Voices in Bioethics

Battlefield Triage

Christopher Bobier, Daniel Hurst — Thu, 19 Sep 2024 00:00:00 +0000

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

End-of-Life Decisions for Isolated Patients Under New York's Family Health Care Decisions Act

Robert N. Swidler — Thu, 19 Sep 2024 00:00:00 +0000

Photo ID 6232629 © Mykola Velychko | Dreamstime.com

ABSTRACT

The most challenging end-of-life cases involve patients who lack capacity and have no surrogate decision-makers. New York's Family Health Care Decisions Act provides alternative criteria for withdrawing or withholding treatment in such cases, including the requirement that the patient "will die imminently, even if the treatment is provided." This article clarifies the interpretation of "imminent" and offers recommendations to improve end-of-life policies, including greater reliance on Ethics Review Committees (ERCs).

INTRODUCTION

Probably the most distressing end-of-life cases involve patients who lack capacity and who are socially isolated – that is, who do not have a health care agent, family member, or friend who knows them, cares about them, and will make decisions for them.^[1] Health care professionals caring for these socially isolated patients struggle with exceedingly difficult professional, ethical, and legal issues.^[2] Several states have enacted laws with standards and procedures for such decisions.^[3] In New York, the Family Health Care Decisions Act (FHCDA) governs end-of-life decisions for most socially isolated patients.^[4] This article examines the provisions for socially isolated patients in the FHCDA. While the FHCDA is just one state’s statute, the clinical, ethical, policy, and even interpretive issues addressed here will be instructive to health care professionals and policymakers in other states as well.

Special attention is given to the FHCDA provision that requires, as a basis for withdrawing or withholding treatment from socially isolated patients, a finding that the patient “will die imminently, even if the treatment is provided.”^[5] That critical phrase is a source of uncertainty, both with respect to time period that qualifies as “imminently” and to the application of the phrase to DNR orders.^[6]A clear, uniform understanding of the “will die imminently clause” will reduce both undertreatment and overtreatment of socially isolated patients at the end of life.

But an additional policy change is needed. This article recommends that, once standards for ethics review committees are strengthened, the FHCDA should be amended to allow the attending physician to decide to withhold or withdraw life-sustaining treatment for a socially isolated patient based on the standards that now apply to surrogate decisions, subject to approval by an ethics review committee. The FHCDA already allows decisions on this basis for socially isolated patients in hospice;^[7] the approach should be broadened.

I. The Family Health Care Decisions Act

The FHCDA governs decisions for patients in hospitals, nursing homes, and hospices who lack capacity and who did not, prior to losing capacity, make the decision personally or appoint a health care agent.^[8] The statute governs consent to treatment and decisions to withdraw or withhold life-sustaining treatment.

In general, the FHCDA provides for the designation of a surrogate decisionmaker from a priority list. The highest priority category on that list is a court-appointed guardian when there is one. After that, the list proceeds through levels of close relatives and ends with the category “close friend.”^[9]

a. A Surrogate Decision to Withdraw or Withhold Life-Sustaining Treatment

Under the FHCDA, a surrogate may decide to withhold or withdraw life-sustaining treatment from the adult patient who lacks decision-making capacity based on the patient’s wishes, if known or ascertainable through reasonable efforts or when the patient’s wishes are unknown and not reasonably ascertainable, on best interests. Whether the patient’s wishes or the best interest standard is applied, certain clinical ethical standards must be met. For example, either:

(i) treatment would be an extraordinary burden to the patient and the patient has an illness or injury which can be expected to cause death within six months, whether or not treatment is provided; or the patient is permanently unconscious; or

(ii) the provision of treatment would involve such pain, suffering, or other burden that it would reasonably be deemed inhumane or extraordinarily burdensome under the circumstances, and the patient has an irreversible or incurable condition.[10]

This standard, referred to in this article as the “surrogate decision-making standard,” does not require a finding that the patient is imminently dying.

b. FHCDA Provisions Regarding Socially Isolated Patients

FHCDA section 2994-g governs decisions for most incapable adult patients without surrogates. Subsections 5 and 5-a establish the three alternative bases for ordering the withdrawal or withholding of life-sustaining treatment for socially isolated adult patients. As explained further below, life-sustaining treatment can be withdrawn or withheld from a socially isolated patient based on:

1) judicial approval;

2) the "will die imminently" test; or

3) decisions regarding hospice care

c. Judicial Approval

First, the FHCDA allows treatment to be withdrawn or withheld from a socially isolated patient if a court finds that the decision meets the surrogate decision-making standard (terminally ill, permanently unconscious, or extraordinary burden).^[11] Prior to the FHCDA, a court had no such authority; it could approve the decision only if it found “clear and convincing evidence” of the patient’s “firm and settled commitment” to forgo treatment under the circumstances.^[12]

d. The “Will Die Imminently” Test

Second, treatment can be withdrawn or withheld from the socially isolated patient where:

The attending practitioner, with independent concurrence of a second practitioner, determines to a reasonable degree of medical certainty that:

(i) life-sustaining treatment offers the patient no medical benefit because the patient will die imminently, even if the treatment is provided; and

(ii) the provision of life-sustaining treatment would violate accepted medical standards.[13]

As noted previously, there is uncertainty among clinicians and others regarding the meaning of “will die imminently”^[14] — what does it mean and how long a time period is “imminently”? Or to use a legal lens: how would the phrase “will die imminently” be construed in an administrative or judicial legal proceeding?

As explained below, the phrase “imminently” clearly includes a period of hours or a few days, probably includes a week and perhaps two weeks, but probably does not include a month or more.

Administrative and judicial definition. There is no NYS Department of Health regulation or guidance that further defines the phrase “will die imminently.”^[15] Such state agency regulation or guidance would have been entitled to considerable deference if a court found that the interpretation required specialized knowledge or expertise.^[16]

Moreover, no published judicial opinion interprets the meaning of “will die imminently” in the FHCDA, so there is no binding precedent.

The words “imminent” and “imminently” appear in several other New York state statutes. For example, under New York Mental Hygiene Law, confidential mental health information can be disclosed to an endangered individual based on the practitioner’s determination that the patient presents “a serious and imminent danger” to the endangered individual.^[17] The Family Court Act defines “neglected child” to mean a child “in imminent danger of becoming impaired....”^[18] Several courts have interpreted those words for the purpose of those other statutes. In a child neglect case, the NYS Court of Appeals explained that “’ imminent danger’” must be “near or impending, not merely possible.”^[19] However, the interpretation of “imminent” for the purpose of statutes other than the FHCDA is not dispositive of its meaning in the FHCDA.

The phrase "imminent death" is also used in Georgia and Vermont laws as a basis for a DNR order.^[20] But the phrase is not defined in those statutes either.

Principles of statutory construction. In the absence of administrative guidance or judicial precedent, a court would define “will die imminently” by using familiar principles of statutory construction.^[21] Initially it would look to the plain, customary meaning of the words as well as the statutory context. If the court needed further guidance, it would consider the legislative history and then possibly professional or scholarly interpretations. A court would be mindful of policy implications, but it could not twist the plain meaning of the words to achieve policy ends.

Plain meaning. Courts typically start with dictionary definitions “as guideposts to determine a word’s ordinary and commonly understood meaning.”^[22] Webster’s International Dictionary, Third Edition (1993) defines “imminent” to mean “Ready to take place; near at hand; impending; hanging threateningly over one’s head; menacingly near.”^[23] The Oxford English Dictionary defines “imminent” to mean “Of an event (almost always of evil or danger): Impending threateningly, hanging over one's head ready to befall or overtake one close at hand in its incidence coming on shortly.”^[24] Merriam-Webster, a commonly used online reference, defines “imminent” as “ready to take place: happening soon.”^[25]

Not surprisingly, none of these definitions specify a time period; the term is intentionally imprecise. It is a qualitative, not quantitative, concept. But it unmistakably means “soon.”

Statutory context. Courts will also construe a statute as a whole and consider sections together with reference to each other.^[26] In this instance, the statutory context is revealing: one of the other bases in the FHCDA for a surrogate decision to forgo life-sustaining treatment is that “the patient has an illness or injury which can be expected to cause death within six months....”^[27] Accordingly, “imminently” must mean something sooner than “within six months.” The Legislature would not have used different phrases for the same time period. Put differently, if the Legislature meant “within six months,” it knew how to say it. It used “imminently” to mean something sooner.^[28]

Legislative history. The legislative history of the phrase “will die imminently” is the most revealing guide to its meaning. The FHCDA was based on the 1992 report and recommendations of the New York State Task Force on Life and the Law, When Others Must Choose – Deciding for Patients Who Lack Capacity.^[29] The Task Force recommended two bases for a decision to forgo treatment for socially isolated patient:

1.) A decision by the attending physician to withhold or withdraw life-sustaining treatment, based on the standard that would apply to a surrogate, subject to ethics review committee approval; or

2. ) “health care without benefit” defined as follows:

a.) An attending physician determines, in accordance with accepted medical standards and to a reasonable degree of medical certainty, that the patient will die within a short time period despite the provision of treatment and that treatment should be withdrawn or withheld; and

b.) one other physician selected by the hospital concurs in this determination.^[30]

The Task Force’s proposed clause in paragraph (2), “will die within a short time period,” is the direct forerunner to PHL 2994-g’s “will die imminently” clause. Moreover, as discussed below, the Task Force regarded “a short time period” and “imminently” as having the same meaning.

The Task Force report devotes a full chapter to “Deciding for Adults Without Surrogates,” with a section on “Treatment Without Medical Benefit.” Its discussion in that chapter in support of the “will die within a short period” standard uses all of these phrases for the same concept:

“during the final days and hours of the dying process”
“the final days of their dying process”
“at the end stage of their dying process”
“will die within a short period even if treatment is provided”
“patients who are imminently dying”

Ultimately, the NYS Legislature deleted the first option of allowing a decision for a socially isolated patient based on the surrogate decision-making standard subject to ethics review committee review proposed by the Task Force. Further below, this article recommends revisiting that option.

More to the point for present purposes, the Legislature modified the Task Force proposed phrase “will die within a short time period” to “will die imminently.” But neither phrase is quantifiable and, as noted above, the Task Force used them interchangeably.

This article cannot provide an authoritative definition of the precise time period conveyed by the phrase “will die imminently.” That would need to come from a court, the legislature or a state agency. But in the absence of such definition, principles of statutory construction indicate that “imminently” clearly includes a time period of hours or a few days, probably includes a week and perhaps two weeks, but probably does not include a month or more.

This conclusion may seem unremarkable. But it may help counter interpretations at opposite ends of the spectrum. If “imminently” is read to mean that the patient must be expected to die within minutes or hours for treatment to be withheld or withdrawn, clinicians may feel compelled to provide highly aggressive treatment to the dying socially isolated patient that most would regard as extraordinarily burdensome in light of minimal benefit. On the other hand, if “imminently” is read to mean that the patient will probably die sometime in the next few months but not the next few weeks, a decision to withhold or withdraw treatment from the socially isolated seems to involve more of a value judgment than a medical judgment.

e. DNR Orders

Applying the term “will die imminently” to DNR orders raises special issues. As explained below, the phrase, as applied to a DNR order means that a DNR order can be written based on a finding that in the event of cardiac arrest, the patient will die imminently even if the treatment is provided. The phrase does not require a finding that the patient is imminently dying at the time the DNR order is written.

A do-not-resuscitate (DNR) order directs the medical staff not to attempt cardiopulmonary resuscitation if and when, at some point in the future, the patient goes into cardiac arrest. New York’s former DNR law, in effect from 1988 to 2010, created a process and standards for securing surrogate consent to a DNR order.^[31] For socially isolated patients, it provided that a DNR order could be entered based on an attending physician and concurring physician determination that resuscitation would be “medically futile.” Per the former statute, “medically futile” means that “cardiopulmonary resuscitation will be unsuccessful in restoring cardiac and respiratory function or that the patient will experience repeated arrest in a short time period before death occurs.”^[32]

Significantly, the standard to enter a DNR order for socially isolated patient did not require a finding about the patient’s condition or life-expectancy at the time of writing the order; it just required a finding about whether, in the event of a future cardiac arrest, resuscitation would work.

The FHCDA was developed to extend the DNR Law to a broader range of life-sustaining treatments.^[33] The Task Force and legislature, in proposing the FHCDA, adopted or adapted DNR Law provisions on, among other topics, determining incapacity, a surrogate priority list, clinical predicates to support a surrogate decision to forgo life-sustaining treatment, the patient‘s wishes or best interest standard, and the use of an ethics committee.

With respect to socially isolated patients, the FHCDA could not simply reproduce the DNR Law’s provision on medical futility because the DNR Law provision was treatment-specific: it referred only to the effectiveness of cardiopulmonary resuscitation. The FHCDA needed to extend the DNR concept of medical futility to encompass decisions about ventilators, feeding tubes, dialysis, antibiotics, and more. Accordingly, the DNR provision on the futility of resuscitation, extended to other treatments, became in the Task Force’s proposal a finding “that the patient will die within a short time period despite the provision of treatment.” In the final FHCDA, that phrase was changed to a finding that “the patient will die imminently, even if the treatment is provided.”

That background illuminates the meaning of the FHCDA term “will die imminently” as applied to a DNR order: It means that a DNR order can be written for a socially isolated patient based on a finding that in the event of cardiac arrest, the patient will die imminently, even if the treatment is provided.

The language of the provision supports the above conclusion. “Will die imminently even if the treatment is provided” ties the phrase “will die imminently” to the time the treatment, resuscitation (when the patient has a cardiac arrest), is provided.

Consider a socially isolated patient dying from cancer that has metastasized. The attending practitioner considering a DNR order may not be able to state with certainty that the patient “will die imminently.” But the physician may well be able to say with certainty that when the disease finally causes the patient’s heart to stop, the patient “will die imminently, even if the treatment is provided.”

This is the standard that was in effect under the DNR Law from 1988 to 2010. Neither the Task Force nor the NYS Legislature intended to disturb that standard in proposing and enacting the FHCDA. As others have noted, “Although the law now uses different words, there are few, if any, cases in this ... category where a DNR order legally could have been issued before FHCDA but could not be issued under FHCDA.”^[34]

A NYS Bar Association website, “The Family Health Care Decisions Act Resource Center,” endorses this view.^[35] It includes an FAQ that states as follows:

Health Care Decisions for Adult Patients Without Surrogates. N.Y. PHL § 2994-g

Q – Under the former DNR law, a DNR order could be entered for an incapable patient who did not have a surrogate if the physician and a concurring physician determined that resuscitation would be “medically futile” (if CPR would “be unsuccessful in restoring cardiac and respiratory function or that the patient will experience repeated arrest in a short time period before death occurs”). Can a practitioner still do that?

A – The language of the standard has changed, but it still ordinarily supports the entry of a DNR order if resuscitation would be “medically futile” as defined above. Under the FHCDA, the practitioner and a concurring practitioner would need to determine that (i) attempted resuscitation (in the event of arrest) would offer the patient no medical benefit because the patient will die imminently, even if the treatment is provided; and (ii) the attempt would violate accepted medical standards.

This NYS Bar Association FAQ, while not an authoritative source of law, was written, reviewed and approved by a broad range of experienced health lawyers and provides strong support for a facility or practitioner that follows this approach.

Moreover, an article by clinicians and bioethicists at the New York City Health + Hospitals, including bioethicist Nancy Dubler, adopted this position as well:

"Life-sustaining treatment decisions should be seen as situation-specific, as they depend on the treatment in question and on the medical condition and prognosis of the individual at the time the adverse event occurs, such as cardiopulmonary arrest. Based upon the dismal CPR survival data for nursing home residents with dementia, in the event of cardiac arrest, CPR likely will result in imminent death."^[36]

The DNR laws in other states specify this temporal concept. For instance, a provision in Vermont’s DNR law allows a physician to write a DNR order for any patient (not just isolated patients) upon a certification “that resuscitation would not prevent the imminent death of the patient, should the patient experience cardiopulmonary arrest. . . .”^[37]

It would seem that the same conclusion can be reached for a do-not-intubate (DNI) order, a nursing home do-not-hospitalize order, or any other order that directs the withholding or withdrawal or life-sustaining treatment in the event of a future clinical contingency. Such orders are distinguishable from noncontingent orders meant to be carried out immediately, such as discontinuing a ventilator or feeding tube. But these treatments may raise different clinical and ethical issues. In any case, the clearest case, based on words and history, relates to DNR orders.

To be sure, it would have been preferable if the drafters of the FHCDA specified, as Vermont did, that for the purpose of a DNR order, the test is whether, in the event of cardiac arrest, the patient will die imminently, even if the treatment is provided. And it would be helpful if policymakers clarified this point now.^[38] Legislative bills to accomplish this have been introduced repeatedly.^[39] The state Department of Health could also accomplish such clarification by a “Dear CEO/Administrator Letter,”^[40] or by revising the MOLST checklist for adults without surrogates.^[41] Such clarification would help decrease uncertainty and misunderstanding among health care professionals and their advisers and allow DNR decisions for socially isolated patients based on longstanding, ethically sound principles.

But even without an official pronouncement, the words and history of the “will die imminently” provision make clear what was meant.

As an aside, advances in resuscitative techniques, such as the increased deployment of Extracorporeal Membrane Oxygenation (ECMO), are increasing the duration of patient survival after resuscitation.^[42] ECMO raises complex medical and ethical issues regarding, among other matters, whether a patient is a candidate for the procedure,^[43] when to discontinue ECMO after it has commenced, and what a DNR order means as applied to a patient on ECMO.^[44] These fraught issues are beyond the scope of this article. In any case, if and when ECMO becomes a standard of care response to an inpatient cardiac arrest, the FHCDA test for a “do not ECMO order” for a socially isolated patient would seem to be whether, in the event of cardiac arrest, the patient will die imminently even if ECMO is provided. This could lead to a different result than applying the standard to a non-ECMO resuscitation. But this rote application of the FHCDA test would not take into account the exceptionally scarce availability of ECMO equipment and staff, which compels distributive justice considerations, specifically resource allocation, well beyond those raised by CPR. It makes the treatment akin in many ways to decisions about scarce transplantable solid organs, or ventilators in a pandemic. So, there is an ethical argument for devoting ECMO to patients who have a prospect of post-ECMO life. Again, these are issues beyond the scope of this article.

f. Decisions Regarding Hospice Care

A 2015 amendment to the FHCDA added a third FHCDA basis for withdrawing or withholding treatment from a socially isolated patient.^[45] It authorizes the attending practitioner to make “decisions regarding hospice care” for the patient, subject to several oversight requirements.^[46] The decision must be made in consultation with staff directly responsible for the patient’s care, with the concurrence of another practitioner, and – significantly — with the review and approval of an ethics review committee.^[47]

The FHCDA defines “decisions regarding hospice care” to mean “the decision to enroll or disenroll in hospice, and consent to the hospice plan of care and modifications to that plan.”^[48] The reference to “plan of care” signifies that the attending is not simply making the hospice enrollment decision, but the treatment plan as well. The provision requires the practitioner to base his or her decisions regarding hospice care for the socially isolated patient on the principles that would apply to surrogate decisions, including the surrogate decision-making standard for end-of-life decisions.^[49] That standard does not require a finding that the patient “will die imminently.”

Data is not available to the extent to which New York hospitals, nursing homes, and practitioners are invoking or even aware of this hospice-related provision as a basis for decisions for socially isolated patients. But by referring to the surrogate decision-making standard, as opposed to the “will die imminently” standard, the provision gives the practitioner and ethics committee a role akin to that of a joint surrogate for the hospice-eligible socially isolated patient. In fact, it approximates the Task Force’s original proposal, which would have allowed the withdrawal or withholding of life-sustaining treatment from an isolated patient based: a decision by the attending physician applying the standard that would apply to a surrogate, subject to ethics review committee approval.^[50]

II. Policy Recommendation

This paper proposes to strengthen ethics review committee standards, then allow the attending practitioner to make end-of-life decisions for a socially isolated patient based on the surrogate decision-making standard, subject to ethics review committee approval.

Clarifying the “will die imminently standard” will improve the quality of care for dying socially isolated patients. But will not remedy another gap – the need to allow carefully considered end-of-life decisions for socially isolated patients who are not expected to die imminently, but who meet the criteria described in the surrogate decision-making standard (a decision based on the patient’s wishes or, if those are not reasonably known, the patient’s best interests and, summarized, a finding that the patient is terminally ill or permanently unconscious, or the proposed treatment would impose an extraordinary burden on the patient).^[51]

The Task Force’s original 1992 proposal would have addressed this gap by allowing a decision by the attending physician to withhold or withdraw life-sustaining treatment for an isolated patient based on the surrogate decision-making standard, subject to ethics review committee approval.^[52] This option would allow for humane, patient-centered, comfort care-oriented end-of-life decisions for socially isolated patients in cases that are not in the “will die imminently” category.

Moreover, this option dovetails well with the “will die imminently” option: The physician/ERC option addresses cases that include prominent ethical or nonmedical questions. For example, what are this socially isolated patient’s wishes or best interests? What are the benefits and burdens of the treatment? These questions make it necessary and appropriate to convene an ERC to review and possibly approve a decision. In contrast, the “will die imminently” basis is primarily a medical question (will the treatment work?). An ERC has no apparent role in that determination unless there is a dispute.^[53]

Indeed, allowing the physician/ERC option may reduce concerns about the meaning of “will die imminently” and the reliability of a prognosis that the patient will die imminently. If the attending practitioner is uncertain about whether the patient “will die imminently” but believes comfort care is appropriate for the patient, she or he would be able to refer the recommended course of treatment to the ERC.

Reliance on institutional ethics committee approval for end-of-life decisions for isolated patients is a hardly novel idea.^[54] The FHCDA itself already relies upon an ERC to approve the practitioner’s decision about hospice, including a hospice plan of care.^[55] It also makes three other types of end-of-life decisions that are subject to ERC approval.^[56] Moreover, some New York hospitals or nursing homes require ERC approval for end-of-life decisions even when applying the “will die imminently” standard.^[57]

Elsewhere, some state’s laws recognize a role for ethics committees in decisions for socially isolated patients (Alabama, Arkansas, Georgia, and Tennessee place ethics committees into the priority list of default surrogates) and in other states, hospitals rely upon ethics committees for such decisions without statutory authority.^[58]

There is a strong case in New York for allowing end-of-life decisions for socially isolated patients who do not meet the “imminently dying” criteria based on a practitioner applying the FHCDA’s surrogate decision-making standard, subject to ERC approval.

III. Criticism of Reliance on Ethics Review Committees

This proposal will encounter serious substantive criticisms, particularly regarding the role of the ERC.^[59]

The foremost criticism is a concern that, in some cases, the attending physician and ERC may make decisions that undervalue the life of the socially isolated patient who is severely and irreversibly ill but not imminently dying. That risk is even greater for socially isolated patients who face health system discrimination for other reasons: people with physical, mental, or developmental disabilities, poor patients, minority patients, patients with substance abuse-related conditions, prisoners, and very elderly patients.

That concern is very real. But the remedy should not be to compel aggressive treatment in all such cases; that approach fails to consider the particulars of each case and can also cause terrible harm to socially isolated patients. The option of involving a court—apart from the delay and expense—does not really address the concern: it transfers decision-making to a judge who is apt to be inexperienced in these matters and may exhibit the same bias.

One argument for referring such cases to courts is that courts, unlike ERCs, will apply procedural due process in reaching a decision.^[60] Typical due process elements are written notice, hearing, legal representation, right to present evidence, rules about the admissibility of evidence, an impartial decisionmaker, written decision, or appeal rights. But these principles are designed to ensure fairness in adversarial procedures. There is a strong case to apply them when the ERC hears and is empowered to resolve a dispute. However, the ERC role envisioned here does not involve dispute resolution. It involves reviewing a decision made on behalf of a socially isolated, incapable, non-objecting patient, based on the patient’s wishes, if known, or else the patient’s best interests. This is a part-medical and part-ethical inquiry. It is emphatically not an adversarial procedure seeking to deprive the patient of rights.

To be sure, procedural due process is intended to achieve fairness and thoroughness, and some elements of due process would enhance any formal review, including an ERC review. Moreover, if any person connected with the case brings an action to challenge or block an ERC decision, far more processes will be due. The full panoply of judicial-type due process elements should not be grafted onto a physician and ERC’s non-adversarial review of a decision on behalf of the socially isolated patient.

There is another persuasive argument for caution: FHCDA ethics review committees have existed in New York since 2010, yet there is little to no information on how well they work in their statutory role. Who is on them? Do they have significant conflicts of interest? What are their credentials? Do they have training in the legal and ethical principles they should follow? How do they collect information about patient wishes and values? Particularly little is known about their current role in approving end-of-life decisions for socially isolated patients in hospice.

Researchers at Massachusetts General Hospital conducted a retrospective cohort study of ethics committee consultations involving decision-making about life-sustaining treatment for socially isolated patients from 2007 to 2013.^[61] They recommended caution before endorsing ethics committees as final decision maker for socially isolated patients.

Another prominent study surveyed hospitals regarding ethics consultants and ethics consulting.^[62] It does not address the role of the ethics committee in making decisions for socially isolated patients. However, some of its inquiries would also be relevant to ethics committees with decision-making authority, including: Is their financial support adequate? How do they gather information? What records do they keep? How are they evaluated?

Before expanding the role of ERCs to include end-of-life decisions for socially isolated patients, there is a need for further study. (As of this writing, the Empire State Bioethics Consortium^[63] is undertaking just such study.) Depending in part on the findings of a study, consideration must also be given to improving the ERC structure and practices. For instance, hospitals and ERCs could be encouraged, or even required, to follow model policies regarding:

Addressing conflicts of interest;
Addressing bias against patient subpopulations;
Training in relevant principles of medical ethics and law;
Procedural steps to follow in end-of-life decision cases, including steps to ascertain patient wishes; Institutional retrospective review of ERC decisions in end-of-life cases (e.g., by the hospital quality assurance committee or other body);
Data collection, subject to QA confidentiality and privilege protections.

In short, ERCs need to adopt some of the formalities that apply to institutional review boards.^[64]

With additional rules and safeguards, and with increased professionalism of ERCS, end-of-life decisions for socially isolated patients could be based on a physician applying the surrogate decision-making standard, subject to ERC approval.

Additional rules and safeguards, informed by data from studies, will enhance the professionalism of ERCs and the quality of their decision-making. After that step, the FHCDA should be amended to add a fourth basis for an end-of-life socially isolated patient: a decision by the attending physician based on the surrogate decision-making standard, subject to ERC approval. This would allow for patient-centered end-of-life care for the socially isolated patient.

CONCLUSION

New York’s Family Health Care Decisions Act authorizes the withdrawal or withholding of life-sustaining treatment from an incapable, socially isolated patient, among other instances, if the attending practitioner finds that the patient "will die imminently, even if treatment is provided.” That phrase is a source of uncertainty, both with respect to time period that qualifies as “imminent” and to the application of the phrase to DNR orders. This study of the phrase, particularly the legislative history of the phrase, indicates that the term “imminently” clearly includes a time period of hours or a few days, probably includes a week and perhaps two weeks, but probably does not include a month or more.

Moreover, with respect to DNR orders, a study of the phrase and its legislative history indicates that a DNR order can be written for a socially isolated patient based on a finding that in the event of cardiac arrest, the patient will die imminently even if the treatment is provided. The clause does not require a finding that the patient is imminently dying at the time the DNR order is written.

Clarifying the “will die imminently standard” will improve the quality of care for dying socially isolated patients, but it will not allow carefully considered end-of-life decisions for socially isolated patients who are not imminently dying, but who meet the criteria described in the surrogate decision-making standard. Policymakers should consider strengthening the standards for ethics review committees to make them more professional. With such changes, the FHCDA should be amended to authorize the attending physician to make an end-of-life decision for an incapable isolated patient based on the same standards that would apply to a surrogate (not the “imminently dying” standard), subject to ERC review and approval. This change will result in more humane, patient-centered end-of-life decisions for socially isolated patients in New York.

[1] N. Karp and E. Wood, Incapacitated and Alone: Health Care Decision-making for Unbefriended Older People. (American Bar Association, Commission on Law and Aging. 2003 Washington, D.C.).

[2] See e.g., H. Kaplan, “Representing Unrepresented Patients,” (Letter from the Editor) AMA Journal of Ethics 21:7:549 (2019) https://journalofethics.ama-assn.org/article/representing-unrepresented-patients/2019-07; T. Dempsey and E.S. DeMartino, “How Should Clinicians Navigate Decision Making for Unrepresented Patients?” AMA Journal of Ethics, Case and Commentary. 21:7:559 (2019); N. Sharadin, “Should Aggregate Patient Preference Data Be Used to Make Decisions on Behalf of Unrepresented Patients?”, AMA Journal of Ethics, Case and Commentary.21:7:566 (2019) https://journalofethics.ama-assn.org/article/should-aggregate-patient-preference-data-be-used-make-decisions-behalf-unrepresented-patients/2019-07; D. Ozar, “Who Are “Unrepresented Patients” And What Counts As “Important” Medical Decisions for Them?” AMA Journal of Ethics, Medicine and Society, 21:7:611 (2019) https://journalofethics.ama-assn.org/article/who-are-unrepresented-patients-and-what-count-important-medical-decisions-them/2019-07; T. Pope, “Five Things Clinicians Should Know When Caring for Unrepresented Patients.” AMA Journal of Ethics 21:7:582 (2019) https://journalofethics.ama-assn.org/article/five-things-clinicians-should-know-when-caring-unrepresented-patients/2019-07.

[3] Meisel, A., K.L. Cerminara and T.M. Pope, Right to Die: The Law of End-of-Life Decision-making (Third Edition 2004.) §8.05; T. Pope, 2017.

[4] N.Y. Public Health Law Art. 29-CC. https://www.nysenate.gov/legislation/laws/PBH/2994-D. The FHCDA does not govern (i) end-of-life decisions for people with developmental disabilities; those are governed by NY Surrogate’s Court Procedure Act §1750-b; or (ii) certain health care decisions for people in mental health hospitals or units, which are governed by Office of Mental Health regulations. Decisions for isolated patients who have a developmental disability or mental illness can be made by a Surrogate Decision Making Committee (SDMC) established by N.Y. Mental Hygiene Law Article 80.

[5] N.Y. Public Health Law § 2994-g.5(b). https://www.nysenate.gov/legislation/laws/PBH/2994-G

[6] This statement is largely based on my experience as counsel to a health care system, my participation in professional conferences on this issue, and my discussions with clinicians, bioethics professionals, and health care attorneys. But also, compare e.g., Howard J. Finger, James Zisfein, Khoi Luong, Cheryl A. Dury, Ravindra Amin, Steven Hahn, Albina Shkolnik, and Nancy Neveloff Dubler, “Life-Sustaining Treatment Decisions for Unbefriended Nursing Home Resident: Application of a Clinical Ethics Algorithm,” NYSBA Health Law J, Fall 2018 at p.81 https://nysba.org/NYSBA/Publications/Section%20Publications/Health/PastIssues1996present/2018/HealthLawJournal-Fall2018.pdf#page=82 (“imminently” is longer than “immediately” but should be no longer than a few weeks or months”) with Robert S. Olick, K. Faber-Langendoen, “Caring for Patients without Surrogates Under the Family Health Care Decisions Act,” https://www.upstate.edu/bioinbrief/articles/2011/2011-03-case-study-patients-without.php (“likely to die within a matter of days to weeks (not weeks to months)”). With respect to confusion about the application of the FHCDA standard to DNR orders, see Elizabeth Dzeng, Thomas Bein, and J Randall Curtis, “The Role of Policy and Law in Shaping the Ethics and Quality of End-of-life Care in Intensive Care,” Intensive Care Med. 2022 Mar; 48(3): 352-354 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8883558/

[7] N.Y. Public Health Law § 2994-g.5-a. https://www.nysenate.gov/legislation/laws/PBH/2994-G

[8] R. Swidler, “New York’s Family Health Care Decisions Act: The Legal and Political Background, Key Provisions and Emerging Issues,” New York State Bar Journal, June 2010. https://nysba.org/NYSBA/Public%20Resources/Family%20Healthcare%20Decisions%20Act%20Resource%20Center/FHDAC%20Files/SwidlerHealthJournSpr10.pdf Life-sustaining treatment decisions for patients with intellectual or developmental disabilities are governed by separate laws: the “Health Care Decisions Act for People with Intellectual or Developmental Disabilities” N.Y. Surrogate’s Court Procedure Act § 1750-b and, for isolated patients with mental disabilities, N.Y. Mental Hygiene Law Article 80 Surrogate Decision-making Committees.

[9] N.Y. Public Health Law §2994-d.1. https://www.nysenate.gov/legislation/laws/PBH/2994-D

[10] N.Y. Public Health Law §2994-d.5. https://www.nysenate.gov/legislation/laws/PBH/2994-D

[11] N.Y. Public Health Law §2994-g.5(a). https://www.nysenate.gov/legislation/laws/PBH/2994-D

[12] Matter of O’Connor (Westchester County Med. Ctr.), 72 N.Y.2d 517 (1988) https://casetext.com/case/matter-of-oconnor-40; Matter of Storar and Matter of Eichner v Dillon, 52 N.Y.2d 363 (1981) https://casetext.com/case/matter-of-eichner-fox, https://casetext.com/case/matter-of-storar-2

[13] N.Y. Public Health Law § 2994-g.5(b). https://www.nysenate.gov/legislation/laws/PBH/2994-G

[14] See note 7 supra. Most of the language in the provision is not problematic. The meaning of “no medical benefit” is clear because the clause itself supplies the definition: it means that “the patient will die imminently, even if the treatment is provided.” With respect to the requirement that “the provision of life-sustaining treatment would violate accepted medical standards,” if the patient will die imminently, even if the treatment is provided, the treatment has no medical benefit. Providing a treatment that has no medical benefit is not consistent with accepted medical standards. American Medical Association Code of Ethics 2024, § 5.5. https://code-medical-ethics.ama-assn.org/ethics-opinions/medically-ineffective-interventions (Although, despite medical standards, treatment is sometimes provided toward the end-of-life for non-medical reasons, such as acceding to patient or family requests, or to avoid real or perceived legal risk. See New York State Task Force on Life and the Law 1992, supra note 7, p.169.)

Finally, the requirement that the determination must be made with “a reasonable degree of medical certainty,” employs a phrase that is commonly used in the FHCDA and other New York health laws. E.g., N.Y. PHL § 2994-c (determination of incapacity); N.Y. PHL §2994-d.5 (surrogate decision-making standard).

As an aside, a recent study provides reassurance that clinicians are generally accurate at identifying patients who are expected to die within 60 days and particularly good at identifying patients who are likely to die within 14 days. M. Orlovic, et al., “Accuracy of Clinical Predictions of Prognosis at The End-Of-Life: Evidence from Routinely Collected Data in Urgent Care Records,” 2023, BMC Palliative Care 22:51 (2023) https://bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-023-01155-y.

[15] The NYS Department of Health approved a Medical Orders for Life-Sustaining Treatment (MOLST) form and posted it on its website. https://www.health.ny.gov/professionals/patients/patient_rights/molst/. That site includes Checklist 4 for “Adult without FHCDA Surrogate.” But the checklist simply recites the “imminently dying” test without further guidance.

[16] Wang v. James, 40 N.Y.2d 497 (2023). https://law.justia.com/cases/new-york/court-of-appeals/1976/40-n-y-2d-814-0.html A recent decision of the United States Supreme Court struck down the “Chevron Doctrine” whereby courts had been directed to defer to an agency’s interpretation of statutes the agency administers. Loper Bright Enterprises v. Raimondo, U.S. S.Ct. Slip Op. 22-451 (June 28, 2024.) But that decision does not affect the deference state courts accord to state agency interpretations of state statutes.

[17] N.Y. Mental Hygiene Law §33.13(c)(6) https://www.nysenate.gov/legislation/laws/MHY/33.13

[18] N.Y. Family Court Act § 1012(f)(i). https://www.nysenate.gov/legislation/laws/FCT/A10P1

[19] Nicholson v. Scoppetta, 3 N.Y. 3d 357, 368, (2004). https://www.nycourts.gov/LegacyPDFS/IP/cwcip/Training_Materials/FP_Training/Nicholson_V_Scoppetta-3N.Y.3D357.pdf

[20] O.C.G.A. §31-39-1.1 (Georgia) https://law.justia.com/codes/georgia/title-31/chapter-39/; 18 V.S.A. §9708(d)(3)(B) (Vermont) https://legislature.vermont.gov/statutes/section/18/231/09708.

[21] People v. Williams, 37 N.Y.2d 314 (2021). https://case-law.vlex.com/vid/broughton-v-state-no-887340191

[22] People v. Williams, 2021.

[23] Webster's Third New International Dictionary of The English Language, Unabridged (1993).

[24] Oxford English Dictionary, Second Edition (1989) Oxford, U.K.

[25] Merriam-Webster online. https://www.merriam-webster.com/dictionary/imminent.

[26] Peyton v. NYC Board of Standards and Appeals, 36 N.Y.3d 271 (2020). https://casetext.com/case/hoffman-v-nyc-bd-of-standards-appeals-in-re-peyton-ex-rel-peyton

[27] N.Y. Public Health Law §2994-d.5(a)(i). https://www.nysenate.gov/legislation/laws/PBH/2994-D

[28] H.G. Finger, C.A. Dury, G.R. Sansone, R.N. Rao, N.N. Dubler. “An Interdisciplinary Ethics Panel Approach to End-of-Life Decision Making.” Journal of Clinical Ethics. 33:2 (2022).

[29] New York State Task Force on Life and the Law, When Others Must Choose: Deciding for Patients Without Capacity. 1992. Albany, NY. ISBN: 1881268004. https://purl.nysed.gov/nysl/27683657. For a description of the Task Force, its background and reports, see https://en.wikipedia.org/wiki/New_York_State_Task_Force_on_Life_and_the_Law. I was Staff Counsel to the Task Force from 1985 – 90, and a member of the Task Force from 2011 to the present but was not affiliated with the Task Force at the time it issued this report. I also authored the Wikipedia article cited in this note.

[30] New York State Task Force on Life and the Law, pp. 259-60 (Emphasis added). https://purl.nysed.gov/nysl/27683657

[31] N.Y. Public Health Law Article 29-B, repealed by NY Laws of 2023, Chapter 23. https://www.nysenate.gov/legislation/bills/2023/S8059

[32] Former New York Public Health Law § 2962.12. https://www.nysenate.gov/legislation/laws/PBH/12

[33] New York State Task Force on Life and the Law 1992, Preface and Chapter 12. https://purl.nysed.gov/nysl/27683657

[34] K. Lipson and J. Karmel, “Honoring Patient Preference at The End of Life: The MOLST Process and the Family Health Care Decisions Act,” NYSBA Health Law Journal 16:1 (2011). https://molst.org/wp-content/uploads/2018/11/Lipson.Karmel.HealthLawJournal.MOLST_.2011.pdf. But see Dzeng, 2022 (the FHCDA standard for DNR futility is being interpreted as narrower than the former DNR Law standard for futility).

[35] New York State Bar Association (2020) Family Health Care Decisions Act Resource Center. https://nysba.org/fhcda-resource-center. I was the principal author of the FAQ cited above, but all the FAQs were reviewed and approved by seven other editorial board members.

[36] Finger, 2022.

[37] 18 V.S.A. § 9708(c)(3)(B) https://legislature.vermont.gov/statutes/section/18/231/09708; O.C.G.A. §31-39-1 et. seq. https://law.justia.com/codes/georgia/title-31/chapter-39/

[38] J.J. Fins, and R.N. Swidler, “A Proposal to Restore Medical Futility as A Clinical Basis for A DNR Order Under New York Law,” NYSBA Health Law Journal 22:1 (2017).

[39] The most recent versions are (NY Senate Bill 2894 (Rivera) (2023) and NY Assembly Bill 7178 (Dinowitz) (2023).

[40] NYS Department of Health – Dear Chief Executive Letters https://www.health.ny.gov/professionals/hospital_administrator/letters/.

[41] https://www.health.ny.gov/professionals/patients/patient_rights/molst/docs/checklist_4.pdf.

[42] H. Ouyang, “The Race to Reinvent CPR,” NY Times, March 27, 2024, NY Times online https://www.nytimes.com/2024/03/27/magazine/ecpr-cardiac-arrest-cpr.html.

[43] I. Wolfe, “On Not Recommending ECMO, Hastings Center Report,” September-October 2020 https://onlinelibrary.wiley.com/doi/full/10.1002/hast.1177.

[44] E.C. Metzer, N.S. Ivascu and J.J. Fins, “DNR and ECMO: A Paradox Worth Exploring,” Journal of Clinical Ethics 25, note 1 (Spring 2014):13-9 https://pubmed.ncbi.nlm.nih.gov/24779313/.

[45] Chapter 107, New York Laws of 2015, enacting Public Health Law § 2994-g.5-a. https://www.nysenate.gov/legislation/laws/PBH/2994-G

[46] T. Kirk and R. Seigel, “Decisions Regarding Hospice Care for Isolated Patients: A Guide to the 2015 Amendment of The Family Health Care Decisions Act”, NYS Bar Association Health Law Journal 21:3 (2016) https://philpapers.org/rec/KIRDRH; A. Hulkower, G. Garijo-Garde and L. Flicker, “Should Dialysis Be Stopped for An Unrepresented Patient with Metastatic Cancer? American Medical Association Journal of Ethics 21:7, 575 (2019) at 588 https://journalofethics.ama-assn.org/article/should-dialysis-be-stopped-unrepresented-patient-metastatic-cancer/2019-07.

[47] N.Y. Public Health Law § 2994-g.5-a. https://www.nysenate.gov/legislation/laws/PBH/2994-G

[48] N.Y. Public Health Law §2994-a.5-a. https://www.nysenate.gov/legislation/laws/PBH/2994-A

[49] N.Y. Public Health Law §2994-g.5-a. https://www.nysenate.gov/legislation/laws/PBH/2994-G

[50] New York State Task Force on Life and the Law, https://purl.nysed.gov/nysl/27683657

[51] Under the surrogate decision-making standard, life-sustaining treatment can be withdrawn or withheld when: (i) treatment would be an extraordinary burden to the patient and the patient has an illness or injury which can be expected to cause death within six months, whether or not treatment is provided; or the patient is permanently unconscious; or (ii) the provision of treatment would involve such pain, suffering or other burden that it would reasonably be deemed inhumane or extraordinarily burdensome under the circumstances; and the patient has an irreversible or incurable condition. N.Y. Public Health Law §2994-d.5. https://www.nysenate.gov/legislation/laws/PBH/2994-D

[52] New York State Task Force on Life and the Law, pp 259-60. https://purl.nysed.gov/nysl/27683657

[53] New York State Task Force on Life and the Law, pp 259-60. https://purl.nysed.gov/nysl/27683657

[54] F. Rosner, “Hospital Medical Ethics Committees: A Review of Their Development,” Journal of the American Medical Association 253(18); (1985) 2693-97.

[55] N.Y. Public Health Law § 2994-g.5-a. https://www.nysenate.gov/legislation/laws/PBH/2994-G

[56] Specifically: in a nursing home, ERC approval is required for a surrogate decision to withdraw or withhold life-sustaining treatment from a patient who is not terminally ill or permanently unconscious (based on extraordinary burden. PHL §2994-d.8(b); In a general hospital, ERC approval is required for the withdrawal or withholding of artificial nutrition and hydration if the attending practitioner objects to such decision by a surrogate. PHL §2994-d.8(c); ERC approval is required for a decision to withdraw or withhold life sustaining treatment from an emancipated minor Public Health Law §2994-3.(3)(a). https://www.nysenate.gov/legislation/laws/PBH/2994-D

[57] Finger,2022.

[58] Pope, 2019.

[59] ERCs will also be denounced by some as “death panels.” This article focuses on substantive ethical and policy criticisms but recognizes that there is a volatile political dimension to this as well.

[60] T. Pope, “The Growing Power and Healthcare Ethics Committees Heightens Due Process Concerns,” Cardozo Journal of Conflict Resolution 15:425 (2014) https://open.mitchellhamline.edu/cgi/viewcontent.cgi?article=1278&context=facsch.

[61] A.M. Courtwright, J. Abrams and E. Robinson. “The Role of a Hospital Ethics Consultation Service in Decision Making for Unrepresented Patients.” Journal of Bioethics Inquiry 14(2): 241-250 (2017).

[62] Ellen Fox, Marion Danis, Anita J. Tarzian & Christopher C. Duke, “Ethics Consultation in U.S. Hospitals: A National Follow-Up Study, The American Journal of Bioethics, 22:4, 5-18, DOI: 10.1080/15265161.2021.1893547. https://doi.org/10.1080/15265161.2021.1893547. However, while the article describes the prevalence of ethics review committees, it does not address their role as decisionmakers at the end of life.

[63] See http://www.empirestatebioethics.org. The author was a founding member of and a current director of the Empire State Bioethics Consortium, as well as a member of the ESBC team conducting the survey of ethics review committees.

[64] Institutional Review Boards, 21 Code of Federal Regulations Part 56, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56.

Dementia Research

Mary Paul — Tue, 30 Jul 2024 00:00:00 +0000

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. 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 principal 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-dementias-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-services-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.pdf

[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-services-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.pdf

[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-services-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

Victims Again

Paul A. Lombardo — Tue, 30 Jul 2024 00:00:00 +0000

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, (4^th 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%20linked%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%20linked%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-research-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.

The Epistemological Consequences of Artificial Intelligence, Precision Medicine, and Implantable Brain-Computer Interfaces

Ian Stevens — Sun, 30 Jun 2024 00:00:00 +0000

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-5f67941fa59e.

[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.

Cultural Relativity and Acceptance of Embryonic Stem Cell Research

Mifrah Hayath, Olivia Bowers — Thu, 16 May 2024 00:00:00 +0000

Photo ID 158378414 © Eduard Muzhevskyi | Dreamstime.com

ABSTRACT

There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

BACKGROUND

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes.^[1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research.^[2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.”^[3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops.^[4] Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I. Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense,^[5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research.^[6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a. US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism,^[7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.”^[8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed.^[9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field.^[10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture.^[11]

b. Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama, which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,”^[12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth.^[13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value.^[14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.”^[15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable.^[16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus.^[17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines.^[18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim.^[19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research.^[20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF. Their use is conditioned on consent, and available only to married couples.^[21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c. Asia

Some Asian countries also have a collective model of ethics and decision making.^[22] In China, the ethics model promotes a sincere respect for life or human dignity,^[23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM),^[24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life.^[25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research.^[26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions.^[27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency.^[28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021.^[29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy,^[30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies.^[31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells.^[32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval,^[33] and in another instance, the oocyte source was unclear and possibly violated ethical standards.^[34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d. Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells,^[35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research.^[36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors.^[37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so.^[38]

Jordan has a positive research ethics culture.^[39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial.^[40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation.^[41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.”^[42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e. Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected.^[43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research.^[44]

For example, in Germany, Lebenzusammenhang, or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.”^[45] Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount.^[46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007.^[47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization.^[48] Spain’s approach differs still, with a comprehensive regulatory framework.^[49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility.^[50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices.^[51]

II. Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.”^[52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception.^[53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible.^[54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research.^[55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided.^[56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden.^[57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all.^[58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero,^[59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all.^[60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime.^[61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit.^[62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets.^[63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life.^[64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception:^[65]

“If she is found pregnant, until the fortieth day it is mere fluid,”^[66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation.^[67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory, which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions.^[68] We only wish to show that the interaction with morality varies between cultures and countries.

III. A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe.^[69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent.^[70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context,^[71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders. This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values.^[72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions.^[73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV. Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values.^[74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities.^[75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments.^[76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.”^[77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices.^[78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.”^[79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds.^[80]

CONCLUSION

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

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[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

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[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics. Oxford University Press.

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[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics, 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight, 49(4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

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[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024. National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80, see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia. UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries. Middle East Fertil Soc J 24, 8 (2020). https://doi.org/10.1186/s43043-019-0011-0; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics, 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences, 8(1). https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction. Frontiers in pharmacology, 13, 1013740. https://doi.org/10.3389/fphar.2022.1013740

[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

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[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine, 12(6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences, 8(1). https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H. et al. Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017. BMC Public Health 22, 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan. Curr Stem Cell Rep 1, 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production. NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work. Nature. https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned. Accountability in research, 13(1), 101–109. https://doi.org/10.1080/08989620600634193.

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36]Association for the Advancement of Blood and Biotherapies. https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics, 23(3), 260–268. https://doi.org/10.1111/dewb.12355; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know. Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics. Research Ethics, 17(2), 228-241. https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics. Research Ethics, 17(2), 228-241. https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France. Biotechnology Law Report, 32(6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ... Revista do Colegio Brasileiro de Cirurgioes, 41(5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India. Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights. Cultura (Iasi, Romania), 14(2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent? Research Ethics, 13(1), 23-41. https://doi.org/10.1177/1747016116650235

[52] The Qur'an (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life. Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics, 31:399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association, 12(4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52. https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation. Journal of Religion and Health, 30(1), 35–41. http://www.jstor.org/stable/27510629; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva. A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. ((King James Bible. (1999). Oxford University Press. (original work published 1769))

^{Jerimiah 1: 5} “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

^{Psalm 139: 13-14}“…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day. Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells. Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology. Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed. Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society, (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law). Journal of assisted reproduction and genetics, 25(6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet). Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do. Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association.; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes. Journal of assisted reproduction and genetics, 35(7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine, 10(12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA. Reproductive biomedicine online, 18(5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

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[76] Stem Cell Tourism: False Hope for Real Money. Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism, See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis. Voices in Bioethics, 3. https://doi.org/10.7916/vib.v3i.6027

[77]Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation, New Genetics and Society, 30:2, 141-153, DOI: 10.1080/14636778.2011.574375

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The Bioethics-CSR Divide

Caio Caesar Dib — Thu, 21 Mar 2024 00:00:00 +0000

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.

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[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.

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[6] Mauricio Andrés Latapí Agudelo, Lára Jóhannsdóttir, and Brynhildur Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility,” International Journal of Corporate Social Responsibility 4, no. 1 (December 2019): 23, https://doi.org/10.1186/s40991-018-0039-y.

[7] Potter, “Bioethics, the Science of Survival.” p. 129.

[8] Latapí Agudelo, Jóhannsdóttir, and Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility.” p. 4.

[9] Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 2003). p. 368-371.

[10] Jonsen. p. 372.

[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.

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[27] Montgomery, “Bioethics as a Governance Practice.” p. 8.

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[31] Jonsen, “Social Responsibilities of Bioethics.”

[32] Evans, The History and Future of Bioethics. p. 75-79, 94-96.

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[36] David Kennedy, “The International Human Rights Movement: Part of the Problem?,” Harvard Human Rights Journal 15 (2002): 101–25.

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[38]. Mirowski, “The Philosophical Bases of Institutionalist Economics.”

[39]. Glenn McGee, ed., Pragmatic Bioethics, 2nd ed, Basic Bioethics (Cambridge, Mass: MIT Press, 2003).

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[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.

What COVID-19 Vaccine Distribution Disparity Reveals About Solidarity

Cornelius Ewuoso — Fri, 02 Feb 2024 00:00:00 +0000

Photo by Spencer Davis on Unsplash

ABSTRACT

Current conceptions of solidarity impose a morality and sacrifice that did not prevail in the case of COVID-19 vaccine distribution. Notably, the vaccine distribution disparity revealed that when push came to shove, in the case of global distribution, self-interested persons reached inward rather than reaching out, prioritized their needs, and acted to realize their self-interest. Self-interest and loyalty to one’s own group are natural moral tendencies. For solidarity to be normatively relevant in difficult and emergency circumstances, solidarity scholars ought to leverage the knowledge of the human natural tendency to prioritize one’s own group. This paper recommends a nonexclusive approach to solidarity that reflects an understanding of rational self-interest but highlights commonalities among all people. A recommended task for future studies is to articulate what the account of solidarity informed by loyalty to the group would look like.

INTRODUCTION

The distribution of COVID-19 vaccines raises concerns about the normative relevance of the current conceptions of solidarity. Current conceptions of solidarity require individuals to make sacrifices they will reject in difficult and extreme situations. To make it more relevant in difficult situations, there is a need to rethink solidarity in ways that align with natural human dispositions. The natural human disposition or tendency is to have loyalty to those to whom one relates, to those in one’s own group (by race, ethnicity, neighborhood, socioeconomic status, etc.), or to those in one’s location or country. While some may contend that such natural dispositions should be overcome through moral enhancement,^[1] knowledge about self-interest ought to be leveraged to reconceptualize solidarity. Notably, for solidarity to be more relevant in emergencies characterized by shortages, solidarity ought to take natural human behaviors seriously. This paper argues that rather than seeing solidarity as a collective agreement to help others out of a common interest or purpose, solidarity literature must capitalize on human nature’s tendency toward loyalty to the group. One way to do this is by expanding the group to the global community and redefining solidarity to include helping the human race when emergencies or disasters are global.

The first section describes the current conception of solidarity, altruism, and rational self-interest. The second section discusses how the moral imperative to cooperate by reaching out to others did not lead to equitable COVID-19 vaccine distribution. The third section argues that solidarity should be rethought to align with natural human dispositions toward loyalty to groups and rational self-interest. The final section briefly suggests the global community be the group for nonexclusive solidarity.

I. Solidarity: Understanding Its Normative Imperatives

Solidarity literature is vast and complex, attracting contributions from authors from countries of all income levels.^[2] Notably, the literature addresses how solidarity develops from interpersonal, then group to institutional, and how it is motivated and maintained at different levels.^[3] Solidarity is unity among people with a shared interest or goal.^[4] The term was popularized during an anti-communist labor movement in Poland.^[5] While a show of solidarity traditionally meant solidarity within a group, for example, workers agreeing with and supporting union objectives and leaders,^[6] it has come to include sympathy/empathy and action by those outside the group who stand with those in need. In bioethics, the Nuffield Council defines solidarity as “shared practices reflecting a collective commitment to carry financial, social, emotional, and or other ‘costs’ to assist others.”^[7] As conceptualized currently, solidarity prescribes a morality of cooperation and may incorporate altruism.

Solidaristic actions like aiding others or acting to enhance the quality of others’ lives are often motivated by emotive connections/relations. For this reason, Barbara Prainsack and Alena Buyx define solidarity as “a practice by which people accept some form of financial, practical, or emotional cost to support others to whom they consider themselves connected in some relevant respect.”^[8] Although this description has been critiqued, the critics^[9] do not deny that sympathy and understanding are the bases for “standing up beside” or relating to others. Political solidarity is a “response to injustice, oppression, or social vulnerability”^[10] and it entails a commitment to the betterment of the group.

“Rational self-interest” describes when parties behave in ways that make both parties better off.^[11] They may be partly motivated by their own economic outcome. It may be that when some regions or groups act solidaristically, they are also motivated by shared economic goals.^[12] Rational self-interest is not always opposed to the commitment to collectively work for the group’s good. Rational self-interest can intersect with collective action when parties behave in ways that make both parties better off. For example, one study found that individuals are willing to bear the burden of higher taxes in favor of good education policies that significantly increase their opportunities to have a good life.^[13] Rationally self-interested persons may be partly motivated by their own economic outcome. It may be that when some regions or groups act solidaristically, they are also motivated by shared economic goals.^[14] Specifically, individuals, organizations, and governments are driven to positively identify with or aid others because they feel connected to them, share the same interest, or would benefit from the same action. Cooperating with others on this basis guarantees their interests. Individuals will be less likely to help those with whom they do not feel connected. Respect, loyalty, and trust among solidary partners are equally grounded in this belief. “[S]olidarity involves commitment, and work as well as the recognition that even if we do not have the same feeling, or the same lives, or the same bodies, we do live on common grounds.”^[15] Although individuals are more likely to exhibit solidarity with those to whom they feel connected, their lives and interests are still different.

Some African philosophers describe solidarity as entailing reciprocal relations and collective responsibility.^[16] The bases for positively acting to benefit others are communal relations and individual flourishing, similar to solidarity as it is described in the global literature. Common motifs and maxims typify this belief: the West African motifs like the Siamese Crocodile and the African maxims like “the right arm washes the left hand and the left arm washes the right arm”, and the Shona phrases “Kukura Kurerwa” and “Chirere chichazo kurerawo” – both meaning the group’s development is vital for the individual’s development.^[17] As a reciprocal relation, solidaristic actions are instrumentalized for one’s self-affirmation or self-emergence. This view underlies practices in Africa like letsema, which is an agricultural practice where individuals assist each other in harvesting their farm produce. It is also the animating force underlying a favorable disposition towards joint ventures like the ajo (an African contributing saving scheme whereby savings are shared among contributors by rotation).^[18] Furthermore, as entailing collective ownership, solidaristic actions become ways of affirming each other’s destiny because it is in one’s best interest to cooperate with them this way or help others realize their life goals given the interconnectedness of lives. One advantage of forming solidary union that reaches out to others is that they possess qualities and skills that one lacks. This application of solidarity is more localized than solidarity among countries or global institutions.

Furthermore, solidarity also entails altruism, an idea that is particularly common in the philosophical literature of low-income countries. On this account, solidarity implies a voluntary decision to behave in ways that make individuals better off for their own sake. Here, it matters only that some have thought about solidarity this way. Moreover, this belief informs pro-social behaviors – altruism is acting solely for the good of others.^[19] Altruistic behaviors are motivated by empathy, which is an acknowledgement of individuals who require aid, and sensitivity, which is a thoughtful response to individuals in need of help. Solidarity can seem to be a call to help strangers rather than a genuine feeling of uniting with people for a common cause. Altruism and solidarity appear similar although they are distinct in that solidarity is not merely helping others. It is helping others out of a feeling of unity. In some cultures in Africa, an indifference to the needs of others or a failure to act solely in ways that benefit others or society are often considered an exhibition of ill will.^[20] Precisely, the phrases “Kukura Kurerwa” and “Chirere chichazo kurerawo” among the Shona people in Southern Africa morally compel one to play an active role in the growth and improvement of others. “The core of improving others’ well-being,” as explained, “is a matter of meeting their needs, not merely basic ones but also those relevant to higher levels of flourishing, e.g. being creative, athletic, theoretical.”^[21] On this basis, self-withdrawal, self-isolation, and unilateralism, would be failures to be solidaristic.

II. COVID-19 Vaccine Distribution Disparity And The Imperative To Reach Out

The strength and benefits of cooperation are well documented. COVID-19 vaccine distribution did not reflect solidarity despite the use of rhetoric suggesting it. COVID-19 vaccine distribution disparity exemplifies how solidarity requires individuals to make sacrifices that they will refuse under challenging circumstances.

Solidaristic rhetoric was not uncommon during the COVID-19 pandemic. This was expressed through maxims like “Stronger together”, “No one is safe until everyone is safe”, “We are all in this together”, and “Flatten the curve”, as well as cemented through actions like physical distancing, mask-wearing, travel restrictions, and limits on social gatherings. Before the pandemic, solidarity rhetoric informed alliances like the Black Health Alliance that was created to enable Black people in Canada to access health resources.

This rhetoric and the global recognition of the vital importance of exhibiting solidarity had little if any impact on preventing vaccine distribution disparity. Notably, the World Health Organization set a goal of global vaccination coverage of 70 percent. The 70 percent figure was recognized as key for ending the pandemic, preventing the emergence of new variants, and facilitating global economic recovery.^[22] The solidaristic rhetoric that no country was safe until all countries were safe did not result in enough vaccine distribution. Nor did the rational self-interest of common economic goals. The economic impact of the pandemic has been huge for most nations, costing the global community more than $2 trillion.^[23] Vaccine distribution disparity across countries and regions undermined international efforts to end the COVID-19 pandemic.

The disparity revealed that self-interested persons, organizations, and countries reached inward, prioritized their needs, and acted to realize their own self-interest. Empirical studies confirmed the disparity at the macro and micro levels. Some of the findings are worth highlighting. The number of vaccine doses injected in high-income countries was 69 times higher than that in low-income countries.^[24] In fact, the UK had doubly vaccinated about 75 percent of its adult population by February 2022, while more than 80 percent of African nations had not received a single dose of the vaccine.^[25] Precisely, the national uptake of vaccines in Uganda (which is a low-income economy without COVID-19 production capacity) was “6 percent by September 2021 and 63 percent by June 2022. The vaccination coverage in the country was 2 percent by September 2021 and 42 percent by June 2022. Yet both the national COVID-19 vaccination uptake and coverage were far below WHO targets for these dates.^[26] Although a report which assessed the impact of COVID-19 vaccines in the first of year of vaccination showed that about 19 million COVID-19-related deaths were averted, they were mainly in the high-income countries rather than in countries that failed to reach the vaccine coverage threshold for preventing the emergence of new variants.^[27] There were more than 250,000 COVID-related deaths in African countries.^[28] Though this figure is significantly lower than reported COVID-19 deaths in North America (1.6 million), the report and other studies confirm that many of the deaths in Africa could have been prevented if the vaccines had been widely distributed in the region.^[29]

Still at the macro level, whereas 78 percent of individuals in high-income countries were vaccinated by February 15, 2022, only 11 percent of persons in low-income countries were vaccinated by the same date.^[30] By February 15, 2022, high-income countries like Lithuania and Gibraltar (a UK territory) had more than 300 percent of doses required for vaccinating their population, while low-income countries in Africa had only managed to secure about 10 percent of the necessary vaccine doses for their people. Burundi had vaccinated less than 1 percent of its population by December 2022.

The disparity between countries of similar income levels was also evident. For example, among 75 low- and middle-income countries, only about 14 countries reported vaccinating at least 50 percent of their population. And, while high-income countries like Qatar had secured more than 105 percent of doses for their people, other high-income countries like Liechtenstein had only managed about 67 percent vaccination coverage by December 2022.^[31] Within countries, vaccination coverage gaps were also evident between urban and rural areas, with the former having higher vaccination coverage than the latter.^[32]

There were many tangible solidaristic efforts to cooperate or reach out through schemes like the COVID-19 Vaccines Global Access (COVAX), African Vaccine Acquisition Trust (AVAT) and Technology Access Pool (C-TAP). Notably, the schemes were testaments of the global recognition to lift others as we rise and not leave anyone behind. Both high-income and low- and middle-income countries supported the programs as an expression of solidarity. Indeed, many low- and middle-income countries secured about 800 million doses through these schemes by the end of December 2021. Nonetheless, this was still far below these countries’ two-billion-dose target by the same date. The wealthier countries’ rhetoric of support did not lead to delivery of enough vaccines. The support by high-income countries seems disingenuous. While high-income countries at first allocated vaccines carefully and faced shortages, they had plentiful supplies before many countries had enough for their most vulnerable people. Thus, these schemes did very little to ensure the well-being of people in low- and middle-income countries that relied on them.

These schemes had many shortcomings. For example, COVAX relied on donations and philanthropy to meet its delivery targets. In addition, despite their support for these schemes, many high-income countries hardly relied on them for their COVID-19 vaccine procurement. Instead, these high-income countries made their own private arrangements. In fact, high-income countries relied on multilateral agreements and direct purchases to secure about 91 percent of their vaccines.^[33] These solidaristic underfunded schemes had to compete to procure vaccines with the more highly resourced countries.

Arguably, many factors were responsible for the uneven distribution of COVID-19 vaccines. For example, vaccine production sites facilitated vaccine nationalism whereby countries prioritized their needs and enabled host states like the UK to stockpile vaccines quickly. Regions without production hubs, like many places in Africa, experienced supply insecurity.^[34] The J & J-Aspen Pharmacare deal under which a South African facility would produce the J&J COVID vaccine did not improve the local supply.^[35] Companies sold vaccines at higher than the cost of production despite pledges by many companies to sell COVID-19 vaccines at production cost. AstraZeneca was the only company reported to have initially sold vaccines at cost until it replaced this with tiered pricing in late 2021.^[36] Moderna estimated a $19 billion net profit from COVID-19 vaccine sales by the end of 2021. Pricing practices undermined solidaristic schemes designed to help low-income countries access the doses required for their populations.^[37]

The unwillingness of Western pharmaceutical companies like Johnson and Johnson, Pfizer-BioNTech, and Moderna to temporarily relinquish intellectual property rights or transfer technology that would have eased vaccine production in low-income countries that lacked production capabilities even when taxpayers’ money or public funding accelerated about 97 percent of vaccine discovery is another example of acting without solidarity. South Africa and India proposed the transfer of essential technological information about COVID-19 vaccines to them to increase local production.^[38] The EU, UK, and Germany, which host many of these pharmaceutical companies, opposed the technology transfers.^[39] Corporations protected their intellectual property and technology for profits.

There were many other factors, like vaccine hoarding. Although the solidaristic rhetoric suggested a global community united to help distribute the vaccine, COVID-19 vaccine distribution demonstrates that individuals, institutions, regions, or states will prioritize their needs and interests. This leads to the question, “What sort of behaviors can reasonably be expected of individuals in difficult situations? In what ways can solidarity be re-imagined to accommodate such behaviors? Ought solidarity be re-imagined to accommodate such actions?

III. COVID-19 Vaccine Disparity: Lessons For Solidarity Literature

COVID-19 vaccine distribution disparity has been described as inequitable and immoral.^[40] One justification for the negative depiction is that it is irresponsible of individual states or nations to prioritize their own needs over the global good, especially when realizing the global interest is necessary for ensuring individual good. Although such contributions to the ethical discourse on COVID-19 vaccine disparity are essential, they could also distract attention from vital conversations concerning how and why current solidarity conceptions can better reflect core human dispositions.

To clarify, the contestation is not that solidaristic acts of reaching out to others are morally unrealistic or non-realizable. There are historical examples of solidarity, particularly to end a common affliction or marginalization. An example is the LGBT support of HIV/AIDS-infected persons based on their shared identities to confront and end the stigma, apathy, and homophobia that accompanied the early years of the crisis.^[41] Equally, during the apartheid years in South Africa, Black students formed solidarity groups as a crucial racial response to racism and oppression by the predominantly White government.^[42] Additionally, the World Health Organization’s (WHO) director, Tedros Ghebreyesus cited solidarity and its rhetoric as the reason for the resilience of societies that safely and efficiently implemented restrictive policies that limited COVID-19 transmission.

To improve its relevance to emergencies, solidarity ought to be reconceptualized considering COVID-19 vaccine distribution. As demonstrated by the COVID-19 vaccine distribution disparity, individuals find it difficult to help others in emergencies and share resources given their internal pressing needs. Moreover, humans have a natural tendency to take care of those with whom they identify. That may be by country or region, race, ethnicity, socioeconomic status, type of employment, or other grouping. By extension, the morality that arises from the tendency towards “the tribe” is sometimes loyalty to one’s broader group. Evidence from human evolutionary history, political science, and psychology yields the claim that “tribal [morality] is a natural and nearly ineradicable feature of human cognition, and that no group—not even one’s own—is immune.”^[43] Tribal morality influences mantras like America First, South Africans Above Others, or (arguably) Brexit. These conflict with solidarity.

As another global example, climate change concerns are not a priority of carbon’s worst emitters like the US, China, and Russia. In fact, in 2017, the US pulled out of the Paris Agreement, a tangible effort to rectify the climate crisis.^[44] Droughts experienced by indigenous people in Turkana, the melting ice experienced by the Inuit, the burning bush experienced by the aboriginal Australians, and the rise in ocean levels that remain a constant threat to the Guna are examples of the harm of the changing climate. In the case of climate action, it appears that governments prioritize their self-interests or the interests of their people, over cooperation with governments of places negatively impacted. In the instance of COVID-19 vaccine distribution disparity, loyalty to the group was evident as states and countries kept vaccines for their own residents.

Solidarity has a focus on shared interests and purpose, but in its current conceptions it ignores human nature’s loyalty to groups. In emergencies that involve scarcity, solidarity needs to be redefined to address the impulse to keep vaccines for one’s own country’s population and the choice to sell vaccines to the highest bidder. For solidarity to be normatively relevant in difficult and emergency circumstances, solidarity scholars ought to leverage the knowledge of human natural tendency to prioritize one’s own group to rethink this concept.

IV. Rethinking Solidarity For Challenging Circumstances

In the globalized world, exhibiting solidarity with one another remains intrinsically valuable. It makes the world better off. But the challenge remains ensuring that individuals can exhibit solidarity in ways that align with their natural instincts. Rather than helping those seen as other, or behaving altruistically without solidarity, people, governments, and organizations should engage in solidarity to help others and themselves as part of the global community. A rational self-interest approach to solidarity is similar, while altruism is distinguishable.

Solidarity can be expanded to apply when the human race as a whole is threatened and common interests prevail, sometimes called nonexclusive solidarity.^[45] That is distinguished from altruism as solidarity involves seeing each other as having shared interests and goals – the success of others would lead to the success of all. For example, cleaner air or limiting the drivers of human-made climate change would benefit all. Warning the public, implementing social distancing and masking, and restricting travel are examples of global goals that required solidaristic actions to benefit the human race.^[46]

Arguably, this conception of solidarity could apply to a scarce resource, like the COVID-19 vaccine. Notably, the solidarity rhetoric that this gives rise to is that COVID-19 vaccine equitable distribution is a fight for the human race. Solidarity has been applied to scarcity and used to overcome deprivation due to scarcity. In the case AIDS/HIV, there were many arguments and then programs to reduce drug prices and to allocate and condoms to countries where the epidemic was more pronounced and continuing to infect people. Similarly, a solidarity-inspired effort led to treatments for resistant tuberculosis.^[47]

Summarily, I suggest that we cannot tackle global health problems without exhibiting solidarity with one another. Humans can exhibit solidarity in ways that align with their natural instincts. To do this, nonexclusive solidarity described in this section, is required. Although the nonexclusive solidarity recognizes difference, it avoids the “logic of competition that makes difference toxic.”^[48] Without necessarily requiring every country's leaders to prioritize global citizens equally, the nonexclusive solidarity at least, prohibits forms of competition that undermine initiatives like COVAX from securing the required vaccines to reach the vaccine coverage target.

CONCLUSION

COVID-19 vaccine distribution disparity does not create a new problem. Instead, it reveals an existing concern. This is the disconnect between dominant human psychological makeup and the sort of solidarity expounded in current literature or solidaristic actions. Notably, it reveals a failure of current solidarity conceptions to reflect the natural human tendency to prioritize the interests of one’s own group. As such, the disparity requires rethinking or reconceptualization of solidarity in ways that align with the dominant human tendency. As conceptualized currently, solidarity enjoins a form of morality that many found very difficult to adhere to during the COVID-19 pandemic. Notably, they perceived solidarity as a call to help strangers. Humans are linked by something that is far more important than a relationship between strangers. The unbreakable bond among humans that this idea gives rise to would necessitate genuine concern for each other’s well-being since we are implicated in one another's lives. The exact ways a conception of solidarity that applies to the global community can inform guidelines and policies in emergencies and difficult situations when individuals are expected to be solidaristic is a recommended task for future studies.

[1] Ingmar Persson & Julian Savulescu 2019. The Duty to be Morally Enhanced. Topoi, 38, 7-14.

[2] M. Inouye 2023. On Solidarity, Cambridge, MA, Boston Review.

[3] Barbara Prainsack & Alena Buyx 2011. Solidarity. Reflections on an Emerging Concept in Bioethics. Summary.

[4] Oxford Languages (“unity or agreement of feeling or action, especially among individuals with a common interest; mutual support within a group.”)

[5] Mikolaj Glinski. 2015. The Solidarity Movement: Anti-Communist, Or Most Communist Thing Ever? The Solidarity Movement: Anti-Communist, Or Most Communist Thing Ever?. https://culture.pl/en/article/the-solidarity-movement-anti-communist-or-most-communist-thing-ever.

[6] Carola Frege, Edmund Heery & Lowell Turner 2004. 137The New Solidarity? Trade Union Coalition-Building in Five Countries. In: FREGE, C. & KELLY, J. (eds.) Varieties of Unionism: Strategies for Union Revitalization in a Globalizing Economy. Oxford University Press.

[7] Barbara Prainsack & Alena Buyx 2011. Solidarity. Reflections on an Emerging Concept in Bioethics. Summary.

[8] Prainsack & Buyx, 2017.

[9] Angus Dawson & Bruce Jennings 2012. The Place of Solidarity in Public Health Ethics. Public Health Reviews, 34, 4.

[10] Sally J. Scholz 2008. Political Solidarity, Penn State University Press.

[11] Emanuele Bertusi. 2017. An analysis of Adam Smith's concept of self-interest: From Selfish behavior to social interest. Libera Universita Internazionale Degli Studi Sociali.

[12] Sally J. Scholz 2008. Political Solidarity, Penn State University Press.

[13] Marius R. Busemeyer & Dominik Lober 2020. Between Solidarity and Self-Interest: The Elderly and Support for Public Education Revisited. Journal of Social Policy, 49, 425-444.

[14] Scholz, 2008.

[15] Sara Ahmed 2004. The Cultural Politics of Emotion, New York, Routledge.

[16] C. Ewuoso, T. Obengo & C. Atuire 2022. Solidarity, Afro-communitarianism, and COVID-19 vaccination. J Glob Health, 12, 03046.

[17] J Mugumbate 2013. Exploring African philosophy: The value of ubuntu in social work. Afri J Soc W 3, 82-100.

[18] Salewa Olawoye-Mann 2023. 55Beyond Coping: The Use of Ajo Culture among Nigerian Immigrants to Counter Racial Capitalism in North America. In: HOSSEIN, C. S., AUSTIN, S. D. W. & EDMONDS, K. (eds.) Beyond Racial Capitalism: Co-operatives in the African Diaspora. Oxford University Press.

[19] Estrella Gualda 2022. Altruism, Solidarity and Responsibility from a Committed Sociology: Contributions to Society. The American Sociologist, 53, 29-43.

[20] Ewuoso, Obengo & Atuire 2022.

[21] T. Metz 2015. An African theory of social justice. In: BIOSEN, C. & MURRAY, M. (eds.) Distributive Justice Debates in Political and Social Thought: Perspectives on Finding a Fair Share. New York: Routledge.

[22] Victoria Pilkington, Sarai Mirjam Keestra & Andrew Hill 2022. Global COVID-19 Vaccine Inequity: Failures in the First Year of Distribution and Potential Solutions for the Future. Frontiers in Public Health, 10.

[23] M. Hafner, E. Yerushalmi, C. Fays, E. Dufresne & C. Van Stolk 2022. COVID-19 and the Cost of Vaccine Nationalism. Rand Health Q, 9, 1.

[24] Mohsen Bayati, Rayehe Noroozi, Mohadeseh Ghanbari-Jahromi & Faride Sadat Jalali 2022. Inequality in the distribution of Covid-19 vaccine: a systematic review. International Journal for Equity in Health, 21, 122.

[25] Graham Dutfield, Siva Thambisetty, Aisling Mcmahon, Luke Mcdonagh & Hyo Kang 2022. Addressing Vaccine Inequity During the COVID-19 Pandemic: The TRIPS Intellectual Property Waiver Proposal and Beyond. Cambridge Law Journal, 81.

[26] Patrick King, Mercy Wendy Wanyana, Richard Migisha, Daniel Kadobera, Benon Kwesiga, Biribawa Claire, Michael Baganizi & Alfred Driwale. 2023. Covid 19 vaccine uptake and coverage, Uganda 2021-2022. UNIPH Bulletin, 8. https://uniph.go.ug/covid-19-vaccine-uptake-and-coverage-uganda-2021-2022/#:

[27] O. J. Watson, G. Barnsley, J. Toor, A. B. Hogan, P. Winskill & A. C. Ghani 2022. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis, 22, 1293-1302.

[28] Arcgis January 21, 2024. African dashboard for tracking the COVID-19 in real-time. https://www.arcgis.com/apps/dashboards/b959be51c0014845ad44142bce1b68fe

[29] Jai K. Das, Hsien Yao Chee, Sohail Lakhani, Maryam Hameed Khan, Muhammad Islam, Sajid Muhammad & Zulfiqar A. Bhutta 2023. COVID-19 Vaccines: How Efficient and Equitable Was the Initial Vaccination Process? Vaccines, 11, 11. O. J. Watson, G. Barnsley, J. Toor, A. B. Hogan, P. Winskill & A. C. Ghani 2022. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis, 22, 1293-1302.

[30] Pilkington, Keestra & Hill 2022.

[31] Kunyenje, et al. 2023.

[32] Pilkington, Keestra & Hill 2022.

[33] Jai K. Das, Hsien Yao Chee, Sohail Lakhani, Maryam Hameed Khan, Muhammad Islam, Sajid Muhammad & Zulfiqar A. Bhutta 2023. COVID-19 Vaccines: How Efficient and Equitable Was the Initial Vaccination Process? Vaccines, 11, 11.

[34] Kunyenje, et al. 2023.

[35] Lynsey Chutel. 2022. Africa's first COVID-19 vaccine factory hasn't received a single order. Africa's first COVID-19 vaccine factory hasn't received a single order. https://www.nytimes.com/2022/05/12/world/africa/south-africa-covid-vaccine-factory.html

[36] Graham Dutfield, Siva Thambisetty, Aisling Mcmahon, Luke Mcdonagh & Hyo Kang 2022. Addressing Vaccine Inequity During the COVID-19 Pandemic: The TRIPS Intellectual Property Waiver Proposal and Beyond. Cambridge Law Journal, 81.

[37] Dutfield, et al.

[38] Hannah Balfour. June 17, 2022 2022. WTO waives intellectual property rights for COVID-19 vaccines. European Pharmaceutical Review https://www.europeanpharmaceuticalreview.com/news/172329/breaking-news-wto-waives-intellectual-property-rights-for-covid-19-vaccines/

[39] Government Uk. 2021. UK statements to the TRIPS Council: Item 15 waiver proposal for COVID-19. UK statements to the TRIPS Council: Item 15 waiver proposal for COVID-19 . https://www.gov.uk/government/news/uk-statement-to-the-trips-council-item-15

[40] Victoria Pilkington, Sarai Mirjam Keestra & Andrew Hill 2022. Global COVID-19 Vaccine Inequity: Failures in the First Year of Distribution and Potential Solutions for the Future. Frontiers in Public Health, 10.

[41] Benjamin Klassen 2021. ‘Facing it Together’: Early Caregiving Responses to Vancouver's HIV/AIDS Epidemic. Gender & History, 33, 774-789.

[42] Mabogo P. More 2009. Black solidarity: A philosophical defense. Theoria: J Soc and Pol Theory, 56, 20-43.

[43] Cory J. Clark, Brittany S. Liu, Bo M. Winegard & Peter H. Ditto 2019. Tribalism Is Human Nature. Current Directions in Psychological Science, 28, 587-592.

[44] Hai-Bin Zhang, Han-Cheng Dai, Hua-Xia Lai & Wen-Tao Wang 2017. U.S. withdrawal from the Paris Agreement: Reasons, impacts, and China's response. Advances in Climate Change Research, 8, 220-225.

[45] Arto Laitinen & Anne Birgitta Pessi 2014. Solidarity: Theory and Practice. An Introduction. In: LAITINEN, A. & PESSI, A. B. (eds.) Solidarity: Theory and Practice. Lexington Books.

[46] X. Li, W. Cui & F. Zhang 2020. Who Was the First Doctor to Report the COVID-19 Outbreak in Wuhan, China? J Nucl Med, 61, 782-783.

[47] Atuire, C. A., & Hassoun, N. 2023. Rethinking solidarity towards equity in global health: African views. International journal for equity in health, 22(1), 52. https://doi.org/10.1186/s12939-023-01830-9

[48] Samo Tomšič 2022. No Such Thing as Society? On Competition, Solidarity, and Social Bond. differences, 33, 51-71.

Fostering Medical Students’ Commitment to Beneficence in Ethics Education

Philip Reed, Joseph Caruana — Tue, 23 Jan 2024 00:00:00 +0000

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 8^th 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.

Consciously Choosing Unconsciousness

Yuna Lee — Mon, 11 Mar 2024 00:00:00 +0000

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.

Alcohol Exclusion Laws and Its Drawbacks

William Ngo — Tue, 12 Mar 2024 00:00:00 +0000

INTRODUCTION

Since the repeal of the 18^thAmendment 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-life-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/.

Competence or Experience

Jonathan Tenenbaum — Tue, 12 Mar 2024 00:00:00 +0000

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.

Shifting Paradigms

Amanda Pisciotta — Tue, 12 Mar 2024 00:00:00 +0000

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%20administered%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%20Communication%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%20recreation%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%2Fevaluation ,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=85%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%20like%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.

Brain Organoids, the Path Forward?

Ashley Diloreto — Tue, 12 Mar 2024 00:00:00 +0000

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

Protecting Confidentiality in the Digital Ecosystem of Humanitarian Aid

Cara Lewis — Tue, 12 Mar 2024 00:00:00 +0000

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%20to%20those,of%20governments%20or%20warring%20parties.&text=The%20principles%20of%20impartiality%20and%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-research-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-report.

^[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.

The United States Healthcare System

Jacob Pollock — Tue, 12 Mar 2024 00:00:00 +0000

INTRODUCTION

Today, United States citizens live in a society guided by a false consciousness.^[1] The presiding culture of the United States (US) has painted a picture – a distorted and surreal mythology – that continues to be admired. This picture is characterized by conservative dogma and intolerance within the political, economic, and ideological spheres of society, leaving individuals unable to ascertain truth. US citizens are provided the inability to see reality for what it is, and instead encouraged to live by a means of pseudo-reality as described by Debord.^[2] As a result, many US institutions, including the prison system and the healthcare system, have become platforms of masked discriminatory and racist practices within today’s world of “colorblindness.” The right to universal health care represents yet another opportunity for US institutions to deploy covert and underlying racist and discriminatory tactics, and continues to remain largely unacknowledged by non-minority citizens of the US, contributing to significantly higher rates of untreated health concerns and concomitant higher death rates in US minority populations.

ANALYSIS

To understand this assertion, it is important to start by examining the ways in which the US prison system acts as a discriminatory and racist institution. Today, African Americans, Hispanics, and other minorities account for roughly 40% of the US population, yet they comprise around 60% of the US’ total incarcerated population.^[3] That is, they are disproportionately represented amongst the incarcerated. To put this in perspective, according to the American Civil Liberties Union, nearly “one in every 15 African American men [become] incarcerated, as opposed to only one in every 106 white men.”^[4] Looking back to the early 1970s when Black Americans were making progress in obtaining civil rights, there was a substantial increase in the number of incarcerated Black individuals, acting as a “stealth counterweight to political and economic progress.”^[5] Thus, prisons were used as a means to suppress the growing success of Black individuals, furthering the disproportionate number of incarcerated minorities.

The prison system is not the only institution within the US that deploys underlying discriminatory, exploitative, and racist tactics towards American minorities. For example, there have been mortgage lending procedures that have “disproportionately exposed minority borrowers to the risky subprime loans that triggered the financial collapse of 2008 and widespread foreclosures in minority communities.”^[6] Also discovered have been numerous obscure tax and insurance policies that have targeted neighborhoods with substantial minority populations.^[7] There are many more examples of US institutions exploiting and discriminating based upon race, yet minority groups cannot simply avoid these tactics; that is, taking out loans and paying taxes can be essential life tasks for most individuals. Thus, as society continues to be governed by a false consciousness, true reality will indefinitely remain uncertain. This becomes clear, as even today there have been minimal studies regarding the exploration of this institutionalized racism.^[8]

As it is clear numerous institutions have and continue to behave in discriminatory ways, it must be considered that the US’ lack of a nationwide right to health insurance represents another means of discrimination based upon race. While at this point in the essay a discussion of the history of slavery within the US may seem extraneous, the lasting effects of slavery continue to play a key role in discrimination towards minorities, contributing to diminished resources for health insurance for minorities in the US. To understand the role of slavery in decreased access to nationwide health insurance, one must come to see the foremost factor as to why individuals do not carry it. That is, “in 2022, 64.2% of uninsured nonelderly adults said they were uninsured because coverage is not affordable, making it the most common reason cited for being uninsured.”^[9] As for the role of long-term effects of slavery, minorities, especially Black Americans, face far greater poverty than their counterparts, predominantly in places where there is a stronger connection to slavery in the past.^[10] Thus, as it is commonly understood the southern half of the US to have experienced the largest impact from slavery, this would indicate the largest impact on poverty struggles as a result of slavery would be in the south. Coincidentally, as one might say, “reflecting geographic variation in income and the availability of public coverage, most uninsured people live in the South.”^[11]

As Black Americans have faced substantial struggles with poverty due to the lasting effects of slavery and previously exploitative southern economies, bearing in mind the primary reason for not carrying health insurance is a lack of funds, it is plain that past discrimination and racism of yesterday has set the stage for wealth and health disparities and discrimination today. That is, the “average wealth of white households in the United States [has become] 13 times as high as that of Black households.”^[12] To further put this problem into context, minorities “made up 45.7% of the nonelderly US population but accounted for 62.3% of the total nonelderly uninsured population.”^[13] Looking at minorities other than Black Americans, the uninsured rate for “nonelderly Hispanic (18.0%) and American Indian and Alaska Native people (19.1%) are more than 2.5 times the uninsured rates for white people (6.6%)”^[14] Moreover, of the uninsured population, most of the 25.6 million nonelderly uninsured adults were from minority groups.^[15]

As posited, Black Americans and other minority groups’ inability to afford health insurance has been created by US citizens themselves, through past legality and support of slavery, leaving lasting effects that have made health insurance unaffordable. In return, some US citizens and their government have failed to remedy the situation, choosing instead to endorse the idea that minorities lack funds to carry health insurance by arguing they are ‘lazy,’ ‘unmotivated,’ or ‘irresponsible.’ In doing so, US citizens have further engaged in the stereotyping of minority groups as inferior through their inability to obtain health insurance. Consequently, through an unfair health insurance access system, US society has maintained a discriminatory attitude towards minority groups. Once there is a determination of a belief of inferiority, a blind eye will indefinitely turn away from discrimination within society’s governance of the false consciousness, leaving its citizens unable to ascertain reality, chiefly developing and supporting their own self interests. Thus, through the contribution and failure to remedy the poverty struggles inflicted on minority groups, including those inflicted on Black Americans largely through the past slavery in the southern US, minority groups, making up 62.3% of all uninsured nonelderly adults, have been made into the problem by society. These individuals have been labeled, ideologically transformed into ‘inferior beings’ per conservative dogma, and thus become further discriminated against with respect to their inability to obtain health insurance in the US.

Considering the ethicality of the lack of a nationwide right to health insurance, one must take the stance of Mill’s Utilitarianism, which revolves around providing the greatest amount of good for the greatest number of people through consequence of action.^[16] First, it is clear by failing to provide a national right to health insurance, the U.S. is leaving indigent, uninsured groups, largely consisting of minorities, to find the means to fund their own insurance. This may contribute to higher and disproportionate crime rates of minority groups out of need for survival and fulfillment of basic human needs; to institutionalized racism; to false ideologies; to stereotypes wrongly placed upon minority groups; and to untreated illness. The resulting human tragedy is seen in myriad situations: minority woman facing high maternal death rates in childbirth, uninsured minority individuals being turned away from hospitals who only take those with insurance, silent suffering and untreated illnesses including high rates of diabetes and heart disease, and more recently, higher death rates and worse outcomes for minorities as a result of the COVID-19 pandemic.^[17]

CONCLUSION

Thus, as the result of a non-existent nationwide right to health insurance, the US is plainly failing to provide the greatest amount of good for the greatest number of people and therefore, per Mill, the failure to provide a national right to health insurance is clearly unethical. The lack of national access for all individuals to health insurance is not only an underlying form of racism and discrimination towards American minorities, but it is unethical as well. To address this, American society must alter its picture of the distorted and surreal reality that has been painted, and shatter its lens of the pseudo-reality that shapes many individuals’ view of the world. That is, there becomes the need for a higher form, or a deeper level, of collective experiential consciousness in order for a symbiotic relationship to occur – a relationship advantageous to all simultaneously – in the biological and sociological realms. Only then can the trend of institutionalized racism and discrimination be broken, and as a part of this, only then can all individuals receive access to health insurance and related healthcare that would improve their quality of life.

^[1] Little, Daniel. “False Consciousness.” False Consciousness, www-personal.umd.umich.edu/~delittle/iess%20false%20consciousness%20V2.htm.

^[2] Debord, Guy. The Society of the Spectacle. Translated by Donald Nicholson-Smith, Zone Books, 1995.

^[3] Harris, Fredrick C., and Robert C. Lieberman. “Racial Inequality After Racism: How Institutions Hold Back African Americans.” Foreign Affairs, vol. 94, no. 2, 2015, pp. 9–20. JSTOR, http://www.jstor.org/stable/24483477.

^[4] Harris, Fredrick C., and Robert C. Lieberman. “Racial Inequality After Racism: How Institutions Hold Back African Americans.”

^[5] Ibid.

^[6] Ibid.

^[7] Ibid.

^[8] Ibid.

^[9] Drake, Patrick, and Jennifer Tolbert. “Key Facts about the Uninsured Population.” KFF, www.kff.org/uninsured/issue-brief/key-facts-about-the-uninsured-population/.

^[10] O’Connell, Heather A. “The Impact of Slavery on Racial Inequality in Poverty in the Contemporary U.S. South.” Social Forces, vol. 90, no. 3, 2012, pp. 713–34. JSTOR, http://www.jstor.org/stable/41682675.

^[11] Drake, Patrick, and Jennifer Tolbert. “Key Facts about the Uninsured Population.”

^[12] Harris, Fredrick C., and Robert C. Lieberman. “Racial Inequality After Racism: How Institutions Hold Back African Americans.

^[13] Drake, Patrick, and Jennifer Tolbert. “Key Facts about the Uninsured Population.”

^[14] Ibid.

^[15] Ibid.

^[16] Mill, John Stuart. Utilitarianism. London, Parker, Son, and Bourn, 1863. Pdf. Retrieved from the Library of Congress, <www.loc.gov/item/11015966/>.

^[17] Tai, Don Bambino Geno, et al. “Disproportionate Impact of Covid-19 on Racial and Ethnic Minority Groups in the United States: A 2021 Update.” Journal of Racial and Ethnic Health Disparities, U.S. National Library of Medicine, Dec. 2022, www.ncbi.nlm.nih.gov/pmc/articles/PMC8513546/#:~:text=Black%2C%20Latinx%2C%20and%20American%20Indian,children%20in%20a%20worrying%20trend.

Autonomy and Its Limits

Maxwell Fry — Tue, 12 Mar 2024 00:00:00 +0000

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.⁷Initially, 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-patient.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.