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 | The examples and perspective in this article deal primarily with the United States and do not represent a worldwide view of the subject. (June 2022) |
Organ donation is the process when a person authorizes an organ of their own to be removed and transplanted to another person, legally, either by consent while the donor is alive, through a legal authorization for deceased donation made prior to death, or for deceased donations through the authorization by the legal next of kin.
Donation may be for research or, more commonly, healthy transplantable organs and tissues may be donated to be transplanted into another person.[1][2]
Common transplantations include kidneys, heart, liver, pancreas, intestines, lungs, bones, bone marrow, skin, and corneas.[1] Some organs and tissues can be donated by living donors, such as a kidney or part of the liver, part of the pancreas, part of the lungs or part of the intestines,[3] but most donations occur after the donor has died.[1]
In 2019, Spain had the highest donor rate in the world at 46.91 per million people, followed by the US (36.88 per million), Croatia (34.63 per million), Portugal (33.8 per million), and France (33.25 per million).[4]
As of February 2, 2019, there were 120,000 people waiting for life-saving organ transplants in the US.[5] Of these, 74,897 people were active candidates waiting for a donor.[5] While views of organ donation are positive, there is a large gap between the numbers of registered donors compared to those awaiting organ donations on a global level.[6]
To increase the number of organ donors, especially among underrepresented populations, current approaches include the use of optimized social network interventions, exposing tailored educational content about organ donation to target social media users.[7] Every year August 13 is observed as World Organ Donation Day to raising awareness about the importance of organ donation.[8]
Process in the United States
Organ donors are usually dead at the time of donation, but may be living. For living donors, organ donation typically involves extensive testing before the donation, including psychological evaluation to determine whether the would-be donor understands and consents to the donation. On the day of the donation, the donor and the recipient arrive at the hospital, just like they would for any other major surgery.[9]
For dead donors, the process begins with verifying that the person is undoubtedly deceased, determining whether any organs could be donated, and obtaining consent for the donation of any usable organs. Normally, nothing is done until the person has already died, although if death is inevitable, it is possible to check for consent and to do some simple medical tests shortly beforehand, to help find a matching recipient.[9]
The verification of death is normally done by a neurologist (a physician specializing in brain function) that is not involved in the previous attempts to save the patient's life. This physician has nothing to do with the transplantation process.[9] Verification of death is often done multiple times, to prevent doctors from overlooking any remaining sign of life, however small.[10] After death, the hospital may keep the body on a mechanical ventilator and use other methods to keep the organs in good condition.[10] The donor's estate and their families are not charged for any expenses related to the donation.
The surgical process depends upon which organs are being donated. The body is normally restored to as normal an appearance as possible, so that the family can proceed with funeral rites and either cremation or burial.
The lungs are highly vulnerable to injury and thus the most difficult to preserve, with only 15–25% of donated organs utilized.[11]
History
The first living organ donor in a successful transplant was Ronald Lee Herrick (1931–2010), who donated a kidney to his identical twin brother Richard (1931–1963) in 1954.[12] The lead surgeon, Joseph Murray, and the nephrologist, John Merrill, won the Nobel Prize in Physiology or Medicine in 1990 for advances in organ transplantation.
The youngest organ donor was a baby with anencephaly, born in 2014, who lived for only 100 minutes and donated his kidneys to an adult with renal failure.[13] The oldest known cornea donor was a 107-year-old Scottish woman, whose corneas were donated after her death in 2016.[14] The oldest known organ donor for an internal organ was a 98-year-old southern Missouri man, who donated his liver after he died.[15]
The oldest altruistic living organ donor was an 85-year-old woman in Britain, who donated a kidney to a stranger in 2014 after hearing how many people needed to receive a transplant.[16]
Researchers were able to develop a novel way to transplant human fetal kidneys into anephric rats to overcome a significant obstacle in impeding human fetal organ transplantations.[17] The human fetal kidneys demonstrated both growth and function within the rats.[17]
Brain donation
Donated brain tissue is a valuable resource for research into brain function, neurodiversity, neuropathology and possible treatments. Both divergent and healthy control brains are needed for comparison.[18] Brain banks typically source tissue from donors that had directly registered with them before their passing,[19] since organ donor registries focus on tissue meant for transplantation. In the United States the nonprofit Brain Donor Project facilitates this process.[20][21]
Legislation and global perspectives
 | This article needs to be updated. (December 2020) |
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.
Consent process
The term consent is typically defined as a subject adhering to an agreement of principles and regulations; however, the definition becomes difficult to execute concerning the topic of organ donation, mainly because the subject is incapable of consent due to death or mental impairment.[22] There are two types of consent being reviewed; explicit consent and presumed consent. Explicit consent consists of the donor giving direct consent through proper registration depending on the country.[23] The second consent process is presumed consent, which does not need direct consent from the donor or the next of kin.[23] Presumed consent assumes that donation would have been permitted by the potential donor if permission was pursued.[23] Of possible donors an estimated twenty-five percent of families refuse to donate a loved one's organs.[24]
Opt-in versus opt-out
As medical science advances, the number of people who could be helped by organ donors increases continuously. As opportunities to save lives increase with new technologies and procedures, the demand for organ donors rises faster than the actual number of donors.[25] In order to respect individual autonomy, voluntary consent must be determined for the individual's disposition of their remains following death.[26] There are two main methods for determining voluntary consent: "opt in" (only those who have given explicit consent are donors) and "opt out" (anyone who has not refused consent to donate is a donor). In terms of an opt-out or presumed consent system, it is assumed that individuals do intend to donate their organs to medical use when they expire.[26] Opt-out legislative systems dramatically increase effective rates of consent for donation as a consequence of the default effect.[27] For example, Germany, which uses an opt-in system, has an organ donation consent rate of 12% among its population, while Austria, a country with a very similar culture and economic development, but which uses an opt-out system, has a consent rate of 99.98%.[27][28]
Opt-out consent, otherwise known as "deemed" consent, support refers to the notion that the majority of people support organ donation, but only a small percentage of the population are actually registered, because they fail to go through the actual step of registration, even if they want to donate their organs at the time of death. This could be resolved with an opt-out system, where many more people would be registered as donors when only those who object consent to donation have to register to be on the non-donation list.[26]
For these reasons, countries, such as Wales, have adopted a "soft opt-out" consent, meaning if a citizen has not clearly made a decision to register, then they will be treated as a registered citizen and participate in the organ donation process. Likewise, opt-in consent refers to the consent process of only those who are registered to participate in organ donation. Currently, the United States has an opt-in system, but studies show that countries with an opt-out system save more lives due to more availability of donated organs. The current opt-in consent policy assumes that individuals are not willing to become organ donors at the time of their death, unless they have documented otherwise through organ donation registration.[26]
Registering to become an organ donor heavily depends on the attitude of the individual; those with a positive outlook might feel a sense of altruism towards organ donation, while others may have a more negative perspective, such as not trusting doctors to work as hard to save the lives of registered organ donors. Some common concerns regarding a presumed consent ("opt-out") system are sociologic fears of a new system, moral objection, sentimentality, and worries of the management of the objection registry for those who do decide to opt-out of donation.[26] Additional concerns exist with views of compromising the freedom of choice to donate,[29] conflicts with extant religious beliefs[30] and the possibility of posthumous violations of bodily integrity.[31] Even though concerns exist, the United States still has a 95 percent organ donation approval rate. This level of nationwide acceptance may foster an environment where moving to a policy of presumed consent may help solve some of the organ shortage problem, where individuals are assumed to be willing organ donors unless they document a desire to "opt-out", which must be respected.[30]
Because of public policies, cultural, infrastructural and other factors, presumed consent or opt-out models do not always translate directly into increased effective rates of donation. The United Kingdom has several different laws and policies for the organ donation process, such as consent of a witness or guardian must be provided to participate in organ donation. This policy was consulted on by Department of Health and Social Care in 2018,[32] and was implemented starting 20 May 2020.[33]
In terms of effective organ donations, in some systems like Australia (14.9 donors per million, 337 donors in 2011), family members are required to give consent or refusal, or may veto a potential recovery even if the donor has consented.[34] Some countries with an opt-out system like Spain (40.2 donors per million inhabitants),[35] Croatia (40.2 donors/million)[35] or Belgium (31.6 donors/million)[35] have high donor rates, however some countries such as Greece (6 donors/million) maintain low donor rates even with this system.[36] 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.[37]
Looking to the example of Spain, which has successfully adopted the presumed consent donation system, intensive care units (ICUs) must be equipped with enough doctors to maximize the recognition of potential donors and maintain organs while families are consulted for donation. The characteristic that enables the Spanish presumed consent model to be successful is the resource of transplant coordinators; it is recommended to have at least one at each hospital where opt-out donation is practiced to authorize organ procurement efficiently.[38]
Public views are crucial to the success of opt-out or presumed consent donation systems. In a study done to determine if health policy change to a presumed consent or opt-out system would help to increase donors, an increase of 20 to 30 percent was seen among countries who changed their policies from some type of opt-in system to an opt-out system. Of course, this increase must have a great deal to do with the health policy change, but also may be influenced by other factors that could have impacted donor increases.[39]
Transplant Priority for Willing Donors, also known as the "donor-priority rule", is a newer method and the first to incorporate a "non-medical" criterion into the priority system to encourage higher donation rates in the opt-in system.[40][41] Initially implemented in Israel, it allows an individual in need of an organ to move up the recipient list. Moving up the list is contingent on the individual opting-in prior to their need for an organ donation. The policy applies nonmedical criteria when allowing individuals who have previously registered as an organ donor, or whose family has previously donated an organ, priority over other possible recipients. It must be determined that both recipients have identical medical needs prior to moving a recipient up the list. While incentives like this in the opt-in system do help raise donation rates, they are not as successful in doing so as the opt-out, presumed consent default policies for donation.[34]
| Country | Policy | Year implemented |
|---|---|---|
| Argentina | opt-out | 2005 |
| Austria | opt-out | |
| Belarus | opt-out | 2007[42] |
| Belgium | opt-out | |
| Brazil | opt-in | |
| Czech Republic | opt-out | September 2002[43] |
| Chile | opt-out | 2010 |
| Colombia | opt-out | 2017 |
| Guatemala | opt-in | February 2024[44] |
| Israel | opt-in | |
| Netherlands | opt-out | 2020[45] |
| Spain | opt-out | 1979 |
| Ukraine | opt-in | [46] |
| United Kingdom (Scotland, England and Wales only) | opt-out | March 25, 2021, May 20, 2020 & December 1, 2015 |
| United Kingdom (Northern Ireland only) | opt-in | |
| United States | opt-in |
Argentina
On November 30, 2005, the Congress introduced an opt-out policy on organ donation, where all people over 18 years of age will be organ donors unless they or their family state otherwise. The law was promulgated on December 22, 2005, as "Law 26,066".[47]
On July 4, 2018, the Congress passed a law removing the family requirement, making the organ donor the only person that can block donation. It was promulgated on July 4, 2018, as Law Justina or "Law 27,447".[48]
Brazil
A campaign by Sport Club Recife has led to waiting lists for organs in north-east Brazil to drop almost to zero; while according to the Brazilian law the family has the ultimate authority, the issuance of the organ donation card and the ensuing discussions have however eased the process.[49]
Canada
In 2001, the Government of Canada announced the formation of the Canadian Council for Donation and Transplantation, whose purpose would be to advise the Conference of Deputy Ministers of Health on activities relating to organ donation and transplantation. The deputy ministers of health for all provinces and territories with the exception of Québec decided to transfer the responsibilities of the Canadian Council for Donation and Transplantation to Canadian Blood Services.[50]
In Québec, an organization called Transplant Québec is responsible for managing all organ donation; Héma-Québec is responsible for tissue donation.[51] Consent for organ donation by an individual is given by either registering with the organ donation registry established by the Chambre des notaires du Québec, signing and affixing the sticker to the back of one's health insurance card, or registering with either Régie de l'assurance maladie du Québec or Registre des consentements au don d'organes et de tissus.[52]
In 2017, the majority of transplants completed were kidney transplants.[53] Canadian Blood Services has a program called the kidney paired donation, where transplant candidates are matched with compatible living donors from all over Canada. It also gives individuals an opportunity to be a living donor for an anonymous patient waiting for a transplant. As of December 31, 2017, there were 4,333 patients on the transplant waitlist. In 2017, there were a total of 2,979 transplants, including multi-organ transplants; 242 patients died while on the waitlist. 250 Canadians die on average waiting for transplant organs every year.[54]
Each province has different methods and registries for intent to donate organs or tissues as a deceased donor. In some provinces, such as Newfoundland and Labrador and New Brunswick organ donation registration is completed by completing the "Intent to donate" section when applying or renewing one's provincial medical care.[55][56] In Ontario, one must be 16 years of age to register as an organ and tissue donor and register with ServiceOntario.[57] Alberta requires that a person must be 18 years of age or older and register with the Alberta Organ and Tissue Donation Registry.[58]
Opt-out donation in Canada
Nova Scotia, Canada, is the first jurisdiction in North America that will be introducing an automatic organ donation program unless residents opt out; this is known as presumed consent.[59] The Human Organ and Tissue Act was introduced on April 2, 2019.[60] When the new legislation is in effect, all people who have been Nova Scotia residents for a minimum of 12 consecutive months, with appropriate decision-making capacity and are over 19 years of age are considered potential donors and will be automatically referred to donation programs if they are determined to be good candidates. In the case of persons under 19 years of age and people without appropriate decision-making capacity, they will only be considered as organ donors if their parent, guardian or decision-maker opts them into the program. The new legislation is scheduled to take effect in mid to late 2020, and will not be applicable to tourists visiting Nova Scotia or post-secondary students from other provinces or countries.[61]
Chile
On January 6, 2010, the "Law 20,413" was promulgated, introducing an opt-out policy on organ donation, where all people over 18 years of age will be organ donors unless they state their negative.[62][63]
Colombia
On August 4, 2016, the Congress passed the "Law 1805", which introduced an opt-out policy on organ donation where all people will be organ donors unless they state their negative.[64] The law came into force on February 4, 2017.[65]
Europe
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.[66] Spain had the highest donor rate in the world, 46.9 per million people in the population, in 2017.[67] This is attributed to multiple factors in the Spanish medical system, including identification and early referral of possible donors, expanding criteria for donors and standardised frameworks for transplantation after circulatory death.[68]
In England, individuals who wish to donate their organs after death can use the Organ Donation Register, a national database. The government of Wales became the first constituent country in the UK to adopt presumed consent in July 2013.[69] The opt-out organ donation scheme in Wales went live on December 1, 2015, and is expected to increase the number of donors by 25%.[70] In 2008, the UK discussed whether to switch to an opt-out system in light of the success in other countries and a severe British organ donor shortfall.[71] In Italy if the deceased neither allowed nor refused donation while alive, relatives will pick the decision on his or her behalf despite a 1999 act that provided for a proper opt-out system.[72] 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.[73]
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.[74]
Scotland conforms to the Human Tissue Authority Code of Practice, which grants authority to donate organs, instead of consent of the individual.[75] This helps to avoid conflict of implications and contains several requirements. In order to participate in organ donation, one must be listed on the Organ Donor Registry (ODR). If the subject is incapable of providing consent, and is not on the ODR, then an acting representative, such as a legal guardian or family member can give legal consent for organ donation of the subject, along with a presiding witness, according to the Human Tissue Authority Code of Practice. Consent or refusal from a spouse, family member, or relative is necessary for a subject is incapable.
Austria participates in the "opt-out" consent process, and have laws that make organ donation the default option at the time of death. In this case, citizens must explicitly "opt out" of organ donation. Yet in countries such as U.S.A. and Germany, people must explicitly "opt in" if they want to donate their organs when they die. In Germany and Switzerland there are Organ Donor Cards available.[76][77]
In May 2017, Ireland began the process of introducing an "opt-out" system for organ donation. Minister for Health, Simon Harris, outlined his expectations to have the Human Tissue Bill passed by the end of 2017. This bill would put in place the system of "presumed consent".[78]
The Mental Capacity Act is another legal policy in place for organ donation in the UK. The act is used by medical professionals to declare a patient's mental capacity. The act claims that medical professionals are to "act in a patient's best interest", when the patient is unable to do so.[75]
India
India has a fairly well developed corneal donation programme; however, donation after brain death has been relatively slow to take off. Most of the transplants done in India are living related or unrelated transplants. To curb organ commerce and promote donation after brain death the government enacted a law called "The Transplantation of Human Organs Act" in 1994 that brought about a significant change in the organ donation and transplantation scene in India.[79][80][81][82][83][84][85] Many Indian states have adopted the law and in 2011 further amendment of the law took place.[86][87][88][89][90] Despite the law there have been stray instances of organ trade in India and these have been widely reported in the press. This resulted in the amendment of the law further in 2011. Deceased donation after brain death have slowly started happening in India and 2012 was the best year for the programme.
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