ABSTRACT:What more can be said about COVID-19 and the social determinants of health? This article describes neglected perspectives that derive from the history of social epidemiology, a field that identifies the social etiology of disease and variations in disease incidence among people differentially located in the social structure. The "discovery" of social determinants of diseases like COVID-19 is nothing new for epidemiology: debate over how to analyze structural determinants versus individual-level risk factors persisted throughout the 19th and 20th centuries. By (...) the late 20th century, research had highlighted fundamental causes of health disparities, such as social conditions and structural racism; these are structural factors, embedded in the social fabric of life. Measurement of structured inequalities within systems faces complex and challenging problems, as research aims to better account for these lived realities at different levels of analysis and as multiple factors merge to influence outcomes (revealed in intersectionality theory). At each of these intersections, there are opportunities for bioethicists to consider their ethical implications. It is imperative to understand the social and ethical roots of our present conversations about health inequalities, in order to partner intelligently with researchers on the forefront of advocating for change. (shrink)

Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...) the Clinical Sequencing Exploratory Research program as well as studies on return of results. Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study (...) nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of the therapeutic misconception — have become (...) important policy issues over the last 20 years because of the ways they have been magnified by genomic research efforts. Research that examines the ethical, legal, and social implications of human genomics research has become a burgeoning international field of scholarship over the last 20 years, thanks in part to its support first by the genome research funding bodies in the U.S. and then by national science agencies in other countries. (shrink)

This paper analyses the activities of five organizations shaping the debate over the global governance of genome editing in order to assess current approaches to public engagement (PE). We compare the recommendations of each group with its own practices. All recommend broad engagement with the general public, but their practices vary from expert-driven models dominated by scientists, experts, and civil society groups to citizen deliberation-driven models that feature bidirectional consultation with local citizens, as well as hybrid models that combine elements (...) of both approaches. Only one group practices PE that seeks community perspectives to advance equity. In most cases, PE does little more than record already well-known views held by the most vocal groups, and thus is unlikely to produce more just or equitable processes or policy outcomes. Our exploration of the strengths, weaknesses, and possibilities of current forms of PE suggests a need to rethink both “public” and “engagement.”. (shrink)

In this target article by Morain and Largent (2023), the authors focus on an investigator’s duty to patient-subjects specifically regarding incidental or collateral findings within the context of e...

The Covid‐19 pandemic has concentrated bioethics attention on the “lifeboat ethics” of rationing and fair allocation of scarce medical resources, such as testing, intensive care unit beds, and ventilators. This focus drives ethics resources away from persistent and systemic problems—in particular, the structural injustices that give rise to health disparities affecting disadvantaged communities of color. Bioethics, long allied with academic medicine and highly attentive to individual decision‐making, has largely neglected its responsibility to address these difficult “upstream” issues. It is time (...) to broaden our teaching, research, and practice to match the breadth of the field in order to help address these significant societal inequities and unmet health needs. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

The three important target articles make a strong case for regarding racism as a public health crisis. Each calls for advocacy by the bi...

Recent ideological positioning on the world stage has born a startling resemblance to a form of positioning within nursing theory – that of taking complex ideas, reducing them to a simplistic binary form, and uncritically adopting one half of that form. In some cases, this adoption of a binary position has led to a passionately held form of ‘othering’ that prohibits a healthy and critical engagement with ideas. As alluring as settling for the binary form may be – we argue (...) for holding binaries in tension as a catalyst for stimulating dialogue – reasoning and exploration of new ways of wrestling with the social and moral complexity of nursing. (shrink)

Business ethics is the continuing process of re-defining the goals and rules of business activity. In times of rapid change, spurred equally by technological innovation within the business community and by societal expectations in the larger community, participants who share in that process of re-defining goals and rules should be sensitive to professional differences. Lawyers and executives, for instance, while seeking a common societal good, will utilize measurably different goals and methods based on differences in leadership style, accountability to constituents (...) and client relationship generally. Because of these differences, definitions of what is ethical will vary as well, spread across a spectrum of ethicality. (shrink)

This book explores images of schoolteachers in America from the beginning of the 20th century to the present, using a wide range of approaches to scholarship and writing. It is intended for both experienced and aspiring teachers to use as a springboard for discussion and reflection about the teaching profession and for contemplating these questions: _ What does it mean to be a teacher? What has influenced and sustained our beliefs about teachers? New in the second edition_ * The focus (...) is shifted to the teaching profession as the 21st century unfolds. * The volume continues to explore teacher images through various genres--oral history, narrative, literature, and popular culture. In the second edition, the authors place more emphasis on the social-political context that has shaped teachers' daily experiences and the teaching profession itself. In the study of teacher images and schooling, the essays draw from feminist research methods and the critical tradition in educational inquiry to probe issues of power and authority, race, social class, and gender. * The emphasis is on the multidimensionality of teacher images rather than normative characterizations. * Six totally new chapters have been written for this new edition: an "invented interview" spanning 100 years of school teaching; portraits of progressive activist teachers; an exploration of teachers in fiction for young adults; a retrospective of the satirical cartoon show, _The Simpsons_; a study of crusading and caring teachers in films; and an overview of progressive classroom practices in "the new millennium." Seven chapters have been thoroughly revised to reflect current scholarship and the authors' evolving knowledge and interests. (shrink)

We examine two different descriptions of the behavioral functions of the hippocampal system. One emphasizes spatially organized behaviors, especially those using cognitive maps. The other emphasizes memory, particularly working memory, a short-term memory that requires iexible stimulus-response associations and is highly susceptible to interference. The predictive value of the spatial and memory descriptions were evaluated by testing rats with damage to the hippocampal system in a series of experiments, independently manipulating the spatial and memory characteristics of a behavioral task. No (...) dissociations were found when the spatial characteristics of the stimuli to be remembered were changed; lesions produced a similar deficit in both spatial and nonspatial test procedures, indicating that the hippocampus was similarly involved regardless of the spatial nature of the task. In contrast, a marked dissociation was found when the memory requirements were altered. Rats with lesions were able to perform accurately in tasks that could be solved exclusively on the basis of reference memory. They performed at chance levels and showed no signs of recovery even with extensive postoperative training in tasks that required working memory. In one experiment all the characteristics of the reference memory and working memory procedures were identical except the type of memory required. Consequently, the behavioral dissociation cannot be explained by differences in attention, motivation, response inhibition, or the type of stimuli to be remembered. As a result of these experiments we propose that the hippocampus is selectively involved in behaviors that require working memory, irrespective of the type of material that is to be processed by that memory. (shrink)

This article presents the Pilgrimage Model as a template for educators wishing to lead students on site-specific studies of engaged learning. During the 2015–2016 academic year, a group of Georgeto...

Tool making has been proposed as a key force in driving the complexity of human material culture. The ontogeny of tool‐related behaviors hinges on social, representational, and creative factors. In this study, we test the associations between these factors in development across two different cultures. Results of Study 1 with 5‐to‐6‐year‐old Turkish children in dyadic or individual settings show that tool making is facilitated by social interaction, hierarchical representation, and creative abilities. Results of a second explorative study comparing the Turkish (...) sample with a sample of 5‐to‐6‐year‐old children in New Zealand suggest that tool innovation might be affected by culture, and that the role of cognitive and creative factors diminishes through social interaction in tool making. (shrink)

In a recent article in The Journal of Clinical Ethics, David Wendler argues that worries about the therapeutic misconception (TM) are not only misconceived, but detract from the larger agenda of a proper informed consent for subjects involved in clinical research. By contrast, we argue that Wendler mischaracterizes those who support TM research, and that his arguments are fragmentary, often illogical, and neglect a critical difference between clinical care and clinical research. A clear explanation about the chief aim of research (...) is, in fact, what gives the other elements in a consent process their meaning. We argue that informed consent must be both trial-specific and context-sensitive, and that concern about the TM is needed now more than ever. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be (...) permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

The ability of 3- and 4-year-old children to disregard advice from an overtly misleading informant was investigated across five studies (total n = 212). Previous studies have documented limitations in young children's ability to reject misleading advice. This study was designed to test the hypothesis that these limitations are primarily due to an inability to reject specific directions that are provided by others, rather than an inability to respond in a way that is opposite to what has been indicated by (...) a cue. In Studies 1 through 4, a puppet identified as The Big Bad Wolf offered advice to participants about which of two boxes contained a hidden sticker. Regardless of the form the advice took, 3-year olds performed poorly by failing to systematically reject it. However, when participants in Study 5 believed they were responding to a mechanical cue rather than the advice of the Wolf, they were better able to reject misleading advice, and individual differences in performance on the primary task were systematically correlated with measures of executive function. Results are interpreted as providing support for the communicative intent hypothesis, which posits that children find it especially difficult to reject deceptive information that they perceive as being intentionally communicated by others. (shrink)

Stigma can influence the prevention and identification of fetal alcohol spectrum disorder, a leading cause of developmental delay in North America. Understanding the effects of public health practices and policies on stigma is imperative. We reviewed social science and biomedical literatures to understand the nature of stigma in FASD and its relevance from an ethics standpoint in matters of health practices and policies. We propose a descriptive model of stigma in FASD and note current knowledge gaps; discuss the ethical implications (...) of stigma based on two distinct criteria ; and describe two cases and the concerns associated with inadvertent stigmatization by public health initiatives for FASD. We recommend further empirical and ethical analyses to examine whether public health policies and practices inadvertently stigmatize and impact the success of public health initiatives and programs for FASD. (shrink)