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)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

This essay summarizes key insights across the essays in the Hastings Center Report's special report “Time to Rebuild: Essays on Trust in Health Care and Science.” These insights concern trust and trustworthiness as distinct concepts, competence as a necessary but not sufficient input to trust, trust as a reciprocal good, trust as an interpersonal as well as structural phenomena, the ethical impermissibility of seeking to win trust without being trustworthy, building and borrowing trust as distinct strategies, and challenges to trustworthiness (...) posed by the contingent nature of science. Together, these insights stand to advance an area of research that we believe has been historically stymied by conceptual confusion and a long‐standing insistence on treating trust as a purely instrumental good. (shrink)

Background Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding their obligations to mitigate harms.Methods We conducted 40 semi-structured interviews with (...) developers of ML predictive analytics applications for health care in the United States.Results Participants varied widely in their perspectives on personal responsibility and included examples of both moral engagement and disengagement, albeit in a variety of forms. While most (70%) of participants made a statement indicative of moral engagement, most of these statements reflected an awareness of moral issues, while only a subset of these included additional elements of engagement such as recognizing responsibility, alignment with personal values, addressing conflicts of interests, and opportunities for action. Further, we identified eight distinct categories of moral disengagement reflecting efforts to minimize potential harms or deflect personal responsibility for preventing or mitigating harms.Conclusions These findings suggest possible facilitators and barriers to the development of ethical ML that could act by encouraging moral engagement or discouraging moral disengagement. Regulatory approaches that depend on the ability of ML developers to recognize, accept, and act on responsibility for mitigating harms might have limited success without education and guidance for ML developers about the extent of their responsibilities and how to implement them. (shrink)

One way of conceptualizing community engaged teaching is as a mode of teaching that directly foregrounds engaging communities who are experiencing particular social realities that are theorized and discussed in classroom settings. Tracing the trajectory of community engaged teaching from the pedagogical paradigm of civil rights era Freedom Schools to contemporary manifestations of their legacy, the author offers two narrative accounts. The first is an account of the emergence of Freedom Schools as quintessential examples of community engaged teaching that exemplify (...) the character and aims of public philosophy as social praxis. The second is an illustrative account of the lessons to be drawn from the Freedom Schools by all who aspire to pursue community engaged teaching in a manner that extends their legacy. Ironically, the racist deployment of the system of education served as the impetus for what took shape as the Freedom Summer's emphasis on radical, liberation‐oriented, and mutually transformative modes of community‐engaged teaching. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. Design Mixed method evaluation involving five substudies, before and after design. Setting NHS hospitals in the United Kingdom. Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. Intervention The SPI1 (...) was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening. (shrink)

Franklin (U. of Colorado) challenges the postmodern or constructivist criticism of science and the post-Kuhnsian climate that dismisses science as a bit of a shady business. His nine essays, most previously published, defend science as a reasonable enterprise based on valid experimental evidence and critical discussion, which provides people with knowledge of the physical world. After establishing his own view of constructivism and postmodernism, he sets out four case studies then uses them to examine issues such as how discord (...) between experimental results is resolved, the calibration of experimental apparatus, and its legitimate use in validating results, and how experimental results provide reasonable grounds for a belief in both the truth of physical theories and the existence of the entities the theories concern. Annotation copyrighted by Book News, Inc., Portland, OR. (shrink)

We propose protein localization dependent signal activation (PLDSA) as a model to describe pre‐existing protein partitioning between the cytosol, and membrane surface, as a means to modulate signal activation, specificity, and robustness. We apply PLDSA to explain possible molecular links between type II diabetes mellitus (T2DM) and Alzheimer's disease (AD) by describing Ca+2‐mediated interactions between the Src non‐receptor tyrosine kinase and p52Shc adaptor protein. We suggest that these interactions may serve as a contributing factor to disease development and progression. In (...) particular, we propose that signaling response is regulated, in part, by Ca+2‐mediated partitioning of lipid‐bound and soluble forms of Src and p52shc. Thus, protein‐protein interactions that drive signaling in response to extracellular ligand binding are also mediated by partitioning of signaling proteins between membrane‐bound and soluble populations. We propose that PLDSA effects may explain, in part, the evolutionary basis of promiscuous protein interaction domains and their importance in cellular function. (shrink)

Scientific articles exemplify standard functional units constraining argumentative structures. Severe space limitations demand every paragraph and illustration contribute to establishing the paper's claims. Philosophical testing and confirmation models should take into account each paragraph, table, and illustration. Hypothetico-Deductive, Bayesian Inductive, and Inference-to-the-Best-Explanation models do not, garbling the logic of papers. Micro-analysis of the fundamental paper in plate tectonics reveals an argumentative structure commonplace in science but ignored by standard philosophical accounts that cannot be dismissed as mere rhetorical embellishment. Papers with (...) illustrations often display a second argumentative structure differing from the text's. Constraints on adequate testing and confirmation analyses are adduced. “Experiments are about the assembly of persuasive arguments, ones that will stand up in court. … The task at hand is to capture the building-up of a persuasive argument about the world even in the absence of the logician's certainty.”—Galison, How Experiments End, 277. (shrink)

A familiar criticism of bioethics charges it with being more conceptual than practical—having little application to the “real world.” In order to answer its critics and keep its feet on the ground, bioethics must utilize the social sciences more effectively. Empirical research can provide the bridge between conceiving a moral vision of a better world, and actually enacting it.

Across the world, an authoritarian and exclusionary form of populism is gaining political traction. Historically, some populist movements have been democratic and based on a sense of inclusive justice and the common good. But the populism on the rise at present speaks and acts otherwise. It is challenging constitutional democracies. The polarization seen in authoritarian populism goes beyond the familiar left-right political spectrum and generates disturbing forms of extremism, including the so-called alternative right in the United States and similar ethnic (...) and nationalistic political movements in other countries. The field of bioethics will be profoundly affected if authoritarian populism displaces constitutional democracy. But the field has a significant contribution to make to rebuilding the communal and civic foundations upon which constitutional democracy rests. (shrink)

Incomplete Archaeologies takes a familiar archaeological concept--assemblages--and reconsiders such groupings, collections and sets of things from the perspective of the work required to assemble them. The discussions presented here engage with the practices of collection, construction, performance and creation in the past (and present) which constitute the things and groups of things studied by archaeologists--and examine as well how these things and thing-groups are dismantled, rearranged, and even destroyed, only to be rebuilt and recreated. The ultimate aim is to reassert (...) an awareness of the incompleteness of assemblage, and thus the importance of practices of assembling (whether they seem at first creative or destructive) for understanding social life in the past as well as the present. The individual chapters represent critical engagements with this aim by archaeologists presenting a broad scope of case studies from Eurasia and the Mediterranean. Case studies include discussions of mortuary practice from numerous angles, the sociopolitics of metallurgy, human-animal relationships, landscape and memory, the assembly of political subjectivity and the curation of sovereignty. These studies emphasise the incomplete and ongoing nature of social action in the past, and stress the critical significance of a deeper understanding of formation processes as well as contextual archaeologies to practices of archaeology, museology, art history, and other related disciplines. Contributors challenge archaeologists and others to think past the objects in the assemblage to the practices of assembling, enabling us to consider not only plural modes of interacting with and perceiving things, spaces, human bodies and temporalities in the past, but also to perhaps discover alternate modes of framing these interactions and relationships in our analyses. Ultimately then, Incomplete Archaeologies takes aim at the perceived totality not only of assemblages of artefacts on shelves and desks, but also that of some of archaeology's seeming-seamless epistemological objects"--From publisher's website. (shrink)

_Explores convergences between the ideas of Friedrich Nietzsche and African American thought._.

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (shrink)

Henry Beecher was a distinguished professor of anesthesia and clinical investigator at Harvard Medical School. He became an iconic figure in bioethics, best known for his 1966 article describing 22 examples of unethical clinical research. This is one of the most frequently cited articles on ethics in the medical literature. Indeed, it may be seen as marking a watershed in the moral climate of medical research. In his history of bioethics, Albert Jonsen characterized Beecher as one of the “stars in (...) the bioethical firmament”. Daniel Callahan, founder of the Hastings Center, explained Beecher’s impact in a 1991 interview:“I think the role of Henry Beecher was very important in the mid 60s when he blew the... (shrink)

Drawing the line on physician assistance in physician-assisted death continues to be a contentious issue in many legal jurisdictions across the USA, Canada and Europe. PAD is a medical practice that occurs when physicians either prescribe or administer lethal medication to their patients. As more legal jurisdictions establish PAD for at least some class of patients, the question of the proper scope of this practice has become pressing. This paper presents an argument for restricting PAD to the terminally ill that (...) can be accepted by defenders as well as critics of PAD for the terminally ill. The argument appeals to fairness-based paternalism and the social meaning of medical practice. These two considerations interact in various ways, as the paper explains. The right way to think about the social meaning of medical practice bears on fair paternalism as it relates to PAD and vice versa. The paper contends that these considerations have substantial force when directed against proposals to extend PAD to non-terminally ill patients, but considerably less force when directed against PAD for the terminally ill. The paper pays special attention to the case of non-terminally ill patients who suffer from treatment-resistant depression, as these patients present a potentially strong case for extending PAD beyond the terminally ill. (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.

Here at the Center, we had the privilege of seeing how Dan Callahan lived out his last days and weeks. True to his nature, Dan never stopped thinking or writing. Indeed, his wife Sidney told me that he finished his last essay one day before his death, on July 16th, insisting that she help him get to the computer so he could discuss it with a colleague. “It's my last one,” he told her with his characteristic self‐awareness. Dan also chose (...) the last topic he would focus on: climate change. At a December 2018 board meeting, Dan presented his desire to develop a workshop to explore the ways in which bioethics in general, and The Hastings Center in particular, might be able to make a valuable contribution to addressing the problem of global warming. (shrink)

In my dissertation, I develop the idea that Nietzsche's perspectivism constitutes a thesis on subjectivity, i.e., a thesis that asserts the indeterminate nature of both reality and the issue of human significance. Simply put, I contend that Nietzsche's perspectivism connotes a broad ranging anti-foundationalism that denies not only the reality of a fixed world of being, but also the idea that human significance is objectively defined in terms of a universal human ideal. ;In addition, I also argue that although Nietzsche (...) heralds the idea of subjectivity, in so far as he develops his perspectivism, he is himself unable to come to terms with it. More precisely, I contend that rather than overcoming a psychological need for objectivity, Nietzsche satiates this need by developing a naturalized account of existence, one that he ultimately appeals to as a means of justifying his own peculiar conception of human significance. ;Structurally, the insights of this project emerge as a consequence of three different discussions. The first is a preliminary discussion that sets the stage for an historical treatment of Nietzsche's perspectivism. Highlighting the fact that much of the contemporary focus on Nietzsche's perspectivism is motivated by a desire to establish the overall consistency of his thought, this first discussion explores the character and shortcomings of the conservative attempt to interpret Nietzsche's philosophy as wholly committed to truth and the radical attempt to interpret it as a complete abandonment of truth. ;Concentrating exclusively on the historical development of Nietzsche's perspectivism, the second discussion focuses on the shift from what first emerges as a very conservative thesis concerning the structure of cognition and the possibility of knowledge to what later emerges as a very radical and broad ranging anti-foundationalism. Highlighting the tension between the pluralistic implications of this perspectivism and the dogmatic nature of many other aspects of Nietzsche's thought, the third discussion explores the psychological underpinnings of Nietzsche's philosophical inconsistency. (shrink)

I have come to believe that the whole framework of our current thought is about to begin a long and radical transformation, based on what I shall call a new science of pure consciousness. The content of most of the matters to be considered by this science have hitherto been the concern of some areas of religion, particularly what in our culture we call ‘mysticism’; but the treatment of it would legitimately be called scientific. Thus one aspect of the transformation (...) would be to overcome that apparent conflict between ‘science’ and ‘religion’, which has been so characteristic of our culture over the last few centuries. (shrink)

Two papers in this issue address the limits of surrogates’ authority when making life-and-death decisions for dying family members or friends. Using palliative sedation as an example, Jeffrey Berger offers a conceptual argument for bounding surrogate authority. Since freedom from pain is an essential interest, when imminently dying, cognitively incapacitated patients are in duress and their symptoms are not manageable in any other way, clinicians should be free to offer palliative sedation without surrogate consent, although assent should be sought and (...) every effort made to work with surrogates as harmoniously as possible. Ellen Robinson and her colleagues report on the implementation of a policy at Massachusetts General Hospital that supports do-not-resuscitate orders when cardiopulmonary resuscitation is likely to be ineffective or harmful, even if surrogates disagree. The “Doing No Harm” policy at MGH allows for what MGH calls a “medically indicated DNR” and what in some other places is called “a unilateral DNR”—the writing of an order not to provide cardiopulmonary resuscitation, regardless of surrogate disapproval. These kinds of DNR policies have emerged in some hospitals across the country and for much the same reason that Berger provides in his argument regarding palliative sedation. I support the reasoning and the policies in both the Berger and Robinson papers. However, as the authors would most likely agree, the problems they aim to remedy are not simply about the scope of surrogate and professional authority. They are also symptoms of inattention to professional obligations and system failures. (shrink)

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because “race” has some correlation with biological and genetic characteristics, there has been a call not to “throw the baby out with the bathwater” by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as a (...) proxy for biology or genetics. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including (...) patients’ motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. (shrink)

Calibration, the use of a surrogate signal to standardize an instrument, is an important strategy for the establishment of the validity of an experimental result. In this paper, I present several examples, typical of physics experiments, that illustrate the adequacy of the surrogate. In addition, I discuss several episodes in which the question of calibration is both difficult to answer and of paramount importance. These episodes include early attempts to detect gravity waves, the question of the existence of a 17–keV (...) neutrino, and the question of the existence of a Fifth Force in gravity. I argue that in these more complex cases, the adequacy of calibration, in an extended sense, was both considered and established. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

We study arithmetic and hyperarithmetic degrees of categoricity. We extend a result of E. Fokina, I. Kalimullin, and R. Miller to show that for every computable ordinal $\alpha$, $\mathbf{0}^{}$ is the degree of categoricity of some computable structure $\mathcal{A}$. We show additionally that for $\alpha$ a computable successor ordinal, every degree $2$-c.e. in and above $\mathbf{0}^{}$ is a degree of categoricity. We further prove that every degree of categoricity is hyperarithmetic and show that the index set of structures with degrees (...) of categoricity is $\Pi_{1}^{1}$-complete. (shrink)