7 March 2006

Ms Tanith Robb Sector Policy Ministry of Health P O Box 5013 WELLINGTON

Dear Ms Robb Submission on Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research Thank you for the opportunity to comment on the Ministry of Health’s proposed Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research (the Guidelines). My response is divided into two sections: 1.

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The role of the Health and Disability Commissioner, and the application of the Code of Health and Disability Services Consumers’ Rights to research using cells from established human embryonic stem cell lines; and My response to the specific questions posed.

I trust that the following comments will assist in the development of the final Guidelines. 1. Health and Disability Commissioner Function of the Commissioner As Health and Disability Commissioner, my role is to promote and protect the rights of health and disability services consumers, as set out in the Code of Health and Disability Services Consumers’ Rights (the Code). Under Section 14(d) of the Health and Disability Commissioner Act (the Act) one of my functions is to make public statements in relation to any matter affecting the rights of health and disability services consumers. Application of the Code to research on human embryonic stem cell lines As stated in Right 9 of the Code, research participants have the protection of the ten Code rights. Of particular relevance to the Guidelines are Rights 4, 6, and 7, which state that every research participant has the right to: •

have those services provided with reasonable care and skill (Right 4(1)), and in accordance with legal, professional, ethical, and other relevant standards (Right 4(2)); P O Box 12 299, Wellington, Level 13, Vogel Building, 8 Aitken Street, Wellington, New Zealand Ph/TTY: (64 4) 494 7900, Fax: (64 4) 494 7901, Toll Free Ph: 0800 11 22 33, www.hdc.org.nz

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receive sufficient information (Right 6). In particular, every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including (but not limited to): an explanation of his or her condition; an explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; notification of any proposed participation in teaching and research, including whether the research requires and has received ethical approval; and any other information required by legal, professional, ethical, and other relevant standards; and make an informed choice and give informed consent (Right 7). In particular, services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of the Code provides otherwise.

Further, Rights 7(9) and 7(10) contain provisions relevant to the use, return, and disposal of body parts and bodily substances. Right 7(9) provides that “every consumer has the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a health care procedure”. Right 7(10) provides that no body part or bodily substance removed or obtained in the course of a health care procedure may be stored, preserved, or used otherwise than with the informed consent of the consumer, or for the purposes of research that has received ethics committee approval, or for quality assurance activities. 2. My responses to the specific questions posed I have reproduced the questions posed for ease of reference. Part One 1. Is it appropriate for guidelines to require ethics committees to review all research using established human embryonic stem cell lines, including basic biological research? If not, why not and should some other form of oversight be put in place? In my view the proposal is appropriate. Human embryonic stem cell research remains controversial, and it is important to many consumers that it proceed only within well safeguarded parameters. Compulsory ethics committee review of all research using established human embryonic stem cell lines will help to foster confidence in such research, and to safeguard against potential abuses. 2. If yes, do you agree that the health and disability ethics committees established under the New Zealand Public Health and Disability Act 2000 are the appropriate ethics committees to consider applications for such research? Research using established embryonic stem cell lines raises novel issues that members of health and disability ethics committees may not routinely be familiar with or suited to assessing. The Guidelines, in themselves, do not provide sufficient guidance to committee members less familiar with the issues posed by such research (particularly in the New Zealand context), when reviewing these research proposals. However, in New Zealand, such research will only occur on a small scale and the establishment of a separate ethics committee with responsibility for reviewing research proposals relating to the use of established embryonic stem cell lines may not be warranted.

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If the existing health and disability ethics committees are to assume responsibility for reviewing such research, members should receive dedicated training on the ethical issues particular to this research, beyond the brief guidance offered in the Guidelines. Training would need to be focussed to ensure members have the requisite expertise and competence in assessing the novel issues raised by such research proposals including, in particular, cultural and social issues (which are currently significantly lacking in the Guidelines). A review of the use of health and disability ethics committees to consider these research proposals should be conducted after two years. The review would consider whether health and disability ethics committees are demonstrating competence in reviewing these research proposals, and whether the increased volume of work has negatively impacted the quality of consideration given to research proposals overall and the time taken to consider proposals. Part Two 3. Given that the Human Assisted Reproductive Technology (HART) Act 2004 advisory committee will produce guidance on the use of embryos for research in New Zealand, do you agree that it is appropriate for guidelines on the research use of established human embryonic stem cell lines to restrict researchers to only using lines derived from surplus in vitro fertilisation embryos? I note that the timing of the Guidelines is interesting, given that the HART Act Advisory Committee (ACART) is yet to produce guidelines on the use of embryos for research. However, if the use of cells from established human embryonic stem cell lines for research is to proceed despite the lack of guidance from ACART on the acceptability of embryo research, then it is appropriate that it proceed within accepted limitations. Limiting research to the use of lines derived only from surplus in vitro embryos would appear to be an appropriate limitation. However, monitoring of public opinion in New Zealand regarding this issue should continue, so that the use of stem cells accurately reflects the values of our society and cultures. 4. Are the proposed provisions around consent adequate to address the consent issues raised by human embryonic stem cell research? If not, why not? The Guidelines envisage that consent to the use of surplus embryos for the purpose of deriving stem cell lines for research will be obtained at the time the embryos are determined to be surplus to the requirements of the couple (i.e. not at the time gametes are first harvested for IVF treatment). The application of the Code to consent for the derivation of stem cell lines from surplus IVF embryos is not clear. Right 7(9) of the Code gives every consumer the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a health care procedure. Right 7(10) gives every consumer the right to make an informed choice about the storage, preservation, or use of body parts or bodily substances removed or obtained in the course of a health care procedure (except in the limited circumstances set out in Right 7(10)(b) and (c)). Section 2 of the Act gives a broad definition of ‘health care procedure’ that would encompass IVF treatment. Although there is no definition in either the Act or the Code of ‘body parts’ or ‘bodily substances’, it clearly would include sperm and eggs removed for IVF treatment. If this is the case, both parties to IVF treatment have the right to make a decision about the return or disposal of their eggs or sperm following that treatment. However, once fertilisation has taken place in the laboratory, a new entity comes into existence which may not qualify as a body part or bodily substance of the consumer for the 3

purposes of Rights 7(9) and 7(10). If it does, then both donors must give their consent before the embryo can legally be destroyed (or used otherwise than for the purposes of Right 7(10)(b) and (c)). If the Code is not applicable, or both donors disagree and no prior agreement as to the disposition of the embryos exists, the common law applies, and the relative interests of the parties will be weighed before a decision is made as to the embryo’s use and destruction. 1 Regardless of the lack of clarity as to the specific application of Rights 7(9) and 7(10) of the Code to decisions made about the research use of embryos deemed surplus to the requirements of a couple, the general principles of the Code with regards to information and consent should apply. At the time gametes are extracted for IVF treatment, the couple should be asked whether they wish any surplus embryos to be destroyed, or whether they would consider donating embryos surplus to their requirements for research. At the time specific consent is sought for the use of the couple’s surplus embryos for the derivation of stem cells, they should be fully informed and their freely given consent obtained. This is consistent with the requirements for informed consent currently used by health and disability ethics committees (which should be applied to the review of these research proposals), consistent with Guideline 2. In my view, the proposed provisions around consent are inadequate to fully address the consent issues raises by human embryonic stem cell research, and further clarification is necessary. In particular: •

Further clarification of Guideline 6 is necessary. By referring to the “consenting people”, it appears that this Guideline requires the consent of both the male and female partners whose gametes created the embryos. This implies that consent of only one of these individuals is insufficient. If this is the case it should be more explicitly stated.

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It would be helpful to clarify Guidelines 6(ii) and 6(iii). Guideline 6(ii) states that the consenting people may “withdraw or amend their consent up until the time when the embryos were used”. The use of the word “amend” implies that the consenting people may place restrictions or conditions upon the use of their embryos. In the discussion document, on page 24, reference is made to “any restriction on what may be done with the cell lines due to the nature of the consent obtained”. This is affirmed in Guidelines 14(vi), which requires ethics committees to record on a register any restrictions on the uses to which human embryonic stem cells from the cell line may be put due to the nature of the consent obtained from the donors of the embryo used to derive the cell line. This is consistent with Right 7(7) of the Code, which provides that every consumer has the right to withdraw consent to services. However, Guideline 6(iii) states that “they would have no control over the use of cells from embryonic stem cell lines derived from the embryo”. If they have no control over that use, in what respect may their consent be amended and how may the consenting couple place “restrictions” as described on page 24 and Guideline 14(vi)?

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Right 6 of the Code sets a “reasonable consumer” test with regards to the information a consumer must receive prior to giving informed consent. In particular, it is important to note that there is no exhaustive list of information in the Code that a consumer must receive in order to be fully informed in accordance with Right 6. In this respect, the exhaustive list of information to be discussed with the “consenting people”, as set out in

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Davis v Davis 842 S.W. 2d 588.

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Guideline 6, is misleading. In order to remain consistent with the Code, I recommend that Guideline 6 be amended as follows: “6. The evidence provided should show that the people who gave consent to the use of the embryo in research were fully informed in accordance with all legal and ethical consent requirements. The information to be provided must include (but is not limited to): …” In terms of the list of particular information that must be provided, the following points should be added to the list already set out in Guideline 6: (a) that their embryos and any resulting stem cell lines will be anonymous; (b) whether they will receive any information about the use to which their embryos are put; and (c) the possibility (if any) that their embryos may be exported to another country. 5. Are the requirements on the evidence that researchers must provide around the level of consent obtained reasonable? Are there instances in which researchers may not be able to meet these requirements? There should be a system to audit fertility clinics in New Zealand for compliance with approved protocols for obtaining consent. Guideline 4 properly requires evidence that “the people whose gametes were used in creating the embryo gave free and informed consent to the use of that embryo to derive embryonic stem cell lines”. However, I have concerns about the ‘adequate evidence’ of consent described in that guideline. A copy of “the original donor consent forms”, in my view, is adequate evidence of consent. However, “a suitably witnessed declaration from the supplier of the consent obtained” may not constitute adequate evidence. Right 7(6) of the Code requires informed consent to be in writing if the consumer is to participate in any research. Furthermore, the purpose of the protocols developed around informed consent could be easily circumvented by a policy permitting a researcher simply to promise that consent was obtained. Given the possible cultural, spiritual, and ethical importance of the donation being made, more stringent criteria for ensuring proper informed consent should be required. However, as Guideline 4 states, “details of the requirement of ethical review and other regulations in the country of origin” are relevant to determining adequate evidence of informed consent. If the country of origin has a tradition of oral consent, then it is possible that “a suitably witnessed declaration from the supplier of the consent obtained” may be acceptable. In addition, in these circumstances researchers should provide evidence of the information given to the donors at the time of consent. Further clarification on these matters would be helpful. If a researcher cannot meet the consent requirements for the use of particular stem cells, the embryos at issue should not be used in research. Part Three 6. Do you agree that human embryonic stem cell research should be limited to research that ‘has the long-term goal of helping to increase human knowledge about either serious diseases and their treatment or the processes of human development’? If not, what boundaries should be placed on such research? 5

This is a reasonable and appropriate boundary to place on this research. 7. Is the requirement for researchers to demonstrate that the research objective cannot be addressed through other types of research reasonable? At this time, that requirement is reasonable and appropriate. 8. Does a requirement that research using human embryonic stem cell lines be peer reviewed in every instance by a suitable independent person or committee adequately address the need for such research to be soundly designed? Poorly designed research yields unreliable data. Accordingly, it is sensible for protocols to be peer-reviewed in this manner prior to submission for ethics committee review. The peerreview of protocols is also appropriate as a further protection against abuses of the Guidelines and the use of established embryonic stem cell lines in research. 9. Do the guidelines deal with the issue of leftover human embryonic stem cells adequately? Is it appropriate for researchers to store such leftover cells, or should they be disposed of once the approved research project has finished? As noted above under question 4, the Guidelines are unclear as to the extent to which consumers may consent to the particular use of cell lines derived from their donated embryos. However, the statement on page 24 of the discussion document and Guideline 14(vi) indicate that it is anticipated that donors may place restrictions on what may be done with the cell lines (and that such restrictions will be noted on the register). In this respect, I note the relevance of Right 7(9) of the Code, which gives consumers the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a healthcare procedure. Consistent with Right 7(9), researchers should first and foremost ensure that their proposal with regards to the storage or disposal of leftover embryonic stem cells is consistent with any limitations placed on storage/disposal during the consent process. It is appropriate for ethics committees to review the researcher’s proposals for the storage and/or disposal of leftover cells. If the ethics committee approves, and it is consistent with the consent obtained, it is appropriate for researchers to store leftover cells. However, the ethics committee must satisfy itself as to the acceptability of the manner of storage. Part Four 10. Do you agree that once a human embryonic stem cell line has been approved for use in a research project in New Zealand, that cell line should be considered as an ‘approved human embryonic stem cell line’ by ethics committees that consider later applications to use the cell line? If not, why not? Evidence of consent should be reviewed as a matter of course in the consideration of any research proposal. This is consistent with Guideline 2, and will be particularly important in the case of restrictions placed on uses of the cell lines during the consent process. 11. Does establishing a publicly available register of approved human embryonic stem cell lines and approved research projects adequately address the transparency and accountability issues involved in this research? 6

I support the establishment of a publicly available register of approved human embryonic stem cell lines and approved research projects. I support the register containing the information set out on page 24 of the discussion document, including notation of any restrictions in the use of stem cell lines due to the nature of consent. The register should be available not only “in electronic form” (such as on a website) as Guideline 15 stipulates, but also in hard copy by mail if requested. 12. Is it appropriate for ethics committees to establish such a register? If not, who should be responsible for its establishment? It would seem more appropriate for one entity to retain responsibility for establishing and maintaining the register, rather than the “ethics committees” in general. A particular issue for consideration is the level of expertise of ethics committees for administering such a register. 13. Are the details that the proposed guidelines specify should be available from the register reasonable? If not, why not? As noted above, these details appear appropriate. It may be desirable to clarify that the “supplier of the cells” mentioned in Guideline 14(v) is not the consenting couple donating the embryos but rather the professional source that collected the embryos.

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General questions 14. Do the proposed guidelines identify all relevant ethical issues that are specific to human embryonic stem cell research? The Guidelines provide a good skeleton framework, but do not identify all relevant ethical issues specific to this research. In particular, no mention is made of New Zealand’s diverse populations’ cultural, spiritual, and religious beliefs associated with human body parts and reproduction. The Guidelines currently fall short of providing comprehensive, clear and workable guidance to ethics committees and researchers on the management of research proposals in this novel and controversial area. Reference to cultural, spiritual, and religious perspectives should clearly be incorporated into the Guidelines. 15. If not, what extra issues should be identified? Please see above. 16. How should these issues be addressed in guidelines? As noted above, the Guidelines should include specific guidance on the social and cultural issues specific to New Zealand with this type of research. I hope that this submission assists in the development of the final Guidelines. If you would like to discuss any of these comments further, please feel free to contact Nicole Li, Legal Advisor, on (04) 494 7929.

Yours sincerely

Ron Paterson Health and Disability Commissioner

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