This article reviews 172 studies that used the Defining Issues Test to investigate the moral development of undergraduate college students and provides an organisational framework for analysing educational contexts in higher education. These studies addressed collegiate outcomes related to character or civic outcomes, selected aspects of students' collegiate experiences related to moral judgement development and changes in moral reasoning during the college years as they related to changes in other domains of development. Findings suggest that dramatic gains in moral judgement (...) are associated with collegiate participation, even after controlling for age and entering level of moral judgement. Although many studies used gross indicators of collegiate context (e.g. institutional type or academic discipline), studies that examine specific collegiate characteristics and educational experiences are better suited to identifying factors that contribute directly or indirectly to changes in moral judgement during the college years. Implications for student development practice and future research are discussed. (shrink)
If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.
It is tempting to think that we have heard just about all we want or need to know about race. As the above quotes indicate, modern notions of race have always revolved around the faculty of vision, with supplementary contributions from other senses such as hearing, as Arendt notes in a tacit allusion to one mark of Jewish difference—the way they sounded when concentrated in urban settings. Yet two very recent works—Mark M. Smith's How Race Is Made and Anne C. (...) Rose's Psychology and Selfhood in the Segregated South —have much to teach us about how race has “worked”, particularly in the twentieth-century South but also, by implication, in the United States in general. Both works assume that, historically, race is no mere add-on to the self, a kind of externality that, once detected, can be relatively easily excised. Rather, it stands right at the heart of personal and group identity in a nation where race and ethnicity continue to assume surprising new shapes and forms. (shrink)
Ontogeny, specifically the role of language in the human family now and in prehistory, is central to Locke & Bogin's (L&B's) thesis in a compelling way. The unique life-history stages of childhood and adolescence, however, must be interpreted not only against an exceptionally “high quality” human infancy but also in light of the evolution of co-constructed, emotionally based communication in ape, hominid, and human infancy.
A contribution to the sixth installment of the Common Knowledge symposium “Apology for Quietism,” this article explores the possibilities for quietist narrative. Since quietism suggests resistance or condescension to telos, suspense, will, and the kinds of spirituality, politics, and ways of being associated with them, it seems unlikely that a narrative would be written or read by a practitioner of “ideal indifference” or by anyone averse on principle to initiative. But Gilbert White's text of 1789, The Natural History and Antiquities (...) of Selborne comes as close to being a quietist narrative as is conceivable. Describing the environment of a single English parish, White's text places stillness on exhibit as an indication of commitment to an ethics of self-unregarding attentiveness. But the stillness of Selborne, King argues, is a conspicuous stillness—a practice of being still in face of the natural world. As an Anglican minister, White explicitly demonstrates the arguments of eighteenth-century natural theology. Having stilled his will to interfere, he can observe the activity of God's creations; and White does so in order to understand God better. Thus, White's desisting or withdrawal is in no way based in defeatism, indolence, or aimlessness. Moreover, King argues, White aims to produce stillness as a formal quality of his text and, through it, to produce a like stillness and attentiveness in the reader. Quietist narrative is meant to help the reader still his or her acquisitiveness and develop instead observational capabilities, a capacity simply to admire (or stand apart, in awe), and, above all, patience. To the extent that it fosters in us a principled “do nothing” stance with respect to our natural ecology, King concludes, quietism of Gilbert White's kind may represent the most radical of environmental politics. (shrink)
At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme?, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme? and saline in the field and, still without consent, randomized between PolyHeme? and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood?the standard treatment for hemorrhagic shock?is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)
Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and (...) honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime. (shrink)
The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an (...) occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. (shrink)
The prospect of using cell-based interventions to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause (...) for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment. (shrink)
At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)
College instructors use a variety of approaches to teach students to reason more effectively about issues with a moral dimension and achieve mixed results. This pre?post study of 423 undergraduate students examined the effects of morally explicit and implicit curricular content and of selected pedagogical strategies on moral reasoning development. Using causal modelling to control for a range of student background variables as well as Time 1 scores, 52% of the variance in moral reasoning scores was explained; we found that (...) these scores were affected by type of curricular content and by three pedagogical strategies (active learning, reflection and faculty?student interaction). Students who experienced more negative interactions with diverse peers were the least likely to show positive change in moral reasoning as a result of participating in any course. Implications for the design of intervention studies are discussed, including the need to attend to selection and attenuation effects. (shrink)
The recent explosion of publicity about the dangers of concussion in contact sports — particularly in football — represents the unraveling of a disinformation campaign by the NFL amid growing public and professional concern about the game's long-term risks of harm. The persistence of controversy and denial reflects a cultural view of football players as serving the needs of the team, a resulting evidentiary skepticism, and resistance to rule changes as excessive or unenforceable. This article considers the cultural context of (...) informed decision making by parents of youth football players and suggests that policy changes designed to lower risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal. (shrink)
Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (n=50). 80% of RECs (...) reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. Conclusions There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants. (shrink)
Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide (...) biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty — that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted “in the public square.”. (shrink)
Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.
We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose (...) unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**. (shrink)
This paper discusses the announcement by a team of researchers that they identified a genetic influence for a range of “antisocial” behaviours in the New Zealand Māori population (dubbed the “warrior gene”). The behaviours included criminality, violence, gambling and alcoholism. The reported link between genetics and behaviour met with much controversy. The scientists were described as hiding behind a veneer of supposedly “objective” western science, using it to perpetuate “racist and oppressive discourses”. In this paper we examine what went wrong (...) in the dissemination of the research. We chose as our framework the debate around the “internal/external” responsibilities of scientists. Using this discourse we argue that when the researchers ventured to explain their research in terms of social phenomena, they assumed a duty to ensure that their findings were placed “in context”. By “in context”, we argue that evidence of any genetic influence on behavioural characteristics should not be reported in isolation, but instead presented alongside other environmental, cultural and socio-economic influences that may also contribute to the studied behaviour. Rather than imposing a new obligation on scientists, we find this duty to contextualise results is in keeping with the spirit of codes of ethics already in place. Lessons from the “warrior gene” controversy may assist researchers elsewhere to identify potential areas of conflict before they jeopardise research relationships, or disseminate findings in a manner that fuels misleading and/or potentially discriminatory attitudes in society. (shrink)
Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical (...) standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. Trial registration number [NCT02588664], recruiting. This article covers the development of consent process that is currentlty being employed in the study. : https://clinicaltrials.gov/ct2/show/NCT02588664. (shrink)