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)

In this paper, the authors describe an aspect of a program of research around grief and clinical practice. The first phase of the study involves examination of experiences of grief with attention to troublesome or problematic beliefs that fuel the extent of suffering in the bereaved. The data, obtained from a review of videotaped clinical interviews with families seen in the Family Nursing Unit at the University of Calgary, were analyzed according to philosophical hermeneutic tradition. Findings suggest that grief is (...) an experience that is ongoing, that changes in nature over time, but that involves a continuing relationship with the deceased; it is a graceful, periodic, deliberate walk backwards while keeping a sure foot in living forward. (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)

BackgroundThe boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and (...) determination of risk level across a broad range of projects and health-related contexts. This paper describes the development of the Public Health Ontario Risk Screening Tool.MethodDevelopment of the PHO Risk Screening Tool included: preparation of a draft risk tool ; expert appraisal; internal stakeholder validation; external validation; pilot testing and evalution of the draft tool; and revision after 1 year of testing.ResultsA risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.ConclusionsThe PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions. (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)

Let V be the cumulative set theoretic hierarchy, generated from the empty set by taking powers at successor stages and unions at limit stages and, following [2], let the primitive language of set theory be the first order language which contains binary symbols for equality and membership only. Despite the existence of ∀∀-formulae in the primitive language, with two free variables, which are satisfiable in V but not by finite sets ([5]), and therefore of ƎƎ∀∀ sentences of the same language, (...) which are undecidable in ZFC without the Axiom of Infinity, truth in V for Ǝ*∀∀-sentences of the primitive language, is decidable ([1]). Completeness of ZF with respect to such sentences follows. (shrink)

The imbalance between supply of organs for transplantation and demand for them is widening. Although the current international drive to re-establish procurement via non-heart beating organ donation/donor is founded therefore on necessity, the process may constitute a desirable outcome for patient and family when progression to brain stem death does not occur and conventional organ retrieval from the beating heart donor is thereby prevented. The literature accounts of this practice, however, raise concerns that risk jeopardising professional and public confidence in (...) the broader transplant programme. This article focuses on these clinical, ethical, and legal issues in the context of other approaches aimed at increasing donor numbers. The feasibility of introducing such an initiative will hinge on the ability to reassure patients, families, attendant staff, professional bodies, the wider public, law enforcement agencies, and the media that practitioners are working within explicit guidelines which are both ethically and legally defensible. (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)

Research on women's preponderance among animal rights advocates explains it exclusively as a product of women's socialization, emphasizing a relational orientation of care and nurturing that extends to animals. The authors propose a more structural explanation: Women's experiences with structural oppression make them more disposed to egalitarian ideology, which creates concern for animal rights. Using data from a 1993 national sample, the authors find that an egalitarian gender ideology is a key difference in women's and men's routes to animal rights (...) advocacy: It differentiates those more likely to endorse animal rights among women but not among men. Neither this ideology nor other variables in the analysis, however, account for women's greater overall support of animal rights in the combined sample. Reasons for this latter finding are explored. (shrink)

Developments in neuroscience have raised the possibility that pharmaceuticals may be used to enhance memory, mood, and attention in people who do not have an illness or disorder, a practice known as “cognitive enhancement.” We describe historical experiences with two medicinal drugs for which similar enhancement claims were made, cocaine in the late 19th and early 20th centuries, and amphetamines in the mid 20th century. These drugs were initially introduced as medicinal agents in Europe and North America before becoming more (...) widely used for a variety of purposes, including what would nowadays be considered cognitive enhancement. Their trajectory of use conformed to the typical use cycle of psychotropic drugs. There was an initial steep rise in prescribing for medical use, followed by expanded nonmedical use that was fueled by enthusiasm for the drugs’ effects. As the number of regular users increased, problems related to use (such as addiction) became apparent, societal concern increased, and laws were passed banning nonmedical use and eventually, medical use. This historical experience draws attention to the adverse side effects of enhancement use that only become apparent with regular, wide-scale use of a drug. We highlight the similarities between the enthusiasms for cocaine and amphetamines and the current enthusiasms for using prescription stimulants for cognitive enhancement. We argue bioethicists should not encourage the cognitive enhancement use of drugs such as methylphenidate in the absence of evidence on the efficacy and safety of their use for cognitive enhancement purposes. (shrink)

Legislation that authorises controversial organ procurement strategies but ignores respect for autonomy is flawed in principle and predictably unworkable in practiceThe UK Human Tissue Act 2004,1 designed to regulate all activity involving human tissue, organs, or bodies, was introduced in the House of Commons in December 2003, received Royal Assent on 15 November 2004,2 and has been partially implemented by Commencement Orders from April 2005. The new act, which repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984, (...) and the Human Organ Transplants Act 1989, has its origins in events of serious public concern, namely the retained organs scandals at Bristol Royal Infirmary3 and the Royal Liverpool Childrens’ Hospital.4 The act is correspondingly dominated by regulation of postmortem examinations and retention of human tissue, with consistent emphasis on the need for fully informed consent. Compliance with these requirements is now mandatory with the threat of up to three years’ imprisonment and/or fines for any deviation.The impact of the original proposals within the bill on research and the clinical practice of pathology have been carefully considered and documented,5 with subsequent amendments to ameliorate professional concerns.6 The act, however, also carries significant implications for medical practice in areas where donor recruitment for transplantation can take place, and representations on these aspects during readings of the bill7 have produced neither clarification, justification, nor amendment within the final legislation.Section 43 will make it lawful for hospital authorities “to take steps for the purpose of preserving the part for use for transplantation and to retain the body for that purpose”. The original explanatory notes for the bill8 while it proceeded through parliament implied that such action, prior to consent to transplantation being sought, was then lawful, clause 44 as section 43 …. (shrink)