This post appears in the June issue of the American Journal of Bioethics.
by Thaddeus Mason Pope, JD
It is time to revise the Uniform Determination of Death Act (UDDA) to assure a consistent nationwide approach to consent for brain death testing. Only two of 56 U.S. jurisdictions address the question in statute or regulation. Unfortunately, leaving this issue up to clinicians and the courts has led to considerable confusion and variability. We can tolerate this no longer. Certainty and clarity are of paramount importance in death determination.
SEVEN POSITIONS ON CONSENT FOR BRAIN DEATH TESTING
Berkowitz and Garrett argue that physicians must obtain informed consent before performing an apnea test to determine death by neurological criteria. They acknowledge that their target question is not binary: consent or no consent. In fact, answers to the consent question can be plotted across a wide spectrum. My examination of the 14 open peer commentaries (OPCs) reveals at least seven distinct positions.
These seven positions can be grouped into three categories. First, some agree with Berkowitz and Garrett that informed consent is required before performing an apnea test. Second, some argue for stronger positions: that more consent is required. Third, some argue for weaker positions: that less or no consent is required.
Informed Consent
Four OPCs agree with Berkowitz and Garrett that informed consent is required primarily because apnea testing imposes significant iatrogenic risks with no countervailing benefit to the patient. Furthermore, each OPC offers some additional rationales for this position. For example, Rodriguez-Arias and colleagues question the very validity of the apnea test. Johnson argues that seeking consent is important, because it shows respect for, and preserves trust with, historically marginalized and exploited communities.
More Than Informed Consent
Two OPCs contend that Berkowitz and Garrett do not go far enough. Paquette et al. argue that the justification for seeking consent lies not in the procedure’s risk but in respect for the moral status and agency of the person. Therefore, they argue that informed consent is required not only for the apnea test but also for all other aspects of brain death testing. Going even further, Joffe argues that clinicians should not perform the apnea test even with informed consent, because the test is contraindicated, serves no diagnostic purpose, and produces a self-fulfilling prophecy.
Less Than Informed Consent
The remaining seven OPCs contend that informed consent is not required for apnea testing. The most common argument challenges one of Berkowitz and Garret’s premises, that the apnea test is a treatment. Because the apnea test is actually an assessment or evaluation, neither informed consent nor the right to refuse applies. Hester similarly argues that the apnea test is not itself health care, but rather a means to determine whether health care is appropriate. Bertino and Potter nicely compare brain death testing to capacity assessment.
In addition to distinguishing treatment and assessment, the OPCs make three other arguments for less than informed consent. Several argue that physicians may unilaterally perform the apnea test, because they have a fundamental responsibility to determine the appropriateness of technological interventions that they administer. Hester similarly argues that physicians must determine where their professional obligations point. Several authors argue that the risks from apnea testing are not as common or serious as Berkowitz and Garrett suggest. Some reference the COVID-19 pandemic to illustrate distributive justice arguments about wasting scarce intensive care unit (ICU) resources on the dead.
Four OPCs are more open to respecting family refusals. Lazaridis argues that while clinicians need not obtain consent, they must respect “legally protected conscientious objections,” by doing ancillary testing instead of apnea testing.
Other authors also seem somewhat open to honoring objections. For example, Hester proposes an “opt-out” system modeled on organ procurement in some jurisdictions. Kon argues for renewed efforts at shared decision making and consensus building. In the subset of cases when that is unsuccessful, Kon argues that the case should be resolved through a fair process of dispute resolution like that used in “medical futility” conflicts over nonbeneficial or potentially inappropriate treatment.
NEED FOR NATIONAL UNIFORMITY ON BRAIN DEATH
From an academic perspective, it is admirable that the OPCs have teased out seven distinct positions on whether and how to obtain consent for apnea testing. But from a practical perspective, this cacophony is horrendous. These seven positions are not just theoretical possibilities; they reflect massive dissonance in current practice.
Right now, a patient might be legally dead in Nevada, New York, or Virginia (where consent is not required). But that same patient might not be legally dead in California, Kansas, or Montana (where consent is required and might be refused).
This variability is intolerable. It is “unconscionable” for different jurisdictions to treat death differently. The legislative history of the Uniform Determination of Death Act (UDDA) is replete with statements about the importance of uniformity. For example, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research emphasized the importance of eliminating the “harm that is risked by diversity”.
In fact, the commission felt so strongly about the importance of uniformity that it was tempted to propose that the federal government enact a statute to preempt the field and take the matter away from the states. In short, consistency among jurisdictions is paramount on “an issue as important as determining when a human being has died”.
Furthermore, nonuniformity reduces credibility and trust, because it makes the determination of death seem uncertain and fallible. Even Berkowitz and Garrett worry about sending “mixed messages”. A disordered legal framework leads to a climate of general uncertainty, shaking public confidence.
REVISED UNIFORM DETERMINATION OF DEATH ACT
The UDDA did not address consent to brain death testing. But because of growing variability, I recently joined several leading neurologists to recommend amending the UDDA to add this language: “Reasonable efforts should be made to notify a patient’s legally authorized decision-maker before performing a determination of death by neurologic criteria, but consent is not required to initiate such an evaluation”.
This formulation emphasizes that family awareness about performance of a brain death determination is important, but that practitioners do not need permission to perform an assessment for the purpose of determining whether a person is alive or dead.
In April 2020, my coauthors and I took steps toward translating our draft Revised Uniform Determination of Death Act (RUDDA) from theory into practice. The Healthcare Law Committee of the Uniform Law Commission (which is responsible for uniform laws like the UDDA) invited us to make a presentation on the need to revise the UDDA. The issue of whether physicians must obtain informed consent before performing an apnea test was one of three amendments that we discussed.
Typically, the Uniform Law Commission (ULC) follows a four-step process. First, if convinced of the need for a uniform law, the Healthcare Law Committee sends the proposal to a Study Committee. Second, the Study Committee prepares a recommendation for the Scope Committee. Third, if the recommendation is positive, the Scope Committee determines whether to form a Drafting Committee. Fourth, the Drafting Committee writes the language of the uniform law for the states to consider adopting.
In this case, the Healthcare Law Committee skipped the Study Committee stage and sent the UDDA proposal directly to the Scope Committee. At its July 2020 meeting, the Scope Committee will consider whether to form a UDDA Drafting Committee. If the ULC forms this committee, the arguments in this issue of AJOB will be of immense help in crafting the most appropriate language on whether and how to obtain consent for performing tests to determine death by neurological criteria.