3

Foundations for a Trustworthy Deceased Donor Organ Transplantation System

As described in Chapter 1, the committee’s charge is to address the doubts expressed by many members of the public about the efficiency, equity, fairness, and transparency of the organ transplantation system and their resulting lack of trust in the system. For example, the 2019 survey data presented in Box 1-1 show that while two-thirds of the respondents affirmed that the system “uses a fair approach to distribute organs,” about half do not trust the system to provide “minority patients” and “poor persons” with an equal chance of receiving an organ transplant as other patients.

The present chapter discusses how the individual and societal trust that the organ transplantation system needs to succeed depends on health care professionals fulfilling their ethical duties to do good and not to harm, to respect patients’ autonomy, and to strive for justice and utility in organ allocation decisions. Additionally, such trust is contingent on other institutions—the organ procurement organizations (OPOs), the Organ Procurement and Transplantation Network (OPTN), and agencies of the federal government—upholding these same values. The chapter pays special attention to the concept of justice as it relates to two important points in the committee’s charge, namely, the “equity” and “fairness” of transplant processes and outcomes, and the relationship of equity and fairness to another objective of the system, namely, “optimizing the quality and quantity of donated organs available for transplantation,” in the words of the committee’s charge (see Box 3-1). The chapter also reflects on the role of transparency as an instrumental value in shaping public beliefs and attitudes about the trustworthiness of the organ transplantation system.

WHY IS TRUSTWORTHINESS IMPORTANT?

For organ transplantation to succeed, people—individually and as a society—must trust that the transplantation system operates in an ethical, just, and efficient manner (Boulware et al., 2007; HHS, 2013). Indeed, transplantation stands out as a part of health care where “public trust is utterly indispensable” (IOM, 2006, p. 81). When public trust declines, so too do deceased donation rates (Boulware et al., 2007; Wachterman et al., 2015). Fewer organs being donated can result in medical burdens and loss of life among patients awaiting a transplant. The committee is therefore troubled that many members of the public do not fully trust our current organ transplantation system, and even more troubled that good reasons exist for this lack of trust, particularly for some groups of patients awaiting a transplant. Some of these reasons are specific to transplantation and others are broader, such as having been treated poorly by health care providers and the history of such abuses in society. Barriers to public trust must be overcome if organ transplantation is going to fulfill its lifesaving and life-enhancing potential.

As vital as public trust is to the success of the organ transplantation system, it is at least as essential that such trust be justified. To be worthy of trust, the transplantation system needs a firm foundation: all parts of the system must adhere to clear, coherent, and justified ethical

principles and must obtain and use donated organs efficiently and effectively. This chapter begins by examining the role that ethical theories and principles play in creating a system for obtaining and distributing organs from deceased donors that is worthy of the public’s trust. In addition to health care professionals’ usual ethical obligations—to act beneficently and to respect persons—the chapter gives special attention to the ethical principle of justice because it is, as John Rawls maintains, “the first virtue of social institutions” (Rawls, 1999, p. 3), such as the government agencies and health care organizations that play central roles in transplantation. In addition to the theory that right action depends on health care professionals and institutions fulfilling their ethical duties to organ donors, recipients, and their families, the chapter also develops the implications of consequentialist theories, including those such as utilitarianism that equate a right action with that which maximizes total well-being. An organ transplantation system that is cost effective and efficient as well as fair and equitable would deserve the trust of the public and transplant professionals.

Besides deserving the public’s trust, the organ transplantation system must also be seen as being trustworthy. Perception depends on the system operating transparently, which means that it is open and honest in communicating its values, methods, and outcomes in ways that are comprehensible to a wide range of stakeholders with different needs and varied levels of interest in, and understanding of, organ transplantation. After discussing the relevant ethical principles, this chapter turns to the important role that the principle of transparency plays in achieving trustworthiness, and explores opportunities for overcoming barriers to achieving trust.

The concepts and arguments developed here are then applied in the chapters that follow. Chapters 4 analyzes current disparities in organ transplantation, such as the lower rates at which poorer patients, patients of color, and women are listed as transplant candidates and often the longer time it takes for them to receive a transplant once listed. The chapter explains why such disparities constitute inequities that can—and must—be eliminated, and recommends practical steps to overcome the barriers to equitable treatment. Chapter 5 examines justice in organ allocation policies, looking first at inequities and then turning to the task of enhancing the fairness of a number of policies. Chapter 6, which examines ways to improve the number and quality of organs donated and increase their use, shows how consequentialism is significant in transplant ethics, and offers a way of combining the goal of maximizing the benefits transplantation provides with the goal of a fair and equitable system.

ETHICAL PRINCIPLES AND THEORIES FOR A TRUSTWORTHY SYSTEM

What principles and theories support an ethical system of organ transplantation? The usual starting point in contemporary health care ethics—namely, an analysis of physicians’ duties to their patients—is well suited for organ transplantation, since the care of organ donors and recipients is at heart a medical activity. But our country’s transplantation system encompasses more than individual patients and their physicians. It depends not only on a multidisciplinary team but also on generous individuals who donate organs. The system also depends on many large private and governmental institutions that handle the process by which donated organs are identified, recovered, allocated, and transported to particular recipients; that fund and oversee this process; and that adopt and administer laws and regulations that make this all possible. For this reason, in addition to looking at the duties of physicians and other professionals, this chapter gives special attention to justice as an obligation not just in medicine, but especially in collective activities such as organ transplantation. In addition to drawing on deontology (from the Greek for “duty”), we examine consequentialist ethics since the perception that the organ transplantation system is inefficient or wasteful

can also undermine trust. After outlining the basic concepts, the chapter applies them to the issues that arise in the procurement and distribution of organs from deceased donors.

The Ethical Duties of Health Care Professionals and Institutions

The utility of an ethical theory in guiding a field of endeavor depends on whether the theory will prove useful in resolving the conflicts that create the need for ethical guidance in the first place. In transplantation, guidance is particularly needed about how donors should be treated in organ procurement and the basis on which donated organs should be allocated. Certain traditions, such as virtue ethics, which focus on the character traits of ethical practitioners rather than on the morality of their actions, offer little that is helpful in addressing the central issues of transplantation (Veatch, 2000). Those issues are, however, well addressed by the dominant approach in contemporary health care ethics, which combines the philosophical traditions of consequentialism and deontology. This approach originated with the Belmont Report, a report of the federal commission empaneled in 1974 to examine and propose responses to revelations of unethical medical research over the preceding four decades, which found that the “codes” crafted by jurists and physicians to govern human subjects research were inadequate to cover ethical complex cases (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Instead, the commissioners offered three ethical principles—beneficence, respect for persons, and justice—that they drew from “our cultural tradition” as the most relevant to the task of providing an analytic framework for resolving the ethical problems that arise in research. Since its conclusions were situated at the level of principles rather than rules, the Belmont Report has proved influential across health care ethics, not just for research (Beauchamp and Childress, 2019). The principles—along with others, such as utility—have been relied upon by the OPTN (through its Ethics Committee) in elaborating the ethical underpinnings of the National Organ Transplant Act (NOTA) and the Final Rule,¹ have been developed by scholars addressing ethical challenges in organ transplantation (Veatch and Ross, 2015), and have been employed in prior National Academies reports on organ transplantation (see Appendix B).

Doing Good and Not Doing Harm

The health care professions are grounded in a set of ethical obligations to patients. Since ancient times, medical practitioners and their patients have realized that the trust necessary for therapeutic relationships would not exist if the profession operated under the norms that govern commercial activities such as caveat emptor (“let the buyer beware”). Therefore, two related moral duties have long been central to medical ethics: nonmaleficence, the obligation not to harm others, and beneficence, the obligation to act to benefit others. These duties are often associated with a commandment attributed to Hippocrates, primum non nocere (“Above all, do no harm”). The Hippocratic Oath expresses this obligation through the promise that the physician will both use treatments “which, according to my ability and

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¹ In “Ethical Principles in the Allocation of Human Organs,” first adopted in 1992 (Burdick et al., 1992) and revised in 2010 (OPTN Board, 2010), the OPTN Ethics Committee concluded that the Final Rule’s “regulatory requirements” for the operation of the OPTN “embody the familiar ethical principles of utility (doing good and avoiding harm), justice, and respect for persons” but that the OPTN needed a policy statement to provide the ethical guidance that is lacking in the Final Rule. In equating “doing good and avoiding harm” with the principle of utility, the committee departed from the prevailing description of utility as the maximization of net welfare and of doing good and avoiding harm as the principles of beneficence and nonmaleficence.

judgment, I consider for the benefit of my patients” and “abstain from whatever is deleterious and mischievous” (Hippocrates, n.d.).

Beneficence sounds like a consequentialist concept: Which action will create the greatest benefit? But in the Hippocratic tradition, this duty is framed in terms of intention rather than consequences, and generates a commitment to the primacy of patients and their interests. In ordinary life, behaving beneficently generally connotes acting in a kind or generous fashion, beyond what one is required to do. In health care, however, beneficence—physicians’ duty to put the interests and welfare of their patients before those of others, including their own—is not supererogatory, or beyond the call of duty, but obligatory. This commitment to placing the patient’s best interests first and acting to help the patient, not only by promoting good, but also by preventing harm, is at the heart of medical deontology, that is, the ethical theory that judges whether an action is right or wrong based on physicians’ adherence to their duties to patients rather than solely on the consequences of the actions. Consequences may still be relevant, however, since fidelity to the patient’s best interests usually means trying to maximize the particular patient’s welfare. Health care professionals typically conceptualize welfare in terms of bodily functioning, absence of disease or disability, length of life, and the like, but other aspects of well-being, such as happiness, feelings of security, and the protection of other interests, such as reputation and financial welfare, are also aspects of patient-centered assessments of welfare. These are in turn manifested in specific rules that are derived from physicians’ basic duties of beneficence and nonmaleficence, such as duties to keep confidential information about their patients and not to take advantage (financially, sexually, or otherwise) of patients’ vulnerability. A major limitation of the principle of beneficence as it is usually understood in a clinical context is that the welfare being sought is solely that of an individual patient, rather than encompassing the consequences for, or duties, to others in the health care system.

Respect for the Patient’s Autonomy

While the ancient precepts of nonmaleficence and beneficence remain central to medical care—and hence to achieving an ethical system of organ transplantation—the second principle of contemporary bioethics, respect for persons, is intended to correct another limitation in the traditional precepts, namely, the equation of benefit with physicians’ judgment about what they believed will best serve their patients’ interests. The Belmont Report described respect for persons as having two facets, treating competent adults as autonomous agents and protecting persons with diminished competence (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Attention usually focuses on the first facet and the principle is condensed to “respect for autonomy” (Beauchamp and Childress, 2019), leaving the second facet to be addressed under the principles of beneficence and nonmaleficence, with ethical concern directed at who may make decisions, and on what grounds, for persons who are not autonomous agents, such as minors and individuals with intellectual disabilities.

The concept of autonomy, or self-rule, has deep roots in Western philosophy, especially as regards the spheres of law and government. People expect that their permission is needed before someone intrudes on their private property or touches their body; even governments, whose authority rests on the consent of the governed, can interfere with someone’s property or person without their approval only as is needed to protect the public from serious harm, such as through public health or traffic laws or court orders.

With the growth of scientific medicine in the twentieth century, treatments became more elaborate and hospital based, and the formality of consent, if not its substance, grew (Capron,

1974). Change was also driven by revelations of vulnerable persons being used in medical experiments without their consent, from European orphanages and charity hospitals at the beginning of the previous century through the Nazi concentration camps during World War II, and from elderly, debilitated patients at the Jewish Chronic Disease Hospital in Brooklyn in the early 1960s to poor black farmers in the United States Public Health Service Syphilis Study at Tuskegee between 1932 and 1972. As the first requirement of ethical medical research, the tribunal that passed judgment on the Nazi doctors after the war stated, “The voluntary consent of the human subject is absolutely essential” (Nuremberg Code [1947], 1996). The judges held that the conditions for an “understanding and enlightened decision” include the person having “the legal capacity to give consent,” being “able to exercise free power of choice,” free of fraud or coercion, and having “sufficient knowledge and comprehension of the elements of the subject matter” (e.g., the nature, duration, and purpose of the experiment; how it will be conducted; what hazards it entails). While medical societies attempted to maintain a wider sphere of discretion in treatment settings,² the principle of autonomous choice—which requires an act that is intentional, with understanding, and free of controlling influences (Beauchamp and Childress, 2019)—came to be recognized as an ethical (and legal) requirement in diagnosis and treatment as well as in biomedical and behavioral research (Faden and Beauchamp, 1986).

Respect for persons includes manifesting a respectful attitude, but it also requires respectful actions: for example, by acknowledging that people may make choices based on their beliefs and values, which others will accept even when they think a different choice would be better. In contemporary terms, autonomy is the ethical bedrock on which patient-centered care is built. Patient autonomy supplants physicians making medical decisions for their patients, a practice which often extended to medical paternalism, that is, the tradition of physicians overriding medical choices made by patients that the physicians believed would not be in the patients’ best interests. Although often thought of as a relic of a medical custom that came to an end in the previous century, the impulse to protect patients from bad choices remains and can lead to subtle and sometimes unnoticed forms of paternalism, including in organ transplantation.

Four aspects of the principle of autonomy deserve special attention. First, the negative version of autonomy—that is, competent patients withholding consent to proposed medical interventions—is much stronger and more absolute than the positive version—that is, patients designing their own treatment. During the 1960s and 1970s, some patients’ rights advocates, in aiming to supplant physicians’ dominant position in health care, sought to assign patients full responsibility for and control over all decisions about their own care. This position—sometimes called “patient sovereignty”—in effect flips medical paternalism on its head, making physicians the servants of their patients, using their technical skills as patients direct and refraining from trying to influence them. Today, it is generally agreed that neither extreme is ethically defensible or even sensible; instead, physicians and patients—each with their own personality, attitudes, and values—should strive for shared decision making, based on mutual respect and joint participation in the process (President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982). The principle of respect for autonomy—and its legal counterpart, informed consent—holds that ultimately, the choice among possible medical options (including, of course, no treat-

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² As originally adopted by the World Medical Association in 1964, the Declaration of Helsinki differentiated between research on normal volunteers, for which “free” and “fully informed” consent was necessary, and “clinical research combined with professional care” for which “the doctor must be free to use a new therapeutic measure, if in his judgment it offers hope of saving life, reestablishing health, or alleviating suffering,” with the informed consent of the patient, “if at all possible, consistent with patient psychology” (WMA, 1964).

ment) belongs to the patient, but health care providers are not obligated to provide medical interventions that have no basis in medical science and practice or that violate their own deeply held moral beliefs.

Second, the principle of autonomy does not imply that patients are, or ever could be, self-directed in the sense of being totally independent of other persons or free from interior or exterior influences. This speaks to the concept of relational autonomy, which rejects traditional understandings of autonomy as both too atomistic and unrealistically rational, and insists instead that autonomy arises from relationships with others, such as parents, teachers, friends, and loved ones (Nedelsky, 1989). In various individualized ways, patients are situated within families, communities, and other social institutions; they have personal histories that shape their understanding of the world and the view of what is possible for them going forward; they have real and perceived social, moral, and financial obligations—or what may feel like obligations—to others, including the health care professionals who provide them with care. Everyone involved in decision making—especially members of the medical team who will implement whatever medical choice the patient makes—should endeavor to help patients in making choices which are consistent with their lives and values as persons within relationships, which can entail assisting them not only cognitively, by providing comprehensible information about the medical options and their benefits and risks, but psychologically and emotionally as well (Walter and Ross, 2014). Since relational autonomy not only rejects the conception of autonomy as complete independence from others but also recognizes that some “choices” actually reflect domination by others or by societal expectations, health care professionals may need to protect patients from coercion, manipulation, or other attempts by third parties to control their choice. Yet it will rarely, if ever, be possible to free the patient from all external influences, or indeed, to identify where a line can be drawn between factors that are external and those that are internal, wherever the latter may have originated. The fact that patients are enmeshed in relationships that strongly influence their medical choices is not inconsistent with the proposition that their “autonomous choices” should be respected; indeed, such relationships are often very helpful in supporting patients in making decisions that are true reflections of their individual selves and the ends they seek to achieve.

Third, while physicians who foster shared decision making can thereby adhere to the principle of autonomy, the principle does not require that all physician–patient relationships take a single form. Certain minimal requirements—disclosure to the patient of material information about the medical options and ensuring the patient has the ability and opportunity to participate in the decision-making process and the right to accept or reject medical interventions—must always be met. Still, each physician and patient can shape their specific search for successful treatment in ways that fit their own abilities and objectives, questions, and hopes as well as their particular situation (e.g., a long-standing primary care relationship versus a one-time consultation with a specialist; preventive care versus life-sustaining treatment; and so forth). Ideally, the nature of the relationship will grow organically, influenced by the personalities and needs of each party as they exchange information and respond to issues that arise. Parties outside the physician–patient dyad, such as the institution where the physician practices and the insurer that pays for some or all of the care, will also affect the contours of the relationship. A variety of arrangements are all consistent with respecting an autonomous exercise of choice about medical care.

Finally, the well-known theory of deontological ethics developed by Immanuel Kant places rational choice of autonomous moral agents at its center. In Kantian ethics, the moral worth of an action depends on its being autonomously chosen based on a universally valid rule, rather than for some other motive. The criterion for judging the validity of a rule is termed the categorical imperative, which says that rules must be universalizable and con-

sistent, that is, not contradict themselves. The most familiar formulation of the categorical imperative is, “One must act to treat every person as an end and never as a means only” (Kant, 1959). In situations where what is being done to a patient is not solely for that person’s benefit, such as when a patient is enrolled in a clinical trial, Kantian deontology holds that such an act is permissible only if the patient had a choice whether or not to take part, thus embracing the objectives of the clinical trial as his or her own end, not solely that of the physician–investigator.³

Justice

Contemporary accounts of health care ethics include justice as an important obligation of physicians and other health care professionals (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). But the principle of justice has its greatest effect when applied at a higher level in health care, from institutions (such as hospitals) to broader systems (such as the organ transplantation system) to society as a whole (such as tax and expenditure policies related to the financing of health care). Adjusting policies and practices to make access to health care—and the distribution of its benefits—more just is not a new goal, but it is a matter of particular urgency today.

The concept of justice applies in a number of ways to social institutions, including health care.⁴ Justice concerns the processes and procedures by which decisions are reached and actions are taken, as well as to the policies that guide those processes. Justice has been articulated in various ways, among which equality, fairness, and equity receive attention here, since each has implications for the goal of achieving justice in the organ transplantation system.

Equality: “Justice” can connote procedural justice, which is usually expressed as equality, namely that people must be treated equally, both by the institutions of government (such as the courts) and in settings open to the general public (such as stores and restaurants). Equality means that all persons will receive equal respect and concern, have equal access to decision makers, and will have their rights and interests equally protected.

What implications does the principle of human equality have for health care policies? Given the huge variation in human health and the wide range of diseases and injuries that

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³ The categorical imperative is often cited as an ethical foundation for informed consent, even though not all instances of a person consenting to a medical intervention (or to any other act by a third party) would meet Kant’s definition of autonomy, which is much narrower than the way the term is used here or generally in medical ethics. Kant limits “autonomy of the will” to actions taken knowingly in accord with a universally valid principle that accords with the categorical imperative, rather than a knowing, voluntary choice made for any reason that is sufficient in the patient’s eyes.

⁴ In treating health care as an activity that should adhere to the requirements of justice, the committee is not suggesting that all policies or practices in society must be judged by their adherence to this principle. Many things in our society are distributed in other ways, such as by inheritance or through the market. While health care is in part a market good, our society does not leave it entirely to the market for several reasons: it is not a free market, it generates large externalities, and, most important, it provides the means for obtaining relief from the burdens of disease and disability which restrict people’s chance to attain a state of well-being or a fair share of the normal range of opportunities (Daniels, 2008; Powers and Faden, 2006). In sum, health care is different because it is closely connected to health which is a basic good that is valued by all people however much they may differ in their other preferences because it is a basic requisite not just for survival but for living a full life, with an opportunity to achieve one’s goals. Thus, for many years, access to the means for attaining and maintaining health has been described as a basic human right (President’s Commission, 1953) or an ethical obligation of a just society (President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982). Recognizing that few people can be certain that they could afford all the medical care they need, most people obtain health insurance, either in the marketplace or as a benefit of employment, while some groups, particularly the elderly, veterans, some children, and other poor people, rely on public insurance or public providers of care.

people experience, justice does not demand that all people receive the same amount of health care services, much less that they are guaranteed to be equally healthy. Indeed, most individuals experience different levels of health—and hence have very different needs for health care—at different times across their life. But in a just society, people whose physical and psychological needs are roughly similar have comparable access to appropriate, timely care, and all are treated as equally deserving of respect in their interactions with the health care system.

Fairness: A maxim attributed to Aristotle—treat like cases alike, and unlike cases differently—suggests that the goal of justice is to avoid arbitrariness or favoritism.⁵ The first precept reiterates the principle of equality, but the second recognizes the inevitability of relevant differences among people. That is, we may be equal before the law in our rights, but the ways in which we differ can legitimately lead to differences in the way we are treated.

One must look beyond the maxim itself to posit which characteristics may be relied on when determining who is similar or dissimilar. Thus, the fairness of a policy that treats certain people in one way and others in a different way depends upon three conditions. First, the right or interest addressed by the policy cannot not be one that must always be based on equality but rather must be one where it is ethically acceptable to treat people differently. Second, the process for arriving at the policy must be fair, meaning that the decision maker is free of bias and all interested parties have an opportunity to present their views. Third, the factors relied upon in distinguishing among people and placing them into groups is ethically justified and supported by the best evidence to the extent possible. Aside from characteristics that antidiscrimination laws exclude from being considered, it is often challenging to determine which features may legitimately be taken into account and which are factually or ethically irrelevant, especially when the features arise from the system itself, such as the jurisdictional or geographic division of activities or authority, or relate to other objectives that the policy is intended to advance, such as maximizing total welfare or redressing past injustices. Justice demands fair processes when policies are adopted that could result in medically similar patients experiencing significantly different access to particular, needed resources, meaning that any factor used to differentiate among people not only is relevant (i.e., it pertains to the right or interest affected by the policy) but also accounts for the effects of drawing the distinction on the groups thus differentiated and on other persons or institutions affected by the policy.⁶

Equity: If questions of fairness arise when debating whether to take certain factors into account in framing a policy, the question of equity comes to the fore when measurable—in fact, often very large—disparities exist among identifiable groups in access to needed services and in health outcomes even though on paper the policies in question entitle all people in the various groups to equal treatment. Justice demands that access to health care be equitable, meaning that persons in equivalent medical circumstances actually receive equivalent

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⁵ Justice, which assumes individuals are members of groups who have interests and claims that compete with other members, provides a possible corrective for the individualistic focus of the principle of beneficence, under which physicians are expected to favor the interests of their own patients over other interests.

⁶ Despite the requirement of fairness that medically similar patients have similar access to resources, it is sometimes suggested that a “coin flip” or a lottery would be the fairest way of distributing a scarce resource since such a method gives all parties an equal chance. Yet for officials to consciously choose to distribute something important, such as potentially lifesaving treatment, in a random fashion can appear disrespectful of the individuals who will be affected. Moreover, it can seem a dereliction of the expectation that such officials will work to identify the factors that are both ethical and scientifically relevant to a fair allocation. On the other hand, adopting a distribution policy that relies on factors that align with membership in an identifiable group (e.g., one defined by age or sex) can be taken as a judgment that the lives of people in the groups that are placed further back in the queue for the resource are worth less than the lives of other people.

medical care, free from irrelevant considerations such as their sex, race, ethnicity, religion, socioeconomic condition, physical and mental capabilities, and similar personal attributes.

For many years, the concept of health equity has been an explicit part of efforts to improve the overall level of population health in our country and strengthen quality improvement efforts (IOM, 2001). Among such disparities, those that are “closely linked with social, economic, and/or environmental disadvantage” are of particular concern (HHS, 2021a). In a just society, such disparities must be regarded as health inequities that are morally unacceptable, not only because they demonstrate a failure in our proclaimed commitment to the equal worth of all people but also because they result from historical and contemporary injustices, many of which are embedded in social institutions (including in health care) and are perpetuated not only by conscious prejudice but also by unexamined practices. To the extent that such disparities are avoidable, then an equitable system will take the steps necessary to eliminate them (see Box 3-2).

A just society is thus one characterized by equality, fairness, and equity. In this report, the committee gives particular attention to the latter two terms (which appear often in our charge), and has chosen to consider them separately. The committee’s decision to do so is pragmatic rather than epistemological, since equity and fairness are—along with “justice” itself—often used as synonyms. But by distinguishing the two terms, the committee can examine the somewhat different ways that the principle of justice—or its absence—can arise in the organ transplantation system. Just as “equity” provides a way to ascertain when justice is manifestly absent because the organ transplantation system treats groups of people very differently for reasons that are unconnected to their medical needs but that align with their membership in a group that is subjected to discrimination, “fairness” is useful in choosing the most just policy from among alternatives, each of which is defended by reasonable people.

Efficiently Maximizing Welfare: Utilitarian Ethics

While the ethics of medical practice and research is typically framed in terms of physicians’ duties, deciding what is the right thing to do in a particular circumstance sometimes

is guided by comparing the potential good and bad results of the available courses of action. This version of consequentialism is therefore consistent with—indeed, inherent in—physicians’ duties of beneficence and nonmaleficence, since it recognizes that serving a patient’s interests usually entails offering the preventive, diagnostic, or therapeutic intervention that is most likely to provide the maximum benefit for the patient. To decide whether a physician’s duty of beneficence has been fulfilled, a consequentialist would thus ask whether the recommended medical intervention will probably produce the greatest benefit for the patient.

When making collective rather than individual (that is, patient-focused) choices and rules, the best known consequentialist theory is utilitarianism. As formulated by Jeremy Bentham and John Stuart Mill, utilitarian ethics holds that the right action is the one that produces the greatest net utility for a population, by impartially giving equal consideration to the legitimate interests of the affected parties (Beauchamp and Childress, 2019). Utility—that is, what is being maximized—has been described in various ways; Bentham, for example, favored happiness. Today, most utilitarian accounts include a diverse set of values, which can be summed up as welfare. In the context of medicine, maximum welfare can be thought of in terms of the value of the population’s health and well-being less the cost of achieving it. In this way, ethical theory supports attending to the efficiency of the health care system, which is one aspect of a trustworthy system of organ transplantation, namely, that the available resources are being used efficiently to maximize welfare.

Utilitarianism faces some objections that are internal to the theory. First, doubts are raised as to whether an “impartial” assessment of individual interests is even possible. Second, how can those interests be combined to calculate net utility? Many of the resources involved in health care are readily monetized (such as facilities, equipment, personnel, and supplies) which facilitates their being brought into a net-cost calculus. But other costs are intangible, such as the anxiety and suffering experienced by patients and their families from illness as well as in efforts to alleviate it. The same is true of the benefits: the restoration of health allows people to return to work and engage in other productive activities, but some of the benefits that people value the most—relief from pain and suffering, return of the ability to form and carry on relationships, and the like—do not have a ready market price. Further, any calculation of net benefit also needs to take into consideration the value of alternative goods that could have been produced using the same resources elsewhere in health care. Given the inherently subjective nature of many of the interests involved, how could one say which is a greater contribution to net social utility, the value to 16,000 people of not having a severe, day-long migraine or the value to one person of not dying suddenly but painlessly at age 25 (with the loss of about 16,000 days of life expectancy)?

Utilitarianism faces other problems when it conflicts with non-consequentialist theories, such as medical deontology, which produce divergent conclusions about what should be done. In particular, utilitarian policies can produce results that appear unjust, particularly when they are framed against an existing set of circumstances that incorporate manifest inequities. Suppose, for example, that when the resources available to treat a potentially fatal condition are limited, more lives could be saved if they were used to treat patients in urban hospitals because the treatment can be provided more efficiently there—each hospital has a large number of patients in need of care and possesses adequate staff expertise and infrastructure to apply the treatment well—compared to using some of the resources in small rural facilities that lack the necessary expertise and infrastructure and that each have only a few patients. While utilitarian theory would direct using the resources only at the urban hospitals, that would challenge the principle of justice if the patients who seek care at the small rural hospitals come from the poorest sector of the population and already bear a much heavier burden of chronic diseases. Just as decisions that are grounded in justice must take into account utilitarian—or, more broadly, consequentialist—concerns, by giving preference

among equitable alternatives to those that use resources most efficiently, so too decisions made using a utilitarian calculus are subject to a justice constraint. The result is that sometimes a choice that would maximize welfare must be rejected in favor of an alternative that creates less utility but avoids creating, or perpetuating, an existing distribution of benefits and burdens that is inequitable.

THE RELEVANCE OF ETHICAL PRINCIPLES FOR THE ORGAN TRANSPLANTATION SYSTEM

To what extent are the ethical expectations generated by the foregoing theories and principles manifested in the policies and practices of our nation’s organ transplantation system? Asked another way, does the system adhere to ethical standards in a way that should inspire people most directly involved to regard organ transplantation as a system worthy of their trust? This section applies the summary of ethics presented above, principle by principle, to a number of policies and practices to illustrate the ways that the system may or may not meet ethical obligations to organ recipients and donors. The chapter aims to show how ethics is relevant to the system, but leaves to subsequent chapters a detailed examination of the ways that organ donation, procurement, allocation, and transplantation policies and practices affect donors and recipients and their families as well as the health care professionals involved with these persons and thereby may create or undermine trust in the system. While most of the issues that the committee was asked to study, such as organ allocation policies and maximizing the use of donated organs, focus on patients who need a transplant, transplantation begins with organ donors and even deceased donors also begin as patients, to whom ethical obligations are owed not only by the health care professionals who care for them, but also by other individuals and institutions within the organ transplantation system with whom they never personally interact.⁷

Beneficence and Nonmaleficence

For patients who experience organ failure, transplantation offers a route back to health and long-term survival. Yet the obvious benefits of a system that provides organ recipients something of such great value does not end all doubts about beneficence and nonmaleficence. To begin, some unique features of the system create dual loyalties among transplant professionals, who have to be both an advocate for individual patients and a steward of a scarce resource that needs to be used to maximize overall welfare (Griffin, 2002; Khazanie and Drazner, 2019; OPTN, 2018). For example, a transplant center may be offered a kidney but then declines it on behalf of the transplant candidate to whom it was first offered. Does this situation entail a failure—or only an appearance of failure—to “put the patient’s interests first” as to those patients for whom the organ would have been medically suitable but who were not selected to receive it? Without knowing the full context of clinical decision making, potential recipients may feel that their trust has been breached upon learning that a kidney that was suitable for them had been given to another patient. If choices of this sort are inevitable for transplant centers and transplant teams, trust might be better protected if this situation were explained in advance.

To say that the organ transplantation system treats potential recipients ethically requires more than individual professionals fulfilling their duty of beneficence. The system as a whole

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⁷ The ethical duties owed to living organ donors (Ross and Thistlethwaite, 2021) overlap with but also differ significantly from those owed to deceased donors.

must do so as well, from the time that a patient develops a medical condition for which transplantation is the best treatment through to the posttransplant phase, when the patient needs continued follow-up and care to maintain a functioning organ. One example is access to the immunosuppressive medication needed to prevent rejection of a transplant. Until recently, the End-Stage Renal Disease program paid up to 80 percent of the cost of antirejection medicines for only 3 years, which placed financial strain on transplant recipients, and in some cases, led to organ failure in transplant recipients who could not afford to buy the medication. The Beneficiary Improvement and Protection Act of 2000 extended coverage of immunosuppressants for the life of the kidney for patients who qualify for Medicare coverage because they are disabled or 65 years or older (Gordon et al., 2008). A further change in the law approved in December 2020 expanded Medicare payment for the antirejection drugs to all kidney recipients who lack other insurance.⁸ The amendment does not, however, extend other Medicare benefits for kidney recipients, including for other transplant-related medications. Failing to provide all care needed to preserve the function of transplanted kidneys is not beneficent—and not efficient, as well—since recipients whose transplant fails will need a second transplant and, in the meantime, dialysis.

The issue of a potential dual loyalty, which can compromise physicians in fulfilling their duty of beneficence, also arises in the care of deceased organ donors, where it is recognized and dealt with directly in the law. Since deceased donation obviously does not occur until the prospective donor has died, a trustworthy organ transplantation system needs to ensure that death will not be declared prematurely and never by anyone involved in transplanting the organs or taking care of the patients who receive them.⁹

Autonomy

Donors

The respect shown for donors’ choices provides a solid basis for trust in the U.S. organ transplantation system. All U.S. states endorsed an autonomy-based donation policy, by enacting the Uniform Anatomical Gift Act (UAGA) in 1968. Further, the UAGA made the deceased person the “giver.” Prior to the UAGA, the common law put disposition of dead bodies in the hands of the legal next of kin. The Act changed that, allowing potential donors to decide during their lifetime, and it made it easy for them to document that choice; only if the deceased had not done so would the decision fall to the legal next of kin. On the federal level, the NOTA of 1984 made explicit that donated organs must be voluntary gifts, neither seized by the state nor purchased. The 1987 revision of the UAGA retreated slightly from autonomy by allowing a state medical examiner or other public health official to authorize the removal of a part from a deceased body in their possession without permission of the family when attempts to contact next of kin had failed. But that authority was removed when the UAGA was amended again in 2006 to emphasize respect for donor’s autonomy by ensuring that a donor’s decision “is to be honored and implemented” even when a family member objects (Sadler and Sadler, 2018).

Since 1993, the Health Resources and Services Administration (HRSA) has contracted with the Gallup organization to conduct four nation-wide public opinion surveys (1993,

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⁸ H.R. 5334, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020, was incorporated in and passed as part of the Consolidated Appropriations Act, 2021. The bill was signed into law on December 27, 2020. For the full text see https://www.congress.gov/bill/116th-congress/house-bill/133/text (accessed November 5, 2021).

⁹ Uniform Determination of Death Act (1980); Revised Uniform Anatomical Gift Act (2006).

2005, 2012, 2019) on the nation’s attitudes and practices toward organ donation. Across the nearly 30 years of survey data, support for organ donation has been high and sustained at over 90 percent (HHS, 2019). This long-standing public support was the basis of the increased focus on personal autonomy in the donation process, and resulted in the Revised UAGA (2006). The revisions simplified the document of gift process to allow individuals to make the personal choice to donate anatomic gifts at the time of their death using the driver’s license documents as the state donor registry. Another key element of the 2006 UAGA was establishing two separate legal avenues to arrive at a “yes” to donation—an individual can make a gift before death, known as first-person authorization, or a surrogate can authorize a gift at the time of the donor’s death (Glazier, 2018). The UAGA also strengthened an individual’s right not to donate by permitting signed refusals.

Donor registries proliferated in all 50 states, plus the District of Columbia and Puerto Rico as a result of the revisions to the UAGA. State donor registries are managed through each individual state’s department of motor vehicles (DMV) in close collaboration with the OPO, tissue and eye procurement entities within a donor service area. In the years since the 2006 UAGA, donor registries have matured, and over 90 percent of the public surveyed who indicated that they had signed up as organ donors stated they joined a donor registry through their state DMV (HHS, 2019). To address the challenges of a mobile population and the limitations of accessing donor registry information when death occurs outside the state of residency, Donate Life America launched the National Donate Life Registry in 2015 as a way to make donor registration an easy and secure process across the country.¹⁰ When a death occurs in a hospital, the OPO accesses the state of residence donor registry and the national donor registry to determine if the individual has made a first-person authorization for donation.

Given the variety of databases, there have been challenges in knitting together nonstandardized data from 52 independent state agencies to better understand the individual registry rates by state and by demographic. Donate Life America notes that 55 percent of all organ donors in the United States have been authorized by first-person authorization via a donor registry (Donate Life America, 2021); with better data, it is estimated the number could be higher. Despite the data challenges, the number of donors registered has grown from 156 million in 2019 to 169 million in 2021 (Donate Life America, 2021). Improved data would also show the gaps in registries—that is, which groups are joining donor registries at rates well below the general population, an important factor in better understanding inequities in the organ donation process. Another area not well understood is how the donor’s autonomy is respected if a surrogate decision maker “at the bedside” expresses opposition to donating organs from a patient whose wish to donate appears in the donor registry.

Accurate knowledge of organ donation and transplantation is fundamental to the success of the transplant enterprise (see Box 3-2). Misinformation and public distrust can lead to reduced rates of organ donation. At the individual level, members of the public vary in their awareness and knowledge of transplantation. Despite efforts to educate the public about organ donation and transplantation, many members of the public report being unaware of organ donation. Making information about organ and tissue donation more readily available to, and comprehensible by, the public, including how to sign a donor registry, is an important part of respecting personal autonomy. Such information can increase people’s awareness of their right to decide for themselves about organ transplantation, including the value of using the registry and how it relates to other aspects of the process, as well as help them to

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¹⁰ For information on the Donate Life Registry see https://www.donatelife.net/national-donate-life-registry (accessed January 28, 2022).

understand how and when donation occurs. Information programs need to take account of differences among the audience being addressed. Targeted interventions have shown promise in increasing black donor registry rates (DuBay et al., 2018). Further research about the attitudes of racial and ethnic groups toward donation is needed if educators are to tailor the information content and manner of presentation to different audiences, whether through DMV offices or by other means that take into account each group’s cultural and religious traditions and beliefs (Craig et al., 2021).

Recipients

If the ethical principle of autonomy is clear as to organ donors, what about for recipients? Like any patient, potential organ recipients receive respect when the transplant professionals who provide their care involve them as informed decision makers in the treatment process from being evaluated and listed for, to then undergoing, a transplant. Respect for autonomy is typically equated with obtaining informed consent, but a good deal can be lost in translation from ethical principle into legal necessity, especially when the latter is reduced to getting a patient’s signature on a consent form before surgery may commence.

Studies have repeatedly shown that many barriers exist to achieving informed consent. Some arise on the patient side: a lack of basic understanding of the illness and its treatment, an inability to process complex information (short of mental incapacity), and anxiety or wishful thinking, which can lead to denial of facts or to false beliefs. A major issue on the doctors’ side is that their busy schedules may not offer time for in-depth discussions with patients, for which they are in any case poorly compensated. Further, they may lack either the maturity or in-depth education needed to navigate such conversations comfortably and productively or to discern the degree to which patients want to be true partners in shared decision making. Instead, clinicians’ main objective is usually to obtain approval for what they genuinely regard as the best course of treatment; this aim can lead to selective disclosure of information on potential harms and benefits and on the relative merits of therapeutic alternatives (Hall et al., 2012).

Transplant professionals are mandated by the OPTN to deliver education to patients initiating transplant evaluation (as well as to potential living donors at the time of donor evaluation). However, the format for delivering transplant education varies from videos to one-on-one education by a nurse to group discussions led by surgeons or nurses; such education may not be available in Spanish or languages other than English (Gordon et al., 2010). Further, dialysis facilities are mandated by the Centers for Medicare & Medicaid Services to inform dialysis patients about the option of transplantation when the patient begins their dialysis treatment,¹¹ though compliance with this policy is not 100 percent (Waterman et al., 2015).

If, as research has shown (Braddock et al., 1999; Hudak et al., 2008), informed consent processes typically fall short in health care generally, might the ethical ideal of autonomous decisions be more achievable for transplant patients? Patients awaiting a transplant typically have considerable time to learn about their disease and its expected progression, to realize how it affects them and how they feel about that, to learn about the different ways it can be treated as well as what is likely to occur if these options are rejected, and to form a therapeutic relationship with the team of professionals managing their care. Thus, assuming that they have, and retain, decision-making capacity and that the decision to have a transplant is voluntary, potential recipients would seem to be in a good position to participate in a process of shared decision making with a surgeon and other members of the transplant team. Yet a

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¹¹ Condition: Patients’ Rights, 42 C.F.R. §494.70 (2021), https://www.ecfr.gov/current/title-42/chapter-IV/subchapterG/part-494/subpart-C/section-494.70 (accessed November 18, 2021).

number of features of organ transplantation pose barriers to shared decision making (Gordon et al., 2013). Indeed, some of these features—such as transplant centers’ ongoing responsibility for a large set of patients waiting for deceased donor organs, the fragmented relationships that occur when patients have to interact with a variety of professionals in multiple settings (e.g., their primary physician’s office; a dialysis center; the transplant center, which they may visit only once a year, or less), and the unpredictable timing of deceased donor offers—can make clinicians’ typical shortage of time for detailed discussions with patients even more pronounced.

Nevertheless, programs need to be forthcoming with organ transplant candidates about the decisions that will need to be made and to find out the extent to which patients want to be involved in those decisions. As noted above, respect for autonomy can manifest through any number of different arrangements between physician and patient; even shared decision making can take many different forms, as chosen by the people involved, with no expectation that patients must exercise their autonomy in a particular way (Hall et al., 2012). But certain ethical requisites must be met—especially disclosure of central, material information about the process and discussion of the choices entailed—if potential recipients are to regard organ transplantation as a trustworthy process.

As discussed in Chapter 6, when an organ has been offered for a particular patient on the waiting list, the patient’s surgeon has little time to decide whether or not to recommend to the patient to accept the organ; yet, if the surgeon concludes that the offer should be declined, the patient may not be alerted. Many factors go into the decision, such as the type of organ (e.g., kidney versus other organs), the patient’s situation (e.g., hospitalized versus outpatient), and technical factors about the organ, its medical suitability for the patient, and why it was declined. Since the decision ultimately turns on whether the probable benefit to the patient of receiving the particular organ outweighs the probable benefit of rejecting the organ and waiting for another, the decision should reflect the patient’s values and goals, and if the surgeon believes that the moment when an organ is offered is not the right time to discuss this topic, then the transplant program must find another time for this conversation in order to meet the expectation that decision making will be patient centered. For example, at the time patients are placed on the list for a transplant and periodically thereafter, members of the transplant team can have conversations with patients about their view of their current situation and about what they hope for, about how they cope with adversity, about their understanding of what is entailed in transplantation, and about similar topics as a means not only of responding to patients’ doubts and confusions but also of learning about their goals and values (Gordon et al., 2013). Once an individual patient’s preferences have been revealed and he or she has reached an understanding with the transplant team about the goals of care, the professionals will be able to carry out their fiduciary duty to make technical decisions (such as whether to accept an organ offer) in a fashion that is informed by, and aligned with, that particular patient’s goals under the circumstances (Joffe and Truog, 2010).

Another opportunity for transplant programs to make sure that prospective recipients are adequately informed about the transplant process is to discuss how decisions are made regarding the allocation of organs that become available to the program. Such disclosure and discussion would enable patients to ascertain whether the reasons are acceptable and pertinent factors have been considered (Emanuel et al., 2008). It may, for example, be material to some patients’ understanding of their status to know how many organs have been offered to and declined by their center in order to gauge their own likelihood of receiving an organ; this can promote a process of shared decision making as to whether the patient wants to reconsider accepting organs that the center would otherwise decline (Mohan and Chiles, 2017).

Discussions about patients’ goals need to include frank consideration of the attendant uncertainties, especially if the patient’s condition is likely to be more emergent by the time an organ is offered, as is the case, for example, with most lung transplants. The progress of disease prior to transplantation can necessitate long periods in intensive care posttransplant, with the resulting complications and debilities, and it is important for these to be discussed (Courtwright et al., 2019).

Likewise, when several alternative approaches are possible and vary in the way they combine probable benefits and harms, assessing the patient’s preferences for these outcomes can be informative. Such conversations need to be repeated with patients who are awaiting a transplant for months or years, since their views on what risks are worth taking may change over time. Finally, transplant teams need to remember that voluntariness is an essential component of informed consent, which means that patients must be able not only to give but to withdraw consent. Remaining patient centered is essential if the organ transplantation system hopes to be worthy of the trust of patients and their families.

Justice

The lack of complete data on health inequities means that the first step in improving justice in the organ transplantation system is to approach data gathering and analysis in a manner that is both broad and deep. Scrutiny of comprehensive, longitudinal data about which patients with organ failure receive transplants and which do not should reveal which disparities in rates reflect inequities. This monitoring and analysis needs to extend to all aspects of the transplant process. For example, as instructed by §121.8 of the Final Rule, the OPTN board has looked closely at the ethical and policy aspects of equitable access to donated organs among patients on a transplant waiting list. Yet, although the “primary barrier” for socioeconomically disadvantaged people in getting a transplant is “gaining access to a waiting list” (IOM, 1999), the OPTN has given only sporadic attention to policies that reduce the inequities in access to transplant services resulting from socioeconomic status, such as policies providing for listing of all patients in need without regard to ability to pay or source of payment, or “procedures for transplant hospitals to make reasonable efforts to make available” themselves or to obtain from others, “financial resources for patients unable to pay” such that they have the opportunity to obtain a transplant.¹² At the heart of this problem is the unacceptable reality that “Many uninsured Americans give organs, but they rarely receive them” (Herring et al., 2008, p. 641). The purview of the OPTN begins when an individual patient is added to the waiting list for a deceased donor organ. As stated throughout this report, the committee finds that this gap in oversight presents a significant challenge to ensuring fairness and equity in the organ transplantation system (Patzer et al., 2012).

While disparities that arise from the discrimination or implicit bias against people based on their color, sex, religion, socioeconomic status, or the like, or from the general effects of racism, ableism, ageism, or sexism, are unquestionably inequitable, other policies that generate claims of unfairness are harder to resolve. For example, some people believe that sending organs donated at a hospital to recipients in distant cities is unfair to patients awaiting an organ at a transplant center located in the same city as the donor hospital; others claim that certain methods of prioritizing potential recipients are unfair because they either neglect important criteria or include irrelevant ones. Such complaints may either be objections to the process by which the algorithm for allocating a type of organ is carried out or objections to the factors that are incorporated into rules that emerge from the process. Both

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¹² OPTN Final Rule, 42 C.F.R. §121.4(a)(3).

types of objections should be considered; a justification is owed whether or not the process of rule development is modified or otherwise enlarged to encompass more stakeholders, or whether or not other factors are incorporated. Achieving health care justice is such a central concern that the next two chapters are devoted to disparities in organ transplantation and when and why they amount to health inequities, as well as how the deceased donor organ allocation system can be made more fair.

TRANSPARENCY: AN INSTRUMENTAL VALUE FOR A TRUSTWORTHY SYSTEM

The ethical principle of respect for individual autonomy requires that health care providers disclose to patients the information they need or want to understand their choices and make an informed decision. Making relevant information available to patients is thus part of what makes the organ transplantation system trustworthy to them. Transparency about the system—that is, its policies and outcomes—is also essential to achieving trust among members of the general public as well as authorities who exercise oversight of the system for the public. This aspect of transparency is an instrumental precept (i.e., a means toward a trustworthy system) rather than a bioethical precept. Indeed, the ethical principle of nonmaleficence imposes on professionals the duty of keeping information about patients confidential, so that the data made available to others to achieve “transparency” is always limited to what the patient permits to be disclosed or what can be disclosed without breaching confidentiality. Within such limits, everyone involved in organ transplantation is well served by erring toward disclosing rather than withholding information, given the relationship between transparency and public trust.

Like many aspects of health care, the organ transplantation system faces increasing demands to provide information beyond existing regulatory and statutory obligations (which began with NOTA because the public has such a substantial stake in whether the process of obtaining and distributing lifesaving materials of human origin is operating fairly and efficiently). Besides trust, transparency is necessary for accountability as well—which is to say, not simply the obligation of the system to provide an account of its operations but also to be answerable for any deficiencies or misfeasance. Only by having access to information about how decisions are made, by whom, and with what premises and goals; about what decision makers are doing or plan to do; and about the results of their policies and practices can outsiders, including the public and its representatives in government, hold the system’s operators accountable. Accountability in transplantation signifies requiring the professionals and bureaucrats involved to explain and accept responsibility for meeting their primary obligations, not merely complying with regulations or meeting managerial performance targets (O’Neill, 2004). Some have posited that trust could be fostered throughout all phases of the transplantation system by respecting family wishes and individual autonomy (Sadler and Sadler, 2018).

When the duty to be transparent is framed in terms of primary obligations, it is important to remember that—as noted earlier—the organ transplant “system” has many components that operate with different degrees of interrelation but that lack a single director who can be

held accountable. At a national level, the policies developed by the OPTN are published by the HRSA, the federal agency which oversees the OPTN contract. Thus, accountability comes from having to explain and justify those policies publicly before they may be implemented. By contrast, when individual transplant programs or donor hospitals, and the professionals who practice in those facilities, develop their own policies, the public is usually not consulted and may be unaware of their content or reasoning.

A different type of transparency exists for data about transplant waiting lists, organs donated and used, and transplant outcomes because of the requirements of law and regulations for annual reports on a national basis. Data from the Scientific Registry of Transplant Recipients and other sources are not only carefully scrutinized by regulators, congressional oversight committees, and advocacy organizations but also sometimes covered by the press. The complexity of the process means that many matters remain obscure to the public. Some situations suggest that decision makers or organizations are motivated by personal interests or are otherwise conflicted.¹³ Thus, while greater transparency of the features of the national, regional, and local arrangements could help to prevent adverse response to media disclosures, some problems are unlikely to be solved by disclosure alone.

When the World Health Assembly updated the World Health Organization (WHO) Guiding Principles on Human Cell Tissue and Organ Transplantation in 2010, it added Guiding Principle 11:

As WHO explained:

The Guiding Principles further state that the objective of transparency goes beyond providing data for scholarly study and government oversight to identifying risks and facilitating their correction “in order to minimize harm to donors or recipients” (WHA, 2010, p. 419).

For the goals of transparency to be met, the information provided must not only be accurate and timely but also readily accessible and easily understood by all segments of the intended audience. The views of relevant stakeholders must be considered when determining the limits of transparency and what information is needed by whom in order to maximize the utility and fairness of transplantation. Yet transparency cannot be achieved simply by making information available to the public (Kass and Faden, 2018). Some members of the public may not have the time, desire, or capacity to read and comprehend complex information or even the ability to access it. Data on performance indicators can be simplified by providing it in numeric or tabular form (i.e., graft survival rates over various periods of time, such as 1 year or 5 years). Still, simplification to improve comprehension can risk losing subtlety or being misleading. For example, were a color-coding method (red, yellow, green) used to indicate whether transplant centers meet graft survival targets, the display of the results may denote that a center’s survival rate is very deficient (red) even though the actual difference

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¹³ See https://oversight.house.gov/news/press-releases/oversight-subcommittee-launches-investigation-into-poorperformance-waste-and (accessed November 18, 2021).

between it and a center designated in yellow is less than 1 percent. More basically, numeric information may lack a narrative for readers to discern the point of the message or they may not put the data in context. If data are disclosed in a way that grades actors against each other—for example, by color-coding, as just described—then people seeing such reports will not be made aware if all the actors are failing to perform as expected. It is, however, possible to provide simplified interactive—yet narrative—information, as shown by the 2021 Annual Data Report of the U.S. Renal Data System. Box 3-3 contains information on public education efforts in organ donation and transplantation.

Transplant experts vary in the clarity and comprehensiveness with which they communicate to the public about organ donation and transplantation. Even though available education materials about organ donation and transplantation may be publicly available, they may not be publicly accessible. Studies document that organ transplant and donation educational consent research used by transplant centers are prepared at college reading levels (Gordon and Wolf, 2009; Zhou et al., 2018). Little is known about the reading grade levels of OPO or other public education materials. Health literacy refers to “the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions” (HRSA, 2019). In 2003, nearly 80 million Americans (36 percent) had limited functional health literacy and thus poor knowledge and ability to understand health-related information (Berkman et al., 2011). Limited health literacy is associated with numerous adverse health consequences including poor medication adherence, increased hospitalizations, and higher mortality (Berkman et al., 2011; Dore-Stites et al., 2020; Taylor et al., 2016; Warsame et al., 2019). Further, limited health literacy is significantly more common among minorities, individuals with less than high school education, the poor, and the elderly (Kutner et al., 2006; Ricardo et al., 2014). Limited health literacy is common among dialysis patients and kidney transplant recipients (up to 30 percent) (Devraj et al., 2015; Muscat et al., 2018; Ricardo et al., 2014; Taylor et al., 2018) and liver transplant recipients (Bababekov et al., 2019; Serper et al., 2015), but there are limited data on health literacy in lung transplant recipients (Lennerling et al., 2018). Thus, given the prevalence of limited health literacy in the population of patients in need of organ transplantation, and the fact that current materials are prepared at a high reading grade level, the committee recommends that health information be communicated and prepared in a simple, accessible fashion.

REFERENCES