Presumed consent for organ procurement--does it have a future in the U.S.? (Ethical-Legal Perspectives).
One alternative for increasing the pool of potential organs is the policy of presumed consent. Healthcare providers and ethicists continue to debate the pros and cons of such a policy change (Caplan, 1983; Cohen, 1992; Dukeminier & Sanders, 1968; Erin & Harris, 1999; Moustarah, 1998; Sadler, 1992; Veatch & Pitt, 1995). What are the lessons learned from countries and states that have implemented forms of presumed consent legislation? In this article circumstances of presumed consent are explored and the implications of a policy change for neuroscience practitioners caring for potential donor patients are discussed.
The Uniform Anatomical Gift Act (UAGA) of 1968 passed in 1971 in all 50 states and the District of Columbia. It addressed various issues related to organ donation. UAGA sought to answer such questions as who might make legal gifts of one's body or body parts, what are the rights of next of kin in setting aside a decedent's wishes, what are the mechanisms for making one's wishes known, and how might gifts be revoked by a donor while alive (Harris & Alcorn, 2001).
Despite a 1983 Gallup survey indicating a predominant willingness by the public to donate their organs after death (Cohen, 1992), there remained a substantial gap between those who stated their willingness and those who actually signed a donor card (Caplan, 1983). Even fewer had discussed their wishes with family members, close friends, or doctors or made note in their wills. Of those who knew about organ donation, 75% said they would give permission to donate their child's kidneys if the child was in a fatal accident, but only 25% said they would give permission to donate their own kidneys after death (Caplan).
The National Organ Transplant Act (NOTA) of 1984 endeavored to make donation more efficient and effective (Harris & Alcorn, 2001). It established OPTN within the U.S. Department of Health and Human Services (DHHS) as a coordinating body among regional organ procurement organizations (OPOs). NOTA prohibited the purchase or sale of human organs.
In the UAGA of 1987, legislation mandated hospitals to establish request policies to qualify for Medicare reimbursement; healthcare providers were required to request consent from families of eligible organ donors. The Joint Commission on Accreditation of Health Care Organizations will not accredit a hospital unless it has a required request policy in place. After CPOs and transplant advocacy groups spearheaded intensive educational programs to increase the public's knowledge about organ and tissue donation, a more recent survey in 1993 indicated that 75% of Americans were willing to donate an organ after death (Siminoff, Arnold, Caplan, Virnig, & Seltzer, 1995). Despite increased public support, however, these policies and programs, which were designed to address the benefits and impact of organ donation, have failed to increase the supply of organs for transplantation.
In a chart review of more than 10,000 cases at 23 hospitals, Siminoff et al. (1995) found that 81% of healthcare professionals correctly identified potential organ donors and donor families were approached in 73% of the eligible cases, yet only 47% of the families agreed to organ donation. The authors recommended educating healthcare professionals to improve their communication skills with potential donor families, because talking about donation during a family's acute grief period was uncomfortable for many healthcare professionals.
DHHS regulations concerning conditions of participation for hospitals regarding organ, tissue, and eye procurement (DHHS, 1998) stipulated that only individuals trained in requesting organ and tissue donation be allowed to make these requests. Representatives of the private OPOs that are charged with all cadaveric organ and tissue procurement within their specified catchment area are assumed to have been trained in the consent process for organ donation.
Wendler and Dickert (2001) conducted a telephone survey of all 61 active OPOs in 1999 about their consent practices for organ procurement. They found "significant divergence" in practices (p. 332). When surveyed about their organizational practice in different scenarios, an equal "number of OPOs (19) follow[ed] the deceased's wishes as follow[ed] the wishes of the next of kin" (p. 332). Wendler and Dickert concluded that the dissimilar practices were attributable primarily to inherent ethical differences. For instance, one group may believe that following the deceased's wishes reduces the emotional effect on the family and the other group believes that it increases the effect on the family.
The current consent process, in which healthcare providers obtain express consent from a donor's recorded wishes or from family, has failed to supply the number of cadaveric organs needed to save the lives of many patients with end-stage organ disease. Is a fundamental change in public policy called for, and which alternative is the best?
Strategies to Increase the Organ Supply
Since the first successful kidney transplant in 1954, one of the focal points of the transplant community has been increasing the organ supply through various procurement methods. The potential reasons for the current shortage of organs in the United States are (a) failure to identify potential donors, (b) refusal to donate, either by potential donors or families, and (c) failure to request donation (Spital & Erin, 2002). Current procurement proposals, which seek to address these concerns, include options of express donation, presumed consent through opting out, presumed consent through conscription, mandated choice, compensation, and an organ market.
The process currently used in the United States to obtain organs for transplantation relies on express or voluntary donation or consent. The principles of informed consent and encouraged voluntarism formed the basis for the UAGA of 1968 (Sadler & Sadler, 1984). According to Sadler and Sadler, who consulted in the drafting of UAGA,
The law is doing well what it was intended to do: providing a clear mechanism for individuals and next-of-kin to consent to organ and tissue donation for humanitarian purposes. It was designed to strike a socially acceptable balance that facilitates organ donation and procurement without infringing upon other deeply held values and rights. (p. 6)
The advantage of express donation is that individuals or families are able to state unequivocally their wishes about organ and tissue donation. The disadvantage is that this policy has failed to procure needed organs for transplantation. Although many people agree in principle with organ donation, they may not take the necessary steps to complete paperwork or discuss the issue with their family or doctor (Caplan, 1983).
Two versions of presumed consent policies exist: opting out and conscription. Opting out policies assume that all people consent to be organ donors upon their death unless they or their families specifically refuse or "opt out" of donation (Davis, 1999). A discussion of the logistics and ethics of adopting this option follows in the next section.
The most inflexible form of presumed consent is the idea of conscription of cadaveric organs. "All usable organs would be removed from recently deceased people and made available for transplantation; consent would be neither required nor requested and, with the possible exception of people with religious objections, opting-out would not be possible" (Spital & Erin, 2002, p. 612). Advantages are seen as obtaining cadaveric organs more efficiently; applying a simpler, less costly process to organ procurement; removing the discomfort of making requests and time delays in locating next of kin; and addressing the ethical principle of distributive justice (Spital & Erin). This proposal is unlikely to be accepted by the American public because of apparent infringements on individual autonomy and lack of respect for the wishes of families or religious beliefs.
Mandated choice, also referred to as required or routine response, would allow people to "have the opportunity to indicate a willingness or objection to donation ... [and] the option to delegate the donation decision to his or her next of kin or designated surrogate" (Presumed Consent Subcommittee, Ethics Committee, UNOS, 1993, p. 9). Using a document that most adults would ordinarily complete, such as a driver's license application or renewal or an income tax return, people would be required to consent or object to donation prior to their death.
Advocates claim that mandated choice respects individual autonomy and might prove to be a bridging mechanism to presumed consent. They suggest that the emergence of a societal consensus on transplant donation may evolve through a policy of mandated choice (Presumed Consent Subcommittee, Ethics Committee, UNOS, 1993). Successful implementation would require that an informed, educated public understand the intent and significance of organ donation (Futterman, 1995).
Organ Donation Compensation
The 1984 NOTA made it illegal to sell any human organ for transplantation. Most Americans disapprove of payments to donors' families for organs, but the majority of people favor "some form of financial or non-financial compensation in an effort to increase the number of organs for donation" (Garcia, 1997, p. 3257). Compensation might take the form of preferred status for the donor or a relative in the event they should need a transplant or reimbursement for hospital or funeral expenses.
A more economically based approach would be to develop an organ market or make direct financial payments for donated organs. Opponents to any form of compensation object because of fears that donors might be killed or allowed to die earlier than necessary or that the poor might be exploited (Childress, 1989). However, because public opinion does not support sales of organs and physicians remain opposed to organ markets, compensation is unlikely to become public policy.
Harris and Alcorn (2001) proposed consideration of a regulated posthumous organ market with "direct and indirect financial encouragement ... structured to avoid abuses, and to reserve altruism as a central motive" (p. 232). Contracts might have safeguards prohibiting relatives from selling a decedent's organs without prior consent, to be based on performance or the actual recovery of fit organs, not just promises to donate organs, exempting minors from participation, or offering bonuses for healthier lifestyles. Distribution of organs would remain under the current OPO structure.
Study of the Options
Economists Barnett and Kaserman (1993) explored six proposed organ procurement systems in the literature and evaluated them to determine the best policy. They used criteria based on the "impacts of the alternative policies on the principal stakeholders": transplant recipients, potential and actual organ donors and their families, taxpayers or other payers of transplants, and physicians or other caregivers (p. 119). Without using ethical considerations, they ranked each policy "in terms of its overall relative desirability" (p. 129). Including physicians' preferences, Barnett and Kaserman found, in terms of societal benefits or yielding the greatest number of organs for transplantation, that conscription and organ markets ranked first and second; presumed consent and express donation tied for last. They determined that mandated choice, organ markets, compensation, and express donation would be ethically acceptable because these policies would not violate any of Childress's moral and ethical principles: respect for persons, beneficence, nonmaleficence, and justice.
Presumed Consent Policy for Organ Procurement
Having identified failure to obtain consent as a key factor in the organ shortage, the transplant community has exerted efforts on putting policies in place that will improve the consent rate. As noted in the previous section, two versions of presumed consent policy, conscription and opting out, exist. Conscription of all usable organs from cadavers, without regard to the wishes of the deceased or family members is the stronger variation. The weaker policy of presumed consent, and the focus of this article, requires that individuals opt out of organ donation. As public policy, it
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 refutal [sic]. (Presumed Consent Subcommittee, 1993, p.1)
Advocates (Caplan, 1983; Dukeminier & Sanders, 1968; Kennedy et al., 1998; Moustarah, 1998) claimed that a presumed consent public policy would increase the number of cadaveric organs available for transplant. It would make the donation process a routine event when an adult dies. It would respect individual autonomy. It would decrease the stress placed on requesters who must approach grief-stricken families for their consent under current policy. It would diminish the emotional pressures on bereaved families to make decisions about donation. Dukeminier and Sanders asserted that the "burden of action" would shift from healthcare providers "to the dead donor or his next of kin" (p. 418).
Opponents (Sadler, 1992; Sadler & Sadler, 1984; Veatch & Pitt, 1995) to the policy of presumed consent argued that it would not increase the number of available organs. According to U.S. surveys, less than 40% of the public, and less than 7% in another survey, support a presumed consent system (Veatch & Pitt). It would remove freedom of choice from individuals. Establishing a central registry to record objections would be problematic. It would place a burden on the individual to register his or her refusal. It would require access to the system with changes in next of kin through marriage, divorce, and death, and add a step to the organ procurement process to verify objections (Sadler & Sadler, 1984). Education would be paramount to ensure that all individuals understand the shift in policy. It would require guaranteed legal immunity for healthcare providers who act in good faith and need to be applied across state lines (Sadler, 1992).
International Policies Based on Presumed Consent
Most European nations, as well as some South American countries, Israel, and Singapore (Harris & Alcorn, 2001), have implemented public policy based on presumed consent. To date, however, no English-speaking nation has adopted a policy of presumed consent regarding organ procurement (Stuart, Veith, & Cranford, 1981).
The laws of the different countries vary on how organs are recovered from the deceased who has not expressed a wish during his or her lifetime (Kennedy et al., 1998). In Norway, organs are removed after relatives are informed of the intent, regardless of their consent, with the exception of the nearest relative. The Italians remove organs only after ensuring the family does not object.
In Austria, organs are removed regardless of the relatives' attitudes after the physician ascertains there is no refusal in the patient's medical records. This policy has led to better rates of kidney procurement than in the United States and most other European nations, but Austria's rates of procurement for other solid organs have not improved (Harris & Alcorn, 2001).
In France, after checking medical records, physicians consult with family members to determine whether the deceased had declared a refusal. In practice, physicians then inquire about the wishes of the next of kin. This policy has essentially turned the employment of presumed consent into a voluntary donation system controlled by the family (Harris & Alcorn, 2001). The policy has had little effect in meeting the country's needs for organs.
The Belgian government passed legislation in 1986 based on presumed consent to procure organs (Roels et al., 1991). Roels et al. reported there was a significant increase in the number of cadaveric kidneys, hearts, and livers available for transplant in the 3 years following enactment of the law. Compared to Austria, another country with presumed consent policy, and to the Netherlands and ER. Germany, both with opting-in policies, they found "that only in the two countries with a presumed consent legislation, [had] multi-organ harvesting increased substantially" (p. 904).
Belgian citizens who wish to opt out of donation may do so at the local town hall. Doctors are still encouraged to contact relatives in all cases, but less than 10% of families object, compared with 20%-30% in other European countries (First, 2001). In a study of objectors to donation, Roels, Deschoolmeester, and Vanrenterghem (1997) found that the cumulative registry of objectors over the initial 8 years of the presumed consent law comprised 1.75% native Belgians and 3.23% foreigners (residing for more than 6 months in the country). Objection rates were highest for minors younger than 14 years, and higher among children of foreigners than natives, and significantly more females of all ages than males objected.
In 1997, Brazil passed a presumed consent law despite opposition from medical organizations, only to repeal the law 1 1/2 years later (Csillag, 1997, 1998). After passage of the law, surgeons continued to ask families for consent prior to removing organs. In October 1998, the law was amended to avoid conflict between the legal mandate and practice policy to require family permission, essentially negating "presumed consent." The implementation of a national registry for transplant recipients failed, and many people feared their organs might be removed precipitously and rushed to register themselves as objectors (Csillag, 1998).
State Policies Based on Presumed Consent
A number of states have enacted legislation based on the weaker "opting out" version of presumed consent. State laws differ in the circumstances in which removal of organs may occur.
Texas, in 1991, was the first state to allow "retrieval of organs without explicit consent, albeit in limited circumstances" (Presumed Consent Subcommittee, 1993, p. 4). If a decedent's next of kin could not be found in a reasonable time, the law allowed removal of organs. When next of kin were contacted, relatives' wishes were respected unless the potential donor had indicated a donation preference in his or her lifetime. If the potential donor was older than 18 years and had indicated a desire to be an organ donor on the driver's license, the law supported honoring the donor's wishes without the consent of any other individual. Since that time, the Texas law has been changed to require next-of-kin consent even if a clearly documented advance directive exists (The Lewin Group, 2000).
Legislative proposals followed in Maryland and Pennsylvania in 1993 (Veatch & Pitt, 1995). In Maryland, the bill would have allowed presumed consent for cases in which a decedent had not opted out. It was defeated, as was a previous version of the law. In Pennsylvania, the proposed act would permit removal of organs and tissues unless the potential donor had refused.
According to the Presumed Consent Subcommittee (1993), the above proposals had similar characteristics using the language of presumed consent. For example, unless the potential donor had expressed an objection to donation, he or she was presumed to have wanted to donate. Next-of-kin objection to donation overrides the potential donor's presumed consent, if said donor had not expressed an objection. The potential donor's recorded preference for donation prevails over the objections of next of kin. Reasonable efforts must be made to contact next of kin.
Reportedly, since then, 10 states have enacted legislation that recognizes a signed driver's license as an advance directive and provides protection "to OPOs, hospitals, and tissue and eye banks when carrying out individuals' advance directives without further consent" (The Lewin Group, 2000). Pennsylvania also has initiated a pilot program that offers $300 toward funeral expenses as an incentive to donate (First, 2001). Will efforts like these lead individuals from making voluntary, humanitarian decisions or donations to making forced, mercenary decisions? Or does presumed consent imply a belief in community generosity?
Scientists and ethicists debate the moral and ethical correctness of the presumed consent concept. Childress (1989) wrote a definitive piece analyzing, from an ethical perspective, various policies on organ procurement "in light of moral principles already embedded in U.S. institutions, laws, policies, and practices" (p. 87). These "embedded moral principles are respect for persons, including their autonomous choices and actions; beneficence, ... nonmaleficence, ... and justice" (p. 88). In addition, there are different views about whether human body parts are property and who has rights to use, possess, dispose, or change possession of this property.
Childress (1989) stated that to find presumed consent ethically acceptable one must view the individual's or family's wishes as "tacit consent," silently or passively expressed "by omissions or by failures to indicate or signify dissent" (p. 96). He argued that this silence may only mean one lacks an understanding of the process or does not know how to register a dissent. In terms of ethical preferability, presumed consent relies on passive altruism, but does not rule out active altruism.
Veatch and Pitt (1995) spoke to the core relationship of the individual to society regarding presumed consent. Specifically, "in liberal Western society certain rights are attributed to the individual ... medical treatment is acceptable only with the consent of the individual or the individual's appropriate surrogate" (p. 1890). If one sees organ procurement as giving, as evidenced by words like "donor," presumed consent can be valid. If one sees organ procurement as taking, society will be asserting its rights over the individual without his or her permission.
Erin and Harris (1999) argued for presumed consent because they "believe it is the right thing to do because ... it is in the best interests of those patients in need of an organ, and that not to remove these organs would be to harm those patients" (p. 365). They agreed that the presumption of consent directly contradicts the principle of respect for individual autonomy. However, "if we are to presume anything, we should presume that people would wish to do the morally right thing" that is, to make cadaver organs "available for life-saving or life-enhancing use" (p. 366).
Other advocates (Caplan, 1983; Cohen, 1992; Kennedy et al., 1998; Moustarah, 1998) followed similar lines of reasoning. Presumed consent policies will uphold the principle of beneficence; saving lives is good. Cohen (1992) wrote that consent or refusal may be required to opt in or opt out of donation, but a presumption must be made with the burden falling "upon those for whom the presumption made is incorrect" (p. 2172).
Although there is no consensus that presumed consent policies are ethically or morally correct or even more effective in procuring organs, all parties agreed that certain measures must be in place if a transition is made from a public policy of expressed to presumed consent for organ procurement.
Effect of Enacting a Public Policy of Presumed Consent
Changing national policy from opting in to opting out of organ donation would require societal changes in attitude of both healthcare providers and the public. Technically, policy change would require the formation of a central registry, an efficient means for individuals to register their objections, and a consistent, reliable method of accessing, entering, updating, and respecting this data (Futterman, 1995). It would necessitate a massive public education program about organ procurement and the new program requirements.
Opponents of presumed consent argue that there is no mechanism in place to consolidate and safeguard objections to donation and that this could be a cumbersome nightmare to achieve. Proponents of presumed consent refute this stance. The United States has large databanks in place for various other nationally required programs such as income tax, Social Security, and the selective service system. Surely with technological capabilities and assistance from countries with effective registry programs in place, these technical difficulties could be overcome (Moustarah, 1998).
Many states currently do not have databases of individuals who have indicated their willingness to be donors. Of the states that do maintain registries, most of these programs involve driver's license/motor vehicle departments and some state health departments, but round-the-clock access is rare (The Lewin Group, 2000).
State legislative efforts on organ procurement vary. Is a national consensus possible? Singapore enacted presumed consent policy for kidney procurement in 1987. Their plan of action was twofold, using presumed and voluntary consent. Muslims were "automatically considered objectors ... on religious grounds" under the presumed consent policy but, "they could voluntarily pledge" by signing a donor card (Teo, 1991, p. 10). Despite ethical questions, the government made "very laudable efforts to make its presumed consent policy ethically defensible" by supporting public knowledge prior to passage of the law (p. 13). They conducted extensive media programs, had well-publicized public and parliamentary discussions, and sponsored public awareness programs and hearings.
Perhaps the greatest hurdle to enacting a presumed consent policy in the United States is the ethical debate. Presumed consent belies the American value of respect for individualism. Diversity in age, culture, education, and economics, and individual responses to bereavement must be considered is making such a dramatic change in organ procurement policy (Futterman, 1995). How will healthcare providers be affected if a presumed consent policy is established?
Implications for Healthcare Professionals
As any bedside nurse, advanced practice nurse, physician, or therapist recognizes, knowledge of a particular healthcare issue and personal insight into one's own knowledge, beliefs, and values about that issue are key to communicating effectively with patients and families. When presumed consent policies are debated in the healthcare or public venues, practitioners have the opportunity to explore their own values and beliefs and make decisions about how to interact with families and patients who may be potential donors or recipients of organs. If a policy transition were to occur, providers would need extensive self-education before educating the public.
It is essential that professionals in the neuroscience, trauma, or critical care domains understand the concepts of brain death and the procedure for procurement of organs for transplantation. If public education campaigns have been successful, in the event of a policy change, families should come to expect the routine recovery of any usable organs from their deceased family member. However, support for the grieving family should be available as well as resources to explain the procurement process if any questions arise.
For professionals in family or primary care, it would be important to understand the changes in process and laws on registering objections to organ donation. Patients may ask questions about the technicalities, their medical care, or the morality of presumed consent. Practitioners may need to learn more about advance directives and become more comfortable addressing the issues of death and dying.
For professionals in organ transplantation, the implementation of a presumed consent policy may improve their patients' chances of receiving a life-enhancing or lifesaving transplant. Practitioners may encounter these individuals when they are discovering they need a transplant, during the evaluation and selection as a transplant candidate, during the waiting period, or after the transplant. Until an increase in available organs becomes more apparent, practitioners need to continue to support the physical and emotional needs of these patients.
Policies of presumed consent to procure organs for transplantation have stimulated discussion of success/failure in increasing organ availability, technical pitfalls, and ethical dilemmas. The presumption of consent has made inroads in public policy internationally and influenced some state policies. A policy of presumed consent remains unlikely in the face of American attitudes of freedom of choice and respect for individual autonomy but healthcare providers need to be aware of potential policy changes and how these changes may affect their practices.
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Questions or comments about this article may be directed to: Carol J. Roberts, MSN RN CCRN, by phone at 804/828-9244 or by e-mail at email@example.com. She is a clinical nurse IV in the neuroscience intensive care unit at VCU Health System, MCV Hospitals and Physicians, Richmond, VA.