Maintaining a principled ethical approach in the face of a global fertility market

A submission to the Advisory Committee on Assisted Reproductive Technology

Earlier this year the Advisory Committee on Assisted Reproductive Technology (ACART) released a background discussion paper on the “Import and Export of Gametes and Embryos.” The paper was in response to growing numbers of New Zealanders looking overseas for fertility treatment. New Zealand requirements surrounding the sourcing and use of gametes and embryos are often very different from, and in many cases more ‘restrictive’ than, other countries. In the face of differing standards, there is increasing pressure from some to loosen the restrictions on what is allowable in New Zealand. Staff of the Nathaniel Centre offered the following reflection on the current situation as part of their contribution to this debate.

Introduction
Robust ethical review requires critiquing the underlying and often unexamined assumptions and convictions that shape individual and societal thinking about a particular issue. We are particularly concerned that in a society such as ours, questions relating to the common good are too easily subsumed by a distorted focus on individual autonomy. When this occurs, we can too easily fail to take full account of the fact that medical technologies, such as human assisted reproductive technologies “create their own culture of practices, institutions and discourses, and these become a powerful force that inscribes individual bodies to its own specifications.”[1]

While we have commented on this issue on a previous occasion, it strikes us that the realities of the global fertility market have introduced a new dynamic into the debate.

A shift in ethical frameworks
A particular feature of contemporary ethical discussions on the use of assisted human reproductive technologies is the way in which the language and thinking of ‘supply and demand’ (the market) is increasingly coming to the fore. This language indicates a shift, in at least some quarters, towards viewing the creation of human life more and more as part of a framework of thinking that is typically characteristic of economic transactions. At the same time the use of such language confirms and further perpetuates such a shift in other people’s minds.  

We accept that, to some degree, the use of ‘market’ language is understandable (and even unavoidable) in the context of exploring genuine questions relating to the regulation of reproductive technologies in a commercial environment. Nevertheless, we find the uncritical use of such language of great concern. Importantly, it betrays a tendency to think more and more about new human life as a ‘commodity’ that is subject above all to the desires, demands and expectations of those paying for the service – the consumers, prospective parents.

This has considerable implications for ethical reflection because the frameworks of thinking we adopt shape the way we look at and think about an issue. In particular, the influence of a market-based paradigm reinforces a particular and impoverished understanding of human freedom. In the words of the philosopher Michael Sandel, human freedom is reduced to mean “the freedom of the consumer.”[2] Consequently, parenting is at risk of becoming reduced to little more than another extension of the consumer mentality that permeates our society.

At the same time, as human procreation becomes increasingly subject to commodification, there arises an increased sense of ‘entitlement’ to a child. From this flows a lower tolerance for regulatory interference of any kind, especially from the State. Thus, when the question of access to assisted human reproductive technologies arises there are many who ask: “What possible business is it of any ethics committee? Why should they have to apply to a bunch of interfering medicos for permission?”[3]

The increased sense of entitlement is typically verbalised as a ‘right’ to access whatever ‘means’ are available for bringing about a child. In addition, and perhaps more worryingly, it is also increasingly framed as the right to exert a kind of consumer freedom over our children. What we mean by this is that the so-called right to a child leads people to believe they have a right to a certain type of child and therefore the right to exert ever greater degrees of control over the ‘products’ of conception.

There exists an urgent need to draw on other frameworks in order to challenge the shift in ethical discourse that is happening in our society. At the same time we need to remain clear about, and committed to, the principles that have given shape to the current New Zealand regulatory framework governing the use of assisted human reproductive technologies. To the extent that we allow a market mentality to shape our thinking it is to be expected that the principles underpinning the HART Act will start to make less sense to some people.  

The threats to a principled approach to decision making
In the wake of an increased sense of entitlement, the need to protect the very narrow meaning of ‘consumer freedom’ that Sandel (and others) speak of emerges for many as the primary ethical issue. This shift in ethical focus has been further exacerbated, we believe, by the increased opportunities that now exist for prospective parents to access assisted human reproductive technologies overseas. Compared with other jurisdictions which lack the robustness of New Zealand’s regulatory system, many people are judging the HART regulatory framework to be unnecessarily and unfairly restrictive. At the same time, others who might be less inclined to see it as ‘restrictive’ are perhaps increasingly inclined to see it as espousing a once workable, but now unworkable, ideal.

Therefore, even while many of the ethical dilemmas surrounding the import and export of embryos and gametes remain largely the same as in the past, it is our view that the realities of the global fertility market pose a new and heightened challenge to responsible human procreation. Indeed, we would go so far as to suggest that what is at stake in the present debate about greater (overseas) access to human assisted reproductive technologies is ultimately nothing less than the continued viability of the current principled approach to decision making that defines the HART Act.

We understand that, already, increased numbers of New Zealanders want to travel overseas to source eggs and embryos, a situation exacerbated by the shortage of donated eggs in New Zealand. While the motivation for this may well be largely pragmatic, rather than because of a desire to circumvent the law in New Zealand, the reality is that the eggs or embryos will be, in many if not most cases, commercially sourced. Because this is in breach of what is allowed in New Zealand, we anticipate this will eventually result in increased pressure to allow commercially sourced gametes and embryos to be directly sourced from within our own country.

We have, in the past, indicated that we are sympathetic to the idea of allowing couples who have previously conceived embryos overseas to bring them into the country for the purposes of having another child that is genetically related. While our position on this remains the same, we recognise that this also has the potential to lead to increased pressure to loosen the restrictions on what is allowable in New Zealand, particularly if some of the imported embryos have been created under standards and principles that fall short of our own.

Furthermore, while there are no legal barriers to couples travelling to countries that allow for embryos to be created in ways that, for good reason, are unacceptable in New Zealand, those without the financial resources will have a case that the ethical standards in New Zealand exist only for those who lack the resources to go overseas.

On all these counts an argument can be made that the status quo, even if unwittingly, fosters a significant degree of ethical inconsistency and unfairness. Why, it will be asked, should other couples not be allowed to have the children they want when precedents exist and all that is required is a simple law change? There is, in other words, a certain inexorable logic that points towards the further liberalisation of HART law in New Zealand, including the current constraints on using imported material that does not meet current New Zealand standards.

This is why we believe that more and more people will, in the future, come to question the viability of the current New Zealand framework including the principles that underpin it.

Managing ethical inconsistency and unfairness
Those, like us, who are hesitant about further ‘opening up the market’ for embryos and gametes because of their commitment to the ethical principles upon which the current New Zealand laws are based, find themselves needing to justify a regulatory approach which allows for ever increasing degrees of ‘inconsistency’ and ‘unfairness’. We readily admit that maintenance of the status quo will involve living with a degree of ‘inconsistency’ and ‘unfairness’ for individuals/couples. How might this be justified?

The arguments in favour of greater liberalisation, as described above, ignore a vital tension. We would describe the source of this tension as originating in the ethical space that exists between the desires and rights of individuals and the welfare or ‘common good’ of the society in which we live. As noted above, one of the (often unnoticed) fundamental issues at stake is the robustness of the (economic) paradigm that is increasingly being used by many to make sense of the world in which we live. More specifically we would argue that the language and thinking associated with ‘transactions’ and ‘entitlement’ is at odds with, and has the potential to undermine, the traditional way in which peoples across many cultures and ages have thought of new human life – what we, as well as many secular philosophers and anthropologists, would describe as an approach centred on ‘gift’ and ‘givenness’.[4] Of great concern for us is the fact that the shift to view human procreation more and more in terms of the market represents a significant departure from the way in which society has long thought about parenting and the role of children.

The very fact that granting individuals increasingly unfettered reproductive freedom will impact on societal understandings surely demands that any changes to the current regulatory system be subject to a ‘societal impact risk assessment’. This is what we find lacking in many of the arguments being put forward in favour of leaving assisted reproductive choices more and more in the hands of individuals or couples. Not unsurprisingly, the shift to consider questions about the transmission of human life within a more ‘market-based’ paradigm makes ethical questions about the societal impact (or common good) seem more and more irrelevant.

Concluding comments
For us, the key ethical issue is not about protecting an increasingly impoverished notion of freedom centred on choice. It is more about protecting a notion of human flourishing that takes into account the effects of the accumulation of individual choices on the society in which we live, including the likely impact on the welfare of the children who are conceived and the institution of parenting. We must be wary of making changes to the current regulatory framework that are premised largely on the value and importance of individual choice. This is especially important when it can be established that such changes are being influenced by the incremental progression of a market-based paradigm into the domain of parenting and families.

We should, of course, limit individual choice only for good reason. One of the challenges we face as a society is that these reasons do not always come to the fore in contemporary debates, not because they are not important but because the particular framework we employ renders them invisible. Such reasons become apparent when we recognise the inadequacy of giving exaggerated emphasis to individual choice and embrace other frameworks of thinking.

Our position is well described by Michael Sandel when he notes:

When science moves faster than moral understanding as it does today, men and women struggle to articulate their unease. In liberal societies, they reach first for the language of autonomy, fairness, and individual rights. But this part of our moral vocabulary does not equip us to address the hardest questions posed by cloning, designer children, and genetic engineering. That is why the genomic revolution has induced a kind of moral vertigo.[5]

And as the New Zealand Bishops have previously stated in an early Submission on the HART Act:

An over emphasis on the sufficiency of individual informed consent, as has been exemplified by a number of commentators with respect to recent debates in the bioethical area, reflects a failure to acknowledge the wider impact of technological interventions.

Finally, we appeal to ACART, in its reflections on this issue, to continue to take full account of the fact that the questions raised by human assisted reproduction are complex and have the potential for transforming the most basic of human relationships. The context which has given rise to the current debate places in jeopardy key principles at the heart of the HART Act. In particular we see that two principles are at risk; (i) the rights of children who are born to access knowledge of their origins and have a relationship with gamete donors, and (ii) a longstanding commitment to the principle that transactions involving body parts not be commercialised.

The current debate calls for a strong stand in favour of upholding the principles that underpin the HART Act. These principles have been debated at length and represent long-held cultural, social, ethical and religious values that promote human flourishing. They are also consistent with general public policy in New Zealand.

This will, in turn, mean saying ‘no’ to certain demands being made by couples or individuals, demands that may well increase as New Zealanders take advantage of the opportunities for having children, not always ethical by our standards, that exist overseas. However, we argue that the current principled approach, along with its growing perception of inconsistencies, can be seen as justified by an ongoing commitment to the common good and, above all, to the dignity and well-being of children. In which case, we will need to accept that it will become increasingly difficult to align New Zealand ethical standards with those of other countries.

In the face of globally varying ethical standards and competing principles, we would argue that the cause of ethical consistency and the well-being of children, parents and society, is best served by New Zealand working with other countries to uphold and promote the key principles that define our current regulatory framework around the use of reproductive technologies. To quote from the Consultation document: “New Zealand should not support or be seen to support, policies and practices in other countries that would be regarded as unethical in this country.”

Staff of The Nathaniel Centre


[1] Lindemann Nelson, Hilde. (1995). Dethroning Choice: Analogy, Personhood, and the New Reproductive Technologies. Journal of Law, Medicine & Ethics, 23, 2: 129-35.

[2] Sandel, M. "The Reith Lectures 2009: Genetics and Morality." A Common Morality for the Global Age: In Gratitude for What We Are Given (2009). http://www.bbc.co.uk/programmes/b00kt7rg [accessed November 3, 2009].

[3] Michael Laws commenting on a request by a gay couple to be surrogate parents.

[4] While the notion of life as a gift is a traditional Christian term, it is also arguably the basis for a common ethic without religious warrants. See, for example, the work of Havard philosopher Michael Sandel (The Case against Perfection: Ethics in the Age of Genetic Engineering. London: The Belknap Press of Havard University Press, 2007) and French-Canadian anthropologists Godbout and Caillé (The World of the Gift. Translated by D. Winkler. Montreal & Kingston: McGill-Queen's University Press, 1998).

[5] Sandel, M.J. (2007). The case against perfection. pp. 9-10.

Submission to ACART on extending the storage period of gametes and embryos

 

Preamble:

The Human Assisted Reproductive Technology Act 2004 (the HART Act) sets a maximum storage period of 10 years for sperm, eggs and embryos unless the Ethics Committee on Assisted Reproductive Technology (ECART) approves extending the storage period. Parliament recently amended the HART Act to clarify that the 10-year period begins from 2004 or later, depending on when the gametes or embryos were first stored. This applies even where gametes and embryos were stored before 2004.

The amendment also clarifies the powers of ECART and the Advisory Committee on Assisted Reproductive Technology (ACART). When deciding applications for extending the storage period of gametes and embryos beyond 10 years, or beyond an approved extended storage period, ECART must use guidelines issued by ACART.

In February 2010 ACART released its proposed guidelines on extending the storage period of gametes and embryos and invited interested parties to respond.

Introductory comments:

In order to avoid a statement of an explicitly philosophical nature, Catholic teaching refrains from defining the embryo as a person. However, as science demonstrates, there is undoubtedly a personal presence at the moment of the first appearance of a human life and a continuity in development from that point on. We hold that such continuity does not allow for positing either a change in nature or a gradation in moral value for the entire span of that individual human life. On this basis the question arises: "How can a human individual not be a human person?" It would never be made human if it were not human already.

Therefore, we reason that the embryo is to be respected and treated as a person from the moment of conception. It follows from this that the rights accorded to a person must be recognised from that same moment. Chief among those rights is the inviolable right of every human being to life, that is, the right not to be killed.

Because it interrupts the natural continuity in development, the cryopreservation of embryos represents an affront to their innate human dignity. Furthermore, it also exposes them to serious risks of physical harm and even loss of life given that a high percentage do not survive the process of freezing and thawing.

In addition, the storing of embryos means that their future (their right to life) becomes subject to decisions made by others; firstly those responsible for bringing about the human life, the commissioning parents in conjunction with the fertility clinics; secondly the state, when regulations (such as those governing the length of time embryos may be stored) mean that an embryo's right to life can also become dependant on various forms of legal concession. It is ethically inconsistent that a fundamental right becomes contingent on concessions, legal or otherwise, conferred by others.

Such regulations, even when they are well intentioned, can easily add to the injustice associated with storing embryos because they may well constitute a further obstacle to the embryo being able to continue on its rightful path of human development. The shape of the regulations may also present a direct obstacle to parents who are genuinely committed to implanting their stored embryos, as well as confusing the question of who is ultimately responsible for their welfare.

Taking into account all of the above, the question of further extending the storage period of embryos poses a unique moral dilemma from our perspective. On the one hand it can only be interpreted as the continuation of a serious injustice because it involves an ongoing risk to their viability and obstructs their right to develop. On the other hand, we recognise that in certain circumstances extending the storage period may be what is required to ensure that particular embryos are given a chance to live the life that is already rightfully theirs.

We accept that by seeking to extend the period that embryos may be stored, the proposed guidelines are, at least in part, designed to make additional provision for embryos to be implanted and to continue the path of their development. To this extent, and while it is regrettable that there are so many embryos in storage, we appreciate that robust guidelines have the potential to impact positively on what will still remain, at best, an unjust situation.

Obviously, the moral issues that characterise the storage of gametes differ because of the differing moral status of gametes when compared to embryos.

Responsibility for making applications to ECART for extending the storage of gametes and embryos:

In light of their moral status, we are concerned about the question of who is morally responsible for particular embryos. In the first instance we believe that it is the commissioning parents who are responsible. It is therefore most appropriate that they should be able to initiate and empower the application process and be perceived as doing such.

We believe that the current wording of the guidelines, insofar as it focuses largely on the role of fertility clinics and researchers, fails to adequately highlight the primary moral responsibility of the commissioning parents. In line with this we believe that all applications relating to the storage of embryos and gametes for fertility reasons need to be in the name of the commissioning party rather than the clinic.

That said, we understand that from a pragmatic point of view it is best that the application process be managed by a clinic because of their access to key information as well as in the interests of consistency. In other words, our criticism is not so much about the process being suggested as it is about the presentation of the process and its implications for people's understanding of what is at stake.

In the case of gametes being held for research purposes, we are happy that researchers take responsibility for any application for extending the storage of gametes knowing that the consent of the donors is integral to this process. Our stance on this reflects the fact that the reasons for such an application are ultimately for the benefit of the researcher rather than the donor. This makes such an application different in essence from any application to extend the storage of embryos as well as different from applications to continue storing gametes for fertility reasons.

Reasons ECART may approve extending the storage of gametes and embryos:

We note positively that the guidelines anticipate couples with 'surplus' embryos created from their own gametes seeking an extension period for the purposes of finding and donating their embryos to a suitable couple.

In line with our introductory comments we agree that the reasons for extending the storage of gametes and embryos must be limited to those individuals seeking fertility preservation in cases where the initial reasons for storage relate to an underlying medical need. We understand, and approve of the fact, that this will rule out those seeking fertility preservation for 'insurance' or 'lifestyle banking' reasons. To act otherwise would only lead to the untenable situation where we would have even more embryos being created and stored for reasons of personal convenience, exacerbating further what is already a problematical state of affairs.

We also approve of the fact that the guidelines rule out extending storage in cases where treatment is prohibited or precluded at the time of an application for extending storage. Again, to act otherwise would only lead to greater numbers of stored embryos unlikely to be implanted.

Informed Consent Requirements:

We wish to make the observation that the provisions around gaining consent from gamete donors for extending the storage of embryos unintentionally create a situation where commissioning couples (whom we argued earlier should have primary moral responsibility for embryos in storage) may be prevented from exercising their rightful parental responsibility.

We foresee situations where couples desiring a child, perhaps wanting a full sibling for other children, and with a keen sense of accountability for the embryos in their care, find themselves unable to carry through their parental commitment because of an inability to make contact with, or otherwise gain consent from, those who originally provided the gametes. Even while we uphold the importance of consent as a key principle in ethical decision making, such a situation strikes us as patently unjust, both from the perspective of the embryo and the commissioning parents. It creates an impossible hurdle to life for the embryo while also creating (abandoning) a particular class of embryo for whom no-one is able to be responsible. It also frustrates the would-be parents whose desire to have a child, which was the source of the original consent sought, has remained singularly constant.

On the other hand, we recognise that giving birth to children who may not be able to ever contact their biological parent or parents (or whose biological parents may not want contact) is also patently unjust and something that would impose a burden on any child that came to be born.

This is a good illustration of the way reproductive technologies have the ability to fracture the inherent relational integrity that should exist between parents and children. It also illustrates some of the unintended and undesirable consequences associated with separating the genetic, gestational and social dimensions of parenting, something that characterises many assisted reproductive procedures. More particularly, it highlights for us the contradictions and inconsistencies inherent in allowing heterologous IVF (i.e. relying on sperm and/or ova donation), something that we have previously stated we are strongly opposed to.

While hoping that honest reflection on the consequences of using heterologous IVF may discourage its use, we acknowledge that the practice has already been embraced by some in our society. Without wanting to further encourage its use in any way, and mindful of the situation we have described above, we suggest that ACART advocate that provision for extended storage of embryos be included as a standard part of the original consent sought from gamete donors.

HDC Consultation on research involving adult participants who are unable to give informed consent (2017)

 General Discussion:

We note and endorse the idea that “The right to make an informed choice and give informed consent before receiving health or disability services, including participating in research, is the cornerstone of New Zealand’s Code of Health and Disability Services Consumers’ Rights”, (HDC Consultation Document, p. 1). In a similar vein, we have previously written about the critical importance of informed consent, advocating that all people have a right not to be experimented on without their knowledge or consent, whatever the nature of the research.1

It is broadly accepted that the history of ‘informed consent’ in human research goes back to the Nuremberg Code of 1947. This Code was developed after the Nuremberg trials at the end of the Second World War which exposed the unethical nature of research carried out by many Nazi researchers. The lesson learnt from this and other well-known instances of unethical research, such as Tuskegee and Willowbrook, is that justifying research on the basis of its potential benefits or outcomes alone, and without reference to the inalienable rights and dignity of human participants, all too easily leads to human exploitation and harm. Upholding informed consent is one of the key ways in which the rights and dignity of research participants can be protected.

In New Zealand, current thinking and practices around ethical review and the centrality of informed consent have been informed by our own instances of unethical research, including the removal and retention of organs from deceased babies without parental consent and the ‘unfortunate experiment’ on patients with cervical cancer carried out at National Women’s Hospital.

The current Code of Health and Disability Services Consumers’ Rights allows research on a person who is unable to give consent to take place only if participation in the research is in the person’s best interests. It thus reflects a strong commitment to the principle of informed consent. It also reflects a commitment to ensuring that the interests of the person must not be subsumed to those of society. In other words, it embodies a rejection of the main premise underpinning utilitarianism, the idea that ‘the greatest good for the greatest number’ is a sufficient measure of what is ethically acceptable.

If there are to be changes to the parameters which currently proscribe non-consensual research on adults, it is critical that our society’s commitment to the notion that the best interests of the person must ultimately always outweigh those of society (Consultation Document, p. 44, n.3) be upheld and not eroded in any way.

We have previously argued that there can be legitimate exceptions to the requirement that informed consent be obtained from research participants, in certain exceptional circumstances. Thus, in 2015 we wrote that the “only exceptions to this are in circumstances where (i) the research is strictly observational or (ii) participants are, for various reasons, unable to give consent, in which case consent must be sought from someone legally entitled to provide consent for them.” In the same article we also stated: “In exceptional circumstances, limited disclosure may be justified or consent might be obtained retrospectively, for example because of the need to avoid a biased response. It is also possible to seek a waiver of consent where the risk is low and where there are strong reasons why it would not be practical or possible to obtain consent.” We then added: “… in these situations, the ethical rider is that such research must always be held up to close scrutiny by an appropriately accredited and independent review body.”2

We note that current practice in New Zealand, by allowing consent to be waived in circumstances when it is deemed to be in the person’s best interests, already constitutes an exception to the principle of informed consent, albeit a very narrow one. This debate, therefore, is about the scope of such exceptions in New Zealand and, more specifically, whether they might now be broadened to include some situations where research on a person unable to give consent is justified on grounds other than being in their personal best interests.

Our overall position is that we are not in principle opposed to broadening the parameters which regulate non-consensual research on adult participants.

Ethical Discussion:

Our response to the two fundamental questions posed in the Consultation document (“Are New Zealand’s current laws regarding non-consensual research [involving adult participants] appropriate and, if not, how should they be amended?” (Consultation document, p.2)) reflects our belief that it is, in theory, both possible and ethical, in certain prescribed circumstances with adequate scrutiny and safeguards, to broaden the parameters that apply to non-consenting- adult participants in research.

We add the qualifier “in theory” because we believe that any moves to broaden the parameters around non-consensual research would be acceptable only within a system of robust, accredited and independent ethical overview. Given the experience of two of the writers of this submission who have previously served as members of an HDEC Ethics Committee for a combined period of 11 years, our concern is that some of the more recent restructures of New Zealand’s HDEC ethical review system have contributed to a less comprehensive and less robust system than was previously the case – fewer committees and fewer members as well as a significantly narrower set of criteria for determining when research requires HDEC review.

Any moves, therefore, to change the current law must, in our mind, first be considered against the current effectiveness of ethical review committees in New Zealand. In which case, a decision in principle to broaden the criteria for non-consensual research (which, as already noted above, we would support) might be considered unworkable or unsafe in the current context of ethical review. The decision might, therefore, be made not to proceed with any changes for pragmatic reasons even while it was otherwise considered ethically acceptable in theory.

In the event it was deemed practically acceptable to broaden the parameters, it is our firm belief that, because of the inherent risks in non-consensual research, such applications should require an additional layer of scrutiny to what is already currently available by a group under the auspices of the Health and Disability Commissioner’s Office that includes representatives of, or people able to speak on behalf of or advocate for, the group of persons on whom the research will be carried out. 

When reflecting on why it might be ethically acceptable to allow non-consensual research on a person when it is not in their best interests and when it will introduce an element of risk, the obvious answer is that there will be benefits for others, whether persons in similar circumstances or, perhaps, society in general. Herein lies the greatest danger in broadening the parameters of non-consensual research because any such move inevitably opens the door to the sorts of utilitarian arguments and premises that have characterised unethical trials such as Tuskegee and Willowbrook.

This danger reinforces for us the need to de-lineate three other parameters when evaluating non-consensual protocols: (i) ‘the interests of the person must always be assumed to outweigh those of society’; (ii) in situations where this is not clear for a specific person, the ‘precautionary principle’ must be automatically invoked which dictates that the person not be included and (iii) any expression of dissent (“whether by showing signs of resistance or otherwise” – Mental Capacity Act 2005 (England and Wales) as quoted in Consultation Document, p. 43) from a potential participant incapable of giving consent should be regarded as sufficient reason for them not to be included (see also Declaration of Helsinki, as quoted in Consultation Document, p. 58).

In addition, as we highlighted in our submission to the National Ethics Advisory Committee (NEAC) on Cross-sectoral Ethics Arrangements for Health and Disability Research (February 2015), we see that it is a significant weakness of the current system of ethical review in New Zealand that there is no mechanism for checking that a particular study is carried out according to the agreed protocol. We believe that such follow up should be mandatory for all non-consensual research projects, something that will require a specific mechanism to be created and funded. This requirement, we note, is stipulated in Paragraph 24 of the Declaration of Helsinki under the heading of Research Ethics Committees: “The committee must have the right to monitor ongoing studies.”

Whereas some might see such requirements as creating unnecessary barriers for researchers, we see that they will ensure that non-consensual research proceeds only when it is absolutely required, and that non-consensual research is undertaken with a strong focus on ethical practice.

An Adjusted Framework for Non-consensual Research on Adult Participants:

Our suggestion is that an adjusted New Zealand Code follow and reflect the relevant sections of the Declaration of Helsinki which address the question of non-consensual research:3

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

 In summary, we argue that the key points of an adjusted Code which would broaden the parameters within which non-consensual research could be carried out in New Zealand are:

•  The research cannot otherwise be carried out using participants capable of providing informed consent and …

•  The research will directly promote the health of the group represented by the potential subject and …

•  The research entails only minimal risk and minimal burden and …

•  The potential subjects dissent, however it is expressed, is respected absolutely and …

•  The research may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group and …

•  Informed consent is sought from a legally authorised representative and …

•  The research is given a full review by the appropriate accredited HDEC Committee and …

•  The research is subject to an additional layer of scrutiny by a group that is overseen by the Office of the Health and Disability Commissioner, a group which includes representatives of, or people able to speak on behalf of or advocate for, the group of persons on whom the research will be carried out and …

•  There is ongoing, independent, effective and active monitoring of the research project while it is being carried out and …

•  The participants’ confidentiality is absolutely respected and …

•  In cases where a participant regains consciousness after having been included in a trial, they are given the option of having their data withdrawn where that is possible and …

•  Any data that is retained after a study is only be able to be used for further research in an aggregated or totally anonymous form unless separate independent ethical consent is sought.

Conclusion:

We are in principle open to the parameters of non-consensual research being broadened within New Zealand in line with the World Medical Association Declaration of Helsinki that we have outlined above. What we are proposing would involve moving from the “best interests framework” that characterises current practice in New Zealand to one that takes account of and permits a degree of minimal risk and minimal burden to participants.

The key questions in moving to an approach that tolerates a degree of risk are ‘Who decides?’ and ‘How will assessments about “minimal risk” and “minimal burden” be made?’ For this reason we have argued that there must first be a degree of confidence in the current system of ethical review in New Zealand. That is, a determination must be made that the HDEC review committees are adequately resourced and adequately trained to foresee and prevent the sort of excesses that have characterised research on vulnerable persons throughout the 20th Century in numerous places around the world including New Zealand.

While broadening the parameters of non-consensual carries inherent attitudinal risks because it can dispose society to the dangerous excesses of utilitarian thinking and make certain actions which undermine the inherent dignity of persons seem morally acceptable, we think this risk can be safely managed by the introduction of an additional layer of ethical scrutiny that is carried out under the auspices of the Office of the Health and Disability Commissioner.

John Kleinsman (PhD) is director of The Nathaniel Centre and a former member and Deputy Chair of the Central Region Health and Disability Ethics Committee. He is a current member of two Institutional Research Ethics Committees.

Sue Buckley (MA(Applied)Soc.Sc.Res) has been involved in social and health research over the last 16 years in both government and university contexts

Associate Professor John France (PhD, DSc, FAACB) is a reproductive scientist (now retired). He is a former member of the Auckland Health and Disability Ethics Committee and former member and Deputy Chair of the Northern Regional Health and Disability Ethics Committee. 

 

1.Kleinsman, J, and S. Buckley. "Facebook Study: A Little Bit Unethical but Worth It?" Bioethical Inquiry 12, no. 2 (2015): 179 - 82.

2. Ibid.

3. Declaration of Helsinki. 64th WMA General Assembly, Fortaleza, Brazil, October 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (emphasis added)

 

 

 

“A Strategy to Prevent Suicide in New Zealand. 2017. A Draft for Consultation”

A Submission to the Ministry of Health by Staff of The Nathaniel Centre

General Discussion

We note and endorse the ambition of the Strategy that ‘everyone is able to have a healthy future and see their life as worth living’. Promoting the concept that every life is worth living is critical, we believe, in addressing the high suicide rates in New Zealand. Exploration of this concept, which raises important philosophical and ethical questions concerning societal views about what a ‘successful life’ looks like, may generate important insights as to why suicide rates for certain groups, such as youth, Māori, elders, and disabled people, are higher than for other groups.

A cornerstone of Catholic teaching is the belief that every human life has “intrinsic value” and is to be protected and nurtured at every stage of its development. Those who do not conform to the increasingly dominant ableist idea of what a successful life looks like (e.g. those who suffer deprivation, disability, mental illness, or the limitations of ageing), are particularly vulnerable to the suggestion that their lives are not worth living. These are the people who are most in need of protection and support. We see that there is an urgent need to focus on reducing the stigma associated with ‘difference’ and to foster the view that every human life has unconditional dignity and worth. Among other things, this will require our society to counter the increasingly accepted and relationally impoverished societal narrative which equates the value of a person’s life with their subjective perceptions about the quality of their life, all too often based on factors that reflect an ableist or functionalist worldview.

Feedback

1. The Strategy provides little specific or material direction for how suicide rates might be reduced:

  • No organisations, agencies or individual roles are identified as taking a lead in developing the activities listed (except the very general – ‘employers’, ‘communities’, ‘whanau’).
  • The ‘Activities’ are very general. Statements like ‘communities working together to establish age-friendly communities’ express admirable aspirations, but are not helpful in providing direction to ‘communities’ or to an agency that might take a lead. There are many such statements in the Strategy.

2. The Strategy does not appear to build on suicide prevention work that is already taking place or on earlier work in this area. It does not explicitly refer to the Action Plan 2013-2016, nor draw on other strategies, for example, the Youth Suicide Prevention Strategy In Our Hands and Kia Piki te Ora o te Taitamariki, and the two evaluations of that Strategy.

3. For these reasons, we have found it difficult to provide specific feedback on much of the Strategy as the pathways and actions are so general they can be interpreted to cover almost all possible interventions.

4. We are concerned at the way that ‘Maori’, ‘Pacific’, ‘Maori communities’ and ‘whanau, hapu and iwi’ are tasked with many Activities while there is no suggestion that any agency has been tasked with funding or providing resources to these groups and individuals. While it is essential that Maori and Pasifika are involved in the development of suicide prevention initiatives for their own communities, it appears from the Strategy that they are expected to already know what is needed to prevent suicide while being left to take full responsibility to undertake the various Activities suggested.

Suicides Amongst our Elders

5. We note that the Strategy focuses largely on young people aged 15 – 24 years, something that is understandable given their markedly higher rates of suicidal behaviour. However, we consider that there needs to be a complementary focus on older age groups as well, particularly for those over 75 years of age.

6. While the rate of suicide tends to decrease over the older age groups, there is an increase in numbers committing suicide in the age groups over 70, and for males over 85 years the suicide rate of 40.9 per 100,000 is the highest for any age group (males 45-49 is 32.6 and males 20-24 is 28.8 per 100,000). The 85+ age group is a particularly vulnerable group, and evidence of increasing loneliness amongst elders and of increasing elder abuse in New Zealand suggests that rates could worsen.  See graph below for 2013 figures:

Figure 1: Age-specific suicide rates, by five-year age group and sex, 2013

Graph suicide

                Notes:

                Rates are expressed per 100,000 population.                Error bars represent 95% confidence intervals. If two confidence intervals do not overlap, there is considered to be a statistically significant difference between the two groups being compared.               Source: New Zealand Mortality Collection.1

 

7. In a presentation to the Suicide Prevention Conference 2013, Prof Yeates Conwellmade several points concerning older adults:

  • Older adults are the most rapidly growing segment of the population
  • 'Baby boomers' have tended to have higher suicide rates than earlier or later cohorts at all points in the life course. The fact that 'baby boomers' are now coming into the older age groups, a time of increased risk and increased lethality, means that we are therefore likely to see more suicides amongst this cohort.
  • There is one completed suicide for every 30 attempts in the general population, but for older adults there is one completed suicide for every 4 attempts. This is because older people are more frail (more likely to die), are more isolated (less likely to be rescued), and older people use more immediately lethal means and use them in ways more likely to result in death.

8. It well accepted that even mild depression – the kind that would not render a person legally incompetent – can have a marked effect on one's predisposition to life, including a person's willingness to consider ending their life prematurely. The Mental Health Foundation of New Zealand identifies depression in the elderly as often linked to health problems. It also notes that "The risk of suicide in people with depression is significant."3

9. Dysthymia, a chronic form of depression that is typically described as a "mild depression" (also referred to as "subthreshold depression") has been shown, because of its ongoing nature, to have a devastating impact on people's lives. Persons with this type of "minor depression" are at increased risk of developing a major depressionand exhibit very similar statistics relating to suicide mortality and number of repeated suicide attempts as persons with major depressive disorders.5

10. While the New Zealand Mental Health Survey indicates that those over 65 years have proportionately lower rates of depression than other age groups, there is evidence that some groups of the elderly suffer high rates of depression. In the New Zealand LiLACS longitudinal study, which recruited 421 Maori aged 80-90 years and 516 non-Maori aged 85 years living in the Bay of Plenty and Rotorua districts, the prevalence of depression (measured by the Geriatric Depression Scale) was reported as ranging from 22 percent for Maori men and 23 percent for non-Maori men to 26 percent for non-Maori women and 30 percent for Maori women.In addition, physical health generally declines with age which has consequences for social functioning and emotional role functioning.7

11. Detection and treatment of depression has been found to be an effective strategy to prevent late-life suicide.8

12. Conwell reported that 'indicated' (e.g. screen, detect and treat depression at primary care level) and 'selective' (e.g. a depression care manager in primary care) interventions are successful, particularly for older women.

13. The 2015 Office for Senior Citizens (Ministry of Social Development) report on Elder Abuse notes a number of studies which have demonstrated links between elder abuse and depression.9  The recent Australian Report on Elder Abuse notes that risk factors for the person experiencing abuse include depression, as well as social isolation and physical disability.10  

14. The Office for Senior Citizens report also notes that "around one in ten older people ... report some form of abuse (closely linked to vulnerability and coercion)". While there are no population-based studies of elder abuse in New Zealand, most research estimates that between 2 to 5 percent of the older population may be victims of elder abuse.11 The proportion increases dramatically when the person is dependent on carers, where studies estimate almost a quarter of older people who are dependent on careers have reported suffering "significant psychological abuse".12 Similarly, Age Concern in New Zealand reports that it receives more than 1,500 confirmed referrals each year of older people facing abuse or neglect.13

15. Reports from the 2001 Census show that there were 450,426 people aged 65 and over living in New Zealand, which means there could be between 9008 (2 percent) and 22,520 (5 percent) older New Zealanders suffering some form of abuse and neglect.  It is estimated that only 16 percent of the actual number of abuse incidents reach service agencies.14

16. Any strategy to prevent suicides amongst our elders must be closely linked to the prevention of abuse experienced by this group.

17. Research has established that those making serious suicide attempts are likely to be characterised by high rates of social isolation, feelings of loneliness, poor social support and lack of a close, confiding relationship.15 Several studies have established that loneliness is a significant problem for elders in New Zealand: an Auckland Council commissioned study found that 9 percent of Auckland residents aged over 50 were severely lonely, and 44.5 percent moderately lonely;16 a study investigating the rate, degree and impact of loneliness in a sample of 332 older community-dwelling New Zealanders found more than half of the sample (52 percent) was found to be lonely to some extent with 44 percent being moderately lonely and 8 percent severely lonely;17 the New Zealand Longitudinal Study of Aging described a minority of participants as 'not lonely' (48.8 percent); the rest were considered 'moderately lonely' (41.2 percent); 'severely lonely' (7 percent); and 'very severely lonely' (3 percent).18

18. While there are many precipitating factors involved in elder suicide, we believe that much more attention needs to be given to critiquing the ageist and ableist societal narrative that is increasingly inclined to equate value of life and personal dignity with health and independence ('not being a burden').

19. A focus on the suicide of elders, while 'targeting' a particular group and raising awareness of the 'value' and dignity of this group, may also work at a universal level by challenging societal attitudes about 'useful' or 'successful' lives that will assist in suicide prevention for all age groups.

  Suicides within Corrections Facilities

20. We note also that there is no mention of prisoners in the Strategy and yet the suicide rate for prisoners is higher than that of the general population. In addition, the rate of suicide amongst Māori men is higher than that for all men (25.6 Māori men compared with 18.8 men per 100,000 in 2012), which the Department of Corrections reports as significant for them, since around 90% of offenders in prison are male and just over half identify as Māori.19

21. The Department of Corrections also reports an increase in 'self-harm threat to life incidents' from six for the year 2011/2012 to 26 for the year 2015/2016. ('Unnatural deaths', with suicide being the most common cause of these, increased from five to 11 over the same period).20

22. Given these figures, and given the high rates of mental health or substance use disorder amongst prisoners,21 we would like to see more emphasis in the Strategy on suicide prevention for the prison population.

Disabled People and Suicide

23. While New Zealand data concerning disabled people and suicide are not readily available, there are a number of reasons why this group should be considered vulnerable to higher suicide rates.

24. It has been found that disability status is a strong predictor of suicide ideation risk.[i] Disabled people are among the most disadvantaged in terms of employment, interpersonal acceptance, economic stability, freedom of mobility and community access, all variables thought to have a significant bearing on suicide potential.23 

25. The New Zealand Disability Survey reports that for 12 percent of adults and 21 percent of children, psychological or psychiatric difficulties were the main impairments.24 It suggests that an estimated 242,000 people (adults and children) were living with long-term limitations in their daily activities as a result of the effects of psychological and/or psychiatric impairments.

26. It is disappointing and concerning that disabled people are not mentioned at all in the Strategy.

Deprivation

27. It is also the case that deprivation and suicide are correlated. The Ministry of Health Report on suicide for 2013 found that rates of suicide increased consistently with the level of deprivation. The highest rate was among those residing in quintile 5 areas (the most deprived areas), with a rate of 15.4 per 100,000 population, followed by quintile 4 (12.1 per 100,000). The lowest suicide rate was seen among those who resided in the least deprived areas, quintile 1 (7.3 per 100,000). For both males and females, the suicide rate was twice as high amongst those residing in the most deprived areas compared with those living in the least deprived areas.25 

28. The association between deprivation level and suicide is most apparent in the youth population (15–24 years) where there were at least four times the number of suicides for this population in deprivation quintiles 3–5 compared with quintiles 1 and 2. For those aged 25–44 years, there were 2.5 times the number of suicides in deprivation quintiles 3–5 compared with quintiles 1 and 2.26 

29. Other studies have found an association between deprivation and suicide rates for young and middle-aged males in England27 and young adults in Scotland.28 

30. The association of deprivation with suicide is not addressed in the Strategy but we suggest this is a potentially a risk factor for suicide, particularly amongst young people, and as such definitely needs consideration. 

State of Mental Health Services in New Zealand:

31. In New Zealand currently, there are clearly pressures on mental health provision, and funding over recent years has not been able to meet increased need. In view of this, we consider that the Strategy should also advocate for increased provision of mental health support at both primary and secondary health care levels as part of its approach in addressing suicide rates amongst all age groups.

32. The Ministry of Health's Director of Mental Health reported29 that specialist mental health and addiction services are experiencing increasing pressure. The number of people engaging with specialist services increased from 143,060 people in 2011 to 162,222 people in 2015. It noted that despite increases in funding, the sector faces 'new and shifting challenges' and that 'services are experiencing increasing pressure'.

33. In a report on discharge planning for mental health patients from hospital, the Auditor-General has recently found that 'the timeliness, quality, and effectiveness of discharge planning (and the associated follow-up work) are impaired by pressures on inpatient and community services and other factors' and that some inpatient units have high occupancy rates – sometimes beyond their capacity – and in some places there is limited availability of community services to discharge people to.30 

34. We note also that those who suffer from mental illness would be particularly susceptible to a premature death under the proposed End of Life Choices Bill being sponsored by David Seymour in which a person is eligible for assisted dying if they suffer from 'a grievous and irremediable medical condition', which can include mental illness.

Links between suicide in the general population and legalised euthanasia and assisted suicide:

35. There is also the potential additional risk of an increase in suicide rates in response to moves to legalise/decriminalise assisted suicide/euthanasia, which needs to be considered and addressed. The strategy document does not address the issue of physician-assisted suicide or euthanasia. While the issues may appear at first glance to be separate, there is sufficient evidence to suggest that they may well be directly linked to the wider issue of suicide in society.

36. Legalising assisted suicide is a particular risk for our elders in a context in which older people are experiencing greater rates of social isolation and depression as noted above. Were euthanasia or assisted suicide to be legalised, many such 'legal' requests could potentially hide what would otherwise have been regarded as tragic suicides linked to a reactive depression that is directly related to abuse or neglect or to the limitations of ageing – a depression that can and should be treated.31

37. The contagion effects of suicide are well known, both the links between media coverage of suicide and youth suicide,32 as well as that between parental and offspring suicidal ideation and suicide attempts.33 It has been found that the relative risk of suicide following exposure to another's suicide is two to four times higher among 15-19 year olds than among other age groups.34

38. Exposure to the suicidal behaviour of family members has been well-established as a risk factor for youth suicidal behaviour.35

39. While it is still premature to make definitive comparisons of suicide rates in jurisdictions that have or have not legalised euthanasia, it is worth noting that in the Netherlands the number of completed suicides (excluding premature death by euthanasia) has risen from 1,500 in 2003 to 1,871 in 2015, that is from 9.6 to 11.1 per 100,000 population (euthanasia was legalised there in 2002).36

40. If assisted suicide/euthanasia were to be legalised, young people and others at risk of suicide would be faced with two competing paradigms - 'acceptable suicide' and 'unacceptable suicide'. The concept of 'rational' suicide, for those who find their lives intolerable and not worthwhile, will be in direct conflict with the fundamental goal and message of suicide prevention programmes.

41. In view of recent attempts to change the law regarding assisted suicide/euthanasia, the Strategy needs to address and challenge this potential development, which would impact significantly on the approach and messages of suicide prevention initiatives.

Conclusion:

While the "Strategy to Prevent Suicide in New Zealand" is wonderfully aspirational, we believe it needs to be more specific in terms of articulating specific interventions and in identifying, and advocating for, the resources and support required to ensure that the expressed aspirations lead to effective action.

While we understand and agree with the need to focus on the groups identified - Māori, mental health service users, Pacific peoples, and young people – we believe that the Strategy has failed to identify other demographic groups at risk of suicide, that is, our elders, persons being detained in correctional facilities and disabled people, as well as those living in the most highly deprived areas. We consider these groups should also be included for targeted activities.

We suggest that those who do not conform to the increasingly dominant ableist and ageist idea of what a successful life looks like, for example, those who suffer deprivation, disability, mental illness, or the limitations of ageing, are particularly vulnerable to the suggestion that their lives are not worth living. We suggest that a strategy to prevent suicide might need to address this underlying social narrative.

Finally, we have highlighted the need to be aware of the competing paradigms that would be created were New Zealand to legalise euthanasia or assisted suicide. Such a move that would effectively amount to acknowledging the notion of 'rational suicide', something which we believe would impact negatively on suicide prevention in the general population.

Endnotes

  1. (Ministry of Health, 2016b, p. 8)
  2. (Professor Yeates Conwell, 2013)
  3. See https://www.mentalhealth.org.nz/get-help/a-z/resource/13/depression
  4. (Cuijpers, 2004).
  5. (Holmstrand, Engstrom, & Traskman-Bendz, 2008)
  6. (Teh et al., 2014)
  7. (Budge, Claire, Stephens, Christine, & Stichbury, Christopher, 2014)
  8. (Turvey et al., 2002)
  9. (Office for Senior Citizens, 2015)
  10. (The Australian Law Reform Commission, 2017)
  11. (Glasgow, K & Fanslow, J.L., 2006)
  12. (Cooper, Selwood, & Livingston, 2008) (2008) 37 Age and Ageing 151 at 158
  13. http://www.ageconcern.org.nz/ACNZPublic/Services/EANP/ACNZ_Public/Elder_Abuse_and_Neglect.aspx
  14. See https://www.ageconcern.org.nz/ACNZPublic/Services/EANP/ACNZ_Public/Elder_Abuse_and_Neglect.aspx#howmuch
  15. (Beautrais, A.L., Collings, S.C.D., Ehrhardt, P., & et al., 2005)
  16. (Waldegrave, Charles, King, Peter, & Rowe, Elizabeth, 2012)
  17. (La Grow, Neville, Alpass, & Rodgers, 2012)
  18. (Noone, Jack & Stephens, Christine, 2014)
  19. (Department of Corrections, n.d., p. 63)
  20. (ibid n.d., p. 63)
  21. A 2015 study found ‘62% of prisoners had experienced a mental health or substance use disorder, while 20%  had experienced both in the 12 months before the study’ (ibid n.d., p. 62)
  22. (Russell, Turner, & Joiner, 2009)
  23. (Gill, 1992)
  24. (Statistics New Zealand, 2013)
  25. (Ministry of Health, 2016b, p. 19)
  26. (Ministry of Health, 2016b, p. 20)
  27. (Rezaeian, Dunn, St Leger, & Appleby, 2005)
  28. (Exeter & Boyle, 2007)
  29. (Ministry of Health, 2016a)
  30. (Office of the Auditor-General, 2017, pp. 3–4)
  31. (O’Connell, Chin, Cunningham, & Lawlor, 2004)
  32. (Crepeau-Hobson & Leech, 2014). (Sisask & Varnik, 2012)
  33. (Goodwin, Beautrais, & Fergusson, 2004)
  34. (Haw, Hawton, Niedzwiedz, & Platt, 2013)
  35. (Crepeau-Hobson & Leech, 2014, p. 59)
  36. https://www.cbs.nl/en-gb/news/2016/26/more-suicides