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...

Thomas Lyson argued that civic markets were possible and could have positive impacts on rural development. Increasingly local governments are being forced into market-based governance regimes of privatization, decentralization and free trade. This article explores the impacts of these trends on rural local governments in the US. These market trends can erode civic foundations, but recent data show local governments are balancing markets with civic concerns and giving increased attention to citizen interests in the service delivery process.

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)

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)

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)

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, “incidental” or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on (...) the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power aforded by new genomic analyses may lead to fndings of statistical, but not necessarily clinical, signifcance. This paper addresses the issues to be considered in deciding whether and how to disclose “incidental” fndings or other fndings of clinical signifcance that arise in the course of human genomic and genetic research. What research results should be ofered, and what should not be ofered? For which research should individual results be ofered to research participants, when should they be ofered, how, and to whom? (shrink)

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)

There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social need (...) for accuracy and thus trying to avoid miscategorization.As Jay Cohn describes in this issue, medical practitioners in particular have used racial and ethnic categories to “enhance diagnostic and therapeutic precision.” He argues for retaining this practice. The plea, motivated by genuine concern for patients, is to avoid “throwing the baby out with the bathwater.” However, Cohn and others mischaracterize the nature of the debate. The argument is not about whether differences among populations exist, or even whether differences among “races” exist. (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)

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)

: 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)

Physically frail, badly educated girls, brought up to lead useless lives as idle gentlewomen, married to dominant husbands, and relegated to "separate spheres" of life—these phrases have often been used to describe Victorian upper-middle-class women. M. Jeanne Peterson rejects such formulations and the received wisdom they embody in favor of a careful examination of Victorian ladies and their lives. Focusing on a network of urban professional families over three generations, this book examines the scope and quality of gentlewomen's education, their (...) physical lives, their relationship to money, their experience of family illness and death, and their relationships to men (brothers and friends as well as fathers and husbands). Peterson also examines the prominent place of work in the lives of these "leisured" Victorian ladies, both single and married. Far from idle, the mothers, wives, and daughters of Victorian clergymen, doctors, lawyers, university dons, and others were accomplished and productive members of society who made substantial public and private contributions to virtually every sphere of Victorian life. (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.

“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)

In 1962 appeared one of the classic articles in Anglo-Saxon manuscript studies, the publication of two eleventh-century fragments of leaves of Old English found in the binding of a seventeenth-century printed book in the library of the University of Kansas, Lawrence. The fragment that more nearly concerns the present article now carries the shelf mark Pryce MS C2:1 in the Kenneth Spencer Research Library . It is a large part of a single leaf from The Legend of the Holy Cross (...) before Christ, an edifying work known in full only in a twelfth-century copy, Oxford, Bodleian Library, MS Bodley 343, fols. 14v–20v . Working from a photograph the great paleographer and codicologist N. R. Ker attributed the hand of the Kansas fragment to the scribe who also wrote the texts of two bits of the same work found in the library of Matthew Parker, archbishop of Canterbury , at Corpus Christi College, Cambridge, now MS 557 . He concluded, no doubt rightly, that all three are part of one manuscript. (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)

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)

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)

Bioethics is reexamining how to implement diversity, equity, inclusion, and justice concerns into scholarship. However, bioethicists should question the categories used to define diversity. The act of categorization is value laden, and classification systems confer power and benefits and generate harms. For example, what conditions count as disabilities? We should consider the equity implications of offering only “male” and “female” options for self‐identification in health records. However, we should also interrogate all ideas about categorization, including how categories are formed, why (...) they are formed, and who decides. Bioethicists cannot comprehend fully what equity and justice mean for underrepresented, underserved, or marginalized people until there is an understanding of how the boundaries of marginalization are created. (shrink)