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An Evaluation Of The Ethics Of Presumed Consent Patricia Hanson, RN, MS, CCTC Ernest E. Hodge, MD Ruud AF Krom, MD, Ph.D. Robert M. Veatch, Ph.D. June 30, 1993 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. Introduction: Alternatives for Reforming Organ Donation The Presumed Consent Subcommittee of the UNOS Ethics Committee was charged with evaluating the ethics of presumed consent as a legal-policy regime for the regulation of the donation of cadaveric organs and tissues for transplantation. The contemporaneity of the discussion is evidenced by the recent introduction of bills based on presumed consent into the Maryland and Pennsylvania state legislatures. In this paper we as a Subcommittee evaluate presumed consent from an ethical perspective and propose an alternative organ donation reform called "required response." We begin with the following definition: Public policy based on presumed consent would offer every adult the opportunity to express and have recorded by publicly accountable authorities his or her refusal to be a donor of solid organs and tissues. A clinically and legally indicated candidate for cadaveric organ and tissue recovery is presumed to have consented to organ and tissue recovery if he or she had not registered a refusal. In the above definition of presumed consent, there is no allowance for the donor's family to interfere with the donation process. This is the strong version of presumed consent. In the state initiatives in Pennsylvania and Maryland, a variant of the weak version is being considered. A weak version of presumed consent requires the permission of the donor's family, if the family can be located, before organs and tissues are removed. Proponents of presumed consent (sometimes referred to as "implied" consent) argue that the policy, if accompanied by public education and an efficient mechanism for recording and transmitting donation refusals, would increase the supply of organs while simultaneously respecting the individual's right to "opt out" of organ donation.(1) Signs are abundant that the current organizational and legal regime regulating donation is perceived as failing the needs of transplantation. The current regime, oftentimes described as "encouraged voluntarism," may be characterized as an "opting-in" system that requires the direct, expressed consent of the donor and, almost always, the donor's family. Dissatisfaction with the current regime stems from a progressive deepening of the tragic imbalance between the need for and supply of solid organs for transplantation. Consequently, a wide-ranging public discussion has focused on the imperative of reforming the laws governing organ recovery as well as reforming procurement organizations. In recent years we have seen a multitude of proposals to reform the system. Proposals for reform tend to fall into the following categories:
Three additional reform proposals -- and the centerpieces of the following discussion -- are:
Below we discuss the ethics of presumed consent, routine salvaging, and the Subcommittee's proposed policy alternative, "required response." Presumed Consent: Previous UNOS Research and Analysis Presumed consent, as one of several contending reform policies, has been considered previously by other UNOS committees and members. The UNOS Ad Hoc Donations Committee evaluated the public's receptivity to presumed consent legislation in its January, 1991 telephone poll of 801 individuals. (2) When asked "Whether physicians should be able to act on implied consent," 38% said "yes," 55% said "no," and 7% were undecided. (3) The Ad Hoc Committee suggested that many (33%) of the respondents may not have fully understood the concept of presumed consent by objecting to presumed consent on the grounds that "a person should make the choice/give consent." In the view of the Ad Hoc Committee, "the individual has made a choice by not objecting to donation" and therefore respondents should not object to presumed consent on the basis that it precludes personal choice. (4) The NKF/UNOS survey would appear to support the assumption that spirited public education in the qualities of presumed consent would need to be conducted as a necessary, if not sufficient, condition for its acceptance. J. Childless underscored this practical point in emphasizing the potential for donors to act on their fears and distrust by "opting out" or "dissent" in such numbers that presumed consent would "actually reduce the number of donated organs." (5) Presumed Consent in Comparative Perspective Public policies that are described in the literature as based on "presumed consent" have been implemented in Belgium, Austria, Finland, France, Norway, Denmark, and Singapore. Their positive impact on organ supply has attracted significant attention in the U.S. (6) To some observers, the above countries condone policies called "presumed consent" that in actuality approximate "routine salvaging of organs". (7) Descriptions of country-specific experiences may be found elsewhere. (8) The most celebrated success of these experiences is the case of Belgium, where organ recovery more than doubled following implementation of its policy of "presumed consent." Because of the increase in donation following enactment of these laws in several nations, the hypothesis that recovery without explicit consent contributes to the effectiveness of organ recovery is now widely accepted. Objections to such recovery policies tend to be based on ethical arguments expressive of non-efficiency values, as discussed below. Policies based on presumed consent are seen in many states' statutes bearing on the retrieval of corneas. Regarding organ and tissue donation, two presumed consent bills were submitted in early 1993 to the state legislatures in Maryland and Pennsylvania, the Maryland version having been introduced and rejected in a previous session. The two bills share the following features:
The Pennsylvania proposal includes provision for empowering the right to refuse to donate by disseminating "non donor cards." Objectors to donation would attach this card to the reverse side of his or her driver's license to indicate the individual's refusal to make a gift of organs or tissues. The Act does a provide for a state registry to record objections in a database accessible to organ procurement organizations. Texas is described as the first state allowing retrieval of organs without explicit consent, albeit in limited circumstances. State law allows retrieval of organs if the decedent's next of kin cannot be reached for consultation after reasonable efforts have been made. In situations where the donor's family is contacted, the wishes of the next of kin are respected unless the potential donor had expressed a preference for donation during his or her lifetime. According to the law, preferences for donation are to be elicited in a manner that anticipates the policy of "required response," described later in this paper, in routinely asking persons who interact with the state's Department of Motor Vehicles if they want to donate their organs after death. Persons affirming this option are to have a symbol affixed to their driver's license demonstrating their wish for donation "be honored without obtaining the approval or consent of any other person" so long as the donor is 18 years or older. (9) The Ethics of Presumed Consent Generally, advocates of presumed consent advance the following in support of their position:
Presumed consent, advocates argue, combines the principles of supply-side efficiency, respect for individual conscience, and individual's positive, yet qualified, duty to promote the good of society. Opponents of presumed consent base their position on the following presuppositions:
Opponents, then, have practical objections to presumed consent based on the predictably positive, if undetermined, probability that individual donation preferences will not be respected in the event of donation candidacy. Advocates and opponents of presumed consent are not distinguished by their divergent assessments of the risk that some persons who object to donation will become donors under the presumed consent regime. Rather, the origin of divergence lies in the ethical assessment of tolerable risk. Advocates of presumed consent find permissible cases of false positives. Such cases are excusable because (i) individual objectors ultimately have the responsibility to register their objections and (ii) false positives which arise due to mechanical breakdowns must be weighed against the greater good of increasing the supply of organs. Opponents, in contrast, perceive a statist, non-individualistic intent behind presumed consent. That is, opponents perceive that advocates of presumed consent can predict -- before the policy is implemented -- that presumed consent will remove organs from persons who objected to donation. Respect for individual conscience, for policy opponents, is a core value that should supersede the social utilitarianism underlying presumed consent. The Subcommittee's Position on Presumed Consent The Subcommittee resolved that at the present time it is unadvisable to pursue the policy of presumed consent. Three main considerations guided us. First, the practicality of the policy must be questioned given that public opinion surveys suggest its unpopularity. The recent NKF/ UNOS survey found support at approximately 37%. A 1985 Gallup survey placed public support at 7%. (10) More profoundly, the policy stands to contradict a profound respect a majority of Americans reserve for the value of individualism, as evidenced in the following pronouncement: Presumed consent is not quite the American way. It is relatively coercive, compared to the more classical freedom of choice that characterizes our way of life. Consent should be positive, not implied. (11) In the Subcommittee's view, the anti-statist, individualistic perspective is sufficiently distributed in the general population to make problematic the acceptance of presumed consent. Second, the Subcommittee was unimpressed with mechanisms in place in countries which employ presumed consent to protect the rights of objectors to donation. These mechanisms often appear to offer only superficial respect for individual autonomy. The mechanistic difficulties convince us that the quality of "consent" likely to be "presumed" would fail the practical challenge of matching individual preferences for donation with candidacy for donation. We as a Subcommittee challenge the integrity of the notion of "presumed consent." Our challenge is based on the fact that data make clear that consent cannot be presumed. Focus groups organized in the NKF/UNOS Organ Donation Study confirmed the findings of national public opinion surveys (12) that a significant portion of the public is opposed to donation on grounds of distrust of the medical community in general and the organ donation and allocation process in particular. (13) The third consideration was the Subcommittee's positive assessment of the alternative of "required response." In our view, the alternative can significantly lead to an increase in the supply of organs without risking the violation of the principle of individual autonomy by removing organs from persons who objected to donation but did not have the preference recorded by the proper authority. The ethical challenges facing "presumed consent" are considerable. They are not, however, insurmountable. The Subcommittee takes an active interest in states' experimentation with presumed consent policy. Part of the ethical test for the states is this: To not use the concept of "presumed consent" to rationalize the acquisition of organs from persons who may have had an objection to donation. States should invest heavily in educating the public in the consequences of not registering an objection, in facilitating the registering of an objection, and in assuring that procurement organizations are made aware of the identities of objectors on a timely basis. Routine Salvaging Routine salvaging is a policy originally proposed by Dukeminier and Sanderse (14) The effect of routine salvaging on the practice of organ procurement would be similar to procurement relying on presumed consent. In either case, organs could be taken without the explicit consent of the donor's family or donor (as indicated, for example, by a signed donor card). The ethical underpinnings, however, are quite different. The policy of routine salvaging is inconsistent with liberal individualism. Liberal societies assume that the individual, not the state, should control his or her physical disposition a liberal society respects this principle by asking for the consent of the donor before organs are recovered. Exceptions to liberal individualism must meet a severe test, as in wartime when the coercive military draft is premised on the need to serve vital national interests. Exceptions to liberal individualism must meet the further test of being the only measures which can plausibly attain the community's objectives. Presumed consent relies on the claim that there is a basis for a presumption that the deceased would have agreed to donating organs had he or she been asked. Routine salvaging, in contrast, does not assume consent is needed. It presupposes the subordination of the individual to the state-led national community, as exemplified by the procurement law in France which codifies the ethic of the "Good Samaritan."(15) Many proposals for routine salvaging soften their approach by permitting individuals who object to having organs procured to "opt out" by registering an objection to organ procurement. For the United States, reforming the organ donation system on the basis of routine salvaging gives more authority to the state-led national community than public opinion -- and American political culture -- would allow at the present time. The reform would require abandoning the current commitment to the importance of the individual, at least for matters of determining how the body is to be treated after death. Since empirical evidence makes clear that (i) we cannot presently presume the consent of Americans to have their organs procured after death and (ii) most Americans appear unwilling to support routine salvaging, a third option seems to this Subcommittee to be preferable, a policy we shall call "required response." Required Response This section of the paper will describe the Subcommittee's proposed alternative to presumed consent and routine salvaging and then discuss its ethical advantages over the two previous alternatives. In the comparative analysis, presumed consent and required response will be emphasized owing to their greater salience in the current policy context. The policy status quo is a state-centered approach relying on the use of the back of driver's licenses, applications for driver's licenses. or the distribution of donor cards to be carried with or attached to the driver's license. (16) The approach is uncoordinated across the states: Not only is there no centralized collection of donation preferences but not even the same data points are collected (i.e., the variations include consent for removal of specific organs, all organs, and all tissues). A policy of required response would replace wasteful uncoordinated state-level programs with a uniform method of collecting and disseminating donation preferences to procurement organizations. A national approach is needed to assure the routine and uniform collection of donation preference data and its dissemination to organ procurement specialists. Required response intends to accelerate the historical increase in the number of Americans who have indicated a willingness to be organ donors. In 1992 approximately 33% of Americans had signed a donor card, compared to 16% in 1985. The need for required response is seen in a result of the NKF/UNOS Organ Donation Survey: Respondents who had not designated a willingness to donate were most likely to cite the fact that they had "never been asked to" (52%). (17) Required response would address this most obvious of reasons why individuals have not designated themselves as willing to donate. The required response proposal was originally made in R. Veatch's Death. Dying. and the Biological Revolution (1976). More recent articulations by Veatch and by A. Spital, as well as the publicity from the NKF's February, 1991 national consensus conference, "Controversies in Organ Donation," have placed the proposal on the public policy agenda. (18) Characteristics of Required Response Under a legal regime of required response, all adults would be required by public authorities to express their preferences regarding organ donation. As shown in the proposed Required Response Form presented later in this paper, individuals will have the opportunity to indicate a willingness or objection to donation. Moreover, the individual would have the option to delegate the donation decision to his or her next of kin or designated surrogate. Donation-regarding preferences would be recorded in a National Donor Registry (NDR), a centralized database accessible by organ procurement organizations. These preferences will carry legal weight. Following death declaration, the OPO would access the NDR to ascertain the donor's preference on donation of organs and tissues. The OPO will have the legal authority to excise organs from a deceased person who had expressed a pro-donation preference. This recorded preference would be shown to the donor's family in order to acquire the cooperation of this key set of actors in the donation process. While respecting the individual's prerogative to "opt in or out" of the donation process, required response would increase the supply of donated organs by decreasing the frequency of refusals by donor families and by granting additional legal protection to OPOs. We expect families of donors to less frequently present an obstacle to donation because of the presentation of evidence that the decedent had a pro-donation preference. The Subcommittee's assumption, based on previous survey research, is that the primary reason more people do not sign their donor cards is because no authority had asked them. Hence the following conclusion: Required response would increase the percentage of donation events in which the OPO had substantial evidence that the donor had a pro-donation preference. In terms of legal immunity, required response would also protect the OPO in the event that the donor's family cannot be reached and the donor had expressed a preference for donation. In short, the efficacy of required response would come about as the result of reducing uncertainty of the donor's wishes by (i) recording the donor's preferences routinely and (ii) making those preferences accessible to OPOs which have a need to know this information on a timely basis. The Subcommittee proposes the policy of required response as the first part of a larger reform strategy. Over time, ideally, the legal regime regulating organ donation will approach the policy of "presumed consent" wherein organs and tissue are recovered without active consent-seeking on the part of OPOs. The envisioned policy evolution is as follows: As adults increasingly "opt-in" to the donation system by expressing "yes" via required response, the practical necessity of checking the database recording preferences will diminish. The evolution is for a societal consensus on transplant donation to emerge, as recorded through required response, so that consent may be safely "presumed" because of universal approval of organ donation. As described further below, a key element in this evolution would be a public education campaign coordinated with the implementation of required response. Organizational Mechanisms Several states have taken measures whose thrust is consistent with the policy of required response. According to a recent UNOS-sponsored survey of State Departments of Motor Vehicles (DMVs), 15 states require DMV employees ask applicants for drivers licenses to ask if the driver would like to be a donor. Twenty states include the donor question on the drivers license application itself. (19) Donor registries have not yet been organized on a scale and accessibility necessary to be useful to organ procurement organizations. Four states (Florida, Ohio, Illinois, and Oregon) have gone furthest in registering donors however, it is unclear whether the collected information assists procurement organizations in the identification of donors. While many states have recognized the need for a more active approach to informing individuals of the importance of expressing their preference toward organ donation, few have begun to collect this preference information systematically. To implement the policy of required response, the federal government would coordinate the activities of DMVs. Coordination is necessary to standardize the form that is used to collect preferences and for computerized recording of preferences and identifying information. Motor vehicle departments would "require responses" from driving-age adults at the time of license acquisition and renewal. In "mandating response," states would be required to distribute the Required Response Form (to be given a less officious name) to individual applicants and collect the signed forms as a condition for individuals to receive a driver's license or renewal. Although the states would administer the form and collect signatures, the information itself would be centralized in a National Donor Registry. On a weekly basis, states would collect signed forms and ship them to the relevant organization for processing. The NDR would be accessible by all OPOs on a real-time basis so that OPOs can be told of the individual's preference towards donation regardless of the individual's place of residence (i.e., in or out of state). Alternative Mechanisms The proposed array of organizational mechanisms rests on the practicality of relying on DMV's to collect donation-regarding preferences. Obviously, the proposal suffers from the fact that many persons do not acquire a driver's license and would be "lost" in the above system. Reliance on DMV's is also subject to the criticism that administration of the required response program will not be perceived as central to the mission of DMV's, leading to uneven quality in the program's administration. Two alternative mechanisms are the collection of donation preferences as part of the completion of federal income tax forms and, if universal health insurance legislation is adopted, the recording of individuals' donation preferences on issued health insurance cards. A Proposed Format The Subcommittee has considered the format which the Required Response Form should assume. Our proposal is as follows: Required Response Form The donation of organs and tissues has the potential for saving thousands of lives each year. Are you willing to have your organs and tissues used after your death, without cost to you or your estate? I hereby make this anatomical gift if medically acceptable for use in transplantation, therapy, medical research, or education, to take effect upon my death.
The Required Response Form has the advantage of collecting information already collected by forms used by the states and, by its flexibility, gives the applicant three options: (i) donation, (ii) no donation, or (iii) delegation of the consent decision to the donor's family. The completed Form would have to be submitted to the DMV for a successful driver's license application to be processed. The Subcommittee has yet to address how the information on this Form would be merged with identifying information (eng., name, date of birth, Social Security Number) in the construction of a central data file. The Key Role of Public Education in the Transition Period The Subcommittee proposes that there be an intensive public education campaign during the transition from the current regime to the new one based on required response. During this campaign, the social desirability of checking "yes" on the Required Response Form will be persuasively justified in terms of medical utility, compassion for the stricken, and the absence of risks and costs of cadaveric donation. The education campaign will explain the organizational mechanisms put in place for identifying individuals as having consented to organ donation. The campaign will also stress the consequences of checking "yes," namely that organs and tissues can be removed on the basis of responses to the Form. Although in practice transplantation professionals would continue to consult with the decedent's family, the public should be encouraged to take the Form seriously by having the campaign emphasize the obligations of checking "yes." The Subcommittee recommends the campaign be supported and coordinated at the federal level to assure national continuity. To reduce burden on state DMV's, the educational campaign will instruct the public in the required response policy so that individuals can be prepared to express their preference without time-consuming deliberation. One method for reducing the burden of DMVs would be for DMVs to share with the National Donor Registry name and address information for persons whose licenses are scheduled for renewal in the near future. These individuals can then be mailed a brochure explaining the benefits of organ and tissue transplantation, the tragedy caused by the shortage of recovered organs, and the procedure for registering his or her donation preference. (20) A sample Required Response Form will be provided to familiarize individuals with the process. The Ethical Advantage of Required Response vis-a-vis Presumed Consent The essential ethical advantage of required response is its undiluted loyalty to the value of individual autonomy. By giving every adult an opportunity to opt-out of the donation system, required response respects the individual's "right" to stand apart from society. On this dimension, required response is distinct from presumed consent because the latter offers less protection against the risk of collecting organs from persons who held reservations toward organ donation. This distinctiveness of required response is also the source of its major limitation because it is uncertain what percentage of the adult population would elect to opt-out of the system. If not accompanied by an effective public education campaign, required response could backfire by empowering a substantial bloc of anti-donation attitudes. The loyalty of required response to the value of individual autonomy, however, should not be overstated, lest we neglect to underscore the term "required" in the policy's title. Society, as represented in the state, would take it upon itself to require individuals to express their preferences for or against organ donation. In a real sense, the provision constitutes a coerced burden, not to mention the burden accruing from public spending on the program of required response. The justification for this added burden is that it will empower individual preferences in the context of organ donation while respecting the right of individuals to remain "whole" in death. Conclusions and Recommendations The Subcommittee concludes that reform of the organ donation process should not be based on the presumed consent model. Ethically, presumed consent offers inadequate safeguards for protecting the individual autonomy of prospective donors. Presumed consent too closely approximates "routine salvaging" in practice, although in rhetoric it pays homage to the value of individualism inherent in the consent model. The Subcommittee recommends the policy of required response as an alternative reform. Under required response, individual adults must express a preference regarding donation to the public authorities. The recording and dissemination of this preference in the event of death would help persuade the decedent's next of kin of the desirability of organ donation. Family refusals to donate constitute a major source of lost donors. Ethically, required response emphasizes the autonomy of the individual, making unnecessary any presumption of the individual's willingness to donate. References
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I give any needed organs or tissues for transplantation