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...

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)

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)

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)

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)

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)

: 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.

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)

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)

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

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)

A belief that high school students have the cognitive ability to analyze and assess moral choices and should be encouraged to do so but have rarely been helped to do so was the motivation for developing Exploring Bioethics, a six-module curriculum and teacher guide for grades nine through twelve on ethical issues in the life sciences. A multidisciplinary team of bioethicists, science educators, curriculum designers, scientists, and high school biology teachers worked together on the curriculum under a contract between the (...) National Institutes of Health and Education Development Center, a nonprofit research and development organization with a long history of innovation in science education. At the NIH, the Department of Bioethics within the Clinical Center and the Office of Science Education within the Office of the Director guided the project.Our overarching goal for Exploring Bioethics was to introduce students to bioethics as a field of inquiry and to enable them to develop ethical reasoning skills so they could move beyond “gut reactions” to more nuanced positions. (shrink)

What is bioethics to do when it strives to assess the quality of its research and scholarship and when it needs to justify its work to prospective funders, especially a funder like the National Institutes of Health that privileges empirical discovery? In “A Conceptual Model for the Translation of Bioethics Research and Scholarship,” Debra Mathews and colleagues take an important first step at advancing an answer. The authors describe what they call a translational process, whereby bioethics “outputs” are translated into (...) changes of three types: in thinking, practice, and policy. It goes nearly without saying that bioethics research and scholarship must be held accountable for changes in thinking. What raison d'etre do we have if not to deepen thinking, question assumptions, and encourage ourselves and others to examine hard issues from novel approaches? Assuredly it is hard to assess quality, and even harder to assess specific changes in thinking for which high-quality scholarship may be responsible, but it is a necessary goal and one for which we should strive without reservation. Bioethics should also affect policy and practice. We should document how it does and the extent to which it does as often and as prominently as possible. However, let us be wary of pinning too much on practice and policy changes as the primary way of establishing bioethics’ worth. (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)

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)

“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)

Recent experiments have been used to “edit” genomes of various plant, animal and other species, including humans, with unprecedented precision. Furthermore, editing the Cas9 endonuclease gene with a gene encoding the desired guide RNA into an organism, adjacent to an altered gene, could create a “gene drive” that could spread a trait through an entire population of organisms. These experiments represent advances along a spectrum of technological abilities that genetic engineers have been working on since the advent of recombinant DNA (...) techniques. The scientific and bioethics communities have built substantial literatures about the ethical and policy implications of genetic engineering, especially in the age of bioterrorism. However, recent CRISPr/Cas experiments have triggered a rehashing of previous policy discussions, suggesting that the scientific community requires guidance on how to think about social responsibility. We propose a framework to enable analysis of social responsibility, using two example.. (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)

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)

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)

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)

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)