Presumed consent and organ donation

Introduction

The expression ‘presumed consent’ has become widely used in recent times as a result of the upsurge of interest in an ‘opt-out’ scheme for postmortem organ procurement. The aim of this paper will be to consider the possible role of this concept in the context of organ donation in particular but also to look at the idea of presumed consent itself: at what we might mean by it, what weight it might have as a component of a moral justification and whether it adds anything to our moral reasoning that is not already available to us in other more familiar terminology.

The background to the discussion will be the assumption that where we seek a moral justification for an intervention like organ retrieval there remains something morally distinctive and important in the idea of obtaining informed consent. It is a view that seems still to be widely shared, despite recent work aimed at moderating the claims made on its behalf. ¹ It would seem that, quite generally, the agreement to an intervention by the very people who will be undergoing it is a moral feature whose significance cannot be captured in any other way, since not only does it involve their judgement of their own best interests but also their judgement of the weight of these interests in an overall assessment of their concerns and preferences considered more broadly. They may, for example, consent partly out of a regard for the interests of others, and respecting the special significance of their own judgement in such matters seems to be in part constitutive of our sense of the value of other people as individuals. ² The significance of this is revealed in cases where we legitimately decide on behalf of those lacking the capacity to decide for themselves: it seems plainly appropriate to act on our judgement of their best interests but much more controversial to do so on a judgement of their supposed altruistic concern for others. ³ It is this combination of judging for oneself, together with the breadth of concerns that are legitimately included, that seems to make consent the moral feature that, where available, we look for above all others. ⁴

Presumed consent not a distinct kind of consent

Where presumed consent is concerned, we can begin by noting the risk of regarding it as a distinct kind of consent. There are at least three possible confusions that, even though superficial, can persistently encourage this misconception. The first, and most obvious, is where we simply take it to be another form in which consent may be given, as though we were adding a further option to those of explicit and tacit (or implied) consent. This seems to be wrong. After all, one can behave (by act or abstention) so as to give consent in either an explicit or a tacit way, but not so as to give it in a presumed way. The second confusion is that the use of ‘presumed’ may sound as though it describes the character of the consent in some way, rather as does the term ‘informed’. This too must be rejected, since while being more or less informed may characterize the basis on which we give consent, there is no equivalent in the case of being more or less presumed. No-one, that is, would ever say that ‘we need to obtain presumed consent’ in order to intervene.

The third confusion is rather different. It is that that ‘presumed consent’ might simply be used merely as an alternative term for tacit consent. This would, I suggest, be an unfortunate policy, not least because it is unnecessary, substituting an unclear and unfamiliar term for a reasonably clear and familiar one. If we therefore set aside this idea of merely using it as a synonym for tacit consent, we can instead investigate the idea of presumed consent as a presumption of some kind about consent. It is a presumption, that is, about acts or abstentions whose nature and moral significance are familiar to us, as opposed to being some novel form or characterization of the consenting behaviour itself. Our inquiry, then, concerns what this presumption might be and to what supposed moral effect it may be invoked.

Two circumstances of presumption

In pursuing the inquiry, we can make use of a broad distinction between two kinds of circumstance in which we might naturally refer to a presumption of consent. The first involves those cases where we have reason to believe consent to have occurred. The second is where we have no reason to believe that there has been either consent or refusal.

To outline the first category, where we believe consent to have occurred, let us suppose a situation in which consent is needed as part of the moral justification for a clinical intervention. There are then circumstances where we might speak of presuming someone's consent and mean merely that we have good reason to assume that consent had actually been given. We may have heard it given by the person concerned, been informed of it by someone else or read it in a document. Equally, of course, we may be mistaken, in that we may have misheard a remark, been misinformed by another or have read the document too hurriedly.

The most straightforward context for this kind of presumption is where it is believed that the usual procedures for explicit consent have been carried out. It could, though, also be made with respect to tacit consent. To take a familiar example, there are circumstances in which the non-verbal behaviour of patients in a clinical setting constitutes consent to the touching involved in a physical examination. In some cases of this kind it would seem to be possible for a clinician to speak of ‘presuming’ that this consent had occurred. Again, mistakes may be made, though in disputed cases slightly different concerns arise compared with explicit consent. In cases of tacit consent the question of whether the patients actually consented seems more likely to raise issues of what behaviour counts as consent, rather than it simply being an issue of whether an event with an agreed significance actually occurred or not.

It is also worth noting that we have here a further reason for rejecting the use of ‘presumed consent’ to mean ‘tacit consent’: that it would undermine this straightforward use of ‘presumed’ in the context of consent in general. In the case of either explicit or tacit consent we may on occasion presume that certain individual requirements for consent have been met (that the patient heard what was said, or understood the form), or indeed presume that consent has finally been given. It is conceptually and morally clearer if we retain a terminology that keeps the issue of what we might or might not have presumed about the process of consent in any particular case quite distinct from the question of what kind of consent is involved. Only then will there be clarity in contested cases when we report that we ‘presumed’ that consent had been given.

What we have so far, then, is presumed consent understood as an attitude towards a person who is believed to have given consent. The content of the attitude is, plainly enough, that they have done so. It is a usage which is most likely to be heard where the occurrence of consent (whether explicit or tacit) is contested. Understood as such its meaning is relatively unproblematic, even if the details of any particular case may be complex and hard to decide.

In contrast, we can now briefly outline the second general kind of circumstance, where presumed consent is understood as an attitude towards a person regarding whom we have no reason to believe either that consent has been given or that it has been refused. In this case the content of the attitude is a rather more complicated matter. In its generic form this ‘presumed consent’ is counterfactual, involving the presumption that such a person would consent were they to be asked. It is in the nature of such presumptions that they are open to many variations in specifying the circumstances of asking. It might be argued, for example, that they can be extended to cover cases of incapacity, to the effect that someone would give consent were they to be capable of doing so. We will return to some of the related conceptual and moral issues later; at this point we need only to note the general form of the presumption. We can now move on to the task of examining the concept of presumed consent in the context of opting-out of organ donation, doing so in terms of the two general kinds of circumstance that have just been outlined.

Opting-out and presuming consent to have occurred

The basic idea of an opting-out procedure for organ donation would involve informing people that their organs may be removed and used postmortem unless they explicitly state that this must not be done. Changing to such a procedure from one of opting-in is sometimes regarded as constituting a radical alteration in the relevant moral presuppositions. That is, it is taken to represent the assumption of a basic right to the postmortem use of organs, given that a positive objection must be lodged if this use is to be prevented. However, although there is a sense in which this is correct, accepting this assessment without question would take us too quickly over one of the most significant aspects of the debate, namely the proposal that opting-out may be regarded as involving a form of consent; or at least, to be more cautious, as meeting a form of consent-related condition. If we take this proposal seriously then the underlying intention is not merely to propose an assumption of a right of use in the absence of any objection, but rather to make the right conditional on a consent-related condition being met. Of course, the controversial aspect (and the one that does give a degree of support to the idea that a radical change in presuppositions would have occurred) is that the consent requirement will be understood already to have been met in some way, simply in virtue of people abstaining from opting out. Quite how it is supposed to have been met will depend upon our interpretation of presumed consent.

We can start with the first of the two general categories mentioned earlier, in which our interpretation of presumed consent amounts to the relatively simple supposition that consent has in fact occurred. On this basis we then have to consider the nature of the putative consent and also the manner in which its requirements might be fulfilled. As to its nature, given that we are dealing with an abstention (from the act of opting out) it seems clear that what we are presuming is the occurrence of a tacit rather than an explicit consent. Regarding this, one point has already been made: if in the end we take ourselves to be dealing with tacit consent, it is arguably preferable to call it by that familiar expression, and only refer to it as ‘presumed’ if there is some doubt as to whether this tacit consent has actually occurred. Nevertheless, since this is one way in which it may be understood, it is important to consider the likelihood of the conditions for tacit consent being met by the opt-out procedures.

Let us go back to the example of the physical examination of a patient and use it to consider the circumstances under which we normally accept the operation of tacit consent. In part these comprise a set of conditions that have to be in place. To list the main ones: the patient must understand what is happening, realize that consent is needed, understand that silent acquiescence will constitute consent, be aware of what actions would constitute refusal, and be able to perform these actions relatively easily and without undue fear of adverse consequences. Equally important, though, is the matter of establishing at the time that these requirements are met. This brings us to a particularly significant aspect of the example, which is that the clinician and patient are meeting face to face. It is important that the clinician is in a good position to check that the patient seems familiar with this kind of process, is not confused or unduly anxious, is able to ask questions, and is physically able to signal dissent if he or she so desires. Obviously it is not an infallible procedure; as mentioned earlier, it is clearly possible for someone to presume in good faith that consent had been given and to be wrong. Yet it is reliable enough for us to accept that this kind of case is typically constitutive of tacit consent. How, then, does this standard example compare with opting-out of organ donation?

Here, much will depend upon the practical details of the process of opting-out. For illustrative purposes we can consider some of the possible elements of the procedure. Most fundamentally, we can suppose that all those thought competent to make the decision would be sent information, including full details of such things as the usefulness of donation, the likely beneficiaries, the circumstances of the decision to remove organs and of the operation itself, and the role (if any) of the donor's surviving relatives. Added to this would be a statement to the effect that the absence of any response will be interpreted as consent to donation, and an account of the method of opting-out if desired. Under circumstances of this kind would it be reasonable to take silence as constituting tacit consent in any given case? It seems very doubtful. ⁵ We cannot rule out such events as non-delivery, the discarding of the letter unopened, a failure to understand the text, the forgetting to respond, or the non-delivery of a reply, each of which possibilities is sufficient to disqualify the supposed consent.

To some degree there are remedies for these problems. For example, the risk of non-delivery can be reduced, though not removed, by multiple mailings of the information. Rather than attempting to consider these exhaustively, though, there is a general point to be made: the more that we attempt to remedy the problems, the more we seem to weaken the rationale for accepting tacit consent as meeting the requirement for a consent-related condition. Suppose, for example, that we wish to ensure that the issue of donation has at least been given some minimal consideration by each recipient. To this end, suppose that it is made a legal requirement, whatever the decision, to return the relevant form, with a box either ticked for ‘opting-out’ or left empty to constitute tacit consent to organ retrieval. The question would then surely arise as to why we were not taking the opportunity to obtain explicit consent from those who wished to donate. True, the original motivation for establishing an opting-out rule might still be thought to apply even in this context. It might be thought, that is, that we will secure more organs if we make inaction regarding the box the condition for agreement rather than requiring a positive action. Nevertheless, if we focus on the issue of consent itself, there seems to be something perverse in favouring the tacit rather than the explicit version in these circumstances. In general, presumably, we prefer to have explicit consent where possible. The exception appears to be where (as in the clinical examination) we think that it would seem simply foolish to keep asking for consent in a situation where it can so easily be manifested in behaviour. Here, after all, the issue will often be one that is relatively straightforward, where the circumstances give good grounds for thinking that consent is highly likely to occur, and where the process is being continually monitored by professional observation. This situation is not replicated in the case of completing an organ donation form at home. Although showing consent by abstaining from ticking the box is physically easy, the issues relating to death and organ removal are not relatively straightforward, the circumstances are not such as to make it highly likely that the person will manifest consent, nor is there any professional monitoring of the process. Thus, if we are assuming that consent matters where donation is concerned, and we add the fact that it is just as easy to obtain explicit as tacit, we would seem to have strong moral grounds for seeking the explicit version.

This point has partly answered what is strictly a distinct issue. Even if we still wished to persist with the idea of seeking only tacit consent, the question will remain of whether opting-out can meet the conditions for its occurrence. In fact, even with the stringent (and unlikely) addition of enforced response, we are left with at least one significant problem unresolved: we still have no equivalent of the face-to-face meeting that seemed important in the example of the examination. We have no mechanism to allow questions to be answered and thus to constitute a satisfactory assurance that the information has been properly understood. Nor is the obvious remedy without problems. We could set up a system whereby the form would be completed in the local health centre, following any necessary discussion with staff, but in this environment the risk of the potential donor feeling under pressure to consent becomes an issue. It may be that the discussion and the recording of the decision need separating, such that we return to the situation of the form being completed at home. Whether this would then in all cases meet the requirements for tacit consent is perhaps an open question, though any doubts will add to the already strong case for seeking explicit consent instead.

Presuming consent counterfactually

We have considered whether failing to opt-out might be presumed to constitute actual consent, on the understanding that this could only be tacit consent. What, though, of the second of the two categories distinguished earlier, that of presumed consent as an attitude towards people where we have no reason to believe either that they have consented or refused consent? Is there a morally relevant ‘consent-related’ attitude which can legitimately be taken towards potential donors in such cases?

To begin, we can note that, in general, this kind of attitude does seem to be familiar to us in everyday life. For example, suppose a situation at work where B is away and out of contact and C inquires of their joint colleagues whether she could use B's office for a day. Of many possible answers, one might well be: ‘Go ahead; I'm sure B would say yes if we could ask him’. It is a response that at least appears to draw justification for an action from presuming that consent would be given were B counterfactually in a position to give judgement on the situation for himself. So, given that this kind of attitude is familiar, the important issues are the basis for the counterfactual claim, and the difference, if any, made by the reference to consent.

What kind of assurance might C take from the response? If given seriously, she could reasonably be assured that this endorsement had not only taken account of the ordinary, predictable office-related interests of someone doing B's kind of work, but also of any personal preferences and foibles that might make B idiosyncratically concerned about others using his office. Clearly, mistakes may be made, but in at least some circumstances this seems to be an accepted justification on which to base a recommendation. However, the relative triviality of the issue, the context of a familiar role of office user, and the reliance on close acquaintance with B are all important elements here, and they are not replicated in the case of presumed consent to organ donation. It is not, I think, a presumption that could legitimately be made about citizens collectively by a body such as the National Health Service in order to justify organ retrieval. In fact, on such a serious and personal issue even friends and family, assessing someone they knew intimately, might not always be confident of having sufficient personal information.

However, even if we rejected it as the basis of a general policy on organ donation, a further issue remains: might this interpretation of presumed consent nevertheless have some legitimate place in health care, perhaps as an attitude towards particular people, held by family or friends who know them well? I think there are reasons for rejecting even this view. Remaining with the office example a little longer, we can note another possible response to the same general effect of supporting the request. Someone might make no direct reference to consent but instead simply say: ‘Go ahead; I cannot think of any reason why B would mind.’ In context, this too seems to convey an assurance that, as far as possible, personal preferences and foibles have been taken into account as well as the more predictable interests of office users in general. Yet it would not be particularly puzzling if, having sincerely asserted this, the speaker declined to commit himself to the assertion that B would consent were it possible to ask him. In fact, stopping short of this assertion would be entirely understandable as a sign of the recognition that consent has an element not just of the unpredictable but of the personal, such that we should not presume to prejudge its being given. The problem, that is, is not simply one of the uncertainty regarding consent, since there is bound to be some uncertainty regarding all the deliberations about B in his absence. It is that, as mentioned at the outset, consent is a different kind of moral feature, not replicated by other considerations. Under the circumstances, the only information that colleagues can have about B is that which would seem to be properly represented by the more limited proposal: that they can think of no reason why B would mind. In such a context ‘I'm sure he would consent’ may have extra rhetorical force, but strictly it is unwarranted and misleading.

Is there, though, any other kind of information that might be thought to make a crucial difference? One situation common in health care is that of patients who lack competence, and involves the belief that an intervention would be in their best interests. Another (particularly relevant to postmortem donation) might be the evidence-based belief that someone had a preference for being of use to others after their death, and thus perhaps a preference for being an organ donor. While the first would raise conceptual as well as moral issues, either of these might nevertheless be thought to provide not merely further evidence of people lacking reasons for objecting but also evidence that they would consent were this possible. However, although this arguably gives us a stronger justification for an intervention, we need to be clear about its source. Even if we appear to draw justification from presuming that consent would be given, arguably this is actually not so. In fact, it would seem that what justification we have strictly has nothing to do with a supposed counterfactual consent but comes solely from the grounds that, in our judgement, support the intervention. Thus, suppose that we were wondering whether to proceed in certain cases where explicit consent from the patients was unobtainable. In deciding we would naturally refer to all those grounds that we would use if we had to judge counterfactually whether they would consent; that is, to such matters as the subjects’ likely interests and preferences. ⁶ Given that, the supposition that they would (or would not) consent seems to add nothing to our case. The grounds we have may or may not be sufficient justification for proceeding, but presuming consent is actually irrelevant to the decision as well as doubtfully warranted.

There is one further consent-related concept that has been discussed in the context of presumed consent. It embodies a quite different kind of presumption, but one which I think is susceptible to broadly the same response as has just been outlined. It is the concept of ‘normative consent’, which advocates treating people as if they have consented on the grounds that they ought to consent. ⁷ In practice it is likely to fall within our second general category, that which comprises cases where we have no reason to believe that people have either consented or that they have refused to do so, rather than the category of cases where we believe consent to have occurred. Strictly, though, it would seem to transcend this distinction. Given that it would hold regardless of whether we thought they would consent or not, it is not, even counterfactually, a presumption about consent. It is instead a claim to the effect that there are overriding moral reasons for consent and that, given such reasons, others are permitted to treat them in those ways normally conditional upon consent being given. Once again, then, we might argue that, successfully or not, it is these reasons that do the moral work, and the required judgement on our part is that of whether these reasons really do exclude or outweigh any opposing moral reasons that favour a requirement for actual consent. ⁸

Conclusion

If we are thinking in terms of consent having occurred, then it seems that the only sense of presumed consent that would relate at all specifically to organ donation would be one synonymous with tacit consent. It was suggested, though, that a move to this terminology would be unwise and that the prospects for meeting the conditions through opting-out would be poor. Similarly, where our context is counterfactual consent, it was suggested that the idea of presumed consent turns out to be unnecessary and misleading. Where such cases involve nothing but a burden, it was argued that any evidence we have about the subject's interests and preferences may adequately and appropriately be reflected in a judgement of the form ‘I do not think he/she would mind’, expressing not a belief that consent would be given but only a denial of any knowledge of reasons for this not being so. We then considered cases involving the best interests of the subject, or his/her preference to be of assistance to others. Here there still seems to be no need to appeal to some notion of counterfactual consent to capture the nature or strength of the evidence available for our judgements regarding the legitimacy of an intervention. The appropriate issue is whether we should act to promote these interests or preferences in the absence of the subject's consent. Furthermore, there are two reasons why appealing to counterfactual consent in these cases would risk being misleading. Firstly, it would fail to reflect as clearly as it should that our customary notion of (actual) consent is one that crucially embodies the personal decision of the subject. Secondly, it may mistakenly be taken as suggesting that the presumption of consent is itself a distinctive element of our justification, rather than merely something we might contentiously conclude on the basis of what actually must do the moral work: the evidence available to us of someone's interests and preferences.

Conflicts of interest: None.

Declaration: This paper has not been nor will be published elsewhere.