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 pluralism of methodologies and severe time constraints pose important challenges to pedagogy in clinical ethics. We designed a step-by-step student handbook to operate within such constraints and to respect the methodological pluralism of bioethics and clinical ethics. The handbook comprises six steps: Step 1: What are the facts of the case?; Step 2: What are your obligations to your patient?; Step 3: What are your obligations to third parties to your relationship with the patient?; Step 4: Do your obligations (...) converge or conflict?; Step 5: What is the strongest objection that could be made to the identification of convergence in step 4 or the arguments in step 4? How can this objection be effectively countered?; and Step 6: How could the ethical conflict, or perceived ethical conflict, have been prevented? (shrink)
This collection of ground-breaking essays considers the many dimensions of prayer: how prayer relates us to the divine; prayer's ability to reveal what is essential about our humanity; the power of prayer to transform human desire and action; and the relation of prayer to cognition. It takes up the meaning of prayer from within a uniquely phenomenological point of view, demonstrating that the phenomenology of prayer is as much about the character and boundaries of phenomenological analysis as it is about (...) the heart of religious life.The contributors: Michael F. Andrews, Bruce Ellis Benson, Mark Cauchi, Benjamin Crowe, Mark Gedney, Philip Goodchild, Christina M. Gschwandtner, Lissa McCullough, Cleo McNelly Kearns, Edward F. Mooney, B. Keith Putt, Jill Robbins, Brian Treanor, Merold Westphal, Norman Wirzba, Terence Wright and Terence and James R. Mensch. Bruce Ellis Benson is Associate Professor of Philosophy at Wheaton College. He is the author of Graven Ideologies: Nietzsche, Derrida, and Marion on Modern Idolatry and The Improvisation of Musical Dialogue: A Phenomenology of Music. Norman Wirzba is Associate Professor and Chair of the Philosophy Department at Georgetown College, Kentucky. He is the author of The Paradise of God and editor of The Essential Agrarian Reader. (shrink)
This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a (...) criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable. (shrink)
"The terrain of the self is vast," notes renowned psychiatrist Arnold Ludwig, "parts known, parts impenetrable, and parts unexplored." How do we construct a sense of ourselves? How can a self reflect upon itself or deceive itself? Is all personal identity plagiarized? Is a "true" or "authentic" self even possible? Is it possible to really "know" someone else or ourselves for that matter? To answer these and many other intriguing questions, Ludwig takes a unique approach, examining the art of biography (...) for the insights it can give us into the construction of the self. In The Biography of the Self, he takes readers on an intriguing tour of the biographer's art, revealing how much this can tell us about ourselves. Drawing on in-depth interviews with twenty-one of our most esteemed biographers--writers such as David McCullough (the biographer of Truman and Theodore Roosevelt), Wallace Stegner (John Wesley Powell), Gloria Steinem (Marilyn Monroe), Leon Edel (Henry James), Peter Gay (Freud), Diane Middlebrook (Anne Sexton), and many others--and interweaving fascinating observations of his own practice, Ludwig takes us through the labyrinthine hall of mirrors we term the self and shows us how malleable, elusive, and paradoxical it can be. In chapters such as "The 'Real' Marilyn," "Psychoanalyzing Freud," "How Did Hitler Live With Himself?" and "What Madness Reveals," we sit in as biographers talk not only about their work, but about their subjects (Allan Bullock on Hitler and Stalin, for instance, or Arnold Rampersad on Langston Hughes) and how their subjects saw themselves. Ludwig describes how biographers must impose a narrative structure on their subjects' lives to create order out of a mass of often contradictory views, baffling behavior, and inconsistent self-representations, much in the same way that psychotherapists try to foster self-awareness and understanding in their patients. In his concluding chapter, Ludwig introduces a new concept--biographical freedom--which brilliantly reconciles free will and determinism. We can, he asserts, become biographers of ourselves. Like the biographer, we are constrained to consider all the available facts of our lives--the personal experiences, cultural forces, and predetermined scripts that shape us--but we remain free to interpret, emphasize, and fashion these givens into a cohesive and meaningful narrative of our own choosing. This thought-provoking volume offers not only a wide-ranging and informative commentary on the biographer's art, but also a highly original theory of the self. Readers interested in biography and in the lives of others will come away with a new sense of what it means to be a "person" and, in particular, who they are. (shrink)