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)
Unlike drugs and medical devices, for which long standing and continuously improving quality assurance/quality control infrastructures exist, many nano-based products lack well-defined standards that are useful to manufacturers and regulators. Inherent variabilities in nanoparticle sizes and shapes, their large surface-to-volume ratios, and their mesoscale interactions with subcellular structures, suggest new complexities and challenges that must be met before widespread application of nanomedicines can be expected.
After historically situating NBIC Convergence in the context of earlier bioethical debate on genetics, ten questions are raised in areas related to the ethics of Convergence, indicating where future research is needed.
This book is for those interested in an extensive review of the field of bioethics. It is for philosophers who wish to understand the core conceptual issues in health care ethics, and for bioethicists who wish to better understand classical problems in philosophy that have a bearing on health care ethics. The Handbook of Bioethics: Taking Stock of the Field from a Philosophical Perspective: -presents a comprehensive survey of bioethics in one volume; -has 27 of the most prominent scholars in (...) the field take stock of the issues they helped define; -contains essays that outline areas where future research is needed; -identifies potential areas for fruitful collaboration between traditional philosophers and bioethicists; -is an ideal text for graduate or upper level undergraduate courses. (shrink)
Many physicians assert that new cost-control mechanisms inappropriately interfere with clinical decision-making. They claim that high costs arise from poorly practiced medicine, and argue that effective utilization of resources is best promoted by advancing the scientific and ethical ideals of medicine. However, the claim is not warranted by empirical evidence. In this essay, I show how it rests upon aesthetic considerations associated with diagnostic elegance. I first consider scientific rationality generally. After a review of analytical empiricist and socio-historical approaches in (...) the philosophy of science, a form of Kant's aesthetic is used to explain how scientific discovery and justification are linked, and to show how meta-theoretical considerations associated with the goals and method of science work together with exemplars of practice. This analysis enables us to understand how the ideals of medicine as a science guide the initial patient history and physical exam in such a way that a parsimonious use of tests is indicated. Aesthetic considerations unite the basic scientific and ethical commitments of the modern medical paradigm and are central for rightly understanding clinical judgment. (shrink)
The arguments against managed care can be divided into two general clusters. One cluster concerns the way managed care undermines the ethical ideals of medical professionalism. Since those ideals largely focus on the physician-patient relation, the first cluster comes under the rubric of micro-ethics; namely, the ethics of individual-individual relations. The second cluster of criticisms focuses on macro-ethical issues, primarily on issues of justice and policy. By reviewing these arguments, it becomes clear that managed care does not easily fit within (...) traditional modes of ethical analysis. It poses a radical challenge to current medical and socio-political norms, and even resists the distinction between micro- and macro-ethical domains, a distinction that reflects the private/public distinction. Managed care organizations call for a third way, an inter-ethic for middle level organizations. The essays in this Journal provide a first step in this radical reassessment, laying the foundation for an organizational ethic that is responsive to the realities and promise of managed care. (shrink)
Conflicts of interest serve as a cipher for a radical rupture in the Flexnerian paradigm of medicine, and they can only be addressed if we recognize that health care is now practiced by institutions, not just individual physicians. By showing how "appropriate utilization of services" or "that which is medically indicated" is a function of socioeconomic factors related to institutional responsibilities, I point toward an administrative and organizational ethic as a needed component for addressing conflicts of interest. The argument is (...) developed by reviewing three important books. First, I consider Mark Rodwin's attempt to configure the economic structures of medicine so that classical fiduciary and scientific ideals can be fostered. Second, I consider E. Haavi Morreim's attempt to modify the classical ideals in order to account for new economic realities. Finally, by considering essays in a recent volume on conflicts of interest edited by Spece, Shimm, and Buchanan, I argue for a constructive dialectic between the approaches of Rodwin and Morreim. In order to properly address conflicts of interest, there must be a radical reassessment of medicine that accounts for the interrelation between scientific, ethical, and economic concerns. Until institutions come into view and professional ethics is developed to account for their role, legitimate interests and obligations of diverse parties cannot be harmonized. (shrink)
Germund Hesslow has argued that concepts of health and disease serve no important scientific, clinical, or ethical function. However, this conclusion depends upon the particular concept of disease he espouses; namely, on Boorse's functional notion. The fact/value split embodied in the functional notion of disease leads to a sharp split between the science of medicine and bioethics, making the philosophy of medicine irrelevant for both. By placing this disease concept in the broader context of medical history, I shall show that (...) it does capture an essential part of modern medical ideology. However, it is also a self-contradictory notion. By making explicit the value desiderata of medical nosologies, a reconfiguration of the relation between medicine, bioethics, and the philosophy of medicine is initiated. This, in turn, will involve a recovery of the caring dimensions of medicine, and thus a more humane practice. (shrink)
The Hyde Amendment and Roman Catholic attempts to put restrictions on Title X funding have been criticized for being intolerant. However, such criticism fails to appreciate that there are two competing notions of tolerance, one focusing on the limits of state force and accepting pluralism as unavoidable, and the other focusing on the limits of knowledge and advancing pluralism as a good. These two types of tolerance, illustrated in the writings of John Locke and J.S. Mill, each involve an intolerance. (...) In a pluralistic context f where the free exercise of religion is respected, John Locke's account of tolerance is preferable. However, it (in a reconstructed form) leads to a minimal state. Positive entitlements to benefits like artificial contraception or nontherapeutic abortions can legitimately be resisted, because an intolerance has already been shown with respect to those that consider the benefit immoral, since their resources have been coop ted by taxation to advance an end that is contrary to their own. There is a sliding scale from tolerance (viewed as forbearance) to the affirmation of communal integrity, and this scale maps on to the continuum from negative to positive rights. Keywords: church and state, Hyde Amendment, Locke, Mill, religious liberty, Title X funding, toleration CiteULike Connotea Del.icio.us What's this? (shrink)
