Drug testing is widely deployed in the United States throughout the public and private sectors. This case study uses two emergent drug-testing technologies—hair analysis and the sweat patch—as examples of techniques of governance that should be subjected to the political equivalent of strict scrutiny. The article contributes to conceptual debates in science and technology studies, arguing that the study of social structure and subject formation should be integral rather than epiphenomenal to analysis in the transdisciplinary field of science and technology (...) studies. The article contextualizes the development and deployment of drug-testing technologies within the structural and epistemological categories of racial and ethnic difference, gender, sexuality, and class formation. Conflicts between proponents of the technologies and critical advocates who seek to constrain their use mark sites of productive theoretical engagement with structural sociology, racial formation theory, critical race theory, and feminist critique.1 Finally, the article demonstrates how STS analyses can contribute to the struggles of strategic counterpublics as they advocate for changing the meaning and material consequences of suspect technologies. (shrink)

The thesis of this paper is that at a fundamental level there are not distinct sets of philosophical problems related to specific kinds of rationality. The evidence presented in favor of this thesis is that the empiricist tradition has been faced with the same philosophical problems in accounting for scientific rationality as philosophy in general has faced in accounting for rationality in general; and that the nature of these problems requires that they be dealt with prior to considering questions which (...) might turn out to be distinct. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known (...) as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known (...) as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

Patient report of functioning is one component of the neurocognitive exam following traumatic brain injury, and standardized patient-reported outcomes measures are useful to track outcomes during rehabilitation. The Traumatic Brain Injury Quality of Life measurement system is a TBI-specific extension of the PROMIS and Neuro-QoL measurement systems that includes 20 item banks across physical, emotional, social, and cognitive domains. Previous research has evaluated the responsiveness of the TBI-QOL measures in community-dwelling individuals and found clinically important change over a 6-month assessment (...) interval in a sample of individuals who were on average 5 years post-injury. In the present study, we report on the responsiveness of the TBI-QOL Cognition–General Concerns and Executive Function item bank scores and the Cognitive Health Composite scores in a recently injured sample over a 1-year study period. Data from 128 participants with complicated mild, moderate, or severe TBI within the previous 6 months were evaluated. The majority of the sample was male, white, and non-Hispanic. The participants were 18–92 years of age and were first evaluated from 0 to 5 months post-injury. Eighty participants completed the 1-year follow-up assessment. Results show acceptable standard response mean values for all measures and minimal detectable change values ranging from 8.2 to 8.8 T-score points for Cognition–General Concerns and Executive Functioning measures. Anchor rating analysis revealed that changes in scores on the Executive Function item bank and the Cognitive Health Composite were meaningfully associated with participant-reported changes in the areas of attention, multitasking, and memory. Evaluation of change score differences by a variety of clinical indicators demonstrated a small but significant difference in the three TBI-QOL change scores by TBI injury severity grouping. These results support the responsiveness of the TBI-QOL cognition measures in newly injured individuals and provides information on the minimal important differences for the TBI-QOL cognition measures, which can be used for score interpretation by clinicians and researchers seeking patient-reported outcome measures of self-reported cognitive QOL after TBI. (shrink)

In recent years, scholars have begun to lay the groundwork to justify a distinct application of ethics to the field of public health. They have highlighted important features that differentiate public health ethics from bioethics, especially public health’s emphasis on population health rather than issues of individual health. Articulations of public health ethics also tend to emphasize the role of social justice compared to the predominance of autonomy in the bioethical literature. Now that the field of public health ethics is (...) developing a unique focus and a language of its own, including a code of ethics disseminated by the American Public Health Association, the future of public health ethics may well be global health ethics, focusing on issues of global justice. As public health ethics evolves from its nascent stage of reflection to a place of action and application in the national and global arenas, two interrelated developments will need to occur: public health professionals, including practitioners, policymakers, and scholars, will need a richer understanding of the ethical challenges practitioners face on a daily basis and scholars will need to develop useful tools that practitioners may employ for identifying and tackling these ethical challenges. (shrink)

Ethical challenges in public health can have a significant impact on the health of communities if they impede efficiencies and best practices. Competing needs for resources and a plurality of values can challenge public health policymakers and practitioners to make fair and effective decisions for their communities. In this paper, the authors offer an analytic framework designed to assist policymakers and practitioners in managing the ethical tensions they face in daily practice. Their framework is built upon the following set of (...) six considerations: determining population-level utility of the proposed action; demonstrating evidence of need and effectiveness of actions; establishing fairness of goals and proposed implementation strategies; ensuring accountability; and, assessing expected efficiencies and costs associated with the proposed action. Together, these considerations create a structured guide to assist decision-makers in identifying potential ethical challenges and in assessing the moral considerations that underlie public health practice - and possibly even, if the conditions are met, reduce the creation of ethical tension. Although the authors’empirical experiences provide the basis for the framework advanced here, their approach remains to be tested and evaluated by public health practitioners. (shrink)

Mr. F. is a fifty‐year‐old father of two school‐aged daughters. Six years ago, he received a double lung transplant because he was suffering from interstitial lung disease, a fatal illness that causes suffocation by progressive scarring of the lungs. He is now experiencing chronic rejection of the transplant and is being considered to receive another. Without it, he is expected to survive only a year and a half. With it, his prognosis will improve, but the numbers are still not good. (...) Three years after his lung transplant, Mr. F. stopped attending his office visits. For a period of sixteen months he went without the studies and attention essential to posttransplant care. He stopped performing the required daily self‐monitoring of his lung function about eight months after his transplant, but he has maintained a regular exercise regimen. While lost to follow‐up, he continued to take his immunosuppressant medications, but he stopped taking medicine to control his high blood pressure because of its expense. (shrink)

In the course of an immune response, antibodies undergo affinity maturation in order to increase their efficiency in neutralizing foreign invaders. Affinity maturation occurs by the introduction of multiple point mutations in the variable region gene that encodes the antigen binding site. This somatic hypermutation is restricted to immunoglobulin genes and occurs at very high rates. The precise molecular basis of this process remains obscure. However, recent studies using a variety of in vivo and in vitro systems have revealed important (...) regulatory regions, base motifs that are preferred targets of mutation and evidence that transcription may play an active role in hypermutation. BioEssays 20:227–234, 1998. © 1998 John Wiley & Sons, Inc. (shrink)

In its comprehensive overview of Alain Locke's pragmatist philosophy this book captures the radical implications of Locke's approach within pragmatism, the critical temper embedded in Locke's works, the central role of power and empowerment of the oppressed and the concept of broad democracy Locke employed.

Increasingly the body is a possession that does not belong to us. It is bought and sold, bartered and stolen, marketed wholesale or in parts. The professions - especially reproductive medicine, transplant surgery, and bioethics but also journalism and other cultural specialists - have been pliant partners in this accelerating commodification of live and dead human organisms. Under the guise of healing or research, they have contributed to a new 'ethic of parts' for which the divisible body is severed from (...) the self, torn from the social fabric, and thrust into commercial transactions -- as organs, secretions, reproductive capacities, and tissues -- responding to the dictates of an incipiently global marketplace. Breaking with established approaches which prioritize the body as 'text', the chapters in this book examine not only images of the body-turned-merchandise but actually existing organisms considered at once as material entities, semi-magical tokens, symbolic vectors and founts of lived experience. The topics covered range from the cultural disposal and media treatment of corpses, the biopolitics of cells, sperm banks and eugenics, to the international trafficking of kidneys, the development of 'transplant tourism', to the idioms of corporeal exploitation among prizefighters as a limiting case of fleshly commodity. This insightful and arresting volume combines perspectives from anthropology, law, medicine, and sociology to offer compelling analyses of the concrete ways in which the body is made into a commodity and how its marketization in turn remakes social relations and cultural meanings. (shrink)

The National Science Foundation's Second Merit Criterion, or Broader Impacts Criterion , was introduced in 1997 as the result of an earlier Congressional movement to enhance the accountability and responsibility as well as the effectiveness of federally funded projects. We demonstrate that a robust understanding and appreciation of NSF BIC argues for a broader conception of research ethics in the sciences than is currently offered in Responsible Conduct of Research training. This essay advocates augmenting RCR education with training regarding broader (...) impacts. We demonstrate that enhancing research ethics training in this way provides a more comprehensive understanding of the ethics relevant to scientific research and prepares scientists to think not only in terms of responsibly conducted science, but also of the role of science in responding to identified social needs and in adhering to principles of social justice. As universities respond to the mandate from America COMPETES to “provide training and oversight in the responsible and ethical conduct of research”, we urge institutions to embrace a more adequate conception of research ethics, what we call the Ethical Dimensions of Scientific Research, that addresses the full range of ethical issues relevant to scientific inquiry, including ethical issues related to the broader impacts of scientific research and practice. (shrink)

During the coronavirus disease 2019 (COVID‐19) pandemic, bioethical analyses often emphasized population health and societal benefit. Hospital policies frequently focused on reducing risk of transmitting SARS‐CoV‐2 by restricting visitors; requiring protective equipment; and screening staff, patients and visitors. While restrictions can be burdensome, they are often justified as essential measures to protect the whole population against a virus with high rates of transmission, morbidity and mortality. Yet communities are not monolithic, and the impacts of these restrictions affect different groups differently. (...) An ophthalmological unit outreach program in Ethiopia serves to illustrate. Pre‐operative screening policies were designed to protect as many patients as possible but had adverse impacts on underserved communities. As this case study demonstrates, creating hospital policies that truly serve the good of the society may require a more holistic review of impacts on inequitably positioned communities. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

This special report is published in commemoration of the fiftieth anniversary of the “Report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death,” a landmark document that proposed a new way to define death, with implications that advanced the field of organ transplantation. This remarkable success notwithstanding, the concept has raised lasting questions about what it means to be dead. Is death defined in terms of the biological failure of the organism to (...) maintain integrated functioning? Can death be declared on the basis of severe neurological injury even when biological functions remain intact? Is death essentially a social construct that can be defined in different ways, based on human judgment? These issues, and more, are discussed and debated in this report by leading experts in the field, many of whom have been engaged with this topic for decades. (shrink)

While tens of thousands of people across the United States serve on hospital and other healthcare ethics committees , almost no carefully prepared educational material exists for HEC members. Ethics by Committee is a one volume collection of chapters developed exclusively for this educational purpose. Experts in bioethics, clinical consultation, health law, and social psychology from across the country contribute chapters on ethics consultation, education, and policy development.

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)