is organ transplant ethical essay

The Hastings Center

Ethics and organ transplantation.

Selected resources on from The Hastings Center.

Bioethics Briefings:

Organ Transplantation The central philosophical question in organ transplantation is how to ensure a fair and just system for the allocation of resources. Rationing is unavoidable in organ transplantation due to the large number of individuals on the waiting list and the limited supply of donated organs. Read our briefing to consider the question: What are the ethics behind organ donation and allocation?

From Hastings Bioethics Forum:

From  Hastings Center Report :

Reevaluating the ethical issues in porcine-to-human heart xenotransplantation.

First published: 13 October 2022

A major limiting factor with heart allotransplantation remains the availability of organs from deceased donors. Porcine heart xenotransplantation could serve as an alternative source of organs for patients with terminal heart failure. A first-in-human porcine xenotransplantation that occurred in January 2022 at the University of Maryland Medical Center provided an opportunity to examine several ethical issues to guide selection criteria for future xenotransplantation clinical trials. In this article, the authors, who are clinicians at UMMC, discuss the appropriate balancing of risks and benefits and the significance, if any, of clinical equipoise. The authors also review the alleged role of the psychosocial evaluation in identifying patients at an elevated risk of posttransplant noncompliance, and they consider how the evaluation’s implementation might enhance inequities among diverse populations. The authors argue that, based on the principle of reciprocity, psychosocial criteria should be used, not to exclude patients, but instead to identify patients who need additional support. Finally, the authors discuss the requirements for and the proper assessment of informed and voluntary consent from patients being considered for xenotransplantation .

Equal Access to Organ Transplantation for People with Disabilities

First published: 13 July 2021

People with disabilities are often denied equal access to organ transplantation despite long-standing federal nondiscrimination mandates. Under the Americans with Disabilities Act and the Rehabilitation Act, people cannot be excluded from consideration for organ transplantation because of disability itself, or because of stereotypes or assumptions about the value or quality of life with a disability. Instead, decisions concerning whether an individual is a candidate for organ transplantation should be based on an individualized assessment of the patient and on objective medical evidence. Recent legal developments underscore these basic guarantees and signal a new focus on the policies, practices, and attitudes that continue to compromise equal access to life-saving organ transplants for people with disabilities .

It Is Time to Abandon the Dogma That Brain Death Is Biological Death

Drawing on a recent case report of a pregnant, brain-dead woman who gave birth to a healthy child after over seven months of intensive care treatment, this essay rejects the established doctrine in medicine that brain death constitutes the biological death of the human being. The essay describes three policy options with respect to determination of death and vital organ transplantation in the case of patients who are irreversibly comatose but remain biologically alive .

A Heart without Life: Artificial Organs and the Lived Body

First published: 25 February 2021

The use of artificial organs is likely to increase in the future, given technological advances, increases in chronic diseases, and limited donor organs. This article examines how artificial organs could affect people’s experience and conceptualization of bodies and our understanding of the relation of body to self. I focus on artificial heart devices and argue that these have two conflicting potential influences. First, they may influence people to regard the body as machinelike and separable from the self. Second, they may effect changes to subjective experience that can be understood as changes to the self, confirming the self’s embodiment. My primary purpose is to increase our understanding of what might change if it becomes more usual to have a body that is partly nonorganic. But I also argue that the analysis points to potential ethical concerns related to strengthening biomedical conceptions of the body and to the devaluing of bodies and body parts .

Living Donors and the Issue of “Informed Consent”

First published: 14 September 2020

This essay considers the issue of informed consent as it arose in the context of 1960s living kidney donors. In one of the earliest empirical inquiries into informed consent, psychiatrists Carl H. Fellner and John R. Marshall interviewed donors about their decision-making process and their experience and reflections on donorship. In their much-cited 1970 paper, the physicians reported that living donors, rather than reaching a reasoned, intellectual, and unemotional decision about donating a kidney (as stipulated in the Ethical Guidelines for Organ Transplantation issued by the American Medical Association’s Judicial Council), instead made instantaneous and “irrational” decisions about participation. Fellner and Marshall’s studies contributed to the public debate and professional discussion about the moral and ethical dimensions of donorship, even as they challenged the developing consensus on informed consent .

Plus ça change : Renée Fox and the Sociology of Organ Replacement Therapy

First published: 20 April 2020

Rereading Renée C. Fox’s “A Sociological Perspective on Organ Transplantation and Hemodialysis,” published in 1970, one is likely to be struck more by continuity than by change. The most pressing of the social, policy, and ethical concerns that Fox raised remain problematic fifty years later. We still struggle with scientific and clinical uncertainty, with the boundary between experimentation and therapy, and with the cost of organ replacement therapies and disparities in how they are allocated. We still have an imperfect understanding of transplant immune responses. We still debate when a potential donor “actually” dies, and we still seem to think better empirical criteria could harmonize the diverse religious, cultural, and socioeconomic values of patients, providers, third-party payers, and policy-makers. Organ transplantation was for Fox both a particular case unfolding in time and an entryway for discussing the difficult moral questions presented by many new medical technologies in a context of high demand and limited resources .

Would a Reasonable Person Now Accept the 1968 Harvard Brain Death Report?  A Short History of Brain Death

First published: 25 December 2018

When The Ad Hoc Committee of Harvard Medical School to Examine the Definition of Brain Death began meeting in 1967, I was a graduate student, with committee member Ralph Potter and committee chair Henry Beecher as my mentors. The question of when to stop life support on a severely compromised patient was not clearly differentiated from the question of when someone was dead. A serious clinical problem arose when physicians realized that a patient’s condition was hopeless but life support perpetuated body function. Thus, the committee stated that its first purpose was to deal with the burdens on patients and families as well as on hospitals and on patients needing hospital beds occupied by comatose patients. They intuited the strategy of “defining” these patients as dead, thus legitimating treatment stoppage. They noted that this would also serve a second purpose. Although the dead donor rule had not yet been clearly articulated, they claimed that defining patients as dead would also address controversy over obtaining organs for transplant .

My mentors’ discussions related to my interest in the intersection between questions primarily of medical fact (When has a human brain irreversibly ceased functioning?) and nonmedical questions of social policy (Should we treat individuals with dead brains and beating hearts as dead humans?). It quickly became clear that most committee members did not appreciate the interplay of these questions .

A Path Not Taken:  Beecher, Brain Death, and the Aims of Medicine

It has been fifty years since a report by an ad hoc committee of Harvard Medical School ushered in the widespread adoption of brain death as a definition of death. Yet brain death remains disputed as an acceptable definition within bioethics. The continuous debate among bioethicists has had three key recurring features: first and foremost, argument over alleged flaws in the conceptual logic and consistency of the “whole-brain” approach as a description of the meaning of death; second, efforts to fix perceived limitations of brain death-based practices to optimize transplantation, especially given that transplantation was the presumed original intended purpose of the definition; and third, a basic unease provoked by the experience of using the criteria and managing a body in this state of “irreversible coma.”

The third feature is the one I find the most compelling, though it is less explored, and it persists because of the failures of the prior two. Brain death remains strange—to medical personnel, families, philosophers. That is not because it hasn’t yet been logically argued well enough or conceptually framed adequately, but because those things don’t matter as much to resolving this strangeness as the bioethical approach to brain death over the last fifty years has assumed it does. It is necessary to look to other things that can anchor the aims of medicine in the midst of this strangeness .

Conceptual Issues in DCDD Donor Death Determination

Despite the popularity, success, and growth of programs of organ donation after the circulatory determination of death (DCDD), a long-standing controversy persists over whether the organ donor is truly dead at the moment physicians declare death, usually following five minutes of circulatory and respiratory arrest. Advocates of the prevailing death determination standard claim that the donor is dead when declared because of permanent cessation of respiration and circulation. Critics of this standard argue that while the cessation of respiration and circulation may be permanent, it may not be irreversible at the moment death is declared because, if cardiopulmonary resuscitation were performed, it might succeed. And because irreversibility of cessation of respiration and circulation is required by both the statute and the biological concept of death, the donor must be alive. Who is correct?

Making two related distinctions clarifies the cause of the disagreement over whether the DCDD donor is dead and points to a possible resolution. First, in a determination of death, there is an important distinction between the  permanent  and the  irreversible  cessation of circulation and respiration—two associated phenomena that are often confounded. Second, there is an important distinction between the medical practice standard for death determination, in which physicians certify the permanent cessation of vital functions as sufficient for death declaration, and the underlying biological concept of death that requires the irreversible cessation of vital functions because death, by definition, is an irreversible event .

Uncontrolled DCD:  When Should We Stop Trying to Save the Patient and Focus on Saving the Organs?

Uncontrolled donation after circulatory death, which occurs when an individual has experienced unexpected cardiac arrest, usually not in a hospital, generates both excitement and concern. On the one hand, uDCD programs have the capacity to significantly increase organ donation rates, with good transplant outcomes—mainly for kidneys, but also for livers and lungs. On the other hand, uDCD raises a number of ethical challenges. In this essay, we focus on an issue that is central to all uDCD protocols: When should we cease resuscitation and shift to organ preservation? Do current uDCD protocols prematurely consider as potential donors patients who could still have some chances of meaningful survival? Can the best interest of patients be fostered once they are considered and treated as potential donors?

A Defense of the Dead Donor Rule

Discussion of the “dead donor rule” is challenging because it implicates views about a wide range of issues, including whether and when patients are appropriately declared dead, the validity of the doctrine of double effect, and the moral difference between or equivalence of active euthanasia and withdrawal of life-sustaining treatment. The DDR will be defined here as the prohibition against removal of organs necessary for the life of the patient—that is, the prohibition of intentionally ending the life of a patient through organ removal. At a minimum, it is difficult not to see the DDR as grounded in a set of laws, norms, values, and practices that are firmly entrenched and have a great deal of philosophical, religious, and legal support. Obviously, the primary argument against the DDR is that it is highly desirable that we continue to procure organs for transplantation, combined with the belief that those from whom we often and possibly typically procure organs are not “really” dead. If donors are not really dead, then we are left with a dilemma: either we abandon organ procurement, or we abandon the DDR. Such a move should be taken only if the way we currently delineate the dead (those from whom it is acceptable to remove organs) cannot be maintained or defended. I will suggest that this is not the case .

The Dead Donor Rule as Policy Indoctrination

Since the 1960s, organ procurement policies have relied on the boundary of death—advertised as though it were a factual, value-free, and unobjectionable event—to foster organ donation while minimizing controversy. Death determination, however, involves both discoveries of facts and events and decisions about their meaning (whether the facts and events are relevant to establish a vital status), the latter being subjected to legitimate disagreements requiring deliberation. By revisiting the historical origin of the dead donor rule, including some events that took place in France prior to the report by the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death, I want to recall that those who first promoted the DDR did not take into account any scientific rationale to support the new proposed criteria to determine death. Rather, through a process of  factual re-semantization , they authorized themselves to decide about the meaning of death in order to implicitly prioritize the interests of organ recipients over those of dying people .

The Public’s Right to Accurate and Transparent Information about Brain Death and Organ Transplantation

The organ transplantation enterprise is morally flawed. “Brain-dead” donors are the primary source of solid vital organs, and the transplantation enterprise emphasizes that such donors are dead before organs are removed—or in other words that the dead donor rule is followed. However, individuals meeting standard diagnostic criteria for brain death—unresponsiveness, brainstem areflexia, and apnea—are still living, from a physiological perspective. Therefore, removing vital organs from a heart-beating, mechanically ventilated donor is lethal. But neither donors nor surrogates nor the public in general are typically informed of this obviously relevant information. Therefore, donors or surrogates do not provide valid consent for a lethal medical procedure. This is a serious moral failing on the part of the transplant community. To address this concern, I advocate for accurate and fully transparent communication of information to the public to allow for an informed civic dialogue about the ethics and legality of lethal organ procurement. Furthermore, I advocate that systems be put in place by the transplant community to allow for valid consent for lethal organ procurement .

Brain Death and the Law:  Hard Cases and Legal Challenges

The determination of death by neurological criteria—“brain death”—has long been legally established as death in all U.S. jurisdictions. Moreover, the consequences of determining brain death have been clear. Except for organ donation and in a few rare and narrow cases, clinicians withdraw physiological support shortly after determining brain death. Until recently, there has been almost zero action in U.S. legislatures, courts, or agencies either to eliminate or to change the legal status of brain death. Despite ongoing academic debates, the law concerning brain death has remained stable for decades. However, since the Jahi McMath case in 2013, this legal certainty has been increasingly challenged. Over the past five years, more families have been emboldened to translate their concerns into legal claims challenging traditional brain death rules. While novel, these claims are not frivolous. Therefore, it is important to understand them so that we can address them most effectively .

Respecting Choice in Definitions of Death

The definition of death was clearer one hundred years ago than it is today. People were declared dead if diagnosed with permanent cessation of both cardio-circulatory function and respiratory function. But the definition has been muddled by the development of new technologies and interventions—first by cardiopulmonary resuscitation and ventilators, which were introduced in the mid-twentieth century, and now by extracorporeal membrane oxygenation, which creates the ability to keep oxygenated blood circulating, with or without a beating heart or functioning lungs. In  Defining Death: The Case for Choice , Robert Veatch and I argue that the definition of death should focus on “what change in a human being is so fundamental that we can say the individual is no longer with us as a member of the human community bearing rights such as the right not to be killed.” We assert that this decision is a normative issue about which different stakeholders may believe that different changes are fundamental, and we therefore propose that the optimal policy solution may be to allow stakeholders to choose their own definition within a reasonable range of options. There are three caveats that need to be highlighted regarding this approach .

The Other Animal of Transplant’s Future

As an anthropologist, I have long been interested in highly experimental science, with my work engaging the moral underpinnings of xenoscience and, more recently, lab animal research. The possibility of employing animals as human “matches” sparks enthusiastic responses among researchers who imagine various creatures as lucrative “donor species” or “source animals” whose organs might replace the failing parts of humans and render obsolete any future need for brain-dead donors. When we attend to how xenoscientists imagine the promissory qualities of various species, we encounter a specialized logic of how and why one type of animal is valued over another .

Well-established bioethical principles might assist us in framing our position in reference, say, to the limits of human suffering, or how to weigh the worth assigned to human versus animal lives, or how we conceive “the quality of life.” But sadly, subjective experience can creep in to shape and cloud those very stances we regard as bioethically principled. Rather than pursue such a well-worn path, I suggest an alternative framework that privileges attentiveness to everyday thought and action over codified bioethics. This framework—described as “everyday” or “ordinary ethics” in anthropology—involves assuming a critical, self-reflexive stance in reference to quotidian ways of seeing and knowing. Like John Berger, who famously asked, “Why Look at Animals?,” I ask, when we look at the lab-based baboon, chimp, or pig, what do we see? How do we think of, or presume to know, the animal in question? How do we think about human-animal relations in science?

Bodies in Transition:  Ethics in Xenotransplantation Research

Xenotransplantation, or the grafting of organs from one species to another, may seem at first a far cry from brain death, but there is rising hope in some quarters of the biomedical community that such transplants may reduce, even obviate, the need to harvest human organs—and hence eliminate the primary reason for needing an unambiguous definition of brain death. As with all research on the frontiers of biomedicine, xenotransplantation raises its own ethical quandaries. One concern that has long occupied ethical thought is the degree to which advances in science and technology should control the boundaries between the human and the nonhuman. Might the dimming of a previously entrenched bright line between species entail negative consequences for concepts, such as human dignity and bodily integrity, that historically anchored the protection of both human and animal subjects in biomedical treatment and research? To date, ethical thinking about xenotransplantation, and about gene editing, has largely been left in the hands of scientists, subject only to loose supervision by institutional review boards and animal welfare committees whose remit may be too narrow to address age-old moral concerns .

Organ Transplantation and the Uniform Anatomical Gift Act:  A Fifty-Year Perspective

First published: 28 March 2018

Fifty years ago this summer, the Uniform Anatomical Gift Act was adopted by the National Conference of Commissioners on Uniform State Laws and approved by the American Bar Association. The UAGA has provided a sound and stable legal platform on which to base an effective nationwide organ donation system. The cardinal principles of altruism, autonomy, and public trust are still important. At a time when confidence and trust in our government and many private institutions has declined, maintaining trust and confidence in our health care system and its commitment to “first, do no harm” has never been more important. Any policies that override these core ethical principles could cause irreparable damage to the public’s faith in our transplant system. While progress has been made to increase organ registration and the number of organs transplanted, much more must be done to realize the potential of life-saving therapy without jeopardizing ethical principles .

Are Transplant Recipients Human Subjects When Research Is Conducted on Organ Donors?

First published: 02 August 2017

Interventional research on deceased organ donors and donor organs prior to transplant holds the promise of reducing the number of patients who die waiting for an organ by expanding the pool of transplantable organs and improving transplant outcomes. However, one of the key challenges researchers face is an assumption that someone who receives an organ that was part of an interventional research protocol is always a human subject of that same study. The consequences of this assumption include the need for oversight by an institutional review board and for research-level informed consent from transplant recipients, all within the complex practical realities of the organ donation and transplantation process in the United States. The current national focus on this issue provides an opportunity to think critically about the policy goals of the human subjects regulations and their application to the nascent field of deceased organ donor intervention research. We propose that for donor research where the transplant recipient does not fall under the definition of human subject, the clinical consent model—rather than the consent model used for human research subjects—best facilitates the policy objectives of balancing clinical innovation, transparency, and protection of patients in an ethically responsible and legally compliant manner .

What Pacemakers Can Teach Us about the Ethics of Maintaining Artificial Organs

First published: 22 November 2016

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient’s own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs.

We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software—particularly software that can be remotely accessed—in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered.

Having Conversations about Organ Donation

First published: 28 September 2015

While 90 percent of participants in a 2005 Gallup poll indicated that they would donate an organ if asked, only 40 percent of Americans have registered to do so, according to 2012 data from Donate Life America; likely even fewer have shared their donation wishes with loved ones. Undoubtedly, the single biggest reason for the discrepancy between the number of potential transplants and the number actually performed is our failure to talk with loved ones about our wishes regarding organ donation. Although many resources already exist to hold these conversations, we can do more, and the emergence of social media provides an intriguing new opportunity. Two years ago, Organize.org set out to create the first nationwide organ donation registry in the United States .

Taking Science Seriously in the Debate on Death and Organ Transplantation

First published: 17 June 2015

The concept of death and its relationship to organ transplantation continue to be sources of debate and confusion among academics, clinicians, and the public. Recently, an international group of scholars and clinicians, in collaboration with the World Health Organization, met in the first phase of an effort to develop international guidelines for determination of death. The goal of this first phase was to focus on the biology of death and the dying process while bracketing legal, ethical, cultural, and religious perspectives. The next phase of the project will include a broader group of stakeholders in the development of clinical practice guidelines and will use expert consensus on biomedical criteria for death from the first phase as scientific input into normative deliberation about appropriate policies and practices .

Surely, science alone cannot resolve the normative and philosophical questions intertwined in debates about moral status, legal and moral rights, the ethics of killing, and personhood and the nature of the self; however, scientific input is necessary for informed moral deliberation. An objective and unbiased investigation of the biology of death is independent of, and should be undertaken prior to, an analysis of the normative questions engendered by debate about determination of death. This strategy is explicitly endorsed by the International Guidelines for Determination of Death and reflects the prevailing view of these issues in the mainstream medical literature. However, this mainstream literature, exemplified by the IGDD group’s recent report, does not exhibit any of the characteristics usually associated with a scientifically rigorous investigation, such as making empirically testable and falsifiable claims, a commitment to evidence and logic over authoritative assertion, or a willingness to revise hypotheses and theories in light of new evidence. Indeed, the core claims and methodologies of the mainstream medical literature on death, both of which are represented by the IGDD report, are not merely scientifically unjustified; they are not science at all. This situation creates a problem for the integrity of science and the academy, and it unjustly obscures and prevents legitimate democratic and moral deliberation about issues that, at bottom, are normative, not scientific .

Faces as Organ Donations:  Who Has the Last Word?

First published: 21 November 2014

Recent policy changes enacted by the Organ Procurement and Transplantation Network designate faces as organs for the purposes of donation and transplantation. The OPTN policy includes no requirement that donors be made aware that faces are among donatable parts, but it does require specific consent to face donation (not just organ donation in general) from either the donor or donor’s family before a face can be transplanted. If you are a registered donor and you do not record your refusal, your family might be approached for your face. If your next of kin says yes, your face will be donated. On the other side, if you do want to donate your face and have recorded your specific consent, but your family says no, tough luck. Should families have greater control than donors over the disposition of the donors’ faces ?

Duty, Distress, and Organ Donation

A man of twenty-two is admitted to an intensive care unit (ICU)after intentionally overdosing on Tylenol. The nurse asks the intensivist on call if someone from the local organ procurement organization should be called in to speak to the family, given a worsening clinical picture and the likelihood that the patient will progress to brain death. The patient’s condition is such that multiple organs, including his heart and lungs, could be donated. The intensivist instructs the nurse not to call, as he wishes to have an end-of-life discussion with the parents. He believes that the parents should know that death is imminent and that further interventions will not save their son. He argues that introducing the OPO at this point will cause the family more distress. He wants the parents to be able to give their son a peaceful death without additional stressors. What are the broader implications of not calling the OPO at this juncture? Does the nurse involved have an ethical obligation to override the intensivist’s instructions by calling the OPO? Should the fact that multiple healthy organs could be harvested from this patient’s body have any bearing on the decision to call the OPO ?

Dying and multiplying life

First published: 17 September 2014

It was only after James P. Lovette’s death, in 2006, that I discovered that the twenty-four-year-old colleague and friend with whom I had spent so many afternoons debating issues in organ transplantation had been the first successful child heart transplantee in the world and one of the longest-living survivors of a second transplant. During the years we met, he never even hinted at the fact that three different hearts had beaten in his chest. The revelation that his life had been an almost uninterrupted chain of medical challenges suddenly made me appreciate his quirkiness in a whole new light .

Organ transplantation crudely exemplifies a traditional moral dilemma between means and ends: in order to save a life, someone else has to die. Bioethicists involved in this field have the role of identifying the ethical issues surrounding organ donation and helping others to argue in an intelligible and convincing way. In my view, bioethicists have the obligation to foster a discussion as open and transparent as possible on these matters. Still, I sometimes fear that I may be helping to cause unnecessary harms to potential recipients who are desperately waiting for a vital organ. Scholars would be chillingly cold if their quest for truth systematically came at the cost of lives lost. Every life can be meaningful and provide meaning to many others. This is true even with organ recipients, who often have short lives full of considerable suffering .

Pig Hearts and Machine-Lathed Kidneys:  The Ethics of Staying Alive

First published: 09 July 2014

To most people outside the relevant laboratories and operating rooms, xenotransplants and artificial organ transplants are bizarre. While the bizarre scares many away and angers others, Lesley A. Sharp approached it and asked, What behooves medical research to take organs out of pigs and primates and design organs out of metal and plastic and use them to replace failing organs in humans? Sharp attended years of conferences, visited countless hospitals and laboratories, and interviewed engineers, scientists, and surgeons to explore the choices and implicit values of decision-makers in alternative transplantation. The Transplant Imaginary: Mechanical Hearts, Animal Parts, and Moral Thinking in Highly Experimental Science is a rich resource for philosophers who wish to expound on the morality of implanting nonhuman animal and mechanical organs into humans. The author’s thorough ethnographic survey of xeno- and biomechanical transplant research leads well into two lines of questioning. First, how ethical is the pursuit of alternative transplant? Second, what is essential for transplant researchers to do their jobs ethically?

On Noncongruence between the Concept and Determination of Death

First published: 18 November 2013

A combination of emerging life support technologies and entrenched organ donation practices are complicating the physician’s task of determining death. On the one hand, technologies that support or replace ventilation and circulation may render the diagnosis of death ambiguous. On the other, transplantation of vital organs requires timely and accurate declaration of death of the donor to keep the organs as healthy as possible. These two factors have led to disagreements among physicians and scholars on the precise moment of death. In this article, I suggest that the debate about exactly when a person dies can benefit from distinguishing the strict biological concept of death from the medical standards for determining human death, and I show how an appreciation of the difference between the permanent and irreversible cessation of circulation is helpful in understanding the reasons for the two approaches to determining when death should be declared .

Casting Light and Doubt on Uncontrolled DCDD Protocols

First published: 11 January 2013

The ever-increasing demand for organs led Spain, France, and other European countries to promote uncontrolled donation after circulatory determination of death (uDCDD). For the same reason, New York City has recently developed its own uDCDD protocol, which differs from European programs in some key ways. The New York protocol incorporates a series of technical and management improvements that address some practical problems identified in response to European uDCDD protocols. However, the more fundamental issue of whether uDCDD donors are dead when organs are procured remains problematic for the New York City protocol and, indeed, for all uDCDD protocols .

In the United States, two amendments to the legal criteria of death have been suggested to avoid a formal violation of the dead donor rule in DCDD protocols: first, replacing the requirement “irreversible” with the weaker term “permanent,” and second, using the term “circulatory” instead of “cardiac” to identify the key function that must be lost to declare death. While intended to facilitate controlled DCDD, these modifications create a problem for uDCDD protocols: if extracorporeal membrane oxygenation is introduced to preserve the organs, then circulation is restored after death is declared. In this issue of the Hastings Center Report, Kevin Munjal and colleagues call for a new ethical construct and policy so that uncontrolled and controlled DCDD can coexist .

Determining Death in Uncontrolled DCDD Organ Donors

The most controversial issue in organ donation after the circulatory determination of death is whether the donor was truly dead at the moment death is declared. My colleagues and I further analyzed this issue by showing the relevance of the distinction between the “permanent” and the “irreversible” loss of circulatory functions. Permanent cessation means that circulatory function will not return because it will not be restored spontaneously and medical attempts to restore it will not be conducted. By contrast, irreversible cessation means that circulatory function cannot be restored using currently available technology. In this issue of the Report, Kevin Munjal and colleagues criticize the unjustified application of the permanent-irreversible distinction, which my colleagues and I developed for cDCDD, to their well-designed and carefully conducted experimental protocol of uncontrolled DCDD (uDCDD) in New York City, for which our analysis was not targeted. They claimed that to determine a donor’s death in uDCDD, it is unnecessary to show that permanence is a valid surrogate indicator of irreversibility because the unsuccessful attempt to resuscitate the patient comprises prima facie evidence of circulatory irreversibility. Ironically, that potent justification defending death determination in uDCDD yields limitations that are similar to those created when our permanent-irreversible distinction is applied to death determination in cDCDD .

A Rationale in Support of Uncontrolled Donation after Circulatory Determination of Death

First published: 18 December 2012

Most donated organs in the United States come from brain dead donors, while a small percentage come from patients who die in “controlled,” or expected, circumstances, typically after the family or surrogate makes a decision to withdraw life support. The number of organs available for transplant could be substantially if donations were permitted in “uncontrolled” circumstances–that is, from people who die unexpectedly, often outside the hospital. According to projections from the Institute of Medicine, establishing programs permitting “uncontrolled donation after circulatory determination of death,” or uDCDD, throughout the United States has the potential to provide 22,000 more donation opportunities annually. In contrast, U.S. controlled donation after circulatory determination of death, or cDCDD, cases have increased progressively over the past decade from 87 to 848 donors, but currently account for only 10.6 percent of all deceased donors. Following the IOM recommendations, several projects exploring the feasibility of uDCDD were funded by the federal government, including a grant from the Health Resources and Services Administration that supported a pilot project in New York City in which the authors of this article participated .

A key feature of our protocol, and indeed of many uDCDD protocols, is the initiation of preservation methods such as chest compressions and extracorporeal membrane oxygenation shortly after death in order to perfuse and preserve the donor’s organs. Critics of uDCDD argue that the means of determining death deviates from generally ascribed principles. They assert that reinstituting circulation in order to preserve organs has the effect of “undoing” the prior determination of death. The result is that cDCDD is widely accepted and practiced routinely even though it only marginally increases the number of organs available for transplantation, and uDCDD is widely considered unacceptable despite being ethically embraced and proven to significantly increase organ donation opportunities in other countries. This article explores the evolution of this counterintuitive state of affairs and calls for a policy that, in line with the IOM report, allows for both cDCDD and uDCDD protocols .

Is It Time to Abandon Brain Death?

First published: 23 March 2012

Despite its familiarity and widespread acceptance, the concept of “brain death” remains incoherent in theory and confused in practice. Moreover, the only purpose served by the concept is to facilitate the procurement of transplantable organs. By abandoning the concept of brain death and adopting different criteria for organ procurement, we may be able to increase both the supply of transplantable organs and clarity in our understanding of death.

Homo Economicus: Commercialization of Body Tissue in the Age of Biotechnology

The human body is becoming hot property, a resource to be “mined,” “harvested,” patented, and traded commercially for profit as well as scientific and therapeutic advances. Under the new entrepreneurial approach to the body old tensions take on new dimensions—about consent, the fair distribution of tissues and products developed from them, the individual and cultural values represented by the body, and public policy governing the use of organs and tissues.

Delimiting the Donor: The Dead Donor Rule

First published: 06 March 2012

The scarcity of vital organs has prompted several calls to either modify the dead donor rule or interpret it more broadly. Given its symbolic importance, however, the rule should be changed only cautiously.

Organ Swapping

Some transplant centers are making use of a four-person organ exchange to encourage live donor kidney transplantation. Although no money changes hands, it is a quasi-contractual arrangement and a step toward for-profit transactions, and it threatens to undermine the organ donor system.

Body Values:  The Case against Compensating for Transplant Organs

Proposals to compensate families for transplantable organs are gathering momentum. These proposals assume that the body is not integral to the self—that it can be treated like property. Most people believe otherwise.

The Fallacy of the “Gift of Life”

In the dominant metaphor for organ transplantation, the organ is the ultimate gift, the dying donor’s life-giving bequest, conveyed and made possible by a heroic transplant team. The metaphor encourages donation and enforces recipients’ compliance with post-transplant treatment. It is also inaccurate and sometimes deeply damaging for the recipient.

The Gift of Life and the Common Good: The Need for a Communal Approach to Organ Procurement

Its critics to the contrary, the “gift of life” metaphor is not to be blamed for the indebtedness and guilt that organ recipients often experience. It is certainly misused, however, both by post-transplant caregivers, who exploit it to manipulate recipients’ behavior, and by the organ procurement system, which has failed to understand that the decision to give the gift of life must be approached communally.

Rethinking the Ethics of  Vital Organ Donations

First published: 08 February 2012

Accepted medical practice already violates the dead donor rule. Explicitly jettisoning the rule—allowing vital organs to be extracted, under certain conditions, from living patients—is a radical change only at the conceptual level. But it would expand the pools of eligible organ donors.

Conversations with Kidney Vendors in Pakistan

In theory, a commercial market for kidneys could increase the scarce supply of transplantable organs and give impoverished people a new way to lift themselves out of poverty. In-depth sociological work on those who opt to sell their kidneys reveals a different set of realities. Around the town of Sarghoda, Pakistan, the negative social and psychological ramifications of selling a kidney affect not only the vendors themselves, but also their families, communities, and even the country as a whole.

Leaving the Field

First published: September 1992

They have watched, as insiders, the first fumbling attempts to transplant kidneys, then hearts, then live-donated lobes of liver and lung. Now the two sociologists most closely identified with organ transplantation have concluded that they must leave the field.

Organs for Transplantation

First published: November 1991

Singapore’s Human Organ Transplant Act presumes that competent adults consent to donate their kidneys in the event of a fatal accident, unless they have refused in writing. No family consent is required. What can other countries wishing to implement a presumed-consent model of organ donation learn from Singapore’s experience?

Anencephalic Donors: Separate the Dead From the Dying

First published: February 1987

Proposals to use organs from anencephalic infants to meet the growing need for transplantable ogans are well-meaning but misguided. It would be unwise to amend the Uniform Determination of Death Act to classify anencephalics as “dead.” They are in the same situation as other patients (such as the permanently comatose). Likewise, amending the Anatomical Gin Act to permit organs to be removed from anencephalics would be unjust would set a bad precedent and would likely reduce overall success in this field.

From The Hastings Center Bioethics Timeline

1953: papal approval of organ transplantation.

At the 26 th  Congress of Urology, Pope Pius XII, quoting St. Thomas Aquinas ( Summa Theologica  II, Question 65, Article I)  endorsed organ transplants  on the grounds of the Totality Principle, which stated that every part of the human body “exists for the sake of the whole.” This permitted the sacrifice of one part of a human being for the continued survival of another.

1954: Successful Kidney Transplants

In December 1954 surgeon Joseph Murray and his colleagues at the Peter Bent Brigham Hospital in Boston performed the first successful human kidney transplant. During the surgery, 24-year-old Richard Herrick received a kidney donated by his identical twin brother, Ronald. Richard lived for nine years with the repurposed kidney. Kidney (and soon other organ) transplants stimulated much ethical discussion and debate over risks to living donors, whether mentally impaired individuals could “donate,” a market in human organs, and how to allot scarce tissue.

J. E. Murray, “ Reflections on the First Successful Kidney Transplantation ,”  World Journal of Surgery  6, no. 3 (1982): 372-76.

R. M. Veatch, and L. F. Ross,  Transplantation Ethics  (Georgetown University Press, 2015).

1963: World’s First Liver Transplant

Dr. Thomas Starzl performs the world’s  first liver transplant  on Bennie Solis, a 3-year-old boy with biliary atresia. Although Solis and many of the other early recipients of livers die, Starzl and other surgeons eventually perfect the technique and save thousands of lives.

1967: First Human-to-Human Heart Transplants Performed by Barnard and Kantrowitz

On December 3, 1967, Dr. Christiaan Barnard performed the  first successful human heart transplant  at the Groote Schubert Hospital in South Africa, placing him and the hospital in an international spotlight. The patient survived for 18 days; although the heart pumped strongly, he succumbed to infection secondary to immune suppression to prevent rejection.

Dr. Adrian Kantrowitz performed the world’s second transplant, and the first in the United States, at Maimonides Hospital in Brooklyn three days after Dr. Barnard’s surgery. The patient, an infant, survived for 6.5 hours. Kantrowitz would go on to be best known for the Intra-Aortic Balloon Pump.

1968: Definition of Death

An ad hoc committee at Harvard Medical School reexamined the  definition of brain death  and defined irreversible coma, or brain death. These definitions and guidelines would facilitate retrieval of organs for transplantation.

“A Definition of Irreversible Coma: Report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death,”  Journal of the American Medical Association  205 no. 6 (1968): 337-40.  

1968: Organ Donation

Uniform Anatomical Gift Act (UAGA) is formulated and recommended by the National Conference of Commissioners on Uniform State Laws for adoption by the states. All states in the United States rapidly passed relatively uniform laws based on the UAGA.

Ethical Guidelines for Organ Transplantation , Judicial Council of the American Medical Association

1974: Publication of Renée Fox and Judith Swazey’s   The Courage to Fail. A Social View of Organ Transplants and Dialysis

Renee Fox and Judith Swazey combine their respective sociological and historical perspectives to explore how biomedical research has influenced medical practice in the United States through a focus on the development of organ transplantation. R. Fox and J. Swazey,  The Courage to Fail. A Social View of Organ Transplants and Dialysis (reprinted: Cambridge University Press, 2012). 

https://www.taylorfrancis.com/books/courage-fail-ren%C3%A9e-fox-judith-swazey/e/10.4324/9781315131504

1981: Defining Death: Medical, Legal, and Ethical Issues in the Determination of Death

The report from the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research addressed the issue of definitions of death, including neurological criteria for death known as “brain death.” The Report called for a uniform definition of death based on a “total brain” standard. This standard defines death as the death of the  entire  brain of a person. The Commission sought to address a need for a legal definition of death which could incorporate advances made by new technologies that could perform necessary bodily functions. There was wide agreement between physician testifiers to the Commission that a definition of death which referred to irreversible loss of brain functions was required. 

https://scholarworks.iupui.edu/handle/1805/707

1983: The Hastings Center Working Group on Organ Transplantation

This group of scholars focused on reforming the Uniform Anatomic Gift Act to include a requirement that potential surrogates be asked to consider donating the organs of deceased; reviewed issues of equity in organ distribution, and accessed alternatives to current policy (e.g., market allocation; presumed consent). No formal report was issued, but members published over a dozen articles on these issues in such publications as the  Journal of the American Medical Association , the New England Journal of Medicine,  and other influential medical journals. 

1984: U.S. National Organ Donor Transplantation Act of 1984

This Act prohibits the sale or purchase of human organs and establishes the Organ Procurement and Transplantation Network (OPTN) to be operated by a private, nonprofit organization under federal contract. (The United Network for Organ Sharing (UNOS) later received this contract.). This act precluded market solutions to organ shortages and makes organ donation (“the gift of life,” so-called) the national model for organ procurement. It also commissioned a Task Force on Organ Transplantation, which issued its report in 1986.

National Organ Transplant Act (1984 Pub.L. 98–507), approved October 19, 1984, and amended in 1988 and 1990.

https://www.medicaldaily.com/organ-transplants-problem-america-30-years-national-organ-transplant-act-was-passed-305578

1986: Transplantation:   Organ Transplantation: Issues and Recommendation

This national task force was established by the 1984 National Organ Transplant Act. Its several recommendations included recognizing “each donated organ . . . [as] a national resource to be used for the public good,” involving the public in setting the criteria for organ allocation and implementing required request-routine inquiry policies which thereby precluded the market allocation of solid organs.

Task Force on Organ Transplantation:  Organ Transplantation: Issues and Recommendation  (U.S. Department of Health and Human Services, Public Health Service, Health Resources and Services Administration, Office of Organ Transplantation, April 1986).

https://www.organdonor.gov/about/facts-terms/history.html

2018: Publication of   Defining Death: Organ Transplantation and the Fifty-Year Legacy of the Harvard Report on Brain Death

The Hastings Center publishes this special report on the definition of death.

https://onlinelibrary.wiley.com/toc/1552146x/2018/48/S4

• What Is Bioethics?
• For the Media
• Hastings Center News
• Diversity, Equity, & Inclusion
• Hastings Center Report
• Focus Areas
• Ethics & Human Research
• Bioethics Careers & Education
• Hastings Bioethics Forum
• FAQs on Human Genomics
• Bioethics Briefings
• Books by Hastings Scholars
• Special Reports
• Ways To Give
• Why We Give
• Gift Planning
• Sign up for Updates

Upcoming Events

Previous events, receive our newsletter.

• Terms of Use

Ethical Principles in the Allocation of Human Organs

Reviewed and updated in june 2015.

Note: This report was adopted by the Ethics Committee in 1992 ia and revised in 2010. ib

I. Preamble

A. ethical principles and regulatory requirements..

Ethical principles and regulatory requirements often overlap. In order to understand the intent of this paper, it is important to provide a brief description of the regulatory framework under which the Organ Procurement and Transplantation Network (OPTN) operates. This paper does not intend to interpret the OPTN Final Rule or the National Organ Transplant Act of 1984, but rather to define the ethical principles that provide the underpinning of the regulations governing the organ allocation system. Nonetheless, we briefly explain below the relationship between NOTA and these principles.

The National Organ Transplant Act ("NOTA") ii created the OPTN and gave the initial guidance regarding the development of organ allocation policies. The Secretary of HHS promulgated regulations for the operation of the OPTN iii , which operationalized the requirements contained in NOTA ("OPTN Final Rule"). The OPTN Final Rule contains the regulatory requirements for the OPTN. While many of the regulatory requirements embody the familiar ethical principles of utility (doing good and avoiding harm), justice, and respect for persons, it is not an ethics document nor would one consider it a place to look for ethical guidance.

As a practical matter, the OPTN (or the contractor operating the OPTN) is not permitted to recommend allocation policies contrary to the requirements of the OPTN Final Rule. The OPTN Final Rule is not intended to be the sole source of ethical guidance for formulating allocation policies, as it enumerates the minimal legal/governmental policy requirements that must be included in a just allocation policy. This document, as written by the Ethics Committee, is intended to go into greater detail than the OPTN Final Rule in defining the principles that provide the ethical framework for national organ allocation policies, and is consistent and fully compliant with the requirements and regulations of the NOTA and the OPTN Final Rule.

B. Allocation Policies and Access to the Waiting List.

Access to the waiting list for an organ transplant is the fundamental prerequisite to organ allocation. Appropriate referral for transplant evaluation is in the province of those caring for the patient with organ failure (such as the end stage renal disease networks in the case of kidney disease), and may be outside the province of the OPTN. Both geographic and socioeconomic challenges may impact referral for transplantation. Furthermore, listing practices and requirements may vary among institutions and from one organ type to another. Allocation practices based on waitlist time need to be routinely examined to assure that different waitlist practices do not discriminate against certain groups of patients. Full consideration of the ethical issues surrounding referral and listing practices for transplant is beyond the scope of this paper. This paper is limited to an examination of the ethical principles that should be considered when determining how to allocate a scarce life-saving resource.

II. INTRODUCTION

The ethics of allocating human organs for transplantation is a specific application of ethical norms to social practices. The principles involved are essentially the same as those that apply to other areas of human conduct. They reflect the conclusions of American public bodies which have examined general principles of ethics. In particular, although we use slightly different language, the principles we articulate are essentially the same as those that appeared in the Belmont Report iv , the report of the federal government's National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The principles provide a general ethical framework for local, regional, and national policy decisions related to allocating organs, including the formulas used in such allocations. They are neither meant to describe precisely what the current norms are, nor are they meant to dictate precise formulas for reforming current practices. Moreover, they do not necessarily reflect the personal ethical positions of individual members of the OPTN Ethics Committee. Rather these principles and the guidelines that follow them are meant to represent our recommendations for norms that are optimal for matters of public policy in a pluralistic society in which individuals hold a variety of conflicting, yet not unreasonable, positions on organ allocation. Furthermore, the specific language used herein is reflective of, and consonant with, that of the National Organ Transplant Act (NOTA) and the OPTN Final Rule.

In that regard, this White Paper refers to "utility", "justice", and “respect for persons” as the major ethical principles to be balanced to achieve an equitable outcome in the allocation of organs for transplantation. The term "equity" might be a better term than "justice" to describe fairness principles in allocation. However, we have used "justice" in order to avoid confusion with the term "equitable" which is used in NOTA and the Final Rule to describe the desired overall outcome of organ allocation.

Ethical principles are general prescriptive norms identifying characteristics of human actions or practices that tend to make them morally right. We view the rightness of these principles as prima facie ("at first view"). That is, they characterize elements of actions or practices that are right insofar as one considers only a single dimension of the action or practice. Since in many actual cases principles will conflict, we shall be able to discern whether an action or practice is right "all things considered" that is, only after all the relevant principles are taken into account.

In the following sections, we first identify the principles most directly applicable to the allocation of organs for transplantation. Then we address the challenge of resolving conflicts among these principles as the allocation process is created and developed.

III. GENERAL ETHICAL PRINCIPLES

For ethical principles to be useful in practical problem solving they need to be general enough to apply to a wide range of decisions and simple enough to be easily understood. We identify three principles of primary importance in the allocation of human organs: 1) utility; 2) justice; and 3) respect for persons (including respect for autonomy). Both utility and justice are distinct components of a morally correct or what NOTA calls "equitable" allocation system. Utility refers to the maximization of net benefit to the community (taking into account both the amount of benefit and harm and the probability of such benefit and harm) and justice refers to the fair pattern of distribution of benefits. The principle of respect for persons incorporates a number of related concepts such as the duty to speak truthfully and keep commitments, but primarily conveys the concept of respect for autonomy. Respect for autonomy holds that actions or practices tend to be right insofar as they respect independent (without coercion or interference) choices made by individuals, as long as the choices do not impose harm to others. This framework should not be taken to imply that these are the only principles and rules that could be relevant. However, these three principles provide an adequate framework for most allocation processes.

The entire enterprise of organ procurement and transplantation is undertaken in order to benefit a group of critically ill patients. The overall good that is done to benefit that group is the primary reason for the program. The principle of utility holds an action or practice to be right if it promotes as much or more aggregate net good than any alternative action or practice. The principle of utility, applied to the allocation of organs, thus specifies that allocation should maximize the expected net amount of overall good (that is, good adjusted for accompanying harms), thereby incorporating the principle of beneficence (do good) and the principle of non-maleficence (do no harm).

Developing an allocation policy grounded in the principle of utility requires that the various goods and harms be compared using standardized outcome measures so that at least a rough estimate can be made in determining which allocation produces the greatest good. Good consequences of transplantation include, but are not limited to: saving life, relieving suffering and debility, removing psychological impairment, and promoting well-being. Data measuring predicted graft survival, predicted years of life added (both from time listed and time transplanted), and even more importantly, predicted quality adjusted life years (QALYs) v added are relevant to such determinations. Possible harmful consequences of transplantation include, but are not limited to: mortality, short term morbidities (post operative surgical complications and acute organ dysfunction and/or rejection), and long term morbidities (side effects and complications from immunosuppressive medications, psychological impairment, and potential rejection of the organ).

The principle of utility takes into account all possible goods and harms that can be envisioned, considering the quantity and probability of the various outcomes. Goods and harms are not limited to what may be defined as "medical goods." For example, factors to be considered in the application of the principle of utility are: 1) patient survival; 2) graft survival; 3) quality of life; 4) availability of alternative treatments; and 5) age.

However, in public policy related to allocation of organs using the principle of utility, there is widespread consensus that certain social aspects of utility should not be taken into account. In particular, the social worth or value of individuals should not be considered, including social status, occupation, and so forth. Moreover, in determining predicted medical benefits and harms, there also is consensus that it is unacceptable to use variations in transplant outcomes among social groups as a basis for predicting individual outcomes. For example, even if there is empirical evidence that survival rates of one race, gender, or socioeconomic group exceed those of another, these factors should be excluded from utility models used to justify allocation decisions.

There is wide societal acceptance of excluding social worth or value and predictors of group outcomes from consideration in utility models of allocation. There are at least two main reasons for such exclusion. First, considering one person more useful to society than another, based on prevailing social values, may be a matter of opinion or good fortune in the random distribution of natural and socially cultivated talents and abilities. We add insult to injury when we withhold the benefits of transplantation from those who may not be as likely to contribute to society as those more fortunately endowed. Second, even if data were to show that socially disadvantaged groups have worse transplant outcomes, considerations of justice require that patients be assessed individually rather than merely by group membership in an attempt to reduce healthcare disparities related to social inequities. vi

This exclusion does not necessarily rule out the use of objective medical predictors of outcome (such as tissue-typing and panel reactive antibody levels) even if it is known that these factors are not randomly distributed among racial or gender groups. It does, however, rule out excluding individual members of a social group or giving them low priority simply because the group has statistically poorer outcomes.

In the application of the principle of utility, there must be evidence that the particular individual has a medical condition (high panel reactive antibody with positive cross match at the time of allocation, for example) that leads to a prediction of poorer outcome. The principle of utility (commonly interpreted as net medical benefit) is so obvious to many in the transplant community that they may assume that well-grounded prediction of good medical outcome is the only reasonable principle upon which an ethical allocation could be based. We believe, however, it is crucial that other principles be recognized as equally important considerations in ethical organ allocation. In particular, the principles of justice and respect for persons will sometimes lead to a justifiable decision that will not necessarily allocate organs in a manner that will do as much aggregate medical good as possible.

The National Organ Transplant Act (NOTA), in its mandate for the establishment of the Task Force on Organ Procurement and Transplantation, specifically expressed concern for "equitable access by patients to organ transplantation and for assuring the equitable allocation of donated organs among transplant centers and among patients medically qualified for an organ transplant." vii The Task Force specifically recommended that selection of patients for waiting lists and allocation of organs be fair, viii and UNOS has continued to express concern for justice in organ allocation. These views reflect a national commitment to a general principle of justice that merits inclusion as a basic principle of an ethic of allocation.

Justice, as used here, refers to fairness in the pattern of distribution of the benefits and burdens of an organ procurement and allocation program. Thus, we are concerned not exclusively with the aggregate amount of medical good that is produced, but also with the way in which that good is distributed among potential beneficiaries. This does not mean treating all patients the same, but it does require giving equal respect and concern to each patient. In general, allocation of organs based on social characteristics (such as race, socioeconomic class, gender) will conflict with the principle of justice, although there may be special cases such as the matching of skin-tone in face and hand transplant that call for exceptions in the allocation of vascularized composite allografts (VCAs), which is beyond the scope of this paper.

In a public program, all members of the public are morally entitled to fair access to its benefits. This means that even if we could determine precise measures of medical benefits such as predicted quality adjusted years of life added, the allocation that maximizes QALYs may not always be the morally right allocation, all things considered. For this reason, allocation schemes routinely consider medical need as well as medical benefits, prioritizing the medically sickest patients even if it is predictable that other patients who are not as sick will have better outcomes.

Many other factors might be included in an allocation policy not because they promote utility, but because it appears necessary to treat potential recipients fairly by giving everyone an equal opportunity to receive an organ when they are in need. Factors to be considered in the application of the principle of justice are: 1) medical urgency; 2) likelihood of finding a suitable organ in the future; 3) waiting list time; 4) first versus repeat transplants; 5) age; and 6) geographical fairness.

Sometimes the principle of justice will be in conflict with the principle of utility; in such cases both are worthy of equal consideration and play a role in shaping a decision about the morally preferable allocation.

C. respect for persons

The Belmont Report provides a third ethical principle: respect for persons. This principle holds that we owe to humans a respect that they should be treated as “ends in themselves,” not merely as means. This principle embraces the moral requirements of honesty and fidelity to commitments made. Most importantly, respect for persons embraces the concept of respect for autonomy.

The concept of respect for autonomy holds that actions or practices tend to be right insofar as they respect or reflect the exercise of self-determination. Persons and their actions are never "fully" autonomous, but nevertheless it is possible to recognize certain individuals and their decisions as more or less substantially autonomous, meaning they have the right to make decisions free from coercion and interference as long as the decisions do not impose harm to others.

If one of the characteristics of actions or practices that tend to make them right is that they respect autonomy, then it is possible that certain policies could be morally right, at least prima facie, even if they do not maximize utility and do not promote equitable distributions. When respect for autonomy conflicts with other ethical principles, on balance, sometimes autonomy deserves respect and sometimes autonomy must give way. For example, our current organ allocation system prioritizes justice over respect for autonomy with regards to selling organs, which is prohibited. Even if selling an organ is an autonomous decision made by the donor, creating a market system that increases healthcare disparities among different socioeconomic groups violates the underlying ethical principle of justice. Factors to be considered in the application of the principle of respect for autonomy are: 1) the duty to respect decisions of donors or those who refuse to donate organs; 2) the right to refuse an organ; 3) free exchanges among autonomous individuals; 4) allocation by directed donation; and 5) transparency of processes and allocation rules to enable stakeholders to make informed decisions. ix

IV. RESOLUTION OF CONFLICT AMONG PRINCIPLES

The ideal allocation would be one that simultaneously maximizes the aggregate amount of (medical) good, distributes the good justly, shows respect for persons including the autonomous decisions of persons, and is in accord with any other ethical principles that might come into play. Unfortunately, as the foregoing discussion has noted, these principles sometimes come into conflict. While this discussion of utility, justice, and respect for persons does not provide a full theory of resolution of conflict among basic principles, it provides a basis for proposing some guidelines for allocation.

Different strategies are available when principles conflict. One approach is to try to rank the principles. For example, a pure utilitarian would give absolute priority to utility over justice and autonomy. On reflection, lexical ordering among these three principles is very difficult to defend. Whatever priority ordering is proposed, it is possible to envision a situation in which adhering to it would seem wrong. As examples, a small increase in utility may in some circumstances require monumental injustices and violations of autonomy, and a modest gain in terms of justice or autonomy may require enormous costs in terms of utility. Another possible approach is to consider all the prima facie principles at the same time and try to balance them by arriving at a single conclusion that integrates all the relevant principles to the best degree possible. This approach presents problems as one endeavors to decide how much relative weight to grant each principle in a given context and how, in practical terms, that weight will be manifested.

When principles appear to conflict, policies should strive to ensure that: the policy is likely to be effective in achieving its aim; the infringement of a principle is minimized as far as possible; the good to be achieved is proportionate to the infringement of conflicting principles; and such policies are developed in a transparent manner allowing input from various stakeholder groups. x

A. Utility and Justice

While members of the transplant community hold diverging positions regarding the ethically correct relationship between utility and justice, a consensus has been reached for purposes of public policy relative to organ allocation that the two need to be balanced. In the 1990s the Ethics Committee proposed that, as a compromise among competing ethical positions, policies strive to give equal weight to the two. That still seems a reasonable compromise. This means that it is unacceptable for an allocation policy to strive single-mindedly to maximize aggregate medical good without any consideration of justice in distribution of the good, or conversely for a policy to be single-minded about promoting justice at the expense of the overall medical good. One group might favor emphasizing one principle over the other. Ensuring that both justice and utility are included in an allocation policy is a fair and workable compromise.

Other possible factors appear to be accounted for adequately by this combined consideration of utility and justice. For example, many clinicians feel morally obliged to give great weight, perhaps absolute weight, to saving a life. Priority would be given to a potential recipient approaching imminent death without a transplant, assuming there is a significant chance of saving the life and extending survival with the transplant. Where such considerations seem reasonable, it is because they can be justified by appeal to principles of justice and/or utility. If one considers the saving of a life to be a great medical good, then utility would partially account for priority for extremely urgent, life-saving cases. However, if the probability of saving a life was greater if the organ went to another patient whose case was not as urgent, then utility would favor giving the organ to the better off patient rather than the one near death.

Justice might also partially explain why priority might be given to a patient for whom death was imminent without transplant. One well-known interpretation of the principle of justice holds that the just or fair arrangement is the one that identifies the worst off persons or groups and arranges social practices so as to benefit that group. xi Applying this interpretation to organ allocation would justify giving priority to patients whose condition is so urgent that death is imminent even if more medical good could be done by giving the organ to a healthier patient.

B. respect for Autonomy

Respect for autonomy sets limits to the ways in which utility and justice should be balanced. The principle of respect for autonomy receives less emphasis in our method of conflict resolution among the principles in organ allocation because respect for autonomy will not often be in conflict with utility and justice. A clear exception is a case of a directed donation to a specified individual, as permitted by NOTA, in which the allocation is based solely upon individual autonomy without regard to either justice or utility. However, when autonomy is in conflict with utility or justice, each of these three principles should be taken into consideration as it does between utility and justice. Thus, for example, OPTN has long opposed donations directed to a social group (based on race, religion, gender, or sexual orientation).

C. Allocation and Access

Equitable access to the transplant waiting list is the cornerstone of equitable organ allocation. The process of placement on the list determines whether ethical principles of allocation are applied in reality. Factors relevant to access to the transplant waiting list, as distinguished from medical criteria used in the equitable allocation of organs, include: ethical rules (e.g., honesty, the duty not to harm), clinical indicators (e.g., co-morbidities, cause of organ failure) and psychosocial factors (e.g., financial and social support, patient adherence). All of these factors can be identified as serving one or more of the three basic principles outlined above. For example, the moral rule to be honest is important for respect for persons; considerations of age and the controversy about listing individuals for multiple organs when others die while waiting for one organ can be examined as considerations of both utility and justice. Other factors such as blood groups and policies that permit or prohibit the allocation of an organ across compatible blood types can also be understood by referring to the three basic principles. Therefore, factors that impact access to the transplant waiting list should also be considered within the context and balance of these three ethical principles.

V. CONCLUSION

Utility, justice, and respect for persons are three foundational ethical principles that create a framework for the equitable allocation of scarce organs for transplantation. Allocation policies should strive to incorporate an appropriate combination of these principles, giving equal consideration to utility and justice, while incorporating the fundamental aspects of respect for persons. An allocation policy that maximizes aggregate utility without considering justice is unacceptable. Similarly, an allocation policy that promotes justice without consideration of the overall medical good is also unacceptable. While the relationship of respect for persons to these principles is complex, incorporation of this principle is also important, even though in some specific situations, its relative lesser importance is uncontroversial. In the development of a national allocation policy of scarce organs for transplant, it is and ought to be the responsibility of those updating allocation formulas to understand how the incorporation of different factors influence the relative importance and potential conflict of these ethical principles, in order to ensure that policy is consistent with an equitable resolution.

ia Burdick, James F., Jeremiah G. Turcotte, and Robert M. Veatch, eds. "Principles of Organ and Tissue Allocation and Donation by Living Donors." Transplantation Proceedings 24 (October 1992, No. 5):2226-2237.

ib Ethical Principles to be Considered in the Allocation of Human Organs (Approved by the Board of Directors on June 22, 2010) http://optn.transplant.hrsa.gov/resources/ethics

ii 42 U.S.C. §273 et seq.

iii OPTN Final Rule, 42 C.F.R. § 121 et seq.

iv The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, (April 18, 1979) accessed at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html [accessed April 9, 2015]. For alternative formulations of essentially the same list of principles see Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics, seventh edition. New York: Oxford University Press, 2013, and Veatch, Robert M., and Ross, Lainie F. Transplantation Ethics, second edition. Washington, DC: Georgetown University Press, 2015.

v Quality-adjusted life years are years of life adjusted for the quality of those lives. Zeckhauser, Richard, and Donald Shepard, "Where Now for Saving Lives?" Law and Contemporary Problems 40 (1976):5-45; Torrance, George W. "Measurement of Health State Utilities for Economic Appraisal: A Review." Journal of Health Economics 5 (1986): l-30: Menzel, Paul. Strong Medicine: The Ethical Rationing of Health Care. New York: Oxford University Press, 1990, pp. 79-93.

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

vii Public Law 98-507, October 19, 1984. National Organ Transplant Act 98 Stat. 2339.

viii Task Force on Organ Transplantation. Organ Transplantation: Issues and Recommendations. Washington, D.C.: United States Department of Health and Human Services, 1986, pp. 8-9.

ix See generally, NOTA and the OPTN Final Rule.

x J.D. Childress et al, Public Health Ethics: Mapping the Terrain, Journal of Law, Medicine and Ethics, 30, 2 (2002), pp. 170-178.

xi Rawls, John. A Theory of Justice, Cambridge, Massachusetts: Harvard University Press, 1971.

Ethical Considerations for Organ Transplantation

• First Online: 02 November 2016

Cite this chapter

• Aviva L. Katz MD, MA, CIP, FACS, FAAP 3  

2457 Accesses

The breadth of transplant surgery, including the need to balance the needs of multiple patients, and the frequent confrontation with issues regarding death expose members of the transplant team to a variety of ethical concerns. Yet, despite extensive training, many transplant team members, including surgeons, still feel ill-prepared to deal with these issues. This chapter provides a framework for understanding and addressing the ethical questions that arise daily among patients and families and includes some familiar as well as newer perspectives on medical decision making. As transplant team members consider the ethical issues in organ donation, it may help to see organ donation as a voluntary act with the potential to morally elevate humankind, rather than viewing the human body as a repository of parts.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

• Available as PDF
• Read on any device
• Instant download
• Own it forever
• Available as EPUB and PDF
• Compact, lightweight edition
• Dispatched in 3 to 5 business days
• Free shipping worldwide - see info
• Durable hardcover edition

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Beauchamp TL, Childress JF. Principles of biomedical ethics. 5th ed. New York: Oxford University Press; 2001.

Google Scholar  

Aristotle, translated by Thomson JAK. The Nicomachean ethics (Books II through VI). New York: Penguin Books; 2004.

Pellegrino ED, Thomasma DC. The virtues in medical practice (Chapter 3). New York: Oxford University Press; 1993.

Gilligan C. In a different voice. Cambridge, MA: Harvard University Press; 1982.

Bonhoeffer D. Dietrich Bonhoeffer Works, Volume 8: Letters and papers from prison. Minneapolis, MN: Augsburg Fortress; 2009.

Cohen IG. Transplant tourism: the ethics and regulation of international markets for organs. J Law Med Ethics. 2013;41:269–85.

Article   PubMed   Google Scholar  

Joralemon D, Cox P. Body values: the case against compensating for transplant organs. The Hastings Center. 2003;33(1):27–33.

Article   Google Scholar  

Participants in the International Summit on Transplant Tourism and Organ Trafficking convened by the Transplantation Society and International Society of Nephrology in Istanbul, Turkey, April 30 through May2, 2008. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism. Clin J Am Soc Nephrol. 2008;3:1227–31.

Reed AI, Merion RM, Roberts JP, et al. The Declaration of Istanbul: Review and commentary by the American Society of Transplant Surgeons Ethics Committee and Executive Committee. Am J Transplant. 2009;9:2466–9.

Article   CAS   PubMed   Google Scholar  

Friedman AL. Payment for living organ donation should be legalized. Br Med J. 2006;333(7571):746–8.

Lauritzen P, McClure M, Smith ML, Trew A. The gift of life and the common good: the need for a communal approach to organ procurement. Hastings Center Rep. 2001;31(1):29–35.

Article   CAS   Google Scholar  

Matas AJ. Working Group on Incentives for Living Donation Incentives for Organ Donation: proposed standards for an internationally acceptable system. Am J Transplant. 2012;12:306–12.

MatchingDonors.com. http://www.matchingdonors.com/life/index.cfm . Accessed 5 Apr 2014.

Bramstedt KA, Delmonico FL. Ethics care: assessing the motives of living, non-related donors. AMA J Ethics. 2012;14(3):186–9.

Ross LF. Media appeals for directed altruistic living liver donations. Perspect Biol Med. 2002;45(3):329–37.

Hilhorst MT. Directed altruistic living organ donation: partial but not unfair. Ethical Theory Moral Pract. 2002;8(1/2):197–215.

Zeiler K, Furberg E, Tufveson G, Welin S. The ethics of non-heart-beating donation: how new technology can change the ethical landscape. J Med Ethics. 2008;34:526–9.

Pntb.org/wordpress/wp-content/uploads/Uniform-Determination-of-Death-1980_5c.pdf

Hoover SM, Bratton SL, Roach E, Olson LM. Parental experiences and recommendations in donation after circulatory determination of death. Pediatr Crit Care Med. 2014;15:105–11.

Truog RD, Miller FG, Halpern SD. The dead-donor rule and the future of organ donation. N Engl J Med. 2013;369(14):1287–9.

Sarnaik AA, Clark JA, Meert KL, Sarnaik AP. Views of pediatric intensive care physicians on the ethics of organ donation after cardiac death. Crit Care Med. 2013;41:1–12.

Lewis-Newby M, Wicclair M, Pope T, et al. on behalf of the ATS. Ethics and Conflict of Interest Committee An Official American Thoracic Society Policy Statement: managing conscientious objections in intensive care medicine. Am J Respir Crit Care Med. 2015;191:219–27.

Hilhorst MT. “Living apart together”: moral frictions between two coexisting organ transplantation schemes. J Med Ethics. 2008;34:484–8.

Leichtman AB, McCullough KP, Wolfe RA. Improving the allocation system for deceased-donor kidneys. N Engl J Med. 2011;364:1287–9.

Ladin K, Hanto DW. Rationing lung transplants—procedural fairness in allocation and appeals. N Engl J Med. 2013;369:599–601.

Ross LF, Thistlethwaite JR. Should age be a factor in the allocation of deceased donor kidneys? Semin Dial. 2012;25:675–81.

Ross LF, Parker W, Veatch RM, Gentry SE, Thistlethwaite JR. Equal opportunity supplemented by fair innings: equity and efficiency in allocating deceased donor kidneys. Am J Transplant. 2012;12:2115–24.

Hippen BE, Thistlethwaite JR, Ross LF. Risk, prognosis, and unintended consequences in kidney allocation. N Engl J Med. 2011;364:1285–7.

Vladeck BC, Florman S, Cooper J. Rationing livers: the persistence of geographic inequity in organ allocation. AMA J Ethics. 2012;14:245–9.

Aulisio MP, DeVita M, Luebke D. Taking values seriously: ethical challenges in organ donation and transplantation for critical care professionals. Crit Care Med. 2007;35:S95–101.

Download references

Author information

Authors and affiliations.

Division of Pediatric General and Thoracic Surgery, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center, 4401 Penn Avenue, 7133 Faculty Pavilion, Pittsburgh, PA, 15224, USA

Aviva L. Katz MD, MA, CIP, FACS, FAAP

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Aviva L. Katz MD, MA, CIP, FACS, FAAP .

Editor information

Editors and affiliations.

Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA

Kathirvel Subramaniam

Department of Anesthesiology The Clinical and Translational Science Institute The McGowan Institute for Regenerative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA

Tetsuro Sakai

Rights and permissions

Reprints and permissions

Copyright information

© 2017 Springer Science+Business Media New York

About this chapter

Katz, A.L. (2017). Ethical Considerations for Organ Transplantation. In: Subramaniam, K., Sakai, T. (eds) Anesthesia and Perioperative Care for Organ Transplantation. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-6377-5_1

Download citation

DOI : https://doi.org/10.1007/978-1-4939-6377-5_1

Published : 02 November 2016

Publisher Name : Springer, New York, NY

Print ISBN : 978-1-4939-6375-1

Online ISBN : 978-1-4939-6377-5

eBook Packages : Medicine Medicine (R0)

Share this chapter

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Publish with us

Policies and ethics

• Find a journal
• Track your research

Quick links

• Find funding
• Find publications
• News centre
• Outcomes of funding rounds
• Sapphire Login

Ethical guidelines on organ and tissue donation and transplantation

Organ and tissue transplantation is an effective and well-established treatment, with the potential to drastically improve the health and life of recipients. However, despite increasing success rates and the broadening of recipient eligibility and organ suitability criteria, the demand for organs and tissues continues to exceed their availability.

The availability of donor organs and tissues for transplantation relies mainly on the generosity of individuals, and their families, to donate. For a system of altruistic donation to flourish, it is important that donation processes are underpinned by ethical principles and values that safeguard donors and their families from exploitation and harm, and engender community faith in the system.  Similarly, for the ongoing success of the transplantation system, decisions about eligibility, suitability, and allocation must be ethically robust, transparent, and guided by ethical principles and values. 

Through the work of the  Australian Health Ethics Committee (AHEC) , NHMRC has issued the following guidelines to provide an overarching framework to guide ethical practice and inform decision-making by everyone involved in organ and tissue donation and transplantation:

• Organ and tissue donation after death, for transplantation – Guidelines for ethical practice for health professionals, 2007  (Under review)
• Making a decision about organ and tissue donation after death, 2007 (Under review)
• Organ and tissue donation by living donors – Guidelines for ethical practice for health professionals, 2007 (Under review)
• Making a decision about living organ and tissue donation, 2007 (Under review)
• Ethical guidelines for organ transplantation from deceased donors, 2016 .

In 2017, NHMRC commenced a review of the organ and tissue donation and transplantation guidelines for currency, relevance and consolidation. 

Review of Guidelines The NHMRC CEO has established the Organ and Tissue Working Committee (OTWC) to advise AHEC on the review of the NHMRC ethical guidelines on organ and tissue donation and transplantation.

Related resources

Saving blood, saving lives: Case Study

Organ and Tissue Working Committee

Organ and tissue donation by living donors

• Ideas Grants 2022 Peer reviewer briefing webinar introductions and presentation
• Indigenous Research Excellence Criteria video transcript
• Funding agreement and deed of agreement
• Institution approvals  
• Institutional Annual Compliance Report 
• Vary your grant
• Financial reporting
• Progress, final and additional reporting
• Direct Research Cost Guidelines
• Previous Personnel Support Package rates
• Previous Salary Support Package rates
• Institutional approvals and grant conditions
• Funding Agreement
• Financial Reports
• Scientific reporting and milestones
• Direct Research Costs and Personnel and Salary Support Packages
• Eligibility
• Peer review
• Research funding data
• Analysis of Australian health and medical research publications
• Medical Research Future Fund
• International Collaborative Health Research Funding
• Funding calendar
• Working together to support research
• Statements of Expectations
• Targeted Calls for Research
• Capacity and capability building and strengthening
• Health Advice and Publications
• Health effects of water fluoridation
• Preventing infection
• How NHMRC develops public health guidelines
• Complementary medicines
• Electronic cigarettes
• Myalgic Encephalomyelitis and Chronic Fatigue Syndrome
• Lead blood levels
• Recreational Water Quality Advisory Committee
• Australian Guidelines to Reduce Health Risks from Drinking Alcohol - Public submissions
• National Statement on Ethical Conduct in Human Research
• Genomics resources for clinicians and researchers
• Vitamin K for newborns
• Guidelines for Guidelines
• COVID-19 impacts
• Clinical trials reform
• Determining whether an embryo model is regulated by the ERLC
• Information for applicants
• Information for Licence Holders
• Mitochondrial Donation Licensing Scheme
• Training and Quality Assurance activities
• Import and export of cell lines
• Database of Licences issued
• Training and Quality Assurance
• Use of animals in NHMRC funded research
• The Human Research Ethics Applications (HREA)
• Ethical issues and further resources
• National Certification Scheme
• Human research ethics committees
• Clinical ethics
• Ethical guidelines for Assisted Reproductive Technology
• Ethical guidelines for research with Aboriginal and Torres Strait Islander Peoples
• NHMRC ethical guidelines on organ and tissue donation and transplantation
• Guideline development
• International engagement
• Research quality
• Research translation
• Research impact
• Dementia research
• NHMRC Special Initiative in Mental Health
• NHMRC’s role in addressing health implications of environmental change
• Submission of Targeted Calls for Research online pathway
• NHMRC health priorities 2021–2024
• Framework for Identifying and Prioritising Targeted Calls for Research
• Targeted Calls for Research Prioritisation Criteria Rubric
• Guide for Proposing Targeted Calls for Research
• Administering Institution Policy
• NHMRC Gender Equity Strategy 2022-2025
• Statement on sex and gender in health and medical research
• Structural priority funding and gender equity
• Accountability and reporting
• Fifteenth edition
• Fourteenth edition
• Ten of the Best Archive
• Ten of the Best
• 2022 Research Excellence Awards
• 2023 Research Excellence Awards
• Health Innovation Advisory Committee 2015-2018
• Legislative basis to NHMRC
• Senior executive and leadership team
• Indigenous Research Ethics Guidelines Review Working Committee
• Natural Therapies Working Committee
• Publications
• Probity Event - Additional Guidance
• NHMRC Complaints Policy
• Temporary Employment Register
• Working at NHMRC
• How we select our people
• Indigenous internship program
• Freedom of information
• Child Safe Policy
• Annual reports and corporate plans
• Consumer and community engagement
• About the review
• Consumer Statement review
• Consumer and community representative involvement in the peer review process of Targeted Calls for Research

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• J Intensive Care Soc
• v.20(2); 2019 May

Is presumed consent an ethically acceptable way of obtaining organs for transplant?

The near-universal acceptance of cadaveric organ donation has been based on the provision of explicit consent by the donor while alive, either in the form of a formal opt-in or informal discussion of wishes with next of kin. Despite the success of transplantation programmes based on explicit consent, the ongoing imbalance between demand and supply of organs for transplantation has prompted calls for more widespread introduction of laws validating presumed consent with facility for opt-out as a means of increasing organ availability. The Department of Health (UK) has recently concluded a consultation on the introduction of such a law for England. This article explores the debate on presumed consent from an ethical point of view and summarises the key arguments on both sides of the ethical divide.

Introduction

The first successful human organ transplant operation was performed in 1954 and involved the transplantation of a kidney from an identical twin. 1 There has since been a progressive increase in the number and range of transplantation procedures performed successfully, driven by improvements in surgical technique and intensive care and the emergence of medical technologies to bridge organ function in the face of irreversible organ failure and to combat rejection. In the UK as elsewhere, a large proportion of solid (unpaired) organ transplants that are currently performed utilize organs obtained from dead donors. 2

From the outset, there was widespread support for the concept of allogenic organ transplantation from the dead. Even disregarding extreme utilitarian views such as the macabre ‘survival lottery’ hypothesised by John Harris, 3 there is logic in a utilitarian and communitarian view that the dead cannot be harmed by removal of their organs, while the living (and society in general) stand to benefit from them. From a deontological (duty-based) perspective, it can be argued that the right to be a recipient when in need of a transplant imposes corresponding duties to be a donor. 4 The Catholic Church was early to realise the benefits to humanity from transplantation and supported organ salvage from the dead. The violation of the sanctity of the dead was justified by the concept of the ‘Ultimate Gift of Charity’ that a human being could leave his fellows. Integral to this concept was the need for this ‘Gift’ to be properly endowed or ‘given’ by the donor, and not be ‘taken’. 5 This could only be guaranteed by a process of ‘informed consent’ by the donor allowing for the violation of his mortal remains after his death.

The earlier view (and one that still prevails in many jurisdictions) is to insist on the exclusive validity of ‘explicit’ consent, where the donor needs to have ‘opted-in’ to becoming a donor. This needs to have taken place by an act of (usually) signing into a donor register, ideally having had access to adequate information. In the event of untimely death of a potential donor with no explicit evidence of consent or dissent to organ donation, most opt-in jurisdictions accept ‘consent’ to donation being provided by his closest relatives. While there is a general acceptance that only the donor has the right to decide how his ‘private property’ is disposed of after his death, a common-sense approach is taken that his closest relatives are likely to know what his wishes would have been, and are most likely to act accordingly. 6 Allowing relatives to consent prevents a valuable resource from going waste, and importantly, ensures that the potential donor’s wishes are adhered to as closely as possible. Most jurisdictions have tacitly extended the right of veto to close relatives claiming an individual may have changed his mind after opting in, and in some cases, using organs against strong objections by relatives (while legal) may cause distress to those left behind and may adversely impact the doctor–patient relationship and social solidarity on which transplantation systems thrive. 7

In the UK, an opinion poll conducted by the organ donation task force has revealed that 90% of adults are in favour of becoming organ donors. 8 However, as of the last available activity report from the NHS Blood and Transplantation service, only about 36% of eligible adults have registered onto the organ donor register. 2 In the case of adults who die without being on the donor register, refusal rates for organ retrieval by relatives is high, with the consent rate being only 46.7%. The consent rates are high (91.2%) if the potential donor was already on the register or if their wishes are known by the relatives. 2 The numbers of patients on the transplant waiting list has increased by 7% between 2001 and 2013, and the gap between the waiting list size and organ availability is increasing alarmingly. The latest available statistics indicate that in the UK, there are 6388 patients awaiting a transplant as of the end of March 2017, and 457 patients on the waiting list dying while awaiting a transplant. 2 This is the background to the idea that alternative forms of consent such as presumed consent (opt-out) or mandatory choice should be considered as a means of increasing the supply of organs. 9 Other methods of obtaining organs for donation such as ‘organ conscription’ 10 or ‘routine recovery’ 11 and ‘normative consent’ 12 have been mooted, but are largely considered theoretical challenges to the existing pragmatic ethical positions. The risk of extreme policy positions alienating public opinion and reducing donation rates is accepted as being real, and this has prevented any jurisdiction from seriously considering their implementation.

The concept of presumed consent, deemed consent or ‘opt-out’

The concept of presumed consent for organ donation is not new and dates to an idea first mooted by Dukeminier and Sanders. 13 The issue had bubbled over in the field of bioethics with Cohen making the case for it and Veatch and Pitt against. 14 , 15 However, the concept was brought to the fore when Professor Ian Kennedy and his co-authors wrote in the Lancet arguing the case for presumed consent as a way of increasing the supply of urgently needed organs. 16 The BMA’s Medical Ethics Committee endorsed presumed consent for organ donation in the UK calling for a consolidated approach to organ donation for the 21st century. 7 , 17 This resulted in a report by the Organ Donation Taskforce (2008), which suggested that while presumed consent was ethically acceptable, an improved opt-in system or a system of mandated choice may be a better way of ensuring that the wishes of the donor were honoured. 18 The review of existing studies commissioned by the taskforce concluded that while most jurisdictions did clearly have higher donor numbers per million population (pmp) after introduction of opt-out legislation, this could by no means be conclusively attributed to the opt-out legislation in isolation. 19 Opt-out countries such as Spain, Austria and Belgium have among the highest donation rates, but some such as Bulgaria and Luxemburg have among the lowest. 20 The taskforce suggested that significant improvements in organ donation rates could be achieved by improvements in infrastructure and education, including public awareness campaigns. They indicated that the issue of presumed consent should be revisited in five years if the targets were not achieved. 18

By enacting the Human Transplantation (Wales) Act 2013, the Welsh Assembly chose to introduce deemed consent for organ donation into Law from 1 December 2015. 21 The review on which the Welsh Assembly based its decision came to a similar set of findings, but suggested that on balance opt-out legislation was likely to increase donation rates. 22 The version of deemed consent chosen by the Welsh Assembly is termed ‘soft opt-out’, where intention is that the state will not go against refusal by the next of kin. The rationale for this (as against a hard opt-out) is to avoid giving the impression that the state was acting as though it had a ‘right’ to the organs from the deceased, potentially provoking opt-outs from individuals. While early data suggest an increase in consent rates, more registered donors and more live donations, there has been a decrease in actual donor numbers. Admittedly, the small size of the population makes it difficult to draw inferences this early. 23 – 25 The Department of Health (DoH) recently commenced a public consultation on the introduction of an opt-out system of organ donation for England as a means of improving organ donation rates. 26 , 27 This consultation ended on 6 March 2018 and has attracted over 11,000 responses highlighting the passionate views held by the public on this topic.

Ethical arguments relating to the presumption of consent

The following discussion looks at the ethical arguments against and for an opt-out arrangement. It is not meant to add to the two excellent reviews and a critique that have looked into the issue of whether introduction of presumed consent will increase the supply of organs in England and Wales. 19 , 20 , 22 An attempt will be made to draw some conclusions that bridge the chasm in normative ethics about the use of presumed consent strategies.

The argument against presumption of consent

One of the key arguments made against the presumption of consent is the concern that informed consent would no longer be involved in the process of organ acquisition. This means that the organ is no longer a gift or donation in the true sense of the word. It appears as something that has been ‘taken’ from the dead. In Pope Benedict XVI’s words, “… In these cases, informed consent is a precondition of freedom so that the transplant can be characterised as being a gift and not interpreted as a coercive or abusive act”. 28 On this basis, Austriaco has urged that all catholic individuals and institutions “… must reject presumed consent and not cooperate with an unjust system of organ procurement.” 29 There is evidence that majority of recipients wish to be certain that the organs were only retrieved in accordance with the donor’s wishes. 30 This concern (among other practical considerations) was one of the factors that made the Organ Donation Taskforce argue against the introduction of presumed consent. 18

The problem is that this assumes the opting-in process to entail ‘informed consent’. With behavioural economic theories (nudge theories) being applied extensively in the public policy sphere, the process of opting into a donor register involves nothing more than a tick in a box during an application for a driving licence or renewing a vehicle excise duty. 31 At the time the application is made, the implications of the tick box are likely far from the applicant’s mind. Similar ‘nudge theories’ are thought to lie behind the use of presumed consent in organ donor registration policy. There is clear acceptance in the domain of behavioural economics that when presented with alternatives, people who are unsure tend towards the default (status quo bias or default bias). 32 This is thought to be one of the reasons behind higher donation rates in presumed consent jurisdictions.

The fact remains that most potential donors in the UK are not on the donor register, and current practice in explicit consent jurisdictions entails asking relatives to ‘consent’ on their behalf. This consent has no real validity in terms of ensuring the gifted nature of the donation process. Besides, it puts an additional strain on the relatives in a situation that is already excruciating. The relatives are being asked to rule against the ‘presumption’ that the donor would not have wished to donate (which is the presumption in explicit consent jurisdictions), and consent to what they might consider as the mutilation of the deceased’s mortal remains. It is therefore not surprising that consent rates for organ retrieval are low when the wishes of the potential donor are not known. There is also the argument that of the 90% of individuals who stated in surveys that they would wish to donate, the 54% who did not register presumably failed to do so primarily due to apathy, and not because they would not want to donate. 8 It could also be argued that the claims made when surveyed may reflect their values, but may not reflect their wishes, hence the disparity between survey results and donor registration rates.

The main argument against presumed consent stems from the potential for violation of the donor’s autonomy: his wish about what should happen to his body after death. Farsides states that “acknowledging and where possible acting in accordance with a person’s wishes regarding treatment of their body signals respect for that autonomy”. 33 The moral wrong involved in interfering with a dead person’s body against his (un)stated wish maybe seen as worse than the moral wrong involved in non-interference with the body against his (un)stated wish. Veatch and Pitt argue that the two wrongs are not morally equal, analogous to the commonly accepted view that it is better to let nine guilty individuals be unjustly freed than for one innocent to be punished. 15 They state that unless it is unequivocally clarified that the overwhelming majority of individuals would want to donate their organs upon their deaths, the only morally correct solution would be to adhere to an explicit consent policy. This is because removal of organs without explicit consent constitutes a blatant violation of bodily integrity (and thence autonomy), whereas failure to remove organs when it may have been desired, is ‘merely’ an unfortunate failure to help bring about a desired outcome.

A further point of objection to presumed consent policies raised by Veatch and Pitt is the view that such policies are actually a misnomer, as no one can presume consent when the person who owns the property is unable to provide such consent explicitly. They state that such policies are attempting to give ‘eminent domain’ policies (that basically state that private property is for the state to use to satisfy a public Good) a cloak of respectability to make them acceptable to a society that values the rights of the individual above everything else. 15

Ben Saunders, a prominent supporter of the opt-out policy for organ donation agrees that the presumption of consent is a misnomer, as consent as we know it involves an active process with its three well known components (capacity, adequate information and ability to balance the information to come to a decision). He argues that ‘an opt-out policy without presumptions’ is ethical, as the failure to register an objection (given adequate chances to do so) can be ‘interpreted’ as implied consent. 34 MacKay counters this with the evidence that across Europe, surveys have shown poor understanding of existing donor registration policies. 35 In the backdrop of this, the assumption that silence means tacit consent would not be ethical. 36

One of the fears raised by the Organ Donor Task Force was the risk of increased opt-outs as a push back against what could be considered interference by the state. In fact, the Welsh experience has shown that about 5% of the eligible population did opt out in the three years since the legislation came into force. 37

The argument for presumption of consent

On the other side, Cohen 14 argues that a presumption is made in either case: either a presumption that majority of individuals do not wish to be donors or to the contrary. 14 In each case, a proportion will be wronged by having their autonomous will violated. He argues that violation of the autonomous will of a dead person is equally wrong: whether it involves a mistaken removal or a mistaken non-removal. The interference with the body is not the moral wrong, but the violation of autonomy. He states that “the present system, depending entirely on the expressed consent of the decedent’s family after death, thus errs in its empirical underpinning, and by that error promotes a great moral mistake”. 14 In this sense, even if 51% of individuals are potential donors, fewer mistakes would be committed with a presumed consent policy. This supports the ‘fewer mistakes’ claim in favour of a presumed consent system of organ donation, assuming that the mistakes are morally equal.

A system of explicit consent (opt-in) with a low uptake that relies on consent from the next of kin may leave an objector open to potential violation, as their relatives may not be aware of their objection and may have values different from the donor. In such a situation, proponents of presumed consent with opt-out argue that the provision of opt-out provides objectors with a clear path to maintain their autonomy. 7

There is also the logical assumption that an individual opposed to organ donation is more likely to opt-out under a system of presumed consent, than someone who desires to donate is to opt-in under an explicit consent system. This assumption stems from the fact that “most of those opposed to organ donation have conspicuous religious or moral objections of which they themselves are very aware, and as a result are unlikely to neglect to opt-out of a system of presumed consent”. 38 In stark contrast, those who wish to donate are doing so out of an altruistic motive, which is “relatively unremarkable”, and are less likely to make their preferences clear before the unexpected eventuality of their death occurs. 38 However, in a stinging counter to this, Kluge argues that presumed consent policies with opt-out protection are akin to a person who does not wish to be violated having to inform trespassers of this fact and is a ‘reversal of polarity of the right to inviolability’. 39

Spital and Taylor make a case for “entirely eliminating the consent requirement for the routine recovery of transplantable cadaveric organs”. 11 They equate this to a situation of total war in which most citizens would accept the concept of a draft in the general public interest. They claim additional benefits to routine removal such as equity, avoidance of additional stress on grieving relatives and removal of potential for exploitation as reasons why this process is more ethical than explicit consent. The issue seems to boil down to whether organ retrieval (or routine salvage as Dukeminier & Sanders referred to it) is actually a ‘give’ by the donor or a ‘take’ by the state.

Gill gives this argument a completely novel dimension by defining the two types of autonomy being referred to implicitly in these two widely varying points of view. He argues this difference in the forms of autonomy being referred to as being a crucial aspect in rationalising the two arguments. 38

To understand this better, it would help to use the relatively simple analogy of disposal of one’s assets. When an individual is alive, he has every right to do what he wants with his assets, and any interference with his wishes goes contrary to his autonomous will. If he dies with a will in place, his autonomous will is clearly stated, and his assets are distributed as he would have wished. This is referred to as the ‘non-interference model’ of autonomy. The two proponents do not differ in their approach to this model of autonomy. If an individual is alive and competent, an invasive procedure will only be performed with his explicit consent. Similarly, if his desires regarding organ donation are clear, the same model would apply.

The divergence happens if this individual dies intestate, or without leaving clear instructions as to his wishes regarding organ donation. The non-interference model is no longer applicable, as the state cannot leave his assets be as they are when he died. Nor can the state leave his body as it is when he dies. ‘Interference’ in some shape or form is mandatory, and the state uses a ‘respect for wishes model’ of autonomy to decide how best to interfere in these scenarios. In the case of his assets, the state takes the view (presumes) that most people would want their assets distributed among their closest relatives and acts accordingly. In so doing, it is likely that in a few cases mistakes will be made: for example, if he wanted all his assets left to charity. From a policy perspective, it makes sense to implement one that makes the fewer mistakes. Gill is categorical in his dismissal of Veatch and Pitt, and Kluge’s claim that mistaken removals violate an individual’s right to non-interference with their bodies, as these individuals when brain-dead, are no longer capable of self-determination. 15 , 39

Gill argues that the same should apply to organ donation after death: “The duty to respect persons’ wishes about what should happen to their bodies after death implies that we should follow the policy that can reasonably be expected to lead to the fewest mistakes”. If the available evidence is right, and points to a majority wishing to donate their organs after death, an organ procurement policy that presumes consent will overall make fewer mistakes than one that insists on explicit consent. In fact, he argues that a society which institutes a presumed consent policy is “a society that does its best to construct policy that respects individuals’ own choices” and not one that fails to adhere to the Nuremberg Code. 40 Mackay counters this argument by clarifying the implications of donor registration policies. Their remit is all about registering currently competent people for an intervention that will occur when they are no longer competent. In this context, autonomy will be only respected if they are asked for authorisation while they are competent rather than use a respect for wishes model when incompetent. He says that consent may not be a necessary step in organ retrieval (if society so decides), but to be respectful of autonomy, a donor registration policy should do everything possible to seek consent (opt-in). 36

What is clear from the arguments presented is that an individual society’s chances of making ‘fewer mistakes’ in preserving autonomy of the donor revolves around knowing for certain what the overwhelming majority of its members would want happen to their bodies after death.

Opponents of presumed consent policies argue that only if the desire to donate applies to the “overwhelming majority” could a presumed consent policy be considered morally acceptable. The proponents argue that if a simple majority emphatically desire to be donors, a presumed consent policy will be justified over an explicit consent policy. Neither disagree that from a communitarian perspective, organ donation is a moral good, and should be encouraged. Both accept that information on the process is the key to ensuring the ethical validity of either approach.

It seems incumbent upon society to ensure that this message gets across to everyone by making information on the benefits of organ donation available in a language that is simple and clear. This would eventually overcome the apathy that seemingly prevents the silent majority from signing on to the organ donor register, and thereby render the whole process almost self-fulfilling. Such a paradigm shift will also not ignore the needs of those who, for whatever reason or no reason at all, are opposed to becoming organ donors. They should be able to make their opposition clear without fear of recrimination, and with the utmost certainty that society will uphold their wishes. This seems to have been the approach taken by the organ donation task force in its report titled “The potential impact of an opt out system for organ donation in the UK: An independent report from the Organ Donation Taskforce”. The taskforce concluded that as things stand, “a presumed consent system has the potential to undermine the concept of donation as a gift, to erode trust in health professionals and the Government, and negatively impact organ donation numbers”.

A presumption of consent is also ethically sound and morally justified in organ retrieval for transplantation, provided information on the opt-out process is readily available in easily comprehensible formats, it is ensured that as many people as possible understand the opt-out process and families are given a say in the final decision. However, the concerns that surround the implementation of such a policy are real and mandate that implementation be preceded by a public information campaign highlighting the moral justification for organ donation as a whole, changes in infrastructure that separate the clinicians involved in the clinical care of potential donors from the staff involved in the diagnosis of brain death, consent process, organ retrieval and organ transplantation and clarification of the legal standing of organ donor cards.

Until this happens in practice, policies that presume non-consent and those that presume consent will continue to make mistakes in individual cases. Society will have to decide whether a moral mistake that saves other lives (mistaken removals in presumed consent policy) is in any way preferable to an equivalent moral mistake that in addition costs lives (mistaken non-removals in a policy of explicit consent). It would be hoped that in a future where organ donation is ‘the norm’, history will not harshly judge us as a society that left its sick to suffer through a desire not to harm the potential autonomous will of its dead.

Acknowledgements

This paper is largely drawn from an essay written by the author as part of the requirements for the ‘end of life’ module of a Master’s degree in Bioethics and Medical Law at St Mary’s University, Twickenham. The author gratefully acknowledges the comments from Dr Pia Matthews, the module director, as part of the evaluation of the essay. The author is also grateful for the suggestions and comments from the MA programme Director, Dr Trevor Stammers that have substantially contributed to the final shape of the paper. The paper has undergone substantial modification based on the suggestions of the original reviewers from the JICS editorial board.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The author(s) received no financial support for the research, authorship, and/or publication of this article.