OPTN/UNOS Ethics Committee: Ethical Principles to be Considered in the Allocation of Human Organs
June 22, 2010
Note: This report is circulated for informational purposes and to stimulate discussion of a very important subject. The report has been presented to the OPTN/UNOS Board of Directors. It has not been adopted as policy.
A. Ethical Principles and Regulatory Requirements.
Ethical principles and regulatory requirements often, but need not necessarily, 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 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")i 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 OPTNii, which operationalized the requirements contained in NOTA ("OPTN Final Rule"). The OPTN Final Rule contains the regulatory requirements for the OPTN, and while many of the regulatory requirements embody the familiar ethical principles of justice, utility, and autonomy, it is not an ethics document per se 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. However, the OPTN Final Rule is not intended to be the sole source of ethical guidance for formulating allocation policies. This document is intended to go further than the OPTN Final Rule in defining principles that provide the ethical underpinning for national allocation policy while being consistent with the requirements of the NOTA and the OPTN Final Rule. This document recommends the adoption of allocation policies that are fully compliant with those regulations.
B. Allocation Policies and Access to the Waiting List.
Access to the waiting list for an organ transplant remains an area of great concern, as it 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 ESRD 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. Listing practices and requirements vary considerably among institutions and from one organ type to another. Nonetheless, 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 regulatory requirements of the OPTN Final Rule are consistent with these principles. However, whereas the OPTN Final Rule enumerates the minimal legal/governmental policy requirements that a just allocation policy must include, this paper provides an ethical framework for use in developing organ allocation policies.
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 Reportiii, 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 framework for local, regional, and national policy decisions related to allocating organs, including any 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/UNOS 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" and "justice" as the major ethical principles to be balanced to achieve an equitable outcome. The term "equity" might be a better term than "justice" to describe fairness principles in allocation since utility (the maximization of benefit) has direct implications for fairness in the distribution of organs. 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 organ transplantation. Then we address the challenge of resolving conflicts among 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: utility, justice, and autonomy. Both utility and justice are distinct components of a morally correct or "equitable" allocation system. Utility refers to the maximization of benefit to the community and justice refers to the fair distribution of benefits. The principle of autonomy holds that actions or practices tend to be right insofar as they respect autonomous choices. This should not be taken to imply that these are the only principles and rules that could be relevant. However, the three principles provide an adequate framework for most allocation issues.
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 very reason for the program. The principle of utility holds an action or practice to be right if it promotes as much or more aggregate good than any alternative action or practice. The principle of utility, applied to the allocation of organs, thus specifies that an allocation should maximize the expected net amount of overall good while minimizing harm, thereby incorporating the principle of beneficence (do good) and the principle of non-maleficence (do no harm).
Among the good consequences of transplantation are the saving of life, the relief of suffering and debility, the removal of psychological impairment, and the promotion of well-being. Data measuring predicted graft survival, predicted years of life added (both from time listed and time transplanted), and even better, predicted quality adjusted life years (QALYs)iv added will be relevant to such determinations.
Among possible harmful consequences are the acute effects of transplantation surgery including mortality, but also any long-term effects related to rejection, side-effects of medication, and so forth. The goal of allocation, from a utilitarian perspective, should be to do as much (net) good as possible. Developing actual allocation policy grounded in the principle of utility requires that the various goods be compared in some manner so that at least a rough estimate can be made determining which allocation produces the greatest good.
But in public policy related to allocation of organs there is a widespread consensus that certain social aspects of utility should not be taken into account. In particular, the social usefulness of individuals should not be considered. Moreover, in determining predicted medical benefits and harms, there also is a 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 it can be shown that survival rates of one racial, gender, or socioeconomic group exceed those of another, these factors should be excluded from models used to justify allocation decisions.
This does not necessarily rule out the use of objective medical predictors of outcome (such as tissue-typing and PRA levels) even if it is known that these 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 PRA with positive cross match, 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 important considerations in ethical organ allocation. In particular, the principles of justice and autonomy 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."vi The Task Force specifically recommended that selection of patients for waiting lists and allocation of organs be fair,vii 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 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.
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, it may not always be the case that the allocation that maximizes QALYs would be the morally right allocation, all things considered. It is for this reason that allocation schemes routinely consider medical need as well as medical benefits and give consideration to the medically sickest patients even if it is predictable that some 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 they seem necessary to treat potential recipients fairly, to give everyone a fair chance of getting 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 time; 4) first vs. repeat transplants; and 5) age.
Sometimes the principle of justice will be in conflict with the principle of utility; in such cases both are worthy of consideration and can play a role in shaping a decision about what is the morally preferable allocation.
The principle of 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.
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. We shall see that when it conflicts with other ethical principles sometimes, on balance, autonomy deserves respect and sometimes autonomy must give way. Factors to be considered in the application of the principle of autonomy are: 1) the right to refuse an organ; 2) free exchanges among autonomous individuals; 3) allocation by directed donation; and 4) transparency of processes and allocation rules to enable stakeholders to make an informed decision.viii
The ideal allocation is one that simultaneously maximizes the aggregate amount of (medical) good, distributes the good justly, respects 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 autonomy 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 in some priority (or lexical) order. 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 is challenging 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 values; and such policies are developed in a transparent manner allowing input from various stakeholder groups.ix
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 this context, balance does not necessarily mean equal. 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. However, inasmuch as: (1) neither side can provide conclusive arguments for its position, and (2) each side can provide plausible arguments for its position; ensuring that both justice and utility are included in an allocation policy is a fair and workable compromise.
Autonomy sets limits to the ways in which utility and justice should be balanced. The principle of autonomy receives less emphasis in our method of conflict resolution among the principles in organ allocation because autonomy will not often be in conflict with utility and justice. A clear exception is a case of a directed donation, 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.
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, and cause of organ failure) and psychosocial factors (e.g., financial and social support and 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 patient autonomy; considerations of age and the controversy about listing individuals for multiple organs when others die 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. It is and ought to be the responsibility of those adapting allocation formulas to understand how these factors influence the principles and their relative importance in order to ensure that their consideration is consistent with an equitable resolution when the principles conflict.
Utility, justice, and autonomy are the foundational principles applied in the equitable allocation of scarce organs for transplantation. Allocation policies should strive to incorporate an appropriate combination of the principles of utility and justice. It is unacceptable for an allocation policy to maximize aggregate utility without considering justice. It is also unacceptable for an allocation policy to promote justice without consideration of overall medical good. The relationship of autonomy to these principles is complicated, although in many specific situations, its relative lower priority is uncontroversial.
i42 U.S.C. §273 et seq.