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)

Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...

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)

In his book Objectivity, William Earle has attempted to give the phenomenologically intentional aspect of awareness its philosophical due. To sharpen the issues, it may be well to review some of the main points of his treatment. Earle combines a realist view of the object of awareness with a partially Hegelian conception of awareness. Awareness, according to Earle, involves three stages, recognizable as thesis, antithesis and synthesis. The thesis is made up of the subject and object intertwined, and not yet (...) distinguished from each other. The antithesis is constituted by a recoil of the subject from the object back upon itself. Earle terms this recoil a primary reflexivity of the subject, which, though ingredient in awareness, is not yet sufficient to constitute awareness. Whereas for Hegel the reflexive recoil of the subject back upon itself constitutes the object for the subject, for Earle this recoil of the subject in no way creates its object. The reflexive withdrawal of the subject from the object simply separates two metaphysically distinct entities. Hegel's separation of subject and object alienates the subject from himself; Earle's separation of subject and object alienates the subject from the world. But for both Earle and Hegel, knowledge of the object does not take place until a redemptive synthesis of subject and object occurs. In the Hegelian scheme the redemptive synthesis unifies the subject with himself. According to Earle, however, the redemptive synthesis achieves only knowledge of the object as other than the subject; that is, it is the object as distant from, therefore intended by, the subject that is known. The final stage in knowledge is thus constituted by a positive approach of the subject to a metaphysically distinct object. Earle must therefore insist, as he does, that immediate self-awareness is, in principle, impossible. He characterizes his own method as retrospectively reflexive, very different from the primary reflexivity involved in the constitution of awareness. To justify the validity and possibility of this retrospective reflexivity, he argues for the metaphysical identity of a subject forever outside of and beyond its own acts, and, of course, inaccessible to knowledge in a way that the world independent of the subject is not. (shrink)

I met Dan Callahan in 1986—when I came to pitch him. Coming from a sleek office setting near Boston, I was intrigued by The Hastings Center's higgledy‐piggledy environment where so many smart people got to work in a relaxed, inviting atmosphere. I had noticed that the Center was producing a great deal of policy work on a wide range of topics but didn't seem to go further than publishing the highly valuable guidance developed under Dan Callahan's leadership. I ended my (...) pitch, “Look, Dan, where Hastings gets bored and wants to go on to the next topic, my group in Boston gets interested.” To my great pleasure, and despite his skepticism, Dan accepted the pitch. Beyond his generous responsiveness to unproven young people, Dan had many other virtues. For one, he was a boundary crosser. (shrink)

Objective: To determine if the medical record might overestimate the quality of care through false, and potentially unethical, documentation by physicians.Design: Prospective trial comparing two methods for measuring the quality of care for four common outpatient conditions: structured reports by standardised patients who presented unannounced to the physicians’ clinics, and abstraction of the medical records generated during these visits.Setting: The general medicine clinics of two veterans affairs medical centres.Participants: Twenty randomly selected physicians from among eligible second and third year internal (...) medicine residents and attending physicians.Main measurements: Explicit criteria were used to score the medical records of physicians and the reports of SPs generated during 160 visits . Individual scoring items were categorised into four domains of clinical performance: history, physical examination, treatment, and diagnosis. To determine the false positive rate, physician entries were classified as false positive , false negative, true positive, and true negative.Results: False positives were identified in the medical record for 6.4% of measured items. The false positive rate was higher for physical examination and diagnosis than for history and treatment . For individual physician subjects, the false positive rate ranged from 0.098 to 0.397.Conclusions: These data indicate that the medical record falsely overestimates the quality of important dimensions of care such as the physical examination. Though it is doubtful that most subjects in our study participated in regular, intentional falsification, we cannot exclude the possibility that false positives were in some instances intentional, and therefore fraudulent, misrepresentations. Further research is needed to explore the questions raised but incompletely answered by this research. (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)

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)

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.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly (...) to include analysis of DNA collected from humans that has implications for human health. This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings. (shrink)

As we write, U.S. cities and states with extensive community transmission of Covid‐19 are in harm's way—not only because of the disease itself but also because of prior and current failures to act. During the 2009 influenza pandemic, public health agencies and hospitals developed but never adequately implemented preparedness plans. Focused on efficiency in a competitive market, health systems had few incentives to maintain stockpiles of essential medical equipment. Just‐in‐time economic models resulted in storage of only those supplies needed then. (...) At the same time, global purchasing in search of lower prices reduced the number of U.S. suppliers, with hospitals dependent on foreign companies. There is still a possibility that the pandemic will be manageably bad rather than unmanageably catastrophic in this country. Immediate, powerful, and sustained federal action could make the difference. (shrink)

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central (...) to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. (shrink)

“There's glory for you!”“I don't know what you mean by ‘glory,’ ” Alice said.Humpty Dumpty smiled contemptuously. “Of course, you dont—till I tell you. I meant ‘there's a nice knock-down argument.’”“But ‘glory’ doesn't mean a ‘nice knock-down argument,” Alice objected.“When I use a word,” Humpty Dumpty said, in rather a scornful tone, “it means just what I choose it to mean—neither more nor less.”“The question is,” said Alice, “whether you can make words mean so many different things.”“The question is,” said (...) Humpty Dumpty, “which is to be master, that's all.”When applied bioethics confronts the topic of futility, the question of who is to be master turns out to be central. Indeed, much of the literature on futility has focused on exactly this question: who gets to define the terms of the debate? Who gets to decide that treatment is “futile” and therefore allowably withheld or withdrawn? (shrink)

As part of the celebrations of The Hastings Center’s fiftieth anniversary, we are launching an annual prize, The David Roscoe Award for an Early‐Career Scholar’s Essay on Science, Ethics, and Society. The award is named in honor of David Roscoe, an accomplished essayist and recent past chair of the Hastings board. The award is intended to highlight the good scholarship that will take the field of bioethics forward into the next fifty years. It will recognize an early‐career scholar—someone who either (...) is currently pursuing a relevant academic degree or has earned one within the last six years—for a published essay on the social and ethical implications of advances in science and technology. More information about the award, along with online submission forms, is available on The Hastings Center’s website. (shrink)

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)

Hastings Center Report, Volume 52, Issue 2, Page inside_front_cover-inside_front_cover, March‐April 2022.

Bioethics in the twenty‐first century is confronting what one might call “collective‐impact problems.” The ethics guidance and policies that are developed to address these kinds of problems will affect not only individuals but everyone living and future generations too. With many collective‐impact problems, all parties will eventually be worse off if there is a failure to develop solutions to head off damage to the shared environment. However, the effects are not felt equally throughout and across societies; some groups are hit (...) far worse. To address collective‐impact problems, bioethics needs to recalibrate. Our field, and especially American bioethics, should find a better balance between individual rights and the best interests of the group, develop more robust tools for examining structural inequities that damage people's health and well‐being, and study how to engage the public in learning about and shaping ethics guidance for these complex problems. (shrink)

Le thème de la femme dans les pays en voie de développement continue à faire couler beaucoup d’encre dans les universités américaines où la division d’hier entre chercheurs confirmant l’exploitation de la femme et leurs collègues prouvant l’éveil de la conscience féministe se mue aujourd’hui en une analyse plus nuancée qui met en évidence la complexité et les contradictions du vécu féminin. En tant que chercheurs examinant la situation de la femme au Maghreb, que nous soyons « insider » ou (...) «... (shrink)

This paper advances a new paradigm in clinical ethics education that not only emphasizes development of individual cli but also focuses on the institutional context within which health care professionals work. This approach has been applied to the goal of improving the care provided to critically and terminally ill adults. The model has been adopted by about thirty hospitals and nursing homes; additional institutions will soon join the program, entitled Decisions Near the End of Life. Here, we describe the history (...) and rationale for this approach, its goals, pedagogical assumptions, and design. (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)