Ethics and Organ Donation After Cardiac Arrest

Since the first successful organ transplant in the 1950s, considerable good has occurred by saving the countless lives of those who would have otherwise succumbed had it not been for this unique gift of life. Medicine has come full circle- uniting the end of one life (cardiac arrest) with the renewed chance of extending the life of another (organ donation after circulatory death). This paper addresses the ethical issues that arise in the transition, respecting our attending need to: first do no harm.

Key points

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Emerging ethical issues in the areas of controlled and uncontrolled donation after circulatory death require our attention to optimize the process and improve outcomes.
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The supply of transplantable organs involves attention to decisions concerning the withdrawal of life sustaining measures, determination of death, as well as which organ donation-related interventions are aligned with the original ethical tenets.
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Presumed consent offers an opportunity to improve the availability of organs when accompanied with enhanced public engagement, education, and a robust organizational structure to support organ donation optimally.
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Moral distress and questions pertaining to procedures during the transition to organ donation continue to arise and need to be addressed.

Abbreviations

cDCD	controlled-donation after circulatory death
CPR	cardiopulmonary resuscitation
DCD	donation following circulatory death
DND	donation after neurologic death
ECMO	extracorporeal membrane oxygenation
ECPR	extracorporeal cardiopulmonary resuscitation
MAiD	Medical Assistance in Dying
WHO	World Health Organization
WIT	warm ischemic time
WLSM	withdrawal of life-sustaining measure

Introduction

Organ donation, as a field of medicine, has extensive literature dedicated toward the ethical dilemmas and ethical vectors imbedded in the decision-making processes of who should donate organs and what medical criteria should be extended to facilitate societal trust on how organ procurement should proceed. Currently there exists 3, legally accepted, types of deceased organ donation processes

1.
Donation following neurologic death wherein clinical criteria are met to determine irreversible loss of brain and brainstem function, also known as donation after neurologic death (DND). This process allows for organs to be removed from a patient with beating heart as the body remains connected to a respirator.
2.
Donation following circulatory death (DCD): In this case, death is determined based on the irreversible loss of cardiac function and usually follows after all life-saving methods to save a patient’s life have been tried. Donation can begin only after the heart has stopped and death is pronounced. DCD is further categorized into 2 types of clinical situations:
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  Controlled-donation after circulatory death (cDCD) concerns donation after withdrawal of life-sustaining measures (WLSMs).
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  Uncontrolled-donation after circulatory death refers to organ donation after a refractory cardiac arrest.
3.
Donation after Medical Assistance in Dying (MAiD) can be an option for some patients. This type of donation is in the same category as DCD and may occur in-hospital (for all perfusing and non-perfusing organs) or in the community (for non-perfusing organ donation only). MAiD is a process where a person who meets eligibility criteria is given medications (oral self-administration or physician-initiated intravenous administration) at their request by a qualified practitioner (physician or nurse practitioner). Death determination is confirmed by a second practitioner after 5 min has lapsed and organ donation occurs immediately afterward. This practice is limited to countries where physician-assisted death is defined by law. ^,

Cardiac arrest patients may evolve during hospital admission to an option for either organ donation process: DND or DCD. Each of the 3 processes described earlier share similar ethical issues; however, each also have their own unique ethical issues. Organ DND is well-established with standardized implementation strategies whereby organs are retrieved before cessation of circulatory function has occurred and thus organs at time of retrieval continue to be perfused. Organ donation rates are 2-fold higher with DND when compared to DCD (3.14 organs per DND donor vs 1.67 organs per DCD donor). Uncontrolled-DCD is donation after refractory cardiac arrest, which may occur in the out-of-hospital or in-hospital setting and the challenges in implementing this system of organ donation are underutilized and described in a recently published international scientific statement. ^, For this publication, the ethical considerations of organ donation following cardiac arrest will be discussed as they pertain to in-hospital WLSM and organ cDCD. Any considerations that share an approach to DND are highlighted as well for efficiency in implementation.

Though not meant to be an exhaustive review of the ethical issues, the areas to be discussed will include: Consent, the impact of the conflicts of interest in the transition from WLSM to organ donation, and religious and cultural considerations.

The various forms of consent for organ donation

Informed-consent is considered the cornerstone of good ethical and legal medical care. It is essential in exercising respect for patient autonomy and can act as a safeguard, when properly executed, against unethical practices.

History is replete with examples of unethical practices in the fields of both medical care and research, where the tenets of informed-consent were not respected. Medical students are exposed to their chosen profession’s history of unethical treatment of patients based on the absence or falsification of consent. Two frequently cited case studies: the Tuskegee study that looked at how untreated syphilis progressed in a cohort of African American males all the while unaware of the harms being presented; and the barbarous Nazi human experiments exposed post-World War II during the Nuremberg trials, serve as staunch reminders of the very real possibility for harm existing in the name of science. ^,

In the United States in 2024, just over 103,000 people were on a waiting list for organs, whereas only 46,000 transplants occurred. The reality is that each day it is estimated that 17 people die awaiting a transplant. In applying the economic theory on supply and demand to the field of organ donation and transplantation one can easily understand the increased value on organ supply and the willingness to explore all avenues to correct this imbalance. In the context of supply and demand these missed opportunities are categorized as wastage. This increased value, in the context of life and death without a means to ultimately satisfy all demand, necessitates enhanced vigilance on what motivations might be used to the increase supply of organs.

Putting aside illicit black-market practices globally, or as in Iran where legalized open market purchasing of kidneys is permitted, the actual procurement of organs utilizes 2 models of consent: explicit/expressed and presumed, with some variations within each model based on location and level of societal tolerance and acceptance.

Consent for organ donation is either expressed (opt-in) or presumed (opt-out). Expressed-consent requires either first person consent (verbal or registration on a national donor list) or second person consent by a legally authorized surrogate decision-maker. The underlying ethos for the preference for expressed consent is that the act of willfully donating an organ is considered to be altruistic, and that this method of consent best supports human agency and autonomy.

In jurisdictions where presumed consent is in place (opt-out), all individuals are by default considered organ donors. They must register their decision formally to opt-out. In this setting, the reasoning behind supporting presumed consent typically considers the following 2 arguments. First, research studies have consistently shown that the actual numbers of registered donors fall significantly below what the general public indicates they would want when surveyed, suggesting there is an unrealized potential to donate. The second argument that supports the presumed consent model is the view that organ donation should be considered a societal duty-one best supported by presumed consent. A 2019 US Gallop poll suggested 90.4% of the sampled population supports organ donation (95% CI 89.7–91.2). This rate of endorsement decreased modestly for young age, non-White race, and education at the level of high school or below. In the same survey over 56% supported presumed consent with modest decreases attributed to non-White race and lower education. Table 1 outlines a general summary of countries where opt-in and opt-out systems are in place.

Table 1

Countries using Opt-out and Opt-in basis when considering Organ Donation

Shepherd L, O’Carroll RE, Ferguson E. An international comparison of deceased and living organ donation/transplant rates in opt-in and opt-out systems: a panel study. BMC Med. 2014;12(1):131. doi:10.1186/s12916-014-0131-4 .

Opt-Out	Opt-In
Spain Austria Belgium France Wales England Scotland Netherlands Argentina Colombia Chile Russia Norway Singapore Brazil (1998–2000) Switzerland Nova Scotia (Canada, 2021) United Kingdom (exception Isle of Mann)	United States Canada (exception Nova Scotia) Germany– explicit consent Denmark– advance registration Greece– explicit consent. Japan– advance registration and explicit consent South Korea– advance registration Ireland Brazil (after 2000)

Rates of participation in organ donation programs are known to be powerfully influenced by the relevant default policy in effect (“opt-in” vs “opt-out”). Globally an estimated 39 countries use a form of presumed consent for organ donation; however, in many cases, information on performance is not readily available. The number of opt-out countries is expected to grow given the continued unmet need for organs. A noticeable exception to this trend is Brazil, where they initially adopted an opt-out law in 1998 only to rescind it in 2000 back to an opt-in approach. Concerns related to public opposition were reported to be the reason for this change. In a recent study published in 2024 of 7 opt-out countries, the presumed available organ donation rate was, on average, 98% (indicating 2% of the population had registered their opposition). Whereas, in 4 opt-in countries, the consent rate was only about 15%. The literature suggests that most people stick with the default donor status because doing so requires no effort, further endorsing the opt-out system.

This difference in consent rates may translate to a difference in organ donation rates. A recent study in Wales, on organ donation statistics following a change to an opt-out system and using a soft consent approach (where families are involved in the decision to proceed with the organ donation) indicated a steady upward trend in the proportion of families consenting to DBD. Whereas, no change in the DCD consent rate was observed. The authors speculated that the consent rate for DCD was less influenced by the legislation change and had more to do with family experiences and concerns related to DCD procedures. On review, these concerns were attributed to the fact that families in DCD cases needed to stay at the hospital on average 12 h longer than in DBD cases to prepare for the WLSM. These delays may contribute to increased withdrawal of consent. There was also a higher degree of acceptance of death in DBD cases and a belief that the family member had moved beyond the possibility of harm, whereas this was not observed consistently in the DCD cases. Additionally, staff noted increased incidences of psychologic and emotional harms to the family when DCD does not proceed due to extended time until death was determined. This extended time interval may be longer than 120 min in 27% to 46% of cases as reported in a systematic review of observational studies. All of these observed differences between DCD and DBD families suggest a need for a more individually tailored approach to the donation conversation with family in DCD situations.

Designated categories, such as opt-in and opt-out, are used to identify potential donors only and typically require some additional steps when seeking consent to the actual donation at a specific juncture in a patient’s journey. In practice 2 types of consent approaches are used, soft or hard consent. In the case of hard consent , policies give complete primacy to an individual wishes as stated in their life. In a hard consent environment, the donation decision registered is binding, and effectively there is no formal role for the family in consenting or authorizing a donation. In a hard opt-in system, a preference for organ donation would need to be stated by the individual. In a hard consent opt-out system, the individual would have needed to opt-out during their lifetime to avoid becoming a donor. In the case of soft consent policies, practitioners involve the potential donor’s family, whether the system is opt-in or opt-out. In opt-in countries, families can be approached to consent to donation where the wishes of a loved-one was never explicitly stated; or to legally authorize donation where they have. The family can still veto an individual’s expressed wish without consequence as donation services are highly concerned about public trust and do not want bad public relations to ensue. In an opt-out scenario where soft consent is used, families are approached to “authorize” the default of donation in terms of the status quo. This gives the family an opportunity to ensure the potential donor’s preferences are regarded, in the event that they have not previously opted out for whatever reason.

Family involvement in organ donation is often attributed to lower actual donation rates in practice, even in cases where the individual expressed specifically a desire to be a donor if the need arose. One would suspect even in countries employing opt-out for organ donation registration that requiring a soft consent approach might decrease consent rates; however, experience suggests this does not have to be the case. By example, Spain is lauded as having the highest-ranking organ donation rates in Europe and arguably the world. A closer look at the Spanish experience reveals several interesting facts: Spain uses the soft consent approach within an opt-out donation system. Their program started in 1979 and donation rates did not begin to significantly rise until 10 y later. In fact, their impressive growth in donation rates is often attributed to other changes within the system-such as the introduction of a top-tiered transplant coordination network and the delivery of enhanced public and health care education programs.

Though not practiced anywhere at this time, mandated choice is an alternative consent method that would allow adults to prospectively address the question of organ donation for themselves. The beauty of this plan is that all competent adults would be required to decide and record whether or not they wish to become organ donors upon their deaths. The mechanism to ensure high-compliance rates might be during the driver’s license applications process, filling of tax returns, or as a step to obtain any identification card. A person’s decision would be binding, not subject to family override. Suspected advantages to this approach include eliminating the family consent barrier, reducing stress on families and staff, and potentially enhancing participation by increasing public awareness of the value of organ donation (since everyone would be forced to consider the issue), and eliminating delays resulting from the current need to obtain family consent. It should be noted that in 1991 Texas law required citizens to make a “yes” or “no” choice about organ donation when they renewed their driver’s license (mandated choice). However, the law had to be repealed in 1997 because the implementation of the mandatory choice resulted in a refusal rate of 80%. This high rate of refusal was attributed to the lack of public education about organ donation.

Assumption or advance registration of choice regarding organ donation and authorizing or consenting to proceed with a donation is a sensitive and complex process. The actual process used requires consideration to the cultural, religious, and societal values where the system is being used. However, if anything can be learned from the literature, it is that no system will be successful without extensive outreach and education being provided to the public, as well as resources to support the infrastructure and personnel needed. Societal trust is a critical component of any organ donation and transplantation program. Public education and outreach are essential to building societal trust and ensuing organ donation has a footing in health care as the system changes over time.

Impact of conflicts of interest on the transition

Conflicts of interest arise when the decision to WLSM is made and the organ donation team is activated. This transition is fraught with competing demands for patient care and comfort versus organ preservation and retrieval. This affects many aspects of the transition including the requirements for WLSM, the determination of death and clinical implications of how the transition from WLSM and confirmation of death to organ extraction is operationalized. In his 2016 article, Truog rightly identified the existence of a tension between both a dead donor and a live organ. He noted how medical and legal societies have tried to create a procedural “ethical firewall” to delineate a clean line of separation between treatment and care, confirmation of death, and the removal of organs. If this transition is not done well, it may lead to confusion and questionable results.

Requirements for Withdrawal of Life-sustaining Measures

The decision to WLSM is done in the context of continuing to care for the patient; providing sedation and comfort measures regardless of the impact on oxygenation and blood flow to organs, which may be donated. This transition requires excellence in palliative critical care. The discipline of critical care considers itself a specialty that takes pride in providing excellent end-of-life care. Favorable assessments of palliative care interventions in the critical care unit have been recorded. In 2003, the Robert Wood Johnson Foundation Critical Care End-of-Life Peer Workgroup conducted a review of reported practices for end-of-life care and named 7 end-of-life care domains for use in the critical care unit: a) patient-centered and family-centered decision-making; b) communication; c) continuity of care; d) emotional and practical support; e) symptom management and comfort care; f) spiritual support; and g) emotional and organizational support for critical care unit staff. Within these 7 domains, 53 End-of-Life quality indicators were proposed. The seamless transition for the patient, family, and staff from active treatment to WLSM and supportive palliative care, and finally to confirmation of death and organ procurement requires excellence in all 7 domains of end-of-life care.

Essential clinical steps for WLSM and organ donation procedures (controlled-DCD) to meet the ethical and professional duties expected from medical care are outlined below as a checklist ( Box 1 ).

Box 1

Suggested checklist of essential clinical steps for withdrawal of life-sustaining measure transition to circulatory death and organ donation

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WLSM decision is based on no further treatment exists and death is being prolonged.
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WLSM decision aligns with patient’s best interests and with informed-consent of the patient or substitute decision-maker.
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WLSM decision is independent of decision to consider organ donation.
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WLSM is completed by the most responsible credentialed physician for the patient’s care.
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Palliative critical care team functions independently of the organ donation team.
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The patient receives excellent palliative critical care. ^,^,^,
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Organ donation aligns with the wishes or actions (opt-out or opt-in) of the patient with informed-consent or authorization for organ donation by the patient or the substitute decision-maker.
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All interventions to enhance organ viability during WLSM are included in consent process for organ donation.
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Death is determined independently by 2 physicians using standardized criteria either 5 mins (no cardiopulmonary resuscitation [CPR]) or 7 min apart (prior CPR) before transfer-of-care to the organ donation team.
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Death determination date and time is confirmed by the first of the 2 physicians. ^,

The informed-consent for WLSM from either the patient or the substitute decision-maker is restricted to the anticipated withdrawal and subsequent circulatory death. Preparing the family for the variability of time interval from withdrawal to death confirmation is important to help manage their expectations. The organ donation team requirements, such as heparin administration, blood and diagnostic tests, such as imaging (i.e. computed tomography and echocardiography) and drug or device interventions to optimize organ perfusion during WLSM may disrupt the experience for staff and family if not managed appropriately. Most importantly, these interventions must be explained to the family during the organ donation consent process (soft or hard consent), align with the palliative care goals of the patient and staff, and be unobtrusive to the experience for the family and role of the staff. The organ donation team should explain during the organ-donation consent process how the variability in the time interval from WLSM to confirmed death may prohibit organ donation; however, the priority is to provide the patient and family with a supported death regardless.

Requirements for Death Determination

Determination of death is standardized across all patients regardless of organ donation by the World Health Organization (WHO) guidelines for confirming cessation of circulation and breathing ( Box 2 ).

Box 2

World Health Organization guidelines for confirming cessation of circulation and breathing

Data from Shemie SD, Hornby L, Baker A, et al. International guideline development for the determination of death. Intensive Care Med. 2014;40(6):788-797. https://doi.org/10.1007/s00134-014-3242-7 .

^a In organ donation, in most countries, 2 physicians confirm death compliant with the time interval and independent of the organ retrieval team.

^b This time interval is referred to as ‘no touch’ or ‘hands off’ time interval between the clinical and organ donation team. It can be institutional specific yet more likely to be 5 min.

World Health Organization guidelines for death determination
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  Absent palpable pulse
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  Absent breath sounds
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  Absent heart sounds
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  Absent respiratory effort or chest wall motion
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  Loss of pulsatile arterial blood pressure by non-invasive measurements
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  Coma and fixed dilated pupils
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  Electric asystole is not required, pulseless electrical activity is acceptable
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  Time interval of 2 to 5 min of death ^a without CPR ^b
Alternatively
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  Time interval of 7 min of observation is required before confirming death ^a with prior CPR ^b