Clinical Case

Ms. D.R. was a 60-year-old woman who presented to the Neurointensive Care Unit with a catastrophic non-traumatic intracerebral hemorrhage. She was found down unresponsive and was intubated in the field. She was transferred from an outside hospital for higher level of care. On neurologic exam at presentation, she appeared comatose, with absent pupillary reflexes bilaterally, and no motor response to noxious stimulus, suggesting a severe diffuse brain injury. Neuroimaging confirmed a devastating intracerebral hemorrhage with diffuse brain edema, hydrocephalus, and early evidence of brainstem herniation. An emergent extra-ventricular drain was placed, however her neurologic function did not improve. Further neurosurgical intervention was not offered given the severity of her injuries at presentation suggesting a poor prognosis. Shortly into her hospital course, Ms. D.R. developed intracranial hypertension refractory to medical treatment.

At 72 hours from presentation, a family meeting was held with Ms. D.R.’s son and daughter-in-law. Family was informed that her neurologic exam was consistent with progression to brain death and that the primary team would proceed with clinical bedside testing and an apnea test to confirm the diagnosis of brain death, as per hospital protocols. During the family meeting, it became apparent that Ms. D.R.’s son and daughter-in-law simply did not share, accept, or even perhaps ‘understand’ the concept of brain death. They described Ms. D.R. as a strong woman who was completely independent and steadfast to always make her own choices before this tragic event, and certainly would not have wanted doctors to disconnect her from a machine ‘if that meant to terminate her life.’ The family remained reluctant to accept the presumptive diagnosis of brain death, argued that the patient’s heart was still beating and therefore the patient had to still be alive. The family requested to withhold the clinical brain death examination and to transfer Ms. D.R. to another hospital for a second opinion.

At that point the Ethics Committee of the hospital was involved to help resolve this conflict. It was agreed to withhold brain death testing and to allow for a second opinion, provided that another facility would accept her. Neither the family nor the primary team could find a facility willing to challenge the patient’s presumed brain death diagnosis. Eventually at day 7 from admission, Ms. D.R. suffered a cardiac arrest and died of ‘cardiovascular death’ after failed resuscitation attempts.  

Origins of Informed Consent

The purpose of informed consent, as it exists now, is primarily to maintain patient autonomy, but additional benefits include the protection of patients, avoidance of fraud, and promotion of rational decisions, amongst others. It is now considered both an ethical and legal obligation which should, at a minimum, always include: 1) the nature of the procedure, 2) the risks and benefits of the procedure, 3) reasonable alternatives, and 4) risks and benefits of alternatives, with an assessment of comprehension of these elements (1).

It is important to note that consent is not required for most physical examinations or for many tests and procedures performed in the hospital, including venipuncture or imaging, as these are considered standard of care and the risk is inherently low. There are exceptions for tests such as  HIV testing or genetic testing that could reveal sensitive information. Otherwise, consent is presumed as part of the patient’s agreement to hospitalization; that is, that patients want tests or procedures that may improve their health or aid in diagnosis unless they expressly decline.

Informed Consent in Brain Death

Historically, consent for brain death testing has not been sought nor required. More recently, the question of whether consent, particularly for apnea testing, should be obtained has been debated. Legal precedent is undecided on this matter, with some court cases supporting that consent is not required and others stating that it is (4-6). Neurologists in a 2015 survey overwhelmingly believed that consent is not necessary before evaluation for brain death (7).

The newest 2023 brain death guidelines published by the AAN (8) state that consent is not required to evaluate for death, in the same way that consent is not sought when auscultating someone’s heart and lungs in order to diagnose death. Other related arguments that have been discussed previously (9) specifically in regards to the apnea test include that: 1) this is performed as the last step of diagnostic testing and only after careful examination confirms a catastrophic brain injury; 2) clear safety stopping rules are in place should the patient experience instability; and that 3) because there is catastrophic brain injury with no chance of recovery, any risk of harm is justifiable to obtain an accurate diagnosis. Instead of consent, current guidelines stipulate that health care providers are required to make reasonable efforts to inform the patient’s family/surrogates that there is a suspicion of brain death, and that testing will be performed to confirm the diagnosis.

Ms. D.R.’s story provides us with an opportunity to reevaluate the current state of consent for brain death testing. By being able to see things from the family’s perspective, several challenging points surrounding the concept of brain death and the construct of its determination arise.

Lack of Accuracy

Brain death determination needs to be completed with perfection each and every time that it is declared – the importance of this cannot be overstated and has been discussed in the literature before (10). The process of brain death declaration has instead shown to be anything but perfect: despite the revisions to the guidelines and the required training and expertise of those declaring it, many aspects of brain death declaration remain dependent upon individual interpretations and are inevitably subject to human error, bias, and variations. Even if anecdotal, there have been errors in determination of brain death. Even now, differences exist around the world in the definition of brain death itself and in the criteria for its determination.

Loss of Autonomy in the Transition between Assumption and Confirmation of Brain Death

Autonomy remains one of the main pillars of medical ethics, and the basis for informed consent. Performing any test or activity on a living individual without consent violates norms of respect for self-determination and bodily integrity. Adhering to this principle is fundamental to inspire public trust in health care. With other instances of informed consent, patients and surrogate decision makers may ultimately decide not to undergo testing or a procedure, and as long as we feel that they understand the risks around that decision, we, as health care providers, support their right to make those decisions.

The current practice of not requiring consent for brain death testing is based on a notion that the patient is already dead; consenting to the declaration does not change that fact and the dead do not have rights to autonomy. However, brain death at this point is an assumed diagnosis. To prove brain death, specific tests are required, notably the apnea test, and/or ancillary testing. Until these tests confirm the diagnosis and the patient is formally declared dead, the individual is assumed to be alive and is treated as such: medications and mechanical ventilation are appropriately provided to support life. Likewise, until that formal declaration of death, this same patient should have the same rights to autonomy granted alive persons.  The assumption of brain death, one that may be proven wrong with subsequent examination, should not be sufficient to turn an individual with a right to self-autonomy into a corpse with no such rights. To do so could be could be construed as a paternalistic manipulation and erode societal trust.

It’s Not the Degree, It’s the Principle

The new brain death guidelines published in 2023 support the continued lack of need for consent in brain death declaration, citing specifically how the risks of an apnea test are minimal if performed correctly. These tests pose a minimal risk, but they are non-zero risk tests. Yet with any other procedures that carry even minimal risk, there is an expectation that informed consent be obtained prior to proceeding. The fact that complications are rare should not preclude the obligation to inform patients and their surrogates of those risks. Acknowledging that these are non-zero risk procedures argues for the need for informed consent.

Can Surrogates Disagree with Death?

Death, as defined as the time after which a ‘life’ has ceased to exist, has a contextual definition. In 2008, the President’s Council on Bioethics convened and debated what the legal definition of death is and agreed that “all criteria used to diagnose human death rely upon the demonstration of the irreversible loss of the capacity to breathe, combined with the irreversible loss of the capacity for consciousness” now referred to as the Unifying Medical Concept of Death.

However, as illustrated by our case, life and death are not universally shared and understood concepts. What evidently constituted death for the provider team – Ms. D.R. was brain dead and therefore dead – was not death to the family. Death is a medicolegal and social construct that can have various definitions, depending on the context. The declaration of neurological death, where a patient is declared dead at one point but wasn’t dead a few minutes before with no physiological changes, demonstrates this construct.

There is scarce research on patient’s families/surrogates’ perceptions and understanding of brain death testing. The concept of brain death is often misunderstood and mis-portrayed in popular media and news sources. Highly publicized cases suggest that despite the legal definition of death, the general public does not comprehend the nuances between severe neurological damage and brain death.

In other medical decisions, if a patient or their surrogate decision maker disagrees with a diagnosis, we provide alternatives, including second opinions or other treatment plans. If a patient’s surrogate decision makers do not agree with the diagnosis of brain death, should there be alternatives offered to the family?

Conscientious Objections to Declaration of Brain Death

There have been increasing legal cases around the country of families raising conscientious objections to the declaration of brain death. Currently, New Jersey is the only state to allow religious objection to the diagnosis of brain death. California, New York and Illinois require “reasonable accommodation” for religious beliefs which translates to maintaining brain dead patients on the ventilator until the family can make alternative arrangements. This raises a question: why are religious or moral beliefs allowed these different accommodations, while those who have a divergent opinion towards proceeding with brain death testing are not? Is there a difference between a ‘religious’ or ‘moral’ belief and a ‘simple’ belief?   

Implications of Consenting for Brain Death

Changing our practices to encourage or require informed consent could have consequences, foreseen and unforeseen. It is possible that requiring consent will reduce brain death testing and declaration, if the surrogate decision maker disagrees. Doing so could place an over-burdened healthcare system in even more dire straits by the need to continue providing ongoing support to persons who will never regain consciousness. This could negatively impact health care resources as patient’s surrogates/representatives may opt for alternatives to brain death. The impact of this on the population, and its ability to maintain access to healthcare is a consideration in light of the medico-ethical duty to preserve distributive justice. However, it is unlikely that health care providers currently explain brain death declaration as a need to save health care resources. Although guided by the important principle of distributive justice, the respect for autonomy when the individual is ‘presumed dead’ yet still alive should still take precedence.

From the beginning, brain death and organ donation have been intertwined and likely will continue to be so. Theoretically, requiring informed consent for brain death testing could reduce potentially available organ donations. However, as organ donation should be a gift made without coercion, this potential impact should not be used as a justification in not assessing a surrogate decision maker’s consent to the procedures.

The Ethical Case for Informed Consent in Brain Death

As explored through this piece, we have reviewed how the process of diagnosing brain death still carries a risk, albeit minimal, if completed properly, including the risk of misdiagnosis. We have reviewed the principles of autonomy and how autonomy may be wrongfully removed from patients before the confirmation of death. We have seen how death is a construct, one whereby we, societally, legally, and medically, have come to accept brain death as an injury so severe that there is no capacity to maintain consciousness nor breathe spontaneously, and equated that with death.  Lastly, we explored the impacts of informed consent for brain death testing.

We argue that there is an ethical case to be made that informed consent should be conducted prior to brain death determination, allowing for objections to it in all 50 states.