7
Presumed Consent

In the United States, deceased organ donation occurs only with express consent1 (often in response to an inquiry or request). This consent may be given in advance by the individual while he or she is still alive, or it may be given by the next of kin after the death of the individual. The state laws that govern organ donation thus require opting in (or contracting in). The default option, in the absence of express consent, is nondonation. Proposals to increase the availability of transplantable organs often recommend a policy of opting out (or contracting out). Under such a policy, organs from deceased individuals could be removed for transplantation unless the decedents—or their families, after their deaths—had followed the prescribed measures for opting out. The default option, in the absence of express objection, would become donation.

Not all opt-out policies are the same, and different issues arise in the analysis and assessment of different policies, particularly presumed consent and routine removal.2 Presumed-consent and routine-removal policies are commonly confused or deliberately conflated. Even though both involve opting out, their differences are significant, and any adequate analysis and

1

The term “express consent” is used to indicate explicit agreement, generally documented in writing.

2

“Presumed consent” or “presumed donation” is shorthand for “presumed consent to donation.” All of these terms are used in the discussion in this chapter. “Routine removal” is also called “routine salvaging” or, even more problematically, “routine harvesting.” Only the term “routine removal” is used in the discussion in this chapter.



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Organ Donation: Opportunities for Action 7 Presumed Consent In the United States, deceased organ donation occurs only with express consent1 (often in response to an inquiry or request). This consent may be given in advance by the individual while he or she is still alive, or it may be given by the next of kin after the death of the individual. The state laws that govern organ donation thus require opting in (or contracting in). The default option, in the absence of express consent, is nondonation. Proposals to increase the availability of transplantable organs often recommend a policy of opting out (or contracting out). Under such a policy, organs from deceased individuals could be removed for transplantation unless the decedents—or their families, after their deaths—had followed the prescribed measures for opting out. The default option, in the absence of express objection, would become donation. Not all opt-out policies are the same, and different issues arise in the analysis and assessment of different policies, particularly presumed consent and routine removal.2 Presumed-consent and routine-removal policies are commonly confused or deliberately conflated. Even though both involve opting out, their differences are significant, and any adequate analysis and 1 The term “express consent” is used to indicate explicit agreement, generally documented in writing. 2 “Presumed consent” or “presumed donation” is shorthand for “presumed consent to donation.” All of these terms are used in the discussion in this chapter. “Routine removal” is also called “routine salvaging” or, even more problematically, “routine harvesting.” Only the term “routine removal” is used in the discussion in this chapter.

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Organ Donation: Opportunities for Action assessment must examine those differences. This chapter briefly discusses routine organ removal and then considers presumed consent in depth. ROUTINE REMOVAL Routine removal presupposes that the state or society has a right of access to the organs of deceased individuals. This right may rest on the state’s or the society’s claimed ownership of or authority over the bodies of deceased individuals, or it may rest on an enforceable duty of individuals and families to provide postmortem organs as needed. The fundamental distinction between policies of routine removal and policies of presumed consent rests on their different interpretations of the relation of the individual and his or her dead body to the state or society. Routine removal is broadly communitarian (Nelson, 1992), whereas presumed consent—like expressed consent—is largely individualistic, even though it may include a role for the family. Policies of routine removal also fall under the broad label of opting out, because they generally allow individuals to opt out under various circumstances. Furthermore, in most countries, organ procurement teams contact the families of decedents, even when the authorizing legislation for routine removal does not mandate consultation with the family (Prottas, 1985). It is also important to note that broad public understanding and voluntariness are not essential for an effective policy of routine organ removal. Instead, state or societal ownership of or authority over the bodies of deceased individuals (or individuals’ and families’ enforceable social obligations) ground the law and social practices of implementation (Childress, 1997). Hence, the removal does not require anyone’s explicit or implicit consent. However, for various reasons, public understanding and voluntary (although passive) acceptance may still be sought. In the United States, as in many countries, the state does not claim complete authority over the disposition of the bodies of deceased individuals, and the recovery of solid organs is grounded in the consent of the donors or their families. Some states in the United States do authorize medical examiners to remove the corneas from bodies that come under their authority to conduct an autopsy to determine the cause of death. These laws do not require express consent. Even though they allow opting out, they generally do not impose an obligation on the medical examiner to notify families, even if the next of kin happens to be nearby. In one case in Florida, a family was in a nearby room while a deceased relative’s corneal tissue was being removed without their express consent (Florida v. Powell3). 3 Florida v. Powell, Fla., 497 So.2d 1188 (1986).

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Organ Donation: Opportunities for Action In Florida v. Powell, the Florida Supreme Court found that state’s law to be constitutional.4 It found that the statute had a reasonable relation to the permissible legislative objective of “providing sight to many of Florida’s blind citizens” through the provision of a larger and superior supply of transplantable corneas from the medical examiner’s office than that available through regular donation. The evidence establishes that this increase in the quantity and quality of available corneal tissue was brought about by passage of the statute and is, in large part, attributable to the fact that [the law] does not place a duty upon medical examiners to seek out the next of kin to obtain consent for cornea removal (Florida v. Powell). These statutes have been considered very effective. For example, substantial increases in corneal transplants occurred after such a statute was passed in Georgia: from 25 in 1978 to more than 1,000 in 1984 (National Conference of Commissioners on Uniform State Laws, 1987). These cornea retrieval statutes do not presume consent; rather, they authorize routine removal subject to the objection of the family. There appears to be little or no effort to educate the public about these laws, and there is no evidence of widespread public understanding that these routine-removal laws exist and will be applied under certain circumstances. Because such routine-removal statutes have passed in state legislatures and survived constitutional challenge, the following question arises: Could states adopt similar laws for obtaining solid organs? Several factors militate against the adoption of this routine-removal model for solid-organ recovery in the United States. First, the current policies of routine removal apply only to the relatively small number of deceased bodies that come under the authority of the medical examiner. Second, corneas can be viewed as more external than solid or vascularized organs embedded in the body. As a result, the removal of the corneas may not arouse some of the ambivalent or negative emotions often associated with the removal of internal organs. Third, the removal of corneas occurs in the context of deaths declared according to uncontroversial applications of traditional circulatory criteria, whereas the removal of solid organs occurs in the context of determinations of death (whatever the criteria) that evoke public confusion and, sometimes, distrust. Finally, the passage and implementation of laws authorizing medical examiners to remove corneas subject to the objection of the family have received little close public scrutiny—perhaps for the reasons given 4 The U.S. Supreme Court has let these laws stand without ruling on their constitutionality. See Georgia Lions Eye Bank Inc. v. Lavant, 255 Ga. 60, 335 S.E.2d 127 (1985); cert. denied 475 U.S. 1084, 106 S.Ct. 1464, 89 L. ed 721 (1986).

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Organ Donation: Opportunities for Action above—in contrast to what could be expected for any proposal for a policy of routine postmortem organ removal and transfer. Proposed routine-removal policies for internal organs are controversial in the United States because they depart from the established ethical, societal, and legal principle of individual and familial dispositional authority over the body of the deceased individual and from the norm of express consent for organ transfer. Even though such policies usually allow the individual and, often, the family to opt out, they still rest on claims that the state or society has dispositional authority over the body of the deceased individual or that individuals and families have enforceable obligations to provide organs postmortem. For this reason, it is misleading when the proponents of routine removal attach the label “presumed consent” to their proposals. This label obscures the degree to which routine-removal policies would depart from U.S. standards and norms, as well as from the value of individualism. Indeed, in practice, if not in rhetoric, some opt-out policies in other countries appear to be policies of routine removal (even with notification) rather than policies of presumed consent (Veatch and Pitt, 1995; Veatch, 2000). In conclusion, there are serious doubts that a policy of routine removal with the possibility of opting out could or even should be adopted in the United States, because of its assumption of state or societal authority over the body of the deceased individual and its organs and the corollary that no individual or familial consent, whether it is express or passive, is necessary for the removal of organs. Even if such a policy were to be adopted by a state legislature, it is likely that public resistance would be strong enough to thwart its primary purpose of increasing the supply of transplantable organs. For these reasons, the committee does not regard routine removal as a viable approach in the United States. Instead, the chapter focuses on presumed consent, which, although also controversial, would be more acceptable because it affirms the principle that dispositional authority rests with individuals while they are alive or with their next of kin after they have died. PRESUMED CONSENT The presumed-consent policy for the recovery of organs from deceased individuals has been explained in the following manner: Public policy based on presumed consent would offer every adult the opportunity to express and have recorded by publicly accountable authorities his or her refusal to be a donor of solid organs and tissues. A clinically and legally indicated candidate for cadaveric organ and tissue recovery is presumed to have consented to organ and tissue recovery if he or she had not registered a refusal (Dennis et al., 1993).

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Organ Donation: Opportunities for Action Such a policy assumes that individuals have and can exercise dispositional authority over their organs postmortem. However, it shifts permission for donation from express consent to presumed consent. In the absence of an explicit and expressed decision, the default would become donation rather than, as is currently the case, nondonation. Varieties of Consent Presumed consent is one of a number of different varieties of consent (Beauchamp and Childress, 2001). The paradigm of consent in biomedical ethics is express consent. It appears in the Uniform Anatomical Gift Act’s framework for organ donation as well as in rules of voluntary, informed consent in both therapy and research involving human participants. However, express consent is not the only kind of consent that can be valid and effective. For instance, there is implicit or implied consent, which is inferred from other actions. In addition—and most relevant for the purposes of this analysis—there is tacit consent, that is, “consent that is expressed silently or passively by omissions or by failures to indicate or signify dissent” (Childress, 1997, p. 277). Under certain conditions, nonobjection or nondissent constitutes valid tacit consent (Simmons, 1976). The potential consenter must be aware of what is going on and know that consent or refusal is appropriate, must have a reasonable period of time for objection, and must understand that expressions of dissent will not be allowed after this period ends. He or she must also understand the accepted means for expressing dissent, and these means must be relatively easy to perform. Finally, the effects of dissent cannot be “extremely detrimental to the potential consenter.” Some of these conditions ensure the consenter’s understanding; others ensure the consent’s voluntariness. When these conditions are met, the potential consenter’s silence may be construed as tacit consent. Such consent may be ethically valid in some circumstances (Childress [1997, p. 277] summarizing and elaborating on the work of Simmons [1976]). Tacit consent presupposes the consenter’s competence. Children, for instance, could not give tacit consent; someone who is competent to make that decision would have to give consent for them. Some critics claim that presumed consent is a “fiction” (Erin and Harris, 1999). However, the description of presumed consent given above as tacit, silent consent indicates that it need not always be a fiction. It can sometimes be actual, valid, and effective consent, depending on the nature and structure of social practices, as well as the competence of the individuals whose silence is presumed to be consent, their understanding, and the voluntariness of their choices. Given the current absence of established social practices in the United States that would warrant such a presump-

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Organ Donation: Opportunities for Action tion, it would not be possible to presume consent for organ donation in this country at this time. This first model of presumed consent construes it as tacit, silent consent. At least two other models appear in the bioethics literature. A second model would presume consent to donation on the basis of a general theory of human values or on the basis of what reasonable, altruistic people should and would do. This is not what the committee’s discussion of presumed consent envisions—such theories or views do not warrant a presumption of consent for organ donation by particular individuals. A third model bases the presumption of consent on what a deceased person would have decided if he or she could be asked. The paradigm case is treatment provided in emergencies when the patient is incapacitated or time does not permit the interactions that would otherwise be needed to elicit valid consent. According to Veatch and Pitt (1995, p. 1889), the presumption of consent makes an empirical claim: “The reasoning behind true presumed-consent laws is that it is legitimate to take organs without explicit consent because those from whom the organs are taken would have agreed had they been asked when they were competent to respond.” This third model marks an advance over the second model, but it is still somewhat abstracted from particular social practices. It rests presumed consent on the basis of current opinion polls that show widespread public support for organ donation. However, such a presumption, if it were implemented now, would be mistaken for a certain percentage of the population (i.e., those who do not currently support donation). It is possible, perhaps even probable, that new social practices, particularly increased levels of public education regarding donation, could make it more reasonable in the future. In principle, presumed donation, as a form of tacit or silent consent (the first model), could be an acceptable basis for organ removal. However, as already indicated, it can be ethically valid only if it satisfies some rigorous conditions. Unless those conditions are met, silence (nonresponse) may indicate only that the individual does not understand the default or the means to avoid it. To be ethically acceptable, a policy of presumed consent would require widespread and vigorous public education to ensure understanding, along with clear, easy, nonburdensome, and reliable ways for individuals to register dissent. In view of the difficulty of interpreting silence, it is not surprising that in most policies of opting out in other countries, organ recovery teams also consult the decedent’s family. Weak and Strong Presumed Consent There are strong and weak versions of the presumed-consent model in organ donation (Table 7-1); they differ in the extent to which the family of the decedent is involved in the donation process. In the strong version,

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Organ Donation: Opportunities for Action TABLE 7-1 Organ Donation Decision-Making Policies Type of Policy Description Default Opt-in policy Current U.S. system Individuals or family members make an express decision to donate Nondonation Opt-out policy     Presumed-consent policy Individuals and, secondarily, family members have the right to determine access to the organs of deceased individuals Individuals and, in some contexts, family members may make an express decision not to donate Donation Weak presumed- consent policy Organ recovery teams must consult with the family Donation Strong presumed- consent policy Organ recovery teams do not have to consult with the family Donation Routine-removal policy The state or society has the right of access to the organs of deceased individuals (policies may still allow opting out) Donation organ recovery teams do not have to check with the family, either about the family’s knowledge of the decedent’s preferences or about the family’s own preferences. In the weak version, organ recovery teams must consult the next of kin after an individual’s death. In many countries with what might be considered strong presumed-consent legislation (or even routine-removal legislation), organ recovery teams in practice still inform the families of decedents. Whether the legal framework is express donation or presumed donation (or even routine removal), practices in different countries are generally quite similar, with the family usually playing or being allowed to play some role in the donation process (Prottas, 1985). In sum, under presumed-consent laws, while individuals are alive they have dispositional authority over their bodies after their deaths; and within an established and well-understood set of rules and practices, their silence, or their nonrefusal of organ donation, can appropriately be construed as valid consent. In this context, organ recovery teams may legitimately remove decedents’ organs without their prior, express consent. They may also consult the family as a procedural safeguard—for example, the family may be aware of the decedent’s objections—or in recognition of familial interests. Within a presumed-consent framework, the dispositional authority over the organs rests primarily with the individual and only secondarily, if

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Organ Donation: Opportunities for Action at all, with the family. Neither the individual, while he or she is alive, nor the family, after the individual’s death, has an enforceable obligation to donate organs. These features, along with important differences in social practice, distinguish presumed consent from routine removal. Although presumed-consent policies are still very controversial, they would be more acceptable than policies of routine removal in the United States. Presumed-consent policies fit better with the ethical, societal, and legal principle of the individual’s (and the family’s) dispositional authority over the individual’s organs postmortem. However, presumed consent is controversial because it departs from the ethical, societal, and legal norms and practices of express consent. The discussion now turns to a closer examination of proposals for presumed-consent policies. Assessment of Presumed-Consent Policies The main argument for policies of presumed consent stresses their potential effectiveness in increasing the supply of transplantable organs, but questions remain about their effectiveness and their cost-effectiveness. A secondary argument for presumed-consent policies stresses their potential benefits for the grieving family by reducing the burden of decision making at a difficult time in their lives. In addition, arguments for presumed consent note that autonomy can be exercised silently or passively in social practices that have donation as the default option. Some counterarguments focus on disrespect for autonomy and on practical problems. Other objections identify possible injustices and the loss of opportunities for individual generosity. In response, supporters emphasize ways to avoid or reduce possible injustices and dispute the threat to individual generosity. The following discussion analyzes the array of arguments that have been presented on both sides of the debate and offers the committee’s comments on presumed-consent policies. Effectiveness and Cost-Effectiveness Effectiveness in Increasing the Number of Transplantable Organs The primary argument in favor of presumed consent is that it would increase the availability of transplantable organs and that such an increase could save lives and enhance the quality of the lives of transplant recipients. If a presumed-consent policy did not have a strong prospect of increasing the number of available organs, there would be no reason to adopt it. Countries with opt-out policies appear to have higher donation rates than countries with opt-in policies (Abadie and Gay, 2004). Nevertheless, there is debate about how to determine effectiveness (for instance, whether the rate of donation per million population is an adequate measure) (Chapter 1).

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Organ Donation: Opportunities for Action In addition, there is debate about the relative contribution of and connections between opt-out policies and other policies, social practices, and conditions that may also help to increase rates of organ donation. For instance, in Spain, which has greatly increased the number of available organs for transplantation, the opt-out policy has been accompanied by other significant changes, especially changes in the infrastructure and the implementation of a program of donation after circulatory determination of death (Chapters 1 and 5). It is difficult, if not impossible, to identify the single most important causal factor. The following is one list of the factors that, along with opt-out policies, appear to have had an impact in such countries as Spain and Belgium (a summary has been provided by English and Sommerville, 2003; see other lists of factors in the works of Roels et al., 1991; Kennedy et al., 1998; Cameron and Forsythe, 2001; Gimbel et al., 2003; Abadie and Gay, 2004): the predominant cause of death (such as the number of road accidents), the availability of beds and staff in intensive care units, the number and efficiency of transplantation coordinators, the number of transplantation surgeons, the number of specialized units in the region, and the number and characteristics of the patients on the waiting list (such as what organs they need). Other factors include religious and cultural views of and attitudes toward death and the body of the deceased individual (Kennedy et al., 1998). Although several of these factors account for much of the international variation in the rates of organ recovery, opt-out legislation “has a positive and sizeable effect on organ donation rates”; and after accounting for other determinations of donation rates, “presumed-consent countries have roughly 25 percent to 30 percent higher donation rates than informed-consent countries” (Abadie and Gay, 2004, p. 15).5 This level of increase would greatly ease, even though it would not totally eliminate, the organ shortage in the United States (Abadie and Gay, 2004). It is also worth noting that per capita donation rates in the United States already exceed those of many countries with presumed-consent policies, so the impact of adopting presumed consent would likely be less than a 25 to 30 percent increase. Another problem in the evaluation of the potential effectiveness of 5 Furthermore, Abadie and Gay (2004, pp. 16ff.) show that the difference cannot be explained by a supposed strong and widespread sociocultural commitment to organ donation that has led to and sustained a presumed-consent law; their analysis uses “annual blood donations (per capita) as an indicator of societal preferences towards organ donation.”

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Organ Donation: Opportunities for Action presumed-consent policies is that the laws in some countries may involve routine removal with the possibility of opting out rather than presumed consent in a strict sense. As a result, claims about and evidence for the effectiveness of presumed-consent policies may be based in part on policies of routine removal. If so, legitimate questions arise about whether a system of presumed consent would be equally effective and cost-effective. For instance, it is an open question whether some of the measures required by ethical presumed-consent policies—for instance, vigorous educational efforts to ensure public understanding—would lead to more refusals and would decrease the effectiveness of such policies. In any event, such measures would be costly. Some recent empirical evidence about the probable effectiveness of presumed-consent strategies for organ donation comes from studies of the effects of default mechanisms in other contexts. Johnson and Goldstein (2003, 2004) view individual preferences as constructed rather than clearly known in advance. In light of this view, they explore the hypothesis that default mechanisms influence choices, including organ donation, in one or more of the following ways: (1) by marking certain (default) actions that are favored by policy makers for the society, (2) by creating options (defaults) that require no effort, and (3) by representing the status quo through defaults, the alteration of which requires trade-offs (Johnson and Goldstein, 2003). Various reports of individuals’ choices regarding insurance or pension savings indicate that default policies often have a considerable impact. In an online experiment, Johnson and Goldstein (2003) asked 161 people whether they would agree to donate organs in response to one of three questions, each with a different default. (1) With an opt-in default policy, participants were asked to assume relocation to a different state with a default of nondonation of organs and to indicate whether they would confirm or alter this default. (2) With an opt-out default policy, participants were also asked to assume relocation to a different state with a default of donation of organs and to indicate whether they would confirm or change this default. (3) With a neutral-choice policy, participants were asked to choose in the absence of a prior default. These scenarios led to very different responses. “Revealed donation rates were about twice as high when opting-out as when opting-in. The opt-out condition did not differ significantly from the neutral condition (without a default condition). Only the opt-in condition, the current practice in the United States, was significantly lower” (Johnson and Goldstein, 2003, p. 1338). Nevertheless, there are concerns about whether a presumed-consent policy would be effective in the United States. In 2005, the Council on Ethical and Judicial Affairs of the American Medical Association (AMA) recommended that physicians not support a presumed-consent policy unless small, well-designed pilot studies established that it would be effective

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Organ Donation: Opportunities for Action (AMA, 2005). The Council believes that unless data from these pilot studies “suggest a positive effect on donation, neither presumed consent nor mandated choice for deceased donation should be widely implemented” (p. 5). At this point, the Council contends, it is unknown whether implementation of presumed consent (or of mandated choice) “would positively or negatively affect the number of organs transplanted” (AMA, 2005, p. 5). The following is a line of argument that expresses the concern that adoption of a presumed-consent policy might be counterproductive in the United States: some individuals now fail to sign donor cards because of their distrust of the system, including their fears that they might not receive the best possible care or that their deaths might even be hastened if they were on record as organ donors, but they may not be opposed to a family decision to donate their organs after their death. Under a presumed-consent policy, some of these same individuals might opt out to avoid the perceived risks of being on record as an organ donor (through their silent or tacit consent) (Wells, 2005); this would prevent familial donation. Therefore, not surprisingly, major questions arise about whether it is wise to seek a dramatic change in a system that works fairly well, although not perfectly. These questions are particularly challenging when the changes could possibly be ineffective or even counterproductive in part because of mistrust and distrust. Preliminary results from the 2005 National Survey of Organ Donation suggest that about 30 percent of respondents would opt out under a presumed-consent law. In response to a question about whether they would register as “nondonors” under a presumed-consent policy, 30.9 percent said “yes,” 63.1 percent said “no,” and 5.9 percent said “I don’t know” (Wells, 2005). If, indeed, over 30 percent of the population (which could perhaps be higher if many in the undecided population settled on “no”) were to opt out, it is possible that fewer transplantable organs would be available under a presumed-consent policy than under the current opt-in policy of express consent. (These data must be used with caution, because the responses do not reflect the results of a vigorous and extensive educational campaign, which would be essential for the implementation of a presumed-consent law.) At present, under the opt-in policy in the United States, the available evidence does not indicate that a large number of people who fail to express their wishes to donate through a document or registry actually forbid their families from donating their organs after death. As a result, family members—rather than individuals while they are alive—are the ones who most often give express consent for organ donation postmortem. If, however, under a presumed-consent donation policy approximately 30 percent of the population were to register as nondonors, almost one-third of the potential donors would effectively block their families from donation.

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Organ Donation: Opportunities for Action for donor cards in the U.S. opt-in framework: the possibility of designating a surrogate to act as the decision maker about postmortem organ donation. That proposal would also be appropriate and potentially helpful in a presumed-consent framework. An individual would not have to decide between remaining silent, thereby allowing donation to proceed (perhaps within a social practice of consultation with the family), or refusing, thereby blocking any use of his or her organs after death. Instead, the individual could designate someone whom he or she trusts to serve as the postmortem decision maker. Autonomy-Based Arguments Different arguments based on autonomy and respect for autonomy can support or oppose presumed-consent policies. Some arguments for presumed-consent policies stress that the majority of respondents in public opinion surveys indicate that they would be willing to donate their organs or to have their organs donated but that less than 50 percent actually sign donor cards. As a result, “explicit consent policies impose the costs of switching on the apparent majority” (Johnson and Goldstein, 2003, p. 1339). A presumed-consent policy “could be a much better method [than opt-in policies] of realising individuals’ wishes” (English and Sommerville, 2003, p. 147). In effect, so the argument goes, a presumed-consent policy would enable the majority to do what they say they want to do or would be willing to have done with regard to organ donation postmortem. English and Sommerville (2003, p. 150) observe: Given that most people, when asked, express willingness to donate their organs after their death, there are reasonable grounds for presuming that they probably really do wish to donate. The current law, however, presumes they do not. Statistically, it seems that the default position is more likely to be correct if it is based on the individual wishing to donate, unless there are clues to the contrary. Arguably, therefore, unless all the opinion polls are wrong, presumption in favour of donation is more likely to realise the autonomy of the deceased person than a presumption against. In view of the gap between the majority’s expressed preferences, as represented in opinion surveys, and what they actually do, a policy of presumed consent would enable the majority to realize its general will more effectively, with less effort, and hence would increase the number of transplantable organs. Proponents of presumed consent further claim that under the current opt-in policy in the United States, the number of false-negative responses (i.e., cases in which silence is mistakenly construed as a refusal to donate) is

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Organ Donation: Opportunities for Action much greater than the number of false-positive responses (i.e., cases in which silence is mistakenly construed as consent to donate) that would accompany an opt-out policy. It is unclear whether this claim is accurate, particularly because it rests on a prediction that people who do not want to donate under a presumed-consent system would be more likely to opt out than people who want to donate under the current system would be likely to opt in (Gill, 2004). Another question is whether “mistaken removals” and “mistaken nonremovals” are morally equivalent. Proponents of presumed consent tend to deny the ethical significance of this distinction (Gill, 2004). By contrast, critics of presumed consent worry more about the infringement of the autonomy of those who, for one reason or another, fail to opt out under such a policy. These critics contend that postmortem organ removal in such cases violates “the right of the individual not to have his or her body invaded” (Veatch and Pitt, 1995, p. 1890). Some critics also emphasize the substantial number of individuals in the United States opposed to organ donation: the figure in opinion polls has hovered fairly consistently around 30 percent (Wells, 2005). Hence, these critics charge, any presumption of consent would necessarily include some decedents who were opposed to donation. Even if many dissenters opted out, some would fail to do so for one reason or another. Because of such concerns, supporters of presumed consent often stress the need to develop a set of social practices before presuming consent to donation (Abadie and Gay, 2004; Siegal and Bonnie, 2006). These social practices would include both improved and extended public education and mechanisms for the clear, easy, nonburdensome, and reliable registration of objection to organ donation. Supporters of presumed consent concede that it would not be ethically justifiable or effective merely to shift legislation from express consent to presumed consent without the development and effective implementation of these social practices over time. Within such social practices, individuals’ previously stated preferences may not be as stable or as strong as they had thought, and the society’s affirmation, through presumed-consent legislation, of the importance of organ donation may help revise those preferences. Justice and Fairness Another set of ethical concerns about policies of presumed consent focus on justice and fairness in the distribution of societal burdens, including the burden of decision making about the donation of organs from deceased individuals. More specifically, concerns have emerged that “some groups, such as those who do not speak English or cannot read and write, and those with limited or fluctuating mental capacity, may have difficulty in expressing a refusal or understanding the system” (Wilks, 1998, p. 151).

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Organ Donation: Opportunities for Action Hence, the argument might go, it would be unfair to expect individuals in these groups to take action to avoid becoming organ donors. This concern could be addressed, in part, by developing and undertaking special educational efforts in minority communities; by creating handy, easy, and non-burdensome mechanisms for registering dissent; and by consulting the family of the decedent. Some critics of opt-out policies also worry about unfairly burdening religious and other conscientious objectors to organ donation by forcing them to take action to avoid having their organs removed after their deaths. Such policies could be “perceived as culturally or religiously insensitive” (AMA, 2005, p. 3). One possible answer might be that relatively non-burdensome measures of dissent could and should be established to protect autonomy and freedom of conscience. Furthermore, supporters of presumed consent would argue, “it is not necessary to remove all need for effort or initiative in exercising these rights” (Muyskens, 1978, p. 95). A partial analogy can be found in the recognition of conscientious objectors to military service in the United States: The selective service system has recognized and provided alternatives for conscientious objectors to military service, but it has also required potential conscientious objectors to take the initiative to register and defend the sincerity of their views. As this analogy suggests, when a government allows nonparticipation in a public policy that serves an important societal goal—such as defending the country or increasing the availability of transplantable organs—it may require non-participants to take some affirmative action without unduly and unfairly burdening their consciences. Still another ethical concern based on justice and fairness may also have an impact on people’s willingness to acquiesce, through their silence, to presumed organ donation. This concern focuses on justice in the distribution of benefits, such as funds for organ transplantation. The national Task Force on Organ Transplantation suggested that in the United States it is unfair and even exploitative to ask poor and rich people alike to donate organs because many of the poor would not have an opportunity to receive a nonrenal organ transplant, if needed, because of the heavy personal costs involved (Task Force on Organ Transplantation, 1986; Childress, 1997).6 Such an argument would be even more powerful in a system that presumes consent to organ donation by all who do not expressly dissent. It is arguably unfair and exploitative to include in a policy of presumed organ donation individuals who would not be able to obtain a transplant if needed 6 By contrast, renal transplants are generally covered by the End-Stage Renal Disease Program of Medicare, at least if the individual’s primary health insurance does not provide coverage, although immunosuppressive medications for many transplant recipients are covered for only 3 years posttransplantation.

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Organ Donation: Opportunities for Action because of the lack of funds or the lack of healthcare insurance coverage, specifically, for costly (nonrenal) transplants. Hence, some would argue, the provision of funds for uncovered organ transplants should be part of any shift to a policy of presumed consent (see, for example, Siegal and Bonnie, 2006). Individual Generosity, Societal Generosity, and Mutual Self-Interest Another objection to presumed consent holds that, in contrast to express consent for donation, presumed consent for donation “would deprive individuals of the exercise of the virtue of generosity” (Ramsey, 1970, p. 210). Supporters could respond in several ways. First, this objection, even if it were relevant, should not prevent a society from developing a policy that would effectively increase the supply of transplantable organs and thereby save the lives and enhance the quality of life of many transplant recipients. Societal generosity may take priority over individual generosity. Second, another counterargument contends that a policy of presumed consent would not in fact prevent individual acts of generosity. On the one hand, it would still be possible for individuals to give express consent. On the other hand, individual acts of nonrefusal or nonobjection themselves can reflect the virtue of generosity. It is a mistake to suppose that only express donation embodies generosity or altruism. A decision not to block presumed donation may also be generous and altruistic, even if express donation is more dramatic (Childress, 1997). How would proposals for presumed consent fit into a model of organ donation rooted in mutual self-interest, reciprocity, and solidarity? The typical reciprocity-driven approach is framed as an opt-in plan based on individual registration (Steinberg, 2004; Nadel and Nadel, 2005). Under this approach, people who want to be eligible to receive organs or to have priority on the waiting list would be required to document their willingness to be organ donors (Chapter 8). However, another reciprocity-driven strategy (Siegal and Bonnie, 2006) is to frame the legal structure as a social contract under which the willingness to be a recipient in the event of need and to be a donor in event of death are both presumed and transplantation costs would be covered for everyone, thereby ensuring the genuine reciprocity now lacking in the U.S. system and addressing the concern about the unfair inclusion of uninsured poor people noted above. Under this approach, individuals who prefer to opt out of the system, perhaps on the basis of religious objections, could do so. It is expected, however, that most people would recognize their mutual self-interest in ensuring an adequate organ supply and would therefore choose to remain within the plan rather than opting out. The committee agrees that reciprocity, based on recognition of a common stake in increasing the organ supply, should play a more

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Organ Donation: Opportunities for Action prominent role in organ donation policy than is now the case, and the committee also acknowledges that presumed consent might be a logical element of a reciprocity-driven system. However, because implementation of this approach would still require individuals to make a genuine choice to remain in the system, most of the autonomy-based concerns raised earlier would still have to be addressed. Could a Presumed-Consent Policy Be Adopted in the United States? This discussion has so far considered whether a presumed-consent policy would probably be effective and cost-effective and whether major ethical concerns could be satisfactorily addressed (Box 7-1). Another basic question is whether such a policy could feasibly be adopted and implemented in the United States. The answer to this question about feasibility is, in many ways, unclear; but there are doubts that a presumed-consent policy could be adopted and effectively implemented, at least for the foreseeable future. The views and attitudes of medical and health professionals, particularly those who would be directly or indirectly involved in organ recovery and transplantation, are important both for enacting presumed-consent laws and for implementing them. Although it is difficult to ascertain their views and attitudes in a systematic way, the evolving opinions of the Council on Ethical and Judicial Affairs of the AMA provide some clues. In 1994 the AMA Council adopted the following statement: “a system of presumed consent for organ donation, in which individuals are assumed to consent to be organ donors after death unless they indicate their refusal to consent, raises serious ethical concerns” (AMA, 1994, p. 812). The Council recommended, instead, a policy of mandated choice. When the Council returned to this topic in 2005, it expressed a less negative view of presumed consent but recommended the adoption of neither presumed consent nor mandated choice until well-designed, small-scale studies could establish their merits (AMA, 2005).7 Opinion surveys also do not indicate strong public support for an opt-out policy. Indeed, although the results of opinion surveys vary, in part depending on the wording of the questions—for instance, there is inconsistency in the labels used for different opt-out policies—they generally indicate substantial opposition to opt-out legislation. The strongest opposition is directed at a policy of routine removal without notification of the family. In a 1985 Gallup poll, 86.5 percent of the respondents indicated that they 7 By contrast, the British Medical Association has recommended adoption of presumed consent (Ashraf, 1999; English and Sommerville, 2003).

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Organ Donation: Opportunities for Action BOX 7-1 Possible Benefits and Barriers of Presumed-Consent Policies Possible benefits of presumed-consent policies include the following: Opt-out policies appear to have been effective, along with other measures, in increasing the supply of transplantable organs in several countries. Opt-out policies have been praised for reducing the grieving family’s burden of decision making, but the family is still consulted in most policies (weak presumed consent) and will probably concur more readily when they are approached from this standpoint. Presumed-consent policies would enable the majority (as identified in opinion polls) to follow through more easily, even passively, on its expressed willingness to donate organs or to have organs donated, whereas these policies shift the burden of decision and action to the minority. Presumed consent would express and effectuate an organ donation policy grounded in the idea that everyone is a potential recipient and has a reciprocal interest in increasing the supply of organs. Concerns about a presumed-consent policy—along with possible responses and ways to address those concerns—include the following: Unfair imposition of burden of opting out on poor and uneducated citizens. Response: This concern could be addressed by developing clear, easy, nonburdensome, and reliable means for opting out. Unfair imposition of burden of opting out on conscientious objectors. Response: Parallel to military service, it is justifiable to ask opponents to take affirmative action to avoid the default in a program that serves an important social good. Unfair incorporation of poor people with little or no insurance in a presumed-consent policy when they would not have access to expensive nonrenal transplants if they needed them. Response: This is an issue in the current opt-in policy, but it would be worse in a presumed-consent policy and is not likely to be effectively addressed in the near future. Denial of opportunity for expression of individual virtue of generosity and altruism. Response: The social virtue of generosity or altruism would be realized in an effective opt-out policy, and the individual virtue could be realized either in express donation (because a policy of presumed donation does not preclude express donation) or in not blocking the presumption of consent. Mistaken presumptions about the wishes of individuals who, for one reason or the other, failed to opt out. Response: To reduce mistakes, vigorous public education would be essential, along with various safeguards, including clear, easy, reliable, and nonburdensome ways to register dissent and perhaps also notification of the next of kin. Possible ineffectiveness and counterproductivity. Response: A major shift in social-cultural attitudes in the United States is a prerequisite for an effective and productive system of presumed consent.

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Organ Donation: Opportunities for Action would oppose legislation that would give doctors “the power to remove organs from people who have died recently but have not signed an organ donor card without consulting the next of kin” (Gallup Organization, 1985). In a 1991 survey of 801 individuals, 55 percent of the respondents indicated that “physicians should not be able to act on implied consent,” 38 percent indicated that “physicians should be able to act on implied consent,” and 7 percent indicated indecision (Dennis et al., 1993). Preliminary analysis from the 2005 National Survey of Organ Donation indicates greater support but still majority opposition for presumed consent. When asked about their support for presumed consent, 53.6 percent said “no,” 43.2 percent indicated “yes,” and 3.2 percent indicated “I don’t know” (Wells, 2005). A policy of presumed consent will fail without the support of the public and of the relevant healthcare professionals. However, questions arise about how policy makers should proceed if they believe that such a policy is the best way to express and balance moral responsibilities to decedents and their families, on the one hand, and to people in need of a transplant, on the other. Should policy makers try to change public opinion and professional opinion? Or should they proceed on the assumption that legislating a shift from express consent to presumed consent would itself have a major impact, at least over time, on public and professional opinion? Should policy makers develop phase-in policies? Some proponents of presumed consent contend that altering the default would probably produce a major cultural shift over time, with donation becoming a strong and pervasive social norm (English and Sommerville, 2003). At the very least, proponents of presumed consent argue that legislation could express and symbolize society’s high valuation of organ donation as well as organ transplantation, which depends on donation. As they see it, the current opt-in laws constitute “a less than energetic endorsement of transplantation” (Kennedy [1979] quoted in English and Sommerville [2003, p. 151]). By instituting a policy of presumed consent, society would put its stamp of approval on both organ transplantation and organ donation, and the societal stamp of approval is one way that default policies shape responses. Along the same line, a presumed-consent approach might be a logical way to express and implement an organ donation policy grounded in reciprocity and mutual self-interest. Nevertheless, some supporters of presumed-consent legislation sound a cautionary note. For instance, Abadie and Gay (2004, p. 18) observe that “it seems likely that in some countries the imposition of a presumed-consent law, without building first sufficient social support, could generate an adverse response towards organ procurement efforts.”

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Organ Donation: Opportunities for Action CONCLUSIONS The committee believes that it would be premature to attempt to enact presumed-consent policies at this time. Although the committee is supportive of the principles of a presumed-consent approach (namely that under certain clear and well-defined circumstances, in the absence of an individual’s expressed decision, one may presume his or her consent rather than refusal to donate), the first step is to build sufficient social support before introducing presumed consent in the United States. This can be accomplished through intensified public education regarding organ donation, building greater trust in the healthcare system, and encouraging a general shift in societal understanding of the value and moral grounding of donation. The current emphasis on the use of first person (donor) consent to organ donation can reinforce the importance of individual decision making. Coupling this change with the move towards use of an expected donation approach with families (Chapter 4) can also strengthen the societal norm of organ donation as a social responsibility and standard practice. Questions have been raised about whether it would be possible to conduct small-scale, pilot experiments of presumed consent to help determine its effectiveness and its ethical acceptability to the public and health professionals. As noted above, the AMA Council on Ethical and Judicial Affairs (AMA, 2005) has recommended such experiments. They would be designed to “measure the change in number of organ transplants, the number of donations, awareness among the public that a presumed-consent system was in place, number of documented refusals to donate, how often families claimed to know of refusals, and acceptance by the population of the undermining of individual self-determination”8 (AMA, 2005, p. 4). Nevertheless, it is not clear that such small-scale, pilot experiments can be successfully undertaken without effectuating a major change in policy and taking the risks associated with doing so. Each state has structured the transfer of organs for transplantation around express consent. Hence, it would not be possible to conduct an experiment of presumed consent in the transfer of transplantable organs without changes in state law, and the experiment would probably need to be at least statewide. Moreover, even if the policy were implemented only in a few states, adverse public reaction could have undesirable spillover effects on public attitudes in other jurisdictions, thereby eroding public support for donation. It is important to note that several possibly important differences exist between prominent U.S. beliefs and values, particularly individualism, and the beliefs and values of most of the countries with opt-out policies. With- 8 Not everyone would agree that presumed-consent policies necessarily “undermine” individual self-determination; as noted above, such policies, under some circumstances, may provide another way in which self-determination can be exercised.

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Organ Donation: Opportunities for Action out a wider consensus in the United States about a policy of presumed consent, its passage and implementation could lead to a decline in the number of transplantable organs because a considerable number of people would probably opt out and, in doing so, would block the possibility of donation by the family after death. Thus, the committee believes that it would be wiser to leave the current law in place while undertaking educational activities and other initiatives designed to promote donation, activities that would be necessary to lay the foundation for a transition to a presumed-consent policy if it were regarded as a prudent reform at a later time. In addition, as has been discussed, fairness requires that financial coverage for transplants and immunosuppressive medications be available so that all citizens who would be presumed to consent to donation would have fair access to transplantation in case of need. Although conditions essential for a change to a presumed-consent policy do not currently exist and do not appear to be likely in the foreseeable future, it is both appropriate and important to seek to realize them over time. When the necessary conditions exist for a shift to a presumed-consent policy it will be critical to provide clear, easy, nonburdensome, and reliable ways to opt out. SUMMARY AND RECOMMENDATION Policies of routine removal of organs and presumed consent for organ donation are distinct, even though both involve opting out. Policies of routine removal assume that the state or society has a right of access to decedents’ organs, whereas presumed-consent policies presuppose the individual’s or family’s dispositional authority over the decedent’s body and organs. In the committee’s judgment, a routine-removal policy, even when it allows individuals or families to opt out, represents such a radical departure from the principle of individual and family control over the bodies of deceased individuals that it could not and should not be adopted in the United States. By contrast, presumed-consent policies accept that principle but allow the transfer of organs from decedents on the basis of their presumed consent rather than on the basis of their express consent. In their weak form, they also require consultation with the family, primarily about the family’s knowledge of the decedent’s preferences. In the United States, a presumed-consent policy would be more attractive than a routine-removal policy because a presumed-consent policy assigns dispositional authority over organs postmortem to the individual while he or she is still alive and, secondarily, to the next of kin (at least, as a safeguard, to confirm the decedent’s choice). Presumed consent as tacit, silent consent can be ethically valid in social practices that involve extensive

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Organ Donation: Opportunities for Action and effective public education in order to ensure public understanding and that make widely available clear, easy, non-onerous, and reliable ways for individuals to register their refusal. Recommendation 7.1 Presumed Consent. At this time, states should not replace the existing legal framework, which requires explicit consent for organ donation, with a framework under which people are presumed to have consented to donate their organs after death unless they have declared otherwise. However, it would be appropriate for all interested parties to seek to create over time the social and cultural conditions that would be essential for the adoption of an effective and ethical system of presumed consent. REFERENCES Abadie A, Gay S. 2004. The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross Country Study. [Online]. Available: http://ksghome.harvard.edu/~aabadie/pconsent.pdf [accessed March 15, 2006]. AMA (American Medical Association), Council on Ethical and Judicial Affairs. 1994. Strategies for cadaveric organ procurement: Mandated choice and presumed consent. Journal of the American Medical Association 272(10):809–812. AMA. 2005. Presumed Consent Organ Donation. Report of the Council on Ethical and Judicial Affairs. CEJA Report 7-A-05. [Online]. Available: http://www.ama-assn.org/ama1/pub/upload/mm/369/ceja_7a05.pdf [accessed March 30, 2006]. Areen J. 1988. A scarcity of organs. Journal of Legal Education 38:555–565. Ashraf H. 1999. Doctor and patient groups vote for presumed consent. Lancet 354(9174):230. Beauchamp TL, Childress JF. 2001. Principles of Biomedical Ethics, 5th ed. New York: Oxford University Press. Cameron S, Forsythe J. 2001. How can we improve organ donation rates? Research into the identification of factors which may influence the variation. Nefrologia 21(Suppl 5): 68–77. Childress JF. 1997. Practical Reasoning in Bioethics. Bloomington: Indiana University Press. Dennis JM, Hanson P, Hodge EE, Krom RAF, Veatch RM. 1993. An Evaluation of the Ethics of Presumed Consent and a Proposal Based on Required Response. A Report of the Presumed Consent Subcommittee of the United Network for Organ Sharing Ethics Committee. [Online]. Available: http://www.unos.org/resources/bioethics.asp?index=1 [accessed February 13, 2006]. Eaton S. 1998. The subtle politics of organ donation: A proposal. Journal of Medical Ethics 24(3):166–170. English V, Sommerville A. 2003. Presumed consent for transplantation: A dead issue after Alder Hay? Journal of Medical Ethics 29(3):147–152. Erin CA, Harris J. 1999. Presumed consent or contracting out. Journal of Medical Ethics 25(5):365–366. Gallup Organization. 1983. Attitudes and Opinions of the American Public Towards Kidney Donations. GO 8305. Conducted for the National Kidney Foundation, Inc. Princeton, NJ: The Gallup Organization. Gallup Organization. 1985. The U.S. Public’s Attitudes Toward Organ Transplants/Organ Donation.

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