Photo ID 23828612 © Thevirex | Dreamstime.com Introduction Physicians are on the lookout for social determinants of health, which are those economic, social, and environmental factors that shape a person’s well-being (or lack of it). Physicians often ask patients what their sleep schedule is like or if they have secure access to food and housing, to construct an accurate picture of the patient’s quality of life. Questions that once might have felt invasive (“Does anyone in your household regularly scream at (...) you?”) now feature regularly in clinical encounters. Given the volatile state of US politics, it might not be unreasonable for physicians to try and determine whether and to what extent political rhetoric takes a negative toll on patients’ health. There is potential for the DSM-5 to include political anxiety as a new disorder. Physicians should begin to take political stress seriously as a social determinant of health. Political Stress and Anxiety A 2020 article investigated the role that partisan politics plays in health outcomes.[1] The title blasted the results: “Partisan Politics may be Literally Killing Us.” According to the authors, “mortality rates increase by 0.7% for every 10% of the population that votes for the losing candidate.” This turns out to be a more than 3 percent increase in mortality rates “for extremely partisan counties.” In other words, the study suggests that Party Loss (PL) has deadly consequences. Although questions of cause versus correlation are beyond the scope of the paper, the authors suggest the answer for the uptick in death might have to do with an increase in anxiety and social isolation. Chronic stress kills — and many voters, it seems, are chronically stressed. In 2019, a psychiatrist at the University of Michigan gave an interview discussing how to avoid “political fatigue.”[2] Signs that political discussions are stressing you out might include high blood pressure, weight fluctuation, and sleep struggles. Her first recommendation: be aware of how much time you spend consuming political media. Easier said than done. Social and mainstream media are an inescapable feature of life in 2024. The media are paid for by advertisements and during campaign season, these advertisements are often political. So, even though you might be sitting down with your family to watch an anodyne program like Jeopardy, you’ll likely see some sort of “attack ad” — the very name of which tells you that it’s been created to foster hostility. It's not only political ads, though. Even mainstream news feels as if it is engineered to elicit the strongest possible response from readers. This has to do with the financial stakes of the news game: with less (or sometimes no) revenue from subscriptions, media are forced to compete for digital audiences. They do so by goading you into clicking on their headlines. The first newsroom I was part of was progressive by most political standards. On one of my first days on the job, I asked a colleague why the televisions in the main office were set to FOX News. “I guess so that when they say something stupid, we can be the first outlet to write an article about it.” I learned that day that this news organization’s mission included not only reporting the news but also making people angry. To some reporters, these were two sides of the same coin. Even when news is not written to elicit anger, it seems constructed to make readers feel emotionally involved with the story. In the past month alone, there have been countless reported variations on a single theme: “Early polling shows the presidential race to be neck and neck, but here’s an alternative data point that might make you feel very strong.” A 2023 poll found that 90 percent of Americans always, often, or sometimes feel “angry” when they think about politics, with about the same number reporting they always, often, or sometimes feel “exhausted.”[3] The same survey asked Americans to sum up their feelings about American politics in a word — four in five respondents used negative words, like “divisive,” “dysfunctional,” and “sad.” Politics in the Doctor’s Office The question healthcare providers need to answer is whether this data ought to make its way into exam rooms. For example, if a patient who complains of sleeplessness comes in for an examination the week before an election wearing a t-shirt advertising a political candidate, a physician might find this clinically relevant. Perhaps the physician might consider asking the patient if the upcoming election is affecting their emotional or mental health. Or if in the days following an election, a patient, similarly dressed, presents to the ED complaining of chest pains, the physician might try to determine whether political disappointment — “Party Loss,” as the above-mentioned study calls it — might be contributing to the patient’s increased anxiety levels. Of course, mentioning politics in clinical settings, especially to patients who seem all too eager to discuss them, carries a certain risk. It is possible that asking about the patient’s level of political involvement might trigger them to launch into a rant, experience a spike in blood pressure, and yell. Or worse, the patient could become hostile towards the provider and ask about the provider’s own political leanings. This, however, need not end in a negative clinical outcome. The physician could calmly explain that she likes to limit discussing politics to certain times and with certain people. By doing this, she is modeling for the patient a different way of engaging politics: with respect, with restraint, and with people of her own choosing (i.e., not strangers on the internet or passing acquaintances). Recommendations Physicians are beginning to take the role that social determinants play in the health of their patients seriously. Given the ubiquity of political rhetoric in the US, physicians have good reason to see “political sentiment” as one such determinant of health. Hostile political rhetoric risks tearing apart friends, families, and neighborhoods. As physicians now understand, a person’s health is inextricably tied up with the health of the communities to which she belongs. Social isolation, for instance, is a good predictor of negative health consequences. If a patient reports that she is not visiting her parents for the holidays because of their political differences, a physician could consider including this information in the patient’s clinical chart. Some might argue that discussing “political anxiety” in healthcare settings is an example of medicalization: political anxiety, they might reason, is a social issue that ought not be brought under the purview of medicine. But social issues have health consequences, both at an individual and population level. While stress might be triggered by, for instance, social phenomena, its physiological effects are profound. It is not always possible to treat the latter without addressing the former. Treatment, however, does not necessarily need to be pharmaceutical: sometimes simply recommending breathing exercises or nature walks might do the trick. In a similar way, physicians discussing political anxiety with their patients will likely not prescribe medications at first. Simply suggesting the patient be mindful about their political content could be a good first step. People experience anxiety for a variety of reasons. The DSM-5 includes Illness Anxiety Disorder (IAD). The next version could even include preliminary recommendations for studying “Political Anxiety Disorder” (PAD) or Obsession With Respect to Controlling Political Outcomes. Just as patients who suffer from IAD obsessively check their online portals for the latest lab results, some patients obsessively check political polls. There should be a point where the physician suspects this patient’s behavior is negatively affecting her health. It is conceivable that a physician ought to recommend a patient take a break from cable news. It might be appropriate for medical organizations to release policy statements urging the general public to be on the lookout for signs of political anxiety in themselves and in their families. While for now other types of anxiety may include political anxiety, noting the importance of politics as a social determinant of health may highlight the need for physicians to develop best practices and recommendations, like limiting political news, taking breaks from social media, and finding common ground with those with opposing views. - [1] Maas A, Lu L. “Elections have Consequences: Partisan Politics may be Literally Killing Us.” Applied Health Economic Health Policy. Jan 2021: 19(1): 45-56. [2] Health Lab. “5 ways to manage political induced stress,” Republication November 4, 2024. [3] Pew Poll Center, September 2023, “Americans’ Dismal Views of the Nation’s Politics”. (shrink)

Photo ID 222412412 © US Navy Medicine | Dreamstime.com ABSTRACT In a non-military setting, the answer is clear: it would be unethical to treat someone based on non-medical considerations such as nationality. We argue that Battlefield Triage is a moral tragedy, meaning that it is a situation in which there is no morally blameless decision and that the demands of justice cannot be satisfied. INTRODUCTION Medical resources in an austere environment without quick recourse for resupply or casualty evacuation are often (...) limited. The shortage extends not only to supplies like blood products and drugs, but physicians and other medical personnel. In the midst of a mass casualty scenario, such as a battle that includes intense ground fighting, the medical staff will stretch scarce resources and triage casualties according to specific criteria. Typically, they proceed by providing care for the most severely wounded first, referred to here as conventional triage. At times, though, the staff may reverse the triage so that soldiers with minor wounds can return to the fight. In a mass casualty situation, when medical personnel apply conventional triage and treat casualties from opposing forces, a dilemma may arise. We argue that it can be permissible for military physicians to prioritize their own soldiers over enemy combatants in a mass casualty triage, where reverse triage does not apply. The case we will focus on is as follows: Battlefield Triage: During combat operations on a remote island in the Pacific Ocean, a compatriot soldier and an enemy combatant arrive at the compatriot soldier country’s medical treatment facility. Both have similar gunshot wounds to the abdomen, and they arrive with similar conditions. Both have low oxygen saturation and excessive blood loss. The sole physician only has enough time to stabilize one person. The scenario is brief, and we are aware that medical rules of eligibility will most often dictate how the physician proceeds,[1] but this scenario is useful in setting up the question we focus on in this paper: would it be wrong to favor the stabilization of a soldier just because the soldier is the physician’s compatriot? In other words, can nationality serve as an ethically justified tiebreaker in a situation such as Battlefield Triage?[2] In a non-military setting, the answer is clear: it would be unethical to treat someone based on non-medical considerations such as nationality. The AMA’s Code of Medical Ethics asserts that physicians have “ethical obligations to place patients’ welfare above their self-interest and above obligations to other groups.”[3] The World Medical Association’s Declaration of Tokyo affirms that “no motive, whether personal, collective or political, shall prevail against this higher purpose” of alleviating distress.[4] Physicians are taught early on that triage decisions must be medically indicated and made without consideration of factors such as race, ethnicity, religion, social status, and nationality. They are taught that public trust and obligations of justice grounded in equality demand that only medical indications be considered. But military physicians in a military setting are beholden to obligations, duties, and responsibilities as members of the military, and when these obligations, duties, and responsibilities conflict, as they do in Battlefield Triage, which loyalties win out and why?[5] Critics of partiality on national grounds argue that partiality undermines public trust in medicine and justice because everyone should be treated equally regardless of nationality.[6] Proponents of partiality argue that military obligations supersede equality and that justice requires partiality in such cases.[7] Despite the critics’ disagreement, both agree that there is a morally right, perhaps even blameless, course of action. Drawing on insights from virtue ethics, we argue that Battlefield Triage is a moral tragedy in which justice is unattainable and there is no action without moral cost. The assumption that there is a morally right choice is flawed. We argue that while no decision in this scenario is free from moral blame, there are reasons to favor treating one’s soldiers over enemy combatants. I. The Case Against Partiality There is a common assumption that there is a morally right or just decision in Battlefield Triage. A number of organizations and scholars claim that it is wrong for military physicians to favor their own soldiers on the grounds of nationality or some form of ‘group membership.’ (In a conflict involving service members from multiple nations working as a coalition, a soldier from an allied country may receive the same priority as the US service member due to ‘group membership.’) The World Medical Association’s WMA Declaration of Lisbon on the Rights of the Patient, which was reaffirmed in 2015, posits that, “[i]n circumstances where a choice must be made between potential patients for a particular treatment that is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination.”[8] This echoes what was set forth in Article 12 of the Geneva Conventions, which states that “[o]nly urgent medical reasons will authorize priority in the order of treatment to be administered.”[9] The argument for impartiality in Battlefield Triage is that every person is morally equal, and equality entails that medical distribution is, “based on a combination of medical need and urgency.”[10] This is in keeping with the bioethical principles that are generally applied.[11] II. The Case for Partiality On the other side, there are arguments that favoritism is the ethically right decision in Battlefield Triage.[12] The argument asserts that members of the military form a morally significant community of friends and participation in these relationships demands partiality. Just as parents have strong ethical duties to their children and not just any children, military personnel have ethical duties to their group, a group that involves an affirmation of mutual aid and support. Some have termed these ‘associative duties. According to Michael Gross, obligations of friendship, care, and solidarity “leave very little room for generally applicable principles of justice that would obligate a medic to treat enemy or non-compatriot wounded ahead of their compatriots.”[13] This is true in Battlefield Triage, but it may also be true even if the enemy’s soldier were more seriously wounded: “the ethics of small group cohesion, largely an ethics of care, mostly replaces the demands of impartial justice.”[14] In a more recent article, Gross explains that preferential treatment is ethically justified based on fighting capability and “the special obligations people owe friends, family, and, no less, comrades-in-arms.”[15] To not show partiality to the US soldier would be morally wrong on the grounds of friendship and mutual care.[16] III. The Moral Tragedy of Battlefield Triage Defenders and critics of Battlefield Triage favoritism based on nationality both frame their position as just or fair. For example, Justin List argues that physicians are “bound to practice medical neutrality,”[17] Marcus Adams denies that physicians “possess special ethical obligations” to enemy combatants because of their profession.[18] These perspectives assume that there is a morally right decision and that justice is attainable. The assumption that there is or can be a morally right Battlefield Triage decision, and we need to put our heads together to figure it out, remains strongly entrenched. However, the facts of the situation should give us pause; there are too many people and too few resources, and this demands a decision-making process that determines who will receive scarce resources. By its very nature, a battlefield triage decision has to be made based on some characteristic or value, a characteristic or value that will inevitably favor some at the expense of others. This is precisely why competing analyses “in the military context struggle to resolve these conflicts satisfactorily.”[19] Drawing on the insights of virtue ethics, we suggest that Battlefield Triage is a moral tragedy. Virtue ethics suggests that morality is about acting virtuously, which is to say that we should do what a virtuous person would do in the situation. Ethics is about figuring out how a just, wise, compassionate, loving, and fair person would act, and then doing that, as one grows in virtue. But life is not always clear cut, and it is possible that virtuous people may find themselves in a moral tragedy, a situation in which, through no fault of one’s own, a person must make a morally objectionable decision. After the action the virtuous person “emerges having done a terrible thing, the very sort of thing that the callous, dishonest, unjust, or in general vicious agent would characteristically do.”[20] Stated differently, a moral tragedy presents a virtuous person with two or more courses of action, all of which have a moral cost.[21] In Battlefield Triage, no matter how the physician goes about deciding, there is going to be defensible concern from those not saved. The fact that there are more people than can be helped fosters competing values in battlefield triage: maximize lives saved, treat people equally, treat the worse off, and support the war effort. Treating people equally may create tension between treating the worse off, maximizing lives saved, and supporting the war effort. Reverse triage is a case in point, as supporting the war effort conflicts with treating the worse off first, as is a fair lottery system since deploying a lottery may not maximize lives saved or support the war effort. There can be reasons why one person is selected over another, to be sure. Yet, there are reasons for making a decision, and that the decision is subject to legitimate moral concern is another. To recognize the moral tragedy of Battlefield Triage is to recognize the impossibility of acting blamelessly in the situation. In this situation, the virtuous military physician is going to have to sacrifice important values such as justice, compassion, and respect for others, even with a defensible criterion in hand. The physician will grieve this sacrifice accordingly. The physician may find her decision difficult or stressful, and rightly so, because of what her circumstances require of her. This kind of moral tragedy results “in actions which betray and violate the rights of persons to whom there may be a strong duty of care. When this happens, it properly triggers an appropriate moral emotion since our moral integrity has been violated and this affects how we think of ourselves and what we have become.”[22] Rather than view her triage decision as the morally superior choice, the virtuous military physician will view her decisions in these circumstances in a different light: it is the least bad option in a terrible situation, and she did something ethically problematic, something that is contrary to her moral character. She deeply regrets the circumstances in which she had to act. IV. Virtue Ethics A virtue ethicist has insight into how one should go about deciding what to do in a moral tragedy, although virtue ethics may not be as helpful as one may hope. The goal of the virtuous military physician in Battlefield Triage is to adopt the best course of action or the action that she feels she ought to do, all things considered. This does not make her choice devoid of serious wrongdoing—a decision must be made, but that does not make it just. The virtuous military physician will approach the situation with courage, responsibility, and insight. She will think about the decision carefully, wisely, and conscientiously; she will weigh the goods and harms of the choices before her, in conjunction with a proper conception of the good life, human worth, and understanding of her obligations to others—including chain of command, fellow soldiers, and the medical community. She is attuned to the value of human life and has a reasonable idea of the various ways her decisions will affect others. She recognizes that she is in this non-ideal situation through no fault of her own: she is not the one fighting in battles; she is serving her country as a physician, whose job it is to save lives, treat everyone justly, and promote military objectives. She regrets the decision she is forced to make in battlefield triage, acting “with immense regret and pain,” Hursthouse explains, “instead of indifferently or gladly.”[23] This is because, no matter what decision is made, the virtuous military physician “does something terrible or horrible,” something she otherwise would not do and is contrary to her values.[24] V. A Resolvable Moral Tragedy Instead of asking whether there is a morally right decision, in which a decision is morally blameless and above reproach, the virtue ethicist asks whether there is a decision with a convincing rationale, knowing that a decision can have a clear rationale but still be morally tragic. It is perfectly reasonable to think that different virtuous persons will arrive at different courses of action: “two virtuous agents, in the same situation,” Hursthouse writes, “may act differently” in irresolvable moral tragedies, in cases in which there is no clear course of action.[25] Because a person must act in a moral tragedy, one goal is to identify reasons for choosing the chosen action. Some decisions are clearly indefensible—treating neither the compatriot soldier nor the enemy combatant in Battlefield Triage would be wrong—and some decisions are more problematic than others. If the military physician selects to treat the soldier because she does not like the enemy combatant’s skin color, such a reason would be deeply problematic. But much of the debate over how to act in a moral tragedy is not over clearly indefensible or problematic criteria. Instead, the literature is largely about different standards or implementations of justice. Some scholars defend nation-impartial triage as right, while others defend nation-aware triage as right, and each argues that the other side is promoting an unjust or otherwise wrong solution to Battlefield Triage. We suggest that Battlefield Triage is a resolvable moral tragedy and that virtue ethics offers convincing reasons to prefer the treatment of the compatriot soldier rather than the enemy combatant on the grounds of national identity. Virtues are integral to living a good life, a flourishing life, but as Aristotle observed long ago, human beings are inherently social, interdependent and interconnected in profound ways.[26] This goes beyond the obvious fact that we need each other to survive day to day (one person makes clothes, another farms, and another makes tools); the claim is that a good or flourishing life depends in large part on one’s social network or community. This is why many of Aristotle’s moral virtues are other facing: justice, friendship, generosity, and magnanimity, to name a few. Courage, a typically self-facing virtue, is understood by Aristotle to be the virtue that regards one’s fear of death in battle, a battle fought on behalf of one’s city.[27] All of this remains true today. Namely, there is an important sense in which our community matters to our lives: it is easier to live a good, flourishing life if one is part of a good, flourishing community. Our community is made up of smaller groups, and it is more accurate to say that we are simultaneous members of different groups within a broader community. A person may be part of a family, friend group, research team, large state university, city, state, and nation. Groups can function well or not, as we all have experienced, and this suggests that there are virtues or excellences that groups can instantiate. Good groups are unified in purpose, with each member doing their duty alongside others for the attainment of that purpose. Good groups manifest solidarity among their members. Although Aristotle does not list solidarity as a virtue, a number of modern-day virtue ethicists have begun examining how group solidarity can be a virtue that contributes to a good or flourishing life.[28] Solidarity is not conceptualized as an individual virtue, a virtue possessed by a person in isolation of others; instead, it is a collective virtue, a virtue that is shared among members of a defined group with particular ends.[29] “A group has solidarity to the extent that its members are disposed to: (1) share values, aims, or goals; (2) care about those values, aims, or goals; (3) act in accordance with those values, aims, or goals; (4) trust the testimony of other group members with respect to those values, aims, and goals; and (5) feel a sense of belonging to the group.”[30] The virtue of collective or group solidarity involves individuals having special concern for each other, shared aims and values, trust, loyalty, and a sense of belonging with these specific others. There is a oneness to the group in the pursuit of a definite goal or purpose, involving mutual support and affirmation of each member. As such, the group has ends and goods above and beyond the good of each individual person. Sometimes solidarity requires personal sacrifice for the collective (for example, a father sacrificing food so his child can eat). The virtue of collective or group solidarity is important to the military and medical community at every level, and for clear reasons. In the military, there is a clear hierarchy of command, unity of purpose and end, mutual trust and support in complex settings, and so on. Soldiers need to know they can count on one another, and solidarity grounds a soldier’s ability to trust others and be assured of mutual aid. In medicine, solidarity maintains self-regulation of the profession, shared values and goals, as well as public support, not to mention that day-to-day operations require physician trust, engagement, and effort toward the ends of clinical care. Physicians need to work together, along with others, in pursuit of health, and disunity is sowed when there is mistrust, selfishness, or disengagement among the healthcare team and organization. Importantly, just as we are all members of various groups and hence may manifest group solidarity in different settings, the virtuous military physician instantiates collective solidarity with both the medical profession and the military. Her dual loyalty contributes to the moral difficulty of acting in Battlefield Triage. The military physician has competing obligations to distinct groups and cannot satisfy all obligations in Battlefield Triage. Solidarity with the military supports the consideration of favoring the soldier for reasons of national identity, whereas solidarity with the medical community does not. Something has to give, which is why it is a moral tragedy. The virtuous military physician, therefore, must weigh the costs of each course of action. To fulfill her obligations to the medical community would require that she does not use nationality and other non-medical considerations in Battlefield Triage. Since the soldier and enemy combatant are equally injured, justice would demand a random process, perhaps a flip of the coin. Although this may satisfy obligations the military physician has to the medical community, this would be costly to the physician’s military group. If word gets out that the physician decides who to treat based on a coin toss, soldiers, families, and citizens may become frustrated and angry. Soldier morale may go down if it becomes known that a coin flip led to the preventable death of a soldier and the saving of an enemy combatant who had killed (or attempted to kill) other soldiers. As Gross highlights, military solidarity involves a mutual aid promise that military personnel promise to help one another.[31] A military physician is part of the military and, as such, is part of the mutual aid promise, which would appear to be violated if the physician flips a coin. Treating a member of one’s own team may be psychologically more beneficial than treating an enemy combatant and may lead to less moral distress.[32] Finally, treating soldiers rather than enemy combatants promotes broader military and social aims, including returning soldiers to health, maintaining unity of purpose, and minimizing community suffering from a soldier’s death. Favoring members of one’s group, that is, triage based on nationality in Battlefield Triage, would fulfill obligations of military group loyalty, which is contrary to the values and duties of medicine. It does not seem as though showing favoritism in this particular situation is very costly to the medical community or general public, but this is because there is recognition that the physician is in the military. Medicine is impartial to non-medical indications partly because of fairness and to promote public trust in medicine. However, Battlefield Triage is unique, as medicine is being practiced in a non-public, wartime setting. In ordinary circumstances, a patient’s identity is irrelevant, and physicians ought not play favorites. Since Battlefield Triage is not an ordinary circumstance, decisions based on patient identity may not undermine public trust in medicine. In addition, it is contestable that fairness in Battlefield Triage requires that no consideration be paid to one’s nationality. Fairness is about giving each person their due, what is owed to them, and the case can be made that soldiers who place themselves in danger for the sake of the common good or a just cause are owed special attention when they suffer harm in the line of duty. In other words, soldiers voluntarily undergo risk to themselves for the greater good, and society owes them for this sacrifice. This plausibly includes preferential treatment in a situation such as Battlefield Triage. So, while the medical community affirms justice demands non-preferential treatment, the military community can affirm the opposite. The demands of fairness are unclear at best or in conflict in this situation: demands of physician justice decry favoritism, while demands of military justice support favoritism. Triage not based on nationality is arguably unfair and triage based on nationality may not undermine public trust, after all. All things considered, there is a clear rationale for favoring nationality-based preferential treatment in Battlefield Triage. Adopting a nationality-based preference in this situation is more defensible than not. This does not make such a decision ethically right or just. Preference based on nationality is the least bad decision, but it is not morally blameless. It involves one in a serious moral wrong, a wrong otherwise avoided and contrary to one’s character. The virtuous military physician is in a situation in which obligations conflict, and we disagree with Gross, who posits that care of fellow soldiers “is important to the near exclusion of all else.”[33] Gross fails to appreciate the collective virtue of solidarity as applied to those in medicine. The military physician has duties to fellow soldiers but also to fellow physicians, to the medical community, and humanity. To favor a soldier on grounds of nationality violates her duties and responsibilities to this latter group. She is involved in a moral tragedy and can only seek the most just action given the circumstances, yet, at least in virtue ethics, the action remains far from blameless. CONCLUSION We argue that Battlefield Triage is a moral tragedy, meaning that it is a situation in which there is no morally blameless decision and that the demands of justice cannot be satisfied. As such, the virtuous military physician incurs a moral cost to acting as she does—there is a moral residue. However, despite being a moral tragedy, there are clear reasons to act in favor of treating one’s own, considering group solidarity. As such, these kinds of tragedies are resolvable: virtuous military physicians should favor treatment of their own, although they would do so with sorrow. - [1] Militaries set forth medical rules of eligibility or guidelines used to determine whether a person qualifies for specific medical interventions or treatments in certain circumstances, and these guidelines are binding for a military physician. For example, despite opposition from medical organizations, militaries have adopted reverse triage guidelines for military physicians to follow. For ethical discussion, see Falzone, Elisabeth, P. Pasquier, C. Hoffmann, O. Barbier, M. Boutonnet, A. Salvadori, A. Jarrassier, J. Renner, B. Malgras, and S. Mérat. "Triage in military settings." Anaesthesia Critical Care & Pain Medicine 36, no. 1 (2017): 43-51. https://doi.org/10.1016/j.accpm.2016.05.004 [2] There are issues that are related to this, including the triage of civilians and allied soldiers. We set related issues aside for purposes of this paper [3] American Medical Association, Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 ed. (Chicago, IL: AMA, 2004), 300. [4] American Medical Association, Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 ed. (Chicago, IL: AMA, 2004), 300. [5] This is termed the “dual loyalty” dilemma in military medicine and has been described at length elsewhere: Institute of Medicine (US) Board on Health Sciences Policy. Military Medical Ethics: Issues regarding Dual Loyalties: Workshop Summary. Washington (DC): National Academies Press (US); 2008. Toward a Framework for Resolving Dual Loyalties. Available from: https://www.ncbi.nlm.nih.gov/books/NBK214853/ [6] See Kenneth G. Swan and K.G. Swan, Jr., “Triage: The Past Revisited,” Military Medicine 161:8 (1996): 448–452. https://doi.org/10.1093/milmed/161.8.448; Jerome A. Singh, “American Physicians and dual loyalty obligations in the ‘war on terror,’” BMC Medical Ethics 4.4 (2003): 1–10. https://doi.org/10.1186/1472-6939-4-4; Beam, Thomas E. "Medical Ethics on the Battlefield." Military Medical Ethics: Sect. IV. Medical ethics in the military. Medical ethics on the battlefield: the crucible of military medical ethics 2 (2003): 369-402; Hereth, Blake. "Health justice for unjust combatants." Journal of Military Ethics 20, no. 1 (2021): 67-81. https://doi.org/10.1080/15027570.2021.1949782. [7] See Adams, Marcus P. "Triage priorities and military physicians." In Physicians at war: The dual-loyalties challenge, pp. 215-236. Dordrecht: Springer Netherlands, 2008. Gross, Michael L. "Comradery, community, and care in military medical ethics." Theoretical medicine and bioethics 32 (2011): 337-350. https://doi.org/10.1007/s11017-011-9189-6. Gross, Michael L. "The limits of impartial medical treatment during armed conflict." In Military medical ethics for the 21st century, pp. 71-84. Routledge, 2016. [8] World Medical Association, WMA Declaration of Lisbon on the Rights of the Patient. 5 December 2022, https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/ [9] Geneva Convention for the Amelioration of the Condition of Wounded, Sick in Armed Forces in the Field. 12 August 1949. https://www.un.org/en/genocideprevention/documents/atrocity-crimes/Doc.30_GC-I-EN.pdf. [10] List, Justin M. "Medical neutrality and political activism: physicians' roles in conflict situations." In Physicians at war: The dual-loyalties challenge, pp. 237-253. Dordrecht: Springer Netherlands, 2008. 240 [11] Beauchamp, T., and J. Childress. 2013. Principles of Biomedical Ethics, 7th ed. Oxford, United Kingdom: Oxford University Press. [12] Adams, Marcus P. "Triage priorities and military physicians." In Physicians at war: The dual-loyalties challenge, pp. 215-236. Dordrecht: Springer Netherlands, 2008. [13] Gross, "Comradery, community, and care in military medical ethics," 347. [14] Gross, “Comradery, community, and care in military medical ethics,” 349. [15] Gross, Michael L. "When medical ethics and military ethics collide." Narrative inquiry in bioethics 13, no. 3 (2023): 199-204. 202 https://dx.doi.org/10.1353/nib.2023.a924191 [16] Our argument draws on virtue ethics, from which care ethics derives, and it is worth clarifying how our argument relates to Gross’s. We do not think that the virtue of friendship grounds triage decisions, for we think it is unlikely that the physician and wounded soldier are friends. Instead, as explained below, we think the collective virtue of group solidarity better captures the moral significance of group loyalty and that Gross would agree with us. But since military physicians are part of distinct groups, with competing obligations, the military physician will be forced to sacrifice a value in battlefield triage cases. In other words, we think Gross downplays the dual group membership of a military physician. [17] List,”Medical neutrality and political activism,” 250. [18] Adams,”Triage priorities and military physicians,” 235. [19] London, Leslie, Leonard S. Rubenstein, Laurel Baldwin-Ragaven, and Adriaan Van Es. "Dual loyalty among military health professionals: human rights and ethics in times of armed conflict." Cambridge Quarterly of Healthcare Ethics 15, no. 4 (2006): 381-391. 383. [20] Hursthouse, R. On Virtue Ethics. OUP 1999. 74 [21] Nussbaum, Martha C. "The costs of tragedy: Some moral limits of cost-benefit analysis." The Journal of Legal Studies 29, no. S2 (2000): 1005-1036, 1007. [22] De Wijze, S. (2005). Tragic-remorse–the anguish of dirty hands. Ethical theory and moral practice, 7(5), 453-471, 457. https://doi.org/10.1007/s10677-005-6836-x [23] Hursthouse, 73 [24] Hursthouse, 81 [25] Hursthouse, 72 [26] Aristotle, Politics 1253a8. Reeve, C. D. C., Indianapolis: Hackett Publishing Co., 2017 [27] Aristotle, Nicomachean Ethics. III.6.114a, 34-35. 2002, Nicomachean Ethics, Christopher Rowe (trans.), Oxford: Oxford University Press [28] Byerly, T. Ryan, and Meghan Byerly. "Collective virtue." The Journal of Value Inquiry 50, no. 1 (2016): 33-50. https://doi.org/10.1007/s10790-015-9484-y; Federico, Veronica. "Conclusion: solidarity as a public virtue." Solidarity as a Public Virtue (2018): 495-542. https://doi.org/10.5771/9783845290058. Rehg, William. "Solidarity and the common good: An analytic framework." Journal of Social Philosophy 38, no. 1 (2007): 7-21. https://doi.org/10.1111/j.1467-9833.2007.00363.x [29] Byerly and Byerly. "Collective virtue." 43 [30] Battaly, Heather. "Solidarity: Virtue or vice?." In Social virtue epistemology, pp. 303-324. Routledge, 2022. 304 [31] Ibid., 2011: 341 [32] It might be thought that displaying altruism by helping an enemy combatant at the expense of one’s fellow soldier may be psychologically satisfiying. For evidence that military physicians find it difficult to treat enemy combatants, see Lundberg, Kristina, Sofia Kjellström, Anders Jonsson, and Lars Sandman. "Experiences of Swedish military medical personnel in combat zones: adapting to competing loyalties." Military medicine 179, no. 8 (2014): 821-826. https://doi.org/10.7205/MILMED-D-14-00038. Lamblin, Antoine, Clément Derkenne, Marion Trousselard, and Marie-Ange Einaudi. "Ethical challenges faced by French military doctors deployed in the Sahel (Operation Barkhane): a qualitative study." BMC Medical Ethics 22 (2021): 1-13. https://doi.org/10.1186/s12910-021-00723-2 [33] Ibid., 2011: 344. (shrink)

Photo by Sean Pollock on Unsplash ABSTRACT Bioethics and Corporate Social Responsibility (CSR) were born out of similar concerns, such as the reaction to scandal and the restraint of irresponsible actions by individuals and organizations. However, these fields of knowledge are seldom explored together. This article attempts to explain the motives behind the gap between bioethics and CSR, while arguing that their shared agenda – combined with their contrasting principles and goals – suggests there is potential for fruitful dialogue that (...) enables the actualization of bioethical agendas and provides a direction for CSR in health-related organizations. INTRODUCTION Bioethics and Corporate Social Responsibility (CSR) seem to be cut from the same cloth: the concern for human rights and the response to scandal. Both are tools for the governance of organizations, shaping how power flows and decisions are made. They have taken the shape of specialized committees, means of stakeholder inclusion at deliberative forums, compliance programs, and internal processes. It should be surprising, then, that these two fields of study and practice have developed separately, only recently re-approaching one another. There have been displays of this reconnection both in academic and corporate spaces, with bioethics surfacing as part of the discourse of CSR and compliance initiatives. However, this is still a relatively timid effort. Even though the bioethics-CSR divide presents mostly reasonable explanations for this difficult relationship between the disciplines, current proposals suggest there is much to be gained from a stronger relationship between them. This article explores the common history of bioethics and corporate social responsibility and identifies their common features and differences. It then explores the dispute of jurisdictions due to professional and academic “pedigree” and incompatibilities in the ideological and teleological spheres as possible causes for the divide. The discussion turns to paths for improving the reflexivity of both disciplines and, therefore, their openness to mutual contributions. I. Cut Out of the Same Cloth The earliest record of the word “bioethics” dates back to 1927 as a term that designates one’s ethical responsibility toward not only human beings but other lifeforms as well, such as animals and plants.[1] Based on Kantian ethics, the term was coined as a response to the great prestige science held at its time. It remained largely forgotten until the 1970s, when it resurfaced in the United States[2] as the body of knowledge that can be employed to ensure the responsible pursuit and application of science. The resurgence was prompted by a response to widespread irresponsible attitudes toward science and grounded in a pluralistic perspective of morality.[3] In the second half of the twentieth century, states and the international community assumed the duty to protect human rights, and bioethics became a venue for discussing rights.[4] There is both a semantic gap and a contextual gap between these two iterations, with some of them already being established. Corporate social responsibility is often attributed to the Berle-Dodd debate. The discussion was characterized by diverging views on the extent of the responsibility of managers.[5] It was later settled as positioning the company, especially the large firm, as an entity whose existence is fomented by the law due to its service to the community. The concept has evolved with time, departing from a largely philanthropic meaning to being ingrained in nearly every aspect of a company’s operations. This includes investments, entrepreneurship models, and its relationship to stakeholders, leading to an increasing operationalization and globalization of the concept.[6] At first sight, these two movements seem to stem from different contexts. Despite the difference, it is also possible to tell a joint history of bioethics and CSR, with their point of contact being a generalized concern with technological and social changes that surfaced in the sixties. The publishing of Silent Spring in 1962 by Rachel Carson exemplifies this growing concern over the sustainability of the ruling economic growth model of its time by commenting on the effects of large-scale agriculture and the use of pesticides in the population of bees, one of the most relevant pollinators of crops consumed by humans. The book influenced both the author responsible for the coining bioethics in the 1971[7] and early CSR literature.[8] By initiating a debate over the sustainability of economic models, the environmentalist discourse became a precursor to vigorous social movements for civil rights. Bioethics was part of the trend as it would be carried forward by movements such as feminism and the patients’ rights movement.[9] Bioethics would gradually move from a public discourse centered around the responsible use of science and technology to academic and government spaces.[10] This evolution led to an increasing emphasis on intellectual rigor and governance. The transformation would unravel the effort to take effective action against scandal and turn bioethical discourse into governance practices,[11] such as bioethics and research ethics committees. The publication of the Belmont Report[12] in the aftermath of the Tuskegee Syphilis Experiment, as well as the creation of committees such as the “God Committee,”[13] which aimed to develop and enforce criteria for allocating scarce dialysis machines, exemplify this shift. On the side of CSR, this period represents, at first, a stronger pact between businesses and society due to more stringent environmental and consumer regulations. But afterward, a joint trend emerged: on one side, the deregulation within the context of neoliberalism, and on the other, the operationalization of corporate social responsibility as a response to societal concerns.[14] The 1990s saw both opportunities and crises that derived from globalization. In the political arena, the end of the Cold War led to an impasse in the discourse concerning human rights,[15] which previously had been split between the defense of civil and political rights on one side and social rights on the other. But at the same time, agendas that were previously restricted territorially became institutionalized on a global scale.[16] Events such as the European Environment Agency (1990), ECO92 in Rio de Janeiro (1992), and the UN Global Compact (2000) are some examples of the globalization of CSR. This process of institutionalization would also mirror a crisis in CSR, given that its voluntarist core would be deemed lackluster due to the lack of corporate accountability. The business and human rights movement sought to produce new binding instruments – usually state-based – that could ensure that businesses would comply with their duties to respect human rights.[17] This rule-creation process has been called legalization: a shift from business standards to norms of varying degrees of obligation, precision, and delegation.[18] Bioethics has also experienced its own renewed identity in the developed world, perhaps because of its reconnection to public and global health. Global health has been the object of study for centuries under other labels (e.g., the use of tropical medicine to assist colonial expeditions) but it resurfaced in the political agenda recently after the pandemics of AIDS and respiratory diseases.[19] Bioethics has been accused from the inside of ignoring matters beyond the patient-provider relationship,[20] including those related to public health and/or governance. Meanwhile, scholars claimed the need to expand the discourse to global health.[21] In some countries, bioethics developed a tight relationship with public health, such as Brazil,[22] due to its connections to the sanitary reform movement. The United Kingdom has also followed a different path, prioritizing governance practices and the use of pre-established institutions in a more community-oriented approach.[23] The Universal Declaration on Bioethics and Rights followed this shift toward a social dimension of bioethics despite being subject to criticism due to its human rights-based approach in a field characterized by ethical pluralism.[24] This scenario suggests bioethics and CSR have developed out of similar concerns: the protection of human rights and concerns over responsible development – be it economic, scientific, or technological. However, the interaction between these two fields (as well as business and human rights) is fairly recent both in academic and business settings. There might be a divide between these fields and their practitioners. II. A Tale of Jurisdictions It can be argued that CSR and business and human rights did not face jurisdictional disputes. These fields owe much of their longevity to their roots in institutional economics, whose debates, such as the Berle-Dodd debate, were based on interdisciplinary dialogue and the abandonment of sectorial divisions and public-private dichotomies.[25] There was opposition to this approach to the role of companies in society that could have implications for CSR’s interdisciplinarity, such as the understanding that corporate activities should be restricted to profit maximization.[26] Yet, those were often oppositions to CSR or business and human rights themselves. The birth of bioethics in the USA can be traced back to jurisdictional disputes over the realm of medicine and life sciences.[27] The dispute unfolded between representatives of science and those of “society’s conscience,” whether through bioethics as a form of applied ethics or other areas of knowledge such as theology.[28] Amid the civil rights movements, outsiders would gain access to the social sphere of medicine, simultaneously bringing it to the public debate and emphasizing the decision-making process as the center of the medical practice.[29] This led to the emergence of the bioethicist as a professional whose background in philosophy, theology, or social sciences deemed the bioethicist qualified to speak on behalf of the social consciousness. In other locations this interaction would play out differently: whether as an investigation of philosophically implied issues, a communal effort with professional institutions to enhance decision-making capability, or a concern with access to healthcare.[30] In these situations, the emergence and regulation of bioethics would be way less rooted in disputes over jurisdictions. This contentious birth of bioethics would have several implications, most related to where the bioethicist belongs. After the civil rights movements subsided, bioethics moved from the public sphere into an ivory tower: intellectual, secular, and isolated. The scope of the bioethicist would be increasingly limited to the spaces of academia and hospitals, where it would be narrowed to the clinical environment.[31] This would become the comfort zone of professionals, much to the detriment of social concerns. This scenario was convenient to social groups that sought to affirm their protagonism in the public arena, with conservative and progressive movements alike questioning the legitimacy of bioethics in the political discourse.[32] Even within the walls of hospitals and clinics, bioethics would not be excused from criticism. Afterall, the work of bioethicists is often unregulated and lacks the same kind of accountability that doctors and lawyers have. Then, is there a role to be played by the bioethicist? This trend of isolation leads to a plausible explanation for why bioethics did not develop an extensive collaboration with corporate social responsibility nor with business and human rights. Despite stemming from similar agendas, bioethics’ orientation towards the private sphere resulted in a limited perspective on the broader implications of its decisions. This existential crisis of the discipline led to a re-evaluation of its nature and purpose. Its relevance has been reaffirmed due to the epistemic advantage of philosophy when engaging normative issues. Proper training enables the bioethicist to avoid falling into traps of subjectivism or moralism, which are unable to address the complexity of decision-making. It also prevents the naïve seduction of “scientifying” ethics.[33] This is the starting point of a multitude of roles that can be attributed to the bioethicists. There are three main responsibilities that fall under bioethics: (i) activism in biopolicy, through the engagement in the creation of laws, jurisprudence, and public policies; (ii) the exercise of bioethics expertise, be it through the specialized knowledge in philosophical thought, its ability to juggle multiple languages related to various disciplines related to bioethics, or its capacity to combat and avoid misinformation and epistemic distortion; (iii) and, intellectual exchange, by exercising awareness that it is necessary to work with specialists from different backgrounds to achieve its goals.[34] All of those suggest the need for bioethics to improve its dialogue with CSR and business and human rights. Both CSR and business and human rights have been the arena of political disputes over the role of regulations and corporations themselves, and the absence of strong stances by bioethicists risks deepening their exclusion from the public arena. Furthermore, CSR and business and human rights are at the forefront of contemporary issues, such as the limits to sustainable development and appropriate governance structures, which may lead to the acceptance of values and accomplishment of goals cherished by bioethics. However, a gap in identifying the role and nature of bioethics and CSR may also be an obstacle for bridging the chasm between bioethics and CSR. III. From Substance to Form: Philosophical Groundings of CSR and Bioethics As mentioned earlier, CSR is, to some extent, a byproduct of institutionalism. Institutional economics has a philosophical footprint in the pragmatic tradition[35], which has implications for the purpose of the movement and the typical course of the debate. The effectiveness of regulatory measures is often at the center of CSR and business and human rights debates: whatever the regulatory proposal may be, compliance, feasibility, and effectiveness are the kernel of the discussion. The axiological foundation is often the protection of human rights. But discussions over the prioritization of some human rights over others or the specific characteristics of the community to be protected are often neglected.[36] It is worth reinforcing that adopting human rights as an ethical standard presents problems to bioethics, given its grounding in the recognition of ethical pluralism. Pragmatism adopts an anti-essentialist view, arguing that concepts derive from their practical consequences instead of aprioristic elements.[37] Therefore, truth is transitory and context dependent. Pragmatism embraces a form of moral relativism and may find itself in an impasse in the context of political economy and policymaking due to its tendency to be stuck between the preservation of the status quo and the defense of a technocratic perspective, which sees technical and scientific progress as the solution to many of society’s issues.[38] These characteristics mean that bioethics has a complicated relationship with pragmatism. Indeed, there are connections between pragmatism and the bioethics discourse. Both can be traced back to American naturalism.[39] The early effort in bioethics to make it ecumenical, thus building on a common but transitory morality,[40] sounds pragmatic. Therefore, scholars suggest that bioethics should rely on pragmatism's perks and characteristics to develop solutions to new ethical challenges that emerge from scientific and technological progress. Nonetheless, ethical relativism is a problem for bioethics when it bleeds from a metaethical level into the subject matters themselves. After all, the whole point of bioethics is either descriptive, where it seeks to understand social values and conditions that pertain to its scope, or normative, where it investigates what should be done in matters related to medicine, life sciences, and social and technological change. It is a “knowledge of how to use knowledge.” Therefore, bioethics is a product of disillusionment regarding science and technology's capacity to produce exclusively good consequences. It was built around an opposition to ethical relativism—even though the field is aware of the particularity of its answers. This is true not only for the scholarly arena, where the objective is to produce ethically sound answers but also for bioethics governance, where relativism may induce decision paralysis or open the way to points of view disconnected from facts.[41] But there might be a point for more pragmatic bioethics. Bioethics has become an increasingly public enterprise which seeks political persuasion and impact in the regulatory sphere. When bioethics is seen as an enterprise, achieving social transformation is its main goal. In this sense, pragmatism can provide critical tools to identify idiosyncrasies in regulation that prove change is needed. An example of how this may play out is the abortion rights movement in the global south.[42] Despite barriers to accessing safe abortion, this movement came up with creative solutions and a public discourse focused on the consequences of its criminalization rather than its moral aspects. IV. Bridging the Divide: Connections Between Bioethics and CSR There have been attempts to bring bioethics and CSR closer to each other. Corporate responsibility can be a supplementary strategy for achieving the goals of bioethics. The International Bioethics Committee (IBC), an institution of the United Nations Educational, Scientific and Cultural Organization (UNESCO), highlights the concept that social responsibility regarding health falls under the provisions of the Universal Declaration on Bioethics and Human Rights (UDBHR). It is a means of achieving good health (complete physical, mental, and social well-being) through social development.[43] Thus, it plays out as a condition for actualizing the goals dear to bioethics and general ethical standards,[44] such as autonomy and awareness of the social consequences of an organization’s governance. On this same note, CSR is a complementary resource for healthcare organizations that already have embedded bioethics into their operations[45] as a way of looking at the social impact of their practices. And bioethics is also an asset of CSR. Bioethics can inform the necessary conditions for healthcare institutions achieving a positive social impact. When taken at face value, bioethics may offer guidelines for ethical and socially responsible behavior in the industry, instructing how these should play out in a particular context such as in research, and access to health.[46] When considering the relevance of rewarding mechanisms,[47] bioethics can guide the establishment of certification measures to restore lost trust in the pharmaceutical sector.[48] Furthermore, recognizing that the choice is a more complex matter than the maximization of utility can offer a nuanced perspective on how organizations dealing with existentially relevant choices understand their stakeholders.[49] However, all of those proposals might come with the challenge of proving that something can be gained from its addition to self-regulatory practices[50] within the scope of a dominant rights-based approach to CSR and global and corporate law. It is evident that there is room for further collaboration between bioethics and CSR. Embedding either into the corporate governance practices of an organization tends to be connected to promoting the other.[51] While there are some incompatibilities, organizations should try to overcome them and take advantage of the synergies and similarities. CONCLUSION Despite their common interests and shared history, bioethics and corporate social responsibility have not produced a mature exchange. Jurisdictional issues and foundational incompatibilities have prevented a joint effort to establish a model of social responsibility that addresses issues particular to the healthcare sector. Both bioethics and CSR should acknowledge that they hold two different pieces of a cognitive competence necessary for that task: CSR offers experience on how to turn corporate ethical obligations operational, while bioethics provides access to the prevailing practical and philosophical problem-solving tools in healthcare that were born out of social movements. Reconciling bioethics and CSR calls for greater efforts to comprehend and incorporate the social knowledge developed by each field reflexively[52] while understanding their insights are relevant to achieving some common goals. - [1]. Fritz Jahr, “Bio-Ethik: Eine Umschau Über Die Ethischen Beziehungen Des Menschen Zu Tier Und Pflanze,” Kosmos - Handweiser Für Naturfreunde 24 (1927): 2–4. [2]. Van Rensselaer Potter, “Bioethics, the Science of Survival,” Perspectives in Biology and Medicine 14, no. 1 (1970): 127–53, https://doi.org/10.1353/pbm.1970.0015. [3]. Maximilian Schochow and Jonas Grygier, eds., “Tagungsbericht: 1927 – Die Geburt der Bioethik in Halle (Saale) durch den protestantischen Theologen Fritz Jahr (1895-1953),” Jahrbuch für Recht und Ethik / Annual Review of Law and Ethics 21 (June 11, 2014): 325–29, https://doi.org/10.3726/978-3-653-02807-2. [4] George J. 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[11] Jonathan Montgomery, “Bioethics as a Governance Practice,” Health Care Analysis 24, no. 1 (March 2016): 3–23, https://doi.org/10.1007/s10728-015-0310-2. [12]. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research” (Washington: Department of Health, Education, and Welfare, April 18, 1979), https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf. [13] Shana Alexander, “They Decide Who Lives, Who Dies,” in LIFE, by Time Inc, 19th ed., vol. 53 (Nova Iorque: Time Inc, 1962), 102–25. [14]. Latapí Agudelo, Jóhannsdóttir, and Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility.” [15]. Boaventura de Sousa Santos, “Por Uma Concepção Multicultural Dos Direitos Humanos,” Revista Crítica de Ciências Sociais, no. 48 (June 1997): 11–32. [16] Latapí Agudelo, Jóhannsdóttir, and Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility.” [17]. Anita Ramasastry, “Corporate Social Responsibility Versus Business and Human Rights: Bridging the Gap Between Responsibility and Accountability,” Journal of Human Rights 14, no. 2 (April 3, 2015): 237–59, https://doi.org/10.1080/14754835.2015.1037953. [18]. Kenneth W Abbott et al., “The Concept of Legalization,” International Organization, Legalization and World Politics, 54, no. 3 (2000): 401–4019. [19]. Jens Holst, “Global Health – Emergence, Hegemonic Trends and Biomedical Reductionism,” Globalization and Health 16, no. 1 (December 2020): 42–52, https://doi.org/10.1186/s12992-020-00573-4. [20]. Albert R. Jonsen, “Social Responsibilities of Bioethics,” Journal of Urban Health: Bulletin of the New York Academy of Medicine 78, no. 1 (March 1, 2001): 21–28, https://doi.org/10.1093/jurban/78.1.21. [21]. 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[30] Volnei Garrafa, Thiago Rocha Da Cunha, and Camilo Manchola, “Access to Healthcare: A Central Question within Brazilian Bioethics,” Cambridge Quarterly of Healthcare Ethics 27, no. 3 (July 2018): 431–39, https://doi.org/10.1017/S0963180117000810. [31] Jonsen, “Social Responsibilities of Bioethics.” [32] Evans, The History and Future of Bioethics. p. 75-79, 94-96. [33] Julian Savulescu, “Bioethics: Why Philosophy Is Essential for Progress,” Journal of Medical Ethics 41, no. 1 (January 2015): 28–33, https://doi.org/10.1136/medethics-2014-102284. [34] Silvia Camporesi and Giulia Cavaliere, “Can Bioethics Be an Honest Way of Making a Living? A Reflection on Normativity, Governance and Expertise,” Journal of Medical Ethics 47, no. 3 (March 2021): 159–63, https://doi.org/10.1136/medethics-2019-105954; Jackie Leach Scully, “The Responsibilities of the Engaged Bioethicist: Scholar, Advocate, Activist,” Bioethics 33, no. 8 (October 2019): 872–80, https://doi.org/10.1111/bioe.12659. [35] Philip Mirowski, “The Philosophical Bases of Institutionalist Economics,” Journal of Economic Issues, Evolutionary Economics I: Foundations of Institutional Thought, 21, no. 3 (September 1987): 1001–38. [36] David Kennedy, “The International Human Rights Movement: Part of the Problem?,” Harvard Human Rights Journal 15 (2002): 101–25. [37] Richard Rorty, “Pragmatism, Relativism, and Irrationalism,” Proceedings and Addresses of the American Philosophical Association 53, no. 6 (August 1980): 717+719-738. [38]. Mirowski, “The Philosophical Bases of Institutionalist Economics.” [39]. Glenn McGee, ed., Pragmatic Bioethics, 2nd ed, Basic Bioethics (Cambridge, Mass: MIT Press, 2003). [40]. Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 7th ed (New York: Oxford University Press, 2013). [41]. Montgomery, “Bioethics as a Governance Practice.” [42]. Debora Diniz and Giselle Carino, “What Can Be Learned from the Global South on Abortion and How We Can Learn?,” Developing World Bioethics 23, no. 1 (March 2023): 3–4, https://doi.org/10.1111/dewb.12385. [43]. International Bioethics Committee, On Social Responsibility and Health Report (Paris: Unesco, 2010). [44]. Cristina Brandão et al., “Social Responsibility: A New Paradigm of Hospital Governance?,” Health Care Analysis 21, no. 4 (December 2013): 390–402, https://doi.org/10.1007/s10728-012-0206-3. [45] Intissar Haddiya, Taha Janfi, and Mohamed Guedira, “Application of the Concepts of Social Responsibility, Sustainability, and Ethics to Healthcare Organizations,” Risk Management and Healthcare Policy Volume 13 (August 2020): 1029–33, https://doi.org/10.2147/RMHP.S258984. [46]The Biopharmaceutical Bioethics Working Group et al., “Considerations for Applying Bioethics Norms to a Biopharmaceutical Industry Setting,” BMC Medical Ethics 22, no. 1 (December 2021): 31–41, https://doi.org/10.1186/s12910-021-00600-y. [47] Anne Van Aaken and Betül Simsek, “Rewarding in International Law,” American Journal of International Law 115, no. 2 (April 2021): 195–241, https://doi.org/10.1017/ajil.2021.2. [48] Jennifer E. Miller, “Bioethical Accreditation or Rating Needed to Restore Trust in Pharma,” Nature Medicine 19, no. 3 (March 2013): 261–261, https://doi.org/10.1038/nm0313-261. [49] John Hardwig, “The Stockholder – A Lesson for Business Ethics from Bioethics?,” Journal of Business Ethics 91, no. 3 (February 2010): 329–41, https://doi.org/10.1007/s10551-009-0086-0. [50] Stefan van Uden, “Taking up Bioethical Responsibility?: The Role of Global Bioethics in the Social Responsibility of Pharmaceutical Corporations Operating in Developing Countries” (Mestrado, Coimbra, Coimbra University, 2012). [51] María Peana Chivite and Sara Gallardo, “La bioética en la empresa: el caso particular de la Responsabilidad Social Corporativa,” Revista Internacional de Organizaciones, no. 13 (January 12, 2015): 55–81, https://doi.org/10.17345/rio13.55-81. [52] Teubner argues that social spheres tend to develop solutions autonomously, but one sphere interfering in the way other spheres govern themselves tends to result in ineffective regulation and demobilization of their autonomous rule-making capabilities. These spheres should develop “reflexion mechanisms” that enable the exchange of their social knowledge and provide effective, non-damaging solutions to social issues. See Gunther Teubner, “Substantive and Reflexive Elements in Modern Law,” Law & Society Review 17, no. 2 (1983): 239–85, https://doi.org/10.2307/3053348. (shrink)

Photo by Maxim Berg on Unsplash INTRODUCTION The brain is one of the most foundational parts of being human, and we are still learning about what makes humans unique. Advancements in technology have allowed for the creation of miniature brain structures using pluripotent stem cells to mimic the embryonic human brain. These stem cells randomly accumulate into brain-like structures, consisting of tens of millions of cells spanning a few millimeters wide.[1] As brain organogenesis becomes more complex, these models may begin (...) to exhibit consciousness, pain, and sentience. If these organoids become more complex, it is necessary to question the rights of brain organoids and the ethics of working with brain-like structures that begin to mirror our own identities. Overall, brain organoid usage has remarkable benefits that outweigh the negative outcomes. However, there must be continued exploration of the moral ramifications of greater levels of consciousness that brain organoids may exhibit in the future. ANALYSIS Knowing whether brain organoids should be used in research requires understanding what constitutes a conscious brain and how to classify a brain organoid. Due to its modeling of a human embryonic brain, it is helpful to explore the ethical considerations researchers should take both currently and as this field of research progresses. This philosophical question concerns the concept of self-identification and what it means to be human. It is also important to explore the levels of autonomy the brain should have due to its core role in how humans define themselves. As brain organogenesis technologies advance and facilitate the development of more complex brain organoids, this question becomes especially relevant. It blurs the line of ethical human subject research and has the power to alter the decisions that the scientific community makes about human-based research. In the brain organoid's current relatively undeveloped state, large bodies of evidence suggest that brain organoids are suitable and viable alternatives for research. Brain organogenesis research aids in various brain-based medical conditions, such as neurodegenerative diseases, developmental disorders, and Zika virus-infected fetuses.[2] Additionally, it allows for an alternative and potentially ethical approach to animal testing in research.[3] I. Brain Organoids Brain organoids are created from randomized self-clustering pluripotent stem cells using signaling factors, essentially modeling the human brain during its embryonic stage.[4] These models can aid in the understanding of both brain development and disorders. This includes a more comprehensive understanding of hereditary brain abnormalities, human evolution, neurological diseases, and psychiatric disorders.[5] Brain organoids replicate many features of human brain development during the embryonic stage, both structurally and functionally however, gyrification, cerebral cortex formation, and neuronal wiring are not fully developed.[6] This creates a relatively accurate novel model that is helping forge the field of neuroscience and strives toward a more accurate representation of the human brain. II. Brain Organoids Deficiencies Brain organoids provide an innovative way to enhance current neuroscience; however, opposing viewpoints would argue about the brain organoids deficiencies such as the several major differences between organoids and an embryonic brain. Firstly, this includes a lack of vascularization, causing cells to eventually die in the center.[7] Additionally, current methods only allow for the growth of neurons, excluding microglia, endothelial cells, blood cells, and immune cells, further altering an accurate neural environment.[8] Lastly, there is a significant amount of variation between the brain organoids based on the laboratory procedure and stem line used.[9] While brain organoids are excellent models, they are unable to accurately represent the adult human brain, and current research methods introduce a high level of mutations.[10] III. Benefits of Brain Organoid Research Brain organoid research should be pursued because it serves as an alternative to animal-based research, helps us understand the differences between hominid-like species, and advances the study of neurodegenerative diseases.[11] Moreover, while the formation of the brain is representative of the human brain, it lacks full complexity, including networking and complete vascularization.[12] This evidence suggests that brain organoids are not yet sentient, making them important replicas and alternatives to animal testing. Modern medicine research routinely uses animals as test subjects which is problematic because animals cannot provide informed consent, and guidelines often focus on harm minimization with little regard for animal welfare as long as it benefits human research.[13] Seeking alternatives, such as the development of brain organoids, could greatly minimize animal suffering and serve as ethical alternatives. Brain organoids provide a way to study neurological disorders and diseases with a more physiologically accurate model. Currently, in the field of neurodegenerative diseases, many preclinical models fail to accurately represent the diseases they work with.[14] For instance, mouse models of Alzheimer's disease are genetically modified to overexpress high levels of human genetic mutations, however, the Alzheimer's phenotype is not expressed as expected.[15] Therefore, brain organoids have been considered the most ideal model for Alzheimer’s disease because they allow researchers to observe Aβ deposits, Tau tangles, and neuronal degeneration.[16] Brain organoids have been far more accurate representations than both the mice and two-dimensional neuron models.[17] In addition to Alzheimer’s studies, investigations about the Zika virus are better understood by examining the mechanisms in the brain organoids that resulted in microcephaly.[18] These studies more effectively capture the structure of the fetal brain during the first and second trimesters of pregnancy and more efficiently deconstruct the formation of microcephaly through the observation of neural progenitor cells and other cellular structures.[19] Furthermore, studying brain organoids enhances our understanding of human brain development in comparison to other hominid-like species, such as one of our closest relatives – Neanderthals. It reveals some of the underpinnings of human evolution and the brain-based advantages that gave humans survival advantages over other hominid-like species. Neanderthal brain organoid research has shown that Neanderthal organoids have an irregular "popcorn-like" shape compared to the spherical shape of human brain organoids.[20] The differences in organoid shape suggest contrasts in their neuronal networks, potentially altering social abilities.[21] This research solidifies the role of the NOVA1 gene in socialization and provides further insight into both autism and schizophrenia.[22] IV. Brain Organoids Consciousness As technology becomes more advanced, brain organoids may eventually exhibit a higher level of consciousness, intelligence, and sentience. Currently, the use of brain organoids is regulated by the Embryonic/Human Stem Cell Research Oversight Committee (E/HSCRO) due to the stem cells used to generate them.[23] If brain organoids become more complex, ethical considerations will need to be expanded.[24] It can be inferred that researchers currently treat brain organoids similar to animal research, as both have reduced abilities to consent to research, allowing greater research freedom. Recent studies indicate that human cerebral organoids exhibit the same brain neuron connectivity and electroencephalogram (EEG) patterns as those collected from preterm babies.[25] This data supports the idea that brain organoids may eventually experience pain or even basic forms of consciousness.[26]Those in opposition to brain organoid research would argue that research supports the claim that brain organoids have achieved a high level of sentience and that experimental research, even at this stage, may be considered unethical. Defining the concept of self is crucial for classifying brain organoids and distinguishing the line between ethical and unethical research. Examining how we perceive self allows us to understand how research will be conducted with brain organoids. In Being and Nothingness, Jean-Paul Sartre states that when someone looks at him, it supports the idea of his existence and sense of self.[27] Since the body would need to be seen within the gaze of another person, it also suggests that people would need to have a body to have an existence or an identity. Therefore, while this primitive brain state may have rudimentary consciousness, it does not have true existence due to a lack of a body. This would exclude the regulations imposed on human and animal research and allow for a laissez-faire approach to the research aside from stem cell regulation. In opposition, Schermer argues that “When we give up mind, as if that is even possible, we are nothing and nowhere.”[28] The creation of a brain organoid is the creation of a mind and therefore even the potential creation of the human self. Human research regulations would then be responsible for brain organoids in their more developed states. CONCLUSION The use of brain organoids is promising and expands our understanding of the brain and how it is affected by other neurological factors, such as disease or genetics. There are significant benefits in advancing our comprehension of neurodegenerative diseases such as Alzheimer’s, the Zika virus, and its effect on the fetus, and gaining a better understanding of our prehistorical brain evolution and development. Moreover, creating brain organoids is an efficient and potentially ethical alternative to animal testing. However, further research into brain organoids has suggested that there is a baseline level of consciousness that mirrors a human embryo, and there are still deficiencies in brain organoids that don’t perfectly replicate the human brain. Considering the rapidly progressing technology, ethical principles must also be evaluated to determine what it means to be human and where to draw the line of ethical research on more developed brain-like models. Overall, in the current state of brain organoids, researchers should work to harness brain organoids to their fullest potential to further contribute to the fields of neuroscience. - [1] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3; Lavazza A. (2020). Human cerebral organoids and consciousness: a double-edged sword. Monash bioethics review, 38(2), 105–128. https://doi.org/10.1007/s40592-020-00116-y [2] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [3] Qian, X., Nguyen, H. N., Jacob, F., Song, H., & Ming, G. L. (2017). Using brain organoids to understand Zika virus-induced microcephaly. Development (Cambridge, England), 144(6), 952–957. https://doi.org/10.1242/dev.140707 [4] Lavazza A. (2020). Human cerebral organoids and consciousness: a double-edged sword. Monash bioethics review, 38(2), 105–128. https://doi.org/10.1007/s40592-020-00116-y [5] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [6] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [7] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [8] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [9] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [10] Hyun, I., Scharf-Deering, J. C., & Lunshof, J. E. (2020). Ethical issues related to brain organoid research. Brain research, 1732, 146653. https://doi.org/10.1016/j.brainres.2020.146653 [11] Chan, W. K., Griffiths, R., Price, D. J., & Mason, J. O. (2020). Cerebral organoids as tools to identify the developmental roots of autism. Molecular autism, 11(1), 58. https://doi.org/10.1186/s13229-020-00360-3 [12] Lavazza A. (2020). Human cerebral organoids and consciousness: a double-edged sword. Monash bioethics review, 38(2), 105–128. https://doi.org/10.1007/s40592-020-00116-y [13] Gerakis, Y. (2019). Hetz, C. Brain organoids: a next step for humanized Alzheimer’s disease models?. Mol Psychiatry 24, 474–478. https://doi.org/10.1038/s41380-018-0343-7 [14] Qian, X., Nguyen, H. N., Jacob, F., Song, H., & Ming, G. L. (2017). Using brain organoids to understand Zika virus-induced microcephaly. Development (Cambridge, England), 144(6), 952–957. https://doi.org/10.1242/dev.140707 [15] Qian, X., Nguyen, H. N., Jacob, F., Song, H., & Ming, G. L. (2017). Using brain organoids to understand Zika virus-induced microcephaly. Development (Cambridge, England), 144(6), 952–957. https://doi.org/10.1242/dev.140707 [16] Qian, X., Nguyen, H. N., Jacob, F., Song, H., & Ming, G. L. (2017). Using brain organoids to understand Zika virus-induced microcephaly. Development (Cambridge, England), 144(6), 952–957. https://doi.org/10.1242/dev.140707 [17] Gerakis, Y. (2019). Hetz, C. Brain organoids: a next step for humanized Alzheimer’s disease models?. Mol Psychiatry 24, 474–478. https://doi.org/10.1038/s41380-018-0343-7 [18] Cohen J. (2018),Neanderthal brain organoids come to life. Science, 360,1284-1284.DOI:10.1126/science.360.6395.1284 [19] Qian, X., Nguyen, H. N., Jacob, F., Song, H., & Ming, G. L. (2017). Using brain organoids to understand Zika virus-induced microcephaly. Development (Cambridge, England), 144(6), 952–957. https://doi.org/10.1242/dev.140707 [20] Hyun, I., Scharf-Deering, J. C., & Lunshof, J. E. (2020). Ethical issues related to brain organoid research. Brain research, 1732, 146653. https://doi.org/10.1016/j.brainres.2020.146653 [21] Cohen J. (2018),Neanderthal brain organoids come to life. Science, 360,1284-1284.DOI:10.1126/science.360.6395.1284 [22] Hyun, I., Scharf-Deering, J. C., & Lunshof, J. E. (2020). Ethical issues related to brain organoid research. Brain research, 1732, 146653. https://doi.org/10.1016/j.brainres.2020.146653 [23] Sartre, Jean Paul. Being and Nothingness, 1943. https://dx.doi.org/10.4324/9780203827123. [24] Hyun, I., Scharf-Deering, J. C., & Lunshof, J. E. (2020). Ethical issues related to brain organoid research. Brain research, 1732, 146653. https://doi.org/10.1016/j.brainres.2020.146653 [25] Lavazza A. (2020). Human cerebral organoids and consciousness: a double-edged sword. Monash bioethics review, 38(2), 105–128. https://doi.org/10.1007/s40592-020-00116-y [26] Lavazza A. (2020). Human cerebral organoids and consciousness: a double-edged sword. Monash bioethics review, 38(2), 105–128. https://doi.org/10.1007/s40592-020-00116-y [27] Sartre, Jean Paul. Being and Nothingness, 1943. https://dx.doi.org/10.4324/9780203827123. [28] Schermer, V. I. (2002). Spirit and psyche: A new paradigm for psychology, psychoanalysis and psychotherapy. Jessica Kingsley Publishers. (shrink)

Photo ID 277640924© Dizain777 | Dreamstime.com INTRODUCTION Medicine is intertwined with promotion of positive health while prioritizing a patient’s diagnosis, prognosis, and treatment. The prioritization of a patient’s needs stems from a branch of morality called biomedical ethics, which focuses on moral principles that arise in healthcare, medical research.[1] Biomedical ethics serves to provide a framework for addressing complex medical questions while safeguarding the rights, dignity, and well-being of individuals.1 Often times in healthcare, decisions made by physicians and patients result (...) in beneficence and/or maleficence. Beneficence implies that healthcare professionals and institutions have a moral duty to act in a patient’s best interest by providing positive health outcomes while minimizing harm (maleficence).1 As a result of biomedical ethics’ emphasis on beneficence and maleficence, healthcare is designed to respect a patient’s needs, beliefs, and decisions. The practice of allowing patients to make their own medical decisions is called autonomy, and it is vital to biomedical ethics because it emphasizes the concerns of the patient.[2] However, it is difficult to ensure that a person has autonomy over their medical decision-making if they are not fully informed about the circumstances of their health or treatment options. ANALYSIS Thus, an important aspect of biomedical ethics is informed consent. Informed consent is a practice in healthcare and research where individuals must voluntarily agree to or decline medical care after being educated about their medical condition.[3] Informed consent protects an individual’s right to express their beliefs and make educated decisions about their health. Furthermore, there is an important distinction to be made between voluntary consent and informed consent. While informed consent emphasizes that individuals are fully educated and comprehend information about a procedure, voluntary consent maintains that a person must freely and willingly make decisions without any form of pressure or coercion.3 While a patient might be educated or informed about their health, they might not have the power to voluntarily make medical choices. Thus, consent must be both informed and voluntary to ensure that a patient is fully educated while preserving the right to make medical decisions. Without autonomy and (voluntary) informed consent, individuals would be deprived of their freedom to make educated medical choices, leading to interventions that do not align with their wishes or desires. However, autonomy and informed consent also have severe limitations and barriers, specifically when it comes to the informedness gap, cognitive capacity, and underestimation or overestimation of treatment risks. According to author Onora O’Neill, the informedness gap occurs when patients may not fully understand the complex medical information provided to them by their physician.[4] The informedness gap is especially prevalent when medical professionals discuss complex procedures or treatments, as the patients may feel overwhelmed by the information and not make truly informed decisions. In addition to the informedness gap, limited cognitive capacity and mental health can hinder effective communication and informed consent.[5] When patients are unable to provide informed consent due to factors like dementia, mental illness, or unconsciousness, ensuring thorough communication and education becomes extremely challenging.4 Additionally, it is important to consider how informed consent is limited by underestimation or overestimation of treatment risks. Patients may be overly optimistic about the success of a treatment or procedure, thereby underestimating the likelihood of complications or adverse outcomes. On the other hand, patients may possess fear and anxiety, causing them to overestimate the effects of treatment. Anxiety can cause a heightened perception of risk, which can lead to refusal of beneficial treatments, despite the presence of objective medical evidence.[6] Overall, these limitations of informed consent demonstrate that even when a patient is educated about their health, they still might not be fully knowledgeable when making medical decisions. In fact, while patients have the power of autonomy to make medical choices, the limitations of informed consent can have fatal effects. This becomes abundantly clear when looking at the case study of the world-famous musician, Michael Jackson. Michael Jackson’s death was the result of acute propofol and benzodiazepine intoxication. Propofol and benzodiazepine are extremely powerful medications commonly used for ICU sedation.[7] Dr. Conrad Murray, Michael Jackson's personal physician, was involved in Jackson’s care leading up to his death and played a central role in the events surrounding it. To briefly summarize the case, Michael Jackson was experiencing chronic insomnia and sought medical treatment after struggling to sleep for months.[8] Initially, Dr. Murray prescribed conventional anti-anxiety medications to help the artist sleep, but he was unsuccessful in resolving Jackson’s symptoms.7 Without coercing the artist, Dr. Murray offered to administer the powerful anesthetics, propofol and benzodiazepine. After Dr. Murray’s brief description of the effects of propofol and benzodiazepine, Jackson voluntarily agreed to this treatment.7 Initially, the treatment was a success, but Jackson was unaware of the significant toll these sedatives had on his health. On June 25th, 2009, after 2 and a half months of treatment, Jackson experienced severe propofol intoxication, causing him to die from cardiac arrest.[9] Clearly, this case highlights how limitations of informed consent, specifically the informedness gap and underestimation of treatment risks, can have fatal consequences. Michael Jackson was granted the autonomy to make medical decisions about treatments for his insomnia, and he was briefly informed that propofol and benzodiazepine are potent sedatives.7 However, according to the artist’s family, Jackson wasn’t fully educated about the level of addictivity and long-term ramifications of the drugs he was administered.8 The Jackson family cited that while the artist voluntarily agreed to treatment, his chronic sleep deprivation caused him to underestimate the effects of his medication. The family explained that Jackson lacked the mental capacity to make informed decisions about his health.8 Perhaps the outcome of this case may have been different if Dr. Murray had fully explored alternatives for treatment or made a thorough effort to fully educate Jackson about the effects of propofol. Additionally, it is difficult to discredit how sleep deprivation hindered Jackson’s ability to make rational decisions about his health.8 While it is true that Dr. Murray informed Michael Jackson about the strength of the sedatives he was administered, that doesn’t mean Jackson fully understood the treatment’s consequences or the weight of his decision. Furthermore, Michael Jackson didn’t suffer from the limitations of informed consent because of his unique status as a celebrity; Jackson is not an exception from the norm. Research suggests that factors such as limited interaction time between patients and physicians causes an informedness gap in about 1 out of every 3 people.[10] Michael Jackson had the wealth and resources to be informed about his health; he could have employed any doctor to provide his treatment. Yet, the average person does not have the resources to employ their own doctor or be thoroughly educated about their health.10 If Michael Jackson wasn’t fully informed about his medical condition or treatment, it is likely that the average person is uninformed as well. CONCLUSION To put it simply, autonomy and informed consent ensure that individuals can express their personal beliefs while making educated decisions about their health. However, it is crucial to consider the limitations of informed consent such as the informedness gap, cognitive capacity, and misjudgment of treatment risks. How useful is autonomy and informed consent if patients lack the ability to think clearly, logically, and holistically about their health?[11] The tragic case of Michael Jackson exemplifies how limitations of informed consent have profound consequences. Although Jackson was informed about the risks associated with propofol and voluntarily agreed to his treatment, he was not fully aware of the drug’s long-term ramifications. If healthcare seeks to achieve positive health outcomes, there is an ongoing need for effective communication and patient education to address the limitations of autonomy and informed consent. - [1]Tom L. Beaucham, Standing on Principles: Collected Essay p, European Journal of Health Law 19, no. 5 (2012): 544–51. [2] Daniel Callahan, “Autonomy: A Moral Good, Not a Moral Obsession,” The Hastings Center Report 14, no. 5 (1984): 40–42, https://doi.org/10.2307/3561098. [3] Onora O’Neill, “Between Consenting Adults,” Philosophy & Public Affairs 14, no. 3 (1985): 252–77. [4] Onora O’Neill, “Some Limits of Informed Consent,” Journal of Medical Ethics 29, no. 1 (February 1, 2003): 4–7, https://doi.org/10.1136/jme.29.1.4. [5] Antoine Aoun, Sibelle Al Hayek, and Flora El Jabbour, “The Need for a New Model of the Physician–Patient Relationship: A Challenge for Modern Medical Practice,” Family Medicine & Primary Care Review 20, no. 4 (2018): 379–84, https://doi.org/10.5114/fmpcr.2018.79351. [6] Rebecca Dresser. "Sunday Dialogue: Conversations Between Doctor and Patient,” The New York Times, August 25, 2012, sec. Opinion, https://www.nytimes.com/2012/08/26/opinion/sunday/sunday-dialogue-conversations-between-doctor-and-p atient.html. [7] Katherine Harmon, “What Is Propofol--and How Could It Have Killed Michael Jackson?” Scientific American, accessed October 15, 2023, https://www.scientificamerican.com/article/propofol-michael-jackson-doctor/. [8] “Doctor Is Guilty in Michael Jackson’s Death - The New York Times,” accessed October 15, 2023, https://www.nytimes.com/2011/11/08/us/doctor-found-guilty-in-michael-jacksons-death.html. [9] B. Lyons, “Medical Manslaughter,” Irish Medical Journal 106, no. 1 (January 2013): 26–27. [10] D. R. Hansberry et al., “Are We Effectively Informing Patients? A Quantitative Analysis of On-Line Patient Education Resources from the American Society of Neuroradiology,” American Journal of Neuroradiology 35, no. 7 (July 1, 2014): 1270–75, https://doi.org/10.3174/ajnr.A3854. [11] Rebecca Kukla, “How Do Patients Know?,” Hastings Center Report 37, no. 5 (2007): 27–35. (shrink)

Photo by Olga Kononenko on Unsplash INTRODUCTION “Because there are no laws barring palliative sedation, the dilemma facing doctors who use it is moral rather than legal.” Dr. Timothy Quill, a professor of psychiatry, bioethics, and palliative care concisely articulates an ethical intricacy in end-of-life care. In a Washington Post article titled, “Assisted suicide is controversial, but palliative sedation is legal and offers peace,” the discussion revolves around the ethical challenges encountered by physicians when deciding to employ palliative sedation, particularly (...) when faced with terminal illnesses causing unbearable physical and existential suffering. Palliative sedation is defined as the intentional lowering of awareness towards, and including, unconsciousness for patients with severe and refractory symptoms.[1] While assisted suicide remains embroiled in legal debates, palliative sedation emerges as a legally sanctioned alternative, thereby burdening medical practitioners with a moral quandary; while the boundary between assisted suicide and palliative sedation is arguably blurred, intent seems to distinguish the two choices– both aim to reduce suffering, but palliative sedation does not have death as the goal. This leads to the ethical question on the permissibility of hastening or causing unconsciousness in dying patients, rather than the issue of whether causing death is ethically justifiable. The absence of explicit laws governing palliative sedation places the ethical dilemma squarely on the shoulders of healthcare professionals, who must grapple with the responsibility of determining if palliative sedation is in the best interest of the patient. Evidently, the choice the clinician makes crucially impacts the patient’s quality of life moving forward, demonstrating the far-reaching consequences of palliative sedation in not just individual experiences in healthcare, but in shaping the future of how palliative care is handled. By integrating clinical and neuroscience knowledge, an argument can be made that the optimal clinical decision is reached by considering the subjective value of consciousness for each individual patient, with candor and transparency being the basis of all counseling approaches to prioritize patient advocacy. ANALYSIS Drawing on the precedent of assisted suicide, a major concern physicians have when debating the use of palliative sedation is the clause to “do no harm”, a principle fundamental to their profession in healthcare. A paradoxical dilemma arises when reducing the pain of a patient may come at the cost of their consciousness– which is more harmful? Having strict guidelines on when palliative seduction is even an option alleviates some responsibility on the physician to make this choice; the choice of the patient, or informed consent, is preliminary for this therapy.[2] By having the patient aware of the risks, and having that patient decide what state they value more, a physician can base their decision on what “harm” means in relation to the patient’s definition. Of course, there are additional considerations that must be contended with before this assumption can be reliably used, such as the state of mind of the patient when this decision is made, as well as the general consensus that exists among the patient, family, and staff about the therapy’s appropriateness. Another concern then seems to be the actual practice of palliative sedation– what are the side effects and unintended consequences of this therapy? So far, the academic literature seems promising in the accuracy of the therapy; according to a review of 1,807 patients, there is no direct evidence from randomized clinical trials that palliative sedation, when appropriately indicated and correctly used to relieve unbearable suffering, has detrimental effect on the survival of patients with terminal cancer, and can be considered as part of a continuum of palliative care.[3] A more cynical viewpoint should also be considered, however, for the integration of different perspectives, possibilities, and predictions that allow for a comprehensive overview of palliative sedation. One possibility, a prospect unfortunately commonly considered in healthcare, is that palliative sedation can lead to death prematurely. This is where the clinician’s knowledge comes into play, particularly their expertise in the field of neuroscience and the operational definitions of consciousness. Various medications used in palliative care may influence the brain's neurochemistry, impacting consciousness and contributing to the relief of suffering. For instance, benzodiazepines such as midazolam and lorazepam, commonly employed in palliative sedation, act as central nervous system depressants. They enhance the inhibitory effects of the neurotransmitter gamma-aminobutyric acid (GABA), leading to sedation, anxiolysis, and amnesia.[4] The neurological effects of these medications involve modulation of neurotransmitter activity, resulting in a calming effect on the brain. Midazolam, in particular, has a rapid onset of action and a short duration, making it suitable for managing acute distress in terminally ill patients.[5] As these medications induce sedation, they may contribute to the lowering of consciousness levels, while also relieving chronic suffering. Ultimately, it is up to the clinician to use their expertise to not only weigh the possible outcomes of the medications, but to also clearly communicate the potential consequences to the patients in a thoughtful manner. The doctrine of double effect (DDE) may also help to ameliorate the ethical conundrum of whether practicing palliative sedation is ethically justifiable. In the context of palliative sedation, the application of the doctrine of double effect becomes particularly salient. According to the criteria set by the DDE, the action of administering sedative medications, such as morphine, is deemed morally permissible if certain conditions are met.[6] Firstly, the action itself, providing relief from severe and refractory symptoms through sedation, is not inherently bad—it is morally neutral or, in some cases, considered good due to its intent to alleviate suffering. The primary intention must be the relief of suffering, with the secondary and potentially adverse effect of unconsciousness or hastening death not being the desired outcome but rather an unintended consequence. The DDE thus allows healthcare professionals to navigate the ethical intricacies of palliative sedation by placing a strong emphasis on the intention behind the action. In cases where consciousness is significantly diminished, as is often the case with palliative sedation, the doctrine provides a framework for evaluating the ethical justifiability of the intervention. The principle that the good effect (relief from suffering) must outweigh the potentially adverse effect (unconsciousness or hastening death) ensures a careful and considered approach to decision-making. The deliberation to use palliative sedation can be framed in the area of the ethics of neuroscience, as the choice to go through with palliative sedation involves the use of clinical decision-making, neuroscience, and ethical considerations related to consciousness.[7] The scientific diagnoses and definitions on how consciousness is perceived and how medications affect consciousness highlights a neuroscientific aspect; the optimal clinical decision-making process involves contemplating this variable value of consciousness. This brings in the ethical dimension, as clinicians must navigate the complexities of respecting individual perspectives and values related to consciousness, which can be influenced by neuroscientific factors such as cognitive functioning, brain health, and subjective experiences. CONCLUSION In summary, the ethical considerations surrounding palliative sedation compel clinicians to navigate the nuances of moral responsibility, patient advocacy, and clinical judgment. In the absence of clear legal guidelines, clinicians bear the weight of deciding the appropriateness of palliative sedation, influencing both individual patient experiences and broader palliative care practices. The doctrine of double effect provides a valuable ethical framework, emphasizing intentionality and the delicate balance between relieving suffering and unintended consequences. Ultimately, a patient-centered approach is essential to make the best decisions possible while upholding the principles of beneficence and non-maleficence, ensuring that end-of-life care aligns with the values of each individual patient. - [1] American Academy of Hospice and Palliative Medicine. 2014. “Palliative Sedation | AAHPM.” Directed by AAHPM. 2023. https://aahpm.org/positions/palliative-sedation. [2] Young et al. 2021. “The Neuroethics of Disorders of Consciousness: A Brief History of Evolving Ideas.” Brain 144 (11): 3291–3310. https://doi.org/10.1093/brain/awab290. [3] Maltoni et al. 2012. “Palliative Sedation in End-of-Life Care and Survival: A Systematic Review.” Journal of Clinical Oncology 30 (12): 1378–83. https://doi.org/10.1200/jco.2011.37.3795. [4] Griffin, CE, 3rd et al. 2013. “Benzodiazepine Pharmacology and Central Nervous System-Mediated Effects.” PubMed. https://pubmed.ncbi.nlm.nih.gov/23789008. [5] Prommer, Eric. 2020. “Midazolam: An Essential Palliative Care Drug.” Palliative Care and Social Practice 14 (January): 263235241989552. https://doi.org/10.1177/2632352419895527. [6] Takla et al. 2020. “A Conscious Choice: Is It Ethical to Aim for Unconsciousness at the End of Life?” Bioethics 35 (3): 284–91. https://doi.org/10.1111/bioe.12838. [7] Roskies, Adina. 2002. “Neuroethics for the New Millenium.” Neuron 35 (1): 21–23. https://doi.org/10.1016/s0896-6273(02)00763-8. (shrink)

Photo by AbsolutVision on Unsplash INTRODUCTION Social media, news headlines, and podcasts implicitly and explicitly remind us of the digital misinformation maelstrom we navigate every day to understand the truth of current events. Misinformation feeds off the topics that impact our lives and draw our attention – war, health, politics, identity, fear, and empathy. Misinformation has a digital reach faster and wider than true information based on its nature of novelty and emotional instigation.[1] It draws from data leakages, twists the (...) truth, incites emotional responses, and can undermine real efforts to protect and aid vulnerable communities. Many of the places and events targeted by misinformation are sites of humanitarian crises such as Gaza, Yamen, and Ukraine among many others. Humanitarian groups conceived to provide relief to vulnerable communities are susceptible to personal harm and impeded aid because the organizational structure is not equipped for misinformation and data security breaches. While propaganda and misinformation did not emerge in the contemporary, their scope, speed, and impact have exponentially increased as the world’s use of digital media for communication developed. The current state of misinformation and data leakages are threats to humanitarian efforts, especially the vital and nuanced task of humanitarian medical aid that now simultaneously relies on the digital information ecosystem. ANALYSIS Humanitarian efforts center on the four main principles of humanity, neutrality, impartiality, and operational independence. The United Nations Refugee Agency specifies that ‘humanity’ refers to addressing human suffering wherever it is found to ensure health and respect, ‘neutrality’ is to not engage in political, racial, religious, or ideological controversies, ‘impartiality’ is to provide aid based on need alone without bias and priority, and ‘operational independence’ is to conduct aid autonomous from agendas or actors in sectors such as political, economic, or military.[2] Medecins Sans Frontieres explicitly states neutrality, impartiality, independence, bearing witness, and accountability in their code of principles. Their statement on medical ethics is much more vague. It aims to “carry out our work with respect for the rules of medical ethics, in particular the duty to provide care without causing harm to individuals or groups. We respect patients’ autonomy, patient confidentiality, and their right to informed consent.”[3] Confidentiality is mentioned, but in the nondescript sense that could refer to confidentiality outlined in any number of medical ethics contexts. Three most commonly referred to ethical codes in Western medicine are the Declaration of Helsinki, the Belmont Report, and the Code of the American Medical Association (AMA). The Declaration of Helsinki places confidentiality in the context of research and was written pre-digital age in the 1960s.[4] The Belmont Report does not mention confidentiality or patient privacy in its summation of medical ethics from 1978.[5] Lastly, the AMA’s Code of Medical Principles upholds that physicians “shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law.”[6] This AMA principle was adopted in 1957 and revised in 2001, still before the onset of widely accessible digital media. These three medical ethics codes are the standard of Western medicine, and yet they are decades obsolete when facing the harm of digital misinformation and data leakages. Humanitarian aid organizations cannot afford to rely on outdated medical ethical codes amid digital misinformation and data leakages. Medical humanitarian relief groups such as Medecins Sans Frontiers, the International Medical Corps, the WHO Global Health and Peace Initiative, and the International Committee of the Red Cross, rely on the medical ethics defined in the aforementioned guides in addition to their humanitarian foundation. These codes, while useful, were written prior to the digital age. And, as our methods of communication, medical delivery, and global action have evolved and digitized, the ethics guiding medical practice should be updated to reflect this dramatic change. Humanitarian medical organizations need the digital ecosystem to store metadata for medical services such as patient history, blood type, metrics on locations in need of aid, missing person searches, and funding. The levels of data vulnerable to misconstruction and hacking exist on the personal and organizational levels. Individual providers and the organizational body should prioritize confidentiality. Thus humanitarian medical ethics should adapt to the reality of the digital age to not endanger the populations receiving aid and to not propagate harm. Misinformation and data leakage can lead to microtargeting, defamation, provider endangerment, and other harms preventing medical service. The European Data Protection Supervisor details how the personal information collected by organizations, such as medical, can be stolen or misconstrued to affect microtargeting, placing individuals in the direct path of echo chambers, digital tracking, and manipulation.[7] The International Broadcasting Trust released a report in 2018 detailing the extent to which misinformation was impacting the humanitarian aid groups it broadcasts to.[8] For example, the report shared that rumors spread by right-wing political groups in 2017 falsely circulated that humanitarian groups in the Mediterranean were collaborating with child trafficking rings.[9] After causing defamation, the right-wing group sent a boat to block and detain the humanitarian group’s search and rescue boat. This was one incident among many where providers and patients were put in harm’s way through misinformation and the misuse of location data. Other disinformation campaigns can be carried out by governments as well; in Syria and Ukraine, the Russian government has been specifically targeting Red ross and White Helmets.[10] Beneficial medical services cannot be delivered if providers and patients are targeted. In January of 2022, the International Association of the Red Cross was hacked. Approximately 515,000 vulnerable persons’ data was leaked and became inaccessible to the IARC providers.[11] If an organization cannot protect access to its digital ecosystem, humanitarian medical aid efforts can be rendered ineffective. Additionally, misinformation and breached data cause the less immediate but more widely impactful harm of distrust. Stakeholders and funding sources can withdraw from supporting medical humanitarian aid organizations. Beneficial medical services cannot be offered if there is no monetary backing. Providers and patients also have their own digital devices and means of communication which can lead to sensitive information being shared online or with non-neutral parties. If a patient cannot trust their provider or the organization a provider acts in the name of, medical services can be refused. Beneficial medical service cannot be conducted if the trust of the patient is compromised by humanitarian groups failing to prioritize patient confidentiality. Confidentiality should be prioritized in humanitarian medical aid to safeguard against the extended harms of data leakage, misinformation, and malintent. Some critiques may postulate that due to the uniqueness of each community aided by medical humanitarian organizations, over-standardization from rigid ethical codes may occur, that standardization can lead to inflexibility with communities and render aid strategies ineffective. However, the reality is that ethical frameworks make sure that individual actors are not monolithic – they allow for collaboration and joint work. The WHO Global Health and Peace Initiative’s recent adoption of conflict sensitivity, along with other organizations’ additions of similar language, ensure that there is a feedback loop incorporated into the ethical code to mitigate unintended harm. Thus, ethical codes are helping providers to respond in unprecedented situations with consciousness to harm propagation. In events of limited time and of crisis, comprehensive ethical codes are especially beneficial because we rely on habits and pre-established information banks. CONCLUSION Humanitarian medical ethics should include a specific guide for confidentiality. Without forethought and the integration of traditional and digital confidentiality as a main tenant, medical humanitarian organizations will continue to act retrospectively. Trust in stakeholder-provider-patient relationships will continue to disintegrate. The current status quo of medical ethics in the humanitarian aid sector poses multiple risks for providers and patients whereas adopting stronger confidentiality language is a tangible step towards the protection of vulnerable communities from the harms of digital misinformation and data leakage. - [1] Vosoughi, Soroush, Deb Roy, and Sinan Aral. “The Spread of True and False News Online.” Science 359, no. 6380 (2018): 1146–51. https://doi.org/10.1126/science.aap9559. [2] “Conflict Sensitivity and the Centrality of Protection.” The Global Portection Cluster, March 2022. https://www.globalprotectioncluster.org/sites/default/files/2023-03/220318_gpc_-_conflict_sens.pdf. [3] “Our Charter and Principles.” MEDECINS SANS FRONTIERES - MIDDLE EAST. Accessed December 24, 2023. https://www.msf-me.org/about-us/principles/our-charter-and-principles#:~:text=We%20give%20priority%2 0to%20those,of%20governments%20or%20warring%20parties.&text=The%20principles%20of%20impartiality%20a nd%20neutrality%20are%20not%20synonymous%20with%20silence. [4] “WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.” The World Medical Association. Accessed December 24, 2023. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-researc h-involving-human-subjects/. [5] Office for Human Research Protections (OHRP). “ The Belmont Report.” United States Department of Health and Human Services, September 27, 2022. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. [6] American Medical Association. “The Code.” AMA principles of Medical Ethics. Accessed December 24, 2023. https://code-medical-ethics.ama-assn.org/principles. [7] “EDPS Opinion on Online Manipulation and Personal Data.” European Data Protection Supervisor. Accessed December 24, 2023. https://edps.europa.eu/sites/edp/files/publication/18-03-19_online_manipulation_en.pdf. [8] Robin. “Faking It: Fake News and How It Impacts on the Charity Sector.” International Broadcasting Trust, March 13, 2020. https://www.ibt.org.uk/reports/faking-it/. [9] Reed, B. “Charities Colluding with Traffickers? Fake News.” The Guardian, February 15, 2018. https://www.theguardian.com/global-development/2018/feb/15/charities-aid-agencies-fake-news-says-rep ort. [10] Sant, Shannon Van. “Russian Propaganda Is Targeting Aid Workers.” Foreign Policy, August 1, 2022. https://foreignpolicy.com/2022/08/01/russia-disinformation-ukraine-syria-humanitarian-aid-workers/. [11] International Committee of the Red Cross. “Hacking the Data of the World’s Most Vulnerable Is an Outrage.” International Committee of the Red Cross, October 27, 2022. https://www.icrc.org/en/document/hacking-data-outrage. (shrink)

Photo ID 193201183 © Orathai Mayoeh| Dreamstime.com ABSTRACT A US Public Health Service study conducted after World War II led to a research scandal involving the intentional infection of 1300 Guatemalans with syphilis and other STIs. That news initially prompted an apology by President Obama to the President of Guatemala and an investigative report from the Presidential Commission for the Study of Bioethical Issues. Despite promises from the US Department of Health and Human Services to invest $1.8 million to “improve (...) the treatment and prevention of HIV and other sexually transmitted diseases,” there is no record that such funding nor any money to compensate the families of people victimized in the research debacle has reached Guatemala. Litigation followed public disclosures. This article analyzes the litigation and explores the likelihood that this lawsuit may represent another episode in the re-victimization of people in Guatemala who still await redress for the wrongs done to their families more than 70 years ago. INTRODUCTION Nine years after its initial filing, In re Estate of Alvarez v. Rockefeller Foundation, the case to recover damages for the infamous World War II-era syphilis experiments that the US Public Health Service (PHS) conducted in Guatemala has been dismissed by the Fourth Circuit Court of Appeals.[1] The plaintiffs sought compensation as victims and descendants of victims of studies in which approximately 1300 Guatemalans were intentionally infected with sexually transmitted infections (STIs), and more than 5000 individuals had biological samples taken without proper consent. After the court rejected claims in 2022 that Johns Hopkins University and Bristol-Meyers Squibb should be held liable for the Guatemala scandal, the Rockefeller Foundation was the only remaining defendant. The Foundation had a longstanding interest in research to find a cure for syphilis. Lawyers representing alleged victims in the Guatemala research claimed that responsibility should accrue to Rockefeller because Thomas Parran was on its board and Frederick Soper was its Associate Director and a board member. Both were intimately involved in the experiments. In this US case, plaintiffs claimed the court should assign responsibility and allow them to recover damages. Its conclusion makes it extremely unlikely that legal action will lead to compensation for those victims now or anytime in the future. The lawsuit described in this article raises the question of whether litigation is an effective avenue for addressing discoveries of historic injustices stemming from breaches of research ethics. Litigation may revictimize the very populations who endured harms during the original experiments. In this case, more than six decades after the studies themselves, and ten years after the details of those studies were publicly revealed, many of the people who became entangled in this litigation are arguably worse off as a result because they endured additional hardships during the litigation, their avenue to justice through the US courts is now foreclosed, and their credibility was called into question throughout the case. BACKGROUND The PHS/Guatemala experiments occurred between 1946-1948, and related studies continued into the 1950s. However, the entire research plan did not become publicly known until the 2010 publication of an historian’s analysis of an archival collection, and a subsequent bioethics commission report in 2011.[2] The PHS researchers who designed the Guatemala studies were attempting to hone methods of prophylaxis against STIs for members of the US military and hoped to take advantage of the then newly discovered power of penicillin as a cure for STIs. Led by John Cutler,[3] a team of PHS doctors collaborated with health professionals in Guatemala City to design a series of experiments that monitored sexual intimacy between prisoners and commercial sex workers who had been confirmed to be carrying an STI. The experiment then moved on to manually infecting prison inmates, psychiatric patients, and soldiers with syphilis, gonorrhea, and chancroid. Between 1946 and 1953, PHS researchers also conducted serology studies on samples of blood and cerebrospinal fluid they had obtained via cervical and lumbar punctures on prisoners, orphans, school children, patients in a psychiatric hospital, and leprosy patients in Guatemala.[4] The research was conducted without consent, without appropriate disclosures, and, in many cases, using the most vulnerable institutionalized populations. While formal standards of ethics for biomedical research later emerged in documents like the Belmont Report and were adopted as part of US law, the consensus of scholars studying the Guatemala experiments is that they violated ethical standards at the time they were carried out, and the scientists and physicians who participated, well aware of their ethical toxicity, intentionally kept them hidden.[5] A few experts in the STI field knew the details of these experiments, but the US government deliberately concealed them from public view for more than sixty years. The public exposure of John Cutler’s papers clarified the scope of the studies, sometimes likened more to torture than medical experimentation, and placed the episode in Guatemala alongside the most infamous of research scandals.[6] News of the scandal initially prompted an apology by President Obama to the President of Guatemala. Lawsuits followed. I. Litigation Public exposé of the experiment’s details led to condemnation of the studies, which in turn prompted calls for legal action. The first lawsuit related to the PHS/Guatemala research, Garcia v. Sebelius, was a class action suit filed on behalf of victims against the US Government in 2011. A federal trial court called the Guatemala STI experiments a “deeply troubling chapter in our Nation’s history” but determined that the law shielded the government against such claims under the principle of sovereign immunity. The court declared itself “powerless to provide any redress…” and dismissed the suit in 2012.[7] In response, the US Department of Health and Human Services promised $1.8 million to “improve the treatment and prevention of HIV and other sexually transmitted diseases … in Guatemala and to further strengthen ethical training on human research protections.”[8] No commitments were made to the victims, and no compensation was delivered to them in Guatemala. Because the Garcia case ruled out a suit against the US government, in 2015, plaintiffs filed another class action lawsuit against Johns Hopkins University, the Rockefeller Foundation, and pharmaceutical manufacturer Bristol Myers Squibb, demanding $1 billion in damages. The suit claimed that Johns Hopkins had been the faculty home for many members of the National Institutes of Health (NIH) syphilis study section that recommended that a grant of financial support be approved to fund the Guatemala project.[9] Most prominent in this group of Hopkins faculty members was Joseph Earle Moore. He chaired the study section and almost every review committee for the NIH that reviewed the study. The Rockefeller Foundation’s board eventually included Thomas Parran, Surgeon General at the time of the experiments and Rockefeller employee Frederick Soper, both of whom held roles critical to the study.[10] The three companies that previously made up Bristol Meyers Squibb manufactured the penicillin used in the experiments to test levels of efficacious dose to cure syphilis.[11] The plaintiffs contended that the web of connections among these entities and the researchers who “helped design, support, develop, encourage, and finance, and participated in and benefitted from the Guatemala Experiments,” made all three entities liable for the damages to compensate Guatemalan research subjects and their descendants. From the initial filing of the suit in 2015 until eighteen months later, defense lawyers attempted to have the case dismissed, arguing that delays in filing a claim violated the statute of limitations and the speculative nature of plaintiff damages rendered them legally inadequate to provide a causal link to the original experiments. In late 2016, the plaintiffs amended their claims a third time to address these issues. At that point, the plaintiff class included more than 800 people made up of spouses, children, and other descendants of deceased individuals alleged to have been part of the intentional infection experiments. But the largest number of listed plaintiffs were school children whose blood had been drawn for serology experiments. While the Presidential Commission had found no evidence supporting this assertion, some of the plaintiffs also claimed to be direct victims of intentional infection experiments conducted at their schools. The court found no evidence that the Rockefeller Foundation controlled or directed either Parran’s involvement in approving the Guatemala project or Soper’s more thorough engagement with the research as a staff member at the Pan American Sanitary Bureau (PASB). The Court stated, “The connection between TRF’s [Rockefeller] interest in finding a cure for syphilis and the work that Dr. Soper did while at PASB is simply far too attenuated to establish an agency relationship...there is no indication that TRF had the ability to exercise control over Soper.”[12] In 2024, with Rockefeller as the only remaining defendant, the motion to dismiss the suit was granted. While the litigation was still active, lawyers deposed people in Guatemala who had been responsible for identifying the plaintiffs named in the lawsuit. By March 2019, it became clear that serious irregularities had occurred in recruiting those participants. Fraudulent testimony and unethical behavior in recruiting sparked the defendants to move for sanctions against the plaintiffs’ attorneys.[13] II. Fraudulent Testimony a. Serology Experiments in Port of San José One kind of experiment conducted in Guatemala included serology testing on blood samples taken from school children. Norma Alicia Lorenzo Lopez was a plaintiff in the lawsuit and former director of the school at the remote Pacific coast town of Puerto San Jose, an initial location for blood draws in school studies during the late 1940s. She signed a copy of a letter certifying that historical records and the testimony of former students verified that plaintiffs were enrolled in school at the time of the experiments. But Lopez eventually admitted under questioning that relevant records for the school were destroyed years ago in several floods and earthquakes. She had no documents to confirm that the claimant’s testimony was correct, nor did she have any personal knowledge of what happened. She then testified that she had no legal authority to issue certifications on behalf of the school and had violated the rules of the Ministry of Education in so doing. Additionally, she admitted that at least one person was dead at the time he was supposed to have given his sworn statement to her.[14] Fraudulent testimony, unfortunately, was not limited to Lopez. Under questioning, many named plaintiffs testified that they did not know why their or their family members’ names had been included among the victims. Another witness, Dr. Orozco Aguirre, reported that he tested hundreds of people who had given blood as children in Puerto San Jose. Some of them were supposed to have also claimed to be infected with syphilis by researchers. But in a hearing before the presiding judge, lead plaintiffs’ counsel confirmed that Aguirre had given false testimony.[15] Aguirre eventually admitted that the effective date of the certificate presented to the court to show his qualifications to run a laboratory in Guatemala had been altered to conceal that it had expired. He also conceded under questioning that his expert report had been plagiarized, then altered to include data that would correspond with his planned testimony in support of the plaintiffs. As a result, plaintiffs’ counsel withdrew Dr. Orozco as an expert witness after his first day of testimony. b. STI Testing in Guatemala City Dr. Pablo Werner Ramirez Rivas, a physician consultant and medical expert for the plaintiffs, former Guatemalan Health Minister Roberto Paiz, and his wife Clara de Paiz had arranged “information sessions” to recruit plaintiffs. Werner’s testimony was intended to provide the factual foundation upon which several of the plaintiff’s claims were based. However, the day after Dr. Aguirre was withdrawn and only a few days before Dr. Werner was scheduled to testify, plaintiffs’ counsel also withdrew him as an expert. Additional reports emerged showing that Clara de Paiz was taken into custody in Guatemala in 2018, following charges by the International Commission Against Impunity in Guatemala with “active bribery” in connection with a scheme to influence the selection of Guatemalan judges in an unrelated case.[16] On March 11, 2019, the plaintiffs’ counsel disclosed that they were “going forward” with a more limited list of plaintiffs and claims. The number of Guatemalan plaintiffs was reduced dramatically; fewer than one hundred remained in the lawsuit. Thirteen of the most important eighteen plaintiffs—those who claimed direct infection in the original experiments or a family relationship to someone who was involved in those experiments — were dropped from the case. III. Sanctions Against Plaintiffs’ Lawyers After extensive discovery, the defendants’ lawyers made a motion for sanctions against the plaintiffs’ lawyers. According to the defendants, depositions and other material “revealed that plaintiffs' claims are based on manufactured evidence, false sworn statements, and unsupportable allegations.”[17] The defendants accused the plaintiffs’ lawyers of doing just what the initial alleged wrongdoers did – withholding positive test results from plaintiffs. It was a major contention of the lawsuit that those who directed the PHS/Guatemala experiments actively deceived the victims. They did not inform victims in the 1940s that they were part of an experiment, that they had been infected with syphilis, or that their condition might expose other family members to infection. Nor did they provide medical care to infected victims or counsel them to seek it. In preparing for the lawsuit, plaintiffs were sent on bus trips lasting up to five hours to reach Guatemala City for syphilis testing. Although Dr. Aguirre claimed in sworn court documents that many of the plaintiffs tested positive for syphilis, their testimony indicated they were not informed of their infection status, nor was treatment offered to those who did test positive. Defendant’s arguments for sanctions declared that by withholding infection status from plaintiffs, their lawyers “did precisely what they had accused others of doing or, more precisely, of not doing.”[18] IV. Unsatisfactory Outcome The original complaint in this case alleged that defendants, Johns Hopkins University, the Rockefeller Foundation, and Bristol Meyers Squibb, had “designed, developed, approved, encouraged, directed, oversaw, and aided and abetted nonconsensual, nontherapeutic, human subject experiments in Guatemala.”[19] But the trial court found that there was “insufficient evidence to support” that conclusion against any of the three defendant organizations. The defendants did not downplay the horrific nature of the PHS/Guatemala syphilis studies, nor the culpability of those who conducted them. They merely rejected the idea that they, as institutions, shared blame for the activities that the government planned, conducted, and subsequently hid from the public eye. In issuing its ruling, the court endorsed that conclusion, stating that any evidence of the defendant’s complicity in these actions “has been lost to the sands of time.”[20] The court emphasized that this result “illustrates the limits of the court system to provide justice for every injustice,” concluding that other remedies were “beyond the power of this Court to grant.”[21] The final decision in this controversy yielded similar language. In a separate opinion, 4th Circuit Court of Appeals Judge J. Harvie Wilkinson said that people working with the Rockefeller Foundation had a relationship that “is too attenuated” to consider them agents of Rockefeller in carrying out the Guatemala experiments. “I thus concur... with some sadness” he said, “that the rule of law is not advanced as an instrument of justice by affixing liability where it does not belong.”[22] CONCLUSION We are left with an unsatisfactory ending to a scandal that festered over more than seventy-five years and legal drama unfolding over more than a decade. An appellate court decision now echoes what scholars and a presidential commission concluded as legal challenges began: “It was our own government... that was the driving force behind these monstrous wrongs.”[23] Fashioning remedies for the horrors of this and other scandals that may yet be uncovered in the archives of scientific and biomedical research remains a job that our own government should still be required to undertake. When hidden scandals perpetrated by deceased individuals in government service are finally revealed, how should accountability be satisfied? We know that suits against the government are exceedingly unlikely to be allowed. As this case has demonstrated, assessing damages against other institutions whose culpability cannot be proven is also likely to fail. First steps taken by government commissions of inquiry that are free to investigate past wrongs and expose them to public scrutiny are a beginning, but never the end of the accounting. They allow some measure of recognition for victims, but those who are long dead can never be made whole. As the 4th Circuit Court concluded, the judiciary is limited in its powers “to provide justice for every injustice.” What is needed beyond all else is a motive for a majority in Congress squarely to face scandals like those that occurred in Guatemala and craft a remedy that more fully addresses their causes and their consequences. At this point, we have few, if any, models of what such remedies would look like, and almost no reason to believe that there is the political will to take on that task. - [1] In re Estate of Alvarez v. Rockefeller Foundation, No. 22-1678, (4th Cir. 2024) March 20, 2024. https://caselaw.findlaw.com/court/us-4th-circuit/115960805.html [2] Reverby, S. “‘Normal exposure” and inoculation syphilis: a PHS ‘Tuskegee’ doctor in Guatemala, 1946–1948.” J Policy Hist 23, no. 1 (2011):6-28 [DOI: https://doi.org/10.1017/S0898030610000291]; Presidential Commission for the Study of Bioethical Issues (PCSBI), “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948 (Washington, D.C.: Government Printing Office; 2011). https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/Ethically%20Impossible%20(with%20l inked%20historical%20documents)%202.7.13.pdf The author was a senior advisor to the Presidential Commission for the Study of Bioethical Issues that issued Ethically Impossible, and he contributed to the research and drafting of the Report as a staff member. He testified by deposition under subpoena and without compensation in the lawsuit described in this article. [3] Cutler [1915-2003] also conducted the Tuskegee syphilis experiments, which included Black American research subjects who were intentionally not informed about the nature of the experiment or the availability of treatment. [4] Spector-Bagdady K, Lombardo P.A. “US Public Health Service STD Experiments in Guatemala (1946-1948) and Their Aftermath,” Ethics Hum Res. 2019;41(2):29-34. [DOI: 10.1002/eahr.500010] [5] See “The Guatemala Experiments—Looking Back, Looking Ahead, and Apportioning Blame,” Presidential Commission for the Study of Bioethical Issues, “Ethically Impossible:” STD Research in Guatemala from 1946 to 1948, 2011, GPO (Washington DC)107-108. [6] Presidential Commission for the Study of Bioethical Issues, “Ethically Impossible:” STD Research in Guatemala from 1946 to 1948, 2011, GPO (Washington DC)., https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/Ethically%20Impossible%20(with%20l inked%20historical%20documents)%202.7.13.pdf H. Brevy Cannon, “Arras, Bioethics Commission Condemn 1940s Guatemalan Syphilis Research as Unethical,” UVA Today, August 31, 2011, https://news.virginia.edu/content/arras-bioethics-commission-condemn-1940s-guatemalan-syphilis-resea rch-unethical. [7] Garcia v. Sebelius, 867 F. Supp. 2d 125 (D.D.C. 2012). https://casetext.com/case/garcia-v-sebelius-2 [8] “HHS Commits Nearly $1.8 million to Health Initiatives in Guatemala and to Improving Global Human Research Protections,” Business Wire, January 10, 2012, [9] Alvarez v. Hopkins, complaint, Case 1:15-cv-00950-JKB Circuit Court Baltimore City (April 1, 2015). Spector-Bagdady K, Lombardo P.A. “’Something of an adventure’: postwar NIH research ethos and the Guatemala STD experiments,” J Law Med Ethics. 2013;41(3):697-710. [DOI: 10.1111/jlme.12080] [10] Thomas Parran [1892-1968] was Surgeon General of the US Public Health Service and approved the funding proposal that resulted in the experiments. He was also a member of the Rockefeller Foundation’s Board of Trustees and the Board of Scientific Directors of the foundation’s International Heath Division. At times his government service and his work at Rockefeller overlapped the work that occurred in Guatemala. Frederick Soper [1893-1977] was an Associate Director at Rockefeller and in 1947 was assigned to work on the Guatemala experiments at the Pan American Sanitary Bureau (PASB). [11] Alvarez v. Hopkins, complaint, Case 1:15-cv-00950-JKB Circuit Court Baltimore City (April 1, 2015). The original complaint filed in the Circuit Court for Baltimore City, was moved to the United States District Court for the District of Maryland. [12] In re Estate of Alvarez v. Rockefeller Foundation, No. 22-1678, (4th Cir. 2024) March 20, 2024. p. 15. [13] Defendant’s Opening Brief in Support of Request for Discovery and Motion for Sanctions, Case No. 1:15-cv-950 TDC, Document 262-1 Filed 04/09/19. [14] Transcript of Norma Alicia Lorenzo Conducted on February 7, 2019, Case 1:15-cv-00950-TDC Document 263-5. [15] Preliminary Transcript of Hearing, Case 1:15-cv-00950-TDC Document 231-1 March 6, 2019., p. 3. [16]Defendant’s Opening Brief in Support of Request for Discovery and Motion for Sanctions, Case No. 1:15-cv-950 TDC, Document 262-1 Filed 04/09/19. Exhibit 8, at J.R.0778 (December 4, 2018, Exhibit 8 at J.R.0775 (record from Guatemala Central Registry of Detainees indicating when Clara de Paiz was taken into custody). She was later acquitted of the bribery charges. [17] Estate of Arturo Giron Alvarez, et al., v. The Johns Hopkins University, et al., Defendant’s.Motion for Discovery and Sanctions, April 9, 2019; Memorandum Opinion https://law.justia.com/cases/federal/district-courts/maryland/mddce/1:2015cv00950/312057/350/ [18] Defendant’s Opening Brief in Support of Request for Discovery and Motion for Sanctions, Case No. 1:15-cv-950 TDC, Document 262-1 Filed 04/09/19. Case 1:15-cv-00950-TDC Document 262-1. April 9, 2019, page 24 of 42. The motion for sanctions was not renewed after the case was dismissed. [19] Memorandum Opinion on Motion for Summary Judgment, Case 1:15-cv-00950-TDC Document 480, page 13 of 77. [20] Id., page 75 of 77 [21] Id., Page 76 of 77 [22] In re Estate of Alvarez v. Rockefeller Foundation, No. 22-1678, (4th Cir. 2024) March 20, 2024, Wilkinson, J., concurring at 20. [23] Id. (shrink)

Photo ID 143764115 © Chris Dorney | Dreamstime.com INTRODUCTION Since the repeal of the 18th Amendment in 1933, alcohol consumption has become prevalent among many Americans. Alcohol intoxication is an increasing contributor to emergency room visits wherein individuals present to the emergency department (ED) in an inebriated state, often with secondary injuries or severe medical co-morbidities related to alcohol poisoning. The ED is a stressful environment with providers working under taxing conditions while triaging difficult cases. Alcohol related visits contribute to (...) this added stress for staff given that intoxicated individuals increase wait times for the ED, use up valuable resources, and have the capacity to act violently towards providers. As one nurse puts it, some intoxicated individuals present with “an aggressive state, perhaps have been in a fight, blood everywhere, careening around the place – it can make things very difficult.”[1] To combat these circumstances, thirty-four States including the District of Columbia have implemented a countermeasure recognized as Alcohol Exclusion Laws (AELs). AELs reduce or cut insurance coverage of certain visits to the ED if the cause of the visit is due to alcohol intoxication.[2] The vast implementation of this law is derived from the idea of individual decision making, that it is an individual’s choice to consume alcohol, and therefore they hold a personal responsibility for their intoxication. By using insurance coverage as a leverage, the law aims at reducing the number of ED visits relating to alcohol intoxication, saving resources, and deterring irresponsible drinking. While the intention behind AELs aims for positive change, it is unethical to use AELs, a form of financial leverage, to address certain problems within emergency medicine. ANALYSIS Stigma is prominent in almost all substance abuse cases including those seen with alcohol intoxication. Many patients feel embarrassment or shame when seeking medical attention for a condition that was brought on by alcohol misuse. A personal account by Jonathan Hunt Glassman, a former alcoholic and NBC contributor, emphasizes on this negative bias. He knows firsthand how unsettling an ED visit can be. He felt demoralized from a superficial prognosis made by a nurse on his complex alcohol abuse condition, in which the nurse said, “You need to stop drinking.”[3] Whether it be from shame or insecurities about an individual’s condition, the stigma behind substance abuse cases in the emergency department and the daunting task of asking for help can turn a lot of patients away from seeking and receiving medical treatment. The implementation of Alcohol Exclusion Laws can amplify this already present stigma. A study conducted by the National Institute of Health (NIH) analyzed States that implemented and continued to enforce Alcohol Exclusion Laws and the stigma in those states surrounding alcohol-related ED visits. The result from the study showed that AELs correlated with an increase in stigmatization regarding medical attention for alcohol-related incidents, and that AELs “negatively impact people’s willingness to seek medical care after alcohol-related injuries or illnesses.”[4] Both the NIH study and the personal account by Hunt-Glassman go on to show that AELs have the adverse effect of reinforcing the stigma surrounding alcohol cases in the ED. While the idea behind AELs is in good faith, it contributes to the stigma. This contribution ethically challenges the idea that the emergency room is a space where the treatment of injuries is carried out without biases infringing on such medical care. The mission of EDs is to provide medical care to anyone in need. AELs have the effect of discouraging these patients from seeking help with the unintended consequence of doing them harm. A point of argument for the implementation of AELs is that it is the individual’s choice to be intoxicated and therefore justifiable that an individual receives less insurance coverage for medical expenses from a preventable intoxication. The idea of it being an individual choice to become intoxicated is one of the strongest supports for these exclusion laws. However, it is unjust to assume that all alcohol intoxications come by choice. Instances that disprove this assumption include both the college party scene and bar scene. Spiked drinks significantly increase alcohol concentration and can cause any responsible drinker to become intoxicated without intention or against their will. Additionally, alcoholic beverages served in various social gatherings like those in or around college campuses may not have a clear percentage of alcohol determination. Liquor containing high percentages of alcohol, such as Everclear which contains up to 190 proofs, are often masked by sweeteners and flavorings. Cocktails like these can cause a person to become dangerously intoxicated without their realization or intention. Some may argue that consuming an alcoholic beverage still holds accountability, that the person should be aware of the potential for a tampered drink, and therefore AELs should remain in use to deter this. However, like any law, AELs needs to have defined restrictions and/or exemptions. If the individual choice argument is used in favor for AELs, then how far reaching can the laws be applied? An attorney who specializes in these exclusion laws believes that AELs often offer more ambiguity than clarification when it comes to insurance policy, which leads to further ways insurance claims can be denied.[5] CONCLUSION In summary, the idea behind the use of Alcohol Exclusion Laws aims to reduce intoxication cases in the ED, however, there are drawbacks and aspects of this law that challenge the ethics of seeking medical care from the emergency department. The present stigma surrounding going to the ED for alcohol-related emergencies is already prevalent in hospitals across the country. When applying AELs, the present stigma may be magnified and further push the idea that seeking help for alcohol-related emergencies is shameful and embarrassing for patients, and therefore should be punished via financial means. Secondly, one of the main justifications for AELs is the idea that it is a deliberate intention to become intoxicated. It isn’t always the intention of individuals to get drunk when they choose to consume alcohol. There are additional factors that may play a part to exonerate a person’s accountability. It is difficult for people to recall the specifics of a situation when they become intoxicated; in some cases, accountability cannot be determined and the used of AELs can become unjustified. Overall, Alcohol Exclusion Laws try to solve the issue of alcohol incidents in a way that produces more detriment than progress. A method to combat the issue of irresponsible drinking and intoxication in the emergency room within the US should not use AELs and financial leverage as one of its forefronts. In fact, a study that based its findings obtained from the Behavioral Risk Factor Surveillance System nationwide survey that spanned twenty-four years from 1993-2017, showed no real impact on binge drinking or increased alcohol consumption.[6] Given the downsides to AELs and its proven non-significant effects, several States have already repealed their AELs. For all these reasons, it would be beneficial to find an alternate method to address alcohol related issues within healthcare. - [1] Gregory, A. (16 Jun 2014). Nurses say drunk patients should be banned from A&E as ‘waste of resources’ UK: Mirror. https://www.mirror.co.uk/news/uk-news/nurses-say-drunk-patients-should-3706280 2(Jan 2008). [2] Alcohol Exclusion Laws. National Highway Traffic Safety Administration. https://www.nhtsa.gov/sites/nhtsa.gov/files/810885.pdf. [3] Glassman, J.H. (28 Apr 2022). Why don’t alcoholics get prescribed the medication they need?. NBC. https://www.nbcnews.com/think/opinion/alcohol-related-deaths-er-visits-rose-covid-solution-use- rcna26425. [4] Azagba, S., Ebling, T., Hall, M., (2023). Health claims denial for alcohol intoxication: State laws and structural stigma. Wiley Online Library. https://onlinelibrary.wiley.com/doi/10.1111/acer.15153. [5] (7 Sep 2021). The Alcohol Exclusion Chart Denied Life Insurance Claim. https://www.lifeinsuranceattorney.com/blog/2021/september/the-alcohol-exclusion-state-chart-denied-l ife-in/. [6] Azagba, S., Shan, L., Ebling, T., Wolfson, M., Hall, M., Chaloupka, F., (26 Nov 2022). Does state repeal of alcohol exclusion laws increase problem drinking? National Institutes of Health. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10099925/. (shrink)

Photo ID 104065762 © Kiosea39 | Dreamstime.com ABSTRACT Dementia is progressive and is characterized by fluctuating cognition, which presents challenges in the assessment of decision-making capacity and, ultimately, for informed consent. The responsibility for ethical research combined with the fluctuating cognition associated with dementia necessitates using a flexible decision-making and capacity assessment process that respects the autonomy of the participant, the uneven decline associated with the disease process, and responds to the urgent need for increased participation in studies. INTRODUCTION Dementia, (...) a common neurodegenerative disorder, is a leading cause of death worldwide and is estimated to affect more than 55 million people.[1] In the United States, 1 in 9 (6.7 million) people aged 65 and older have Alzheimer’s disease—the most common type of dementia.[2] While dementia is a research priority and the National Institutes of Health funding for it exceeds $3.7 billion annually, further clinical research and research participants are needed to understand and identify new approaches to prevent, diagnose, and treat dementia.[3] A significant barrier to research is the recruitment of persons with dementia as participants, specifically because of challenges in evaluating decision-making capacity and obtaining truly informed consent.[4] Continued successful advocacy for additional dementia research requires more research at all stages of the dementia disease process[5] to better understand how and why the brain changes.[6] To reduce the physical, psychological, and financial impact on individuals and society, this research should include drug trials, medical devices, diagnostic tools, and both behavioral and lifestyle changes.[7] A potential ethical solution is the use of a supported decision-making model for persons with dementia, which would not only reduce barriers to research participation but also promote individual autonomy. BACKGROUND While dementia is progressive, it is also characterized by fluctuating cognition, which presents challenges in the assessment of decision-making capacity and, ultimately, informed consent.[8] Meaningful consent requires that the person providing it has the capacity to do so, yet these capacities may be reduced by the cognitive impairment and fluctuation associated with dementia.[9] Cognitive fluctuation means that decision-making capacity not only changes during different situations and over time but also may be time and task-specific.[10] The responsibility for ethical research combined with the fluctuating cognition associated with dementia necessitates the use of a supported decision-making and capacity assessment process that respects the autonomy of the participant, the uneven decline associated with the disease process, and responds to the urgent need for increased participation in studies. I. Research Participants and Barriers to Dementia Research Increased investment in dementia research has increased the number of treatment, prevention, and care studies and has produced an urgent need to recruit and enroll participants in studies.[11] For example, Alzheimer’s clinical trials are seeking more than 270,000 participants, with only one in ten persons screened being eligible for participation.[12] Research participation poses challenges, with the top barriers being the participant (study partner) burden and lack of awareness and resources among primary care physicians.[13] Many studies require participation by those who can provide informed consent and adhere to study procedures. Yet many caregivers of the patient, such as a spouse or family member, are reluctant to participate in studies due to extensive time commitments and unwillingness to authorize extensive screening tests that may not help the participant and may even cause discomfort or harm.[14] Furthermore, research participation may have risks of drug side effects. Additionally, physician offices may not be equipped to perform dementia-related diagnostic assessments and screening and may be unaware of opportunities for research participation.[15] Informed consent and the recruitment of persons with dementia for research is complex because of fluctuating and progressively diminishing capacity of persons with dementia.[16] The inability to make one type of decision does not mean that there is an overall lack of ability to make decisions. Persons with dementia, for instance, may not have the capacity to agree to a complex treatment program or surgery, but they may have the ability to decide to take a new medication or to get a flu shot.[17] II. Capacity Assessment and Supported Decision-making Decision-making capacity varies along a continuum and is affected by factors such as mood and motivation, yet the research review and approval processes require a categorical, binary determination about a continuous phenomenon.[18] Decision-making capacity is not always linear and includes factors such as mood, trust, and timing.[19] Informed consent and the associated assessment of decision-making capacity for research is determined by the investigator where the exposure to the potential participant over time is intermittent and limited, and where the researcher's goal is generalizable knowledge rather than treatment of the patient. This responsibility means that Therefore, while the principal investigator should have the most comprehensive knowledge about the potential risks and harms of any drugs or procedures being performed as part of the research, the principle investigator might have limited knowledge of potential participant values, preferences, and goals, and how the participant might view risks and harms.[20] Current literature demonstrates that while researchers are willing to support the decision of persons with dementia to participate or not, researchers are not equipped to assist in decision assistance and concrete decision support measures.[21] Further, decision assistance by the researcher may not be appropriate and could create a conflict of interest. Persons with dementia should participate in decision-making about research participation, although they may lack decisional capacity when it comes to other decisions, including other healthcare decisions, and they may need support in making those decisions. If they understand the risks and the responsibilities of the research study, then they should be able to decide, even if a surrogate decision-maker has been identified. Surrogate decision-makers can fail to incorporate the nuanced context related to fluctuating capacity. Clinicians, surrogates, or other legally authorized representatives are oftentimes “gatekeepers” to potential research participants and may not make a decision that reflects what the patient would want.[22] Institutional review boards provide inadequate protection from misaligned decisions by surrogates because they also lack knowledge of the participant’s current values and preferences.[23] Due to the slow, progressive nature of dementia and the need to assess decision-making capacity for medical treatments early in the disease process, the default position may be overreliance on surrogate decision-making throughout the disease process for all decisions, even when the individual has some capacity and desire to make decisions autonomously.[24] Capacity assessment is not an all-or-nothing proposition, and supported decision-making could enable persons with dementia to retain their ability to make autonomous choices.[25] Supported decision-making is a structured yet flexible process that fosters independence. As of 2024, 18 states plus the District of Columbia have passed supported decision-making laws.[26] Trusted advisors, called supporters, often selected by the individual, help the person understand, consider, and communicate decisions about areas where decision-making assistance may be needed, such as research participation.[27] Supporters, for example, would gather relevant information, including from the researcher and care provider, and provide information to the potential participants, enabling them to make their own decisions. The research participants would make decisions about when, where, and how capacity tests would be performed in addition to decisions about their medical care and research participation. Ideally, the selected test would be relevant to the risk of the intervention, decisional complexity, and consequences of the intervention and should be performed under optimal circumstances and conditions.[28] Supported decision-making helps fulfill the researcher’s obligation to assure adequate consent with a process that promotes autonomous participant decision-making rather than defaulting to a proxy or surrogate. This collaboration between supporters and research participants should enhance the participant’s understanding of the risks and benefits of the research. Working together, clinicians, researchers, research participants, and relatives can mitigate challenges such as stakeholder biases, role confusion, and paternalistic behaviors.[29] An estimated 75 percent of caregiving for a patient with dementia is provided informally by friends and family.[30] This already existing informal network provides the foundation for a more structured, supported decision-making model that recognizes the strengths and capacities of various stakeholders and trusted advisors, with an aim to promote participant autonomy. These trusted advisors should know the individual’s values and goals and should assist the potential participant to express, not construct, their decisions. Structured, supported decision-making with trusted advisors can be implemented on a case-by-case basis for individuals determined to have dynamic functional impairments. Implementation begins with the identification of the areas of assistance needed specific to the research study under consideration. Next, the persons who could serve as supporters should be identified. The individual should discuss the role with each potential supporter and any agreement should be documented.[31] Supporters are selected by the beneficiary and are usually friends, family members, or experts who know and respect the individual’s will and preferences. The role of the supporter is to provide information to the individual so that the individual can decide. For example, if the research is social or behavioral in nature, and involves physical activity or interaction with other individuals, a friend who has knowledge of the individual’s daily activities could provide guidance as to an optimal time of day for participation. If the research involves medical testing, a family member could gather and present pros and cons of the procedure to the individual. Most importantly, supporters are people who know and respect the values of the potential participant and commit to assisting the individual in making their own decision. A supported decision-making model will not only increase much-needed research participation but will also promote the autonomous decision-making of the participant. This model for research participation decision-making shifts the process from a traditional assessment of decisional capacity to a study-specific assessment that engages trusted stakeholders earlier and throughout the participation period and assesses capacity with a relevant task at an optimal time. III. Counterarguments to Supported Decision-making Despite its benefits, supported decision-making has its limits and its risks. First, while dementia is characterized by fluctuating capacity, dementia is progressive and may require other surrogate approaches to decision-making, especially in the late stages of the disease. Surrogate or proxy decision-making may be appropriate for persons who consistently lack capacity, and the appropriateness of supported decision-making for persons with fluctuating capacity must be regularly evaluated and modified as needed. Second, no systematic method for determining whether a supporter has offered non-biased or non-controlling advice to the individual or if the individual’s decision has been properly represented or communicated has been identified. These challenges are not unique to supported decision-making, however. For example, surrogates may not easily identify or prioritize the relevant values associated with a particular decision, such as quality versus quantity of life. Further, a surrogate may make decisions based on personal desire for patient survival. Frameworks for value-based decision-making have been developed to support surrogates and to manage biases.[32] These frameworks could serve as a model for trusted stakeholders to adopt as part of the supported decision-making model. Third, the processes and roles of the stakeholders remain somewhat vague. The determination of which supporter is assigned to which decision or topic can be complex and requires good collaboration and communication among supporters and researchers. Through a supported decision-making model, an opportunity exists to blend the skills, expertise, and knowledge of all parties toward the benefit of appropriate research along with an effort to reinforce, rather than override, individual autonomy. IV. Counterarguments to Encouraging Research Participation There is a growing need to include persons with dementia in research. At the same time, many people may believe that research on individuals with diminished decisional capacity can place this vulnerable population at risk of physical, social, and psychological harm.[33] Further, this research may lead to drugs for future patients rather than the research subjects, many of whom would be nearing the end of life. Research undertaken with any vulnerable population raises concerns about how human dignity is both promoted and protected. However, failure to include this population in appropriate research can also contribute to the harm of individuals by slowing the development of evidence-based interventions.[34] Representation of the interests of individuals with dementia, along with the protection of their rights, is paramount when ensuring research is ethical. Researchers, institutional review boards, and individual decision-makers must adhere to ethical research practices. Rather than posing unacceptable risks to research participants, low-risk research performed ethically could benefit patients by allowing them to contribute to solutions. While research is generally for the good of others or society, some research would increase the possibility of new treatments during the research subject’s lifetime. CONCLUSION Research to prevent, diagnose, and cure dementia remains a national priority due to both the human and societal impact of dementia as well as the direct and indirect costs associated with dementia care. Research funding toward these ends continues to increase at a rate that exceeds available participants.[35] Research participation is always a choice. Informed consent is the gold standard by which researchers protect participant autonomy and prevent coercion and biases so that the potential participant can make an informed choice. The progressive and fluctuating capacity associated with dementia poses significant and unique challenges to informed consent and associated decisional capacity assessment. A principal investigator’s determination that a research protocol is minimal risk increases the likelihood that the research can ethically proceed, yet that determination has risks and challenges. The fluctuating and, at times, impaired decisional capacity of persons with dementia makes recruiting participants difficult.[36] Different circumstances or conditions may demand different functional abilities—different tests of capacity based on risk.[37] Promoting autonomous decision-making in participants with impaired capacity does not necessarily require an alternate decision-maker but a supported decision-making structure that can adapt to the fluctuating capacity and risk of the decision. A supported decision-making model that honors professional obligations and responsibilities, and brings together researchers, clinicians, caregivers, family, and friends in response to the fluctuating capacity of the potential participant is one way to increase research participation while respecting individual autonomy. The goal is to prioritize improved, autonomous decision-making for as long as possible so that persons with diminished decisional capacity can participate in dementia research—the right research at the right time with the right participant. - [1] WHO. (2024). World Health Organization. https://www.who.int/news-room/fact-sheets/detail/dementia#:~:text=Key%20facts,nearly%2010%20million% 20new%20cases. [2] Association, A. s. (2024). Alzheimer's Association. https://www.alz.org/alzheimers-dementia/facts-figures [3] NIH. (2022). National Institutes of Health, National Institute on Aging. Department of Health and Human Services. https://www.nia.nih.gov/research/blog/2022/07/looking-forward-nihs-alzheimers-disease-and-related-de mentias-fy-2024-bypass#:~:text=For%20FY%202024%2C%20NIH%20estimates,dementias%20research%20totaling% 20%243.87%20billion. [4] Lepore, M. S., Sari B.;Wiener, Joshua M.;Gould, Elizabeth (2017). Challenges in Involving People with Dementia as Study Participants in Research on Care and Services. https://aspe.hhs.gov/reports/challenges-involving-people-dementia-study-participants-research-care-s ervices-0 [5] Cohen-Mansfield, J. (2019). Who is informed and who uninformed? Addressing the legal barriers to progress in dementia research and care. Isr J Health Policy Res, 8(1), 17. https://doi.org/10.1186/s13584-018-0279-z [6] NIA. (2020). The Urgent Need for Increased and Diverse Participation in Studies. United States Department of Health and Human Services Retrieved from https://www.nia.nih.gov/report-2019-2020-scientific-advances-prevention-treatment-and-care-dementia/ urgent-need-increased [7] Ibid. [8] Trachsel, M., Hermann, H., & Biller-Andorno, N. (2015). Cognitive fluctuations as a challenge for the assessment of decision-making capacity in patients with dementia. Am J Alzheimers Dis Other Demen, 30(4), 360-363. https://doi.org/10.1177/1533317514539377 [9] Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., & Saks, E. R. (2006). Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry, 163(8), 1323-1334. https://doi.org/10.1176/ajp.2006.163.8.1323 [10] Trachsel, M., Hermann, H., & Biller-Andorno, N. (2015). Cognitive fluctuations as a challenge for the assessment of decision-making capacity in patients with dementia. Am J Alzheimers Dis Other Demen, 30(4), 360-363. https://doi.org/10.1177/1533317514539377 [11] NIA. (2020). The Urgent Need for Increased and Diverse Participation in Studies. United States Department of Health and Human Services Retrieved from https://www.nia.nih.gov/report-2019-2020-scientific-advances-prevention-treatment-and-care-dementia/ urgent-need-increased [12] NIA. (2018). Together We Make the Difference: National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research United States Government: United States Department of Health and Human Services Retrieved from https://www.nia.nih.gov/sites/default/files/2018-10/alzheimers-disease-recruitment-strategy-final.pd f [13] Ibid. [14] Ibid. [15] Ibid. [16] Trachsel, M., Hermann, H., & Biller-Andorno, N. (2015). Cognitive fluctuations as a challenge for the assessment of decision-making capacity in patients with dementia. Am J Alzheimers Dis Other Demen, 30(4), 360-363. https://doi.org/10.1177/1533317514539377 [17] Barstow, C., Shahan, B., & Roberts, M. (2018). Evaluating Medical Decision-Making Capacity in Practice. Am Fam Physician, 98(1), 40-46. [18] Rosenstein, D. L. M., Franklin G. (2008). Research Involving Those at Risk for Impaired Decision-Making Capacity. In The Oxford Textbook of Clinical Research Ethics (pp. 437-445). Oxford University Press. [19] Ibid. [20] NIH. (2023). Office of Human Subjects Research Protections. US Government Office of Intramural Research. https://irbo.nih.gov/confluence/display/ohsrp/Researchers [21] Wied, T. S., Poth, A., Pantel, J., Oswald, F., & Haberstroh, J. (2021). How do dementia researchers view support tools for informed consent procedures of persons with dementia? Z Gerontol Geriatr, 54(7), 667-675. https://doi.org/10.1007/s00391-020-01779-2 (Wie bewerten Demenzforscher:innen Entscheidungsassistenz für die informierte Einwilligung zur Forschungsteilnahme von Menschen mit Demenz?) [22] Lepore, M. S., Sari B.;Wiener, Joshua M.;Gould, Elizabeth (2017). Challenges in Involving People with Dementia as Study Participants in Research on Care and Services. https://aspe.hhs.gov/reports/challenges-involving-people-dementia-study-participants-research-care-s ervices-0 [23] Harrison, R. R. (2023). Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives. Ethics Hum Res, 45(2), 14-25. https://doi.org/10.1002/eahr.500158 [24] Wilkins, J. M. (2018). Narrative Interest Standard: A Novel Approach to Surrogate Decision-Making for People With Dementia. Gerontologist, 58(6), 1016-1020. https://doi.org/10.1093/geront/gnx107 [25] Mezey, M., Teresi, J., Ramsey, G., Mitty, E., & Bobrowitz, T. (2000). Decision-making capacity to execute a health care proxy: development and testing of guidelines. J Am Geriatr Soc, 48(2), 179-187. https://doi.org/10.1111/j.1532-5415.2000.tb03909.x ; Representation, C. f. P. (2024). Supported Decision-Making. https://supporteddecisions.org/about-supported-decision-making/ [26] Representation, C. f. P. (2024). Supported Decision-Making. https://supporteddecisions.org/about-supported-decision-making/ [27] Ibid. [28] Lahey, T., & Elwyn, G. (2020). Sliding-Scale Shared Decision Making for Patients With Reduced Capacity. AMA J Ethics, 22(5), E358-364. https://doi.org/10.1001/amajethics.2020.358 [29] Ibid. [30] Wong, W. (2020). Economic burden of Alzheimer disease and managed care considerations. Am J Manag Care, 26(8 Suppl), S177-s183. https://doi.org/10.37765/ajmc.2020.88482 [31] Peterson, A., Karlawish, J., & Largent, E. (2021). Supported Decision Making With People at the Margins of Autonomy. Am J Bioeth, 21(11), 4-18. https://doi.org/10.1080/15265161.2020.1863507 [32] Scheunemann, L. P., Arnold, R. M., & White, D. B. (2012). The facilitated values history: helping surrogates make authentic decisions for incapacitated patients with advanced illness. Am J Respir Crit Care Med, 186(6), 480-486. https://doi.org/10.1164/rccm.201204-0710CP [33] West, E., Stuckelberger, A., Pautex, S., Staaks, J., & Gysels, M. (2017). Operationalising ethical challenges in dementia research-a systematic review of current evidence. Age Ageing, 46(4), 678-687. https://doi.org/10.1093/ageing/afw250 [34] Ibid. [35] NIA. (2018). Together We Make the Difference: National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research United States Government: United States Department of Health and Human Services Retrieved from https://www.nia.nih.gov/sites/default/files/2018-10/alzheimers-disease-recruitment-strategy-final.pd f [36] Lepore, M. S., Sari B.;Wiener, Joshua M.;Gould, Elizabeth (2017). Challenges in Involving People with Dementia as Study Participants in Research on Care and Services. https://aspe.hhs.gov/reports/challenges-involving-people-dementia-study-participants-research-care-s ervices-0 [37] Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., & Saks, E. R. (2006). Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry, 163(8), 1323-1334. https://doi.org/10.1176/ajp.2006.163.8.1323. (shrink)

Photo ID 117847165© Mohamad Faizal Ramli|Dreamstime.com INTRODUCTION In our cosmic narrative, for centuries we believed the Earth held the universe's center, a belief that shifted with evidence and transformed our understanding of our cosmic place. Correspondingly, paradigms surrounding autism have been shaped by medical assumptions that label it a condition, a disorder, or even a tragedy. Just as our understanding of celestial perceptions evolved, that Earth was not at the center of the universe, it is time for a seismic shift (...) in how we perceive and address autism. ANALYSIS Venturing into autism research, we see the prevailing medical paradigm that defines Autism Spectrum Disorder (ASD) as a developmental disability caused by neurological differences.[1] Social communication, repetitive behaviors, language, movement skills, cognitive abilities, and emotional reactions—all cast as deficits.1 This narrative, embraced by researchers, medical professionals, and society, serves as the foundation of our current understanding. Yet, delving deeper unveils a counter-narrative—one not etched by researchers but articulated by those living with autism. This narrative introduces us to the neurodiversity paradigm, a revolutionary lens that sees autism as a part of the rich tapestry of human neurological development, fostering a stable cognitive landscape.[2] It posits that there is no singular "healthy" brain; and no definitive way of neurocognitive functioning.2 Shockingly, although this perspective is more inclusive, portraying autistic people as crucial contributors to humanity, it remains the more controversial model in society. Contrasting with the classical medical view that treats autism as a disease to be eradicated, the neurodiversity paradigm challenges the notion of normalizing society and underscores the importance of recognizing autism as an advancement. Without it, we would lose invaluable perspectives, strengths in attention to detail, visual perception, creative and artistic talents, mathematical and technical abilities, and expertise in ‘niche’ areas.[3] Asserting that every form of neurological development holds equal validity, deserving of respect and human rights, the neurodiversity paradigm counters the deficit mindset perpetuated by the traditional medical view. The repercussions of our medical-centric assumptions extend beyond perception; they infiltrate the very fabric of societal structures. Autism is labeled a disability. But is it autism that disables individuals, or is it the societal environment that excludes and alienates cognitive diversity? The traditional medical model points fingers at individuals, placing the onus on the differently abled person, not the disabling environments. For example, our societal perspective on disability is largely framed by the medical model, which views disability as an individual problem. According to this model, the disability is located within the person experiencing it—within individuals like me.[4] For instance, I often find myself becoming excessively overstimulated in places like department stores. The bustling environment—loud, brightly lit, unpredictable, and crowded—is a sensory challenge. Following the medical model attributes my struggle in department stores to a perceived problem with the way my brain processes sensory inputs, attributing it to my autism. The consequences of the medical model are far-reaching and profound, particularly in shaping our understanding of autism. This perspective places undue blame on those with autism and directs the focus of research toward "curing" autism rather than addressing societal structures that contribute to exclusion and alienation. One glaring example of this misguided approach is the predominant focus of autism research on finding a cure, as seen in 2020 with a major research theme centered around gene therapies aimed at altering the genetic factors associated with autism-related conditions.[5] Even influential organizations like Autism Speaks, until 2016, subscribed to the notion of seeking a cure.[6] Their evolution, acknowledging the need to listen to the lived experiences of autistic individuals, led to a shift in their mission—from searching for a cure to promoting advocacy, support, understanding, and acceptance.6 This shift highlights the importance of moving away from the medical model. Instead, we should adopt more inclusive models like the neurodiversity or social model of disability, which are rooted in the idea that neurological differences, including autism, are natural variations of the human brain. Listening to the voices of those with autism and embracing the social model of disability allows us to recognize that disabling factors often reside in societal structures, not within the individuals themselves. This paradigm shift is crucial for fostering an inclusive society that values and accommodates cognitive diversity. For instance, when we enter the social model of disability—an alternative lens that shifts the blame from the individual to the environment, it views disability not as a characteristic but as an action done to individuals by society4. In this model, going to a department store is not a struggle for me because there is something inherently wrong with me, but it is a struggle because the environment around me does not cater to my diverse needs. Imagine if our world, including department stores, were designed with neurodiversity in mind—quiet, dimly lit, predictable, and spacious. Neurodivergent individuals would still be cognitively different, but their surroundings would not disable them. Adopting the social model of disability would catalyze shifts in research and attitudes toward autism, reflecting the transformative changes observed in the department store examples. Rather than focusing on changing autistic individuals to fit societal norms, the emphasis would shift to enhancing the lives of neurodivergent people by advocating for structural changes in society. This shift aims to foster inclusivity while preserving individuals' authenticity and embracing their unique differences. Autistic individuals are not seeking a cure for autism because our neurodivergent way of thinking is integral to our identity. Yet, the considerable funding directed toward researching autism's causes for prevention or a "cure" underscores a lack of consideration for our voices in deciding how research funds are utilized. The emphasis on normalization, a cornerstone of the medical model's view of autism, prioritizes societal desires over the well-being of autistic individuals already part of our society. It is imperative to recognize this flaw in research that aims to cure autism, as it risks genetic research for eugenic purposes, necessitating regulation by the autistic community.[7] Redirecting resources from the pursuit of an unwanted cure to research supporting and empowering autistic people to lead fulfilling lives is essential. This redirection involves investing in communication research, offering tools such as communication boards, picture exchange communication systems, speech-generating devices, or sign language for nonverbal or speech-challenged autistic individuals, giving them a voice in our society.[8] Community living research, centered on community inclusion programs, not only provides services but also educates and reinforces accommodations for daily activities such as in schools, workplaces, or even in department stores as stated in the example.[9] Attention to support services for autistic individuals and their families, including residential and day support programs, respite, recreation, and transportation, is crucial.[10] A commitment to promoting lifelong support for autistic individuals necessitates advocating for caregiver support, home and community-based services, financial planning resources, and more.10 Additionally, research aiming to identify qualitative results of adaptation and modification strategies to support inclusive education for autistic students is paramount at school and classroom levels.[11] Research to improve healthcare quality and the healthcare system for autistic individuals is also essential, as they face shorter lifespans and worse health than non-autistics.[12] All these research initiatives align with the principles of the social model of disability. However, as a society that does not follow the social model; the bulk of our understanding of autism is rooted in research driven by medical assumptions and paradigms. In 2022, the United States allocated $306 million to autism research[13]. However, a considerable portion of this research approaches autism as a problem to be solved. An examination of a comprehensive study focused on the allocation of NIH autism research funding from 2008 to 2018 reveals a striking trend. In this distribution, 49.7% of the total funds were allocated to treatment development and evaluation, which represented 53.6% of all projects.[14] This statistic underscores a predominant emphasis on genetic and biological research. However, the goal of such research is not only to understand the underlying reasons for autism so we can cure it. But this research also explores ways of prevention or management of autism through pharmacological treatment or behavioral therapies like intervention or Applied Behavioral Analysis, both of which are intervention models focused on changing the external behaviors of autistic individuals, with the goal of making an autistic person look and act non-autistic.14,[15] Contrastingly, only a minimal fraction of NIH funding—9.1%, approximately $225 million out of nearly $2.5 billion dedicated to ASD research—was channeled towards services-related research.14 This includes critical areas such as improving accessibility and quality of services in the community, characterizing understudied groups, policy development, dissemination, and implementation.14 This glaring discrepancy highlights a diminished emphasis on services research in funding decisions, revealing an imbalanced focus on biological and risk factor research, aiming to eliminate differences rather than seeking ways to integrate accommodations that allow autistic individuals to authentically express themselves within societal structures. The consequence of this skewed prioritization is evident in distressing statistics. Autism affects about 1 in 100 children worldwide, and yet 85% of college-educated adults on the autism spectrum face unemployment—twice the rate of their non-autistic peers.[16],[17] 7 out of 10 autistic individuals wrestle with mental health conditions, including anxiety, depression, ADHD, or OCD.[18] Alarmingly, the suicide rate among autistic individuals is three times higher than the general population.[19] Similarly, individuals with autism have an average life expectancy of 54 years, a staggering 16 years less than the average age of mortality for the general population.[20] And we deserve better. These disheartening realities underscore the urgent need for a paradigm shift in our approach to autism within society. It is crucial to recognize that masking autistic traits is not the optimal outcome for individuals with autism. In fact, hiding autistic traits has been linked to worse mental health outcomes and increased suicidality in autistic adults.15 Services and support systems are required to enable autistic individuals to lead long, happy, and fulfilling lives while respecting their right to be authentically autistic. Embracing neurodiversity is not only a matter of ethical consideration and benefit for autistic individuals but also cultivates progress, acceptance, and overall societal growth for all. CONCLUSION The call for change is clear—we need research initiatives led by autistic individuals, addressing the questions that matter most to the community. We need more autistic individuals in the medical profession to advocate for improvements in the medical perspective. Having only 1% of autistic individuals in the medical profession is no longer enough.[21] Just as the sun is not the center of our universe, individuals with autism are not a tragedy. They deserve a future built on understanding, inclusion, and support. - [1] “Signs and Symptoms of Autism Spectrum Disorders.” Centers for Disease Control and Prevention. Last modified, 28 Mar. 2022, www.cdc.gov/ncbddd/autism/signs.html#:~:text=Autism%20spectrum%20disorder%20(ASD)%20is,%2C%20moving% 2C%20or%20paying%20attention. [2] Robinson, John Elder. “What Is Neurodiversity?” Psychology Today, Sussex Publishers, 7 Oct. 2013, www.psychologytoday.com/us/blog/my-life-aspergers/201310/what-is-neurodiversity. [3] “Focus on Strengths as Well as Challenges.” Autistica, 17 Oct. 2019, www.autistica.org.uk/news/focus-on-strengths-and-challenges. [4] “Office of Developmental Primary Care.” Medical and Social Models of Disability | Office of Developmental Primary Care. Accessed 26 Oct. 2023, https://odpc.ucsf.edu/clinical/patient-centered-care/medical-and-social-models-of-disability. [5] “Hot Topics in Autism Research, 2020.” Spectrum, 3 Mar. 2023, www.spectrumnews.org/features/hot-topics-in-autism-research-2020/#:~:text=Gene%20scene,be%20administ ered%20early%20in%20life. [6] “Questions and Answers.” Autism Speaks. Accessed 26 Oct. 2023, www.autismspeaks.org/autism-speaks-questions-answers-facts#:~:text=It%20was%20the%20right%20decision ,research%20for%20the%20autistic%20community. [7] “Research.” Autistic Self Advocacy Network, 31 Aug. 2023, autisticadvocacy.org/research. [8] “7 Autism Behavior and Communication Strategies.” National University, 23 Sept. 2021, www.nu.edu/blog/7-autism-behavior-and-communication-strategies/#:~:text=Strategy%20%231%3A%20Using%2 0Communication%20Boards,photographs%2C%20illustrations%2C%20or%20symbols. [9] “Inclusion: Ensuring Access for Everyone.” Autism Speaks. Accessed 26 Oct. 2023, www.autismspeaks.org/tool-kit-excerpt/inclusion-ensuring-access-everyone. [10] “Support for Family Members.” Autism Speaks. Accessed 26 Oct. 2023, www.autismspeaks.org/autism-support-family-help#:~:text=People%20with%20autism%20and%20the,%2C%20rec reation%2C%20transportation%20and%20others. [11] Petersson-Bloom, Linda, and Mona Holmqvist. “Strategies in Supporting Inclusive Education for Autistic Students-A Systematic Review of Qualitative Research Results.” Autism & Developmental Language Impairments, U.S. National Library of Medicine, 21 Sept. 2022, www.ncbi.nlm.nih.gov/pmc/articles/PMC9620685/. [12] Weir, Elizabeth, et al. “Autistic Adults Have Poorer Quality Healthcare and Worse Health Based on Self-Report Data - Molecular Autism.” BioMed Central, BioMed Central, 26 May 2022, molecularautism.biomedcentral.com/articles/10.1186/s13229-022-00501-w. [13] Mikulic, Matej. “Research Funding for Autism by U.S. NIH 2011-2024.” Statista, 2 June 2023, https://www.statista.com/statistics/1237464/autism-research-funding-united-states-by-nih/#:~:text=In %20fiscal%20year%202022%2C%20research,U.S.%20dollars%20back%20in%202016. [14] Cervantes, Paige E, et al. “Trends over a Decade in NIH Funding for Autism Spectrum Disorder Services Research.” Journal of Autism and Developmental Disorders, U.S. National Library of Medicine, 10 Oct. 2020, www.ncbi.nlm.nih.gov/pmc/articles/PMC8035332/#:~:text=Funding%20for%20treatment%20development%2Feval uation,averaging%20%2410.2%20million%20per%20year. [15] For Whose Benefit? - Autistic Self Advocacy Network. Accessed 26 Oct. 2023, https://autisticadvocacy.org/wp-content/uploads/2021/12/ACWP-Ethics-of-Intervention.pdf. [16] “Data & Statistics on Autism Spectrum Disorder.” Centers for Disease Control and Prevention. 4 Apr. 2023, www.cdc.gov/ncbddd/autism/data.html. [17] Peralta, Paola. “85% of Adults on the Autism Spectrum Are Unemployed - and Hiring Practices May Be to Blame.” Employee Benefit News. 10 Aug. 2023, www.benefitnews.com/news/how-to-create-equitable-workplace-experiences-for-autistic-talent#:~:text=8 5%25%20of%20adults%20on%20the,practices%20may%20be%20to%20blame. [18] “Autism and Mental Health.” Mental Health Foundation. Accessed 26 Oct. 2023, www.mentalhealth.org.uk/explore-mental-health/a-z-topics/autism-and-mental-health#:~:text=Just%20lik e%20everyone%2C%20autistic%20people,%2Dcompulsive%20disorder%20(OCD). [19] Welch, Ashley. “Rate of Suicide 3 Times Higher for Autistic People.” Healthline, Healthline Media, 2021, www.healthline.com/health-news/rate-of-suicide-3-times-higher-for-autistic-people. [20] Elemy. “Why Do People with Autism Have a Lower Average Lifespan?” Elemy, 2021, https://elemy.wpengine.com/autism/average-lifespan. [21] “Doctors with Autism Speak out against Stigma.” Spectrum, 10 Mar. 2023, www.spectrumnews.org/news/doctors-with-autism-speak-out-against-stigma/#:~:text=The%20condition%20is %20typically%20diagnosed,worry%20they%20will%20be%20stigmatized. (shrink)

PHOTO ID 121339257© Designer491| Dreamstime.com ABSTRACT When physicians use their clinical knowledge and skills to advance the well-being of their patients, there may be apparent conflict between patient autonomy and physician beneficence. We are skeptical that today’s medical ethics education adequately fosters future physicians’ commitment to beneficence, which is both rationally defensible and fundamentally consistent with patient autonomy. We use an ethical dilemma that was presented to a group of third-year medical students to examine how ethics education might be causing (...) them to give undue deference to autonomy, thereby undermining their commitment to beneficence. INTRODUCTION The right of patients to choose which treatments they prefer is rooted in today’s social mores and taught as a principle of medical ethics as respect for autonomy. Yet, when physicians use their clinical knowledge and skills to advance the well-being of their patients, there may be a conflict between patient autonomy and physician beneficence. We are skeptical that today’s medical ethics education adequately fosters a commitment to beneficence, which is both rationally defensible and fundamentally consistent with patient autonomy. I. An Ethical Dilemma The impetus for this paper arose when students who were completing their third clinical year discussed a real-life ethical dilemma. A middle-aged man developed a pulmonary hemorrhage while on blood thinners for a recently placed coronary stent. The bleeding was felt to be reversible, but the patient needed immediate intubation or he would die. The cardiologist was told that the patient previously expressed to other physicians that he never wanted to be intubated. However, the cardiologist made the decision to intubate the patient anyway, and the patient eventually recovered.[1] Students were asked if they believed that the cardiologist had acted ethically. Their overwhelming response was, “No, the patient should have been allowed to die.” We looked into how students applied ethical reasoning to conclude that this outcome was ethically preferred. To explore how the third-year clinical experience might have formed the students’ judgment, we presented the same case to students who were just beginning their third year. Their responses were essentially uniform in recommending intubation. While there is likely more than one reasonable view in this case, we agree with the physician and the younger medical students that intubation was the ethically appropriate decision and will present an argument for it. But first, we explain the reasoning behind the more advanced medical students’ decision to choose patient autonomy at the expense of beneficence. II. Medical Ethics Education and the Priority of Autonomy Beauchamp and Childress’s Principles of Biomedical Ethics, first published in 1979 and now in its 8th edition, is a significant part of the formal ethics education in medical school.[2] Students learn an ethical decision-making approach based on respect for four ethical principles: autonomy, beneficence, nonmaleficence, and justice. While Beauchamp and Childress officially afford no prima facie superiority to any principle, the importance of respect for patient autonomy has increased through the editions of their book. For example, early editions of their book opposed the legalization of physician-assisted death compared to recent editions that defended it.[3] As another example, Beauchamp and Childress make paternalism harder to justify by adding an autonomy-protecting condition to the list of conditions for acceptable paternalism.[4] Authority, they contend, need not conflict with autonomy—provided the authority is autonomously chosen.[5] “The main requirement,” they write, “is to respect a particular patient’s or subject’s autonomous choices, whatever they may be.[6] In the principlism of Beauchamp and Childress, autonomy now seems to have a kind of default priority.[7] However, the bioethics discourse has strong counternarratives, noting some movement to elevate the role of beneficence and to respect the input of stakeholders, including the family and the healthcare team. Ethics education achieves particular relevance in the third clinical year when students become embedded in the care of patients and learn from what has been called the informal curriculum. They observe how attending physicians approach day-to-day ethical problems at the patient’s bedside. In this context, students observe the importance of informed consent for serious treatments or invasive procedures, a practice that highlights the principle of patient autonomy. In both the formal and informal curriculum, medical students observe how, in the words of Paul Wolpe, “patient autonomy has become the central and most powerful principle in ethical decision-making in American medicine.”[8] In short, students appear to learn a deference for patient autonomy. This curricular shift in favor of autonomy coincides with legal developments that protect patients’ rights and decision-making with respect to their healthcare choices. The priority of autonomy in medicine benefits patients by reflecting their choices and, in some cases, their fundamental liberty. III. The Practice of Medicine and the Commitment to Beneficence There are many critiques of the dominant place that autonomy has in biomedical ethics,[9] especially considering that autonomy seems to be biased toward individualistic, Western, and somewhat American culture-driven values.[10] In addition, many bioethical dilemmas are cast as a conflict between autonomy and beneficence. Our point is that medical students bring to their study of medicine a commitment to beneficence that seems to be suppressed by practical ethics education. We think this commitment is rationally defensible and should be nurtured. It is striking that young medical students have a pre-reflective commitment to beneficence at all. For, as we mentioned, it is not just medicine but Western culture generally that prioritizes autonomy in settling ethical dilemmas. In wanting to act for the good of others (rather than simply agreeing to what others want), physicians are already swimming somewhat against the cultural tide.[11] However, doing so makes sense, given the nature of medicine and the profession of healing. When prospective medical students are asked why they wish to become physicians, the usual answer is some variation on caring for the sick and preventing disease. It is unlikely that a reason to become a physician is to respect a patient’s autonomy. It would be easy to dismiss medical students’ commitment to beneficence as a mere intuition and contrary to a more reasoned and deliberative approach. Beauchamp and Childress seem to minimize the value of physician intuition, stating that justifications for certain procedures are “…supported by good reasons. They need not rest merely in intuition or feeling.”[12] Henry Richardson writes that “situational or perceptive intuition…leaves the reasons for decision unarticulated.”[13] We think this is a crude and rather thin way of understanding intuition. Some bioethicists have defended intuition as essential to the practice of medicine and not something opposed to reason.[14] In the case we describe, we believe the ethical justifications s for the patient’s intubation are fundamentally sound: the patient did not have a “do not intubate” order written in the chart, the emergency intubation had not been foreseen, so the patient did not have the opportunity to consent to or reject intubation; the patient had consented to the treatment for his cardiac disease so his consent for intubation could have been assumed;[15] and the consequences of respecting his autonomy did not justify allowing him to die.[16] While it is possible to have more than one reasonable view on this case, we think the case for beneficence is strong and certainly should not be dismissed out of hand. We do not deny that if a patient makes a clearly documented, well-informed decision to forgo intubation that this decision ought to be respected by the physician (even if the physician disagrees with the patient’s decision). But, in this situation, as in many others in the practice of medicine, the patient’s real wishes and preferences are not well-articulated in advance. There are many cases where a physician acts based on what she believes the patient, or the surrogate, would want, sometimes in situations that do not allow much time for reflection. An example might be resuscitation of a newborn at the borderline of viability. In their ethics education, beneficence would mean acting first to save a life. If the patient or surrogate makes an informed decision to the contrary, a beneficent physician respects that autonomous decision. In the case presented, the patient expressed gratitude to the cardiologist when extubated. But what if he had expressed anger at the physician for violating his autonomy? There are those who could argue that not only was intubation ethically wrong but that the cardiologist put himself in legal jeopardy by his actions (especially if there had been a written refusal applicable to the specific situation). In the example we use, we point out that the cardiologist may not have escaped a lawsuit if the patient had died without intubation. His family, when hearing the circumstances, may have sued for failure to act and dereliction of the cardiologist’s duty to save him. Beyond a potential legal challenge for either action or inaction, there is an overriding ethical question the cardiologist had to address: what course would be most satisfying to his conscience? Would he rather allow a patient to die for fear of recrimination, or act to save his life, regardless of the personal consequences? In the absence of real knowledge about the patient’s considered wishes, it is most reasonable to err on the side of promoting patient well-being. A physician’s commitment to beneficence is not necessarily a way of undermining a patient’s autonomy. In acting for the patient's good, physicians are also acting on what it is reasonable to believe a patient (or most patients, perhaps) would want, which is obviously connected to what a patient does want. Pellegrino and Thomasma argue that beneficence includes respect for a patient’s autonomy since “the best interests of the patient are intimately linked with their preferences.”[17] Instead of conceptualizing ethical dilemmas in medicine as conflicts between autonomy and beneficence, it is possible that medical schools could teach students that truly practicing beneficence is a way of valuing patient autonomy, especially when the patient’s wishes are not specific to the situation and are not clearly expressed. CONCLUSION It is important for students and practicing physicians to understand the principle of respect for patient autonomy in a pluralistic society that demands personal self-determination. However, the role of the physician as a beneficent healer should not be diminished by this respect for autonomy. Respecting a patient’s autonomy is grounded in and manifested by physician beneficence.[18] That is, seeking what is good for the patient can only be good if it respects their personhood and dignity. We propose that a commitment to beneficence, incipient in young medical students, should be developed over time with their other clinical reasoning skills. Such a commitment need not be sacrificed on the altar of patient autonomy. Beneficence needs greater relative moral weight with students as they proceed in their ethics education. - [1] S. Jauhar, “When Doctors Need to Lie,” New York Times, February 22, 2014, https://www.nytimes.com/2014/02/23/opinion/sunday/when-doctors-need-to-lie.html. [2] T. L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York, NY: Oxford University Press, 2019). [3] Louise A. Mitchell, “Major Changes in Principles of Biomedical Ethics,” The National Catholic Bioethics Quarterly 14, no. 3 (2014): 459–75, https://doi.org/10.5840/ncbq20141438. [4] Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York, NY: Oxford University Press, 2019), 238. [5] Beauchamp and Childress, 103. [6] Beauchamp and Childress, p. 108. [7] For other accounts that prioritize autonomy, see e.g. Allen E. Buchanan and Dan W. Brock, Deciding for Others: The Ethics of Surrogate Decision Making (Cambridge University Press, 1989), 38–39; R Gillon, “Ethics Needs Principles—Four Can Encompass the Rest—and Respect for Autonomy Should Be ‘First among Equals,’” Journal of Medical Ethics 29, no. 5 (October 2003): 307–12, https://doi.org/10.1136/jme.29.5.307. For examples of critiques of these accounts, see footnote 9. [8] P. R. Wolpe, “The Triumph of Autonomy in American Bioethics: A Sociological View,” in Bioethics and Society: Constructing the Ethical Enterprise, p. 43. [9] V. A. Entwistle et al., “Supporting Patient Autonomy: The Importance of Clinician-Patient Relationships,” Journal of General Internal Medicine 25, no. 7 (July 2010): 741–45; C. Foster, Choosing Life, Choosing Death: The Tyranny of Autonomy in Medical Ethics and Law, 1st ed. (Oxford ; Hart Publishing, 2009); O. O’Neill, Autonomy and Trust in Bioethics, The Gifford Lectures, University of Edinburgh 2001 (Cambridge, UK: Cambridge University Press, 2002). [10] P. Marshall and B. Koenig, “Accounting for Culture in a Globalized Bioethics,” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 32, no. 2 (2004): 252–66; R. Fan, “Self-Determination vs. Family-Determination: Two Incommensurable Principles of Autonomy,” Bioethics 11, no. 3–4 (1997): 309–22. [11] Arguments stressing the importance of beneficence, as ours does here, certainly approach paternalistic arguments. We set aside the complex issue of paternalism for purposes of this paper and simply note that the principle of beneficence as such does not say anything specifically about acting against the patient’s will. In the case study that focuses this paper, we do not believe the patient’s will or wishes were clearly indicated. [12] Beauchamp and Childress, Principles of Biomedical Ethics, p. 20, see note 2 above. [13] H. S. Richardson, “Specifying, Balancing, and Interpreting Bioethical Principles,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 25, no. 3 (January 1, 2000): 285–307, p. 287. [14] H. D. Braude, Intuition in Medicine a Philosophical Defense of Clinical Reasoning (Chicago ; University of Chicago Press, 2012). [15] R. Kukla, “Conscientious Autonomy: Displacing Decisions in Health Care,” The Hastings Center Report 35, no. 2 (2005): 34–44. [16] M. Schermer, The Different Faces of Autonomy: Patient Autonomy in Ethical Theory and Hospital Practice, vol. 13, Library of Ethics and Applied Philosophy (Dordrecht: Springer Netherlands, 2002). [17] E. D. Pellegrino and D. C. Thomasma, For the Patient’s Good - the Restoration of Beneficence in Health Care (New York, NY: Oxford University Press, 1988), p. 29. [18] Pellegrino and Thomasma, For the Patient’s Good. 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ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. [xx] Stefan Feuerriegel et al., “Causal Machine Learning for Predicting Treatment Outcomes,” Nature Medicine 30, no. 4 (April 2024): 958–68, https://doi.org/10.1038/s41591-024-02902-1. [xxi] Sunderland Baker et al., “Ethical Considerations in Closed Loop Deep Brain Stimulation,” Deep Brain Stimulation 3 (October 1, 2023): 8–15, https://doi.org/10.1016/j.jdbs.2023.11.001. [xxii] David Haslacher et al., “AI for Brain-Computer Interfaces,” 2024, 7, https://doi.org/10.1016/bs.dnb.2024.02.003. [xxiii] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 103–4; “Premarket Approval (PMA),” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026. [xxiv] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 104. [xxv] Burdette and Swartz, 126. [xxvi] Sean L. Metzger et al., “A High-Performance Neuroprosthesis for Speech Decoding and Avatar Control,” Nature 620, no. 7976 (August 2023): 1037–46, https://doi.org/10.1038/s41586-023-06443-4. [xxvii] Hao Fang and Yuxiao Yang, “Predictive Neuromodulation of Cingulo-Frontal Neural Dynamics in Major Depressive Disorder Using a Brain-Computer Interface System: A Simulation Study,” Frontiers in Computational Neuroscience 17 (March 6, 2023), https://doi.org/10.3389/fncom.2023.1119685; Mahsa Malekmohammadi et al., “Kinematic Adaptive Deep Brain Stimulation for Resting Tremor in Parkinson’s Disease,” Movement Disorders 31, no. 3 (2016): 426–28, https://doi.org/10.1002/mds.26482. [xxviii] Young-Hoon Nho et al., “Responsive Deep Brain Stimulation Guided by Ventral Striatal Electrophysiology of Obsession Durably Ameliorates Compulsion,” Neuron 0, no. 0 (October 20, 2023), https://doi.org/10.1016/j.neuron.2023.09.034. [xxix] Nho et al. [xxx] Nho et al.; Erik Robinson, “Brain Implant at OHSU Successfully Controls Both Seizures and OCD,” OHSU News, accessed March 3, 2024, https://news.ohsu.edu/2023/10/25/brain-implant-at-ohsu-successfully-controls-both-seizures-and-ocd. [xxxi] Awuah et al., “Bridging Minds and Machines”; Haslacher et al., “AI for Brain-Computer Interfaces.” [xxxii] Awuah et al., “Bridging Minds and Machines.” [xxxiii] Sara Green, Barbara Prainsack, and Maya Sabatello, “The Roots of (in)Equity in Precision Medicine: Gaps in the Discourse,” Personalized Medicine 21, no. 1 (January 2024): 5–9, https://doi.org/10.2217/pme-2023-0097. [xxxiv] Green, Prainsack, and Sabatello, 7. [xxxv] Robyn Bluhm and Kirstin Borgerson, “An Epistemic Argument for Research-Practice Integration in Medicine,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 43, no. 4 (July 9, 2018): 469–84, https://doi.org/10.1093/jmp/jhy009. [xxxvi] Vijay Mahant, “‘Right-to-Try’ Experimental Drugs: An Overview,” Journal of Translational Medicine 18 (June 23, 2020): 253, https://doi.org/10.1186/s12967-020-02427-4. [xxxvii] Michael S. Okun et al., “Deep Brain Stimulation in the Internal Capsule and Nucleus Accumbens Region: Responses Observed during Active and Sham Programming,” Journal of Neurology, Neurosurgery & Psychiatry 78, no. 3 (March 1, 2007): 310–14, https://doi.org/10.1136/jnnp.2006.095315. (shrink)

Photo ID 129550171© Katarzyna Bialasiewicz|Dreamstime.com INTRODUCTION One night in 2016, I fell sound asleep, then awoke to painkiller-induced, nightmarish hallucinations in the ICU. Despite being unable to identify myself or surroundings, I can clearly remember the discordant beeping of hospital monitors, acrid smell of saline wash, and taste of sickly sweet orange amoxicillin syrup. I was unaware that, the morning after I’d fallen asleep, I’d skied off an unmarked 30-foot cliff, breaking my legs, jaw, eye socket and nose, rupturing my (...) right ear canal, and shattering nearly all of my teeth. Over the years that followed, I was fortunate enough to receive care from skilled, compassionate physicians. This not only allowed me to return to ski racing, but to dream of becoming a surgeon. Having grown older and thus more aware throughout my years as a pediatric patient, I’ve developed a nuanced understanding of what treatment made me feel heard. In fact, I found the most radically varying aspect of my care to be the degree to which I was addressed as a conscious, capable individual versus an extension of my parents. This is unsurprising as the proper amount of authority lended to pediatric patients persists as highly disputed in bioethics. Over the course of this paper, several perspectives will be considered in order to evaluate the current position of the pediatric patient in medical decision-making. First, the ambiguity of maturity and reactions to pediatric autonomy will be considered through the Mature Minor Doctrine, especially important in the refusal of life-saving therapies. Next, the need for improved pain management, rooted in the misalignment of experienced and perceived pain in pediatric patients. Finally, this paper will prove, through the lenses of communitarianism and mosaic decision-making, the need for a more nuanced approach to pediatric care that structurally accounts for the patient’s voice without neglecting their place within a greater network. Therefore, there exists a great need for a more direct, balanced integration of pediatric patients’ as well as revisiting prevailing notions of where pediatric patients stand in relation to reason and experience. ANALYSIS To begin, Fleischman’s Pediatric Ethics opens with an exploration of what makes pediatric bioethics distinct.[1] Fleischman quickly runs into the most problematic of principles in the treatment of pediatric patients– autonomy. The ethical ambiguity of the degree of autonomy to offer pediatric patients and at what point in their lives is a central point of conflict. Many in favor of expanded authority point to the neurobiological similarity between young adults and late teenagers.[2] Furthermore, while parents are treated as natural decision-makers for their children, there are several cases of minors facing pressure to undergo medical treatment against their wishes.[3],[4] In response to these concerns, the Mature Minor Doctrine was created, a common law exception to the parental consent requirement. The doctrine allows a minor “to refuse or consent to medical treatment if [they possess] sufficient maturity to understand and appreciate the benefits and risks of the proposed medical treatment.”[5] The doctrine has spurred extensive and impassioned bioethical discourse, especially in relation to the refusal of life-saving therapies. In “Health Care Decisionmaking by Children'', Ross draws a clear distinction between the notion of competence, often cited in psychological justifications of the Mature Minor Doctrine, and sound judgment.[6] Her points against child liberationists can be simplified as follows: (a) children need time to develop virtues that preserve their life-time autonomy versus their present-day autonomy, (b) pediatric patients possess “limited world experience and so [their] decisions are not part of a well-conceived life plan,”[7] and (c) it serves parents and children alike for parents to make decisions in line with their view of a good life. I find all three points convincing, but each of them to be uniquely rooted in this same, critical lack of experience possessed by pediatric patients. I can attest to this. There were times where I suffered so desperately that I longed for relief by any means. I even told my mother that I was content only hearing out of one ear, willing to do anything to prevent another surgery. Now, I am fearful to imagine a world where, at my lowest, I had full autonomy. Hence, the broad aversion to expanded pediatric autonomy is largely rooted in potential misuse, especially in the possibility of a unilateral, misinformed decision in favor of death via refusal of life-sustaining therapy.[8],[9] Yet, one might argue, the desire for death has concrete rationale beyond lack of life experience— pain and suffering. As Foley describes, “The public's fear of pain and the media's portrayal that physician-assisted suicide and euthanasia are the only reliable options for pain relief… demand that health care delivery systems commit their efforts to improve pain relief at an institutional level.”[10] Indeed, the issue of insufficient pain management is all too common in pediatrics. One study comparing postoperative pain assessments surveyed 307 patients, 207 of whom were verbal. Across the board, nurses’ pain estimations produced significantly lower pain scores than parents and children, and were consistently closer to estimated pain scores of independent observers.[11] In another study, a total of 356 nurses across 22 Japanese PICUs were surveyed, and despite possessing a median of 4 years of experience, a mere 32.6% expressed confidence in their ability to accurately assess pain.[12] It is alarming and telling that even in verbal pediatric patients, pain is significantly underestimated by medical personnel, reflecting a real gap in pediatric patient-professional communication. I can, again, personally attest to this. In the children’s ward, I was offered only Tylenol for severe nerve pain in my legs that kept me awake most nights. Relatedly, the spirited debate in response to the Mature Minor Doctrine is somewhat disproportionate. Despite the suggestion of various commentators that the law broadly recognizes the doctrine or that states are trending in its direction, only eight states have adopted a mature minor exception, and even these states condition this authority greatly.[13] With this in mind, a crucial issue is illuminated– an aversion to the pediatric patient voice altogether. As Flesichman writes, “Children should be informed about the nature of their condition, the proposed treatment plan, and the expected outcome… appropriate to their developmental levels.”[14] Hence, it is vital to curtail pediatric autonomy in complex and life-threatening choices, but it is worth seriously considering that the current landscape might excessively minimize or avoid pediatric patients’ expression, merely serving to inform them rather than account for their voice. The experience that pediatric patients do possess, in the form of knowing their body, past medical experiences, and thus present pain-related needs, is systemically underrepresented. This is a pressing issue. Before considering expansion of the pediatric voice, though, it is first important to consider the manner in which the patient’s capacity is further complicated by their role within a larger community. It is worthwhile explicitly mentioning communitarianism, a prevailing school of thought in modern bioethics, defined by Callahan as “a way of… assum[ing] that human beings are social animals… and whose lives are lived out within deeply penetrating social, political, and cultural institutions and practices.”[15] Pediatric patients present a uniquely communitarian case as the perspectives of parents and the needs of patients’ families are vital considerations in offering care. The pediatric patient’s role in a larger family unit and community should be kept in focus so long as the well-being of the patient isn’t compromised, such as in potentially life-threatening religious preferences, as the obligation of the physician is, first and foremost, to the patient. Nonetheless, the status quo demands a more thoughtful and structural accounting of the pediatric voice to ensure that they feel heard and empowered in complex decision-making and regular care alike. Hence, it is necessary to develop and evaluate clinical models and frameworks that directly account for the pediatric voice, that integrate pediatric patients’ input as continuous, regular, and required elements of treatment. For instance, there may be promise in a model similar to that of mosaic decision-making, a means of restoring the capacity of reemergent patients following brain injury. Rather than enabling complete surrogate authority, the model would enable a pediatric patient’s emergent voice to be accommodated but to not “speak beyond its range and capabilities” via group deliberation between surrogate and patient, a medical professional, and a patient advocate.[16] Opting for such a model would enable the active involvement of pediatric input without excessively empowering the patient in a manner that neglects their communitarian role and lack of experience. CONCLUSION In the heated response to the largely unenforced mature minor doctrine, one finds the invaluable and lacking factor of experience in pediatric patients, especially in decisions to withdraw or refuse life-sustaining medical treatments. In this same response, however, one finds a sharp aversion to the pediatric voice, reflected in pervasive under-medication. Deficits in pain management must be addressed to more effectively treat discomfort, an effort bolstered by a more structural accounting of the pediatric voice and thus pain-related needs. Finally, frameworks that regularly involve the pediatric patient perspective while valuing their communitarian importance and lacking experience, such as the mosaic model, hold real promise moving forward. - [1] Fleischman, Alan. Pediatric Ethics: Protecting the Interests of Children. (Oxford: Oxford University Press, September, 2016), p. 1-16. [2] Coleman, Doriane & Rosoff, Philip. “The Legal Authority of Mature Minors to Consent to General Medical Treatment.” (Itasca: American Journal of Pediatrics, March 2013), p. 1. [3] Hawkins, Susan. “Protecting the Rights and Interests of Competent Minors in Litigated Medical Treatment Disputes.” (New York: Fordham Law Review, March 1996), p. 1. [4] Derish, Melinda & Heuvel, Kathleen. “Mature Minors Should Have the Right to Refuse Life-Sustaining Medical Treatment.” (Boston: The Journal of Law, Medicine & Ethics, January 2021), p. 1-14. [5] Derish, Melinda & Heuvel, Kathleen. “Mature Minors Should Have the Right to Refuse Life-Sustaining Medical Treatment.” p. 7. [6] Ross, Lainie. “Health Care Decisionmaking by Children. Is It in Their Best Interest?” (Garrison: The Hastings Center Report, November-December 1997), p. 1-5. [7] Ross. “Health Care Decisionmaking by Children''. p. 5. [8] Penkower, Jessica. “The Potential Right of Chronically Ill Adolescents to Refuse Life-Saving Medical Treatment - Fatal Misuse of the Mature Minor Doctrine.” (Chicago: DePaul Law Review, 1996), p. 1-8. [9] Burk, Josh. “Mature Minors, Medical Choice, and the Constitutional Right to Martyrdom.” (Charlottesville: Virginia Law Review, September 2016), p. 1-15. [10] Foley, Kathleen. “Pain Relief Into Practice: Rhetoric Without Reform.” (Alexandria: Journal of Clinical Oncology, 1995), p. 1-3 [11] Hla et. al. “Perception of Pediatric Pain: A Comparison of Postoperative Pain Assessments Between Child, Parent, Nurse, and Independent Observer.” (Melbourne: Pediatric Anesthesia. 2014) p. 1-5. [12] Tsuboi et. al. “Nurses' perception of pediatric pain and pain assessment in the Japanese PICU.” (Tokyo: Pediatrics International, February 2023), p. 1-3, 10-12. [13] Coleman, Doriane & Rosoff, Philip. “The Legal Authority of Mature Minors”. p. 1-3. [14] Fleischman, Alan. Pediatric Ethics. p. 115. [15] Callahan, Daniel. “Principlism and communitarianism.” (Garrison: The Hastings Center Report, October 2003), p. 2. [16] Fins, Joseph. “Mosaic Decisionmaking and Reemergent Agency after Severe Brain Injury”. (Cambridge: Cambridge University Press, September 2017), p. 6. (shrink)