Reviewed and Updated in June 2015
Note: This report was adopted by the Ethics Committee in 1992ia and revised in 2010.ib
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 OPTNiii, 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.
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 Reportiv, 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.
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.
iaBurdick, 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.
ibEthical 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
ii42 U.S.C. §273 et seq.
iiiOPTN Final Rule, 42 C.F.R. § 121 et seq.
ivThe 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.
vQuality-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.
viOPTN Final Rule, 42 C.F.R § 121.4(a)(3).
viiPublic Law 98-507, October 19, 1984. National Organ Transplant Act 98 Stat. 2339.
viiiTask Force on Organ Transplantation. Organ Transplantation: Issues and Recommendations. Washington, D.C.: United States Department of Health and Human Services, 1986, pp. 8-9.
ixSee generally, NOTA and the OPTN Final Rule.
xJ.D. Childress et al, Public Health Ethics: Mapping the Terrain, Journal of Law, Medicine and Ethics, 30, 2 (2002), pp. 170-178.
xiRawls, John. A Theory of Justice, Cambridge, Massachusetts: Harvard University Press, 1971.