 43. The Council believes that the proposed guidelines are premature in light of:
The guidelines may potentially pre-empt or inhibit these democratic processes, and have the effect of determining the future direction of policy in this area. Recommendations44. The Council recommends that any guidelines relating to stem cell lines should not be issued until:
45. Alternatively, the Council recommends that the guidelines should be of an interim nature only and that they be reconsidered following ACART’s consultation processes once the human tissue legislation is in force. 46. The Council recommends that a basic public education programme relating to use of embryos and stem cell lines be instituted. Such programme should include realistic assessments of potential clinical applications from the research. 47. The Council recommends ongoing dialogue with the public about the use of embryos. Such dialogue should be in addition to the consultations undertaken by ACART and be directed toward the cultural, ethical and spiritual values relating to embryos. 48. The Council recommends that the guidelines contain a requirement that a certain percentage of applications to import cell lines be independently audited to verify the provenance of the cell lines and the documentation supplied. 49 The Council recommends that the terms “excess” or “surplus” not be used when referring to embryos created by IVF which will not be implanted. 50. The Council recommends clarification of the point at which embryos are “used”. 51. The Council recommends that the expression “informed consent” not be used in the guidelines. The expressions “consent” or “authorisation” are more appropriate. 52. The Council recommends that researchers must provide evidence that the donors of the embryos were clearly made aware that they will have no ongoing control over:
53. The Council recommends that “authorisation” or “consent” of both gamete providers must be obtained. 54. The Council recommends that the lead researcher be required to produce evidence that no embryos were created beyond those necessary for the assisted reproduction programme of the gamete providers. 55. The Council recommends that the guidelines require, in communicating with potential donors, a clear separation between the medical professionals dealing with assisted reproduction and those collecting embryos for use in research. 56. The Council recommends clarification of the meaning of the term “serious disease” and how such seriousness should be determined. 57. The Council recommends that these guidelines be overseen by a monitoring authority.
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