II. ETHICAL AND LEGAL ISSUES REGARDING LIVING DONORS

History and Background

As the number of suitable cadaver organs available for transplantation has leveled off in the last decade, the use of living donors has become increasingly important. However, the history of living donors goes back to the earliest successes in transplantation. In 1954 Dr. Joseph E. Murray performed the first successful organ transplantation at Peter Bent Brigham Hospital in Boston by transplanting a healthy kidney from twenty-three year-old Ronald Herrick into his identical twin brother Richard—thus proving the viability of soild organ transplantation. While the histories of other types of transplantation primarily consist of cadaver donors, a shortage of organs as well as improved results have led to the use of living donors for kidney, lung, liver, pancreas, and small-bowel transplantations.

The first kidney transplantation surgeries were successful because there were no immunological barriers—the organs came from identical twins. Once transplantation was proven possible, research increasingly focused on overcoming immunological barriers that cause organ rejection. Success came in the early 1960s with the immunosuppressive agent azathioprine. "Its use in combination with chronic corticosteroid therapy provided the first effective means for preventing immune-mediated destruction of allografts in clinical transplantation" (Woodle, p. 902). Improved results throughout the 1970s led to an increasing shift to cadaver sources. Living donors were still used in this period, but until the early 1980s surgeons restricted living organ donations to kidneys and usually required the donor to be a parent, sibling, or child of the recipient (Fox and Swazey). Further success came in 1979 when results from trials at Peter Bent Brigham Hospital and the University of Colorado showed that cyclosporine combined with steroids controlled rejection better than any past drug therapy. By 1983 the FDA released cyclosporine for general use, increasing graft survival by 30 percent or more. Due to increasing public education throughout the 1980s, the number of cadaver organs available for transplantation continued to grow. This in conjunction with the increasing success of immunosuppressive agents led to an increased use of cadaveric kidneys; due to advances in immunosuppression there was no need for a genetic match. Outcome data were still better for living transplants than cadaver, but many speculated that the need for living organ donors would continue to diminish. In 1985 Thomas Starzl, a pioneering transplant surgeon, argued that advances in cadaver transplant would challenge the morality of living organ donations.

By the early 1990s the number of suitable cadaver donor organs leveled off and waiting lists grew, leading to a renewed interest in living organs. Other types of living organ transplantation became increasingly more successful. The first successful living related liver transplantation in the United States took place in 1989. At first the recipients were typically infants receiving a lobe from a parent. But transplantation between adults has been increasingly successful; the first successful adult living liver transplantation was reported in Japan in 1994 and the first in the United States occurred in 1998. Adult to adult transplantation is technically more difficult than the pediatric procedure and the risk to the donor is far greater than a kidney donation. The death in January 2002 of Mike Hurewitz, who donated a portion of his liver to his brother at Mt. Sinai Hospital in New York, has increased safety concerns. The New York State Department of Health shut down the hospital's transplant program, one of the largest in the country, for six months. An investigation found no fault with the surgery, only with post-surgical care. Living donors for liver transplantation are almost always genetically or emotionally related to the recipient; so-called Good Samaritan or nondirected donations are very rare. UNOS reports that out of 5,327 liver transplants in 2002 only 359 were from living donors.

The first successful living lung transplantation took place at Stanford University in October 1990. In living lung donation a pair of adult donors each donate one lobe (left or right) to one recipient. The number of such transplantations is still quite low. In 2002 only 13 living donor lung transplants were reported in the United States (UNOS). Other living donor transplantations also include the pancreas and small-bowel. Because there is no shortage of cadaveric sources for either organ, living donor transplants are rare, but increasing due to better patient outcomes (Margrieter). Living donor pancreas transplantation is increasingly being supplanted by islet cell transplants.

Drug therapies continue to improve, and since the number of cadaveric organs remains fixed and there is a growing gap between the available supply and demand of organs and tissue, living donation increases. New technologies such as laparoscopic live-donor nephrectomy first performed in 1995 have made it less burdensome to be a living kidney donor. According to UNOS data, between 1999 and 2000 living donor kidney transplants increased 16.5 percent. In 2001, of the 24,076 organ transplantations performed in the United States, more than 6,507 were living donor transplantations. In 2000 UNOS began pilot testing "paired exchange" and "list-paired exchange" programs that provide further incentives for living donations. Transplant centers increasingly accept Good Samaritan or nondirected living kidney donors (Matas et al.).

Ethical, Legal and Policy Issues

ETHICAL ISSUES. While living organ donors were initially limited to blood relatives to reduce the risk of immune rejection, improved immunotherapy has expanded the pool of potential donors far outside of those related by blood, to those who are emotionally related to each other. This has resulted in expanding the notion of "relatedness" to include people related by marriage (spouses and in-laws) as well as those who are not traditionally considered relatives—friends, co-workers, members of the same church or other community group, and even those with very limited emotional ties, such as so-called Good Samaritans. With this extension of the concept of living donation, it became a logical and relatively short step from tangentially related directed living organ donors to organ donations from altruistic strangers.

How far should living donation be allowed to go? Is informed consent sufficient to justify any living donation to which a prospective donor would voluntarily consent? In other areas of medicine, and clinical research, there are limits to the risk to which healthy people—related or not—should be allowed to consent. For many, increasing risk to the donor tilts the balance away from being acceptable, meaning that at very high levels of risk, no living donor should be allowed to undertake organ donation.

One of the concerns in nondirected or Good Samaritan living donation is that strangers should not be allowed to accept the same level of risk as related donors. The argument is that relatedness matters, such that related donors have more to gain from the donation and so can be allowed to accept greater risk. The justification is that seeing a loved one's life saved or health improved is a greater benefit than the psychological benefit to a stranger of performing an altruistic act. But one can also argue that both types of donors stand to realize substantial benefits, albeit of different varieties, and that it should be up the individuals to determine whether the benefits are sufficient to justify taking the associated risks.

Some thinkers have argued that intimates may actually have an obligation to be a living organ donor (Ross), but this would seem to create a duty of heroism. There is a history of courts refusing to require beneficent acts on the part of individuals, even if they would be lifesaving (McFall v. Shimp, 1978). In moral philosophy, this is the distinction between actions that are obligatory and those that are supererogatory. We laud people to perform acts that are "above and beyond the call of duty," but do not require such acts of them—to do so would create a duty of heroism, demanding too much of individuals in the process and undermining the value of what it means to be truly heroic. That being said, we may think it is more understandable, and even expected, for relatives to donate an organ to someone within their family, which raises its own ethical concerns. The most important problem is pressure within the family to donate and the effect it can have on decision making—undermining effective informed consent, which must be a mainstay of any living organ donation (The Authors for the Live Organ Donor Consensus Group). Many transplant centers go so far as to offer prospective donors false medical excuses so they do not need to tell their family member that they are unwilling to donate (ibid).

LAW AND POLICY. Specific laws covering living organ and tissue donors vary greatly between countries. In the United States the chief law addressing organ donation is the National Organ Transplant Act of 1984 (NOTA). NOTA established the Organ Procurement and Transplantation Network (OPTN), which is responsible for maintaining a national registry for organ matching, increasing the "effectiveness and efficiency of organ sharing and equity in the national system of organ allocation," and increasing the "supply of donated organs available for transplantation." The United Network for Organ Sharing (UNOS) administers the OPTN under government contract. The OPTN does not oversee living donor transplantation. However, UNOS collects data about living donor transplants in the United States and develops and recommends policies covering a range of issues including living donors. Living donation is handled by the center or hospital performing the transplantation and Medicare dictates the only organ transplantation regulations. A hospital or transplant center can opt to ignore these regulations, but will be ineligible for Medicare reimbursements.

A number of international organizations have adopted policies on human organ transplantation that include specific guidelines for living donors. For example, the World Health Organization's (WHO) "Guiding Principles on Human Organ Transplantation" states:

Organs for transplantation should be removed preferably from the bodies of deceased persons. However, adult living persons may donate organs, but in general such donors should be genetically related to the recipients. Exceptions may be made in the case of transplantation of bone marrow and other acceptable regenerative tissues. An organ may be removed from the body of an adult living donor for the purpose of transplantation if the donor gives free consent. The donor should be free of any undue influence and pressure and sufficiently informed to be able to understand and weigh the risks, benefits and consequences of consent.

In addition, "The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited" (WHO). The World Medical Association's "Statement on Human Organ and Tissue Donation and Transplantation" also states that "In the case of living donors, special efforts should be made to ensure that the choice about donation is free of coercion" and persons incapable of making informed decisions should be donors in only "very limited circumstances." The Live Organ Donor Consensus Group argues that a living donor should be competent, willing, and free of coercion as well as medically suitable and psycho socially suitable (The Authors for the Live Organ Donor Consensus Group). Living donor qualifications usually include good general health, physically fit, free from high blood pressure, diabetes, cancer, kidney, and heart disease.

Donation by Minors

The early case law in the United States focuses on minors or persons incapable of consenting to being living kidney donors. In 1957 the Massachusetts Supreme Court ruled in Masden v. Harrison that the 19-year-old twin brother Leonard Masden could be a living kidney donor to his brother Leon. Based on the testimony of a psychiatrist who had interviewed both brothers, the court recognized that although the operation had no therapeutic value to Leonard, it had a compelling psychological value. The death of his brother would have "grave emotional impact" on Leonard. While the NOTA does not specifically address the use of minors as donors, many countries have legislation specifically addressing this issue. For example, Spain, Greece, and the Russian Federation prohibit the removal of organs from minors, although many make exceptions for bone marrow donation to a family member. In France donation is restricted to first-degree relatives. The Live Organ Donor Consensus Group was generally opposed to the use of a minor, but recognized that there may be exceptional circumstances. When the donor is mentally retarded or ill, courts have often concluded that the donor would benefit emotionally or psychologically.

Financial Incentives

Title III of the NOTA prohibits the purchase of organs: "It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce" (NOTA Sec. 301 [a]; emphasis added). Violators are subject to a fine up to $50,000 and/or up to five years in prison. According to the statute, "The term 'valuable consideration' does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ donor in connection with the donation of the organ" (NOTA Sec. 301 [a]). The Department of Justice is responsible for enforcing this prohibition, but there have been few public cases. There remains great confusion over how valuable consideration should be interpreted and understood. For example, a Pennsylvania plan to offer donor families $300 towards funeral expenses was replaced out of fear that it came to close to violating NOTA. Its replacement, the Expense Benefit Plan for Organ Donors and Their Families offers a $300 benefit per organ donor to pay for food and lodging costs.

There are reports of an increasing worldwide black market in human organs and there are few policy approaches to addressing it. For example, federal law does not prevent people from re-entering the United States after transplantation.

Health insurance coverage varies. If the recipient is covered by Medicare's end-stage renal disease program, Medicare covers the donor's expenses. The Organ Donor Leave Act of 1999 provides 30 days of paid leave for federal employees who are living donors for transplantations. A handful of states have passed similar laws. There have been some movements to provide donor insurance to cover the medical risk of donation.

Exchange Programs

The goal of exchange programs is to increase the supply of kidneys available for transplant to overcome problems of ABO and cross-match incompatibilities. In paired exchange, two living donors, who are mismatched donors for their intended recipient, effectively swap kidneys. In list-paired exchanges, a living donor donates a kidney to the general pool. In return, the intended (but mismatched) recipient advances on the waiting list for a cadaveric kidney. In 2001 Tufts-New England Medical Center launched the first exchange program, indicating it was approved by UNOS. But it is unclear what authority UNOS has over such programs. UNOS' general counsel argues that Section 301 does not apply to exchange programs, but others have expressed concerns over the meaning of "valuable consideration."

Distribution of Nondirected Donations

In recent years transplant centers have begun considering nondirected kidney donations by community members. A National Conference on the Nondirected Live Organ Donor advocates caution and suggest a framework for institutions that are considering accepting nondirected kidney donations. The conference document recommends ethical and practice guidelines. Some question how nondirected donations should be distributed. Should they remain at the transplant center first solicited, or should they enter the general pool? There is general agreement that donors cannot request that certain demographic groups do or do not receive their donation. There have been recent calls for a national system to be developed so that organs from nondirected donors can go to the first patient on a national list rather than to the first patient at the center where the organ is donated. Such an approach has been developed on a local basis by the consortium of transplant centers in the Washington, D.C. area, and may serve as a model for national expansion.

Conclusion

The growing gap between the available supply and the demand for solid organs means that the search will continue for new sources of organs. We can all agree that living donation is a growing source of solid organs, as evidenced by the fact that the number of transplanted kidneys from living donors has surpassed the number from cadaveric donors at some of the leading transplant centers in the United States. The question is not whether living organ donation will continue, but rather what conditions and policies ought to apply to make it ethically acceptable.

jeffrey kahn

susan parry

SEE ALSO: Beneficence; Bioethics, African-American Perspectives; Cybernetics; Death, Definition and Determination of; Dialysis, Kidney; Healthcare Resources, Allocation of; Informed Consent; Medical Futility; Medicare; Mistakes, Medical; Obligation and Supererogation; Organ Transplants, Medical Overview of; Organ Transplants, Sociocultural Aspects of; Technology;Xenografts; and other Organ and Tissue Procurement subentries

BIBLIOGRAPHY

The Authors for the Live Organ Donor Consensus Group. 2000. "Consensus Statement on the Live Organ Donor." Journal of the American Medical Association 284: 2919–2926.

Fox, Renée C., and Swazey, Judith P. 1992. Spare Parts: Organ Replacement in American Society. New York: Oxford University Press.

Margreiter, Raimund. 1999. "Living-Donor Pancreas and Small-Bowel Transplantation." Langenbeck's Archives of Surgery 384: 544–549.

Matas, Arthur J.; Garvey, Catherine A.; Jacobs, Cheryl L.; Kahn, Jeffrey P. 2000. "Nondirected Donation of Kidneys from Living Donors." New England Journal of Medicine 343: 433–436.

McFall v. Shimp. 10 Pa. D. & C.3d 90. Allegheny County Ct. (1978).

National Organ Transplant Act. Public Law No. 98–507 (1984).

Organ Donor Leave Act. H.R. 457, Pub Law No. 106–56 (Sept. 24, 1999).

Ross, Lainie F.; Rubin, David T.; Siegler, Mark; et al. 1997. "Ethics of a Paired-Kidney-Exchange Program." New England Journal of Medicine 336: 1752–1755.

World Health Organization. 1991. "Guiding Principles on Human Organ Transplantation." Geneva, World Health Organization.

World Medical Organization. 2000. "Statement on Human Organ and Tissue Donation and Transplantation." Adopted by the 52nd WMA General Assembly in Edinburgh, Scotland.

Woodle, E. Steve. 2003. "A History of Living Donor Transplantation: From Twins to Trades." Transplantation Proceedings 35: 901–902.

INTERNET RESOURCES

Ritsch, Malcolm E., Jr. 2003. "Intended Recipient Exchanges, Paired Exchanges and NOTA § 301." Available from <http://www.unos.org/news/newsDetail.asp?id=265>.

United Network for Organ Sharing. 2003. "Transplants by Donor Type." Available from <http://www.optn.org/latestData/rptData.asp>.