In Depth: Presuming Consent in Organ Donation- Part Two (Electric Boogaloo)

27 Nov
 
Here, at last, is the second part of this post. It was unavoidably delayed by a combination of sudden busyness and industry on my part, but I’m sure that wont be a problem in the future. This part carries directly on from the first, which can be found HERE. There, I looked at the normative ethics of presumed consent, and here, I’m going to look at the legal standpoints involved.
 

The last post brings me to address another contentious issue inherent to a policy of presumed consent for post-mortem organ donation, which is that to have any moral authority over the populace, legislation must assume that all those within its remit actively engage with it. Such a concept is enshrined in UK law through the Human Tissues Act (HTA) 2004, the “guidance [of which] is clear that consent is a positive rather than a passive process”. That is to say that in the milieu of the proposed system the term ‘presumed’ is perhaps inaccurate, and instead the system operates on the basis that “consent can be given implicitly, by one’s actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent”, which maybe implies that inaction is itself a defined action. I’d venture, however, that this approach could be seen as objectionable and liable to meet with challenge by the public in the actual event of its invocation. Furthermore, in the instance of UK law, a proposal on this basis was thought to require definitive legislative change to elements of the then-recently passed HTA because:

[T]he change from opt in to opt out for transplant purposes could risk undermining the 2004 act’s consent provisions, which safeguard the rights of individuals or their families to be asked if tissue can be used for a variety of other purposes.

De Wispelaere offered a counterpoint to the implied consent position by proposing a system in which “the probability of the consenting act coinciding with what the ‘consenter’ really wants (independently of the procedure) satisfies some threshold value—for example, more than 50%”, which he termed ‘approval-tracking’. You can infer that this suggestion would not necessarily provide a legislative methodology analogous to the dissent solution, but would provide less of a diktat upon those who failed to actively signal their preference. If you reason, then, that consent is not implicit in a failure to act, how do you reconcile the proposed regime with the notion that elements of the population may fail to act through either apathy, fear, or disorganisation? In the latter case, the subject may possess the intention, but lack the will. Impassivity such as this is not to be encouraged in matters of public health, but neither can we condemn a person to a fate against their wishes. There is evidence that this situation would feasibly arise: the NHSBT’s annual report for 2009-2010 found that although 90% of the UK population support organ donation as a concept, only around 30% are members of the Organ Donor Register. Polling in the US to explain similar statistics found that amongst supporters of donation

the most common reasons cited for not [actively registering] were mistrust (of doctors, hospitals, and the organ allocation system), a belief in a black market for organs in the United States, and deservingness issues (that one’s organs would go to someone who brought on his or her own illness, or who could be a “bad person”)

Probably easier than doing this, though.

which we might take as indicative that in an opposite situation- id est, that of our proposed solution- a comparable mistrust or misunderstanding would lead to a significant percentage of dissenters failing to register as such.

To reason a solution to the problem I latterly detailed is no simple matter, not least because it involves non-definite values. Any legislation that was resolved as being appropriate for institution would be faced with the problem from one side or another, and as such could be held to be untenable. The only practicable solution would be to enact a system as described by Saunders, but as I suggested before, such a hard ruling could appear mildly undemocratic. Furthermore, I’d conjecture that this method may well serve to encourage active dissent by those who feel pushed into a decision. This, then, is the opposite of what such legislation might intend and in extremis may even serve to reduce donation in the short term. One reason for this possible reaction could be a desire to exhibit caution until such a time as one is able to contemplate the issue further, which leads me to another question that the proposed policy would raise.

As I have already mentioned, there exists a readily foreseeable circumstance in which one who has in fact made a conscious decision (and has acted in whatever manner is necessary to make this  their official declaration; disregarding,for the sake of argument, the paradox I have latterly discussed) may wish to alter their response. This may be as a result of rumination, as suggested, or a result of a change in personal circumstance such as reaching the age of majority; but it represents a fundamental desire not to commit to their previous assertion, or that which was made on their behalf. Therefore, I’d be justified in considering such an eventuality as a change in will. In this instance, then, it would appear reasonable and fair to allow one to reflect this will in practical terms; to permit change is to fulfil generally held principles of self-determination and body sovereignty, as exemplified in John Locke’s belief that an individual “has a right to decide what would become of himself and what he would do…

However, you might say that this attitude is contrary to the general ethos of an opt-out system. While not denying that such a policy allows freedom of choice, we have previously expended discussion on the idea that a dissent solution is inherently presumptive- and that this act of presumption may act against the true will of the individual. If we take this position, logic would suggest that to ignore person A’s desire to opt out, which has not yet been registered, but to allow person B who has registered and desires to revoke this status is somewhat hypocritical. In the example stated, we might also declare it to be self-serving, allowing an increase in donor registration but prohibiting the opposite. While this increase is an admirable goal, it can be argued that it is ethically unsound to achieve it at the cost of self-determinative liberty. A counterpoint to this argument might be found in the work of Cohen, who claimed that “each person enjoys, over himself and his powers, full and exclusive rights of control and use, and therefore owes no service or product to anyone else that he has not contracted to supply“- which I’ll interpret as a possible rationalisation of the example outlined. Despite the rationality that might lead to such a situation, though, it is unfair to claim that this is a necessary result of presumed consent. The system would not be weakened in practical terms by providing for the paradox allowing changes of stance, and so this cannot be held to be anything more than a conceptual flaw.

A policy of dissent, then, provides fertile ground for philosophical and theoretical debate. It is perhaps of more actionable advantage however to pause my examination of such subtle affairs, and focus instead on matters of practicality that we might find arise from a legislative change.

In discussing the concept in Part One, I touched upon the topic of who we may and may not ask to give consent. Although since overturned on theological advice by the Islamic Religious Council (MUIS) of the country, who declared that “The general consensus… is that organ transplant and donation by the deceased is permissible in Islam”, prior to 2008 the Singaporean Human Organ Transplants Act (HOTA) provided that the Muslim population of the state were not held to its opt-out system on the basis that without express consent to the contrary, there is an Islamic belief that the dead should be interred intact. Religious stances such as this are a major consideration that must be treated with sensitivity in the institution of bio-legal regimes. The matters of organ donation and the post-mortem treatment of remains are particularly sensitive due to their import under religious interpretations of human dignity and morality, which often “reflect a state of moral paternalism rather than pragmatism”.

Although most major world religions are in favour of donation-often with caveats such as led to the Islamic exception originally a part of the Singaporean HOTA- there are groups which prohibit it. These include followers of Romany gypsy traditions; and the Japanese faith in and cultural conventions of Shintoism, which hold the body after death to be impure.

Yeah, actually I totally buy that.

However small a representation of such faiths there may be in a country, it is a primary principle of international human rights law to uphold freedom of religious belief and practice, as stated in Article 18 the Universal Declaration of Human Rights: “Everyone has the right to freedom of …religion; this right includes freedom to …manifest his religion or belief in teaching, practice, worship and observance.”

It is therefore arguable that it is reprehensible to institute a system by which inaction, for whatever reason, by an individual would render that person unable to practice their belief. Equally, I might suggest that it is illogical to force the participation of a group when they will be obliged to opt out immediately. Conversely, consider one rejoinder to the HOTA given by the MUIS- that there are plenty of opportunities given to opt out- to be a solid defence against such religious critics of presumed consent policies. Whatever the prevailing sentiment, in the Singaporean example or in any nation, it can only be sensible to avoid any appearance of religious inequity; especially bearing in mind the natural wariness and scrutiny any such major policy change would entail.

I previously suggested that the institution of presumed consent legislation would necessitate ensuring a standard of education and awareness of the changes and the ramifications of such on what was required of the public. It would be foolish and unethical to fail to inform those within it  of the parameters of the new system. Beyond the ideas I have already discussed regarding presumption of consent in the event of inaction, we need not dwell upon such supplementary concerns as they do no not constitute problems in the same fundamental manner as some of the aforementioned.

However, one situation bears examination. The goal of the proposal, as stated in Part One, is to raise the numbers registered to donate organs, and thereby to raise donation rates and transplant surgeries. This will, however, place a logistical burden on the health systems of a state, particularly those which are nationalised such as the UK’s NHS. We might regard two related facets of this eventuality, the day-to day financial aspect and the need for a suitable infrastructure. In long-term monetary considerations, private sector health care would have little difficulty given that procedures are funded by the recipient or their insurer; but for nationalised services an increased number of expensive procedures could prove problematic, especially in services already struggling with funding. The ailing NHS reported a deficit of £1.2 billion by 2005, and is at the time of writing in a period of turmoil. The immediate impact of the need for new infrastructure and organisation is of particular concern: far beyond the simple (yet, in the current situation, difficult to implement given bed shortages) requirements for physically increased capacity for surgery and care, there would exist a need for extra staff; new computerised systems; and the aforementioned public awareness campaigns. All these necessities would prove highly, perhaps prohibitively, expensive- the UK’s Organ Donation Taskforce (ODT) report on the practicalities of an opt-out system estimated these costs to be “approximately £45 million in set up costs for IT and communications… £2 million per year in IT running costs and an additional £5 million every few years to refresh public messages”.

Whilst it is unethical to invoke this issue as the sole reason to abandon a change in regime, on the basis that “[a]ny attempt to assign a monetary value to the human body, or body parts, either arbitrarily, or through market forces, diminishes human dignity”; I’ll observe that such a financial output would take significant efforts and health policy adaptations to achieve.

Of course, if the family can’t agree, you can decide the fate of your loved one’s remains with this fun game!

Another major issue debated by academics regarding organ donation is the legal necessity of the family veto. It is commonplace in states utilising an opt-in system to devolve the final decision on consent to the relevant family members or legal guardian on grounds of compassion, as is clearly denoted in the Code Of Practice of the UK Human Tissue Authority (HTA):

The emphasis in these difficult situations should be placed on having an open and sensitive discussion with those close to the deceased where the process is explained fully to them. Healthcare professionals should also consider the impact of going ahead with a procedure in light of strong opposition from the family, despite the legal basis for doing so.

Conversely, states operating a ‘hard’ opt-out policy- wherein those who have failed to dissent are treated as donors regardless of familial protest- might be thought to be in keeping with the consequentialist ethical theory, and also to correctly follow the reasoning of Saunders’ posited actively “implicit consent”; as I have previously discussed. This latter scenario is, however, demonstrably controversial. To return to our use of the Singaporean HOTA prescribed dissent solution, we can observe the example of the 2007 Sim Tee Hua case. As discussed by various academics including Stirton and De Wispelaere, the corneas and kidneys of the deceased were removed while “nine police officers entered the ward and restrained the distraught family” who had “wanted doctors to wait one more day before turning off the life support”. A resultant media storm served to encourage an increased rate of opt-outs and the incident generally heightened mistrust of the system. I could also object to such a situation on the grounds of basic ethics, through the idea that it is indefensible to cause such emotional harm to the family of the subject- especially if we consider the likelihood of their distress at bereavement- although this argument is difficult to arbitrate given that it has been pointed out that where families are consulted, there is frequently epistemological uncertainty over the true wishes of the subject.

However, much in the same manner as we saw that strict logic may lead to the prohibition of the ability to change one’s mind, you might imagine that it is once again against the crudest hypotheses of the presumed consent proposal to allow the subject’s response under the terms of the system to be overturned. I’d also note that the potential logical paradox created by allowing veto is further complicated by the distinct possibility that the failure to allow familial influence could be ruled a breach of international law. For instance, The UK ODT found that “a ‘hard’ opt out system that did not seek evidence from families about the deceased’s own opinions or wishes could be open to a potentially successful challenge under the European Convention on Human Rights [ECHR]”.

Were this to be the case, the scale of this issue could cause a fundamental failure in the proposed system, leading to either its withdrawal or substantive  alteration.

It would be possible to write almost endlessly on the conceivable problems that would be created by the inception of an opt-out system of organ donation. However, I’ll note once more that in large part these questions are conjectural in nature, and it is the case that such legislation exists and is highly successful in many countries. This fact forms the basis of most proposals to institute presumed consent protocols, supported by the undeniable data portraying significantly higher rates of donation or donor registry in such states than in non-participating countries. This data, such as the Spanish figure of 34 donors per million of population, is strong evidence as to the benefits that can be wrought under the proposed system; and is rendered even more attractive when considered in context with the high shortfall rates of countries such as the US or UK. As such,  our analysis has attempted to focus on the most feasible practical issues that would be faced by opt-out legislation, alongside the ethical and philosophical quandaries that could arise as a result. In considering the ‘economist’-style analysis of the result of a new regime, I found myself led to examine  the verdict of a selection of ethical theories. Both consequentialist and deontological viewpoints can be interpreted to suggest that morality supports a system of beneficial intent, but pragmatic ethics dictates that you cannot discount the commonly held views of society. Consequently, it is necessary not to disregard ethical shortcomings of any proposal, the most significant of which is how the new law would define consent. This question is of value because not only does it govern who can be held to the legislation, but also it leads to further problems which could cause conflict with documents such as the 2005 Mental Capacity Act and rulings such as in the Gillick case. It also causes the partial collapse of the conventions held regarding proxy decision making. I also considered the notion that to be ethically and legally sound, it would be necessary for an opt-out system to entail 100% engagement and active participation by the population; a concept which is neither realistic nor in keeping with its general ethos. I was able also to question how a dissent solution would be able to deal with the vagaries of changing opinions, and dependent on this, with  the action of familial veto, and I was not able to find a satisfactory conclusion that did not entail legislative change adversely affecting other areas of public health policy. Finally, I raised questions over the potentially insurmountable financial consequences that would require solving both during and after the institution of a new regime, along with the potential need for later redress regarding religious freedoms.

As a result, you might judge that while the central premise of a presumed consent solution to organ donation is, in valuative terms, hugely beneficial; the potential problems raised by such a radical overhaul of a legal framework are at least of equal weight. So you have to ask, do the pros really outweigh the cons? For the record, I’d say they do, but it’s too close to call for anything less subjective.

2 Responses to “In Depth: Presuming Consent in Organ Donation- Part Two (Electric Boogaloo)”

  1. Nathan Emmerich (@BioethicsUK) November 27, 2012 at 8:11 pm #

    So after all that, it is yes to presumed consent? I think the problem is presumed consent is that it assumes there is one question: to be (a donor) or not to be (a donor)? [Sorry]. There isn’t. There are also questions about which organs you are willing to donate and, increasingly, questions about under what circumstances you might be willing to be a donor. Under Brain death criteria, controlled or uncontrolled cardiac/ circulation death, when electively ventilated. These are not reflected in the current UK register but, I think, should be. Such a system would require greater engagement with the population to increase donation/ registration rates. A more ethical approach that will, in the longterm, be more successful than presumed consent.

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  1. In Depth: Presuming Consent in Organ Donation, Parte the Firste « biojammer - February 5, 2013

    […] the second part of this post, I’m going to wax lyrical about the legislative position on presumed consent, and how a […]

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