Jared Smith

Tom Beauchamp’s contributions to the field of bioethics are as influential as they are numerous. Here we reflect on his intellectual legacy, specifically his role in establishing principlism as a method of bioethical analysis. Despite its prominence in medical ethics education, in our experience as clinical ethicists and researchers, we rarely analyze ethical issues the way principlism suggests, either in the clinic or our scholarship. In this paper, we consider the complex ways in which principlism may fruitfully relate to other approaches to ethical analysis in clinical ethics (e.g., the four-box method) as well as its relative strengths and drawbacks pedagogically, explanatorily, and translationally. We conclude with some reflections about the intellectual flexibility of principlism and its role in fostering interdisciplinary bioethics.

Background Increasing interest in deploying artificial intelligence tools in clinical contexts has raised several ethical questions of both normative and empirical interest. One such question in the literature is whether “responsibility gaps” (r-gaps) are created when clinicians utilize or rely on such tools for providing care, and if so, what to do about them. These gaps are particularly likely to arise when using opaque, “black box” AI tools. Compared to normative and legal analysis of AI-generated responsibility gaps in health care, little is known, empirically, about health care providers views on this issue. The present study examines clinician perspectives on this issue in the context of black box AI decisional support systems (BBAI-DSS) in advanced heart failure.Methods Semi-structured interviews were conducted with 20 clinicians (14 cardiologists and 6 LVAD nurse coordinators). Interviews were transcribed, coded, and thematically analyzed for salient themes. All study procedures were approved by local IRB.Results We found that all clinicians voiced that, if someone were responsible for the use and outcomes of black box AI, it would be physicians. We compare clinician perspectives on the existence of r-gaps and their impact on responsibility for errors or adverse outcomes when BBAI-DSS tools are used against a taxonomy from the literature, finding some clinicians acknowledging an r-gap and others denying it or its relevance in medical decision-making.Conclusion Clinicians varied in their view about the existence of r-gaps but were united in their ascriptions of physician responsibility for the use of BBAI-DSS in clinical care. It was unclear at times whether these were descriptive or normative judgments (i.e., is it merely inevitable physicians will be responsible, or is it morally appropriate that they be held responsible?) or both. We discuss the likely normative inadequacy of such a conception of physician responsibility for BBAI tool use.

It is increasingly common for bioethicists to consult with the public to solicit their judgments and attitudes about ethical questions and issues, especially ones that arise with new and emerging technologies. However, it is not always clear what the purpose of this engagement is or ought to be: do bioethicists seek the input of the public to help them arrive at a morally correct justified policy position, or do they seek this input to help them shape and frame their already-established moral position, or something else entirely? In this essay, we discuss four distinct possible functions of collecting moral judgments from the public: issue spotting, messaging for adherence and social stability, substantive moral guidance, and procedural fairness. For each function, we offer core examples from the literature before discussing the strengths and weaknesses attendant to each. We conclude with several preliminary questions bioethicists can ask themselves to clarify their own purpose for soliciting moral judgments from the public.

Given the need for enforceable guardrails for artificial intelligence (AI) that protect the public and allow for innovation, the U.S. Government recently issued a Blueprint for an AI Bill of Rights which outlines five principles of safe AI design, use, and implementation. One in particular, the right to notice and explanation, requires accurately informing the public about the use of AI that impacts them in ways that are easy to understand. Yet, in the healthcare setting, it is unclear what goal the right to notice and explanation serves, and the moral importance of patient-level disclosure. We propose three normative functions of this right: (1) to notify patients about their care, (2) to educate patients and promote trust, and (3) to meet standards for informed consent. Additional clarity is needed to guide practices that respect the right to notice and explanation of AI in healthcare while providing meaningful benefits to patients.

Introduction Deep brain stimulation (DBS) is approved under a humanitarian device exemption to manage treatment-resistant obsessive-compulsive disorder (TR-OCD) in adults. It is possible that DBS may be trialed or used clinically off-label in children and adolescents with TR-OCD in the future. DBS is already used to manage treatment-resistant childhood dystonia. Evidence suggests it is a safe and effective intervention for certain types of dystonia. Important questions remain unanswered about the use of DBS in children and adolescents with TR-OCD, including whether mental health clinicians would refer pediatric patients for DBS, and who would be a good candidate for DBS.Objectives To explore mental health clinicians’ views on what clinical and psychosocial factors they would consider when determining which children with OCD would be good DBS candidates.Materials and Methods In depth, semi-structured interviews were conducted with n = 25 mental health clinicians who treat pediatric patients with OCD. The interviews were transcribed, coded, and analyzed using thematic content analysis. Three questions focused on key, clinical, and psychosocial factors for assessing candidacy were analyzed to explore respondent views on candidacy factors. Our analysis details nine overarching themes expressed by clinicians, namely the patient’s previous OCD treatment, OCD severity, motivation to commit to treatment, presence of comorbid conditions, family environment, education on DBS, quality of life, accessibility to treatment, and patient age and maturity.Conclusions Clinicians generally saw considering DBS treatment in youth as a last resort and only for very specific cases. DBS referral was predominantly viewed as acceptable for children with severe TR-OCD who have undertaken intensive, appropriate treatment without success, whose OCD has significantly reduced their quality of life, and who exhibit strong motivation to continue treatment given the right environment. Appropriate safeguards, eligibility criteria, and procedures should be discussed and identified before DBS for childhood TR-OCD becomes practice.

The ongoing debate within neuroethics concerning the degree to which neuromodulation such as deep brain stimulation (DBS) changes the personality, identity, and agency (PIA) of patients has paid relatively little attention to the perspectives of prospective patients. Even less attention has been given to pediatric populations. To understand patients’ views about identity changes due to DBS in obsessive-compulsive disorder (OCD), the authors conducted and analyzed semistructured interviews with adolescent patients with OCD and their parents/caregivers. Patients were asked about projected impacts to PIA generally due to DBS. All patient respondents and half of caregivers reported that DBS would impact patient self-identity in significant ways. For example, many patients expressed how DBS could positively impact identity by allowing them to explore their identities free from OCD. Others voiced concerns that DBS-related resolution of OCD might negatively impact patient agency and authenticity. Half of patients expressed that DBS may positively facilitate social access through relieving symptoms, while half indicated that DBS could increase social stigma. These views give insights into how to approach decision-making and informed consent if DBS for OCD becomes available for adolescents. They also offer insights into adolescent experiences of disability identity and “normalcy” in the context of OCD.

Imagine a person with a compulsive illness that leads her to frequently wash her hands. She will scrub her hands under all sorts of bizarre conditions, such as seeing a garbage truck drive down the road or hearing the word ‘trash’ on television. Sometimes her hands do need to be cleaned but this is usually a fortunate coincidence. This person does not have control over her behavior because she cannot help herself from washing her hands (unless dire consequences were to follow, such as the threat of imminent death, poisonous gassing of her children, and so on). Because she lacks control over her behavior, most people are inclined to think that she is not responsible for her compulsive washing or any harm that comes of it. We might even think that it is inappropriate to blame her if she cannot stop washing when she ought to. Importantly, the impact of her illness extends beyond the issues of responsibility and blame since it impacts the degree to which she is autonomous. After all, if she experiences extreme discomfort or alienation from her washing then it seems reasonable to suppose that her compulsive behavior does not truly represent her (or her deeper self). This is the story that many philosophers of agency who have written about obsessive-compulsive disorder (OCD) tell. These theorists tend to depict those with OCD as lacking control over their behavior to such a degree that their moral responsibility and capacity for self-governance are impaired or obviated. So understood, people with OCD are of interest to philosophers of agency only insofar as they provide a colorful counterexample to one theory or another. But this story is false. In fact, it is really a caricature of the disorder that not only obscures its nature but, and more importantly, obscures the serious implications that OCD (properly understood) has for our understanding of core agential concepts, such as moral responsibility or identification with an attitude. In my dissertation I both correct this long-standing and entrenched misunderstanding of OCD in philosophical literature and work out the implications it carries for our understanding of human agency. On my approach, an accurate understanding of OCD requires examining leading psychiatric literature on the disorder as well as consulting the words and experiences of people living with OCD. Although the disorder is formally defined in terms of experiencing thoughts, images, or impulses (obsessions) alongside rituals the person feels pressure to complete (compulsions), the thematic presentation of these symptoms can vary widely. For example, in Story of a Soul, St. Therese of Liseaux describes “a terrible disease of the scruples” that filled her with seemingly sinful thoughts, driving her to repeatedly pray and visit confession with little relief. In contrast, J. J. Keeler describes painful obsessions about unknowingly causing a fatal traffic collision, leading to hours spent retracing her route, scouring the news for reports of a hit-and-run, and so on. Yet despite this diversity, nearly all manifestations of OCD involve dysfunctional beliefs. These beliefs typically over-represent the chance of harm associated with an action and the person’s responsibility for preventing or causing harm. Consequently, they make those with OCD more likely to experience exaggeration of certain features of their environment or stimuli, skewing and disrupting their thinking and deliberation, leading them to engage in, as I argue, voluntary and intentional compulsive rituals aimed at averting harm and relieving anxiety. St. Therese’s sinful thoughts involve her dysfunctional beliefs about perfection, about what harms or helps her relationship with God, and about her responsibility for having those thoughts. She is driven to voluntarily pray as an attempt to relieve her anxiety and to make good with God. By comparison, Keeler obsesses that she may have caused or will cause a death and so checks her behavior on the road constantly and reduces ‘dangerous activities’ (such as driving on highways). In these memoirs we see that the pattern of beliefs at work in OCD can lead agents like Therese and Keeler to interpret certain acts as courting disaster when they are not especially risky, or certain thoughts and ideas as blasphemous when they are not representative of who that person is. As noted, when philosophers discuss OCD in the context of moral responsibility, their depictions tend to stress a lack of control over one’s behavior. In reason-responsive theories, the person with OCD is thought to be unable to properly react to sufficient reasons for action even if she is able to recognize that they exist and have bearing. This is termed a failure of reason-reactivity. This is how one theorist, Michael Mckenna, frames his example of Handy the compulsive handwasher. Handy is a purported counterexample to Fischer & Ravizza’s reason-responsive theory (semicompatibilism) because Handy can recognize and react to at least one sufficient reason to refrain from washing his hands (despite ostensibly being a compelled agent). McKenna caricatures OCD by under-describing Handy’s mental states and over-emphasizing his limited ability to abstain from washing his hands in the presence of powerful countervailing considerations (e.g., to save the life of his child). McKenna’s example of Handy chiefly ignores the robust cognitive features of the disorder described above, specifically the agent’s beliefs about her own obsessions and compulsions and how they relate to the world around her. In contrast to this depiction of OCD, I argue that people with OCD are overly receptive to apparent reasons for action, seeing reasons where there are none or distorting the weight certain reasons have in deliberation. Furthermore, an accurate picture of OCD reveals that most people with the disorder do possess guidance control and are thus morally responsible. If we wish to argue that these agents are blameless, we must refine our understanding of what it means to ‘resist’ a compulsion. Instead, we must understand the difficulty associated with resisting the dysfunctional beliefs at the heart of OCD. The fact that people with OCD are overly receptive to apparent reasons for action has implications not just for responsibility and freedom but also for other core concepts in agency like identification and autonomy. Identification generally refers to attitudes that ‘stand for’ an agent and so have the authority to represent her. Some philosophers argue that internal attitudes (those the agent identifies with) must be explicitly endorsed by the agent in some kind of reflective process, while others argue that more fundamental attitudes (such as our cares) are internal. Stretching back to Frankfurt’s first description of identification, obsessions have long been considered external to the agent, usually because obsessive thoughts are experienced as unwanted or upsetting. For example, Keeler’s thought that she has caused a fatal hit-and-run is distressing because the thought of having harmed someone so much is unbearable. Similarly, the rituals Keeler engages in, like checking the news for accident reports or searching the exterior of her car for blood, are upsetting to her even though they are aimed at relieving her distress. However, the same features of the disorder that lead people with OCD to become overwhelmed by reasons also appear to lead some to develop caring-like behaviors. For example, when Keeler experiences obsessions about the risk of hitting someone with her car, she becomes particularly attuned to situations in which she perceives her behavior as a threat to others on the road. In response Keeler takes serious steps to change her driving habits, including driving on surface roads rather than highways or traveling well under the speed limit. This behavior closely tracks the way agents behave when they care about something (whether it is a person, a value, an outcome). This means that, contrary to the way philosophers have hitherto understood clinical obsessions, obsessions can be internal to the agent and speak for her in a meaningful way. As I argue this is a feature and not a bug. In fact, it is a very significant, and from a therapeutic point of view, very worrying feature. This is because those cases of OCD that most resemble caring are also those in which the person lacks significant insight into her own disorder. The disorder is hidden from her own insight precisely because it is expressed in what she most cares about. Such individuals are often the most ill in terms of symptom severity and recovery trajectory. Reframing this behavior as dysfunctional caring explains why these obsessions take on ever greater significance to the agent and take up increasing space in her deliberative horizon. This finding, in turn, may indicate that therapies aimed at externalizing obsessions and removing them from one’s deliberative agenda could wear away at otherwise recalcitrant obsessions and compulsive rituals. Mischaracterizations of OCD in philosophy of agency have driven a number of problematic depictions of the disorder, and the arguments built around such mischaracterizations are necessarily deficient. Depicting OCD as largely about control has yoked our discussions of the disorder’s symptoms to older, inaccurate conceptions of psychological compulsion as a kind of force. This has been to our theoretical detriment since it has concealed the degree to which compulsion in OCD is both voluntary and purposeful as well as driven significantly by dysfunctional beliefs. Recognizing these features of OCD and their impact on agency has significant implications for the way we theorize about concepts like responsibility and identification. For example, if people with OCD do possess guidance control then we must reassess our intuition that they are excused from blame, or else modify our understanding of what the relevant excusing conditions are. Similarly, understanding that seriously ill people with OCD may display caring-like behavior may inform our understanding of internality’s role in agency as well as potential treatment methods.

Rapid advancements in artificial intelligence and machine learning (AI/ML) in healthcare raise pressing questions about how much users should trust AI/ML systems, particularly for high stakes clinical decision-making. Ensuring that user trust is properly calibrated to a tool’s computational capacities and limitations has both practical and ethical implications, given that overtrust or undertrust can influence over-reliance or under-reliance on algorithmic tools, with significant implications for patient safety and health outcomes. It is, thus, important to better understand how variability in trust criteria across stakeholders, settings, tools and use cases may influence approaches to using AI/ML tools in real settings. As part of a 5-year, multi-institutional Agency for Health Care Research and Quality-funded study, we identify trust criteria for a survival prediction algorithm intended to support clinical decision-making for left ventricular assist device therapy, using semistructured interviews (n=40) with patients and physicians, analysed via thematic analysis. Findings suggest that physicians and patients share similar empirical considerations for trust, which were primarilyepistemicin nature, focused on accuracy and validity of AI/ML estimates. Trust evaluations considered the nature, integrity and relevance of training data rather than the computational nature of algorithms themselves, suggesting a need to distinguish ‘source’ from ‘functional’ explainability. To a lesser extent, trust criteria were also relational (endorsement from others) and sometimes based on personal beliefs and experience. We discuss implications for promoting appropriate and responsible trust calibration for clinical decision-making use AI/ML.

Background Deep brain stimulation is approved for treating refractory obsessive-compulsive disorder in adults under the US Food and Drug Administration Humanitarian Device Exemption, and studies have shown its efficacy in reducing symptom severity and improving quality of life. While similar deep brain stimulation treatment is available for pediatric patients with dystonia, it is not yet available for pediatric patients with obsessive-compulsive disorder, although soon could be. The prospect of growing indications for pediatric deep brain stimulation raises several ethical concerns relating to bodily integrity, the ability to offer informed assent, and the role pediatric patients play in the decision-making process. Objective The aim of this study is to solicit and assess the views of stakeholders (children, parents, clinicians) on pediatric assent, autonomy, and bodily integrity in the context of potential pediatric deep brain stimulation for obsessive-compulsive disorder. Methods Semi-structured interviews were conducted with pediatric obsessive-compulsive disorder patients ( n = 21), caregivers of pediatric obsessive-compulsive disorder patients aged 14–18 ( n = 19), and clinicians with experience treating refractory obsessive-compulsive disorder ( n = 25). Interviews were transcribed and coded in MAXQDA 2018 and 2020 software and processed for thematic content analysis to isolate and compare specific themes. Results A majority of respondents (74%, 48/65) across all three stakeholder groups voiced that the decision-making process should be collaborative and involve everyone (clinicians: 84% or 21/25, caregivers 71% or 15/21, and patients 63% or 12/19). We identified a split between respondents’ views on who should have the final say in the event of disagreement (38% or 25/65 favored the patient versus 35% or 23/65 favoring caregivers). A split between respondents also emerged concerning the maturity relevant for deep brain stimulation decision-making, with 45% (29/65) favoring developmental maturity (age/physiological development) and 45% (29/65) favoring decisional maturity (capacity to understand and weigh information). A majority of clinicians indicated that they would not move forward with deep brain stimulation without securing patient assent (80% or 20/25), with some stating the only exception is if patient quality of life was very poor and/or they lacked insight. Both caregivers and patients expressed a significant respect for the patient's right to bodily integrity, with 67% of caregivers (14/21) and 68% of patients (13/19) justifying patient involvement in decision-making specifically with reference to infringements of bodily integrity. Conclusion Our findings demonstrate that despite broad agreement across stakeholders that the decision-making process for pediatric deep brain stimulation for obsessive-compulsive disorder should be collaborative and somehow involve pediatric patients, there is disagreement about what this process entails and what factors determine patient involvement in the process. However, there is agreement that children have a right to bodily and brain integrity, which should only be infringed upon in rare circumstances.

In ‘Patients, doctors and risk attitudes,’ Makins argues that, when physicians must decide for, or act on behalf of, their patients they should defer to patient risk attitudes for many of the same reasons they defer to patient values, although with a caveat: physicians should defer to the higher-order desires of patients when considering their risk attitudes. This modification of what Makins terms the ‘deference principle’ is primarily driven by potential counterexamples in which a patient has a first-order desire with one risk attitude (either risk-seeking or averse) and a second-order desire that this risk attitude not be effective in guiding their choices.1 There are two reasons we might think people with obsessive–compulsive disorder (OCD) are particularly relevant patients for evaluating Makins’ proposal. Not only might their first-order risk attitudes be irrational, but many people with OCD also judge their own OCD behaviours to be excessive or unwarranted making them structurally similar to the counterexamples outlined above. Yet, I argue that recent research about risk and decision-making under uncertainty for those with OCD complicates Makins’ proposal by raising questions of whether and to what degree their risk attitudes are irrational such that they should not play a part in the surrogate decisions made by physicians. This places more …

In ‘Reification and Assent in Research Involving Those Who Lack Capacity’, Smajdor argues that adults with impaired capacity to grant informed consent (AWIC) are often excluded from participating in biomedical research because they cannot provide informed consent, leading to decreased chances AWIC will benefit from such research. Smajdor uses Honneth’s concept of reification to propose that securing assent (rather than consent) in cases involving AWIC offers patients moral recognition that is not tied to their capacities. Assent provides this recognition by including the patient in a shared moral sphere, highlighting her agency and worth without reducing her to her incapacity or a thing-to-be-managed. Assent also avoids grounding in, or a reliance on, the future development of autonomy (pp.5–6).1 Our recent research on patient and caregiver perspectives of potential paediatric deep brain stimulation (pDBS) for refractory obsessive–compulsive disorder (OCD) and dystonia demonstrates that paediatric neurosurgery patients desire the kind of recognition Smajdor associates with assent, and their caregivers largely agree.2 3 Since (generally) paediatric patients in the USA are unable to grant informed consent, their caregivers must provide it instead. This raises the question of how to properly integrate paediatric patients into the DBS decision-making process. One dimension along which this is evident is that …