Need for Reliable Assessments
In an accompanying editorial, Michael J. Young, MD, MPhil, director of neuroethics at the Massachusetts General Hospital Center for Neurotechnology and Neurorecovery, and Christof Koch, PhD, an investigator at the research organization the Allen Institute who specializes in consciousness, wrote that decisions to withdraw life-sustaining treatment in cases of DCD (aka “controlled donation”) need to be made with an appreciation of the “limits of reliably assessing consciousness in critically ill, behaviorally unresponsive patients.”
“Controlled donation has expanded, now approaching nearly half of deceased donors, underscoring its clinical importance and the obligation to implement it in step with contemporary knowledge of the neural substrate of consciousness and methods of neuroprognostication,” they wrote.
Donating organs after circulatory death—after the heart and lungs stop functioning irreversibly, as distinct from donation after brain death—has become an important way of getting organs to those who need them. Outcomes for DCD have been found to be similar in the short and long term to organ donation after brain death.
When it comes to heart donation, though, there are special complexities because a period of warm ischemia always occurs after doctors withdraw life-sustaining therapy. So, historically, they restart, or reanimate, the heart to evaluate its function. But these methods can be costly, result in considerable organ discard rates, or raise concerns about reperfusing the brain and spinal cord.
In their editorial, Drs. Young and Koch pointed to near-misses in recent years when patients scheduled for organ recovery showed unexpected signs of consciousness that were recognized just moments before surgery, prompting the U.S. Health Resources and Services Administration (HRSA) to call for more safeguards.
“The ethical structure of controlled donation rests on several key premises: first, that decisions to limit or withdraw treatment are consistent with a patient's values, preferences, and goals and are made independent of considerations related to organ donation, and second, that the patient is unconscious when peridonation procedures begin,” the editorialists said.
The risk of mismanagement is heightened by the close proximity of withdrawal of treatment and organ donation, both in time and in space, they added.
“Reliance on early or single neurological assessment risks self-fulfilling prophecy and premature decision-making,” Drs. Young and Koch wrote. “Such bias can shape goals-of-care discussions toward viewing continued treatment as futile, even when a patient remains conscious or retains a meaningful chance of recovering awareness and function.”
They also cautioned about the possibility of “covert consciousness,” or the possibility of someone having subjective experience even when their behavior reveals no sign of it. Studies have documented this phenomenon, including one from 2024 that found “covert command-following” was discovered through functional MRI (fMRI) and electroencephalography (EEG) in a quarter of behaviorally unresponsive patients. An HRSA review of 351 cases in which organ donation was attempted but not performed found that 29 percent exhibited “concerning features” and 21 percent involved “neurological findings [that] were inconsistent with current standards for eligibility for controlled donation, yet procurement preparations nonetheless proceeded.”
Unlike cases of death by neurologic criteria, the role of neurologic assessment in controlled donation is “upstream of determination of death,” the editorialists wrote. But as this type of donation has spread into community settings, advanced neurologic testing and prognostic expertise “remain specialized and scarce,” they added.
Drs. Young and Koch pointed to opportunities to reinforce controlled donations with standardized, serial neurologic assessments on evolving neurobehavioral findings, pharmacological exposure, and neurophysiology and neuroimaging data, emphasizing “repeated, confounder-aware assessments.” This, they said, could avoid transplant teams being mobilized unnecessarily and reduce potential distress regarding warm ischemia times and halted procurement.
They also called for clearer procedures for identifying and addressing pharmacological and metabolic confounders, with standardized holding periods and pharmacokinetic modeling for sedatives and neuromuscular blockers “along with expended access and validation of covert consciousness testing.”
“Efforts to develop scalable approaches for guideline-directed detection of consciousness are accelerating and warrant sustained institutional and policy support,” the editorialists said.
Additionally, they suggested formalizing and studying “time-out mechanisms” allowing for interdisciplinary review of neurologic status, risk of pain and discomfort, or “persistence of consciousness at the threshold of death”; any member of the care or procurement team, along with family representatives and surrogates, would be empowered to call for a temporary suspension of the proceedings if appropriate.
Aligning controlled donation with what contemporary neuroscience reveals about “the presence of awareness and its absence will help sustain compassion and humility at the center of medicine's most consequential decisions, grounded in recognition that even at life's edge and before death occurs, consciousness may persist, however faintly,” Drs. Young and Koch said.
Neuroethicists Weigh In
The fiduciary duty of the neurologist and intensivist is always to the patient being cared for and not the prospective transplant recipient, and “every reasonable effort” should be made to understand the patient's prospect for awareness and potential recovery, said Michael Rubin, MD, MA, associate professor of neurology and neurological surgery at the University of Texas Southwestern. Clinicians should communicate this clearly to the patient's family and have appropriate palliative medications available if signs of distress arise after life-sustaining treatment stops.
“The choice of medications should not be influenced by the donation process but rather follow the same protocol that would be used if the patient were to undergo limitations of life-sustaining therapy in the intensive care unit,” Dr. Rubin said.
Clinicians should tell families about the intentional separation between patient care and organ procurement, he said, noting that he is an advocate for informed authorization, potentially involving a third party, such as an ethics consultant.
Overall, Dr. Rubin said, the safeguards typically in place work well.
“The bottom line to me is that transparency and trust are in the interests of all concerned parties,” he said. “Like any complex process with lives on the line and profound ethical questions, we need to be able to continuously assess the foundational principles guiding our work as well as the practical consequences and notable exceptions.”
Benjamin Tolchin, MD, MS, associate professor of neurology at the Yale School of Medicine and director of the Center for Clinical Ethics at Yale New Haven Health, said neurologists have a key role in helping patients and families make such high-stakes decisions.
“Frequently, families' decisions about withdrawing life-sustaining treatment and pursuing organ donation depend significantly on their understanding of the patient's neurologic injuries and prognosis,” he said, and families making these decisions need to understand the possibility of covert consciousness.
“They don't necessarily need a guarantee that there is no covert consciousness,” he added. “Indeed, it is often impossible for us to offer this assurance in the absence of experimental advanced fMRI and/or EEG modalities, which are not available at most hospitals and medical centers. Rather, the family needs to know that neurologists and other clinicians have thoroughly assessed the patient's level of consciousness and neurologic prognosis given all available and feasible technologies.” Neurologists should help families understand the best possible, worst possible, and most likely outcomes for the patient.
Validating and disseminating use of fMRI and EEG for revealing covert consciousness is important for the future, Dr. Tolchin said, but “this will necessarily be a slow process,” precluding wide availability in the near future.
“In the meantime, serial standardized neurological examinations are a valuable tool to assess the trajectory of neurological function and assess for subtle and fluctuating responsiveness to external stimuli,” Dr. Tolchin said. “These are particularly valuable in combination with serial neuroimaging and clinical neurophysiologic testing. Teleneurology consultation can be valuable in areas where serial examinations by neurology experts are not feasible.”
https://neurologytoday.aan.com/doi/full/10.1097/01.wnt.0001193556.00933.bd
Young MJ, Koch C. Consciousness and Controlled Donation After Circulatory Determination of Death. JAMA. 2026 Mar 10;335(10):850-853. doi: 10.1001/jama.2025.27045. PMID: 41587025.
Plain language summary
This Perspective discusses the limitations of reliable assessment of consciousness in critically ill, behaviorally unresponsive patients in light of recent situations in which such patients exhibited signs of consciousness moments before initiation of organ recovery surgery.
Weiss MJ, Hornby L, Rochwerg B, van Manen M, Dhanani S, Sivarajan VB, Appleby A, Bennett M, Buchman D, Farrell C, Goldberg A, Greenberg R, Singh R, Nakagawa TA, Witteman W, Barter J, Beck A, Coughlin K, Conradi A, Cupido C, Dawson R, Dipchand A, Freed D, Hornby K, Langlois V, Mack C, Mahoney M, Manhas D, Tomlinson C, Zavalkoff S, Shemie SD. Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death-Summary Report. Pediatr Crit Care Med. 2017 Nov;18(11):1035-1046. doi: 10.1097/PCC.0000000000001320. Erratum in: Pediatr Crit Care Med. 2018 Feb;19(2):178. doi: 10.1097/PCC.0000000000001415. PMID: 28925929; PMCID: PMC5671796.
Abstract
Objectives: Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada.
Methods: We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners.
Results: We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report.
Conclusions: This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation.
Weiss MJ, Hornby L, Witteman W, Shemie SD. Pediatric Donation After Circulatory Determination of Death: A Scoping Review. Pediatr Crit Care Med. 2016 Mar;17(3):e87-e108. doi: 10.1097/PCC.0000000000000602. PMID: 26727103.
Abstract
Objective: Although pediatric donation after circulatory determination of death is increasing in frequency, there are no national or international donation after circulatory determination of death guidelines specific to pediatrics. This scoping review was performed to map the pediatric donation after circulatory determination of death literature, identify pediatric donation after circulatory determination of death knowledge gaps, and inform the development of national or regional pediatric donation after circulatory determination of death guidelines.
Data sources: Terms related to pediatric donation after circulatory determination of death were searched in Embase and MEDLINE, as well as the non-MEDLINE sources in PubMed from 1980 to May 2014.
Study selection: Seven thousand five hundred ninety-seven references were discovered and 85 retained for analysis. All references addressing pediatric donation after circulatory determination of death were considered. Exclusion criteria were articles that did not address pediatric patients, animal or laboratory studies, surgical techniques, and local pediatric donation after circulatory determination of death protocols. Narrative reviews and opinion articles were the most frequently discovered reference (25/85) and the few discovered studies were observational or qualitative and almost exclusively retrospective.
Data extraction: Retained references were divided into themes and analyzed using qualitative methodology.
Data synthesis: The main discovered themes were 1) studies estimating the number of potential pediatric donation after circulatory determination of death donors and their impact on donation; 2) ethical issues in pediatric donation after circulatory determination of death; 3) physiology of the dying process after withdrawal of life-sustaining therapy; 4) cardiac pediatric donation after circulatory determination of death; and 5) neonatal pediatric donation after circulatory determination of death. Donor estimates suggest that pediatric donation after circulatory determination of death will remain an event less common than brain death, albeit with the potential to substantially expand the existing organ donation pool. Limited data suggest outcomes comparable with organs donated after neurologic determination of death. Although there is continued debate around ethical aspects of pediatric donation after circulatory determination of death, all pediatric donation after circulatory determination of death publications from professional societies contend that pediatric donation after circulatory determination of death can be practiced ethically.
Conclusions: This review provides a comprehensive overview of the published literature related to pediatric donation after circulatory determination of death. In addition to informing the development of pediatric-specific guidelines, this review serves to highlight several important knowledge gaps in this topic.
