Each year, thousands of people die in the United States while waiting for a kidney or liver transplant and tens of thousands remain on the waiting list for these organs. The primary source of transplant organs in the US is brain dead donors, who make up about 12,000 of the 2 million people who die in the US each year. Although they are a small percentage of the people who die in the US, brain dead individuals make up 92 percent of organ donors. Even if 100 percent of brain dead individuals were both eligible and willing to donate their organs, this would not clear the transplant waiting list.

An obvious goal of the transplant community is to increase the number of organs available for transplantation to shorten waiting time and decrease waiting list mortality. One strategy for increasing the availability of transplant organs is to increase the pool of individuals who are eligible to donate their organs. This requires looking beyond brain dead donors to those who die according to cardiopulmonary criteria (i.e. their heart stops).

In the US, controlled donation after cardiac death (cDCD) protocols have been implemented to allow organ donation from individuals who have devastating and irreversible neurologic injuries, but do not meet the criteria for brain death. These protocols involve stopping all interventions other than pain medication and allowing the patient to die in an operating room according to cardiopulmonary criteria prior to organ procurement. It is controlled in the sense that the donor operation is planned prior to the patient’s death.

While cDCD protocols increase the number of potential organ donors, there are still a large number of individuals who are not eligible for cDCD because they either die in the pre-hospital setting or they die in the hospital without meeting criteria for cDCD protocols (e.g., a patient who dies suddenly in a hospital because of a pulmonary embolism would not be a candidate for cDCD because a donor operation would not be planned prior to their death).

If these individuals were included in the potential donor pool through the development of uncontrolled donation after cardiac death (uDCD) protocols, the number of available organs would be significantly increased. uDCD allows for individuals who die either in the hospital or in a pre-hospital setting to have their organs preserved quickly at the time of death so that they can be organ donors. Given the need for additional donors to meet the demand for organs, the US should consider adopting this practice. In doing so, we should be aware of the ethical and legal issues associated with uDCD.

‘Uncontrolled Donation After Cardiac Death’ In Practice

Uncontrolled donation after cardiac death protocols have been implemented in several European countries. The general process starts with an individual who suffers a heart attack outside of the hospital setting. Cardiopulmonary resuscitation (CPR) is attempted for at least half an hour and is ultimately declared futile. The individual is then transported to a participating hospital with the continuation of chest compressions, mechanical ventilation, and IV fluids.

Upon arrival, death is declared and there is a mandatory five minute “hands- off” period. Big IV lines are put into the patient’s groin and they are hooked up to a machine that keeps blood circulating (called ECMO). At this point in the process, the individual’s family is contacted for consent for organ donation. Even though some countries have presumed consent laws for organ donation, it is routine to contact next of kin before proceeding with procurement and to respect refusal even in the absence of express refusal of the potential donor.

A Question Of Consent

There are several legal, ethical, and societal questions that need to be addressed in creating uDCD protocols in the US, the foremost of which is if and how to obtain consent for organ preservation. In the US, it is clear both legally and ethically that consent is required before organs can be procured from an individual. However, it is not as clear as to what the consent requirements are for organ preservation. Organ preservation in uDCD requires cannulation of the femoral vessels and initiation of ECMO. This needs to be done as quickly as possible in order for organs to be viable for transplantation. Given the need for expedient intervention, there is generally not time to obtain consent from next of kin or determine the individual’s preferences with respect to donation prior to cannulation.

One proposed theory is that there should be a dual consent process in which next of kin are asked about organ preservation directly following the individual’s death and later asked about organ donation after they have had time to process the death. This approach may not be possible in some situations. For example, next of kin may not be immediately present when the patient dies or may be unable to make a decision about organ preservation because they are distressed. There should be alternative options for when these situations arise.

The Law And Consent For Organ Preservation

No law explicitly allows for organ preservation in the absence of consent in the US. However, there is precedent in a common practice: individuals who are declared brain dead are routinely kept on ventilatory and cardiac support for the purpose of organ preservation while next of kin is contacted. This practice is protected by the Uniform Anatomical Gift Act (UAGA), which allows for organ procurement organizations to make a reasonable search for information regarding the donor status of a deceased individual.

As a practical matter, during the time it takes to search for organ donor consent in brain dead individuals, organs have to be preserved so that the individual can donate if consent is provided. Based on current practice with brain dead individuals and the UAGA, organ preservation without consent in itself is not only legally permitted in the US, but already common practice.

The character of organ preservation measures for uDCD are not significantly different than that of donation after brain death (DBD). The main difference between uDCD and DBD is that with DBD, support is merely continued while consent is sought, while in uDCD, an invasive procedure (femoral vessel cannulation) is done to a dead body before consent is obtained.

To answer questions surrounding the legal requirements for consent prior to organ preservation in uDCD, one must look at legal precedent regarding ownership of a body following death and regulations regarding interference with a dead body. The purpose of laws governing the treatment of a dead body are to prevent persons from interfering with the family’s interest in proper treatment of the body, as ownership of the body defaults to the family following death. Historically, successful legal actions surrounding this issue have been grounded in the emotional suffering of families who experienced disturbance, desecration, or mutilation of their loved one’s body or were deprived of the opportunity to bury or dispose of the body in accordance with religious beliefs.

Organ preservation measures should not interfere with the interest of the family in proper or timely burial or disposal of the body. Moreover, they do not significantly alter the appearance or state of the corpse. Femoral vessel cannulation for ECMO is not likely to cause severe distress to the family of a deceased individual. However, because the body does not belong to the organ procurement organization or to the hospital where the deceased individual is located, the family of the deceased could bring legal action against them for causing distress or emotional suffering.

From a legal viewpoint, while consent is not required for organ preservation under the Uniform Anatomic Gift Act or legislation regarding the postmortem treatment of bodies, there is definitely room for legal action against individuals and organizations who choose to perform organ preservation interventions on deceased individuals without consent. This issue would have to be further clarified with respect to uDCD before presumed consent for organ preservation could be considered legal.

Ethics And Consent For Organ Preservation

Along with legal considerations, it is also important to explore the ethical aspects of consent for organ preservation. In the US, respect for autonomy is one of the central principles of bioethics, which states that persons have the right to make decisions regarding their medical care, and if they are unable to make decisions, they have the right to a surrogate who makes decisions based on their expressed preferences or best interests. With respect to organ donation, the US has an opt-in system, in which express consent by either first person (through donor registries or a driver’s license) or by next of kin is required for donation.

If individuals’ preferences are not known when organ preservation is required, there are two options. One is not to initiate organ preservation and negate the possibility of organ donation. The other option is to initiate organ preservation, allowing time to determine the individual’s or next of kin’s preferences with respect to donation. The second option still allows for the decision not to donate while at the same time preserving the option of donation. So, in the absence of an expressed preference for organ donation, initiating organ preservation prior to consent for organ donation allows the time for obtaining either records of first-person consent or next of kin consent for organ donation. This arguably increases autonomy rather than infringing upon it.

Public Perceptions Of Consent For Organ Preservation

Little is known about the general public’s perceptions of uncontrolled donation after cardiac death. One survey study found that 84 percent of their participants would want to donate their organs after an unexpected cardiac arrest, and 81 percent supported organ cooling in order to achieve this goal. Seventy-two percent of participants in this study supported a law allowing for routine organ cooling, as a preservation measure without consent, while 39 percent were in favor of organ cooling only if patients or their families gave permission.

While this was a small study, it did demonstrate that a sizeable minority of individuals are in favor of consent prior to organ cooling for uDCD protocols. This study would suggest that a publicly accepted approach to uDCD would be to require consent prior to organ preservation, even if this is not legally or ethically required.

Should uDCD Protocols Be Pursued In The US?

Uncontrolled donation after cardiac death protocols provide an opportunity to expand the organ donor pool, thereby decreasing waiting list time and improving outcomes for potential organ recipients. Given that the waiting list for organ donation has not significantly changed in the past several years, and thousands of people continue to die or have a poor quality of life while awaiting organs, efforts should continue to be made to increase the donor pool. Uncontrolled donation after cardiac death could be a viable option for increasing the donor pool but potential legal and ethical challenges must be addressed. Specifically, consent requirements for organ preservation must be established prior to beginning uDCD programs.