Article Text
Abstract
Although advance directives have become a familiar instrument within the context of treatment, there has been minimal support for their expansion into the context of research. In this paper I argue that the principle of precedent autonomy that grants a competent person the right to refuse life-sustaining treatment when later incompetent, also grants a competent person the right to consent to research that is greater than minimal risk. An examination of the principle of precedent autonomy reveals that a future-binding research decision is within the scope of a competent person's critical interests, if the decision is consistent with what the person believes gives her life intrinsic value.
- Autonomy
- Clinical Trials
- Research Ethics
- Research on Special Populations
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Introduction
According to figures published by the Alzheimer's Association, 5.2 million people in the USA had Alzheimer's disease in 2013 and it is estimated that 13.8 people will have the disease by 2050. In 2013 the aggregate cost of care was US$203 billion and this number is predicted to rise to US$1.2 trillion in 2050.1 There were an estimated 44.4 million people worldwide with the disease in 2013, a number that is expected to rise to 135.5 million in 2050.2 The total worldwide cost of dementia was US$604 billion. As the report states, ‘if dementia were a country it would be the world's largest economy, ranking between Turkey and Indonesia’.
At present there are medications (cholinesterase inhibitors and memantine) to treat the cognitive symptoms of Alzheimer's disease, for example confusion and memory loss; however, these medications tend to be efficacious only in the early stages of the disease and delay the progression of the disease for approximately 12 months. A number of clinical trials are ongoing and it is possible that new treatments will be developed that will have a significant impact on the course of the disease, for example, those involving deep brain stimulation, neural stem cells, or the injection of neurotrophin growth factor into the brain. Research into the development of new treatments has focused on the early to moderate stage of the disease and has generally been of minimal risk. At this stage of the disease, the research participant may still have the capacity to assent or consent to participate in the clinical trial, and to make his or her wishes known to caregivers. And since the research is of minimal risk, the participant is not exposed to undue harm. It is plausible to contend, however, that in the future potential treatments will be developed that require the participation of those with moderate to severe Alzheimer's. Furthermore, it is possible that some of these potential treatments will expose the participant to more than minimal risk. In this paper I wish to consider whether it would be ethical to conduct such research if the person had consented to participate prior to the loss of decision-making capacity. The position that I defend in the paper is that if we are prepared to accept advance directives in the context of treatment, then we should also accept them in the context of research. More specifically, I argue that the principle of precedent autonomy that grants a competent person the right to refuse life-sustaining treatment when later incompetent, also grants a competent person the right to consent to research that is greater than minimal risk when later incompetent.
The scope of critical interests
A review of the regulations governing human subjects research in the USA,3 the UK4 and Canada reveals that only the Canadian regulations make explicit mention of advance directives for research.5 (The Mental Capacity Act, 2005, which applies to England and Wales only, permits an individual to prospectively refuse to participate in research.6 The regulations governing clinical trials in the UK permit advance consent to be given, although the scope of the advance consent is unclear.7 For further information regarding the role of advance directives in EU law, see Lötjönen.8) There has been considerable discussion about the role of assent and consent in research involving incapacitated individuals, although little call for the expansion of research advance directives.9–12 Within the context of treatment, however, advance directives have become a familiar, if controversial, instrument in the USA to enable currently competent individuals to make treatment decisions for a later time once competence has been lost. The legitimacy of this approach is based on the understanding that whereas the previous decision is reflective of the person's core or ‘critical’ interests and hence part of their autonomy, the later experiences and desires of the incompetent individual are not accurate reflections of these core interests, and, hence, should be accorded less weight. Over the years there has been considerable debate about the merit of these claims and, more broadly, the coherence of the very notion of precedent autonomy. Critics of this notion have argued that the loss of competence entails that the relevance and value of the core interests are substantially diminished, and accordingly our obligation is to respect the interests of the later incompetent individual.13 ,14
The main position of this paper is that the arguments presented in support of advance directives within the context of treatment apply also within the context of research. In defending this position, I will assume, for the sake of argument, that a currently competent person does have an autonomous right to make treatment decisions for a later time once competence has been lost, and hence that advance directives are an appropriate instrument for treatment decisions. Accordingly, I will have little to say in what follows about the arguments denying that a currently competent person has that right, apart from the following. One objection that has been traditionally raised against advance directives is that the future is too epistemically opaque for a future-binding decision to be a rational one to make. One might question the validity of a decision that was made 10 years ago to forego life-sustaining treatment on the grounds that the person could not have known what the future would be like—the person may now have a different set of beliefs and values, new treatments may have been discovered. As Berghmans15 has argued, we can raise similar epistemic worries with regard to advance directives for research, and ask whether the antecedent consent can ever be sufficiently informed. To answer this question, we need to compare the treatment and research contexts and consider whether the latter is any less transparent than the former. Here we might consider the theory and practice of informed consent in these contexts and, particularly, the guidelines and regulations that serve to make this consent voluntary and informed. I think it is plausible to claim that consideration of the above suggests that the research context is no more opaque than the treatment one. It is true that by its very nature research is inquisitive and that neither researcher nor participant can know for sure what the research will show or fully anticipate what might occur; but one can equally claim that the patient and the physician do not know what a future with dementia will be like or whether future treatments will be discovered. Accordingly, if one is prepared to grant that the treatment context is sufficiently transparent to enable a voluntary and informed decision to be made, then a similar conclusion should be drawn regarding the research context.
Ronald Dworkin16 has presented what is arguably the most influential defence of what is termed ‘precedent autonomy’—the right of a competent individual to make decisions for a later time once competence has been lost. According to Dworkin, the value of autonomy derives from its relation to integrity, that is to say, to its capacity to allow a person to express her own character, and to live her life according to her own commitments, convictions and values. With regard to a person's subjective interests there are, says Dworkin (p. 210),1,6 “two kinds of reason people have for wanting their lives to go one way rather an another”. The first of these is the person's ‘experiential’ interests. These are the experiences that help make life worth living and that give it its colour, and they can range from the base and decadent to the lofty and profound. For example, a person might enjoy playing rugby or dining at fine restaurants, or hiking, swimming or making clay animals. Importantly, experiential interests have a distinctive temporal feature: a person has an interest in fulfilling an experiential interest only if at the time of undertaking the relevant action she still believes the experience to be desirable. Thus it is correct to say that Sally has an interest in going for a hike this afternoon only if at that time she still has the desire to do so. (It might still be true to say that she has an interest in hiking on the grounds that exercise is beneficial, but this would not amount to an experiential interest.)
The second type of reason a person has for wanting life to go a certain way pertains to the person's ‘critical’ interests. These interests are defined by Dworkin as “critical judgments rather than experiential preferences” and are judgments that a person makes about the narrative and character of their life. As Nelson1,7 has described, they are inherently normative. A person's critical interests establish the framework and goals for the type of life that the person wishes to live, to identify the standards according to which he or she would understand his life to have been successful. Critical interests, therefore, are those interests that the person thinks that she should have, the interests that dictate how a person thinks that she ought to lead her life, interests that define the person's character.
In contrast to experiential interests, critical interests do not require concurrent desires: there may be elements that are part of a person's critical interests even though she does not currently find these elements desirable. For example, we can imagine a person who wishes to lead an ascetic life and dedicates his life to doing so. It is plausible to contend that at various times he finds such a life to be arduous and miserable; nevertheless, his critical interest remains intact for the decision to lead such a life remains consistent with his character and the narrative of his life even though his current desires are not consistent with that decision. Critical interests are appropriately thought, therefore, not to depend upon the person's contemporaneous experiential desires, for their normative component is based on the person's beliefs and convictions—the self-narrative—rather than on experiential interests. Critical interests thus retain their authority even if they run counter to a person's experiential interests, for, in considerable part, this is precisely their function. This is not to suggest that experiential interests should always be subordinated to critical interests, for as Dworkin (p. 229)1,6 grants, there may be ‘good reasons’ for respecting the wishes of the now incompetent patient; rather the point is that the authority and legitimacy of critical interests are not negated by contradictory experiential interests. Accordingly, to respect the wishes of the now incompetent patient is to over-ride a legitimate exercise of the individual's autonomy. We may feel that the probability of great harm that might befall the incompetent individual if the previous decision is upheld provides good reason to over-ride the decision; however, given the importance that we grant to autonomy in our normative systems, one can suppose that for Dworkin at least, the reasons would have to be especially good to justify doing so.
On the basis of Dworkin's account of precedent autonomy, we have a clear idea of the appropriate course of action to take in the following case:Mary Smith is a 78-year-old woman who is currently a patient in University Hospital. Prior to her retirement 13 years ago, Mary was a professor of history at the university. A remarkably intellectually agile person, Mary loved her work and the academic life. She dreaded the thought that one day she might become ‘befuddled’ and the thought of developing dementia terrified her. She informed all of her family, friends and colleagues that she had written an advance directive requesting that all life-sustaining treatment should be withheld if she should become incompetent. Mary now suffers from moderate to severe dementia. She barely recognizes her family and friends although she enjoys their visits. She smiles when she watches television and likes sitting in the sun when the weather is fine. Overall she appears content. Mary has recently developed pneumonia and the clinical staff are considering whether to treat her with antibiotics.
Since Mary's earlier decision to forego life-sustaining treatment represents an autonomous critical interest that takes precedence over the later experiential interest, we should respect Mary's advance directive and withhold the antibiotics.
Advance directives in research
Let us now return to the main topic of the present paper and consider whether Dworkin's analysis can be applied to the research context. Consider the following case that parallels the one above:William Green is a 75-year-old man who suffers from mild-to-moderate dementia. Prior to his retirement 13 years ago, William was a professor of history. A remarkably intellectually agile person, William loved his work and the academic life and the thought of developing dementia greatly alarmed him. When he was first diagnosed with Alzheimer's and the disease was in its early stage, William and his wife, Rosa, talked about the disease and their future. William said on many occasions that he was committed to helping find a cure for the disease, and that he wanted to participate in any research program, even those that might involve significant risk and offer no direct benefit to himself.
A year ago William and Rosa's physician, Dr. Smith, contacted them to tell them about a phase II clinical trial that was recruiting subjects suffering from moderate dementia. The clinical trial is investigating whether the progression of Alzheimer's can be delayed or even reversed by the injection of a drug that appears to repair damage caused by neurofibrillary tangles. According to the research protocol, participants will be divided into two main cohorts: one half will receive the new drug injected into the brain every 6 months for 2 years; the other half will receive a placebo. At the end of the trial those who receive the placebo will receive the new drug if it has been shown to be safe and efficacious. During the conversation with Dr. Smith, William listened carefully and appeared to understand what was being discussed. He told Dr. Smith that he and Rosa had talked this over and that he was happy for Rosa to make this and future decisions about his participation in the clinical trial. Rosa enrolled William in the trial.
During the past year William's condition has deteriorated markedly. He no longer recalls previous discussion of the research or understands what he is being asked to do. Rosa knows well that William would have very much wanted to continue with the trial, but is it fair to make him do so?
In order to answer the above question, we need to determine whether William's earlier decision to participate in the clinical trial is a legitimate exercise of his precedent autonomy, and to make that determination we need to see whether his decision falls within the scope of his critical interests. If it does, then, other things being equal, the decision should be respected. To recall, Mary's decision is thought to fall within the scope of her critical interests because it is a critical judgment upon what she believes makes her life valuable, a judgment that is formed by her interests, values and goals. The decision is intertwined with her autonomy, integrity and her self-narrative and represents a critical, normative judgment about how Mary believes her life should go. Can William's decision be legitimately described in the same way? At first glance it would seem that William's decision does fall within the scope of his critical interests: he made that decision after careful reflection about what he believes gives his life value and the decision is consistent with his interests, values and goals. Like Mary, William cherished the intellectual life and one may suppose he would regard its loss as bitterly as would Mary; but his love of that life was also a core reason why he wished to participate in research in order to benefit others.18
Nevertheless, there appear to be three significant differences between the two cases, and these differences might lead us to reconsider the above tentative conclusion. First, whereas Mary's decision to forego treatment can be understood as a judgment about the value of living a particular life, William's decision to participate in research relates to how one person might benefit others. Second, the right of non-interference that underlies Mary's decision to forego treatment does not seem directly relevant to William's request to participate in a project that requires the assistance of others. Third, Mary's decision can be seen as falling under the principle of autonomy, whereas William's decision is best understood as an example of beneficence.
The value of continued existence
According to the above description of the two cases, Mary and William have similar self-narratives and values. They both value the intellectual life and it is reasonable to suppose that both of them would regard the forthcoming dementia as the progressive destruction of what gives life much of its value. We can distinguish between two ways in which a person might judge his or her life to have value. First, a person might view her life as having intrinsic value if that life is valuable to her—if she takes pleasure in leading that life and she finds that life fulfilling; second, a life can be viewed as instrumentally valuable if that life brings benefit or happiness to others. Most of us aspire to a life that is valuable in both senses, however it is important to note that a life can be instrumentally valuable without being intrinsically so—a person's life might bring benefit and happiness to others but not to herself—and more obviously, a life can be intrinsically valuable and have minimal instrumental value. A further important point is that the instrumental value of a life may be an important element in what gives life its intrinsic value. For example, an altruistic person would find life to be enjoyable and fulfilling precisely because she can be of benefit to others.
On the basis of the above distinction, it is plausible to contend that Mary believed that the future life of the demented individual lacked intrinsic value for it was missing the very elements that were essential to her for making life enjoyable and fulfilling. We do not know whether Mary believed that the future life had any instrumental value, but in any case, whatever instrumental value it might have had was insufficient to trump the lack of intrinsic value. Accordingly, the decision to respect Mary's directive may be heavily influenced by the thought that to over-ride the directive is to condemn her to a life that she thought had no value and expressly sought to avoid.
If we now turn to William's case, the distinction between intrinsic and instrumental value allows us to describe his decision in two ways. First, we can say that he regarded his future life as having intrinsic value. By this we mean that, unlike Mary, he saw the future life of progressive dementia and the opportunity to participate in research as, in some important sense, fulfilling. This would be the case if he believed the future life to still possess some elements that make life valuable and worth living for him. It might seem implausible to contend that he would find the future life of dementia to be fulfilling, but this would be a plausible description if William believed his ongoing participation in the clinical trial to be very important. This might be the case, for example, if William had always been a very altruistic person and had repeatedly expressed his desire to help those suffering from dementia, and since the initial Alzheimer's diagnosis he had worked tirelessly to help others with the disease.19 On this evidence there is reason to think that William would see his future life as being of value to others and, hence, of value to himself since he is an altruistic person; in other words, William would regard his future life as having intrinsic value. Accordingly, to over-ride William's directive and to prevent him from participating in the research is to deny him the opportunity to continue to lead a life that he expressly sought to pursue, or, to put the matter in negative terms, it is to make him lead a life he expressly sought to avoid, namely one in which he is of no benefit to others. If this is correct then it is plausible to contend that William's decision to participate in the research is consistent with his critical judgment about what makes life valuable, a judgment that is formed by his interests, values and goals. It is a decision about how William believes his life should go.
It might be objected that what gives Mary's decision its force is the element of self-preservation: we might suppose that her decision is governed by her belief that dementia will rob her of her mind and hence of her very identity—Mary does not want to go on living as a mere shadow of her former self and we think that it is prima facie wrong to make her do so. William's decision, however, is not about self-preservation: it might be the case that he sees the future life as valuable and consistent with his critical interests, but in the absence of future research participation or some other altruistic actions he would no more wish to lead a future life of progressive dementia than Mary would. In response one can agree that the two cases are different in the way described, but ask why this difference should invalidate William's decision as a judgment about how he would wish his life to go. William's decision to participate in the research may well be counterfactual, that is to say, if this opportunity to participate in research did not exist he might, like Mary, believe that future life has little value; however, since he can participate in the research, his future life does have value and his decision is consistent with his critical interests.
A further objection is that in order for William to believe that the future life has intrinsic value, he must find that life to be fulfilling, but it is difficult to imagine that William, or anyone for that matter, could find a future of progressive dementia to be rewarding or enjoyable. In response one can recall Dworkin's distinction between critical and experiential interests and the claim that critical interests do not require concurrent desires. In order for William's decision to be within the scope of his critical interests and, therefore, for his life to have intrinsic value, it is not necessary that at the later time William finds his life to be pleasurable or that at the later time he has the relevant concurrent desire. What is required is that the decision is consistent with the person's critical judgment about what gives life value, and there seems to be no in-principle reason why a person could not regard the benefit of others to be what gives life value.
The second way that we can describe William's decision is to say that he regarded the future life as lacking intrinsic value but possessing only instrumental value. More fully, we would understand him to believe that progressive dementia would rob him of the elements that are intrinsically valuable and essential to him but, nevertheless, he wishes to participate in the research so as to be of benefit to others. He does not, therefore, believe the future life to be fulfilling or enjoyable for him even though it may be for others. Like Mary, William regards the future life as lacking the elements that give life intrinsic value; unlike Mary, he wishes the life to continue in order to benefit others.
In this case, William's decision to participate in research appears to be somewhat troubling, for it would seem to expand the concept of precedent autonomy to a controversial degree. According to this concept we think that Mary has the right to decide to forego treatment because her autonomy grants her the authority to decide how her life should go, to decide what gives her life its intrinsic value. And if the analysis above is correct, autonomy also grants William the right to decide to participate in future research if that decision is consistent with his determination of life's intrinsic value. In the last case, however, we have a person who has determined that no intrinsic value exists in continued existence but who wishes to volunteer to participate in future research. If such a decision is within the scope of precedent autonomy, then it is difficult to see what decisions would be excluded from this concept, for the concept would appear to grant a competent person the right to ‘dispose’ of his later self in the way that a person can decide to donate his body to medical science after death. Accordingly, we might limit the scope of precedent autonomy by excluding future-binding decisions in which the person believes that the future life has no intrinsic value.
Positive and negative rights
The second difference between the cases of Mary and William pertains to the type of right that each of them can be understood to be asserting. According to an orthodox analysis, Mary's decision to forego life-sustaining treatment can be understood as the assertion of a negative right of non-interference. The right of a competent individual to refuse treatment, even life-saving treatment, is regarded as a fundamental value and the right can be over-ridden only in exceptional cases, for example, where there are legal or public health concerns. We can see Mary's decision to follow directly from our respect for her autonomy, specifically her autonomous right to restrict interventions by others into her physical body, and to choose what she perceives to be in her best interests.
The decision by William to participate in research is not so readily understood as a negative right. (Some would see it as a duty.20) For William is seeking to participate—his desire is for physical intervention—rather than to prevent intervention. Accordingly, he is asking others to help him participate in research rather than to refrain from interfering with his intended course of action. For the most part, our obligations to help promote the interests of others are less demanding than our obligations to refrain from interfering with those interests, for our right to demand the assistance of others is limited by the extent to which the interests of the other person are compromised. If we think that the right to assistance readily follows from a person's critical interests, then Mary would be justified in demanding that others actively assist her in her death; the controversy of such a claim, however, suggests that this right to assistance does not so clearly follow.
To further understand the nature of the right asserted by William, one can compare his decision with two other instances where analogous rights are asserted: the right to participate in research and the right to donate an organ. With regard to the first of these rights, perhaps we should understand William to be asserting an equality right, namely the right to participate in (ie, not to be excluded from) research. Accordingly, to exclude William from participating would run counter to the principle of justice. The trouble with this response is that it somewhat begs the question, for the issue at hand is precisely whether William does have a legitimate claim to participate in research. It may be entirely appropriate to exclude him and other similarly situated persons from participating in research, for the question is whether a previously competent person does have the right to make future-binding research decisions. If we turn to the matter of organ donation, a similar analysis can be presented. For even if we conclude that a competent person has the right to donate organs and, therefore, a limited obligation is placed on others to assist in the donation, it is an open question whether that person has the right to donate organs at a later time when he or she has become incompetent.21
The difference between negative and positive rights and the two cases may lead us to conclude that the treatment and research contexts are significantly different with regard to the rights of the person and the obligations of others. If so, this could lead us to conclude that precedent autonomy is limited to the treatment context. However, it is important to point out that the fundamental question is not whether others are obliged to assist William in his request to participate in research, but whether the scope of a person's critical interests is limited to actions performed by the person and restrictions on the actions of others. To return to our earlier discussion of Mary, the conclusion drawn was that Mary's decision to forego treatment was within the scope of her critical interests because it reflected a considered, critical judgment about the value of her life and how she wants her life to go. Clearly, more can be included within the scope of how a person wants her life to go than merely restrictions on the actions of others, for it can also include actions performed by the person herself and by others. For example, we can imagine a global development worker who has focused her life and career on working with communities in the developing world on educational projects. In this example, the person's critical judgment on how life should go involves and requires the assistance of others in order to achieve his or her goals.
If this is correct, then there would appear to be no clear reason why the fact that William's decision to participate in research requires the assistance of others entails that the decision is beyond the scope of his critical interests. We might conclude that the obligation on others to assist William is limited, as we customarily do with such obligations, but this conclusion does not entail the denial of the claim that his decision is within the scope of his critical interests. We may not be obliged to help the development worker direct projects to improve education in developing countries, but this does not mean that she would not regard her failure to do so as constituting a significant failure in her life.
Altruism and beneficence
From the perspective of the currently competent person, a future in which dementia has destroyed the fabric and character of life is one in which continued life has little value or quality, and one in which the person may see herself as absent. We may suppose that one of the main reasons for why a person decides to forego life-sustaining treatment is precisely because he or she regards the future life to lack quality. If we consider why a person might decide to participate in research, we can see that self-interest can play an important role. A person might decide to participate in a clinical trial, for example, because he believes that this offers the best chance of receiving the latest, and, hopefully, best therapy; or, perhaps, participating in research provides the person with the only chance to receive an experimental and potentially significant new treatment. Nevertheless, the necessarily experimental nature of research, and the distinction between treatment and research, means that we should view the goal of therapeutic benefit in a cautious way. For in the clinical case at least, the principle of clinical equipoise dictates that the research context is epistemically opaque, that is to say, the participant cannot know in advance that participation will be beneficial (for if he could, then the necessity of the research would seem to be questionable). Furthermore, in some cases, for example, dementia research, research might be at a sufficiently early stage that expected therapeutic benefits, if any, are a long way off. For these reasons, it seems that altruism and beneficence, rather than self-interest, serve as a better explanation for why a person might decide to participate in future research.
This difference between self-interest and altruism provides us with a second potential reason to differentiate the treatment and research contexts. Advance consent in the treatment context is based on a person's first-person concerns including her own welfare, the autonomy of her physical body, and the type of life she believes it is valuable to lead. The concerns are foundational in that we think of them as part-and-parcel of what it means to be a rational person and our prima facie obligation to respect these self-interested desires is a core part of our commonsense moral framework. In contrast, advance consent in the research context is based in considerable part on a person's concern for the welfare of others, for example, future sufferers of the disease. This type of altruistic, beneficent desire has a different place in our moral framework: we generally regard such desires as praiseworthy and supererogatory, rather than as essential elements of what it means to be a rational person. Moreover, our obligation to respect a person's third-person concern is much weaker than the obligation to respect the person's first-person concern, particularly if we believe that the person is not acting in his or her own self-interest. We applaud people who are altruistic, but we do not generally expect or require people to be so, and our obligations to help another person to be altruistic are limited: out of respect for your autonomy I should not interfere with your desire to give all of your worldly goods to charity, but I have no obligation to help you do so.
This supposed difference between the treatment and research contexts is complicated, however, by consideration of the fact that altruism and beneficence can play a part in a person's decision to forego life-sustaining treatment, for example, to spare family and loved ones from the financial and emotional hardship of having to care for the person. A person may also believe that she has had a ‘good innings’ and would prefer that time and money be better spent providing treatment for others.
The fact that the decision is based in considerable part of the person's concern for the welfare of others, rather than her own welfare, does not thereby invalidate it. Although we might disagree with the person's decision to forego treatment for the benefit of others, and believe in good faith that it is not in her best interests, this does not provide us with sufficient reason to over-ride the decision. An appropriate strategy would be to determine whether the decision is consistent with the person's interests and values and judgment of what gives life value. If we conclude that it is appropriate for a person to decide to forego treatment for altruistic reasons, then it seems difficult to exclude this as a reason for research participation. In both cases we can understand the individual's previous decision in terms of his or her ideas and values as to what makes life important, specifically the importance of sacrificing one's own interests in order to benefit others.
Degree of risk
If the arguments above have been successful, then we have shown that a decision to participate in future research is within the scope of a person's critical interests and hence consistent with precedent autonomy. Our task now is to determine whether it is legitimate to limit participation to research that is no greater than minimal risk. One of the ways in which research regulations attempt to protect the interests of individuals lacking decision-making capacity is to limit the degree of risk to which the participant can be exposed. Perhaps the appropriate strategy is to restrict the use of advance consent for research to only those cases where the proposed research is no greater than minimal risk. This strategy would certainly protect the experiential interests of the later incompetent individual, and hence the individual from harm, but this strategy will be unappealing for a supporter of advance consent. For exactly the same considerations are present in the context of treatment and are thought to be subordinate to the critical interests of the previously competent person.
According to a supporter of precedent autonomy, a previously competent person can decide to forego life-sustaining treatment at a future time when competence has been lost, and this decision over-rides the competing interests and values of the later incompetent individual. The position advocated is to give priority to Mary's enduring critical interests over her current and future experiential interests and desires, or to put the matter in a rather stark and provocative way, precedent autonomy endorses the position that it is better that the life of a demented but happy individual be ended rather than that the interests of a previously competent person be disregarded.
There is good reason, therefore, to think that an advocate of precedent autonomy would endorse the position that a previously competent person should be able to give her advance consent to future research that is greater than minimal risk, even significantly so. For it is difficult to see the difference between the treatment and research cases. If we believe that it is appropriate to subordinate the welfare and experiential interests of the later incompetent individual to the critical interests and autonomy of the previously competent person in the context of treatment, then on what grounds could one believe that it is inappropriate to do so in the context of research? Imagine, for example, that Mary is a Christian Scientist who has requested that she receive no pain medications should she become incompetent. It seems that if we are prepared to support the view that Mary's request should be respected, then this is to say that we believe that it is morally appropriate to sacrifice a life or to permit an incompetent person to suffer considerable pain rather than to over-ride the previously competent person's wishes. Let us suppose that the research to which William has consented to be of moderate risk, and let's add the plausible claim that the incompetent William will find participation to be distressing. In such a case it is difficult to see on what grounds a supporter of advance consent would decide to over-ride his previous wishes, for the potential harm and suffering of William is no greater than that of Mary. Of course, one might argue that the treatment and research contexts are fundamentally different, or that advance consent for research falls outside the scope of critical interests since research participation is of instrumental rather than intrinsic value; I hope, however, that the arguments of the previous sections have provided good reason to think that this is not the case.
Conclusion
It is important to point that the arguments presented in support of advance consent to research are not intended to show that a person's decision should always be respected. In this regard, research advance directives parallel those in the treatment context. As previously mentioned, Dworkin himself grants that there may be in some cases ‘good reasons’ to respect the wishes of the later incompetent individual. Within the research context, we may have reason to believe at the present time that the participant's antecedent consent was insufficiently informed or voluntary—that there are material aspects of the research that were unknown to the participant at the time consent was granted, and that caregivers or proxies now believe would have made the participant decide not to participate. Additionally, new information about the research may lead caregivers to re-evaluate the previous decision in light of the trial's progress. For example, early data from the research may suggest that the new drug is performing less well than the placebo or perhaps even causing severe discomfort and potential long-term harm to subjects. The responsibilities of caregivers and proxies, and our obligation to protect the interests of vulnerable subjects, dictate that the subject's previous decision to participate not be regarded as foreclosing further ethical debate; rather the essential point is that this decision should be regarded as a legitimate exercise of autonomy, and hence should be granted appropriate importance in the ethical debate.
In this paper I have attempted to show that an influential set of arguments in support of advance directives in the context of treatment apply equally well in the context of research. Accordingly, precedent autonomy grants a competent person the right to consent to participate in research that will continue after competence has been lost and, furthermore, this research can involve greater than minimal risk. For some this conclusion will seem intuitively troubling, even those who are generally in favour of advance directives for treatment, and I think that what troubles us is that it is one thing to ‘sacrifice’ the interests of the later incompetent individual for the interests of the previously competent person, and quite another to sacrifice them for the benefit of others. Nevertheless, I believe that the argument in this paper, if successful, shows that precedent autonomy grants the competent person the right to choose to benefit others in this way.
Footnotes
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
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- Limits of advance directives in decision-making around food and nutrition in patients with dementia
- Precedent autonomy should be respected in life-sustaining treatment decisions
- Should we respect precedent autonomy in life-sustaining treatment decisions?
- Dementia research and advance consent: it is not about critical interests
- Advance directives for oral feeding in dementia: a response to Shelton and Geppert
- Socially and temporally extended end-of-life decision-making process for dementia patients
- Ethics of care challenge to advance directives for dementia patients
- Advance euthanasia directives and the Dutch prosecution
- Best interests and the sanctity of life after W v M