Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. (...) Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

Research Ethics, Volume 18, Issue 2, Page 132-150, April 2022. Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to (...) explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

Because idealizations frequently advance scientific understanding, many claim that falsehoods play an epistemic role. In this paper, we argue that these positions greatly overstate idealiza...

Under what conditions does machine learning (ML) model opacity inhibit the possibility of explaining and understanding phenomena? In this article, I argue that nonepistemic values give shape to the ML opacity problem even if we keep researcher interests fixed. Treating ML models as an instance of doing model-based science to explain and understand phenomena reveals that there is (i) an external opacity problem, where the presence of inductive risk imposes higher standards on externally validating models, and (ii) an internal opacity (...) problem, where greater inductive risk demands a higher level of transparency regarding the inferences the model makes. (shrink)

East Asians and Westerners differ in various aspects of perception and cognition. For example, visual memory for East Asians is believed to be more influenced by the contextual aspects of a scene than is the case for Westerners (Masuda & Nisbett, 2001). There are also differences in visual search: for Westerners, search for a long line among short is faster than for short among long, whereas this difference does not appear to hold for East Asians (Ueda et al., submitted). However, (...) it is unclear how these group-level differences originate. To investigate the extent to which they depend upon environment, we tested visual search and visual memory in East Asian immigrants who had lived in Canada for different amounts of time. Recent immigrants were found to exhibit no search asymmetry, unlike Westerners who had spent their lives in Canada. However, immigrants who had lived in Canada for more than two years showed performance comparable to that of Westerners. These differences could not be explained by the general analytic/holistic processing distinction believed to differentiate Westerners and East Asians, since all observers showed a strong holistic tendency for visual recognition. Results instead support the suggestion that exposure to a new environment can significantly affect the particular processes used to perceive a given stimulus. (shrink)

In this chapter, we address the roles that exemplars might play in a comprehensive response to epistemic injustice. Fricker defines epistemic injustices as harms people suffer specifically in their capacity as (potential) knowers. We focus on testimonial epistemic injustice, which occurs when someone’s assertoric speech acts are systematically met with either too little or too much credence by a biased audience. Fricker recommends a virtue­theoretic response: people who do not suffer from biases should try to maintain their disposition towards naive (...) testimonial justice, and those who find themselves already biased should cultivate corrective testimonial justice by systematically adjusting their credence in testimony up or down depending on whether they are hearing from someone whom they may be biased against or in favor of. We doubt that the prominent admiration­emulation model of exemplarism will be much use in this connection, so we propose two ways of learning from negative exemplars to better conduct one’s epistemic affairs. In the admiration­emulation model, both the identification of what a virtue is and the cultivation of virtues identified thusly proceed through the admiration of virtuous exemplars. We show that this model has serious flaws and argue for two alternatives: the envy­agonism model and the ambivalence­avoidance model. (shrink)

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

Trust makes cooperation possible. It enables us to learn from others and at a distance. It makes democratic deliberation possible. But it also makes us vulnerable: when we place our trust in another’s word, we are liable to be deceived—sometimes intentionally, sometimes unintentionally. Our evolved mechanisms for deciding whom to trust and whom to distrust mostly rely on face-to-face interactions with people whose reputation we can both access and influence. Online, these mechanisms are largely useless, and the institutions that might (...) supplant them need to have their own trustworthiness verified. Currently, those institutions are mostly corporations such as Facebook and Twitter, which have checkered track records at best. To make matters worse, the social media sector is a natural monopoly, and companies like Facebook have shown that they are willing to use their market power unscrupulously. For these reasons, we argue that social media should be treated like other natural monopolies: it should either be nationalized, highly regulated, or broken up through antitrust legal actions. (shrink)

Political ethics, a subfield of applied ethics, is concerned with normative questions about voters, politicians, lobbyists, and other individual political agents. Compared with other fields in applied ethics political ethics has not developed into an area of intense interest in academic philosophy. Debates over the main questions in political ethics occur in mainstream news, on social media, in living rooms and neighborhood bars, etc., but for the most part have not bled over into the pages of philosophy journals and books. (...) This volume aims to fill this gap in the philosophical literature. It contains seventeen original papers by a diverse range of leading scholars on central questions in political ethics. (shrink)

With regard to the morality of war, political philosophers have defended one of two basic positions, just war theory or absolute pacifism, but between thesetwo opposing views are various moderate positions. Throughout its long history, the Catholic Church has taken various stances, some strong and others more moderate, on the question of war. Unfortunately, the most recent formulation of the Church’s position is a moderate position without clear guidelines. In this paper I argue that if one wishes to maintain that (...) war is permissible in certain circumstances, it is important to have a position which rules out certain other types of wars as wrong in principle. Neither conditional pacifism nor the modern formulation of just war theory provides such a principled position; instead, the most plausible attempt to place the appropriate limits on war ought to begin from traditional just war theory. This view, which I refer to as strict just war theory, emphasizes particular aspects of traditional just war theory. (shrink)

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...) that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

Demystifying Legal Reasoning defends the proposition that there are no special forms of reasoning peculiar to law. Legal decision makers engage in the same modes of reasoning that all actors use in deciding what to do: open-ended moral reasoning, empirical reasoning, and deduction from authoritative rules. This book addresses common law reasoning when prior judicial decisions determine the law, and interpretation of texts. In both areas, the popular view that legal decision makers practise special forms of reasoning is false.

Coregulation refers to the process by which relationship partners form a dyadic emotional system involving an oscillating pattern of affective arousal and dampening that dynamically maintains an optimal emotional state. Coregulation may represent an important form of interpersonal emotion regulation, but confusion exists in the literature due to a lack of precision in the usage of the term. We propose an operational definition for coregulation as a bidirectional linkage of oscillating emotional channels between partners, which contributes to emotional stability for (...) both partners. We propose several distinctions and raise unanswered questions that will need to be addressed in order to understand the relevance of coregulation for well-being in adulthood. (shrink)

What do humility, intellectual humility, and open-mindedness mean in the context of inter-group conflict? We spend most of our time with ingroup members, such as family, friends, and colleagues. Yet our biggest disagreements —— about practical, moral, and epistemic matters —— are likely to be with those who do not belong to our ingroup. An attitude of humility towards the former might be difficult to integrate with a corresponding attitude of humility towards the latter, leading to smug tribalism that masquerades (...) as genuine virtue. These potentially conflicting priorities have recently come to the fore because “tribal epistemology” has so thoroughly infected political and social discourse. Most research on these dispositions focuses on individual traits and dyadic peer-disagreement, with little attention to group membership or inter-group conflict. In this chapter, we dilate the social scale to address this pressing philosophical and social problem. (shrink)

The author argues for the following as constituents of the moral virtue of open-mindedness: a second-order awareness that is not reducible to first-order doubt; strong moral concern for members of the moral community; and some freedom from reactive habit patterns, particularly with regard to one's self-narratives, or equanimity. Drawing on Buddhist philosophical accounts of equanimity, the author focuses on the third constituent, equanimity, and argues that it is a central, but often ignored, component of the moral virtue of open-mindedness, and (...) its absence can explain many failures of open-mindedness. (shrink)

It is widely conceded by liberals that institutions alone are insufficient to ensure that citizens behave in the ways required for a liberal state to flourish, be stable, or function at all. A popular solution proposes cultivating virtues in order to secure the desired behaviours of citizens, where institutions alone would not suffice. A range of virtues are proposed to fill a variety of purported gaps in the liberal political order. Some appeal to virtues in order to secure state stability; (...) Rawls, for instance, claims that ‘citizens must have a sense of justice and the political virtues that support political and social institutions’ in order to ensure an ‘enduring society’. For Galston, citizens must possess a range of virtues in order for the state to function, including the virtues of courage, independence, tolerance, willingness to engage in public discourse, and law-abidingness. (shrink)

People sometimes use speech to interfere with other people’s speech, as in the case of a heckler sabotaging a lecture with constant interjections. Some people claim that such interference infringes upon free speech. Against this view, we argue that where competing speakers in a public forum both have an interest in speaking, free speech principles should not automatically give priority to the ‘official’ speaker. Given the ideals underlying free speech, heckling speech sometimes deserves priority. But what can we say, then, (...) about situations in which heckling clearly seems to infringe upon people’s civil liberties, in a way that intuitively justifies intervention? In such cases, we argue, heckling infringes upon people’s associative freedom. We present and defend an ethical framework for the institutional management of ‘Speech Fights’, geared around this insight. (shrink)

This paper addresses the ways that we can understand and transform our strong emotions and how this project contributes to moral and spiritual development. To this end, I choose to think with two Tibetan Buddhist thinkers, both of whom take up the question of how passionate emotions can fit into spiritual and moral life: the famous, playful yogin Shabkar Tsodruk Rangdrol (1781–1851) and the wandering, charismatic master Patrul Rinpoche (1808–1887). Shabkar's The Autobiography of Shabkar provides excellent examples of using one's (...) own passionate emotions to connect to others and gain insight into the world. Patrul Rinpoche's The Words of My Perfect Teacher (kun bzang bla ma'i zhal lung) focuses on passionate empathy with the emotions of others. Drawing on these texts, I present a (distinctly Buddhist) conception of a passionate life and argue that passionate emotional experience is a central part of moral and spiritual development more broadly construed. (shrink)

Exploring the intimate tie between body movement and space and time, Lee begins with the position that body movement generates space and time and explores the ethical implications of this responsibility for the situations one’s body movements generate. Whiteness theory has come to recognize the ethical responsibility for situations not of one’s own making and hence accountability for the results of more than one’s immediate personal conscious decisions. Because of our specific history, whites have developed a particular embodiment and body (...) movement that generates places that can only be characterized as more comfortable and more enabling to whites. (shrink)

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how should they (...) be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps. (shrink)

The question of authenticity centers in the lives of women of color to invite and restrict their representative roles. For this reason, Gayatri Chakravorty Spivak and Uma Narayan advocate responding with strategic essentialism. This paper argues against such a strategy and proposes an epistemic understanding of the question of authentic- ity. The question stems from a kernel of truth—the connection between experience and knowledge. But a coherence theory of knowledge better captures the sociality and the holism of experience and knowledge.

This essay explores how the distinctively anthropological concept of culture provides uniquely valuable insights into the workings of science in its cultural context. Recent efforts by anthropologists to dislodge the traditional notion of culture as a homogenous, stable whole have opened up a variety of ways of imagining culture that place power differentials, flux, and contradiction at its center. Including attention to a wide variety of social domains outside the laboratory, attending to the ways nonscientists actively engage with scientific knowledge, (...) and focusing on the complex interactions that flow both into and out of research laboratories are ways the activities of both scientists and nonscientists can be situated in the heterogeneous matrtx of culture. Three images—the citadel, the rhizome, and the string figure—allow us to picture the discontinuous ways science both permeates and is permeated by cultural life. (shrink)

Empirical psychology documents widespread evidence of bias in the ways that people select, interpret, and selectively interpret evidence in forming and revising their beliefs. These biases can function to create and perpetuate epistemologies of ignorance. I argue that virtue epistemology can help us explain what goes epistemically wrong in these cases, and can offer positive advice, orienting us toward ways to right it. In particular, I defend the virtue approach from epistemic situationist worries about the empirical plausibility of individual agents' (...) ability to develop corrective virtues. I argue that situational virtues are genuine responsibilist virtues, and are one of the tools at our disposal for overcoming epistemologies of ignorance. (shrink)

The rule of rescue describes the moral impulse to save identifiable lives in immediate danger at any expense. Think of the extremes taken to rescue a small child who has fallen down a well, a woman pinned beneath the rubble of an earthquake, or a submarine crew trapped on the ocean floor. No effort is deemed too great. Yet should this same moral instinct to rescue, regardless of cost, be applied in the emergency room, the hospital, or the community clinic? (...) -/- In health care, the desire to save lives at any cost must be reconciled with the reality of resource scarcity. As one example, the estimated cost for prophylactic Factor VIII to treat one patient with hemophilia for one year is $300,000. Costs of this magnitude have been accepted by public and private insurers in the developed world, even though, in principle, these sums could provide greater overall health benefit if allocated to pay for the unmet health care needs of many other patients. Looking forward, however, broad application of the rule of rescue will be increasingly untenable. But the moral instinct will remain: the desire to help those weakest among us, especially when their small numbers allow us to see them as unique individuals. What, then, is the ethical framework that can guide coverage and reimbursement decisions for orphan drugs into the future? (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

Colombia, a country at civil war for over 50 years, has one of the highest rates of landmine injury in the world. This article is based on ethnographic research conducted at the Amputation and Rehabilitation Unit of Bogota’s Central Military Hospital. Through an ethnographic description of surgical amputation and rehabilitation, I examine medical understandings of vitality and masculinity in respect to the senses – primarily that of pain in the act of amputation.

We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about (...) how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems. (shrink)

We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about (...) how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems. (shrink)

Exploring key topics in contemporary aesthetics, this work analyzes the issues that arise from the unique works of Frank Sibley (1923-1996), who developed a distinctive aesthetic theory through a number of papers published between 1955 and 1995. Here, thirteen philosophical aestheticians bring Sibley's insight into a contemporary framework, exploring the ways his ideas foster important new discussion about issues in aesthetics. This collection will interest anyone interested in philosophy, art theory, and art criticism.

In the Buddhist ethical traditions, equanimity along with love, compassion, and sympathetic joy form what are called the four boundless qualities, which are affective states one cultivates for moral and spiritual development. But there is a sense in which equanimity seems very unlike the three others: love, compassion, and sympathetic joy all imply an emotional investment in others, whereas equanimity seems to imply an absence of such investment. This observation has provoked debate as to how to properly understand the relationship (...) between equanimity and the other three qualities. In this paper, I propose that equanimity - like love, compassion, and sympathetic joy - is itself a virtue of good intimate relationships and not in conflict with such virtues. (shrink)

Madison Kilbride recently argued that insurance ) should cover in vitro fertilisation with preimplantation genetic testing services for couples at high risk of having a child affected with a genetic condition. She argues that IVF-PGT meets CMS’s definition of ‘medically necessary care’, where such care includes ‘services or supplies needed to diagnose or treat an illness, injury, condition, disease or its symptoms’. Kilbride argues that IVF-PGT satisfies this definition in two ways: as a diagnostic tool and as a treatment. Contradicting (...) Kilbride, however, I argue that IVF-PGT provides neither diagnosis nor treatment under CMS’s definition. Thus, as long as we accept CMS’s definition of medically necessary care—which Kilbride does, explicitly—it follows that IVF-PGT does not count as medically necessary care. Still, there may be other reasons to conclude that IVF-Preimplantation genetic testing should be covered, and so, it would be a mistake to reject Kilbride’s conclusion altogether. The problem is simply that Kilbride’s argument—that the procedure should be covered because it is medically necessary per CMS’s definition—is not sound. I conclude by discussing a number of other genetic services that are not currently being covered despite the fact that they do seem to satisfy CMS’s definition of ‘medically necessary diagnosis or treatment’. These services, I argue, should be provided under CMS before we consider expanding coverage to include elective procedures such as IVF-PGT. (shrink)

The last decade has witnessed renewed attempts to regulate the conduct of transnational corporations. One way to do this is via global ethics codes. This paper examines seven such codes (the Sullivan Principles, UN Center for Transnational Corporations’ Draft Code, OECD Guidelines, ILO's Tripartite Declaration, the Caux Round Table Principles for Business, Global Compact, and the United Nations Norms) to determine their coverage of human rights and concludes that if these initiatives succeed, particularly the more recent codes, transnational corporations may (...) emerge as a major force in promoting human rights globally. (shrink)

Volume 19, Issue 9, September 2019, Page 62-64.

In Physics 2.4–6, Aristotle offers an account of things that happen “by luck” and “spontaneously”. Many of these things are what we might think of as “lucky breaks”: cases where things go well for us, even though we don’t expect them to. In Physics 2.5, Aristotle illustrates this idea with the case of a man who goes to the market for some reason unrelated to collecting a debt he is owed. While he is there, this man just so happens to (...) run into his debtor and get his money back—which is what he “wanted” all along. This case has a number of features that have proved puzzling. Most notably, Aristotle seems to think that while “it happened accidentally to him to come and to do this for the sake of getting the money”, nevertheless the man “did not come for the sake of this”—though he “would have”. What must such a proceeding be like to be described in these ways? Physics 2.4–6 makes several important moves towards answering this question. One of them—among the earliest and seemingly a foundational one—is the claim that “for the sake of something are as many things as could be done by thought and by nature”. The aim of this paper is to identify the role that this claim plays in Aristotle’s account of spontaneous proceedings. It defends two main claims. First, Aristotle’s suggestion that spontaneous proceedings could be done by nature and by thought is the product of a more general strategy. His approach is to sketch an intuitive pattern of explanation for proceedings that happen for the sake of something in the ordinary—non-spontaneous—way, and then to try to extend that model to the case of things that do so spontaneously, preserving as much of it as possible. Applying this strategy reveals that whereas nature and thought in fact function as efficient causes of ordinary proceedings that are for the sake of something, this cannot be the case in spontaneous ones. Instead, nature and thought could function as their causes. Second, I argue that Aristotle’s implementation of this strategy is rooted in his account of causation and especially Physics 2.3’s list of “modes” of causes. When he claims that spontaneous proceedings “could” be done by nature and by thought, he is saying that nature and thought are their efficient causes in capacity. In the practical case, spontaneous proceedings are caused by agents who have certain capacities, connected with their desires and abilities. In the right circumstances, these agents would actively exercise those capacities in acting for the sake of a given end. (shrink)

In this issue of the Hastings Center Report, James Sabin and his colleagues ask what responsibility investigators in a learning health organization have to patients when research—particularly research of which patients might be unaware—illuminates problematic aspects of the patients' care. Sabin and his colleagues were confronted by this question in the midst of designing a randomized controlled trial that sought to determine if an educational intervention targeted at patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants. Worried (...) about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a “workaround.” But the “workaround,” I suggest, was not a solution to the negligent bystander problem. Nor was it a solution to the problem as I would alternatively frame it—how to address instances of suboptimal patient care identified through research within learning health organizations. (shrink)