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The transplantation of organs from living donors has always involved a balancing of the physical risks and psychological benefits to the donor against the benefits to the recipient. Early in the history of transplantation, the expectation was that the outcomes for recipients of transplants from living unrelated donors and for recipients of cadaveric transplants would be similar and that the risks to unrelated living donors would therefore not be justified.
As the outcome of kidney transplantation improved and the criteria for accepting patients for transplantation were expanded, greater numbers of patients with end-stage renal failure opted for transplantation rather than long-term dialysis. Consequently, the waiting lists for cadaveric kidneys grew longer. To alleviate this problem (and in response to pressure from potential donors who wanted to help), many transplantation centers began using organs from genetically unrelated but "emotionally related" donors, such as a spouse or a close friend. Numerous clinical studies have shown that the rates of patient and graft survival are similar for transplants from living unrelated donors and for those from living related donors.
Our center has extensive experience with the transplantation of kidneys from living donors. Since June 1963, we have performed more than 2500 such transplantations. We have occasionally been approached by persons offering to donate a kidney to any patient on the waiting list for a cadaveric organ -- a process we call "nondirected donation." Our policy has been to turn down these offers. But in view of the excellent outcome with the use of transplants from emotionally related donors, the long wait for cadaveric transplants, and the persistent offers of donor volunteers, we decided to establish a policy for nondirected donation. Since the policy was implemented, we have performed four transplantations involving nondirected donation; the first was performed in August 1999. In this article, we discuss the basis for this policy.
We assembled a group to develop a policy for nondirected donation of kidneys. The group consisted of physicians, transplant coordinators, a social worker, a bioethicist, a psychologist, a hospital administrator, and a hospital attorney. In addition, we consulted with the institutional review board and nursing services at our university. Our policy covers six main areas.
When any potential donor contacts our transplantation center, a brief screening interview is conducted by telephone. In most cases, the person is then sent a packet of information about the outcome of transplantation, surgical risks to donors, the expected recovery time, and procedures for evaluating donors. In addition, our traditional, living unrelated (but emotionally related) donors also routinely undergo a psychosocial evaluation. Many donors live outside our geographic area, and they are usually evaluated in their local communities.
For nondirected donation, we decided that the potential donor should be evaluated at our institution to ensure a detailed discussion of the operative risks as well as the reasons for the offer. In addition, we decided to require a detailed psychosocial evaluation in order to rule out any underlying psychiatric disorders and to assess the person's competence to make an informed decision about donation.
With other living donors, we require that the decision to accept a donor be made by a team that is separate from the team caring for the potential recipient. We included this requirement in our policy for nondirected donation.
We decided that the recipient of a nondirected kidney would be chosen from the pool of patients on the waiting list for a cadaveric transplant and that we would rank the potential recipients according to the same point system used to allocate cadaveric kidneys. This system takes into account the extent of HLA matching between donor and recipient and the length of time the recipient has been on the waiting list.
To maximize the chance of success, we decided to limit the pool of recipients to patients on the waiting list at our institution who were candidates for a first or second transplant and who had no history of noncompliance with a medical regimen.
Because many of our potential recipients have been on the waiting list for years, we decided that once a potential recipient was selected, we would do an outpatient reevaluation to ensure that he or she was medically ready for a transplant. At the time of the reevaluation, the possibility of nondirected donation would be discussed. We would make sure that the potential recipient was comfortable with any preconditions (e.g., anonymity) and understood that the transplantation could be cancelled at any time (e.g., because of the donor's decision to withdraw from the program).
With nondirected donation, as with traditional living donation, the donor's surgery and the transplantation itself are elective procedures. We decided to require an interval of several weeks between the evaluations of the donor and the recipient and their admission for surgery, so that the donor would have sufficient time to reconsider.
We wished to ensure that the potential donor was motivated by altruism. Some members of our policy group were concerned that a donor might make demands of the recipient either before or after the transplantation. We concluded that if the donor and the recipient remained unknown to each other, altruism would be the only motive for the donation. Yet we recognized that even an entirely altruistic donor might legitimately wish to meet the recipient and see firsthand the good that would come from the donation. We also recognized that the recipient might want to express gratitude to the donor in person. We decided to honor requests for such meetings, but only after the transplantation and only if both the donor and the recipient agreed to the meeting.
We discussed the possibility that the donor, the recipient, or both would want to remain anonymous. We decided that matching the donor's desires in this regard would be one of the criteria for the selection of a recipient. If the donor wanted to remain anonymous, the recipient would have to agree to this request.
In addition, we discussed how to handle any other conditions specified by the donor. For example, what if the donor wanted the recipient to be a child or a Christian? We felt strongly that there were compelling arguments for turning down such requests and decided to accept only donors who would be willing to have their kidneys allocated according to our protocol. This is another reason for our requiring that any meeting between donor and recipient take place only after the transplantation.
We decided that with a nondirected donation, any communication between the donor and the recipient would be routed through our transplantation center. We were concerned about subsequent communication if the donor and the recipient chose to meet. We thought that the possibility of future demands made by donors was unlikely, but we concluded that fully informed donors and recipients have the right to accept this risk as part of the decision to undergo the transplantation.
In most cases, insurance plans will not pay for travel, other expenses, or lost wages associated with organ donation. Our transplantation program currently provides limited financial assistance, when requested and needed, for both donors and recipients to help defray the costs of travel, lodging, and meals. We decided that if the donor of a nondirected donation requested financial assistance, we would address the request just as we would a request from other donors.
We decided to conduct long-term follow-up studies of donors and recipients of nondirected donations, including studies of their quality of life, as we do with all living related donors and recipients.
Since our policy on nondirected donation was introduced, we have begun to evaluate potential donors. As of March 31, 2000, 98 persons had contacted us for information on nondirected donation. Eighteen of these persons have been evaluated, and 20 are being evaluated or are about to be evaluated; the other 60 persons have not pursued donation. Of the 18 persons who have been evaluated, 6 have been accepted as donors (the transplantation has been performed in 4 cases and scheduled in 2), the evaluation of 1 person is being reviewed, and 11 persons have not been accepted as donors because of medical or psychosocial factors.
The donors for our first four nondirected transplantations have remained anonymous. Maintaining their anonymity led to some logistic problems. We elected to admit each donor under an alias. Since the initial evaluation had been done with the use of the donor's real name, obtaining the chart and radiographs and having them available at the time of surgery required careful planning (the same hospital number was used on the pretransplantation and admission charts).
With the use of organs from living related donors, both the donor and the recipient are usually admitted on the day of surgery. For our nondirected donations, the donors and the recipients (each accompanied by family members) were admitted to different parts of the hospital to maintain anonymity. In all four cases, the recipient's family waited at the nursing station rather than in the postoperative waiting room with the donor's family.
The operations in the donors and the recipients were performed simultaneously with the use of standard open techniques. The transplanted kidneys functioned immediately. Neither the donors nor the recipients had complications. In all four cases, the transplanted kidneys have continued to function well during follow-up periods ranging from 2 to 10 months (serum creatinine level, 1.2 to 1.9 mg per deciliter).
After the procedure, all four recipients wanted to express their appreciation to the donors. The message was conveyed by staff members at our transplantation center.
Our new policy raises two major ethical questions. The first, which has been debated for decades, is whether the transplantation of organs from living donors is ethically justified and, if so, under what conditions. Those who favor the use of transplants from living donors argue that the higher rates of patient and graft survival with such transplants (as compared with cadaveric transplants), the increasingly long wait for a cadaveric kidney, and the psychological benefits to the donor justify the use of organs from living donors. Opponents argue that the physical risks to the donor make such a policy unjustifiable. This debate seems largely settled in practice, since between 1994 and 1998, there was a 38 percent increase, from 3009 to 4156, in the number of transplants from living donors in the United States. The acceptance of organs from emotionally related donors accounts for much of the increase.
The second question is whether the balance between risks and benefits is altered when there is no relationship (genetic or emotional) between the donor and the recipient. Is the single benefit of altruism enough to balance the risks of donation? Of course, in the absence of a prior relationship between donor and recipient, there is no need for concern that the donor may be under pressure to make the donation.
The main argument against the use of transplants from living donors is the risk to the donor. The death rate associated with kidney donation has been estimated to be 0.03 percent; the most common cause of death has been pulmonary embolism. In a recent series, the overall morbidity rate was less than 10 percent. Major complications were rare; the most common problems were minor wound infections, urinary tract infections, and low-grade fever. Donors are generally discharged from the hospital by the fourth day after surgery, and they usually return to work within six weeks. Despite anecdotal reports of renal failure in kidney donors, long-term follow-up of large series has not shown an increased rate of renal failure. Most insurance plans do not increase premium rates for clients who have donated a kidney.
Although kidney donation confers no physical benefits, studies have shown that donors experience increased self-esteem and feelings of well-being. Long-term follow-up studies of genetically related donors using standardized tests, have shown that their health-related quality of life is similar to or better than that of the general population. None of the emotionally related donors reported feeling any pressure to donate; among genetically related donors, siblings were most likely to feel such pressure.
Some of the decisions we made in launching our program were arbitrary. Most algorithms for the allocation of organs are based on an attempt to balance two potentially competing objectives: to maximize the probability of a successful outcome and to make allocation equitable. For nondirected donation, we used the algorithm in place at our center for the allocation of cadaveric kidneys. However, because nondirected donation was a divergence from standard practice, we were particularly intent on maximizing the chances for success. Therefore, we limited our pool of recipients to patients in need of a first or second transplant, eliminated potential recipients with a history of noncompliance with medical regimens, and required that the transplantation be performed at our institution.
Each of these preconditions can be debated. Transplantation of a first or second graft is technically easier (since there is no scar tissue) and is associated with better short- and long-term outcomes than is transplantation of a third or fourth graft. We continue to perform third or fourth transplantations, but not as part of the program for nondirected donation. Noncompliance is a contraindication to transplantation in our program. However, some candidates for cadaveric transplants who have a history of noncompliance have subsequently complied with medical regimens. These patients are monitored for compliance while they remain on the waiting list. Finally, we thought that the logistics of beginning a program of nondirected donation would be difficult enough to deal with in one institution and that opening it up to potential recipients at other institutions would be unworkable, at least until we had gained some experience with the program. In any case, successful transplantation of a kidney obtained through nondirected donation in a recipient on the waiting list at our center incrementally reduces the competition for cadaveric organs, and thus might improve chances for others on the waiting list -- both at our center and at others.
We decided not to allow a donor to specify the characteristics of the recipient (e.g., age or race). We realized that a policy requiring donors to donate to an unspecified pool of recipients rather than to recipients with particular characteristics would be unlikely to change any morally troublesome views (such as racism or sexism). But we believed that our program should not tacitly endorse such views by permitting this type of directed donation. In addition, potential donors who feel strongly about the destination of their organs are free to seek out like-minded persons through emotionally related donation.
There are other situations in which the donation is directed to a specific recipient, even though the donor and the recipient are not genetically or emotionally related. For example, potential donors have responded to newspaper stories or church bulletins about a person in need of an organ. In such cases, the donor and the recipient meet beforehand, and if they decide to proceed with the transplantation, the donor will have the opportunity to learn the results. With a paired exchange, the donor and the recipient do not know each other initially, but the donor's family benefits from the donation -- that is, a member of Recipient A's family donates an organ to Recipient B in exchange for an organ donated by a member of Recipient B's family to Recipient A. It has also been proposed that a willing (and medically eligible) donor who was ABO-incompatible or crossmatch-positive could donate an organ to a patient on a waiting list in exchange for having his or her own family member moved up on the list. Such situations challenge the long-standing prohibition of a quid pro quo for donation, pointing to the need for further discussion of the ethical, legal, and policy implications of novel approaches to increasing the supply of organs.
In our four transplantations involving nondirected donation, the donors and the recipients have not met. The donors (and their family members) have had no benefit other than the psychological benefit of performing an altruistic act. We are aware of two other recent instances in which donors offered kidneys to any recipient on the waiting list. In 1997, a transplantation surgeon in Europe underwent nephrectomy, and the kidney was allocated according to that center's usual criteria for the allocation of cadaveric transplants. In September 1999, a donation coordinator at an organ-procurement organization in the United States donated a kidney to a child on the waiting list at Johns Hopkins University in Baltimore; the donor and the recipient met before the transplantation.
A major concern expressed during our policy discussions was that the donor might ask the recipient for financial or other help at some point in the future. Although we stipulated that donors and recipients of nondirected donations remain unknown to each other initially, if they met after the transplantation, such a request could be made (just as it could if the donor and the recipient were known to each other before the transplantation). We decided that fully informed recipients have the right to accept the risk of future requests for financial or other help in exchange for the benefits of the transplantation.
Finally, we decided, for now, that nondirected donation should be limited to kidney transplantation. Lung, pancreas, and liver transplantations of organs from living donors have all been performed many times. Liver and lung transplantations are lifesaving; for patients with end-stage liver or lung failure, there is no alternative to a transplant. But the rates of morbidity and mortality associated with removing part of the liver, part of the lung, or part of the pancreas are higher than the rates associated with removing a kidney. As we gain more experience with transplanting parts of other organs from living donors, it is likely that the risks of donation will decrease. We will then need to reconsider our policy of restricting nondirected donation to kidney transplantation.
Supported by a grant (13083) from the National Institutes of Health.
We are indebted to Stephanie Daily for assistance in the preparation of the manuscript, to Mary Knatterud for editorial assistance, and to the many donors and their families who make transplantation of organs from living donors possible.
Copyright © 2000 by the Massachusetts Medical Society.
This article posted August 16, 2000.