Autonomy,trust and ante-mortem interventions to facilitate organ donation

Introduction

Trust is a factor in organ donation that is not always fully appreciated, yet it is crucial to achieving and maintaining public cooperation with both the opt-in system that exists throughout most of the UK and the opt-out system that has recently been introduced in Wales. ¹ Currently, public trust in the organ donation programme is limited and the supply of organs is inadequate for the needs of the thousands of patients who remain on the transplant waiting list. ² Limited public trust in organ donation contributes to both low levels of registration on the opt-in Organ Donor Register (ODR) (36%) and persistently high levels of family refusal of organ donation (37%). ² Amongst the most common reasons given by people who support organ donation for not registering on the ODR are a lack of information, a lack of trust and concern about being viewed as an organ donor rather than a patient. ³ These same concerns contribute to family refusal and to the subsequent regret of refusal that affects approximately one-third of refusing relatives.^4–6 However, despite implementing policies which change the way that potential organ donors are treated before death,^7,8 NHS Blood and Transplant (NHSBT) has not yet introduced informed consent standards for the organ donation process.

Since the recommendation of the Organ Donation Taskforce (ODT) in 2008 that organ donation be viewed as a usual part of end-of-life care, ⁹ policies have been implemented which identify and treat brain-injured patients as potential organ donors before death.^7,8 In practice, this may include interventions such as vasoactive drugs, the cannulation of major blood vessels, and potentially also heparin administration and non-therapeutic ventilation.^10,11,12 All of these interventions are performed with the sole aim of improving the chances of successfully transplanting their organs into third parties. As most patients identified as potential organ donors are mentally incapacitated, doctors are legally required to act in the potential organ donor’s best interests. ¹³ However, as I have previously argued, the current system makes it difficult to determine where those interests lie as it provides no way of ascertaining the individual’s specific wishes in the circumstances. ¹⁴ The policies have not been accompanied by any changes to the information provided to potential registrants on the ODR and there is no opportunity to record specific consent or refusal to the procedures. This appears to be out of fear that introducing informed consent standards could “put people off ” ¹⁵ registration and reduce the supply of organs.^15,16 In this paper, I argue that the incorporation of patient autonomy into donor optimisation policy is in fact necessary for the long-term maintenance of trust in the organ donation programme and for the achievement of an adequate supply of organs for transplantation.

Autonomy and the potential organ donor

Although NHSBT’s current strategy is to interpret registration on the ODR as encompassing changes to the end-of-life care of registered organ donors within their best interests, ¹⁷ ODR registrants are neither informed of nor give consent to these changes to end-of-life care. They are not able to determine for themselves whether or not to undergo ante-mortem interventions to facilitate organ donation. As I will argue in this paper, this requires redressing not only because of the importance of autonomy to potential organ donors but because of the relationship between autonomy, trust and the supply of organs.

Autonomy is of both intrinsic and instrumental value to an individual who may be subject to donor optimisation procedures. Being the “architect and builder” of their own life plan ¹⁸ may have a positive psychological effect on the ODR registrant, improving their sense of self-worth and allowing them to reflect on and express their ethical commitments and values. ¹⁹ Incorporating autonomy into donor optimisation policy would also ward off the very real sense of a lack of control over future medical interventions perceived by some individuals who currently lack trust in the organ donation programme.^18,20 Having the option to refuse donor optimisation procedures would protect those individuals who do not want to undergo ante-mortem donor optimisation procedures from the physical risks of these procedures. Having the choice whether or not to undergo these interventions would promote the individual’s values at the end of life and the dignity and integrity of the ODR registrant once incapacitated.

Invasive and pharmacological interventions before death to facilitate organ donation carry risks of physical harm. Non-therapeutic ventilation, for example, could potentially cause serious neurological damage such as a permanent vegetative state. ²¹ Femoral cannulation could cause a range of vascular complications. ²² Heparin carries the risk of haemorrhage. ²³ For some individuals these risks are outweighed by the potential benefit of organ donation, but individuals have different benefit–risk preferences and not all would wish to take these risks to improve the chances of successful organ donation. ¹⁴ Upholding the individual’s own benefit–risk preferences is important to improve individual and public trust that registration on the ODR will only result in interventions that the registered organ donor has agreed to. As I argue throughout the rest of this paper, this informed trust in the organ donation programme is critical to achieving and maintaining an adequate supply of organs for transplantation.

Trust in the organ donation programme

Trust exerts considerable influence over the outcomes of healthcare policy. In the context of an organ donation programme that retains an element of individual choice, trust is the most critical factor in securing an adequate supply of organs. However, this does not mean that autonomy can be disregarded as it is not in opposition to trust and as both autonomy and appropriately directed trust are reliant on the information that is available about the future consequences of decision-making. The information that is currently available to ODR registrants does not reflect the realities that they may face at the end of life and the only trust they can bestow is blind trust in the organ donation programme. As I will argue in this paper, this is a precarious form of trust that could readily be replaced by distrust should the realities of the organ donation process be revealed in the media. In contrast, appropriately directed trust based on adequate information about the consequences of ODR registration would, I argue, be a stable and enduring form of trust in the long term and have a safeguarding function for the outcome of organ procurement policy.

In his influential thesis on the necessity of trust in a complex society, Luhmann defines trust in relation to future events, equating it to “confidence in one’s expectations”. ²⁴ Trust is a means of coping with future uncertainties: “[T]o show trust is to anticipate the future. It is to behave as though the future were certain”. ²⁴ Trust’s function in healthcare decision-making is to enable individuals to cope with a future characterised by the complexities generated by modern medical technologies. ²⁵ Trust is needed if future eventualities exist that the individual might wish to avoid, ²⁵ such as having one’s dying process altered by medical interventions. It is not only the complexities of the medical technologies that accompany organ donation that suggest that trust is needed, but the potential for harm and the possibility that these technologies could begin before the donor is dead.

Trust is based on the information, if any, that is available about the nature and risks of healthcare practices. If this information is incomplete or inaccurate, trust may be misplaced and bestowing trust can have detrimental consequences to the trusting individual. The more accurate the information available, the more accurate the anticipation of future eventualities and the more appropriately directed the trust. The information, or misinformation, on which trust is based is not limited to that directly provided to patients, or in this context to organ donor registrants, but encompasses all other sources that contribute relevant information. The reputation of the organ donation programme, based on its past record as reported in the media or spread by word of mouth, contributes to the information that the ODR registrant has available and may be a determining factor in the level of trust they are willing to confer on it. ²⁶ A reputation of treating potential organ donors fairly, protecting their critical interests, and not exploiting them before death, is crucial to achieving and maintaining trust in the organ donation programme. Any breaches to the past record of treatment of potential organ donors, no matter how minor or infrequent, cast doubt upon the trustworthiness of the organ donation programme and this doubt can have a devastating effect on the conferment of trust on the organ donation programme.

For trust in the organ donation programme to be well founded, reliable information that allows potential ODR registrants to accurately anticipate the future consequences of registration is needed. However, O’Neill – one of the most prominent yet controversial scholars in the field of trust – argues that gaining autonomy in relation to healthcare practices can result in a loss of trust. ²⁷ Nevertheless, she clearly acknowledges that the reasonable placement of trust requires information about the undertakings that individuals are invited to trust. ²⁸ Her statement that “[t]he only trust that is well placed is given by those who understand what is proposed, and who are in a position to refuse or choose in the light of that understanding”, ²⁹ recognises two factors as being essential to well-placed trust. These two factors, understanding and the opportunity to make a choice, are defining attributes of self-determination. This self-determination is a necessary condition for well-placed trust. Well-placed trust relies on autonomy, and a gain in autonomy increases this form of trust. It appears that if any trust is lost by a gain in autonomy, it is not well-placed trust.

The individual judging whether or not it is reasonable to trust in the organ donation programme needs information about the organ donation process, as well as some means of judging whether that information is accurate. ²⁸ This is difficult, as there is no apparent means for individuals considering ODR registration to judge whether the available information about the organ donation process is complete, yet alone accurate. In the specific circumstances of donor optimisation policies there is very little openness and transparency. There is also little to suggest to ODR registrants that the information provided about the organ donation process is incomplete or inaccurate. They have been provided with so little information that they cannot know whether any trust they may confer on the organ donation programme is reasonably placed.

Trustworthiness can be damaged, as O’Neill acknowledges, by the lack of incorporation into legislation, regulation and institutions of important bioethical obligations and their corresponding rights. ³⁰ Achieving or at least avoiding damage to trustworthiness would therefore seem to rely on the incorporation of these important bioethical obligations and rights into these structures. Respecting and promoting the right to make an autonomous decision about medical treatment is usually held to be an important bioethical obligation. ³¹ This seems to suggest that improving trustworthiness relies on the incorporation of autonomous decision-making into law, policy and practice. Yet O’Neill is also concerned that measures introduced to improve individual autonomy and to protect against non-consensual treatment may have a damaging effect on trust. ²⁷ The relationship between trustworthiness and trust might not always be a positive one. Although trust may be based on the information available about the trustworthiness of the institution, it does not necessarily coincide with the trustworthiness of the institution. Trust is sometimes misplaced, but so is distrust. ³² Fears that facilitating autonomous decision-making – which would improve trustworthiness itself – might have a damaging effect on trust could explain NHSBT’s reluctance to introduce informed consent standards for donor optimisation procedures.

Increasing trust requires measures that not only increase trustworthiness but also make people more willing to confer trust. ³³ The same measures to incorporate autonomy into donor optimisation policy could, however, fulfil both of these considerations in increasing trust. As Ranson and Stewart argue, “[o]ur active participation in creating projects which are to shape our selves as well as the communities in which we live provides the sense of purpose to work together with others and to secure trusting relations with them”. ³⁴ The sense of purpose and moral worth provided by measures to involve ODR registrants actively in decisions regarding donor optimisation procedures may incline them to trust. ³⁵ The policy-makers’ fears could be addressed and proved unfounded by the introduction of measures that simultaneously encourage trust built on a sense of purpose and moral worth and develop the self-determination of potential ODR registrants.

In the long term, the type of trust conferred may be crucial to achieving the aims of the organ donation programme. Active involvement in decision-making is crucial to enable ODR registrants to confer informed or well-placed trust. As O’Neill acknowledges, “[w]ell-placed trust requires discrimination: it is directed selectively at specific claims and at specific undertakings”. ³⁶ Well-placed trust requires autonomy, without which the individual cannot be discriminating. Informed or well-placed trust requires that the potential ODR registrant has enough information to be able to direct their trust to specific undertakings, including those undertakings that may occur whilst they are still alive. ODR registrants are currently excluded from active involvement in end-of-life decision-making and not able to discriminate between those parts of the organ donation process that occur before and those parts that occur after death. The type of trust they are able to confer is not informed trust but uninformed trust. As I will argue throughout the remainder of this paper, the reliance of the organ donation programme on uninformed trust in the organ donation process poses significant risks for the achievement of its aim of securing an adequate supply of organs for transplantation.

Types of trust, distrust and the supply of organs

In this paper, I have argued that autonomy and trust are not in opposition to each other but that the latter flows from the inclusion of the former in healthcare decision-making. I have also distinguished between two types of trust. The first, autonomy-based or informed trust, is based on accurate information about the nature and risks of the relevant healthcare practice. The second, blind or uninformed trust, is conferred in the absence of accurate information about that healthcare practice. These types of trust are different notions, existing at opposite ends of the spectrum of what might be called trust. Both fulfil the definitions of trust in the sociological literature, providing the patient with the sense of security needed to engage with healthcare practices. However, they not only are conferred in different circumstances but have different consequences for the individual and for healthcare outcomes. In the context of organ procurement policy, as I will argue in this section, the risks of relying on blind trust include the potential for triggering a transplantation crisis.

Blind trust is something that is fallen back on when autonomous decision-making is denied. It is placed indiscriminately to cover the gaping hole left by the absence of information about a practice. The lack of accurate information leaves the patient, or ODR registrant, resorting to a blind act of faith that they can only pray does not result in unwanted outcomes. The potential unwanted outcomes include both iatrogenic harm and damage to the patient’s ethical commitments and values. The consequences of bestowing blind trust on healthcare professionals and institutions may include the manifestation of these unwanted outcomes. In contrast, informed trust is a more enabling notion, facilitated by the inclusion of the patient in autonomous decision-making and providing a well-founded sense of security that only anticipated outcomes will ensue from engagement with a healthcare practice. The patient’s expectations are based on accurate information about potential future eventualities and the confidence that results in those expectations is appropriately directed. The consequences of bestowing informed trust are limited to those future eventualities that the individual had anticipated and considered to be either acceptable outcomes or acceptable risks to take. The key advantage of informed trust is that it does not result in the unanticipated and unwanted outcomes that bedevil blind trust.

Current organ procurement policy is fundamentally reliant on trust. Trust is what makes it possible for people to register as organ donors and also what encourages relatives to consent to deceased organ donation. Individuals registering on the ODR are not currently informed about that part of the organ donation process that occurs before death, so the type of trust they can confer on the organ donation process is not informed trust. They cannot specifically direct their trust to the specific undertakings of ante-mortem donor optimisation procedures, and they cannot specifically consent to or refuse these procedures. They are entirely excluded from decisions about changes to their end-of-life care to facilitate organ donation. The trust they confer on the organ donation programme rests perilously over a huge void in information provision. Although the individual may be informed about deceased organ donation, they are not informed about ante-mortem interventions to facilitate organ donation, and the trust that they confer on the organ donation programme as a whole is much closer to the blind end of the spectrum.

Blind or relatively uninformed trust rests on shaky grounds and is at risk of being withdrawn and replaced by distrust. This is not merely a theoretical concern. It is a practical concern based on the damage done in the past to organ donation programmes by media revelations regarding organ procurement policy. Media revelations regarding the way potential donors are treated before death can inflict serious and long-lasting damage on uninformed trust and cause it to be replaced by the more pernicious concept of distrust. Over several decades and across several countries, there have been many examples of media reports that have legitimately raised concerns about organ procurement policy and these concerns have led to a withdrawal of trust, its replacement by distrust, and plummeting organ donation rates.^37,38

Fears of media revelations triggering public distrust exist in many countries. One of the most recent countries in which this fear has been realised is Germany, where public trust in the organ donation programme has been badly affected by allegations that doctors have falsified medical records to bump their patients up the organ transplantation waiting list.^39–41 This damage to trust is not due to sensationalist reporting but, in this particular case, due to the alleged criminal manipulation of patient records uncovered by investigations by Germany’s medical council.^41,42 As with other cases in which public trust has been damaged by the media’s exposure of the reality of organ procurement policy and practice, significant and longstanding drops in organ donation rates ensued. ⁴¹ In the UK, the most directly comparable events are the exposure of the practice of non-consensual organ retention, which triggered the drafting of the Human Tissue Act 2004, ⁴² and the oft-cited example of the 1980 BBC Panorama programme questioning the validity of brain-death criteria.^37,43,44 Although these are different practices that are being exposed or debated, negative media reports all have the same result, which is the destruction of public trust and a reduction in the supply of organs.

The so-called “Panorama effect” ⁴³ on the supply of organs might be blamed on irresponsible reporting. However, its true cause may be a lack of openness and transparency surrounding organ procurement policy. Panorama viewers may not have torn up their donor cards, ⁴⁴ and the 15-month drop in donor referrals may have been avoided, ³⁷ had they been fully informed about brain-death criteria prior to registration. Similarly, openness and transparency about ante-mortem donor optimisation policy could well have prevented the damage to public trust and the drop in organ donation rates that followed media exposure of an American clinic’s policy for treating brain-injured patients in a way that facilitated organ donation. ³⁸ This openness and transparency may have saved hundreds of lives in the years it took for organ donation rates to recover. It is lives that are put at risk by the current lack of openness and transparency in the UK about ante-mortem donor optimisation policy: lives that the organ donation programme cannot afford to gamble with.

Blind trust in organ donation is the result of a lack of openness and transparency and is easily damaged by media revelations. The gap in information is filled by the media revelations which lead previously trusting individuals to the conclusion that their trust in the organ donation programme was misplaced. This results in feelings of betrayal, the withdrawal of trust and the replacement of trust by distrust.^45,46 Distrust involves expectations that the actions of others will be harmful or detrimental. ⁴⁷ It results in individuals taking protective measures against the distrusted, the refusal of consent to healthcare practices, and other steps to avoid that healthcare practice. ⁴⁷ This could include the withdrawal of their individual names from the ODR, campaigning to ensure that others are not subject to the same risks, and potentially the refusal of intensive interventions at the end of life. Should this distrust take hold within society, the supply of organs to those desperately in need could be drastically reduced. Distrust can take years to shift, even if accurate information about organ procurement policy is subsequently provided. It is too late by then – trust is already gone.

The initiation of donor optimisation procedures without the consent of either the individual or their relatives could have particularly damaging effects on trust if those procedures cause physical harm. The public already harbour low levels of trust in the organ donation programme, with many people fearing that they will be viewed as an organ donor rather than a patient. ³ Media reports of dying patients being caused physical harm by non-consensual interventions for the benefit of third parties could be the last straw for trust. There is a real risk of this happening as a consequence of the distress caused to families by the discovery that their loved one has been harmed by invasive interventions that neither the patient nor their relatives had given informed consent for. Should just one family’s distress cause them to inform the media about physical harm caused by non-therapeutic and non-consensual procedures, organ donation rates could plummet. However, as was established following the media revelations of the practice of non-consensual organ retention, the lack of consent alone is enough to generate widespread public distrust. ⁴² It is the non-consensual nature of current donor optimisation policy that generates the risk to trust, and not necessarily the risks of physical harm – which may be more acceptable to the public if they are risks that they can choose whether or not to take.

The potential for a transplantation crisis to be generated by the exposure of current organ procurement policy could be alleviated by the provision of information and the active involvement of ODR registrants in decisions about donor optimisation procedures. As Almassi comments, ‘[a]t its best, organ donation occurs within a social atmosphere of morally and rationally justified trust”. ⁴⁸ That moral and rational justification relies on evidence that the organ donation programme will act in the interests of the organ donor. This evidence could be provided by affording ODR registrants the informed decision whether or not to undergo donor optimisation procedures. Their informed trust in the organ donation programme would be morally and rationally justified as they would have made their own decision regarding where their interests lay at the end of life.

Informed trust in the organ donation programme would not carry the same risks of being withdrawn and replaced by distrust that beset uninformed trust. It would be a real and well-founded confidence in one’s expectations, reached by a process of deliberation on the available information regarding the timing, nature, and risks of the organ donation process. If trust was placed on the basis of accurate information, there would be no gap in information that could be filled by media exposure of the reality of the organ donation process. ODR registrants would already know about the nature and risks of donor optimisation procedures, and if a system of specific advance consent were available, some would have agreed to these procedures. Any physical risks would have been consented to, so the fall-out in terms of public distrust is likely to be lower and the supply of organs protected from media revelations regarding the complications of these procedures.

It should not be beyond the wit of policy-makers to design a system which promotes both autonomy and trust in the organ donation programme. This does not mean that ODR registrants should be required to consent to “numerous, highly specific propositions”, ⁴⁹ but that NHSBT needs to identify and disclose the information that is relevant for the realisation of autonomy. Informed trust should be possible with the provision of relevant and understandable information on the timing, nature and risks of donor optimisation procedures. The relevant – and readily understandable – information includes the fact that they occur before death, that they are performed solely for the clinical benefit of others, that they may alter the dying process and that they may cause physical harm to the donor. The fear that providing this information will reduce the supply of organs is not based on any empirical evidence. In reality, the UK population is probably more willing to accept policy change, particularly which furthers the right to autonomy, than might be supposed by NHSBT. ⁵⁰

Informed trust would have a safeguarding role for the organ donation programme and could also potentially have a facilitating role for organ donation. The provision of accurate information and the active engagement of potential ODR registrants in decisions about their end-of-life care could, if handled well, make them more inclined to trust in the organ donation process. The knowledge that healthcare professionals are only going to treat registered organ donors at the end of their lives in the ways that they have agreed to could provide that sense of security in one’s expectations that often appears to be missing in relation to organ donation. The fear that one’s own interests will be subjugated to others in society could be replaced by confidence that one’s own active decision whether or not to undergo donor optimisation procedures will be upheld. The change in emphasis from the infliction of a non-consensual procedure to an altruistic decision to help others could improve trust in the organ donation process. This is needed to protect the organ donation programme from the harms generated by distrust and could also potentially increase the supply of organs to patients dying from organ failure. It is acknowledged that the impact on the supply of organs cannot be definitively determined in advance but this should not prevent NHSBT from implementing a system of specific advance consent to donor optimisation procedures. Autonomy is too important an ethical principle to disregard without even establishing whether an autonomy-based framework could succeed in securing the supply of organs for transplantation.