Organ donation is the donation of biological tissue or an organ of the human body, from a living or dead person to a living recipient in need of a transplantation. Transplantable organs and tissues are removed in a surgical procedure following a determination, based on the donor's medical and social history, of which are suitable for transplantation. Such procedures are termed allotransplantations, to distinguish them from xenotransplantation, the transfer of animal organs into human bodies. This is very uncommon but may be done.
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As recently as the late 1960s and early 1970s, irreversible cardiopulmonary failure was the only standard for determining death for purposes of donation after cardiac death.[1] This was replaced by brain death, the irreversible loss of all function, including the brain stem, though donation after cardiac death is a resurgent source for transplantation.[1]
The laws of different countries allow potential donors to permit or refuse donation, or give this choice to relatives. The frequency of donations varies among countries.
There are two main systems for voluntary systems: "opt in" (anyone who has not given consent is not a donor) and "opt out" (anyone who has not refused is a donor). In some systems like in Australia (13.8 donors per million, 309 donors in 2010), family members are required to give consent or refusal, or may veto a potential recovery even if the donor has consented. Opt-out legislative systems dramatically increase effective rates of consent for donation.[2] However, because of cultural and infrastructural factors, public policies and other factors, this does not translate directly into increased rates of donation.
Some countries with an opt-out system like Spain (34 donors per million inhabitants) or Austria (21 donors/million) have high donor rates and some countries with opt-in systems like Germany (16 donors/million) or Greece (six donors/million) have lower rates. However Sweden, which has an opt-out system, has a low rate as well (15 donors/million). The president of the Spanish National Transplant Organisation, has acknowledged Spain's legislative approach is likely not the primary reason for the country's success in increasing the donor rates, starting in the 1990s.[3]
Under the law of the United States, the regulation of organ donation is left to states within the limitations of the Uniform Determination of Death Act, the National Organ Transplant Act of 1984, and the United Network for Organ Sharing (UNOS). Each state's Uniform Anatomical Gift Act seeks to streamline the process and standardize the rules among the various states. Many states have sought to encourage the donations to be made by allowing the consent to be noted on the driver's license. Donor registries allow for a central information center for an individual's wish to be a donor. It is a pure consent system rather than an extended consent system or a dissent opt-out system.
Within the European Union, organ donation is regulated by member states. As of 2010, 24 European countries have some form of presumed consent (opt-out) system, with the most prominent and limited opt-out systems in Spain, Austria, and Belgium yielding high donor rates.[4] In the United Kingdom organ donation is voluntary and no consent is presumed. Individuals who wish to donate their organs after death can use the Organ Donation Register, a national database.[5] The UK has recently discussed whether to switch to an opt-out system in light of the success in other countries and a severe British organ donor shortfall.[6] In 2008, the European Parliament overwhelmingly voted for an initiative to introduce an EU organ donor card in order to foster organ donation in Europe.
Landstuhl Regional Medical Center (LRMC) has become one of the most active organ donor hospitals in all of Germany, which otherwise has one of the lowest organ donation participation rates in the Eurotransplant organ network. LRMC, the largest U.S. military hospital outside the United States, is one of the top hospitals for organ donation in the Rhineland-Palatinate state of Germany, even though it has relatively few beds compared to many German hospitals. According to the German organ transplantation organization, Deutsche Stiftung Organtransplantation (DSO), 34 American military service members who died at LRMC (roughly half of the total number who died there) donated a total of 142 organs between 2005 and 2010. In 2010 alone, 10 of the 12 American service members who died at LRMC were donors, donating a total of 45 organs. Of the 205 hospitals in the DSO’s central region—which includes the large cities of Frankfurt and Mainz—only six had more organ donors than LRMC in 2010.[7]
The rate of organ donation in Japan is significantly lower than in Western countries.[8] This is attributed to cultural reasons, some distrust of western medicine, and a controversial organ transplantation in 1968 that provoked a ban on cadaveric organ donation that would last thirty years.[8] Organ donation in Japan is regulated by a 1997 organ transplant law, which defines "brain death" and legalized organ procurement from brain dead donors.
Organ selling is legally banned in India. Numerous studies have documented that organ vendors have a poor quality of life (QOL) following kidney donation. Live related renal donors have a significant improvement in the QOL following renal donation using the WHO QOL BREF in a study done at the All India Institute of Medical Sciences from 2006 to 2008. The quality of life of the donor was poor when the graft was lost or the recipient died.[9]
Certain groups, like the Roma (gypsies), oppose organ donation on religious grounds, but most [10] of the world's religions support donation as a charitable act of great benefit to the community. Issues surrounding patient autonomy, living wills, and guardianship make it nearly impossible for involuntary organ donation to occur.
From the standpoint of deontological ethics, the primary issues surrounding the morality of organ donation are semantical in nature. The debate over the definitions of life, death, human, and body is ongoing. For example, whether or not a brain-dead patient ought to be kept artificially animate in order to preserve organs for procurement is an ongoing problem in clinical bioethics.
Further, the use of cloning to produce organs with an identical genotype to the recipient has issues all its own. Cloning is still a controversial topic, especially considering the possibility for an entire person to be brought into being with the express purpose of being destroyed for organ procurement. While the benefit of such a cloned organ would be a zero-percent chance of transplant rejection, the ethical issues involved with creating and killing a clone may outweigh these benefits. However, it may be possible in the future to use cloned stem-cells to grow a new organ without creating a new human being.
A relatively new field of transplantation has reinvigorated the debate. Xenotransplantation, or the transfer of animal (usually pig) organs into human bodies, promises to eliminate many of the ethical issues, while creating many of its own. While xenotransplantation promises to increase the supply of organs considerably, the threat of organ transplant rejection and the risk of xenozoonosis, coupled with general anathema to the idea, decreases the functionality of the technique. Some animal rights groups oppose the sacrifice of an animal for organ donation and have launched campaigns to ban them.
On teleological or utilitarian grounds, the moral status of "black market organ donation" relies upon the ends, rather than the means. In so far as those who donate organs are often impoverished and those who can afford black market organs are typically well-off, it would appear that there is an imbalance in the trade. In many cases, those in need of organs are put on waiting lists for legal organs for indeterminate lengths of time — many die while still on a waiting list
Organ donation is fast becoming an important bioethical issue from a social perspective as well. While most first-world nations have a legal system of oversight for organ transplantation, the fact remains that demand far outstrips supply. Consequently, there has arisen a black market trend often referred to as transplant tourism. The issues are weighty and controversial. On the one hand are those who contend that those who can afford to buy organs are exploiting those who are desperate enough to sell their organs. Many suggest this results in a growing inequality of status between the rich and the poor. On the other hand are those who contend that the desperate should be allowed to sell their organs and that preventing them from doing so is merely contributing to their status as impoverished. Further, those in favor of the trade hold that exploitation is morally preferable to death, and in so far as the choice lies between abstract notions of justice on the one hand and a dying person whose life could be saved on the other hand, the organ trade should be legalized. Conversely, surveys conducted among living donors postoperatively and in a period of five years following the procedure have shown extreme regret in a majority of the donors, who said that given the chance to repeat the procedure, they would not.[11] Additionally, many study participants reported a decided worsening of economic condition following the procedure.[12] These studies looked only at people who sold a kidney in countries where organ sales are already legal.
A consequence of the black market for organs has been a number of cases and suspected cases of organ theft[13][14] including murder for the purposes of organ theft.[15][16] Proponents of a legal market for organs say that the black-market nature of the current trade allows such tragedies and that regulation of the market could prevent them. Opponents say that such a market would encourage criminals by making it easier for them to claim that their stolen organs were legal.
Legalization of the organ trade carries with it its own sense of justice as well. Continuing black-market trade creates further disparity on the demand side: only the rich can afford such organs. Legalization of the international organ trade could lead to increased supply, lowering prices so that persons outside the wealthiest segments could afford such organs as well.
Exploitation arguments generally come from two main areas:
Economic drivers leading to increased donation are not limited to areas such as India and Africa, but also are emerging in the United States. Increasing funeral expenses combined with decreasing real value of investments such as homes and retirement savings which took place in the 2000s have purportedly led to an increase in citizens taking advantage of arrangements where funeral costs are reduced or eliminated.[22]
Brain death may result in legal death, but still with the heart beating, and with mechanical ventilation all other vital organs may be kept completely alive and functional,[23] providing optimal opportunities for organ transplantation.
Most organ donation for organ transplantation is done in the setting of brain death. In some nations (for instance, Belgium, Poland, Portugal and France) everyone is automatically an organ donor, although some jurisdictions (such as Singapore, Poland, France, or New Zealand) allow opting out of the system. Elsewhere, consent from family members or next-of-kin is required for organ donation. The non-living donor is kept on ventilator support until the organs have been surgically removed. If a brain-dead individual is not an organ donor, ventilator and drug support is discontinued and cardiac death is allowed to occur.
| “ | In order to be dead enough to bury but alive enough to be a donor, you must be irreversibly brain dead. If it’s reversible, you’re no longer dead; you’re a patient. And once you start messing around with this definition, you’re on a slippery slope, and the question then becomes: How dead do you want patients to be before you start taking their organs? | ” |
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—David Crippen, M.D., a critical care specialist at the University of Pittsburgh Medical Center[1] |
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In the United States, where since the 1980s the Uniform Determination of Death Act has defined death as the irreversible cessation of the function of either the brain or the heart and lungs,[1] the 21st century has seen an order-of-magnitude increase of donation following cardiac death. In 1995, only one out of 100 dead donors in the nation gave their organs following the declaration of cardiac death. That figure grew to almost 11 percent in 2008, according to the Scientific Registry of Transplant Recipients.[1] That increase has provoked ethical concerns about the interpretation of "irreversible" since "patients may still be alive five or even 10 minutes after cardiac arrest because, theoretically, their hearts could be restarted, [and thus are] clearly not dead because their condition was reversible."[1]
There are also controversial issues regarding how organs are allocated to recipients. For example, some believe that livers should not be given to alcoholics in danger of reversion, while others view alcoholism as a medical condition like diabetes.
Faith in the medical system is important to the success of organ donation. Brazil switched to an opt-out system and ultimately had to withdraw it because it further alienated patients who already distrusted the country's medical system.[24]
Adequate funding, strong political will to see transplant outcomes improve, and the existence of specialized training, care and facilities also increase donation rates. Expansive legal definitions of death, such as Spain uses, also increase the pool of eligible donors by allowing physicians to declare a patient to be dead at an earlier stage, when the organs are still in good physical condition.
Allowing or forbidding payment for organs affects the availability of organs. Generally, where organs can not be bought or sold, quality and safety are high, but supply is not adequate to the demand. Where organs can be purchased, the supply increase somewhat, but safety declines, as families and living donors have an incentive to conceal unfavorable information.
Healthy humans have two kidneys, a redundancy that enables living donors (inter vivos) to give a kidney to someone who needs it. The most common transplants are to close relatives, but people have given kidneys to other friends. The rarest type of donation is the undirected donation whereby a donor gives a kidney to a stranger. Less than a few hundred of such kidney donations have been performed. In recent years, searching for altruistic donors via the internet has also become a way to find life saving organs. However, internet advertising for organs is a highly controversial practice, as some scholars believe it undermines the traditional list-based allocation system.[25]
The National Transplant Organization of Spain is one of the most successful in the world, but it still can't meet the demand, as 10% of those needing a transplant die while still on the transplant list.[26] Donations from corpses are anonymous, and a network for communication and transport allows fast extraction and transplant across the country. Under Spanish law, every corpse can provide organs unless the deceased person had expressly rejected it. Because family members still can forbid the donation,[27] carefully trained doctors ask the family for permission, making it very similar in practice to the United States system.[28]
In the overwhelming majority of cases, organ donation is not possible for reasons of recipient safety, match failures, or organ condition. Even in Spain, which has the highest organ donation rate in the world, there are only 35.1 actual donors per million people, and there are hundreds of patients on the waiting list.[24] This rate compares to 24.8 per million in Austria, where families are rarely asked to donate organs, and 22.2 per million in France, which—like Spain—has a presumed-consent system.
In the United States, prisoners are not discriminated against as organ recipients and are equally eligible for organ transplants along with the general population. A 1976 U.S. Supreme Court case ruled that withholding health care from prisoners constituted "cruel and unusual punishment". United Network for Organ Sharing, the organization that coordinates available organs with recipients, does not factor a patient’s prison status when determining suitability for a transplant.[29][30] An organ transplant and followup care can cost the prison system up to one million dollars.[30][31] If a prisoner qualifies, a state will allow compassionate early release to avoid high costs associated with organ transplants.[30]
Because donor organs are in short supply, there are more people waiting for a transplant than available organs. When a prisoner receives an organ, there is a high probability that someone else will die waiting for the next available organ. A response to this ethical dilemma states that felons who have a history of violent crime, who have violated others’ basic rights, have lost the right to receive an organ transplant, though it is noted that it would be necessary "to reform our justice system to minimize the chance of an innocent person being wrongly convicted of a violent crime and thus being denied an organ transplant" [32]
A South Carolina proposal to shorten prisoners’ sentences in exchange for bone marrow and kidney transplants was proposed as a solution to organ shortages. The idea is criticized by physicians and ethicists because a prisoner is not able to consent to the procedure in a free and non-coercive environment.[33] A program started by Maricopa County Sheriff Joe Arpaio encourages inmates of the Arizona state prison system to voluntarily sign up to donate their heart and other organs.[34]
All major religions accept organ donation in at least some form on either utilitarian grounds (i.e., because of its life-saving capabilities) or deontological grounds (e.g., the right of an individual believer to make his or her own decision). Most religions, among them the Roman Catholic Church, support organ donation on the grounds that it constitutes an act of charity and provides a means of saving a life, although certain bodies, such as the pope's, are not to be used.[35] Some religions impose certain restrictions on the types of organs that may be donated and/or on the means by which organs may be harvested and/or transplanted.[36] For example, Jehovah's Witnesses require that organs be drained of any blood due to their interpretation of the Hebrew Bible/Christian Old Testament as prohibiting blood transfusion,[37] and Muslims require that the donor have provided written consent in advance.[37] A few groups disfavor organ transplantation or donation; notably, these include Shinto[38] and those who follow the customs of the Gypsies.[37]
Orthodox Judaism considers organ donation obligatory if it will save a life, as long as the donor is considered dead as defined by Jewish law.[37] In both Orthodox Judaism and non-Orthodox Judaism, the majority view holds that organ donation is permitted in the case of irreversible cardiac rhythm cessation. In some cases, rabbinic authorities believe that organ donation may be mandatory, whereas a minority opinion considers any donation of a live organ as forbidden.[39]
The demand for organs significantly surpasses the number of donors everywhere in the world. There are more potential recipients on organ donation waiting lists than organ donors. In particular, due to significant advances in dialysis techniques, patients suffering from end-stage renal disease (ESRD) can survive longer than ever before. Because these patients don't die as quickly as they used to, and as kidney failure increases with the rising age and prevalence of high blood pressure and diabetes in a society, the need especially for kidneys rises every year.
In the United States, about 108,000 people are on the waiting list,[40] although about a third of those patients are inactive and could not receive a donated organ.[41] Wait times and success rates for organs differ significantly between organs due to demand and procedure difficulty. Three-quarters of patients in need of an organ transplant are waiting for a kidney,[42] and as such kidneys have much longer waiting times. At the Oregon Health and Science University, for example, the median patient who ultimately received an organ waited only three weeks for a heart and three months for a pancreas or liver — but 15 months for a kidney, because demand for kidneys substantially outstrips supply.[43]
In Australia, there are 10.8 transplants per million people,[44] about a third of the Spanish rate. The Lions Eye Institute, in Western Australia, houses the Lions Eye Bank. The Bank was established in 1986 and coordinates the collection, processing and distribution of eye tissue for transplantation. The Lions Eye Bank also maintains a waitlist of patients who require corneal graft operations. About 100 corneas are provided by the Bank for transplant each year, but there is still a waiting list for corneas.[45]
"To an economist, this is a basic supply-and-demand gap with tragic consequences."[46] Approaches to addressing this shortfall include:
In hospitals, organ network representatives routinely screen patient records to identify potential donors shortly in advance of their deaths.[54] In many cases, organ-procurement representatives will request screening tests (such as blood typing) or organ-preserving drugs (such as blood pressure drugs) to keep potential donors' organs viable until their suitability for transplants can be determined and family consent (if needed) can be obtained.[54] This practice increases transplant efficiency, as potential donors who are unsuitable due to infection or other causes are removed from consideration before their deaths, and decreases the avoidable loss of organs.[54] It may also benefit families indirectly, as the families of unsuitable donors are not approached to discuss organ donation.[54]
The Center for Ethical Solutions, an American bioethics think tank, is currently working on a project called "Solving the Organ Shortage," in which it is studying the Iranian kidney procurement system in order to better inform the debate over solving the organ shortfall in the United States.[55]
The United States has two agencies that govern organ procurement and distribution within the country. The United Network for Organ Sharing and the Organ Procurement and Transplant Network (OPTN) regulate Organ Procurement Organizations (OPO) with regard to procurement and distribution ethics and standards. OPOs are non-profit organizations charged with the evaluation, procurement and allocation of organs whithin their Designated Service Area (DSA). Once a donor has been evaluated and consent obtained, provisional allocation of organs commences. UNOS developed a computer program that automatically generates donor specific match lists for suitable recipients based on the criteria that the patient was listed with. OPO coordinators enter donor information into the program and run the respective lists. Organ offers to potential recipients are made to transplant centers to make them aware of a potential organ. The surgeon will evaluate the donor information and make a provisional determination of medical suitability to their recipient. Distribution varies slightly between different organs but is essentially very similar. When lists are generated many factors are taken into consideration; these factors include: distance of transplant center from the donor hospital, blood type, medical urgency, wait time, donor size and tissue typing. For heart recipients medical urgency is denoted by a recipients "Status" (Status 1A, 1B and status 2). Lungs are allocated based on a recipients Lung Allocation Score (LAS) that is determined based on urgency and wait time. Livers are allocated using both a status system and MELD/PELD score (Model for End-stage Liver Disease/Pediatric End-stage Liver Disease). Kidney and pancreas lists are based on location, blood type, Human Leukocyte Antigen (HLA) typing and wait time. When a recipient for a kidney or pancreas has no direct antibodies to the donor HLA the match is said to be a 0 ABDR mismatch or zero antigen mismatch. A zero mismatch organ has a low rate of rejection and allows a recipient to be on lower doses of immunosuppressive drugs. Since zero mismatches have such high graft survival these recipients are afforded priority regardless of location and wait time. UNOS has in place a "Payback" system to balance organs that are sent out of a DSA because of a zero mismatch.
Location of a transplant center with respect to a donor hospital is given priority due to the effects of Cold Ischemic Time (CIT). Once the organ is removed from the donor, blood no longer perfuses through the vessels and begins to starve the cells of oxygen (ischemia). Each organ tolerates different ischemic times. Hearts and lungs need to be transplanted within 4–6 hours from recovery, liver about 8–10 hours and pancreas about 15 hours; kidneys are the most resilient to ischemia. Kidneys packaged on ice can be successfully transplanted 24–36 hours after recovery. Developments in kidney preservation have yielded a device that pumps cold preservation solution through the kidneys vessels to prevent Delayed Graft Function (DGF) due to ischemia. Perfusion devices, often called kidney pumps, can extend graft survival to 36–48 hours post recovery for kidneys. Research and development is currently underway for heart and lung preservation devices, in an effort to increase distances procurement teams may travel to recover an organ.
People committing suicide have a higher rate of donating organs than average. One reason is lower negative response or refusal rate by the family and relatives, but the explanation for this remains to be clarified.[56] In addition, donation consent is higher than average from people committing suicide.[57]
Attempted suicide is a common cause of brain death (3.8%), mainly among young men.[56] Organ donation is more common in this group compared to other causes of death. Brain death may result in legal death, but still with the heart beating, and with mechanical ventilation all other vital organs may be kept completely alive and functional,[23] providing optimal opportunities for organ transplantation.
In 2008, California transplant surgeon Hootan Roozrokh was charged with dependent adult abuse for prescribing what prosecutors said were excessive doses of morphine and sedatives to hasten the death of a man with adrenal leukodystrophy and irreversible brain damage, in order to procure his organs for transplant.[58] The case brought against Roozrokh was the first criminal case against a transplant surgeon in the US, and resulted in his acquittal.
At California's Emanuel Medical Center, neurologist Narges Pazouki, MD, said an organ-procurement organization representative pressed her to declare a patient brain-dead before the appropriate tests had been done.[54] She refused.
In September 1999, eBay blocked an auction for “one functional human kidney” which had reached a highest bid of $5.7 million. Under United States federal laws, eBay was obligated to dismiss the auction for the selling of human organs which is punishable by up to five years in prison and a $50,000 fine.[59]
On June 27, 2008, Indonesian, Sulaiman Damanik, 26, pleaded guilty in a Singapore court for sale of his kidney to CK Tang's executive chair, Mr. Tang Wee Sung, 55, for 150 million rupiah (US$ 17,000). The Transplant Ethics Committee must approve living donor kidney transplants. Organ trading is banned in Singapore and in many other countries to prevent the exploitation of "poor and socially disadvantaged donors who are unable to make informed choices and suffer potential medical risks." Toni, 27, the other accused, donated a kidney to an Indonesian patient in March, alleging he was the patient's adopted son, and was paid 186 million rupiah (US$ 21,000).
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