Switch to: Citations

Add references

You must login to add references.
  1. Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
    The biomedical literature and popular media are full of upbeat reports about the health benefits we can expect from medical innovations using nanotechnology. Some particularly enthusiastic reports portray nanotechnology as one of the innovations that will lead to a significantly extended human life span. Extreme enthusiasts predict that nanotechnology “will ultimately enable us to redesign and rebuild, molecule by molecule, our bodies and brains….”Nanomaterials have special characteristics that could contribute to improved patient care. But the same characteristics that make nanotechnology (...)
    Download  
     
    Export citation  
     
    Bookmark   8 citations  
  • Handling Worker and Third-Party Exposures to Nanotherapeutics during Clinical Trials.Gurumurthy Ramachandran, John Howard, Andrew Maynard & Martin Philbert - 2012 - Journal of Law, Medicine and Ethics 40 (4):856-864.
    Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...)
    Download  
     
    Export citation  
     
    Bookmark   2 citations  
  • (1 other version)The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods. [REVIEW]Johannes J. M. Van Delden Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers - 2012 - BMC Medical Ethics 13 (1):6.
    BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...)
    Download  
     
    Export citation  
     
    Bookmark   3 citations  
  • Is there an objective way to compare research risks?John Rossi & Robert M. Nelson - 2012 - Journal of Medical Ethics 38 (7):423-427.
    Determining whether a research risk meets or exceeds a regulatory standard of risk acceptability is difficult. Recently a framework called the systematic evaluation of research risks (SERR) has been proposed as a method of comparing research risks with predetermined standards of acceptability. SERR purports to offer a systematic and largely determinate (definite) way to compare risks and say whether a specific research risk falls below or above an acknowledged standard of acceptable risk. Here the authors review some philosophical problems with (...)
    Download  
     
    Export citation  
     
    Bookmark   2 citations  
  • Risk, Uncertainty and Profit.Frank H. Knight - 1921 - University of Chicago Press.
    Role of the entrepreneur in a distinct role of profit.
    Download  
     
    Export citation  
     
    Bookmark   302 citations  
  • Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson's disease.Z. Master, M. McLeod & I. Mendez - 2007 - Journal of Medical Ethics 33 (3):169-173.
    Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson’s disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies transplanting (...)
    Download  
     
    Export citation  
     
    Bookmark   11 citations  
  • Prudent Precaution in Clinical Trials of Nanomedicines.Gary E. Marchant & Rachel A. Lindor - 2012 - Journal of Law, Medicine and Ethics 40 (4):831-840.
    Medical technologies, including nanomedicine products, are intended to improve health but in many cases may also create their own health risks. Medical products that create their own health risks differ from most other risk-creating technologies in that the very purpose of the medical technology is to prevent or treat health risks. This paradox of technologies intended to reduce existing risks that may have the effect of creating new risks has two conflicting implications. On one hand, we may be more tolerant (...)
    Download  
     
    Export citation  
     
    Bookmark   1 citation  
  • A Portrait of Nanomedicine and its Bioethical Implications.Rebecca M. Hall, Tong Sun & Mauro Ferrari - 2012 - Journal of Law, Medicine and Ethics 40 (4):763-779.
    While the definitions employed by different governmental agencies and scientific societies differ somewhat, the term “nanotechnology” is generally understood to refer to the manufacturing, characterization, and use of man-made devices with dimensions on the order of 1-100 nanometers. Devices that comprise a fundamental functional element that is nanotechnological are also frequently comprised within nanotechnology, as are manufactured objects with dimensions less than one micrometer. The differences in definition lead to occasional paradoxes, such as the fact that the most widely used (...)
    Download  
     
    Export citation  
     
    Bookmark   5 citations  
  • Ethics at Phase 0: Clarifying the Issues.Jonathan Kimmelman - 2007 - Journal of Law, Medicine and Ethics 35 (4):727-733.
    Many commentators have expressed concern that large investments in biomedical research over the past two decades have not been translated effectively into clinical applications. In its Critical Path Report, the Food and Drug Administration characterized the problem as a “technological disconnect between discovery and the product development process,” and documented that the number of investigational new drugs submitted to the agency had declined “significantly” since 2000. Along a similar vein, another study found that only five of 101 basic science studies (...)
    Download  
     
    Export citation  
     
    Bookmark   8 citations  
  • (1 other version)A treatise on probability.J. Keynes - 1924 - Revue de Métaphysique et de Morale 31 (1):11-12.
    Download  
     
    Export citation  
     
    Bookmark   293 citations  
  • (1 other version)Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.[author unknown] - 2000 - Journal of Medicine and Philosophy 25 (2):259-266.
    Download  
     
    Export citation  
     
    Bookmark   47 citations  
  • A Treatise on Probability.Clarence Irving Lewis - 1922 - Philosophical Review 31 (2):180.
    Download  
     
    Export citation  
     
    Bookmark   36 citations  
  • IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review.Emily E. Anderson & James M. DuBois - 2012 - Journal of Law, Medicine and Ethics 40 (4):951-969.
    Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...)
    Download  
     
    Export citation  
     
    Bookmark   10 citations  
  • Concepts of Risk in Nanomedicine Research.Linda F. Hogle - 2012 - Journal of Law, Medicine and Ethics 40 (4):809-822.
    Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration foreground procedures for minimizing risk for human subjects and require (...)
    Download  
     
    Export citation  
     
    Bookmark   2 citations  
  • Addressing the Ethical Challenges of First in-Human Trials.Audrey R. Chapman - 2011 - Journal of Clinical Research and Bioethics 2 (4).
    Download  
     
    Export citation  
     
    Bookmark   11 citations  
  • Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research.Council of Europe - 2005 - Jahrbuch für Wissenschaft Und Ethik 10 (1):391-402.
    Download  
     
    Export citation  
     
    Bookmark   40 citations  
  • Nanomedicine–emerging or re-emerging ethical issues? A discussion of four ethical themes.Christian Lenk & Nikola Biller-Andorno - 2007 - Medicine, Health Care and Philosophy 10 (2):173-184.
    Nanomedicine plays a prominent role among emerging technologies. The spectrum of potential applications is as broad as it is promising. It includes the use of nanoparticles and nanodevices for diagnostics, targeted drug delivery in the human body, the production of new therapeutic materials as well as nanorobots or nanoprotheses. Funding agencies are investing large sums in the development of this area, among them the European Commission, which has launched a large network for life-sciences related nanotechnology. At the same time government (...)
    Download  
     
    Export citation  
     
    Bookmark   12 citations  
  • Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor.James A. Anderson & Jonathan Kimmelman - 2012 - Bioethics 28 (3):138-146.
    Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, (...)
    Download  
     
    Export citation  
     
    Bookmark   3 citations  
  • Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field.Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline - 2012 - Journal of Law, Medicine and Ethics 40 (4):716-750.
    Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...)
    Download  
     
    Export citation  
     
    Bookmark   9 citations  
  • Predicting harms and benefits in translational trials: ethics, evidence, and uncertainty.Jonathan Kimmelman & Alex John London - unknown
    First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns on claims (...)
    Download  
     
    Export citation  
     
    Bookmark   18 citations  
  • (1 other version)A Treatise on Probability.J. M. Keynes - 1989 - British Journal for the Philosophy of Science 40 (2):219-222.
    Download  
     
    Export citation  
     
    Bookmark   296 citations  
  • Articulating and responding to uncertainties in clinical research.Benjamin Djulbegovic - 2007 - Journal of Medicine and Philosophy 32 (2):79 – 98.
    This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to (...)
    Download  
     
    Export citation  
     
    Bookmark   13 citations  
  • Explaining life. Synthetic biology and non-scientific understandings of life.Anna Https://Orcidorg Deplazes-Zemp & Nikola Https://Orcidorg Biller-Andorno - 2012 - .
    Download  
     
    Export citation  
     
    Bookmark   3 citations