Education is important in the consent process for any potential living donor. The potential donor must understand all aspects of the donation process and understand the risk and benefit associated with being a living donor as well as center-specific risk factors. Most living donors give their organ to a family member or acquaintance. However, some living donors are nondirected and do not influence the placement of their donated organ.
However, it is difficult for transplantation teams, independent donor advocate teams, and prospective donors themselves to perform their analyses and assessments of risks, benefits, and risk-benefit ratios because of incomplete data about the health outcomes of living donation.
Even for the more than 67, living donors who donated a kidney through , the data on short-term health outcomes are not comprehensive, and there has been little long-term follow-up to determine the physical and psychosocial effects of living donation over time Ellison et al.
An example of the need for follow-up data is the number of patients who after donating a kidney later need kidney transplant; as of , an analysis of the OPTN database identified 56 living donors who had subsequently received a kidney transplant or were on the waiting list for renal transplant Ellison et al. For those who have donated parts of their liver, lung, or intestines, the data on the health outcomes of donation come from recent, short-term studies that are not comprehensive; little is known about the long-term effects of these donations see, for example, Renz and Roberts, ; Beavers et al.
Nevertheless, on the basis of the currently available data, it is apparent that the risk-benefit ratio largely depends on the organ or organ part to be. A highly motivated donor may derive significant psychological benefit from his or her donation and may thus be willing to incur more risk.
Regardless of the organ that is donated, however, complications may occur at the time of the donor workup, during and shortly after the surgery, or long after donation. In addition, the act of donation may result in some negative psychosocial consequences.
For example, lingering health problems could delay or prevent a return to work, and may create difficulties in obtaining life, health, and disability insurance Russo and Brown, Furthermore, the donor may confront significant financial costs.
These costs, which may be a major disincentive to prospective donors, include lost wages as well as travel, lodging, and other expenses. For these reasons, the federal government and transplantation organizations have begun to take steps to make organ donation as financially neutral as possible.
In , the U. This law allows federal employees to take 7 days of paid leave to be a bone marrow donor and 30 days of paid leave to be a solid-organ donor. A number of states and many private-sector businesses have followed suit and have created similar leave provisions for their employees Davis and Delmonico, ; NCSL, Efforts are also under way to implement the provision of the Organ Donation and Recovery Improvement Act Public Law that provides for the implementation of programs that would grant reimbursement for travel and subsistence expenses and incidental nonmedical expenses incurred by living organ donors Davis and Delmonico, In addition to the ethical considerations involved in risk-benefit analyses and assessments, living organ donation raises several other ethical concerns.
Whatever the relationship between the potential donor and the recipient, it is crucial that the potential donor be adequately informed and that the decision be made in an environment that is conducive to thoughtful decision making without undue influence or coercion.
Discussions on the issues regarding children as living organ donors continue see, for example, Ross, ; Abecassis et al. Nevertheless, even when individuals are competent, problems with communication may compromise the process of informed consent in living donation as well as in other settings, such as therapy and research Beauchamp and Childress, Chapter 3. In addition, the close affective ties in most donations involving related donors may lead the prospective donor to make a decision to donate before he or she fully receives and understands all the pertinent information, particularly about the risks involved Simmons et al.
The knowledge that a loved one needs a life-saving or life-enhancing transplant may be powerful enough by itself to lead the individual to agree to donate an organ or part of an organ without extensive deliberation. The goal of the informed-consent process in living donation is adequately informed consent. Even if the individual immediately agrees to donate, it is appropriate to provide the range of relevant information and to ask the potential donor questions to ensure that he or she has an adequate understanding of the act of donation and its possible and probable effects.
Nevertheless, adequate understanding i. Robust informed consent thus remains an elusive ideal because the data about specific health and other risks have not been rigorously collected and analyzed. For example, little is known about the time to recovery; the nature and extent of subsequent morbidities and.
Hence, it is important to develop registries that can track such outcomes for living donors. A few years ago the DHHS Advisory Committee on Transplantation made several recommendations about living donation that called for the creation of a database with data on the health outcomes of all living donors ACOT, When the prospective donor is related to the recipient, which usually involves close affective ties as well as the genetic relationship, specific concerns focus on the dangers of undue influence, pressure, and coercion, even if he or she is competent, has received adequate information, and appears to understand that information.
Potential donors sometimes feel trapped in a process that they do not know how to stop without jeopardizing their relationships with members of their family or other people. A donor advocate can often be helpful in such circumstances. The transplantation team or donor advocate may sometimes believe that it is justifiable to offer a medical excuse to enable the potential donor to escape the pressure of donation and still protect his or her relationships with the family and others who have an interest in the transplantation.
Transplantation teams and donor advocates also need to recognize that, for poorly understood reasons, a striking gender imbalance exists in living renal transplantation: women donate kidneys at a significantly higher rate than men. For example, in , Examining the data for living kidney transplants between and , Kayler and colleagues , p. Gender disparities in living donor transplantation result from a higher proportion of wife-to-husband donations and disproportionate female-to-male donations among biological relatives and unrelated pairs.
A much earlier study, which needs to be updated, indicated that men and women donate at roughly the same rates when they are asked to do so and suggested that women were asked more often Simmons, Transplantation and donor advocacy teams need to attend to any factors, such as power imbalances, that might lead to the singling out of particular individuals as prospective donors and to pressure on them to donate. An ethical concern about living unrelated donation that frequently arises is that the organ is actually being sold or, at least, that financial incentives partially motivate the donation.
For example, such concerns have arisen with regard to solicitations on the Internet Steinbrook, Money may be a factor in living related donations, too. Compensating living donors opens up the possibility of exploiting poor and underprivileged people and also increases the risk that potential donors will withhold relevant medical information.
These proposals have yet to gain traction in the United States because they are incompatible with the fundamental values and norms that govern transplantation Delmonico et al. Although the. Although some contend that a regulated market would be a better solution than prohibition, critics doubt that it could avoid all of those negative consequences.
Furthermore, they worry about the broader societal impact of the commodification of organs on human dignity. These ethical concerns also apply to markets for organs that operate, often illegally, in other countries and attract an international clientele Scheper-Hughes, Goyal and colleagues conducted a cross-sectional survey of individuals in Chennai, India, who had sold one of their kidneys.
Ninety-six percent of the respondents stated that paying off debt was their motivation; however, selling a kidney did not produce any long-term economic benefit among those interviewed. The results of the study demonstrated a one-third decline in family income, and the majority of participants were still in debt and living below the poverty line at the time of the survey on average, 6 years after they had sold their kidney.
Eighty-six percent of those interviewed reported deterioration in their health status following the nephrectomy. In addition to the risks to the sellers of a kidney, so-called medical tourism often creates problems for the buyers. A study of the health outcomes of 16 individuals mainly from Macedonia 10 years after they had purchased organs from living unrelated donors mainly in India found relatively poor outcomes and several deaths as a result of severe pulmonary infections because of sepsis, hepatitis B with liver cirrhosis, and other complications.
Two patients died in the first month, and two patients died at the end of the first year after transplantation Ivanovski et al. These results suggest that surgical and medical complications arising from such transplantation practices may outweigh the benefits, all other ethical issues aside Ivanovski et al.
Although the committee believes that the whole practice of organ donation by living donors now needs a careful review and assessment on its own, in the interim the committee makes a few specific recommendations, building on ethical concerns and proposals already present within the transplantation community and drawing on the ethical perspectives that inform this report Chapter 3.
Ethical needs include the generation of better information through a registry for living nonrenal donors and a registry or rigor-. The specific recommendations that follow are particularly important for partial liver transplantation and partial lung transplantation because of their greater medical risks and inadequate data about those risks, but they would also be valuable in the context of kidney transplantation.
In determining which potential living donors will be accepted, transplantation teams serve as ethical gatekeepers, with less societal oversight than occurs in much of transplantation. Additionally, they may have an inherent conflict of interest because they seek to obtain an organ for patients on the waiting list while assuming major responsibilities to potential and actual donors. Such a team can best protect the donor if it offers the multidisciplinary expertise needed to address the whole range of medical, ethical, social, and psychological questions and issues.
Each team should include a clinician with experience in transplantation, a social worker or other mental health professional with experience in interpreting donor motivations and addressing intrafamilial conflict, and a nurse.
Whether these healthcare professionals or another group of healthcare professionals are involved, the goal is to provide the expertise and skills necessary to ensure 1 that the potential donor adequately understands the risks that surround his or her donation and recognizes the uncertainties involved, especially in the absence of comprehensive data about outcomes, and 2 that the potential donor is making a voluntary decision regarding donation without undue pressure or coercion by family members or by anyone else.
Focusing on the welfare and rights of the donor, the donor advocacy team can also act as a safety valve by providing a confidential way out for prospective donors who believe that they are being pressured or coerced to donate. As this chapter has stressed repeatedly, more information is needed about the short-term and long-term health and other effects of living organ donation, particularly the donation of nonrenal organs.
For the most part, living donation developed on an ad hoc basis in various transplant centers and has never had the central oversight and supervision that has marked practices of donation by deceased individuals. As a result there is no national infrastructure for gathering information and for ensuring accountability as there is for donation by deceased individuals.
Establishing registries of living donors would be a first step in developing the infrastructure needed for follow-up studies. Registries are particularly important for nonrenal transplants, and they could be developed without excessive cost because the numbers are small: there are just over living liver donors and about 30 living lung donors for about 15 lung transplants each year HRSA and SRTR, It could be argued that such a registry is not needed for living kidney donors because this procedure has been used for decades and many thousands of living donors have provided a kidney.
However, it is important to start the process of registering all living donors and then to determine, through an appropriate mechanism, what data should be collected after the first year, at what intervals, and for how long, balancing the costs and probable benefits of the data collection. Important concerns for registries and for sample studies include the long-term effects as well as the short-term effects of donation on physical and mental health and on financial resources, insurability, and other relevant issues.
OPTN could be the locus for data collection and management because it is well situated for managing large data sets relating to transplantation. In addition, placing the responsibility for the collection of long-term data on living donors within OPTN would effectively bring living donation under the general scrutiny of the transplantation community and the public.
The committee further observes that many of the available studies of the decision-making process about living donation by potential donors were conducted years ago with living kidney donors see, for example, the work of Simmons et al. In addition to continuous quality improvement in the process of selecting, informing, and ensuring the voluntariness of the decisions of prospective donors, transplantation and donor advocacy teams need information from rigorous studies of their processes and of donor and nondonor decision making.
The realistic goal of the recommendations developed in this report is to reduce the gap between the supply and the demand for transplantable. One important effect of the reduction of this gap would be the reduction in the need for organs from living donors because such donations are often ethically problematic in view of the risks to donors, particularly in nonrenal transplants, and the difficulty of ensuring voluntary, informed consent.
Recommendation 9. Hospitals that perform living-donor transplantations should pro vide each potential living donor with an independent donor advo cacy team to ensure his or her voluntary and informed decision making. HRSA, OPTN, and transplant centers should work to establish registries of living donors that would facilitate studies of both short- term and long-term medical and other outcomes of living donation.
Consensus statement on the live organ donor. Journal of the American Medical Association 22 — Department of Health and Human Services. Principles of Biomedical Ethics, 5th ed. New York: Oxford University Press. The living donor experience: Donor health assessment and outcomes after living donor liver transplantation. Meanwhile, some US hospitals are rewarding live donors with vouchers that can be used to obtain organs in the future.
But many objections have been raised to these sorts of incentive schemes, with perhaps the most serious being that they are exploitative and coercive. Suppose the government decides to allow a private market for live kidney donations. Almost all donors are unemployed and in financial need, and most recipients are well-off.
On one interpretation, the worry is that organ buyers are taking advantage of the vulnerability of the poor. Buyers use this vulnerability to obtain organs for a lower price than they would have had to pay were the donors not vulnerable. This problem could be avoided by guaranteeing a minimum price for organs.
Either way, if the reward is large enough that the donor would donate even if not vulnerable, then the buyer would no longer be profiting from vulnerability. Now some will raise a new objection: this scheme risks coercion because, for those in financial need, the reward will be effectively irresistible. To avoid exploitation, we may need to ensure that incentives for organ donation are large enough that donors would donate even if they are not vulnerable.
But if incentives become too large, some will regard them as coercive.
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