This paper was prepared solely to aid discussion for the September 2006 meeting, and does not represent the official views of the Council or of the United States Government.

Staff Discussion Paper

Living Donors: Process, Outcomes, and Ethical Questions

Ginger A. Gruters, M.A.*

* With special thanks for the collaboration of my colleagues, Eric Cohen and Dan Davis, Ph.D.

Outline

I. Some General Background

II. Organ by Organ: Donation Process and Health Outcomes

1. Kidney
2. Liver
3. Lung
4. Pancreas
5. Intestine
6. Conclusion

III. Some Ethical Questions

1. The Moral Obligation of Doctors
2. Acceptable versus Unacceptable Risk
3. The Moral Meaning of "Who Donates?" and "Why?"�����

Appendix 1: Living Kidney Donor Evaluation Guidelines

Appendix 2: Living Liver Donor Evaluation Guidelines

Living Donors: Process, Outcomes, and Ethical Questions

The contemporary practice of organ transplantation began in 1954 with a kidney transplant from a living donor to his identical twin brother.¹ Since then, much has changed: the field of organ transplantation has grown tremendously, saving, improving, or extending thousands of lives. Thanks to advances in immunosuppressive medications, it is no longer necessary to be a close genetic relative to be a living donor; and thanks to improvements in surgical techniques, the recovery time for living donors has decreased for many procedures, while graft survival has improved. This success has heightened interest in expanding the pool of living organ donors, especially in light of the growing demand and need for transplantation and the limited supply of deceased donors.

Certain crucial facts remain, however. Removing organs from living donors still involves performing surgery on a healthy patient for reasons that have nothing to do with his or her physical health, and with genuine risk of physical harm. Thus, living donation, by its very nature, presents us with a unique ethical dilemma in the practice of medicine, which has long been guided by the ethical maxim: "First, do no harm." Although there are accumulating data on the perioperative risks of being a living donor, there remains a dearth of data on the longer-term outcomes for living donors.

The aim of this working paper is to provide background on the process of living organ donation, with particular attention to what we know about the health outcomes for living donors, and especially the significantly different risks between kidney donation and liver or lung donation, the three most common types. Part I provides some basic information on the state of organ donation from living donors. Part II surveys the donation process and health outcome data organ by organ. Part III raises some of the relevant ethical questions, which the Council might discuss in light of the empirical information presented here.

I. Some General Background

A living donation takes place when an individual willingly allows the removal of an organ (or part of an organ) for the purpose of transplanting it into another. Most living donors are family members or friends of the intended recipient, but there is also a growing number of so-called anonymous altruistic donors. Prior to living donation, potential donors must undergo rigorous evaluations of their physical and psychological health, must be informed of the risks of living donation, and must voluntarily consent to donation. OPTN/UNOS has not issued specific policies to govern the process of living donation, but two consensus statements have been developed by the transplant community to ensure greater uniformity in the selection and pre- and post-operative care of living donors: the Ethics Statement of the Vancouver Forum on the Live Lung, Liver, Pancreas, and Intestine Donor and the Consensus Statement of the Amsterdam Forum on the Care of the Live Kidney Donor.² Both consensus statements emphasize the process of informed consent and the opportunity for refusal.

Although "the OPTN/UNOS Board of Directors has recommended the development of a standardized tool to inform potential living donors and recipients about the living donation process, a nationally standardized informed consent process does not currently exist."³� It is thus within the purview of the transplant center to establish its own procedures for informing donors and recipients about the following kinds of issues:

• The fact that communication between the donor and the transplant center will remain confidential
• The evaluation process
• The surgical procedure
• The availability of alternative treatments for the transplant recipient
• The potential medical or psychosocial risks to the donor
• The national and transplant center-specific outcomes for both donors and recipients
• The possibility that future health problems related to the donation may not be covered by the donor's insurance and that the donor's ability to obtain health, disability, or life insurance may be affected
• The donor's right to opt out of donation at any time during the donation process⁴

In addition, the HHS Advisory Committee on Organ Transplantation (ACOT) recommends that the following ethical principles and informed consent standards be implemented, such that all living donors are:

• competent, that is, they possess decision-making capacity;
• willing to donate;
• free from coercion;
• medically and psychosocially suitable;
• fully informed of the risks and benefits of donating; and
• fully informed of the risks, benefits, and alternative treatment available to the recipient.

Two related ethical principles that ACOT endorses are:

• The benefits to both the donor and the recipient must outweigh the risks associated with the donation and transplantation of the live donor organ; and
• A clear statement that the potential donor's participation must be completely voluntary, and may be withdrawn at any time.⁵

Ensuring that the decision to donate is voluntary and uncoerced is a challenge considered in greater depth in the final section of this paper.

By far, the most common organ to be donated by living donors is the kidney (about 95% of all living donations), but it is also possible to donate all or part of the liver, lung, pancreas, intestine, and heart.^{6 7} At this time, there are "no absolute age limits to organ donation," but "individuals considered for living donation are usually between the ages of 18-60 years of age."^{8 9}� Additionally, UNOS reports, "a handful of medical conditions will rule out organ donation, such as HIV-positive status, actively spreading cancer (except for primary brain tumors that have not spread beyond the brain stem), or certain severe, current infections. However, for most other diseases or chronic medical conditions, organ donation remains possible."¹⁰� In the process of clinical evaluation, potential living donors generally undergo the following tests: blood test, tissue typing, crossmatching, antibody screen, urine tests, X-rays, arteriogram, psychiatric and/or psychological evaluation, gynecological examination, and a final blood test.¹¹

In 1988, the effort to compile various types of data on living donation was launched in the United States, and since then there have been 80,516 living donors in the U.S., with the percent of living donor transplants compared to cadaveric donor transplants rising in the last decade.¹² In 1995, living donation accounted for 35.1% of all transplants; in 2005, living donation accounted for 47.6% of all transplants.

II. Organ by Organ: Donation Process and Health Outcomes

Although it is possible to generalize about certain features of living donation per se, it is important to analyze this increasingly significant source of human organs on an organ by organ basis, to review briefly the history of the relevant procedures, to look more closely at donor evaluation, and, especially, to survey what is known about perioperative and long-term risks to donors. After reviewing the available statistics on morbidity and mortality associated with living donation, the transplant community's recommendations for improved tracking and response to longer-term health outcomes of living donation will be discussed. Most of the information and data concern living donation of kidneys, livers, and lungs; for the other organs and parts of organs, living donation is relatively rare and significant data do not exist.

A. Kidney

Living Donors:
1995: 3,392
2005: 6,564
To date (from January 1, 1988-April 30, 2006): 76,297¹³

Nephrectomy, the surgical removal of a kidney, was apparently first performed by the German surgeon Gustav Simon on August 2, 1869.� This proved that a human being could still live with only one functional kidney-the first step toward the age of living donor kidney donation. At present, "potential kidney transplant candidates constitute approximately 70% of the individuals on the entire Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) waiting list," while, as said above, kidney donation constitutes roughly 95% of all donation from living donors.¹⁴

For recipients of kidneys from living donation, the evidence is encouraging. The survival rate for recipients of living donor kidneys is measurably better than that of deceased donor kidneys: at one year, research shows a 97.9% survival rate for living-donor kidneys versus a 94.6% survival rate for deceased-donor kidneys; at five years, the living-donor kidney survival rate is 90.2% versus 81.1% for deceased-donor kidneys.¹⁵ The National Kidney Foundation also notes certain additional advantages with living donor kidneys:

Thus, with living donor kidney donation, the outcome for recipients is generally better, and due to progress in preventing immune rejection complications, the outcome for recipients of living unrelated donors is equivalent to that of related donors.¹⁷ In addition, laparoscopic nephrectomy is an option today, where "smaller incisions make for faster recovery time and less pain" for the donor (though, as we will see, not necessarily better long-term outcomes).¹⁸ Nonetheless, all of these advantages exist alongside a major comparative disadvantage: "a living donor . is required to have a major operative procedure that is associated with morbidity, mortality and the potential for adverse long-term consequences of living with a single kidney."¹⁹�

Donor Evaluation

The OPTN/UNOS Ad Hoc Living Donor Committee has offered potential Living Kidney Donor Evaluation Guidelines, and although they are not current OPTN/UNOS policy, it is possible that these guidelines could become the standard for practice in living kidney donor evaluation (see Appendix 1).²⁰  At this time, however, the precise procedures and process are within the purview of the transplant center.

The process of evaluating a potential living donor begins with educating the donor about the donation process and reviewing the donor's health history.� The donor's blood type is determined early on, so as to determine the potential donor's compatibility with the recipient.²¹ � The importance of full disclosure is central to the whole process of eliciting the potential donor's consent or refusal to donate, including discussion of "the impact of donation on their social and financial well-being, short-term morbidity and mortality directly related to the surgery, future risk for renal insufficiency and failure, risk for de novo medical problems with renal and overall health (i.e., hypertension, diabetes), and risk for allograft failure in the recipient because of rejection, technical problems, recurrent disease, and/or comorbid medical problems."²²� The more detailed health evaluation consists of myriad tests to assess the following: "donor hypertension, body mass index, dyslipidemia, renal function, malignancy, and a history or current presence of infectious diseases such as tuberculosis or hepatitis."²³� In addition, the potential donor's age, amount of proteinuria, degree of hematuria, and the evaluation performed in those with a history of nephrolithiasis and a strong family history of diabetes are taken into account.^{24 25 26 27 28}� This is necessary, as factors such as obesity, hypertension, type II diabetes, and infectious diseases have potentially detrimental effects to the donor, in addition to making the donor candidate's organs potentially ineligible for transplant.

Perioperative Risk and Long-Term Risk

One study of the kidney donation process notes the following: "the risk of donating a kidney includes both the short-term perioperative risk, including pain and discomfort, and the long-term risk of having only one kidney. Exactly what information potential donors are told about the risks involved in renal donation appears to vary substantially from center to center."^{29 30} Moreover, with living kidney donation, "information on perioperative risk comes from three sources: published data on the risk of any major surgery, published data on the specific risk of donor nephrectomy, and the personal experiences of the transplant team."³¹�

In living kidney donation, the donor may opt for one of two types of surgery: an open nephrectomy or a laparoscopic nephrectomy. The open nephrectomy involves making an incision of several inches (6-10 inches) in the donor's abdomen area, and it requires the removal of all (or part of) a rib, in order to allow removal of the kidney.^{32 33} The laparoscopic nephrectomy requires 3 to 5 small incisions (1-inch or less) to be made in the donor's abdomen, and this procedure is characterized by its use of a laparoscope, a telescopic device which is inserted into the incisions in order to provide viewing capabilities for the surgeon.^{34 35} Surgical instruments are then inserted into the incisions as well, and with the help of the laparoscope, the removal of the kidney is made possible. In the end, the incisions require cutting through three layers of muscle, and the kidney is then removed through the largest incision (about 2.5 inches).³⁶ Studies to date have shown that laparoscopic procedures usually result in less pain, shorter hospital stays, and faster recovery, yet there is also evidence of a higher relative incidence of complications.³⁷�

For an open nephrectomy, hospital stays average 6 days; with laparoscopic nephrectomy, hospital stays average 4.1 days. Those who have the open procedure typically return to work in about 12 weeks, while those who have the laparoscopic procedure typically return in 5 weeks. After open surgery, one can drive a car after 6 weeks; with laparoscopic surgery, the wait is 2 weeks. One can exercise after 11 weeks with open surgery and after 4 weeks with laparoscopic surgery.³⁸� Due to this greater ease of recovery, laparoscopic nephrectomy is now the more common surgical procedure used with living kidney donation today. ^{39 40 41 42} Yet the laparoscopic procedure is also relatively new, first conducted in 1995 at Johns Hopkins Bayview Medical Center.⁴³ Unlike open nephrectomy, laparoscopic nephrectomy is an intraperitoneal operation (i.e., takes place within the area that holds the abdominal organs), meaning that the risks of reoperation for hemorrhage or bowel obstruction are typically higher.⁴⁴ Matas and colleagues conducted a survey which "found some differences between donation techniques in the rates of reoperation, complications, and readmissions-all higher with laparoscopic nephrectomy."⁴⁵ It should also be noted that there are surgical variations, such as "hand-assisted laparoscopic" and "mini-open" nephrectomy that involve characteristics of both laparoscopic and open nephrectomy, and if at any time complications arise in the course of laparoscopic surgery, the procedure can be changed to an open nephrectomy. ^{46 47}

Perioperative risks include, but are not limited to, the following: pneumothorax, small peritoneal damage, superficial wound infection, deep wound infection, pneumonia, urinary tract infection, renovascular injury, bowel injury, bowel obstruction, hernia, hematoma, pulmonary embolism, transfusion, orchalgia, transient neuromuscular injury, fever, liver bleeding, acute renal failure, bradycardia, hemorrhage, anaphylactic reaction, or even re-operation.^{48 49 50 51 52}

Along with the perioperative risks, the long-term health outcomes for living kidney donors are a topic of great concern in the transplantation community. One of the major long-term concerns for living kidney donors "is whether having a unilateral nephrectomy predisposes to the development of kidney disease and/or premature death."⁵³ According to the statistics available, mortality after living kidney donation is .03% and morbidity is less than 10%." ^{54 55 56} Yet, "of concern is the recent finding that mild renal dysfunction or proteinuria correlates with cardiovascular risk.� All donors lose 20% renal function; and. proteinuria is not uncommon after kidney donation."⁵⁷ Thus, the effects of proteinuria and mild renal dysfunction need further investigation, in light of the association of these phenomena with risks to the cardiovascular health of living kidney donors. All of these findings suggest that additional, systematic follow-up, especially concerning long-term outcomes or effects on the health of living kidney donors, is needed.� Arthur Matas, a transplant surgeon at the University of Minnesota and an analyst of living donation, presents six pressing questions in need of research:

1. Does kidney donation increase the long-term risk of developing End Stage Renal Disease (ESRD)?

2. Is the mild increase in blood pressure seen in some donors progressive, and is it a risk for ESRD or survival?

3. Does the incidence of protoeinuria increase after donation?

4. Do donors with increased BMI or a history of smoking have increased risk for development of proteinuria and renal dysfunction?

5. Are donors who subsequently develop type II diabetes or hypertension at increased risk for ESRD, and does ESRD develop more rapidly?

6. Does the mild renal impairment, increase in blood pressure, and proteinuria associated with uninephrectomy increase cardiovascular risk? ⁵⁸

While "studies to date have suggested that there is not an increased incidence of ESRD vs. the age-matched general population" with living kidney donors, there are insufficient data to prove that living donors are not at an increased risk.⁵⁹� As the Amsterdam Forum states:

As in the general population, based upon age and other medical risk factors (e.g., hypertension, proteinuria, hyperlipidemia, impaired glucose tolerance test), kidney donors should undergo long-term follow-up of body weight, blood pressure, blood sugar, serum creatinine, and urinalysis.� Abnormalities should be treated promptly by either the local medical physician or the transplant nephrologist.� Long-term collaborative prospective studies and comprehensive national registries should be established to determine whether the incidence of medical risk factors and renal dysfunction is different from the general population.⁶⁰

B. Liver

Living Donors:
1995: 54
2005: 323
To date (since January 1, 1988-April 30, 2006): 3,066

On November 27, 1989, the first successful liver transplantation with an organ from a living donor took place at the University of Chicago Medical Center. The donor was 29-year old Teresa Smith, the mother of a 21 month-old daughter, Alyssa, who suffered from biliary atresia, a congenital condition that can prove fatal if not treated. Alyssa graduated high school on May 27, 2006. She is completely recovered, leads a "normal" teenage life, and for the past three years has been free of taking anti-rejection medications. The mother is also reported to be doing well, and is very thankful for the success of the transplant that took place years ago.⁶¹�

Donor evaluation

A potential living liver donor must be in excellent physical and psychological health, and is required to undergo extensive examinations and testing, including a radiological imaging of the liver which assesses the anatomy, liver volume, and size.⁶² It has been noted that "a liver biopsy may be performed," but this practice is not mandated.^{63 64}� The OPTN Ad Hoc Living Donor Committee has issued Living Liver Donor Evaluation Guidelines, but these are not currently OPTN/UNOS Policy (see Appendix 2).⁶⁵ There is no national standard of evaluation for living liver donors at this time, leaving each transplant center to make the final decision regarding the suitability and health of the potential live liver donor.��

Perioperative Risks and Long-term Risks

Today, live liver donation is considered one of the most dangerous living donations in terms of risks to the donor, even though the donor's remaining liver segments have the ability to regenerate themselves after donation and recover total function. It is necessary to remove the gallbladder and in general to remove 25 to 65% of the liver.⁶⁶ The Vancouver Forum maintained that live liver donation should take place "only if deceased donor transplantation is not possible," and "after careful analysis of the recipient risk to benefit ratio as it relates to severity of liver failure, quality of life, and expected wait list time for a deceased donor."⁶⁷ Recipients of living liver donation are usually genetically or emotionally related to the donor; non-directed living liver donation is "unusual."⁶⁸

The perioperative risks associated with living liver donation include: infection (e.g. urinary tract infection), pneumonia, blood clotting, allergic reaction to anesthesia, injury to the bile duct or other surrounding organs or tissues (e.g. spleen or bowel), obstruction of the intestine, liver failure, biliary strictures, and/or possible death. ⁶⁹ Additionally, with a living liver donor, it is necessary to remove a portion of the saphenous vein in the donor's leg to connect the donated liver to the recipient.⁷⁰ This procedure usually takes from 5 to 8 hours, and the resultant hospital stay usually lasts about 7 days.� Barring complications, the donor then may return to work or normal activity (if not overly physically strenuous) in 4 to 6 weeks.

The Vancouver Forum reports that "the estimated risk of mortality and morbidity currently associated with live donor right hepatectomy is 0.4% and 35% respectively."⁷¹ These risks are thus dramatically higher than the risks associated with living kidney donation-more than 13 times higher for mortality and 3.5 times higher for morbidity. In looking at worldwide statistics, "right lobe liver donation is associated with an increased morbidity and more severe complications than that associated with left lobectomy or left lateral segmentectomy."⁷²� Specifically, "mortality approaches 0.5% for the right lobe donor in contrast to approximately 0.1% for left lobe donation.⁷³

It is recommended that a live liver donor's operative follow-up consist of at least one year.⁷⁴ Yet, there is concern in the literature that restrictions in donor health insurance may influence the feasibility of such long-term follow-up.⁷⁵� The Vancouver Liver Group maintains that "since the risk to the donor is considerable, programs performing live donor liver transplantation should institute procedures and protocols that insure that donor mortality and morbidity is minimized."⁷⁶ Given the high relative risks of this surgery (compared to kidney transplantation involving living donors), ACOT has recommended "that a process be established that would verify the qualifications of a center to perform living donor liver (or lung) transplantation."⁷⁷� Another recommendation, from the Vancouver Forum's Liver Group, states that a registry of live donor complications should be established and that donor deaths should be reported to the registry.⁷⁸���

C. Lung

Living Donors:
1995:45
2005:2
To date (since January 1, 1988-April 30, 2006): 461������

Live donor lung transplantation began in 1990, and this particular transplantation "generally involves three simultaneous operations: two donor lobectomies and a recipient bilateral pneumonectomy and lobar implantation."⁷⁹� In other words, one donor gives the right lower lobe, the second donor gives the left lower lobe.⁸⁰� This living donation procedure thus "places two donors at risk for each recipient."⁸¹

Donor evaluation

Donor selection entails identifying donors with good health, who have adequate pulmonary reserve for lobar donation, and are free from coercion in making the decision to donate.⁸²� Potential living lung donors "receive a series of exams and tests including chest radiography, pulmonary function testing, ventilation-perfusion scanning and computed tomography, and a cardiac stress test" in order to determine personal health and their further suitability and compatibility with the recipient.⁸³ Additionally, the potential donors' lungs must be the correct size and volume, so that there are sufficient lung capabilities for the recipient. For adult recipients, "the donors should be at least as tall as the recipient."⁸⁴�

Perioperative Risks and Long-Term Risks

The perioperative risks with living lung donation include, but are not limited to, the following: allergic reaction to anesthesia, pneumonia, urinary tract infection, pleural effusions, bronchial stump fistulas, bilobectomy hemorrhage (necessitating blood transfusion), phrenic nerve injury, atrial flutter, bronchial stricture, persistent air leaks, pericarditis, arrhythmia, transient hypotension, atelectasis (lung collapse), ileus, subcutaneous emphysema, loculated pleural effusions, Clostridium difficile colitis, and infection.⁸⁵� To date, there have been no reported deaths from living lung donation, but "the perioperative morbidity is high, with complication rates ranging from 20-50% of donors."⁸⁶ Additionally, in some long-term (>1 year) donor follow-ups, donor complaints included chronic incision pain, dyspnea, pericarditis, and non-productive cough.⁸⁷� In response, the Vancouver Lung Group has recommended that "comprehensive short-term follow-up should be mandatory and long-term follow-up be strongly encouraged and funded by government/insurance authorities."⁸⁸

D. Pancreas

Living Donors:
1995: 7
2005: 2
To date (since January 1, 1988-April 30, 2006): 70

Living pancreatic donation requires a portion of the pancreas to be removed, and even though the pancreas is unable to regenerate, it still maintains the ability to function at a reduced size. The first successful living-donor (segmental) pancreas transplant took place in the United States in 1979, by Dr. David Sutherland of the University of Minnesota in Minneapolis. Compared to other organs, living pancreas donors are quite rare. Pancreas transplants are almost always performed in conjunction with a simultaneous kidney transplant, typically from the same donor.⁸⁹

Post-operative hospitalization for a live pancreas donor usually requires 5 to 7 days; although no donor deaths have been reported after segmental pancreatectomy, 15% of donors may need a splenectomy performed due to complications involving insufficient blood supply or bleeding.⁹⁰� This is a rather serious complication, and merits further investigation. As with other higher-risk areas of donation, the Vancouver Forum recommends "the establishment of a pancreas donor registry and database for lifelong follow-up."⁹¹�

E. Intestine

Living Donors:
1995: 1
2005:7
To date (since January 1, 1988-April 30, 2006): 33

The first live donor intestinal transplant took place in 1989, as a treatment for patients who are suffering with "life threatening complications of intestinal failure."⁹² Without a transplant, the patient faces long-term parenteral nutrition.

Live intestinal donation, as with all other living donations in the United States, is to be done out of voluntary, altruistic motives (no coercion).⁹³� A donor must be at the age of legal consent and should be a first or second degree relative of the recipient, or else they should have close emotional ties. ⁹⁴ It is reported that with this operative procedure, "it is essential to preserve at least two-thirds of the small bowel length in the donor."⁹⁵� Several problems can occur early in the post-donation period, including small bowel obstruction, diarrhea, weight loss, and dysvitaminosis. The risk of perioperative death is 0.03%.⁹⁶� According to the Vancouver Forum, the minimum follow-up schedule should include postoperative visits at 2 and 4 weeks, and donor teams need to be aware of� B₁₂ deficiency, as it must be monitored at 6 months and annually for 3 years.⁹⁷ Experience with intestinal living donation is limited, and though live donor intestinal transplants are not considered experimental, "this procedure should be regarded as an innovative and an evolving technology." ^{98 99}

F. Conclusion

From this brief survey of the process of organ donation from living donors and the health outcomes for living donors, the following preliminary conclusions can be drawn:

(1) By far, the most common and least risky form of living donation occurs with kidneys. It is critical, nonetheless, to remember that there are genuine risks of both morbidity and (rarely) mortality, and there has been an inadequate follow-up study of the long-term health effects of kidney donation on living donors.

(2) The second most common forms of donation from living donors involve the donation of parts of livers or lungs. These procedures involve significantly greater health risks compared with kidney donation, and similarly lack adequate long-term follow-up study.

(3) Other types of donation from living donors-such as pancreas or intestine donation-are so rare that it is difficult to generalize in any way.

(4) Among the various groups that have examined current practices in living donation, there is broad interest in developing binding policies and protocols to ensure the health of living donors, or at least full recognition of all the risks. To this end, ACOT recommends "that a database of health outcomes for all live donors be established and funded through and under the auspices of the U.S. Department of Health and Human Services." ¹⁰⁰ But, as of now, no such database exists, and its practical feasibility remains a complicated question. In addition, ACOT recommends support for "a consortium of investigators to conduct epidemiologic research on the outcomes and health needs of live organ donors" that would focus on "the medical and functional outcomes of individuals who have donated a kidney or a lobe of a lung for transplantation."¹⁰¹

III. Some Ethical Questions

Living organ donation raises myriad complicated ethical questions-three of which have been selected to guide the Council's discussion in this area: (1) the moral obligations of physicians performing surgery on living donors; (2) the moral distinction between acceptable and unacceptable levels of risk for living donors; and (3) the moral meaning of who donates.

A. The Moral Obligations of Doctors

Since the Hippocratic era, one of medicine's core ethical precepts has been primum non nocere, "First, do no harm." With the removal of organs from healthy, living donors, this ethical maxim is, in effect, suspended: in the interests of benefiting a patient suffering or dying from organ failure, a surgical procedure is performed on the donor, an intervention in the body that cannot benefit the donor himself physically but does hold the potential for bringing physical harm. In the usual circumstances, patients present themselves to physicians as patients, as sufferers of some malady that demands and needs the care that only physicians can provide. In the circumstances of living donors, such individuals only become patients through their encounters with the transplant surgeons.

For most living donors, the physical risks of surgery are seen as warranted by the desire to help another, usually a family member or friend who is suffering or dying. Thus, the transplant physician can help the living donor achieve some benefit, the benefit to be derived from helping a loved one enjoy a better quality of life or even survive through transplantation. In this non-bodily sense, the doctor does good for the donor-patient by helping him do good for another. The physician might serve the well-being of the donor as a whole, even if this requires the donor to place his own physical health at risk. But we are still left to ask: Is the doctor truly acting as a doctor by achieving this sort of benefit for the donor, by serving this non-bodily good? Or is the physician using a medical technique (e.g., kidney removal) to serve a non-medical end (e.g., the moral and spiritual goal of helping another)?

Interestingly, the Institute of Medicine reported that in "a survey of 100 liver transplant surgeons, Cotler and colleagues (2003) found that 77 percent experienced a moral dilemma in placing a living donor at risk.� Nevertheless, 72 percent also agreed that transplant centers had a duty to offer their patients the possibility of transplantation using living donors."^{102 103}

B. Acceptable versus Unacceptable Risk

The ethics of living donation turns, in critical ways, on the assessment of acceptable vs. unacceptable risk. At the extreme, some forms of living donation are clearly impermissible-such as a father who wished to give his son a heart. Here, the risk of death is 100 percent. The more complicated questions come in discerning how much risk (or how much additional risk) of morbidity or mortality is morally acceptable-both from the perspective of the physician who performs the surgery and from the perspective of the donor who submits to it. As we have seen, the risks of liver and lung donation are significantly higher than the risks of kidney donation. The question is: Are they too high?� And conversely, on what grounds might a physician turn down a potential donor who wants to help a loved one, knowing full well what the risks are?

This points us to another major problem: to some degree, the risks are unknown, especially the long-term risks of being an organ donor. As the Institute of Medicine reports, "it is difficult for transplantation teams, independent donor advocate teams, and prospective donors themselves to perform their analysis and assessments of risks, benefits, and risk-benefit ratios because of incomplete data about the health outcomes of living donation."¹⁰⁴ According to Robert Steiner, "centers may justifiably reject certain donors because they feel that, try as they might, the risk of donation cannot be estimated: that they have 'no idea' of the risks taken by these donors."¹⁰⁵

According to one study, most transplant professionals believe that "the risk assumed by the donor depends on the benefit of donation to the donor, i.e., how their life will be enhanced if they donate.� For instance, if a husband or wife donates to their spouse, their own quality of life may improve; therefore, more risk is accepted for the common benefit, whereas in the altruistic situation, there is no donor benefit other than the sense of helping someone in need, and even marginally increased medical personal health risk is especially important if the prospective living donor is a minor."^{106 107 108}�

C. The Moral Meaning of "Who Donates" and "Why"

Some of the more complex ethical questions in living donation have to do with who donates and why. It is well known that the majority of living donors are close relatives or close friends, but there is also an increasing number of so-called anonymous or non-directed living donors, who give an organ (almost always a kidney) as an act of altruism to a stranger. With donation to a loved one, the psychological motivation is humanly intelligible and (in general) morally praiseworthy, though the extent to which donation is voluntary or coerced, subtly or explicitly, is still of concern. With non-directed donation, anonymous donation, or donation to an individual whom one does not intimately know, the psychology is more complicated. We must evaluate: Does the donor understand fully what he or she is doing? Is she doing it for the right reasons? Does she expect more than just the psychic rewards of doing good for another? Might she believe that her act of donation puts a claim on the recipient to repay her in some way, or might she suffer post-donation troubles when her life returns to normal, or when her normal life never returns due to unexpected health problems from the donation? Of course every case is different. But the increasing rate of anonymous/non-directed donation requires greater attention to the procedures and regulations governing this practice. Consequently, the Advisory Committee on Organ Transplantation has recommended "that the Secretary of HHS direct the OPTN to develop allocation policy pertaining to non-directed, living-donor organs."¹⁰⁹

It is interesting to note that not too long ago, non-directed donation was a rather unaccepted practice.� In 1994, concerning living kidney donation, a survey was conducted whose results "suggested that only 15% of the transplant centers in the US would consider a non-directed living kidney donor (NDLD)."¹¹⁰� Today, however, "the willingness to consider NDLD is growing."¹¹¹��� The OPTN/SRTR Annual Report 2005 stated that "there was a general consensus that the growing number of living non-directed donors results from two factors: (1) increased public awareness of the organ donor shortage, and (2) a new willingness on the part of transplant centers and OPOs to participate in these cases."¹¹² In fact, one study noted that "a total of 24 of 25 (96%) of transplant centers and 23 of 25 (92%) of OPOs surveyed reported that they had received inquiries from people interested in serving as an NDLD."¹¹³ However, there is justified concern about the recent growth in non-directed living donation because "although non-directed living donation is growing, there are no unified policy guidelines agreed on and accepted by those organizations practicing (or planning to practice) NDLD."¹¹⁴

Another set of ethical questions relating to who donates involves potential disparities concerning the age and gender of living donors. In living donation, there has consistently been a disproportionate number of female living organ donors compared to males.¹¹⁵ In 2005, women constituted 59.1% of live organ donors.¹¹⁶� The underlying reasons for this significant disparity remain unexplained. A British medical journal concluded that "instead of congratulating women on their altruism, we need to ask about possible reasons for the gender imbalance and check it for matters of fairness and undue pressure on a vulnerable group."¹¹⁷�

The data also suggest that living organ donors are often younger than organ recipients. In 2004, 45.5% of living donors were between the ages of 35 and 49 years old, while the next highest percentage were those between the ages of 18 and 34 at 33.3%. By contrast, since 1998, the majority of organ transplants were received by those between 50 and 64 years old (41% in 2005) and those between 35 and 49 years old (27.75% in 2005), though the OPTN data does not distinguish between living donors vs. deceased donors as the source of these received organs. This leaves open an ethically significant question: Are we "using" the younger generation as organ suppliers for a growing elderly population?� And should the young put themselves even at minimal risk to help the generation above them?

APPENDIX 1

APPENDIX 2

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ENDNOTES

1. A 23-year old patient, Richard Herrick, was suffering and dying from chronic kidney failure; his identical twin brother, Ronald, agreed to donate one of his kidneys. Dr. Joseph Murray, a trained plastic surgeon who had become interested in transplants during World War II, performed the surgery at the Peter Bent Brigham Hospital (now Brigham and Women's Hospital) in Boston. The procedure lasted five and a half hours and was lauded a tremendous success. Ronald gave his brother eight more years of life by agreeing to be a living donor; more than fifty years later, he is still living and promoting organ donation.� In 1990, Dr. Murray won the Nobel Prize in Medicine for introducing organ transplantation to the world.

20. OPTN/UNOS Ad Hoc Living Donor Committee, Living Kidney Donor Evaluation Guidelines, http://www.unos.org/ContentDocuments/Living_Kidney_
Donor_Evaluation_Guidelines2(1).pdf#search=%22optn%2C%20
living%20kidney%20donor% 20evaluation%20guidelines%22 (accessed August 22, 2006).

117. Nikola Biller-Andorno, "Gender Imbalance in Living Organ Donation," Medicine, Health Care and Philosophy 5, no. 2 (2002): 199-204.