Voices in Bioethics

Beyond Moral Regret

Jeremy Glenn Tuvida — 2026-06-14

Photo ID 11672535 © Cammeraydave | Dreamstime.com

Abstract

Tragic dilemmas, situations in which available courses of action result in inevitable harm or loss of life, impose a psychological burden of moral regret. Moral regret persists despite an agent’s reasoned deliberation, yet, paradoxically, it exists because of human agency. Empirical studies in clinical psychology, neuroscience, and behavioral economics show that agent-centric and calculative models of decision-making amplify rather than alleviate moral regret. Conventional coping strategies, namely, denying the reality of tragic dilemmas (illusionism), deferring choice to others (delegation), and embracing total accountability (responsibilisation), each prove inadequate in isolation. This article addresses a fundamental question: How should moral agents cope with moral regret arising from tragic dilemmas? This paper argues that asymmetric altruism offers a viable framework for mitigating moral regret while preserving accountability. By re-centering ethics on the pre-cognitive and non-reciprocal responsibility for the Other, Levinasian thought displaces the self-referential and procedural rationality that exacerbates regret. This paper claims that asymmetric altruism provides a more adequate response to tragic dilemmas than conventional coping strategies.

Introduction

Moral dilemmas pervade human experience in varying degrees. They present the moral agent with competing duties, obligations, and values that are on a par, necessitating moral deliberation. The moral agent can weigh, compare, and justify a decision based on principles, anticipated consequences, and virtues. Despite making a difficult choice, a moral agent does not always experience lingering regret, especially when confident he or she made the right choice.

However, tragic dilemmas are a different type of moral dilemma. In tragic dilemmas, the agent cannot avoid wrongdoing: both options require compromising a moral position and lead to tragic consequences. The agent can decide only which obligation to break or which harm to condone. The last bed dilemma, where a physician must decide who among his critically ill patients receives the sole remaining intensive care unit bed, exemplifies this condition with tragic clarity. During the COVID-19 pandemic, these dilemmas became common across healthcare systems globally, especially in low-income countries where resources were already scarce. A global study of intensive care management during the COVID-19 pandemic found inequitable access to ICUs since large numbers of patients required critical care, resources were limited, and non-COVID cases were severely compromised.^[1]

The fundamental question that this article addresses is both philosophical and practical. How should moral agents cope with the inevitable moral regret arising from tragic dilemmas without succumbing to self-deception, relinquishing responsibility, or experiencing psychological exhaustion?

Recognizing that altruism is asymmetric and grounded in non-reciprocal responsibility provides a framework for coping with moral regret. First, the paper argues that agent-centric and calculative models of decision-making amplify moral regret rather than reducing it. Second, the paper demonstrates that conventional coping mechanisms, such as denying regret, delegating accountability, and assuming total responsibility, are individually inadequate because moral agency remains inescapable and accountability alone cannot resolve moral regret. Third, the paper reconstructs Levinas’ ethics of the face-to-face encounter, emphasizing the concepts of being different, or “otherness,” vulnerability, and asymmetrical and infinite responsibility. Fourth, the paper recommends a model of asymmetric altruism grounded in vulnerability, proximity, and the concept of going beyond one’s duties. The paper demonstrates how these principles diffuse the psychological impact of moral regret. The conclusion considers the broader philosophical question of how to live with the choices we cannot avoid making.

The Nature of Tragic Dilemmas and the Inevitability of Moral Regret

When facing a moral dilemma, the moral agent does not know what he ought to do because he must compromise a moral position. In tragic dilemmas, every available choice has a bad consequence.^[2]

The last bed dilemma is an example of a tragic dilemma. It occurs when resources are scarce, and circumstances demand a decision that cannot escape tragedy.^[3] This tragic dilemma has three features. First, options are on a par because no decision-making procedure can establish that saving patient A is objectively superior to saving patient B. Second, an unquantifiable good, namely human life, is at stake. Third, treating both patients simultaneously is impossible. The dilemma is simply a constraint of reality.

However, several philosophers argue that the last bed dilemma is a fallacy. The objection rests on two claims. First, triage exists precisely to avoid such dilemmas because it provides an objective criterion for prioritization; second, no two patients ever present with identical levels of criticality.^[4] However, triage systems do not eliminate tragic choices; rather, they relocate decision-making to physicians.^[5] In effect, physicians’ personal preferences and biases influence decision-making. While no two patients have exactly the same level of severity, the influx of COVID-19 infections overwhelmed healthcare systems, leaving them unable to meet patients' medical needs.^[6]

Moral Regret as Constitutive of Tragic Choice

In tragic dilemmas, the moral agent cannot divest himself of conflicting obligations. The physician, who decides to leave a patient in the hospital corridor because no beds remain, continues to have a moral obligation to the patient but cannot meet it due to scarcity. For many physicians who faced this dilemma during the pandemic, moral regret ensued.

Furthermore, moral regret persists even within utilitarian and deontological frameworks. On the one hand, utilitarianism, at least in its simplest form, treats any form of regret as irrational, especially when the agent has maximized expected utility. It dismisses the reason for regret when the physician has saved the patient with a greater chance of survival. On the other hand, deontologists do not blame the agent because he fulfilled a moral duty despite compromising the competing moral duty. However, regret persists despite doing the right thing according to those philosophies. In other words, the moral agent understands what was at stake and regrets being unable to do both.

There are documented cases of “agent-regret” among clinicians whose faultless actions nevertheless result in harm or death.^[7] Surgical operations go awry despite foolproof techniques; life-saving interventions and correct triage decisions leave physicians guilt-stricken. It should be clear that regret is not tantamount to guilt, for guilt presupposes fault. In this case, the physician is faultless, yet he cannot escape the burden of regret following the patient’s death. Even when moral agents acknowledge that they could not have acted otherwise, persistent feelings of regret impact their well-being.^[8]

Amplification of Regret in Agent-Centric Decision-Making

The intensity and persistence of regret depend on both what is at stake and the mode of decision-making. Empirical research nevertheless reveals a counterintuitive result: more extensive deliberation tends to intensify regret rather than alleviate it.^[9]

Neuroscientific studies link regret to the orbitofrontal cortex, a brain region associated with counterfactual thinking and comparative evaluation.^[10] Regret arises when agents imagine better outcomes that might have followed from alternative choices. Deliberation increases the range and vividness of these counterfactuals and strengthens agent responsibility for both chosen and unchosen options. Consequently, deliberation can heighten regret.

Studies further show that forced choices, common in tragic dilemmas, amplify regret regardless of the outcome.^[11] The suppression of moral agency may appear to relieve the agent of regret, but really it intensifies regret and perceived responsibility, especially under uncertain outcomes. Studies show that regret increases as agents identify themselves with decisions whose outcomes they neither intended nor controlled.^[12] Both agentic decision-making and enforced choices amplify regret because they heighten the sense of ownership over the decision without assuring moral correctness.

These studies have profound implications for the standard view of moral deliberation in relation to regret. If the weighing of reasons, comparative evaluation of outcomes, and acceptance of responsibility amplify regret, then increased deliberation cannot resolve it. Paradoxically, deliberative processes may even intensify regret rather than mitigate it.

The Inadequacy of Conventional Coping Strategies

(i) Illusionism: Denial as a Defense

One strategy for avoiding moral regret is to deny the existence of tragic dilemmas. Illusionism treats the appearance of a genuine moral dilemma as a cognitive illusion that rational deliberation can dispel.^[13] If no situation requires wrongdoing regardless of choice, then an agent who reasons correctly has nothing to regret. The feeling of regret is an effect of a flawed and incomplete analysis. The fallacy argument against the last bed dilemma exemplifies illusionism. In insisting that proper triage protocols be applied, illusionists transform a tragic dilemma into a technical problem requiring a determinate technical solution. The regret that physicians felt in this strategy is a failure to apply established procedures correctly. Illusionism promises relief from regret without requiring any change in how decisions are made.

However, the promise comes at the cost of self-deception. Cognitive dissonance theory explains how individuals confronted with conflicting beliefs reduce discomfort by denying the evidence and preserving the illusion of coherence.^[14] Here, the tension between the reality of a tragic dilemma and the conviction that none exists produces cognitive dissonance, where the denial of the evidence can preserve an illusion of internal harmony. Such denial is not only epistemically dishonest but morally troubling because it leaves the moral agent unprepared to confront genuine tragic dilemmas when they arise. Denial of tragic dilemmas does not eliminate moral regret. They are only repressed and later surface in more harmful forms. Illusionism, then, offers denial rather than a genuine strategy for coping with moral regret.

(ii) Delegation: Passing the Buck

If illusionism fails, a moral agent may defer responsibility to another.^[15] Delegation, which is the transfer of decision-making authority to another person, committee, or system, offers relief from moral responsibility and regret. Such “passing the buck,” particularly in complex, high-stakes, and blame-laden decisions, is well documented.^[16] While the delegating agent may regret the outcome, he may not regret the decision itself because it was not his choice.

Choice deferral illustrates the psychology of delegation. It involves refusing or postponing decision-making by delaying or avoiding judgment altogether.^[17] For example, a physician may defer to a triage system to avoid the burden of choice and accept the system’s calculative judgment in deciding critical cases. In this example, delegation insulates the physician from external blame and internal guilt.

Delegation, however, has the same problem as illusionism. It undermines moral agency. The physician who delegates the decision to allocate the last bed does not cease to be responsible for the patient who dies. He obscures this responsibility from himself. When delegation becomes the sole response, responsibility shifts downward through the organizational hierarchy. Lower-level authorities experience the brunt of moral accountability and regret. Delegation, therefore, does not solve the problem of moral regret. It redistributes responsibility and moral regret to others while preserving the delegator’s presumed innocence. Delegation is not a genuine coping strategy for moral regret but a mechanism for shifting moral responsibility onto others.

(iii) The Burden of Taking Total Responsibility

The third conventional strategy is responsibilisation, which unconditionally affirms moral responsibility.^[18] Rather than denying or deflecting responsibility, the agent claims ownership of both choices and the corresponding moral regret. Rooted in the Western moral tradition, responsibilisation preserves moral seriousness more faithfully than either illusionism or delegation.

However, responsibilisation risks collapsing into pathological hyperagency. Agents cannot coherently be held responsible for everything that falls within the causal ambit of their choices, particularly outcomes that were unforeseeable or unpreventable.^[19] The physician becomes vulnerable to pathological hyperagency when assuming total responsibility for a patient who could not be saved, exemplifying not moral excellence but failure to recognize the limits of agency. A hyperagentic disposition amplifies rather than mitigates regret, though it may not be the cause of one’s regret.^[20] Responsibilisation, when pursued as an exclusive strategy, becomes a source of moral stress, burnout, and diminished capacity to care.

The shortcomings of each strategy do not negate their usefulness. First, illusionism recognizes that some dilemmas are resolved through better reasoning. Second, delegation acknowledges the value of collective decision-making and institutional protocols. Lastly, responsibilisation correctly rejects the denial of accountability. However, all three strategies share an agent-centric conception of moral experience that fails to account for the richness of ethical experience. While differing in their approach toward tragic dilemmas, they leave the assumption that the moral agent must remain the center of ethical reflection unexamined.

Levinas and the Decentering of the Ethical Subject

(i) The Priority of the Other

Emmanuel Levinas tried to displace the self as the primary ground of ethics in favor of the Other; he focused on the Other rather than on the self’s logic, rationality, and self-interest. According to his philosophy, the Other is absolutely other: transcendent, infinite, irreducible to any category of the self, and vulnerable.^[21] Ethics, therefore, emerges from the encounter between the self and the Other rather than from the application of moral values and principles.

This inversion reshapes the understanding of moral regret. If ethical subjectivity is grounded in responsibility for the Other through the immediate encounter, then moral experience should not be reduced to deliberation and evaluation of choices. Immediate ethical responsiveness precedes reflection. In effect, the self finds itself already responsible. Moral regret, on this view, reflects the unwavering obligation that persists even when it could not be fulfilled rather than a failure of a decision or outcome. This account shifts moral regret from the domain of moral agency to moral encounter.

The encounter is immediate and pre-reflective, calling for response rather than recognition or deliberation of the Other. Ethical responsibility establishes the priority of direct responsiveness over moral justification.

(ii) Asymmetry and Infinite Responsibility

Responsibility that arises is asymmetrical because it is non-reciprocal.²² The self is responsible for the Other regardless of whether that responsibility is returned. While reciprocity may arise in social or institutional contexts, Levinasian ethical responsibility is fundamentally one-directional and constitutive of subjectivity.

Moral responsibility for the Other is also infinite. It cannot be discharged completely or one cannot claim to have done enough. Each encounter renews the ethical obligation.

Levinasian Asymmetric Altruism: Three Principles for Coping with Moral Regret

(i) The Vulnerability Principle

Vulnerability is the fundamental condition of human existence and the primary state in which the Other makes an ethical claim.²³The vulnerability principle reframes tragic dilemmas. Standard utilitarian or deontological theories begin by asking what the agent ought to do and seek resolution through a decision procedure. The vulnerability principle, by contrast, begins from the recognition that all patients are vulnerable and therefore morally significant. Vulnerability cannot be ranked or reduced to any measurable metric. A less critically ill patient is no less real or morally commanding than one in greater danger.

This perspective clarifies the ethical status of triage as an institutional mechanism that seeks justice for all patients under conditions of severity or scarcity. Triage is a tragic necessity rather than a technical and moral solution. When a physician follows triage protocols, the inability to treat a patient reflects limited capacity rather than the termination of his responsibility. The vulnerability principle consequently shifts the source of regret. It relieves the physician of the burden of proving that a decision was objectively correct or optimal. Moral regret, thus, is a mark of fidelity to the person who cannot be saved rather than a moral failure. This shift from an ethics of agency to an ethics of relationality transforms regret from accusation into a testimony of infinite responsibility to the Other.

(ii) Proximity Principle

Proximity denotes the condition of being immediately present to the Other.²⁴ Ethical responsibility emerges from exposure to the Other and not from deliberate and rational selection of whom to care for.

The proximity principle offers guidance when vulnerability alone underdetermines choice or triage criteria remain indeterminate. Medical realities resist clear ranking, and small differences often fail to justify the moral weight placed on life-and-death decisions. On such occasions, proximity demands that the physician’s primary responsibility is to the patient encountered most immediately. However, this claim requires careful qualification in relation to the general rule of “first come, first served.” Proximity is a description of an ethical relation and not a procedural standard. The patient who confronts the physician face-to-face is proximate in the ethical sense, while other patients remain proximate through institutional mediation. Proximity complements rather than replaces triage systems in guiding actions when protocols are indeterminate.

Proximity also reframes moral regret. Instead of attaching moral regret to the choice, proximity locates regret within the tragic situation. What is regretted is not the decision but the limiting conditions that prevent care for all. Moral regret, therefore, reflects the tragedy of the one’s finitude and situation rather than a defect in moral agency.

In addition, proximity addresses the problem of cognitive depletion, which leads decision makers to become progressively less capable of sound judgment.²⁵A physician who must repeatedly decide who gets to live and who does not is at risk of such depletion, with dire consequences for patient care and well-being. In such circumstances, attentive and intuitive responsiveness may be ethically preferable to exhaustive calculation. Proximity legitimizes immediate responses as adequate moral approaches under extreme conditions.

(iii) The Supererogation Principle

Levinas’s account of responsibility as non-reciprocal and infinite aligns with supererogatory actions, or acts performed freely for the benefit of others, often at the cost of the agent, that go beyond a duty.²⁶ Supererogatory actions are not required, but they express deep ethical commitment. When moral regret persists despite correct decision-making, supererogatory action can diminish the force of regret without denying its legitimacy.²⁷ Examples involve staying with the patient, being physically present, administering palliative care, or ensuring the patient does not die alone.

Such prosocial actions do mitigate negative feelings.²⁸ Further studies establish a positive correlation between prosocial behavior and psychological well-being.²⁹ These findings affirm that supererogatory actions actively counteract the psychological burden of unavoidable harm and promote the psychological resilience needed to remain present to the vulnerable Other.

Together, the three principles form a coherent ethical response to tragic dilemmas and moral regret. Vulnerability affirms that every other person commands a personal response; proximity guides actions when protocols underdetermine the right action; supererogation sustains responsibility beyond duty. Rather than denying tragedy, delegating responsibility, or embracing absolute culpability, Levinasian asymmetric altruism offers a relational ethics capable of coping with moral regret without collapsing under it.

Counterarguments

Many would argue that many philosophers, e.g., Kant’s duty-based ethics strongly require caring for the vulnerable/recognizing vulnerability. An abstract Other is not necessarily going to make a physician less regretful. Many healthcare workers were deeply moved by the vulnerability they witnessed.

Moral regret could continue alongside vulnerability, proximity, and supererogation, which is consistent with many philosophies, and, in practice, many healthcare workers did this – they helped facetime relatives, etc. Proximity and vulnerability are built-in to triage.

Conclusion

Particularly in clinical settings, tragic dilemmas generate forms of moral regret that cannot be eliminated with better rules or clearer decision-making processes. Levinasian asymmetric altruism offers a more adequate response to tragic dilemmas than the conventional strategies of illusionism, delegation, and responsibilisation. By shifting ethics from agency to responsibility for the Other, it reframes moral regret as evidence of the self’s infinite and irreplaceable responsibility rather than as a failure of moral agency.

This reframing of moral regret is given practical shape through the principles of vulnerability, proximity, and supererogation. Together, they direct ethical life away from rule-following and toward sustained responsiveness even under conditions of constraint. Such a perspective transforms moral regret as a sign of moral fidelity rather than moral culpability.

Although the experience of moral regret in tragic dilemmas is undesirable and ineliminable, it need not be corrosive and debilitating. Through Levinasian asymmetric altruism, moral regret becomes more bearable by affirming human finitude and plenitude, and enduring responsibility to the Other that persists beyond what one was able to do.

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^[[2]] Ives, J. (2020, March 14). Coronavirus may force UK doctors to decide who they will save. The Guardian. https://www.theguardian.com/commentisfree/2020/mar/14/coronavirus-outbreak-older-people-doctors-treatment-ethics.

^[[3]]Teres, D. (1993). Civilian Triage in the Intensive Care Unit: The Ritual of the Last Bed. Critical Care Medicine 21 (4): 598-606. DOI: 10.1097/00003246-199304000-00022.

^[[4]^] Valera, L., Castro, R., & Carrasco, M. (2022). Fallacy of the Last Bed Dilemma. Journal of Medical Ethics 48 (11): 915-921. DOI: 10.1136/medethics-2021-107333.

^[[5]] Smith, E., Kulasegaran, N., Cairns, W. et al. (2024). Physician experiences of critical care triage during the COVID-19 pandemic: a scoping review. Discover Health Systems 3 (30). https://doi.org/10.1007/s44250-024-00086-6

^[[6]] Jiaoling, H., Ying, Q., Yuge, Y., Hong, L., & Laijun Z. (2024). Addressing Hospital Overwhelm During the COVID-19 Pandemic by Using a Primary Health Care-Based Integrated Health System: Modeling Study. JMIR Medical Informatics 12. https://doi.org/10.2196/54355

^[[7]] Enck, G., & Condley, B. (2023). Agent-Regret in Healthcare. The American Journal of Bioethics, 25(2), 6–20. https://doi.org/10.1080/15265161.2023.2276166

^[[8]^]de Snoo-Trimp, J., Van Den Hoven, M., & Molewijk, B. (2025). Agent-Regret in Healthcare: Toward a More Precise and Empirical-Based Look into the Dynamics of Agent-Regret Experiences. American Journal of Bioethics 25 (2):29-31. https://doi.org/10.1080/15265161.2024.2441744

^[[9]] Vickers, A. J. (2017). Decisional Conflict, Regret, and the Burden of Rational Decision Making. Medical Decision Making: An International Journal of the Society for Medical Decision Making, 37(1): 3–5. https://doi.org/10.1177/0272989X16657544

^[[10]]Turin, M. (2023). The Neuroscience of Regret: Why it Haunts us. Science News Today. https://www.sciencenewstoday.org/the-neuroscience-of-regret-why-it-haunts-us

^[[11]^]Matarazzo, O., Abbamonte, L., Greco, C., Pizzini, B., & Nigro, G. (2021). Regret and Other Emotions Related to Decision-Making: Antecedents, Appraisals, and Phenomenological Aspects. Front. Psychol.,12, sec. cognition. https://doi.org/10.3389/fpsyg.2021.783248

^[[12]] Connolly, T., Ordóñez, L. D., & Coughlan, R. (1997). Regret and responsibility in the evaluation of decision outcomes. Organ. Behav. Hum. Decis. Process. 70, 73–85. doi: 10.1006/obhd.1997.2695

^[[13]] Danaher, J. (2022). Tragic Choices and the Virtue of Techno-Responsibility Gaps. Philosophy and Technology 35 (2):1-26. doi:10.1007/s13347-022-00519-1

^[[14]]Festinger, L. (1957). A Theory of Cognitive Dissonance. Stanford University Press.

^[[15]] Danaher, 2022.

^[[16]] Steffel M., Williams, E., & Perrmann-Graham, J. (2016). Passing the buck: Delegating choices to others to avoid responsibility and blame. Organizational Behavior and Human Decision Processes, 135: 32-44. doi.org/10.1016/j.obhdp.2016.04.006.

^[[17]] Bhatia, S., & Mullett, T.L. (2016). The Dynamics of Deferred Decision. Cognitive Psychology, 86, 112-151. https://doi.org/10/1016/j.cogspych.2016.02.002

^[[18]^]Danaher, 2022.

^[[19]^] Levy, N. (2011). Hard Luck. Oxford University Press; Levy, N. (2014). Consciousness and Moral Responsibility. Oxford University Press.

^[[20]^] Matarazzo et al., 2021.

^[[21]^] Levinas, 1979. p. 194 (alterity).

[22] Levinas, 1979. p. 216.

[23] Levinas, 1979. p.199.

[24] Bernasconi, R. (2018). When Alterity Becomes Proximity: Levinas' Path. In The Oxford Handbook of History of Phenomenology. (Dan Zahavi, Ed.) Oxford University Press.

[25] Ariely, D. (2012). The Honest Truth about Dishonesty. Harper Collins Publishers.

[27] Schwind, P. (2019). “Do Psychological Defeaters Undermine Foundationalism in Moral Epistemology? - a Critique of Sinnott-Armstrong’s Argument against Ethical Intuitionism.” Ethical Theory and Moral Practice. 22 (4):941-945. https://www.jstor.org/stable/45237961.

[28] Espinosa JC, Antón C and Grueso Hinestroza MP (2022). Helping Others Helps Me: Prosocial Behavior and Satisfaction With Life During the COVID-19 Pandemic. Front. Psychol. 13:762445. doi: 10.3389/fpsyg.2022.762445

[29] Kakulte, A., & Shaikh, S. (2023). Prosocial Behavior, Psychological Well-Being, Positive and Negative Affect Among Young Adults: A Cross-Sectional Study. Industrial Psychiatry Journal. 32 (1):127-130. https://doi.org/10.4103/ipj.ipj_214_23

Legal Uncertainty after Dobbs and Its Impact on Clinical Practice

Shiv Mehrotra-Varma — 2026-06-14

Photo ID 315013029 © Zimmytws | Dreamstime.com

Introduction

The US Supreme Court’s 2022 decision to overturn Roe v. Wade sparked widespread scrutiny due to its far-reaching legal, medical, and societal consequences. In the immediate aftermath, numerous states enacted or enforced abortion bans that triggered the rapid closure of abortion clinics. These closures have led many patients to travel long distances to obtain care, often encountering significant delays that disproportionately burden low-income individuals, rural populations, and racial and ethnic minority groups.^[1]

Yet focusing primarily on access — as much of the public health literature and advocacy research has done — obscures another significant long-term impact of Dobbs: the introduction of legal uncertainty into routine clinical decision-making.^[2] Legal scholars and clinicians began documenting these risks immediately after the decision was issued.^[3] This form of uncertainty reflects the ambiguity in how statutory restrictions are interpreted and applied in clinical settings. In states with abortion restrictions, physicians must consider potential legal ramifications with each medical decision, often under extreme, high-pressure conditions and with limited information. This has reshaped how care is delivered across a variety of clinical settings, so the health consequences of the Dobbs decision cannot be fully understood by focusing solely on abortion and miscarriage.

Researchers and clinicians increasingly report that abortion restrictions have destabilized standard medical practice beyond access to abortion itself.^[4] Bans have complicated the evidence-based management of miscarriages and obstetric emergencies, delayed or denied fertility treatments, constrained cancer therapies, and introduced uncertainty into the prescribing of medications with teratogenic or abortifacient potential, including methotrexate, misoprostol, and mifepristone.^[5]^[6] Abortion restrictions have affected multiple aspects of standard health-care delivery, creating uncertainty for patients and clinicians.

Delays Due to a Need for Legal Advice

As a result, clinicians may seek legal counsel before making decisions.^[7] However, much of the existing medical literature has focused on disruptions in abortion care rather than on how legal ambiguity affects routine clinical practice. Delays in treatment are a well-established source of harm, particularly in obstetric and emergency settings.^[8] When clinicians must delay intervention until conditions worsen, patients face higher risks of infection, hemorrhage, and long-term morbidity and mortality. Investigative reporting and case analyses have documented instances in which doctors turned away patients seeking emergency medical care for a miscarriage multiple times, even as some patients developed severe sepsis.^[9]

Emerging evidence indicates that legal uncertainty is already associated with worse clinical outcomes. A study of Texas hospitals following the implementation of Senate Bill 8, a near-total ban on abortions after approximately six weeks of gestation, reported delays and denials of care for patients with pregnancy complications, including in instances where abortion was the standard of care.^[10] A subsequent analysis found that Texas abortion restrictions delayed care and significantly increased maternal morbidity.^[11] These findings raise concerns that the state laws restricting abortion in the aftermath of the Dobbs decision may be influencing patient outcomes.

Qualitative research further illustrates the impacts. This new form of defensive practice, termed “hesitant medicine,” occurs when providers delay, withhold, or modify care to avoid legal scrutiny.^[12] Physicians described prioritizing legal defensibility alongside clinical judgment in urgent scenarios. Legal ambiguity in other restrictive states has produced similar patterns.^[13]

Crucially, this phenomenon extends beyond abortion treatment. Emergency departments, inpatient services, outpatient clinics, and specialty practices all exist within the same legal environment. A lack of legal clarity can influence a multitude of related decisions (e.g., management of miscarriage, ectopic pregnancy, sepsis, cancer treatment). In a multi-state qualitative study, clinicians reported delaying or avoiding first-line, teratogenic therapies for reproductive-age patients who were not pregnant due to concern that a subsequent pregnancy could require abortion.^[14] These effects extend to wanted pregnancies and clinical care in other specialties.

Contribution to Physician Shortages

There are also broader implications for the capacity of health systems nationwide. Whether through limiting the scope of practice, declining to provide certain services, or leaving restrictive areas altogether, legal threats are accelerating existing workforce and infrastructure challenges. A national analysis showed reductions in residency programs in states with abortion bans following the Dobbs decision, raising concerns about future access to care in such areas.^[15] Reports also suggest that some physicians have left or are considering leaving restrictive states, potentially further exacerbating workforce shortages. These shortages may exacerbate pre-existing gaps in care in the most vulnerable areas.

Conclusion

Ultimately, the uncertainty about criminal liability impacts clinical practice. The constant need to analyze legal risks in routine, everyday decision-making produces downstream consequences that extend well beyond abortion care.

Research focused solely on reduced access to abortion complements research on the legal uncertainty itself and its impact on many areas of clinical care. While some researchers and organizations focus on access to abortion care, it is crucial also to consider the impact of a fear of liability on clinical care beyond abortion, and even beyond pregnancy.

Laws governing reproductive care that do not allow clinicians to act on medical judgment in good faith — without fear that appropriate treatment will later be construed as criminal conduct — risk undermining not only abortion care, but the integrity of clinical practice.

[1] Fuentes, L. (2023, January). Inequity in US abortion rights and access: The end of Roe is deepening existing divides. Guttmacher Institute. https://www.guttmacher.org/2023/01/inequity-us-abortion-rights-and-access-end-roe-deepening-existing-divides

[2] Bearak, J., Popinchalk, A., Ganatra, B., Moller, A.-B., Tunçalp, Ö., Beavin, C., Kwok, L., & Alkema, L. (2020). Unintended pregnancy and abortion by income, region, and the legal status of abortion: Estimates from a comprehensive model for 1990–2019. The Lancet Global Health, 8(9), e1152–e1161. https://doi.org/10.1016/S2214-109X(20)30315-6

[3] Dobbs Reingold, R. B., Gostin, L. O., & Goodwin, M. B. (2022). Legal risks and ethical dilemmas for clinicians in the aftermath of Dobbs. JAMA, 328(17), 1695–1696. https://doi.org/10.1001/jama.2022.18453

[4] Buchbinder, M., Arora, K. S., McKetchnie, S. M., & Sabbath, E. L. (2025). Social Science & Medicine, 369, 117856. https://doi.org/10.1016/j.socscimed.2025.117856;
Joffe, C., & Kimport, K. (2025). Journal of Women’s Health, 34(6), 754–759. https://doi.org/10.1089/jwh.2024.0589

[5] Kimport, K., & Kaller, S. (2025). Contraception, 151, 111043. https://doi.org/10.1016/j.contraception.2025.111043;

[6] Zia, Y., Somerson, E., Folse, C., et al. (2024). Reproductive Health, 21, 171. https://doi.org/10.1186/s12978-024-01908-9

[7] Buchbinder, M., Arora, K. S., McKetchnie, S. M., & Sabbath, E. L. (2025). Social Science & Medicine, 369, 117856. https://doi.org/10.1016/j.socscimed.2025.117856

[8] Gerdts, C., et al. (2016). "Impact of clinic closures on women obtaining abortion services after implementation of a restrictive law in Texas." American Journal of Public Health, 106(5), 857–864. https://doi.org/10.2105/AJPH.2016.303134

[9] Arey, J., et al. (2022). A preview of the dangerous future of abortion bans—Texas Senate Bill 8. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMp2207423

[10] Arey, J., et al. (2022). A preview of the dangerous future of abortion bans—Texas Senate Bill 8. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMp2207423

[11] Nambiar, A., Patel, S., Santiago-Munoz, P., Spong, C. Y., & Nelson, D. B. (2022). American Journal of Obstetrics & Gynecology, 227(4), 648–650.e1. https://doi.org/10.1016/j.ajog.2022.06.060

[12] Lilly, A. G., Newman, I. P., & Bjork-James, S. (2024). Social Science & Medicine, 350, 116912. https://doi.org/10.1016/j.socscimed.2024.116912

[13] Buchbinder, M., Arora, K. S., McKetchnie, S. M., & Sabbath, E. L. (2025). Social Science & Medicine, 369, 117856. https://doi.org/10.1016/j.socscimed.2025.117856

[14] Physicians for Human Rights. (2025). Cascading harms: How abortion bans lead to discriminatory care across medical specialties. https://phr.org/our-work/resources/cascading-harms-how-abortion-bans-lead-to-discriminatory-care-across-medical-specialties/

[15] Association of American Medical Colleges. (2024). States with abortion bans see continued decrease in U.S. MD senior residency applicants. https://doi.org/10.15766/rai_dnhob2ma

An Ethical Consideration of Medical Drones in Wartime

John Rego — 2026-05-31

Photo by Fikri Rasyid on Unsplash

Abstract

While nations race to expand the capabilities of drone technology, there is a need to consider how this technology is reshaping our ethical obligations. The prevailing ethical-legal framework that informs international wartime bioethics is the Geneva Conventions, but at the time they were concluded, they could not have anticipated how medical drones would affect the treatment of the wounded. This essay argues that medical drone technologies demand fresh consideration of moral duties and proposes solutions to prospective moral issues within the framework of the Geneva Conventions.

Introduction

The civilian and military sectors are increasingly using drones. The Russia-Ukraine war has demonstrated the indispensability of drones on the contemporary battlefield. Innovators, engineers, and strategists are developing and evaluating drone technology while considering cost and function. As seems to be the case for many innovations, thoughtful ethical consideration tends to lag. This paper aims to raise awareness of the ethical considerations surrounding drone technology in modern conflict, asking which moral duties rightly accompany this extraordinary technology. Rather than attempt to establish a universally agreed-upon ethic, analysis of whether the Geneva Conventions (to which the US and 195 other nations are signatories) require the use of medical drones to support wounded opposition personnel, and, if so, to what extent. This paper argues that, to meet the requirements of the Geneva Conventions, militaries must use their best efforts to adhere to the duty to rescue wounded enemies. When drone use is exclusively medical, and a drone is so marked, drones and their operators should be afforded special protection.

Duty to Rescue Enemy Wounded

The word choice of Articles 12 and 15 on the treatment of wounded Armed Forces is undeniably strong. Article 12 states, “… they shall not willfully be left without medical assistance and care,…”.^[1] In the same chapter, we find, “At all times… Parties to the conflict shall, without delay, take all possible measures to search for and collect the wounded and sick…”^[2] These statements leave little room to debate the obligation of Parties to the conflict to assist the wounded on the battlefield. An ethics textbook used by the US military says, “…military physicians cannot, as members of the armed forces, live up to the expectations and responsibilities of the Geneva Conventions.”^[3] While it may be difficult, I argue that military ethics should call for rescuing enemy wounded in accordance with the Geneva Conventions, with reasonable exceptions based on risk to the rescuers. Traditionally, the Geneva Conventions impose a reasonable duty to act in good faith, based on a reasonable commander standard.

The US military follows a hybrid ethical system with duty-bound deontological and consequentialist elements. Even if there is a duty to attend to the wounded opposing forces “without delay” in accordance with the Geneva Conventions, rescuers may justify noncompliance with this moral burden by arguing that there is an unacceptable risk of harm to themselves, which would impair the unit’s ability to care for current and future casualties – an unacceptable outcome. Applying utilitarianism, military officers may conclude that saving the life of one wounded enemy is not worth risking the lives of four of our friendly forces. Hypothetically, suppose those friendly forces are dispatched anyway, and they become casualties. This development would further expand both the moral responsibility and risk of medical planners. The neglect of the duty to assist enemy wounded, for the regard and safety of our personnel and resources, is a well-discussed ethical dilemma and appears to be an accepted normative practice that contradicts the Geneva Conventions. This invokes a threshold deontology, in which the duty to rescue enemy wounded is binding when circumstances permit but may be overridden when circumstances involve unacceptable risk.

Emerging drone medical technologies change the risk calculus. A team of stretcher-bearers is no longer necessary to evacuate a non-ambulatory casualty. In Ukraine, ground drones have been used to traverse disputed battlefields to identify friendly wounded forces and evacuate them to safety. Germany has been developing an unmanned aerial vehicle called “Grille” which is intended to transport casualties by air.^[4] These technologies challenge the established norm that allows consideration of the risk to rescuers. One may conclude that with emerging drone medical technologies, parties to the conflict now risk only non-human resources (and, arguably, some degree of operational security due to observable drone movements).^[5] Rather than evaluating whether one opposition casualty is worth the lives of four friendly medics, the question becomes whether one opposition wounded person is worth $35,000 in equipment and a small operational security risk.^[6] Considering emerging medical drone technologies, I propose that the Geneva Conventions compel strategic medical planners to ask themselves whether and how moral obligations should shift due to the possibility of using drones rather than soldiers.

Protections of Drones

Chapter III of the Geneva Conventions mainly concerns the protections granted to medical persons, buildings, materials, and vehicles involved with the evacuation and care of wounded individuals. It is silent as to what protections might apply to drones. Like persons, they perform actions and are unlike inanimate material or a conventional vehicle without an internal operator. But they are unlike persons in that a drone possesses no “will” and is compelled only by a distant operator. Furthermore, persons have a claim to dignity, and arguably, the Geneva Conventions obligate military actors to respect human dignity. It would seem inappropriate to grant that dignity to a drone.

Instead, drones may be more like medical material or vehicles in Articles 33, 35, and 36. In either case, the designation of these drones as specifically and exclusively as medical equipment appears to be essential for protection under the Geneva Conventions. Drones are highly versatile tools. For example, a drone can drop a medical aid kit or a grenade. Even a medical drone operated under the most peaceful intentions collects reconnaissance on the battlefield in which it is operating. Medical drones that enjoy protection as medical equipment must be specifically marked as such and have their capabilities limited to the sole purpose of aid and rescue, or else abandon their protections and risk rightful destruction as tactical assets on the battlefield.

Drones are responsible for between 70 and 80 percent of those injured on both sides of the war in Ukraine.^[7] This makes drone operators the deadliest individual agents of this contemporary conflict. Both Russia and Ukraine are seeking skilled drone operators. Furthermore, it is in the interest of both sides to capture or neutralize drone operators. Under Article 25 of the Geneva Conventions, “auxiliary personnel” such as stretcher-bearers are afforded “respect and protection” if they come into contact with the enemy or fall into enemy hands at the time that they are carrying out their duties. A medical drone operator searching for or carrying wounded out of the battlefield may be like a stretcher bearer, unlike drone operators performing military tactical operations. For drone operators performing both medical and tactical roles, it is less clear whether it is ethical or practical to afford them the same protections as a field medic or orderly in a field hospital.

Ethical and Legal Issues

Military strategic and medical planners should be proactive rather than reactive to the ethical challenges posed by emerging medical drone technologies. Under the current ethical framework of the Geneva Conventions, Parties to a conflict have a duty to provide for enemies wounded on the battlefield. With new technologies, this duty may be performed with minimal or no risk to military personnel.^[8] How to characterize drone operators performing both medical and military tactical operations is an open issue.

On Articles 12 and 15 – A Duty to Aid

The first Geneva Convention in 1864, and even the Fourth Geneva Convention in 1949, did not anticipate that battlefield wounded could be cared for and recovered without risking friendly personnel. However, the Conventions most likely anticipated that recovery of enemy wounded required a significant resource expenditure and did not consider resource expenditure a cause for exception to the moral duty. But resources are not infinite. Some may argue that it is neither reasonable nor practical to expect a Party to expend great resources to a cause that does not directly advance its military and political goals amidst the conflict. If we accept the resource expenditure, planners and political bodies must budget accordingly. Advanced consideration of anticipated risk to equipment would help Parties prepare for fulfilling the ethical duty under the Conventions.

On Protection Conferred to Drones under the Geneva Conventions

As with many historical technological innovations that have had non-military use (metallurgy, gunpowder, aviation), war has expedited drone development.^[9] In the Russia-Ukraine war, drones observe from above to coordinate ground forces or weaponry and drones can carry deadly payloads to harm opposition personnel or equipment. If medical drones are to enjoy protection, there must be a clear distinction between medical drones and non-medical drones. Chapter VII of the Geneva Conventions discusses the use of the distinctive emblem (red cross, red crescent, red lion and sun, etc.) on “all equipment employed in the Medical Service.”^[10] At a minimum, medical drones should conform to this standard and bear the distinctive emblem. But displaying an emblem does not limit medical drones’ capabilities. Infrared optics, audio recording, and pyrotechnics could serve multiple functions. While innovators continue to push the functional capabilities of drones, I propose we question which capabilities medical drones may possess if they wish to be treated as exclusively medical under the Geneva Conventions or pertinent international law.

On Treatment of Medical Drone Operators and Medical Drone Units

Notably, the skillset that makes a sniper a lethal agent in an armed conflict differs significantly from that which makes a medic an effective stretcher-bearer. And yet, the skillset that makes an explosive drone-operator an effective lethal agent (namely, control and navigation of their drone) is not markedly different from the skillset of an effective medical drone operator. In the Russia-Ukraine war, opposing forces target drone operators. There are accusations of prisoner mistreatment, which might be seen as punitive toward drone operators due to their occupation as particularly lethal agents.^[11] Persons dedicating their skills to the rescue and treatment of friendly and opposing casualties should not be subject to the same hostility. Yet, it is arguable that highly lethal drone operators should not have the same protections as dedicated medical personnel merely because the drone is being used for a medical purpose at the time of capture. I propose that medical units should possess dedicated medical drone operators – operators who are not responsible for any destructive or reconnaissance activities. I propose that these medical units, their operators, and the specifically designed and designated medical drones should enjoy the protections conferred by the Geneva Conventions. One counterargument is that the overlapping roles are efficient. I suggest that efficiency should be accompanied by a lack of special protection.

Conclusions

Medical drones are already part of the battlefield and will continue to have a greater role in modern conflicts. Yet ethical considerations are developing alongside these emerging technologies. We may apply existing legal-ethical frameworks, such as the Geneva Conventions, or develop mutually agreed-upon laws and guidelines so that these technologies may be used ethically and reduce suffering. I argue that a proactive approach is required of our strategic and medical planners. If we accept our duty to care for wounded enemies on the battlefield, then we must prepare for that duty by securing the resources and budgets needed to address this moral burden. If we prepare to use medical drones, we should do so ethically under protections outlined in mutually agreeable international law. Any nation ill-prepared for technological advances risks a fatal disadvantage. While we consider the functional ability of these technologies, we must anticipate the evolving ethical issues that accompany them.

[1] Geneva Convention (I) for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field, Aug. 12, 1949, 75 U.N.T.S. 31, art. 12.

Note: Readers will benefit from having the verbatim text of the Geneva Conventions available to them for reference while considering this essay. The text is available at: https://ihl-databases.icrc.org/en/ihl-treaties/geneva-conventions-1949additional-protocols-and-their-commentaries

[2] Geneva Convention I, art. 15.

[3] Victor W. Sidel and Barry S. Levy, “Physician-Soldier: A Moral Dilemma?” in Military Medical Ethics, vol. 1, ed. Michael L. Gross (Dordrecht: Springer, 2006), 303.

[4] Avilus GmbH, “Grille,” https://www.avilus.com/solution/grille

[5] However, drone operators are vulnerable due to the limited range of drones.

[6] Iliya Kesaiev, “Robot Helps Wounded Ukrainian Soldier Evacuate with Russian POW,” NV (English edition), February 13, 2026, https://english.nv.ua/nation/robot-delivers-aid-saving-both-ukrainian-soldier-and-russian-captive-50583544.html

The price for a ground drone used for medical transport of casualties being $33,500-$34,000

[7] Eva Hartog, “Latvian Report: Drones Are Mass Killers on the Ukraine Front,” Politico (European edition), January 26, 2026, https://www.politico.eu/article/latvian-report-drones-are-mass-killers-on-the-ukraine-front/

[8] Drone operators may face risks, partly depending on the range of the drone.

[9] DeVore, Marc R. 2023. “‘No End of a Lesson:’ Observations from the First High-Intensity Drone War.” Defense & Security Analysis 39 (2): 263–66. doi:10.1080/14751798.2023.2178571; CSIS. 2025. “The Russia-Ukraine Drone War: Innovation on the Frontlines and Beyond.” Csis.org. 2025. https://www.csis.org/analysis/russia-ukraine-drone-war-innovation-frontlines-and-beyond

[10] Geneva Convention I, art. 39.

[11] Anderson, Kenneth, and Matthew C. Waxman. “The Continuing Autonomous Arms Race.” Lieber Institute for Law and Warfare, United States Military Academy at West Point, April 20, 2022. https://lieber.westpoint.edu/continuing-autonomous-arms-race/

Excluded by Design

Vidhi Bansal — 2026-05-06

Photo ID 105439831 © Atthapon Raksthaput | Dreamstime.com

Abstract

Dementia affects millions of people worldwide. Migrant communities are at increased risk of dementia while simultaneously experiencing inequity in diagnoses. This article argues that contemporary dementia diagnostic standards systematically exclude the cognitive experiences of the global majority, rendering migrants epistemically invisible within clinical systems calibrated to Western populations. Diagnostic justice warrants the development of inclusive diagnostic standards, ancestry-diverse biological research, and equitable global research collaborations.

Introduction

Dementia affects over 55 million people worldwide, yet there are global disparities in diagnostic distribution.^[1] Despite being more vulnerable to dementia, migrants in high-income countries are more often misdiagnosed, diagnosed late, or undiagnosed, especially if they are of African or Asian origin.^[2] These disparities are frequently attributed to cultural distance, language barriers, or individual clinician limitations.^[3] While these factors affect clinical practices, they fail to explain why diagnostic failure is so systematic, persistent, and institutionally reproduced. This paper argues that inequities in dementia diagnostics among migrant populations reflect not a failure of cultural competence but an ethical failure of knowledge production. These inequities stem from epistemic injustice embedded in global research structures that determine whose cognitive experiences generate the evidence used to define dementia. By examining how global research inequities shape diagnostic tools, clinical encounters, and institutional responsibility, I contend that achieving diagnostic justice requires epistemic repair at a global scale.

Dementia Underdiagnosis in Migrant Populations Is Not Accidental

While low- and middle-income countries (LMICs) account for an estimated two-thirds of the global dementia population,^[4] this distribution reflects their large share of the world’s population rather than a higher age-adjusted prevalence. The key disparity lies in diagnostic capacity: despite bearing the majority of cases, LMICs possess only a fraction of the diagnostic infrastructure available in high-income countries (HICs), resulting in formal diagnosis rates below 10 percent in many LMICs^[5] compared to approximately 50 percent in high-income regions.^[6] For migrants, this structural gap creates a distinct paradox: individuals of African and Asian origin in HICs face significantly elevated dementia risk — particularly vascular dementia — yet they remain systematically underdiagnosed. They have a higher prevalence of vascular comorbidities, as well as higher rates of social isolation and lower educational attainment. While care-seeking norms vary, reluctance to pursue diagnosis cannot explain why, when migrants do present for care, diagnostic tools fail to validly capture cognitive impairment.^[7] This paradox emerges because migrants come from systems where dementia is rarely diagnosed and find themselves in health systems whose tools are not calibrated to their linguistic, educational, or epidemiological backgrounds, effectively ensuring that their heightened objective risk remains clinically invisible.^[8]

Standard reform efforts typically emphasize “cultural competence” as a silver bullet for these gaps. While this approach is valuable, it does not explain persistent disparities seen across clinicians and institutions. Attributing underdiagnosis of migrants to clinician training, individual bias, or a lack of cultural competence obscures a more structural cause: the diagnostic tools and evidentiary standards used in the consulting room are derived from a research ecosystem that excludes much of the global majority.^[9]

Epistemic Injustice in Dementia Diagnosis

The persistent underdiagnosis of dementia in migrant populations is a form of epistemic injustice. It occurs when clinicians exclude patients as credible sources or conveyors of knowledge within clinical systems. In dementia care, this exclusion operates through two mechanisms. First, migrants experience testimonial injustice when clinicians discount or misclassify their narratives of cognitive change. This often arises from intersecting biases, including ageism and assumptions about how cognitive decline presents in culturally diverse populations, leading clinicians to attribute reported symptoms to “normal aging” or psychosocial factors rather than initiating formal evaluation. As a result, patient-reported concerns are deprioritized, delaying or preventing diagnostic workup. Second, migrant populations face interpretive injustice due to a collective gap in interpretive resources. Because standard diagnostic tools were not designed to accommodate the linguistic, cultural, or educational backgrounds of many people from LMICs, clinicians lack adequate interpretive frameworks to evaluate cognitive symptoms when they are expressed.^[10] Consequently, diagnostic systems fail to register migrant patients’ experiences as clinically meaningful.

How Global Research Inequity Produces Diagnostic Harm

A global research monoculture has produced the downstream diagnostic harm that migrants experience. Approximately 90 percent of all dementia studies rely on high-income populations in the US and Europe, despite these regions representing only 10 to 15 percent of the global population.^[11] This imbalance narrows the “standard” of cognitive health to a specific demographic: Western, English-speaking, and relatively highly educated.^[12]

Examples of this research inequity appear in widely used cognitive tests, including the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Researchers standardized these tests using Western cohorts, introducing biases in education, literacy, and test design.^[13] Individuals in rural schools in LMICs or unfamiliar with standardized testing formats may score lower due to test design rather than cognitive impairment. Such miscalibrated tools produce dual harm: false positives and false negatives. False positives pathologize cultural and educational differences. False negatives delay recognition of true impairment when clinicians, wary of test bias, misattribute genuine decline to “normal aging” or cultural variation, thereby increasing the risk of misdiagnosis.^[14]

Biomarkers and genomic risk factors, such as the APOE-ε4 allele, are validated primarily in European-ancestry populations, even though the association between these markers and dementia risk varies meaningfully across genetic ancestries.^[15] Furthermore, interpreter-mediated assessments using standard tools can lead to severe distortion, as even professional translators often unknowingly alter the core meaning of cognitive items or provide cues that compromise the test’s validity. Finally, the lack of clinical standards for bilingualism and late-life language attrition leads clinicians to mislabel complex linguistic patterns as pathology.^[16] In India, for example, 22 official languages and hundreds of dialects complicate the development of a single standardized cognitive battery. Similar gaps exist across Africa and Southeast Asia.^[17] National health systems in many LMICs rely on diagnostic tools developed and standardized in high-income countries, which often fail to reflect local sociocultural contexts or educational distributions. At the same time, migrants in HICs are assessed using the same instruments, despite their misalignment with patients’ backgrounds, reinforcing a form of structural dependence on Western-derived standards.

Migrants enter HIC health systems without the valid reference standards necessary for accurate diagnosis. Existing diagnostic norms do not account for their linguistic, educational, and cultural heterogeneity, leading systems to misinterpret differences as pathology. Underdiagnosis in some populations also reinforces a self-perpetuating feedback loop: communities excluded from diagnosis remain underrepresented in research, ensuring that the evidentiary gaps driving diagnostic failure persist over time. When the entire scientific foundation of dementia diagnosis — from cognitive batteries to PET-imaging thresholds —relies on data obtained in HICs, diagnostic inequity becomes a predictable outcome.^[18]

Over time, these diagnostic failures produce downstream harms that extend beyond clinical delay. Both overdiagnosis and underdiagnosis — arising from the same epistemically miscalibrated tools — distort access to care. Misclassification may either restrict access to appropriate treatment or inappropriately medicalize individuals whose cognitive differences reflect education, language, or culture rather than pathology. These errors increase caregiver burden, limit patient autonomy, and affect eligibility for disability benefits, immigration proceedings, and social services, further amplifying existing structural vulnerabilities.^[19]

Ethical Responsibility and Institutional Obligation

The systematic underdiagnosis and misclassification of dementia in migrants is not a failure of individual clinical cultural competence.^[20] While clinicians bear responsibility for individual encounters, they often operate with low confidence and insecurity because they use structurally inadequate tools. This uncertainty leads clinicians to delay referrals, avoid complex assessments, or defer diagnosis until symptoms become severe.^[21] Instead, the ethical responsibility lies with research institutions, global health funders, and international collaborations that generate and legitimate diagnostic standards.^[22]

The failure of institutions to correct these inequities perpetuates an ongoing harm against vulnerable populations. When institutions and NIH-equivalents continue to fund and rely on research in which people of European ancestry are overrepresented, they exhibit an institutional form of ignorance that systematically limits who can be recognized as a legitimate clinical subject.^[23] Therefore, epistemic repair must be viewed as a fundamental institutional duty, rather than a charitable endeavor.

What Diagnostic Justice Requires

Achieving diagnostic justice imposes three concrete institutional obligations. First, institutions must undertake epistemic repair by developing and implementing multilingual, education-stratified diagnostic tools. Instruments like the Rowland Universal Dementia Assessment Scale (RUDAS) and the Cross-Cultural Dementia Screening (CCD) perform well across diverse linguistic and educational backgrounds. Yet they remain underused because they lack large-scale validation, integration into guideline frameworks, and reimbursement support. These tools must be scaled and embedded into national clinical guidelines to ensure the diagnostic process is not a privilege of the highly educated.^[24] Critically, this repair is not merely about increasing diagnostic volume but ensuring accuracy. Some tests yield false-positive rates as high as 42 percent in non-impaired minority groups, and false negatives delay recognition of true impairment.^[25] By embedding these tools into guidelines, institutions ensure that the diagnostic process is a reliable resource for the global majority.

Second, institutions must ensure epistemic inclusion in biological diagnostics. Biomarker research and genomic risk models, including those involving the APOE-ε4 allele, cannot remain ancestry-neutral when the association between these markers and dementia varies meaningfully across genetic ancestries. Expanding ancestry-diverse biobanks is a scientific necessity to prevent the reproduction of molecular inequities. While some may argue that these disparities could be addressed through improved cultural competency among clinicians, such a framing is insufficient; no amount of individual skill can rectify a research enterprise that systematically excludes the global majority from its foundational evidentiary standards.

Finally, institutions have an obligation to epistemic sovereignty, requiring a shift away from extractive research practices toward equitable international collaborations. Collaborations should support local LMIC leadership and promote sustainable capacity building to ensure that the normative data generated in countries of origin provides the essential reference standards for accurate diagnosis across settings. Addressing the concern that diagnosis leads to unwanted medicalization, diagnostic justice recognizes that while many families prefer home-based care and view facilities as a last resort, a valid diagnosis remains a prerequisite for autonomy. Accurate knowledge of a condition allows individuals and their families to make informed financial, legal, and care decisions within their preferred cultural frameworks, rather than being thrust into medicalized care after years of diagnostic neglect.^[26]

Conclusion

Framing the systematic underdiagnosis of dementia in migrant populations as an unfortunate by-product of cultural distance or clinical uncertainty obscures a more disturbing reality: diagnostic inequity reflects a global research ecosystem that defines cognitive normalcy using evidence drawn from a narrow segment of humanity. When migrants encounter diagnostic systems that are calibrated to highly educated, monolingual standards, they are rendered invisible and suffer harm that far exceeds mere clinical delay. This harm represents a deep form of epistemic injustice rooted not in individual clinicians but in institutional decisions about whose cognitive experience defines universal diagnostic standards. Ethical responsibility for these systematic failures thus extends beyond the consulting room to the research institutions and global funders that legitimate and disseminate exclusionary diagnostic schema. Achieving global diagnostic justice requires adopting epistemic repair, including the structural integration of culturally anchored cognitive models and ancestry-diverse biological research. The legitimacy of dementia diagnosis in an increasingly migratory world depends not on individual competence but on whether the evidentiary base of clinical practice reflects the full diversity of human cognition.

[1] Islam, B., Li, T., Xu, M., Yang, D., Lv, H., Gassara, G., Ibrahim, T. I., Radman, B. A., & Wang, J. (2024). Emerging trends in cognitive impairment and dementia among older populations in Asia: A systematic review. Journal of global health, 14, 04233. https://doi.org/10.7189/jogh.14.04233; Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3

[2] Selten, J. P., Termorshuizen, F., van Sonsbeek, M., Bogers, J., & Schmand, B. (2021). Migration and dementia: a meta-analysis of epidemiological studies in Europe. Psychological medicine, 51(11), 1838–1845. https://doi.org/10.1017/S0033291720000586

[3] Hurley S, Turnbull S, Calia C. Barriers and facilitators to diagnosing dementia in migrant populations: a systematic review of European health professionals' perspectives. Int J Geriatr Psychiatry. (2024) https://doi.org/10.1002/gps.6118; Leroi, I., Vaitheswaran, S., Sheikh, S., Chaudhry, N., Goswami, S. P., Miah, J., Sakel, M., Tofique, S., Husain, N., & SENSE-Cog Asia Collaboration (2020). Capacity & capability building for applied dementia research in low- & middle-income countries: Two exemplars from South Asia. The Indian journal of medical research, 152(6), 614–625. https://doi.org/10.4103/ijmr.IJMR_2095_19; Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7

[4] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3; Selten, J. P., Termorshuizen, F., van Sonsbeek, M., Bogers, J., & Schmand, B. (2021). Migration and dementia: a meta-analysis of epidemiological studies in Europe. Psychological medicine, 51(11), 1838–1845. https://doi.org/10.1017/S0033291720000586; Hurley S, Turnbull S, Calia C. Barriers and facilitators to diagnosing dementia in migrant populations: a systematic review of European health professionals' perspectives. Int J Geriatr Psychiatry. (2024). https://doi.org/10.1002/gps.6118

[5] Kalaria, R., Maestre, G., Mahinrad, S., Acosta, D. M., Akinyemi, R. O., Alladi, S., Allegri, R. F., Arshad, F., Babalola, D. O., Baiyewu, O., Bak, T. H., Bellaj, T., Brodie‐Mends, D. K., Carrillo, M. C., Celestin, K., Damasceno, A., de Silva, R. K., de Silva, R., Djibuti, M., … Ismail, O. (2024). The 2022 symposium on dementia and brain aging in low‐ and middle‐income countries: Highlights on research, diagnosis, care, and impact. Alzheimer’s & Dementia, 20(6), 4290–4314. https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13836

[6] Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7

[7] Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7

[8] Selten, J. P., Termorshuizen, F., van Sonsbeek, M., Bogers, J., & Schmand, B. (2021). Migration and dementia: a meta-analysis of epidemiological studies in Europe. Psychological medicine, 51(11), 1838–1845. https://doi.org/10.1017/S0033291720000586; Hurley S, Turnbull S, Calia C. Barriers and facilitators to diagnosing dementia in migrant populations: a systematic review of European health professionals' perspectives. Int J Geriatr Psychiatry. (2024). https://doi.org/10.1002/gps.6118

[9] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3; Hurley S, Turnbull S, Calia C. Barriers and facilitators to diagnosing dementia in migrant populations: a systematic review of European health professionals' perspectives. Int J Geriatr Psychiatry. (2024). https://doi.org/10.1002/gps.6118; Leroi, I., Vaitheswaran, S., Sheikh, S., Chaudhry, N., Goswami, S. P., Miah, J., Sakel, M., Tofique, S., Husain, N., & SENSE-Cog Asia Collaboration (2020). Capacity & capability building for applied dementia research in low- & middle-income countries: Two exemplars from South Asia. The Indian journal of medical research, 152(6), 614–625. https://doi.org/10.4103/ijmr.IJMR_2095_19; Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7

[10] Spencer L. (2022). Epistemic Injustice in Late-Stage Dementia: A Case for Non-Verbal Testimonial Injustice. Social epistemology, 37(1), 62–79. https://doi.org/10.1080/02691728.2022.2103474

[11] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3

[12] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3; Hurley S, Turnbull S, Calia C. Barriers and facilitators to diagnosing dementia in migrant populations: a systematic review of European health professionals' perspectives. Int J Geriatr Psychiatry. (2024). https://doi.org/10.1002/gps.6118

[13] Czerwinski-Alley, N. C., Chithiramohan, T., Subramaniam, H., Beishon, L., & Mukaetova-Ladinska, E. B. (2024). The Effect of Translation and Cultural Adaptations on Diagnostic Accuracy and Test Performance in Dementia Cognitive Screening Tools: A Systematic Review. Journal of Alzheimer's disease reports, 8(1), 659–675. https://doi.org/10.3233/ADR-230198

[14] Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7; Czerwinski-Alley, N. C., Chithiramohan, T., Subramaniam, H., Beishon, L., & Mukaetova-Ladinska, E. B. (2024). The Effect of Translation and Cultural Adaptations on Diagnostic Accuracy and Test Performance in Dementia Cognitive Screening Tools: A Systematic Review. Journal of Alzheimer's disease reports, 8(1), 659–675. https://doi.org/10.3233/ADR-230198; Goudsmit, M., Uysal-Bozkir, Ö., Parlevliet, J. L., van Campen, J. P. C. M., de Rooij, S. E., & Schmand, B. (2017). The Cross-Cultural Dementia Screening (CCD): A new neuropsychological screening instrument for dementia in elderly immigrants. Journal of Clinical and Experimental Neuropsychology, 39(2), 163–172. https://doi.org/10.1080/13803395.2016.1209464

[15] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3

[16] Spencer L. (2022). Epistemic Injustice in Late-Stage Dementia: A Case for Non-Verbal Testimonial Injustice. Social epistemology, 37(1), 62–79. https://doi.org/10.1080/02691728.2022.2103474; Storey, J. E., Rowland, J. T. J., Conforti, D. A., & Dickson, H. G. (2004). The rowland universal dementia assessment scale (Rudas): A Multicultural Cognitive Assessment Scale. International Psychogeriatrics, 16(1), 13–31. https://doi.org/10.1017/s1041610204000043

[17] Porrselvi, A. P., & Shankar, V. (2017). Status of Cognitive Testing of Adults in India. Annals of Indian Academy of Neurology, 20(4), 334–340. https://doi.org/10.4103/aian.AIAN_107_17

[18] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3

[19] Nkimbeng, M., Rosebush, C. E., Akosah, K. O., Yam, H., Russell, W. N., Bustamante, G., Albers, E. A., Shippee, T. P., Sasikumar, A. P., & Gaugler, J. E. (2022). The Immigrant Memory Collaborative: A Community-University Partnership to Assess African Immigrant Families' Experiences with Dementia. International journal of environmental research and public health, 19(7), 4075. https://doi.org/10.3390/ijerph19074075

[20] Leroi, I., Vaitheswaran, S., Sheikh, S., Chaudhry, N., Goswami, S. P., Miah, J., Sakel, M., Tofique, S., Husain, N., & SENSE-Cog Asia Collaboration (2020). Capacity & capability building for applied dementia research in low- & middle-income countries: Two exemplars from South Asia. The Indian journal of medical research, 152(6), 614–625. https://doi.org/10.4103/ijmr.IJMR_2095_19

[21] Storey, J. E., Rowland, J. T. J., Conforti, D. A., & Dickson, H. G. (2004). The rowland universal dementia assessment scale (Rudas): A Multicultural Cognitive Assessment Scale. International Psychogeriatrics, 16(1), 13–31. https://doi.org/10.1017/s1041610204000043

[22] Allegri, R.F. Dementia research in low-income and middle-income countries — a view from Latin America. Nat Rev Neurol 21, 499–505 (2025). https://doi.org/10.1038/s41582-025-01125-3; Leroi, I., Vaitheswaran, S., Sheikh, S., Chaudhry, N., Goswami, S. P., Miah, J., Sakel, M., Tofique, S., Husain, N., & SENSE-Cog Asia Collaboration (2020). Capacity & capability building for applied dementia research in low- & middle-income countries: Two exemplars from South Asia. The Indian journal of medical research, 152(6), 614–625. https://doi.org/10.4103/ijmr.IJMR_2095_19

[23] Kidd, I. J., Spencer, L., & Carel, H. (2025). Epistemic injustice in psychiatric research and practice. Philosophical Psychology, 38(2), 503–531. https://doi.org/10.1080/09515089.2022.2156333

[24] Storey, J. E., Rowland, J. T. J., Conforti, D. A., & Dickson, H. G. (2004). The rowland universal dementia assessment scale (Rudas): A Multicultural Cognitive Assessment Scale. International Psychogeriatrics, 16(1), 13–31. https://doi.org/10.1017/s1041610204000043

[25] Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7

[26] Sagbakken, M., Spilker, R. S., & Nielsen, T. R. (2018). Dementia and immigrant groups: a qualitative study of challenges related to identifying, assessing, and diagnosing dementia. BMC health services research, 18(1), 910. https://doi.org/10.1186/s12913-018-3720-7

Open-Label Placebos Are Deceptive and Should Not Be Used in Clinical Practice

Steven Tresker — 2026-05-06

Photo ID 198462485 © Nastassia Samal | Dreamstime.com

Open-label placebo (OLP) research has proliferated rapidly in the past two decades, with studies claiming benefit for irritable bowel syndrome, chronic pain, ADHD, allergic rhinitis, and other conditions.^[1] Some scholars even suggest using OLPs in clinical practice.^[2] A central tenet of such research is that OLPs carry the benefits of placebos but without the deception.^[3]

The premise is simple. Patients are told they are receiving an inert pill, something “like sugar pills,” often paired with an explanation that placebos have been shown to produce mind–body healing “in rigorous clinical testing.” This message, or close variants, appears across much of the literature.^[4] What follows is often framed as a surprising result: the pill, despite being openly disclosed as inert, still appears to help.

This apparent breakthrough, however, rests on a sleight of hand. The improvement observed in OLP trials does not follow from the pill itself (such as if it were to be shorn of its context and administered surreptitiously). OLP researchers are well aware of this, attributing the effect to the total encounter: the framing, the ritual, the patient–clinician relationship, uncertainty, subtle cues of hope and legitimacy, and even mechanisms such as prediction, error processing, and embodied cognition.^[5] Indeed, what OLP research has indicated is that, unlike traditional placebos, the mechanisms underlying OLPs’ putative positive effects don’t appear to strongly involve positive expectations.^[6]

However, in OLP trials, researchers treat the taking of the pill as if it were the active element and do not clearly or accurately explain to study participants how OLPs might exert their putative benefits. This problem would seem to reach a boiling point in clinical practice: even if it were theoretically possible to explain to patients how OLPs work, or at least their risks and benefits, in a way that adequately informs them according to principles of informed consent, clinicians should explain that context is the likely source of the potential benefit; it could arise from ritual, hope or optimism, or even the attention from the doctor. Clinicians should be careful not to overstate effectiveness or extrapolate potential outcomes based on clinical trials with a blinded placebo arm. Patients should be told that placebos administered openly are qualitatively different from traditional placebos in terms of mechanisms and potential or expected effects.

OLPs thus engage in a different kind of dishonesty than that of traditional deceptive placebos—one that centers not on what the patient is physically given, but on what they are led to believe. Patients are told the name of what they’re receiving (“a placebo”), but not the ambiguity of that term. They’re told it’s inert, but also that it can help. But if a placebo is inert, then by definition it does not have a therapeutic effect. The claim that it has been shown to produce improvement contradicts the very definition OLP researchers offer. In this sense, the deception has not been removed but has been subtly reframed. What this reveals is not merely a problem of communication, but of conceptual coherence. There is no consensus—philosophical, clinical, or regulatory—on what a placebo even is. Yet OLP scripts speak as if there were. The result is a contradiction embedded in the heart of the treatment. Patients are not just misled about the pill’s therapeutic features. They are misled about its significance and about the very nature of the placebo concept. Some patient testimony already points to the idea that if OLPs were offered in clinical practice, this could make them feel frustrated and disheartened, as if they were being told their ailments were all in their mind.^[7]

Other concerns have also been raised, including confusion between placebo effects and responses, the lack of patient involvement in OLP research, and ethical risks such as stigmatization, erosion of trust, and delayed access to effective care.^[8] None of this denies that meaning and ritual can heal. Indeed, what OLPs inadvertently highlight is that the context of medicine—the words, the theatre, the rituals—matters deeply. While our focus here is on OLP use in clinical practice, research on OLPs may be beneficial. For example, it could further elucidate the role of hope and other mechanisms in medical treatments in general. But the ethical response in clinical practice is not to rebrand these forces as a new, honestly delivered, scientifically grounded treatment. That is where they would represent a step backward. In trying to mitigate the deceptive aspects of placebos, OLPs obscure both their epistemic fragility and their philosophical complexity. They replace one kind of ambiguity with another while claiming to do neither.

Nonetheless, as some have argued,^[9] given their potential safety, low cost, and ease of administration, OLPs may appear to offer a useful option in clinical practice for certain patients. However, given the ambiguity of the term “placebo,” respecting informed consent would require that such interventions not be presented as open-label placebos, but rather as what they are—for example, sugar pills—explained in a way that makes that simple fact clear to patients. Moreover, if claims of effectiveness are to be made, then, as with other treatments, these interventions should first be evaluated in appropriately controlled trials. This raises the question of what would count as a valid control for a sugar pill. Yet a sugar pill in clinical practice is never just a sugar pill; it is administered within a therapeutic encounter shaped by explanation, ritual, and clinician interaction. What such trials would therefore need to isolate is not the pill itself, but the contribution of that broader context. Extensive research on the placebo effect has shown these contextual elements to indeed have therapeutic value.^[10] But if so, the challenge is to deliver them honestly and effectively, not to repackage them under the label of a placebo. What clinical practice may need more than OLPs, then, is not sugar pills embedded in contextual healing, but stronger and more transparent forms of contextual care alongside treatments with independently established clinical effects.

Open-label placebos were meant to resolve a long-standing tension: how to harness the placebo effect without deception. But in trying to remove deception, a subtler and more conceptually troubling form has taken its place.

[1] Fendel JC, Tiersch C, Sölder P, Gaab J, Schmidt S. Effects of open-label placebos across populations and outcomes: an updated systematic review and meta-analysis of randomized controlled trials. Sci Rep. 2025;15(1):29940. https://doi.org/10.1038/s41598-025-14895-z

[2] Hardman D, Miller F. A worthwhile wager: the ethics of open-label placebo treatment in clinical practice. J Med Ethics. 2025;51:689-692. https://doi.org/10.1136/jme-2024-110270

[3] Kaptchuk TJ, Friedlander E, Kelley JM, et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010;5(12):e15591. https://doi.org/10.1371/journal.pone.0015591

[4] Heiss U, Rosenfield M, Bernstein MH. Can the open label placebo rationale be optimized? Front Pain Res (Lausanne). 2021;2:734882. https://doi.org/10.3389/fpain.2021.734882

[5] Kaptchuk TJ. Open-label placebo: reflections on a research agenda. Perspect Biol Med. 2018;61(3):311-334. https://doi.org/10.1353/pbm.2018.0045

[6] Ibid.

[7] Jones CMP, Lin CC, Blease C, Lawson J, Abdel Shaheed C, Maher CG. Time to reflect on open-label placebos and their value for clinical practice. Pain. 2023;164(10):2139-2142. https://doi.org/10.1097/j.pain.0000000000003017

[8] Blease CR, Bernstein MH, Locher C. Open-label placebo clinical trials: is it the rationale, the interaction or the pill? BMJ Evid Based Med. 2020;25(5):159-165. https://doi.org/10.1136/bmjebm-2019-111209

[9] Hardman D, Miller F. A worthwhile wager: the ethics of open-label placebo treatment in clinical practice. J Med Ethics. 2025;51:689-692. https://doi.org/10.1136/jme-2024-110270

[10] Louhiala P. Placebo Effects: The Meaning of Care in Medicine. New York: Springer 2020.

Animal Ethics Concerns Could Be More Pronounced in Islet Xenotransplantation

Sheetal Mohanty — 2026-03-15

Photo by Towfiqu barbhuiya on Unsplash

Abstract

Type 1 diabetes mellitus (T1D) necessitates life-sustaining insulin therapy or islet allotransplantation, which is limited by organ scarcity. While islet xenotransplantation offers a solution to donor shortages, patient perceptions regarding this emerging therapy remain unexplored. This small-scale study tested what would happen to patient support for xenotransplantation when T1D patients learned that upwards of 50 pigs may be needed to treat one adult human patient. Patient viewpoints toward islet xenotransplantation are important to incorporate into xenotransplantation research, as they may impact future clinical uptake. While our sample size is limited, we cautiously suggest that animal ethics concerns regarding xenotransplantation may extend to the magnitude of animals required to treat a single patient. As clinical trials advance, addressing these specific patient-centered values and risk tolerances is essential for developing informed consent frameworks and therapies that are sensitive to patient concerns.

Introduction

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease characterized by immune-mediated destruction of pancreatic beta cells, resulting in absolute insulin deficiency. It affects over 8 million people globally, of whom 20 percent are under 20 years old.^[1] Despite advances in treatment, many patients face challenges related to insulin dependence, including risks of severe hypoglycemia and complications stemming from poor glycemic control. Treatment options for T1D also remain limited. Islet allotransplantation, an alternative treatment for T1D, remains limited by the scarcity of donor organs, the need for lifelong immunosuppression, and the decline in graft survival over time. Pancreatic beta cell islet xenotransplantation (genetically modified porcine-to-human transplantation) is an alternative to exogenous insulin therapy.^[2] Researchers estimate it would take between 25-50 piglets to provide enough islets to treat one adult human.^[3] This ratio of 25:1 or 50:1 is much different from the ratio in solid organ xenotransplantation, which is often framed as one pig to one or multiple patients.

Understanding how accepting the public and, more importantly, patients, are toward xenotransplantation is a critical component of it being accepted as a clinical alternative to exogenous insulin therapy or allotransplantation. Several studies have examined attitudes toward xenotransplantation, but most focus on solid organ transplantation rather than on islet xenotransplantation.^[4]

This study explores a research question that, to our knowledge, has never been tested empirically: Would learning that 25-50 piglets may be required to treat one adult change T1D patients’ attitudes toward islet xenotransplantation?

Methods

We conducted a cross‐sectional pilot study from June to December 2025. We gave our survey to patients with T1D who were part of a diabetes support group in New Jersey. The research team developed the survey in Qualtrics (Provo, Utah) in consultation with experts in endocrinology, bioethics, and quantitative methods, and the survey was informed by prior xenotransplantation studies conducted by the principal investigator and by a review of the literature.^[5] The initial draft of the survey was pilot-tested among a small sample at the research team’s university and then revised as needed for clarity.

After ethics approval was obtained,^[6] participants were recruited via two methods: in-person at insulin user support groups and through posting on the online social media support group. Participants were 18 years of age or older with a self-reported diagnosis of T1D. The electronic survey contained an informed consent form that asked for an acknowledgement before the participant was allowed to proceed with the survey. Qualtrics collected the data. Because of the small sample size, the research team used descriptive statistics (counts, percentages) to analyze attitudes.

Results

Nineteen complete responses were collected. Twenty participants began the survey; one stopped after the demographic section, resulting in a 95 percent completion rate. Due to the nature of participant recruitment, overall response rate was unable to be calculated as we were unable to determine how many potential participants viewed the survey flyer in the online support group. Demographic characteristics of participants can be viewed in Table 1. Eighteen of the nineteen participants relied on insulin injections daily to control their T1D.

Participants were informed about two emerging therapies–islet allotransplantation and islet xenotransplantation–and asked a series of questions about each of these (Table 2). Islet xenotransplantation is the focus here. Participants were told that researchers have been attempting to transplant islet cells from pigs into people with T1D, which could eliminate the need for insulin injections if effective, and asked how they felt about it. When given response choices ranging from very positive to very negative, initially, five participants (26 percent) checked off “very positive”; eight participants (42 percent) “somewhat positive”; only one participant (5 percent) responded “very negative,”; and five participants (26 percent) were neutral. When participants were asked how comfortable they personally would be if clinicians used pig islets to treat their T1D, six participants (32 percent) stated they were either “extremely uncomfortable” or “somewhat uncomfortable,” while five participants (26 percent) were neutral and eight (42 percent) stated they were “somewhat comfortable.”

Participants were then informed that it may take 25 or more piglet donors to treat one adult human with T1D and asked how they felt about that. The survey provided three options. Five participants (26 percent) responded that this would make them “much less willing to support this research,” and six participants (32 percent) responded that this would make them “somewhat less willing to support this research.” Eight participants (42 percent) responded that their view remained the same with the new information.

Discussion

When informed that treating a single adult might require islet cells from 25 or more piglets, over half of the participants (58 percent; 11/19) reported that this made them less willing to support the research. While we recognize the limitations inherent in a small-scale study, the findings cautiously suggest that patient objections to xenotransplantation grounded in animal ethics issues may extend beyond the mere use of animals to include concerns about the number of animals required. Ethically, this raises questions of proportionality—whether the therapeutic benefit to one human justifies the use of dozens of animal lives. For some patients, the 25:1 ratio may cross an ethical threshold. The survey question that revealed the need to use 25 or more animals for one person’s treatment asked whether the participants would change their view, but the response options used language about “supporting research”. The survey did not ask whether they would be willing to accept the therapy personally knowing 25 or more animals were necessary to treat one person. It is possible that the discomfort or negative view toward such research would be even more pronounced if people had to consider their own care, or alternatively, that when faced with a possible solution for themselves, participants may waver on their discomfort level and compromise their animal ethics position.

Limitations

The interpretation of these findings is constrained by the limitations of a small-scale study. With a small sample size (n=19), our results are descriptive and cannot be generalized to the broader T1D population. Furthermore, the sample was demographically homogenous, consisting primarily of white, female, and highly educated participants. As perceptions of medical trust, animal welfare, and risk tolerance vary significantly across cultural and socioeconomic lines, future studies must recruit a more diverse cohort to ensure that consent frameworks are inclusive and equitable.

Conclusion

This study provides preliminary insight into the complex attitudes of individuals with T1D toward islet xenotransplantation and will inform larger planned studies. The findings demonstrate that patient support for islet xenotransplantation may be fragile. In our sample, the ethical implications of the high donor pig-to-recipient ratio appeared to be a significant barrier to acceptance. As islet xenotransplantation moves from the laboratory to the clinic, biological success cannot be the sole measure of progress. Patient values must inform trial design and be evaluated within the specific context in which trials are conducted. Future research requires larger and more diverse cohorts to determine whether these findings hold in broader populations.

Table 1: Demographic information of participants

Table 2: Attitudes toward islet allotransplantation and xenotransplantation

[1]Gregory GA, Robinson TIG, Linklater SE, et al. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol. Oct 2022;10(10):741-760. doi:10.1016/s2213-8587(22)00218-2

[2] Groth CG, Korsgren O, Tibell A, et al. Transplantation of porcine fetal pancreas to diabetic patients. Lancet. 1994;344(8934):1402-1404. doi:10.1016/s0140-6736(94)90570-3

[3] Ekser B, Bottino R, Cooper DKC. Clinical Islet Xenotransplantation: A Step Forward. EBioMedicine. 2016;12:22-23. doi:10.1016/j.ebiom.2016.09.023; Cooper DKC, Mou L, Bottino R. A brief review of the current status of pig islet xenotransplantation. Front Immunol. 2024;15:1366530. doi:10.3389/fimmu.2024.1366530

[4] Hurst DJ, Rodger D, Padilla LA, Ovalle F. Attitudes toward pig islet xenotransplantation for type 1 diabetes: a scoping review. J Endocrinol Invest. 2025;48(10):2249-2260. doi:10.1007/s40618-025-02626-0; Padilla LA, Hurst DJ, Zink A, Parent B, Kimberly LL. Public attitudes to xenotransplantation: A national survey in the United States. Am J Transplant. 2024;24(11):2066-2079. doi:10.1016/j.ajt.2024.07.018; Al-Haboubi M, Boadu P, Pacho A, Cronin AJ, Mays N. Public views on xenotransplantation from the first representative sample survey in the UK. Lancet. 2025;406(10508):1083-1085. doi:10.1016/S0140-6736(25)01195-X

[5] Padilla et al., 2024; Hurst et al., 2025

[6] There was an anonymous peer review process. The study was approved by the Virtua Health Group IRB #G25061

Envisioning Originalism Applied to Bioethics Cases

Robert Swidler — 2026-03-15

Photo ID 123697425 © Alexandersikov | Dreamstime.com

Abstract

Originalism is an increasingly prevalent method for interpreting provisions of the US Constitution. It requires strict adherence to the root meanings of constitutional terms, irrespective of drastically different contexts and without regard to consequences. This article offers a brief description of Originalism and summarizes key criticisms of Originalism in principle and in practice. It then examines a mix of past and pending legal cases that implicate bioethical principles and require interpretation of the Constitution, and it envisions an originalist approach to deciding them.

Introduction

Originalism and bioethics are distinct approaches to shaping public policy and private conduct. Originalism, an increasingly prevalent method for interpreting provisions of the US Constitution, requires strict adherence to the meaning of constitutional terms as understood at the time the provision was enacted, irrespective of drastically different contexts and without regard to consequences. Proponents suggest that it removes the policy preferences of judges from decision making and provides neutrality and objectivity. Critics regard it as an unreliable tool, used selectively by conservative justices to reach their desired legal conclusions.

Bioethics emerged in large part as a multidisciplinary effort to examine issues raised by advances in medicine and biotechnology, from late-20th-century developments like the ventilator, in vitro fertilization, and organ transplantation to today’s use of ECMO, CRISPR, and artificial intelligence. Bioethicists strive to identify the competing ethical values at stake, weigh them, and propose ethical bedside and policy answers to them.

Originalism matters to bioethicists because courts have and will continue to invoke the theory to resolve constitutional questions concerning such advances, including questions the Framers could not have envisioned.

This article offers a brief description of originalism and the rationale for it and summarizes key criticisms of originalism in principle and in practice. It then examines a mix of past and pending constitutional law cases relevant to bioethics and envisions an originalist approach to deciding them.

Since there is no single bioethics position on the issues presented in these cases, it is not possible to state whether an originalist approach would align or conflict with a bioethical position. Even so, the exercise is illuminating: it alerts bioethicists, with their diverse views, to the possible impact of originalism in bioethical matters.

Originalism

Originalism claims to offer an objective interpretation of constitutional provisions, free from judicial preference, politics, and policy.^[1] Essentially, it calls upon judges to examine historical documents to reveal the original understanding of the provision and adhere to it. Originalism differs from textualism, a related doctrine that calls upon judges not to stray from the text of a constitutional provision or statute. To a strict textualist, the First Amendment, which states that “Congress shall make no law abridging the freedom of speech,” has no exceptions. An originalist, however, would point to laws from that period against libel, fraud, obscenity and more, and conclude that the original meaning of the Free Speech clause included such exceptions.

A key recent example of an originalist opinion is NYS Rifle & Pistol Assn, Inc. v. Bruen.^[2] Plaintiffs claimed that New York’s handgun licensing law violated the Second Amendment, which states that “a well-regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms, shall not be infringed.” Years earlier, the Supreme Court ruled that the right to bear arms did not depend upon service in a militia, and that the term “arms” is not limited to arms in existence in the 18th century.^[3] The sole issue in Bruen was whether the handgun licensing law infringed the right “to keep and bear arms.”

In an opinion written by Justice Thomas, the majority approached the question as follows: it stated that the plain text of the Second Amendment protects the plaintiff’s right to possess arms, which would include a handgun. The Court dismissed as irrelevant New York’s argument, based on precedent, that it had a compelling interest in its gun licensing law and had narrowly tailored the law to address that interest. Rather, the Court held that New York must prove that in the era in which the Second Amendment was passed there were similar licensing laws. It regarded the original understanding of the clause as determinative. The Court then reviewed historical sources produced by the litigants and concluded that there was no analogous licensing law in the history of the colonies or the early Republic. As a result, the Court invalidated New York’s handgun licensing statute.

The next day, the Court issued an opinion by Justice Alito that employed a similar originalist methodology, this time to strike down the constitutional right to abortion. In Dobbs v. Jackson Women's Health Organization,^[4] the issue was whether a Mississippi law restricting abortion violated the 14th Amendment due process clause, a result seemingly compelled by the precedent Roe v. Wade^[5] and its progeny. The Court again started with the text and found that the Constitution “makes no mention of abortion.”^[6] It acknowledged that its prior decisions accepted the "theory" that the due process clause protects some unspecified substantive liberty interests, but only those "deeply rooted in [our] history and tradition.”^[7]

The Court then engaged in an examination of the historical evidence presented by the parties and concluded that abortion rights were not deeply rooted in American history and tradition, nor were they part of the mid-to-late 19th century understanding of the meaning of the due process clause. Accordingly, the Court found that abortion rights are not constitutionally protected. Of interest to bioethicists, the Court noted that its originalist analysis was similar to the analysis it had employed to uphold state laws against “assisted suicide.”^[8]

Since Bruen and Dobbs, the Court and lower courts have increasingly used originalism to rule on the constitutionality of other acts of Congress, agency regulations, or state statutes.^[9] As one legal author put it, “Originalism is ascendent on the Supreme Court.”^[10]

Criticisms of Originalism

When applied in good faith, originalism seeks to address the most fundamental challenge in judicial philosophy: how to interpret the law objectively, without regard to personal policy preferences or bias. In theory, originalism promises almost automated decision making: once a judge feeds the relevant clause and the historical record into the analysis, the ruling is inexorable and unassailable. Arguably, the approach avoids the subjectivity of competing judicial philosophies, primarily activism or “living constitutionalism,” that invite judges to interpret constitutional provisions in light of the social and political problems of the day. Put differently, originalism is designed to ensure that judges strictly apply the law and not act like legislators. However laudable its purpose, originalism is subject to a long list of formidable criticisms in principle and as practiced.^[11]

Criticisms of Originalism Theory

Critics have questioned whether it is appropriate for courts to research and evaluate centuries-old historical records and, indeed, whether they are qualified to do so. One legal scholar and historian wrote that most historians regard the Court’s attempts to identify history and tradition “with detached disdain, puzzled wonderment, and even dismissive bemusement – as in: ‘Surely, they can't be serious.’”^[12]

There is also the question of whether it is desirable or even morally defensible to resolve today’s issues based on textual interpretations of the Framers and early legislative bodies, given their composition.^[13] Invariably, they consisted exclusively of male, white, wealthy landowners, including slaveholders. Consider this comment by Osagie K. Obasogie:

[T]he precise historical moments sought to serve as moral and interpretive reference points—a period of slavery, genocidal eradication of Native Americans, conquest and illegitimate land capture, patriarchy and deep gender bias, and other discriminatory attitudes—were so doggedly inequitable that it becomes hard to justify transporting eighteenth-century legal mores into the present as anything other than an attempt to maintain white male privilege."^[14]

To be sure, not all Framers shared the same morals or views. But the different perspectives among them further erode the argument for an originalist approach. It is doubtful that all the Framers understood key clauses the same way, so there may be no single original understanding of a clause.^[15]

An even more fundamental attack on originalism is that the original understanding of a clause was based on the circumstances of that day, not the circumstances of today. The historical record cannot reliably answer whether the Framers would have supported a right to bear arms if the arms included today’s high-powered weapons. Similarly, their views on extending free speech to unlimited corporate election spending are impossible to know. Nor did the Framers claim to be resolving future issues: as the Supreme Court observed, the Founders “knew they were writing a document designed to apply to ever-changing circumstances over centuries.”^[16]

Next, at least some originalist justices exhibit a striking disregard for stare decisis – the legal doctrine of respect for precedent.^[17] Both Bruen and Dobbs gave scant regard to the longstanding and largely settled caselaw. In fact, it is fair to ask why longstanding precedents such as Roe v. Wade do not now demonstrate our history and tradition, entitling them to as much, or greater, deference than historical records from the founding period. As one writer put it, “Does tradition afterward count?”^[18]

An especially sharp criticism of originalism is its disregard of justice, of consequences to people. Originalist judges consider this dispassionate adjudication a feature, not a flaw. If the historical record does not support handgun licensing, so be it; the potential for mayhem is not a relevant consideration. (Although, in some cases, the originalist approach would lead to results too intolerable for at least some originalists to bear. For example, in a case in which a violent spouse abuser challenged a court order restricting his access to weapons, all but one of the Bruen originalists relaxed their analysis to uphold the restriction.^[19] Justice Thomas, dissenting, would have allowed the violent abuser to have his weapons, explaining that “[n]ot a single historical regulation justifies the statute at issue.”)

Criticisms of Originalism in Practice

A key criticism of originalism in practice is that it is applied selectively.^[20] The conservative majority on the Supreme Court employed originalism in cases where, in its view, the historical record disfavored a right to medical aid-in-dying, disfavored a right to abortion, and favored a right to carry unlicensed firearms. However, the Court chose not to employ an originalist analysis in deciding whether corporations have the right to make unlimited campaign contributions^[21] or whether the president of the United States has broad immunity from prosecution for federal criminal laws.^[22]

Furthermore, originalists are charged with cherry-picking historical evidence in support of their political or ideological aims. For example, the dissenters in Dobbs accused Justice Alito of choosing items from the historical record that supported the decision he favored, while disregarding the contrary historical evidence. Whether true in that case or not, in practice originalism is not structurally guaranteed to be an objective methodology; judges can use history selectively to reach the desired result.

Originalism Applied to Bioethics Cases

This section reviews past and pending bioethics-related cases and considers both how originalism would affect the outcome and how bioethicists might view such outcomes.^[23]

Past Bioethics-Related Cases

I. The 14th Amendment Due Process Clause and the Right to Refuse Life-Sustaining Treatment

In the 1990 Supreme Court case, Cruzan v. Director, Missouri Department of Health,^[24] the parents of a permanently unconscious patient sought a court order directing the hospital to discontinue the patient’s feeding tube. In a decision authored by Chief Justice Rehnquist, the Court held that (1) a competent person has a liberty interest under the due process clause in refusing unwanted medical treatment, but that (2) in the case of an incompetent patient, Missouri may constitutionally require clear and convincing evidence of the patient’s wishes to exercise that right.

An originalist analysis would likely overrule the first part of this precedent. It would first find that the text of the Constitution does not include a right to refuse unwanted medical treatment. The analysis would entail a review of the record from the latter half of the 19th century (the 14th Amendment was passed in 1866 and ratified in 1868) to see whether the original understanding encompassed such rights. In the absence of such evidence, it would reject the first holding in Cruzan; it would find that there is no 14th Amendment due process right to refuse unwanted medical treatment.

In fact, Justice Scalia, in a concurring opinion, followed this precise originalist formula in contending that there is no constitutional right to refuse treatment. He wrote:

It is at least true that no “substantive due process” claim can be maintained unless the claimant demonstrates that the State has deprived him of a right historically and traditionally protected against state interference. . . ^[25]

To raise up a constitutional right here we would have to create [it] out of nothing (for it exists neither in text nor tradition) . . . ^[26]

Interestingly, an originalist decision overruling the constitutional right to refuse unwanted medical treatment would not appear to have a great practical impact on decisions regarding life-sustaining treatment. Both red and blue states have laws or state court decisions that allow patients to forgo life-sustaining treatment, either directly or through advance directives, most of which predate Cruzan. Most states also allow surrogate decision-making. Respect for the right to forgo life-sustaining treatment is a rare area of consensus in a time of culture war.

In fact, overruling Cruzan's constitutional right to refuse unwanted medical treatment may prove a greater barrier to persons claiming a right to refuse vaccination or other pandemic-related treatments. Many of the challenges by vaccination opponents rely upon Cruzan as among the constitutional bases for their asserted right.^[27]

As noted at the outset, there is no single bioethics position on the ethical issues raised by medicine and biomedical technology. However, a pervasive theme in bioethical literature is respect for autonomy and specifically respect for capable adult patients’ decision to accept or decline recommended treatment.^[28] The option of declining treatment necessarily follows from the fundamental ethical obligation to secure a patient’s informed consent to treatment. The constitutional right to forgo life-sustaining treatment recognized in Cruzan aligns with the mainstream bioethics perspective. An originalist rejection of such a constitutional right would conflict with the predominant bioethical perspective.^[29]

As an aside, while there is no Supreme Court decision on point, originalism likely would not support a constitutional right to informed consent, a key bioethical value. The roots of informed consent do not run deep enough to satisfy originalists.^[30] Like the right to forgo unwanted treatment, the principle of informed consent more recently became enshrined in common law, statutes, and regulations, and well as in nationwide professional standards.

Cruzan is just one example of how originalism might impact cases that construe the 14^th Amendment due process clause in the sphere of bioethics. Over the past 75 years, the clause was invoked as a basis for a constitutional right to contraceptives^[31] and abortion.^[32] Due process also provides a basis for constitutional protections, procedures, and limitations to protect people from unjustified involuntary mental health commitment.^[33] among other rights. The federal right to abortion is already a casualty of originalism;^[34] the others would be at risk from a challenge based on the 19^th-century legislators’ original understanding of due process.^[35]

II. The First Amendment Free Speech Clause and Countering Misinformation about Vaccines in a Pandemic

Murthy v. Missouri (2024)^[36] addressed an issue highly relevant to bioethics: whether and to what extent the federal or state government can suppress views that it believes endanger public health.

During the Covid-19 pandemic, officials in the Biden administration publicly and privately urged social media platforms like Facebook not to allow misinformation about the pandemic and the Covid-19 vaccine on their websites. Two states and five individual social media users sued, claiming that the Biden administration’s actions constituted censorship in violation of the First Amendment’s free speech clause. The Biden administration contended that it was merely calling the platforms’ attention to harmful misinformation and encouraging them to guard against it. But the District Court found that the government engaged in unconstitutional censorship and issued an injunction. The Fifth Circuit affirmed that decision.^[37]

The Supreme Court dismissed the complaint on the grounds that the plaintiffs lacked "standing", i.e., a sufficient personal stake in the lawsuit to meet the requirement that the court may only hear a case or controversy. Justice Alito dissented, declaring that “this is one of the most important free speech cases to reach the court in years.”^[38] He contended that the record showed egregious coercion and suppression of disfavored anti-vaccination speech. He argued that the Court should have recognized the plaintiffs’ standing and reached the merits.

Assessing the merits under a traditional (not originalist) analysis, a court would first determine whether the government in fact suppressed speech. Having determined that it did so, the court would consider whether the restriction of speech fell within an exception, such as the government’s ability to block speech “directed to inciting or producing imminent lawless action and … likely to incite or produce such action.”^[39] In this case, the Biden administration made no such claim. Accordingly, under a traditional analysis, if not for the standing defect, the Court likely would have found that the government violated the free speech clause.

Now, turning to a hypothetical originalist analysis, the most restrictive view is that espoused by Robert Bork, the conservative legal scholar and a founder of originalism. He contended, based on his reading of the history of the First Amendment, that it protects only “speech that is explicitly political.”^[40] Under that view, the federal government could suppress disfavored views about vaccines and every other nonpolitical topic.

Most originalists would not go that far. They would engage in a narrower historical inquiry, such as whether the public understood the First Amendment to bar the government from pressuring the media of their day to not publish content that the government believed posed a threat to public health.

There may well be historical evidence that could answer that question. Epidemics and governmental efforts to contain them occurred intermittently throughout US history.^[41] Perhaps early lawmakers expected the free speech clause to apply to such measures, perhaps not. But significantly, Justice Alito’s lengthy dissent did not address that question. He opted to forgo an originalist analysis of the case.

Government censorship of or opposition to disfavored views has arisen with even greater force during the second Trump administration. The current administration has punished or threatened universities,^[42] law firms,^[43] and other institutions^[44] with the loss of millions of dollars of funding for expressing, or allowing their community members to express, disfavored views about diversity, equity, and inclusion (DEI), the war in Gaza, and other issues. Of direct interest to bioethics, it is punishing hospitals and physicians for supporting gender reassignment procedures.^[45] It will be interesting to see if the Court or dissenters condemn censorship here as well, or whether it applies an originalist analysis and perhaps finds historical support for the government’s conduct.

III. The 14th Amendment Equal Protection Clause and a State Prohibition of Gender Reassignment Treatments for Minors

This example is based on United States v. Skrmetti (2025).^[46] Plaintiffs challenged a Tennessee statute that restricted sex transition procedures for minors, claiming it employed sex-based classifications in violation of the equal protection clause. That clause provides that a State shall not “deny to any person within its jurisdiction the equal protection of the laws.”

The Court employed a traditional (not originalist) equal protection analysis, which involved querying whether the statute injured either a suspect class or a fundamental right – in which case it would be subject to heightened scrutiny. It found that the statute did neither; rather, it used classifications based on age and medical conditions, which are subject only to rational review. It then found that the state law had a rational relationship to a legitimate government interest, satisfying rational basis review.

An originalist analysis would likely reach the same result, but through a different path. First, originalists like Professor Bork and Justice Alito contended that the equal protection clause was originally understood to protect only the legal treatment of black citizens post-slavery.^[47] Accordingly, in his view, the clause does not guarantee equal protection for women, people with disabilities, LGBTQ people, noncitizens, or other groups.^[48]

A less radical originalist approach would be to examine the history to answer the narrower question presented in Skrmetti: would mid-19^th-century lawmakers or the public have understood the equal protection clause to protect transgender persons? Laws from that period that discriminated against or punished conduct by transgender persons would weigh against the argument that the original understanding of equal protection included protection of this class. It seems doubtful that these plaintiffs could have established their historical right to equal protection.

The Skrmetti example illustrates how fundamentally conservative originalism is: the doctrine requires that whatever groups were subjected to injustices and prejudices considered acceptable at the time the Constitutional provision was adopted must remain unprotected by the provision.

In Obergefell v. Hodges, which held that the due process and equal protection clauses require states to recognize same sex marriage, Justice Kennedy wrote:

The nature of injustice is that we may not always see it in our own times. The generations that wrote and ratified the Bill of Rights and the Fourteenth Amendment did not presume to know the extent of freedom in all of its dimensions, and so they entrusted to future generations a charter protecting the right of all persons to enjoy liberty as we learn its meaning.^[49]

Originalism emphatically rejects that view. It would require judges to continue historical injustices because they are historical. To the originalist, the equal protection clause should not have been construed to prohibit laws against same-sex marriage because such laws were publicly accepted at the time the clause was adopted.

In any event, this is another instance in which the Court inexplicably chose not to follow originalist methodology in favor of a traditional, less controversial equal protection analysis that was sufficient to reach the same result.

Pending Bioethics-Related Cases

I. The 1st Amendment Free Exercise Clause and the Right to a Religious Exemption from Mandatory School Immunizations

This example is based on a pending lawsuit, Miller v. McDonald.^[50] The plaintiffs in Miller claim that New York’s mandatory vaccination law for school children infringes their free exercise rights under the First Amendment by failing to allow religious exemptions. The federal Court of Appeals upheld the statute as a law of general applicability that the legislature deemed necessary to protect child health. However, the Supreme Court remanded the case to the Court of Appeals to reconsider its decision in light of Mahmoud v. Taylor, its most recent free exercise ruling.

In Mahmoud, the Court held that a school must allow parents to excuse their children from having to read LGBTQ+ related stories that they found objectionable on religious grounds. The Court found that the mandate imposed an undue burden on the parents’ free exercise rights. For present purposes, what is notable about Mahmoud and other recent pro-religious exemption decisions^[51] or dissents^[52] is that they do not employ originalist analyses. Indeed, the cases mentioned do not address the historical understanding of the free exercise clause at all.

An originalist analysis of the religious exemption claim would review the historical record regarding exemptions to mandatory vaccination. The Supreme Court addressed that record in its 1905 decision, Jacobson v. Massachusetts.^[53] In response to a smallpox outbreak, the city of Cambridge, Massachusetts, passed a regulation requiring its inhabitants to be vaccinated. A resident objected to the regulation on constitutional (though not specifically religious) grounds. The Court per Justice Harlan essentially applied an originalist analysis: it provided extensive historical support for authority of a state to enact quarantine laws and “health laws of every description.”^[54] It also noted the practice of compelling persons to be drafted in war time, “without regard to his personal wishes or his pecuniary interests, or even his religious or political convictions.”^[55]

Arguably, Jacobson’s originalist approach supports mandatory vaccination without exemption only in the case of a public health emergency, as opposed to mandatory routine preventive vaccinations. And there might well be historical support from the constitutional era for religious exemptions. But significantly, the Miller Court chose not to raise the historical question at all. That failure illustrates the key criticism mentioned earlier: the subjective choice to employ the originalist approach only when it will lead to politically desired outcomes undermines the claim that originalism ensures neutrality and objectivity. Put differently, the Court could have, but chose not to, review or remand the case in light of Bruen and Dobbs.

Bioethicists disagree among themselves about the ethics of offering a religious exemption to a vaccination mandate. Some focus on the fundamental importance of individual autonomy, including respect for religious belief; others focus on the principle of justice, including obligations to the community. But the point here is that the bioethical debate would turn on competing ethical values, not on whether there was an original understanding that religious objectors would be exempt from mandatory vaccinations.

II. The Article II Vesting Clause and the Prohibition of Gender Reassignment Treatment for Minors

At least three major lawsuits^[56] are challenging an executive order of President Trump that aims to eliminate gender reassignment treatment to persons under age nineteen by directing the US Department of Health and Human Services (HHS) and other agencies to eliminate research and educational grants and taking other regulatory action against providers and institution that offer such treatment.^[57] A key claim in the legal challenges is that the executive order in question is beyond the constitutional authority of the president under Article II of the Constitution and usurps the legislative function. In legal jargon, the executive order is ultra vires.

An originalist analysis would start with the text of the Article II vesting clause, which states that "The Executive Power shall be vested in a President of the United States of America.” It must be read in conjunction with Article I, which states that “All legislative powers granted by the Constitution are given to Congress....” In short, the Constitution gives Congress the exclusive power to legislate and the executive branch the exclusive power to execute the laws.

The originalist analysis would then research the historical record to discern whether the Framers and the public at the time would have regarded an executive order restricting a disfavored medical procedure as more akin to legislating or to executing federal law. It would be an interesting analysis: on one hand, a core purpose of the American Revolution was to achieve independence from a tyrannical king; yet the early experiment of the Articles of Confederation demonstrated the need for an executive with significant authority, albeit within the bounds of law.

Ultimately, a historical analysis would likely show that the Framers viewed the president’s authority as far narrower than the view prevalent today. Turning then to an executive order against gender reassignment treatments, an originalist analysis would likely view this as a legislative action, rather than an execution of existing laws.

This raises a broader point: an originalist approach to interpreting the Article II vesting clause would likely restrict presidential authority to a degree far greater than that which recent presidents routinely exercise. If applied uniformly, it would restrain presidential initiatives that many bioethicists might support, as well as others that many would oppose.

Conclusion

This exercise offers only a few examples of how originalism might be applied to cases in bioethics. Originalism is extremely conservative in the literal sense – it compels the resolution of today’s novel legal issues by mining the views of lawmakers from long ago. Advances in medicine and biotechnology have often “outpaced” the law.^[58] When that happens, originalism stands guard in the doorway, defiantly barring constitutional law from catching up. It is an especially firm bulwark against the recognition of rights that are not specified in the Constitution, including those highly relevant to bioethics, such as privacy, contraception, abortion, and medical-aid-in dying.

While originalism is inherently conservative, the examples studied in this article reveal some surprises: in some cases, it yields results that would not be regarded as conservative by today's standards. For example, an originalist analysis would likely support a law mandating vaccination without a religious exemption. And it might disfavor an executive order, issued without legislative support, that restricts gender reassignment treatments. Or the denial of funding to suppress speech.

Accordingly, originalism can be politically fickle; it might in some cases point to an arguably progressive result.^[59] Perhaps for that reason, the doctrine seems to be used selectively by the Court. But that selectivity undermines its rationale as an objective judicial philosophy, in contrast to judicial legislating.

In constitutional cases involving modern bioethical issues, while originalism can lead to outcomes across the political spectrum, ultimately, the public is ill-served by the Supreme Court's demand for evidence of the inapposite views of our ancestors.

[1] Antonin Scalia, “Originalism: The Lesser Evil,” University of Cincinnati Law Review 57 (1989): 849. https://teachingamericanhistory.org/document/originalism-the-lesser-evil/

[2] 597 U.S. 1 (2022). https://www.oyez.org/cases/2021/20-843

[3] District of Columbia v. Heller, 554 U.S. 570 (2008). https://supreme.justia.com/cases/federal/us/554/570/

[4] 597 U.S. 215 (2022). https://supreme.justia.com/cases/federal/us/597/19-1392/

[5] 410 U.S. 113 (1973). https://supreme.justia.com/cases/federal/us/410/113/

[6] Dobbs, 597 U.S. at 225. https://supreme.justia.com/cases/federal/us/597/19-1392/

[7] Ibid., 597 U.S. at 231.

[8] Ibid., 597 U.S. at 239, referring to Washington v. Glucksberg, 521 U.S. 702 (1997).

[9] E.g., Moore v. Harper, 143 S.Ct. 2065(2023). https://supreme.justia.com/cases/federal/us/600/21-1271/#tab-opinion-4757256 (federal court review of state election laws); Trump v. Anderson, 144 S.Ct. 662 (2024). https://supreme.justia.com/cases/federal/us/601/23-719/ (meaning of insurrection clause); Kennedy v. Bremerton Sch. Dist., 142 S. Ct. 2407 (2022). https://supreme.justia.com/cases/federal/us/597/21-418/ (prayer on school football field does not violate establishment clause).

[10] Ian Bartrum, “Structural Originalism: A Second Amendment Case Study,” University of Pennsylvania Journal of Constitutional Law 27 (2025): 846. https://doi.org/10.58112/jcl.27-4.3

[11] Bruen, 83 - 133 (Breyer, dissenting). See also, Erwin Chemerinsky, Worse than Nothing (Yale University Press, 2022); Thomas Wolf, Seth Breidbart, and Chika Isozaki, Countering Originalism: A Guide for Litigators (New York: Brennan Center for Justice at New York University, December 2025), https://www.brennancenter.org/media/14809/download/bcj-166-countering-Originalism.pdf.

[12] William J. Novak, “Some Realism about Originalism,” Michigan Law Review 123 (2025): 1185–1190. https://doi.org/10.36644/mlr.123.6.some; Saul Cornell, “Learning to Read Like an Eighteenth-Century Lawyer: The Historical Critique of Originalism Revisited,” William & Mary Bill of Rights Journal 33 (2024): 439. https://scholarship.law.wm.edu/cgi/viewcontent.cgi?article=2104&context=wmborj

[13] Chemerinsky. The Abhorrence Problem. In Erwin Chemerinsky, Worse Than Nothing: The Dangerous Fallacy of Originalism (Yale University Press, 2022),

[14] Osagie K. Obasogie, “Can Originalism Save Bioethics?” in Critical Approaches to Science and Religion, chap. 4 (New York: Columbia University Press, 2023), 97.

[15] Chemerinsky. The Epistemological Problem. In Erwin Chemerinsky, Worse Than Nothing: The Dangerous Fallacy of Originalism (Yale University Press, 2022).

[16] NLRB v. Noel Canning, 573 U.S. 513, 533–34 (2014). https://supreme.justia.com/cases/federal/us/573/513/

[17] J. Bernstein, "Originalism's Precedent Problem," 45 Northern Illinois University Law Review 172. https://huskiecommons.lib.niu.edu/niulr/vol45/iss2/6/

[18] "Conservative Caution v. Progressive Originalism: How Justices Barrett and Jackson Are Paving Their Own Paths on the Court," symposium, 31 Cardozo Journal of Equal Rights and Social Justice 607 (2025) at 636. https://larc.cardozo.yu.edu/cgi/viewcontent.cgi?article=1029&context=cardozoersj

[19] United States v. Rahimi, 602 U.S. 680 (2024). https://supreme.justia.com/cases/federal/us/602/22-915/

[20] Chemerinsky. The Hypocrisy Problem. In Erwin Chemerinsky, Worse Than Nothing: The Dangerous Fallacy of Originalism (Yale University Press, 2022).

[21] Citizens United v. Federal Election Commission, 558 U.S. 310 (2010). https://supreme.justia.com/cases/federal/us/558/310/

[22] Trump v. United States, 603 U.S. 593 (2024). https://supreme.justia.com/cases/federal/us/603/23-939/

[23] Obasogie, “Can Originalism Save Bioethics”,” 97. Obasogie, addressing a related but separate topic, observes that "Germline engineering, embryo screening, and similar techniques give rise to the ability of science and medicine to enhance or eliminate populations in ways that would make nineteenth-century eugenicists utterly giddy." He then calls for bioethicists to employ Originalism, to "reorient itself away from principalism and back toward its original founding value: anti-eugenics."

[24] 497 U.S. 261 (1990). https://supreme.justia.com/cases/federal/us/497/261/

[25] Ibid. At 294.

[26] Ibid. at 300.

[27] E.g., Health Freedom Defense Fund, Inc. v. Carvalho, 148 F.4th 1020 (9th Cir. 2025). https://cdn.ca9.uscourts.gov/datastore/opinions/2025/07/30/22-55908.pdf; Johnson v. Kotek, NO. 22-35624, 2024 WL 747022 (9th Cir. 2024). https://www.supremecourt.gov/DocketPDF/24/24-173/322395/20240813193006226_Johnson%20v%20Kotek%20Petition.pdf; Children's Health Defense, Inc. v. Rutgers, the State University of New Jersey, 93 F.4th 66 (3rd Cir. 2024). https://law.justia.com/cases/federal/appellate-courts/ca3/22-2970/22-2970-2024-02-15.html; We The Patriots USA, Inc. v. Connecticut Office of Early Childhood Development 76 F.4th 130 (2nd Cir. 2023). https://law.justia.com/cases/federal/appellate-courts/ca2/22-249/22-249-2023-08-04.html

[28] Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York: Oxford University Press, 2019).

[29] A bioethicist might respect a patient’s decision to forgo treatment as an ethical matter but not support it as constitutional right. While principled arguments could be made for holding those separate positions, the positions are not “aligned” in whether they support the patient’s decision.

[30] Ruth R. Faden and Tom L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

[31] Carey v. Population Services International, 431 U.S. 678 (1977). https://supreme.justia.com/cases/federal/us/431/678/ (An earlier right-to-contraceptives decision. Griswold v. Connecticut, 381 U.S.479 (1965), relied upon a combination of constitutional provisions, but principally the First Amendment).

[32] Roe v. Wade, 410 U.S. 113 (1973). https://supreme.justia.com/cases/federal/us/410/113/

[33] O’Connor v. Donaldson, 422 U.S. 563 (1975); Parham v. J.R., 442 U.S. 584 (1979). https://supreme.justia.com/cases/federal/us/422/563/

[34] Dobbs v. Jackson Women’s Health Organization (2022).

[35] See e.g. Erwin Chemerinsky, “The Future of Substantive Due Process: What are the Stakes?,” 76 SMU Law Review 427 Summer 2023); Parker Wilkson, “The Danger of Dobbs: Substantive Due Process, Fundamental Rights, And a Critique of the Theory of Historical Tradition.” 35 U. Fla. J.L. & Pub. Pol'y 197 (Spring 2025).

[36] Murthy v. Missouri, 603 U.S. 43 (2024). https://supreme.justia.com/cases/federal/us/603/23-411/

[37] Missouri v. Biden, 83 F.4th 350 (5th Cir. 2023). https://law.justia.com/cases/federal/appellate-courts/ca5/23-30445/23-30445-2023-09-08.html

[38] Murthy v. Missouri, 603 U.S. at 77 (Alito,J., dissenting).

[39] Brandenburg v. Ohio, 395 U.S. 444, 447 (1969). https://supreme.justia.com/cases/federal/us/395/444/

[40] Robert Bork, “Neutral Principles and Some First Amendment Problems,” 47 Indiana Law Review (1971):1, 20. https://www.repository.law.indiana.edu/cgi/viewcontent.cgi?article=2720&context=ilj

[41] See Polly Price, Plagues in the Nation: How Epidemics Shaped America (Beacon)(2022).

[42] E.g., “Columbia Agrees to Trump’s Demand After Federal Funds Are Stripped,” New York Times, March 21, 2025. https://www.nytimes.com/2025/03/21/nyregion/columbia-response-trump-demands.html

[43] “Trump Expands Attacks on Law Firms, Singling Out Paul, Weiss,” New York Times, March 28, 2025. https://www.nytimes.com/2025/03/14/us/politics/trump-law-firm.html

[44] “When It Comes to D.E.I. and ICE, Trump Is Using Federal Grants as Leverage,” New York Times, April 7, 2025. https://www.nytimes.com/2025/04/07/us/politics/trump-homeland-security-ice-dei-grants.html

[45] President Donald J. Trump, Exec. Order No. 14,187, “Protecting Children from Chemical and Surgical Mutilation,” n.33 supra. https://www.federalregister.gov/documents/2025/02/03/2025-02194/protecting-children-from-chemical-and-surgical-mutilation

[46] United States v. Skrmetti, 605 U.S. 495 (2025). https://www.justice.gov/crt/media/1404486/dl?inline

[47] United States v. Virginia, 518 U.S. 515, 568-69 (1996)(Scalia, J. dissenting). https://supreme.justia.com/cases/federal/us/518/515/

[48] Chereminsky, ibid., Chapters 4 and 5.

[49] Obergefell v. Hodges, 576 U.S. 644, 664 (2015). https://supreme.justia.com/cases/federal/us/576/644/

[50] Order 25-133 (December 8, 2025) https://www.supremecourt.gov/orders/courtorders/120825zor_i4ek.pdf

[51] Fulton v. City of Philadelphia, Pennsylvania, 593 U.S. 522 (2021). https://supreme.justia.com/cases/federal/us/593/19-123/; Roman Catholic Diocese of Brooklyn v. Cuomo, 592 U.S. 14 (2020). https://www.oyez.org/cases/2020/20A87

[52] Dr. A. v. Hochul, 142 S.Ct. 552 (2021). https://www.supremecourt.gov/opinions/21pdf/21a145_gfbi.pdf (Gorsuch, dissenting)

[53] Jacobson v. Massachusetts, 197 U.S. 11 (1905). https://supreme.justia.com/cases/federal/us/197/11/

[54] Id. at 25.

[55] Id. at 29.

[56] PFLAG, Inc. v. Trump, 8:25-cv-00337 https://storage.courtlistener.com/recap/gov.uscourts.mdd.575616/gov.uscourts.mdd.575616.1.0_3.pdf; Commonwealth of Massachusetts v. Trump, 25 CV- 12162, at p 2. https://storage.courtlistener.com/recap/gov.uscourts.mad.287522/gov.uscourts.mad.287522.1.0.pdf; San Francisco Aids Foundation v. Trump, 3:25-cv-1824 https://storage.courtlistener.com/recap/gov.uscourts.cand.444946/gov.uscourts.cand.444946.1.0.pdf (challenging several executive orders)

[57] President Donald J. Trump, Exec. Order No. 14,187, “Protecting Children from Chemical and Surgical Mutilation,” January 28, 2025, https://www.govinfo.gov/content/pkg/DCPD-202500192/pdf/DCPD-202500192.pdf.

[58] E.g., Susan M. Wolf et al., “Anticipating Biopreservation Technologies That Pause Biological Time: Building Governance & Coordination Across Applications,” Journal of Law, Medicine & Ethics 52 (2024): 534–552. https://doi.org/10.1017/jme.2024.129; Susan L. Crockin, Alta L. Charo, and M. Edmonds, “The History and Future Trends of Art, Medicine and Law,” Family Court Review 59, no. 1 (January 2021): 22–45, https://doi.org/10.1111/fcre.12550.

[59] Novak at 1190 (discussing "Dreams of a Progressive Originalism"). https://repository.law.umich.edu/cgi/viewcontent.cgi?params=/context/mlr/article/14175/&path_info=

Specimens and Data, Not Evidence

Melissa Jones — 2026-03-12

Introduction

Clinical laboratories are built on trust, with patients expecting their specimens and associated data for diagnosis or treatment to remain confined to clinical purposes. However, notable cases demonstrate how easily clinical samples and related medical records can be repurposed for criminal investigations.^[1] For instance, police used DNA from a routine pap smear in the Blind Torture Kill (BTK) case; authorities in New Jersey accessed decades-old newborn blood spots in the Brian Avis case; and investigators used relatives’ genetic data from a genealogy database in the Golden State Killer case.^[2] These incidents highlight a growing tension between medical care and law enforcement, underscoring critical ethical concerns about patient autonomy, confidentiality, and the limits of clinical sample use.

Law enforcement’s growing interest in clinical laboratory data raises pressing questions about whether patient specimens are being treated as investigatory evidence rather than components of healthcare. While the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA) regulate privacy and laboratory standards, both have broad exceptions for law enforcement and do not address specimen retention or secondary use.^[3] Since these laws offer limited protections, constitutional safeguards become central. This paper argues that existing legal and regulatory frameworks inadequately safeguard clinical specimens and medical records from investigatory repurposing. After outlining the ethical principles that protect patients, the analysis turns to constitutional doctrines affecting law enforcement access, variations across states, and real-world examples illustrating the impacts of these gaps. The paper concludes by proposing reforms to enhance transparency, autonomy, and public trust in the clinical laboratory.

Ethical Frameworks: Principles Guiding Patient Protection

Deontological ethics holds that specific actions are impermissible regardless of their outcomes. In the clinical laboratory, deontological ethics includes respecting autonomy, maintaining confidentiality, and honoring fidelity. Using specimens collected for clinical care in criminal investigations without explicit, voluntary consent violates these duties, even when HIPAA permits it under its law-enforcement exceptions.^[4]

Utilitarian arguments for using clinical laboratory specimens and related data often emphasize the benefits of solving crimes, but this perspective risks treating patients as means to an end and ignoring broader harms. Evidence shows that concerns about genetic privacy decrease participation in newborn screening, biobanking, and other public health efforts.^[5] Therefore, a utilitarian approach must consider long-term effects, such as reduced trust and lower engagement with healthcare systems. Ethical frameworks delineate clear boundaries: clinical specimens are collected for care, not surveillance. Despite these ethical imperatives, the legal system provides uneven protection, particularly where constitutional doctrines intersect with law enforcement interests. This tension becomes most apparent in the Fourth Amendment context.

Constitutional Limitations

Regardless of the regulatory structure governing clinical laboratories, the constitutional landscape ultimately determines the extent to which law enforcement may access patient specimens and data. Because statutory protections are limited, courts have become the primary arbiters of what constitutes a permissible intrusion.^[6]

The Special Needs Doctrine: Lessons from Skinner

In Skinner v. Railway Labor Executives’ Association (1989), the Supreme Court upheld warrantless drug and alcohol testing of railway employees. The Court reasoned that the government’s interest in public safety constituted a “special need” beyond ordinary law enforcement. This decision established the modern Special Needs Doctrine, which permits warrantless searches, including the collection of specimens, when the primary purpose is considered administrative. ^[7] Although Skinner arose in the context of transportation safety, the Court’s reasoning has been extended to other settings, weakening Fourth Amendment protections for clinical specimens.

The Third-Party Doctrine

Under the Third-Party Doctrine, individuals forfeit constitutional privacy protections for information they voluntarily shared with third parties, including hospitals and laboratories. In the clinical laboratory context, this doctrine treats disclosures made for medical care as equivalent to disclosures made for non-medical purposes, a conflation that undermines patient autonomy and confidentiality. ^[8]

Fourth Amendment Case Law

Courts have long debated the extent of bodily intrusion allowed under the Fourth Amendment when law enforcement seeks biological evidence. In Schmerber v. California, the Court upheld a warrantless blood draw under limited exigent circumstances. ^[9] However, subsequent rulings have narrowed that reasoning. In Missouri v. McNeely (2013), the Court rejected a categorical rule that the natural dissipation of alcohol in the bloodstream alone creates exigency and instead required a case-by-case evaluation.^[10] In Birchfield v. North Dakota (2016), the Court distinguished breath tests, which can be performed without a warrant, from blood tests, which generally require a warrant.^[11]

Courts have also condemned more invasive procedures. In Winston v. Lee, the Court ruled that forced surgical removal of a bullet violated the Fourth Amendment, and in United States v. Fowlkes (2015), the Ninth Circuit found forced catheterization to obtain urine to be an unreasonable search.^[12] These cases demonstrate that the level of bodily intrusion is a key constitutional issue and that the use of medical procedures for law enforcement raise serious Fourth Amendment concerns.

State-Level Variation

Although the Fourth Amendment sets a federal constitutional baseline, states vary significantly in how they interpret and apply bodily‑intrusion case law. Some states adopt broad implied‑consent statutes that authorize blood or urine testing following arrest, while others limit implied consent to breath tests or require warrants for all invasive procedures. For example, Nevada’s statute permits expansive implied‑consent testing and authorizes chemical testing under a wide range of circumstances.^[13] By contrast, California limits implied consent to situations following a lawful arrest and requires warrants for blood draws absent exigency.^[14] Utah protects healthcare workers who refuse warrantless blood draws, emphasizing clinician autonomy and liability.^[15] Historically, Pennsylvania required healthcare workers to comply with police requests for blood samples, reflecting a more law-enforcement approach.^[16] States also differ in their treatment of forced catheterization, the collection and retention of clinical laboratory specimens and data, and other invasive procedures as means of evidence collection, with some courts viewing them as categorically unreasonable and others permitting them under narrow circumstances.^[17]

Ultimately, the degree of protection afforded to patients depends heavily on state-level choices regarding consent, clinician authority, the permissibility of invasive procedures, and law enforcement access.

Toward Ethical Integrity: Policy Reform Proposals

The interplay of statutory gaps, including the exception to HIPAA’s privacy rule, constitutional limitations, and divergent state practices demonstrates that current frameworks inadequately protect clinical specimens from investigatory use. This landscape highlights the need for reforms that reinforce ethical and legal safeguards.

Reform 1: Require Voluntary, Explicit Consent

Law enforcement access to specimens or metadata should require explicit, voluntary consent. In the clinical laboratory, presumed consent — where agreement is inferred from silence, unconsciousness, or routine clinical encounters — is ethically indefensible. It treats patients as passive subjects of investigation rather than autonomous individuals. Although some contend that explicit consent may delay investigations, deontological ethics holds that convenience cannot override autonomy. Utilitarian reasoning likewise supports explicit consent, considering the long-term harms of eroding trust.^[18]

Reform 2: Prohibit Conditioned Consent

Healthcare access must never depend on investigatory cooperation. Conditioning medical care on a patient’s willingness to provide specimens or information for law enforcement purposes undermines autonomy and erodes trust in the clinical relationship. Evidence shows that coercive consent reduces willingness to share sensitive information and discourages engagement with healthcare systems, ultimately harming individual care and public health.^[19]

Reform 3: Protect Specimens and Metadata Equally

Metadata can be reidentified through linkage with other datasets.^[20] Treating metadata as less sensitive creates exploitable loopholes. Policies must extend protection to both specimens and associated data.

Reform 4: Mandate Independent Oversight and Transparency

Oversight bodies should evaluate investigatory requests and issue transparency reports. Rather than adding bureaucratic burden, oversight enhances accountability and clarifies the separation between clinical care and criminal investigations. However, most jurisdictions lack an independent entity to monitor how often patient records are accessed for law enforcement or how metadata is queried, linked, or reused.^[21] Without such oversight, patients and clinicians lack visibility into the frequency and scope of investigative access, and policymakers lack the data needed to evaluate whether current practices align with ethical and constitutional norms.

Reform 5: Update Newborn Screening Policies

Newborn screening programs should adopt opt-in consent for secondary uses and establish clear limits on the retention of residual blood spots. Research consistently shows parental opposition to non-consensual secondary use and highlights trust as essential to program participation.^[22]

Conclusion

Unrestricted law enforcement access to clinical specimens risks transforming clinical encounters into a surveillance pathway. Deontological ethics demands the protection of patient rights regardless of investigatory outcomes, while utilitarian analysis warns against systemic harms caused by privacy erosion. Legally, HIPAA and CLIA offer insufficient safeguards, particularly regarding specimen retention and metadata use. Reform must begin with explicit, revocable consent, independent oversight, and a clear separation between clinical care and criminal investigation.

The clinical laboratory is not a forensic repository. It is a space of healing, trust, and ethical responsibility. Policymakers, administrators, and clinicians must act now to establish statutory reforms that prevent investigatory misuse, mandate transparency, and restore public trust.

[1] Ram, N., Guerrini, C. J., & McGuire, A. L., “Genealogy Databases and the Future of Criminal Investigation,” Annual Review of Genomics and Human Genetics 22 (2021): 467–489; Hazel, J. W., & Clayton, E. W., “The Law and Ethics of Using DNA from Clinical Samples for Criminal Investigations,” Journal of Law, Medicine & Ethics 49, no. 2 (2021): 235–244: Ram, Guerrini, & McGuire AL, “Genealogy Databases,” 467–489.

[2] State of Kansas v. Radar, No. 05 CR 2101(2005). The criminal case is for murder, but the ethically relevant detail is how investigators used clinical samples from a relative to identify and apprehend Rader; State of New Jersey v. Brian Lee Avis (2021) (case number unavailable). In this case, the formal criminal charges were for sexual assault. This case is ethically significant because law enforcement allegedly obtained DNA from a child’s Guthrie card to implicate Avis.

[3] Abraha, H., “HIPAA and CLIA: Gaps in Regulating Specimen Retention and Metadata Use,” Journal of Health Law & Policy 14, no. 2 (2021): 201–220.

[4] Beauchamp, T. L. and Childress, J.F., Principles of Biomedical Ethics, 5th ed. (Oxford: Oxford University Press, 2003); Mandal, J., Ponnambath, D. K., and Parija, S. C., “Utilitarian and Deontological Ethics in Medicine,” Tropical Parasitology 6, no. 1 (2016): 5–7.

[5] Mandal, Ponnambath, and Parija; Tuazon, J., Smith, A., and Patel, R., “Utilitarian Perspectives on Forensic Use of Clinical Specimens,” Journal of Forensic Ethics 12, no. 2 (2024): 101–118; Ruhl, D. S., et al., “Public Attitudes Toward Genetic Privacy and Law Enforcement Access,” Genetics in Medicine 22, no. 1 (2020): 145–152; Tuazon, J., A. Smith, and R. Patel, “Utilitarian Perspectives on Forensic Use of Clinical Specimens,” Journal of Forensic Ethics 12, no. 2 (2024): 101–118.

[6] Abraha, “HIPAA and CLIA,” 201–220.

[7] Skinner v. Railway Labor Executives’ Association, 489 U.S. 602 (1989). In Skinner, the Supreme Court upheld federal regulations authorizing warrantless drug and alcohol testing of railway employees following accidents or safety violations. The Court reasoned that the government’s interest in preventing catastrophic harm in the transportation sector constituted a “special need” beyond ordinary law enforcement, allowing searches without individualized suspicion or a warrant.

[8] Kerr, O. S., “The Case for the Third‑Party Doctrine,” Michigan Law Review 107, no. 4 (2009): 561–601; Slobogin, C., Privacy at Risk (Chicago: University of Chicago Press, 2018).

[9] Schmerber v. California, 384 U.S. 757 (1966).

[10] Missouri v. McNeely, 569 U.S. 141 (2013).

[11] Birchfield v. North Dakota, 579 U.S. 438 (2016).

[12] Winston v. Lee, 470 U.S. 753 (1985). In this case, the Court ruled that extreme bodily intrusion violated the Fourth Amendment and the individual’s right to bodily integrity; United States v. Fowlkes, 804 F.3d 954 (9th Cir. 2015). The Ninth Circuit held that forced catheterization to obtain urine was an unreasonable search, noting the significant physical intrusion and the availability of less invasive alternatives.

[13] Nevada Legislature, NRS 484C.160–484C.180 (2024). Nevada’s implied‑consent framework authorizes chemical testing of blood, breath, or urine following arrest for driving‑related offenses and permits testing under certain circumstances even without express consent. https://www.leg.state.nv.us/NRS/NRS-484C.html.

[14] California Vehicle Code § 23612 (2024). California’s statute limits implied consent to breath tests following lawful arrest and requires warrants for blood draws unless exigent circumstances exist. https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=23612&lawCode=VEH

[15] Utah Code Ann. § 26‑1‑30 (2024). Utah law protects clinicians who refuse warrantless blood draws and require warrants or patient consent except in narrow circumstances. https://le.utah.gov/xcode/historical.html?date=1/16/2024&oc=/xcode/Title58/Chapter67/C58-67-S305_2022050420220504.html

[16] Commonwealth v. Shaw, 770 A.2d 295 (Pa. 2001); 75 Pa. Cons. Stat. § 1547 (2024). Pennsylvania courts historically interpreted implied‑consent statutes to require compliance with police requests for blood samples.

[17] State v. Thompson, 886 N.W.2d 224 (Iowa 2016) (holding forced catheterization unconstitutional); contrast with State v. Trahan, 886 N.W.2d 216 (Minn. 2016) (evaluating catheterization under a totality‑of‑the‑circumstances analysis). These cases illustrate divergent state approaches to invasive evidence‑collection procedures.

[18] Beauchamp, Principles of Biomedical Ethics; Grady, C., “Enduring and Emerging Challenges of Informed Consent,” New England Journal of Medicine 372, no. 9 (2015): 855–862. DOI: 10.1056/NEJMra1411250

[19] American Medical Association. “Informed Consent.” AMA Code of Medical Ethics, Opinion 2.1.1. https://code-medical-ethics.ama-assn.org/ethics-opinions/informed-consent

[20] Hazel, J. W., and Slobogin, C. “Reidentification Risks in Genomic Data.” Journal of Law and the Biosciences 10, no. 1 (2023): lsad001

[21] Ram, N., C. J. Guerrini, and A. L. McGuire, “Genealogy Databases and the Future of Criminal Investigation,” Annual Review of Genomics and Human Genetics 22 (2021): 467–489.

[22] Yin, X., et al., “Parental Awareness and Perspectives on Newborn Screening in China,” BMC Medical Ethics 25 (2024): 140; Armstrong, B., et al., “Parental Attitudes Toward Standard Newborn Screening and Newborn Genomic Sequencing,” Frontiers in Genetics 13 (2022): 867371.

Silencing Sorrow

Katherine Shiells — 2026-03-03

Introduction

In a world where every emotion seems to require a diagnosis, grief has become medicine’s most misdiagnosed form of suffering, not ignored but absorbed into clinical categories like depression that obscure its meaning. This paper applies a historical lens to evaluate how diagnoses function as both medical conditions and cultural constructs. The analysis examines how grief-related suffering, particularly chronic sorrow, is still routinely misclassified as clinical depression despite the DSM-5 TR’s 2022 addition of prolonged grief disorder (PGD) as a distinct diagnosis,^[1] and its role in society and culture. While the DSM-5-TR (2022) now recognizes prolonged grief disorder as distinct from major depressive disorder, this paper argues that a broader category of grief-related suffering—chronic sorrow—remains unaddressed by either diagnosis and continues to be mislabeled as depression in clinical practice.^[2] Drawing on the concept of diagnostic logic, the reflex to read all suffering as a symptom, what is often identified as depression in social and clinical contexts, can be better defined as chronic sorrow, a subtype of grief. Chronic sorrow comes from losses that continue to affect a person over time and can be clinically recognized without being framed as a disorder. This paper does not argue that grief should be excluded from diagnostic frameworks, nor that it should be universally pathologized; rather, it argues that clinicians need narrative competence^[3] to interpret grief-based suffering contextually rather than defaulting to pharmaceutical intervention.

Diagnostic Systems and Power

Economic, institutional, and cultural powers shape modern psychiatry’s diagnostic system, medicalizing depression while excluding grief, unless it is prolonged.^[4] The DSM-5-TR’s inclusion of prolonged grief disorder in 2022 was a significant development, classifying it under trauma- and stressor-related disorders rather than depressive disorders.^[5] Yet PGD applies only to grief following death that persists beyond twelve months; it does not address chronic sorrow arising from ongoing, nonfinite losses such as disability or caregiving.^[6] Insurance systems and pharmaceutical development impact diagnostic symptom checklists. Scientific clarity does not solely determine diagnosis.^[7] The “sick role” is granted to individuals who suffer from depression through exemptions and expectations of recovery.^[8]

Chronic Sorrow Versus Clinical Depression

Clinical depression is a mood disorder characterized by ongoing low energy, lack of interest, and difficulties in functioning.^[9] Its symptoms are broad and may persist beyond any specific precipitating event, even when a clear cause is present. In contrast, chronic sorrow arises from ongoing loss, causing exhaustion from repeatedly coping with it.^[10] The feelings are directly linked to the loss and typically do not improve with medication.^[11] Chronic sorrow often arises in the context of illness, disability, or other enduring conditions that repeatedly reopen emotional wounds for patients or caregivers. Loss may take the form of identity, independence, social role, status, or imagined futures.^[12] Mislabeling chronic sorrow as depression risks trapping patients in cycles of misunderstanding and ineffective treatment.

Scholars have linked symptoms of depression, including nervousness and exhaustion, to modern urbanization, capitalism, and alienation, with depression often described as a “disease of civilization.”^[13] Grief, however, is frequently overlooked within this framework and treated as depression despite its capacity to build community through rituals, religion, and shared meaning. While the global expansion of depression diagnoses has helped many sufferers, it has also displaced cultural grief practices.^[14] Unlike depression, grief and mourning often affirm love, loyalty, and meaning through social recognition rather than medication.

Grief and Medicalization

Grief itself is a natural response^[15], and when society frames it as pathological, ethical concerns arise. Such distress can be psychological, physical, and psychosomatic,^[16] yet the experience remains nonfinite and evolving, affecting individuals and those around them.^[17] Although grief may resemble illness in its social effects, it does not comfortably fit within a biomedical disease model. It should be resistant to medicalization. However, bureaucratic and pharmaceutical forces influence what is formally recognized as a disease.

Disenfranchised Grief and Institutional Failure

At a systems level, the failure to distinguish between chronic sorrow and clinical depression, a distinction the DSM-5-TR addresses for prolonged grief but not for ongoing nonfinite losses, reflects the problem of disenfranchised grief in medicine, where grief is acknowledged not through diagnosis, but through appropriate clinical support and referral.^[18] When grief is overlooked or misdiagnosed, patients’ rights to appropriate support are undermined,^[19] leading institutions to rely on medication rather than adaptive, relational forms of care.^[20]

Narrative Competence and Ethical Diagnosis

Critiques of diagnostic logic emphasize the need for greater attention to contextual meaning in clinical practice.^[21] In this paper, I am critiquing diagnostic logic rather than arguing that sorrow should be diagnosed as a disorder by default. Through training in narrative competence, clinicians can read patient stories holistically rather than as symptom lists, incorporating cultural variation and moral reflection before assigning psychiatric diagnoses.^[22] With this framework, clinicians can better recognize grief-based suffering without reducing it to pathology, and support patients by referring them to social supports when diagnosis is not the best fit. This approach encourages ethical awareness in the use of diagnosis and treatment.^[23]

Counterargument: Access to Care

A common counterargument is that diagnosing grief as depression facilitates access to existing medical and insurance systems. While access concerns are significant, diagnostic inaccuracy risks inappropriate treatment^[24] and further marginalization of grief. Ethical care requires institutional reform that expands support without reducing grief to pathology.

Medicine often treats depression pharmaceutically at the individual level, while chronic sorrow reflects a systems-level condition rooted in ongoing relational and social loss. Improved screening and training can help clinicians recognize this distinction and avoid unnecessary medication, supporting patients in ways that promote autonomy, beneficence, and justice.

[1] American Psychiatric Association. (2022). Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) (5^th ed.).

[2] Eakes, G. G., Burke, M. L., & Hainsworth, M. A. (1998). Middle-range theory of chronic sorrow. Image--the journal of nursing scholarship, 30(2), 179–184. https://doi.org/10.1111/j.1547-5069.1998.tb01276.x; Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/

[3] Charon, R. (2001). Narrative medicine: A model for empathy, reflection, profession, and trust. JAMA, 286(15), 1897–1902.

[4] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[5] Szuhany, K. L., et al. (2021). Prolonged grief disorder: Course, diagnosis, assessment, and treatment. Focus, 19(2), 161–172.

[6] Lindgren, C. L., et al. (1992). Chronic sorrow: A lifespan concept. Scholarly Inquiry for Nursing Practice, 6(1), 27–40.

[7] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[8] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[9] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[10] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[11] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.; Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/

[12] Breen, L. J., & Fernandez, M. E. (2019). Grief and mental illness. In Harris, D. L. (Eds.), Non-Death loss and grief, pp. 227–236. Routledge. https://doi.org/10.4324/9780429446054-22.

[13] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[14] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[15] Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/

[16] Breen, L. J., & Fernandez, M. E. (2019). Grief and mental illness. In Harris, D. L. (Eds.), Non-Death loss and grief, pp. 227–236. Routledge. https://doi.org/10.4324/9780429446054-22.

[17] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[18] Thompson, N., & Doka, K. J. (2017). Disenfranchised grief. In N. Thompson & G. R. Cox (Eds.), Handbook of the sociology of death, grief, and bereavement: A guide to theory and practice (pp. 177–189). Routledge. https://doi.org/10.4324/9781315453859-15.

[19] Thompson, N., & Doka, K. J. (2017). Disenfranchised grief. In N. Thompson & G. R. Cox (Eds.), Handbook of the sociology of death, grief, and bereavement: A guide to theory and practice (pp. 177–189). Routledge. https://doi.org/10.4324/9781315453859-15.

[20] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[21] Harris, D. L., & Winokuer, H. R. (2019). Living losses: Nonfinite loss, ambiguous loss, and chronic sorrow. In Principles and practice of grief counseling (3rd ed., pp. 121–137). https://doi.org/10.1891/9780826173331.0008.

[22] Harris, D. L., & Winokuer, H. R. (2019). Living losses: Nonfinite loss, ambiguous loss, and chronic sorrow. In Principles and practice of grief counseling (3rd ed., pp. 121–137). https://doi.org/10.1891/9780826173331.0008.

[23] Harris, D. L., & Winokuer, H. R. (2019). Living losses: Nonfinite loss, ambiguous loss, and chronic sorrow. In Principles and practice of grief counseling (3rd ed., pp. 121–137). https://doi.org/10.1891/9780826173331.0008.

[24] Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/