Switch to: References

Add citations

You must login to add citations.
  1. Gene Therapy Oversight: Lessons for Nanobiotechnology.Susan M. Wolf, Rishi Gupta & Peter Kohlhepp - 2009 - Journal of Law, Medicine and Ethics 37 (4):659-684.
    Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene (...)
    Direct download (4 more)  
     
    Export citation  
     
    Bookmark   8 citations  
  • Law & Bioethics: From Values to Violence.Susan M. Wolf - 2004 - Journal of Law, Medicine and Ethics 32 (2):293-306.
    Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While George Annas has praised law and rights-talk for creating modern bioethics, Carl Schneider has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one account, typified by Albert Jonsen, bioethics largely grew out of philosophy and theology, not law. (...)
    Direct download (5 more)  
     
    Export citation  
     
    Bookmark   2 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. (...)
    Direct download (7 more)  
     
    Export citation  
     
    Bookmark   9 citations  
  • What is Unique About Nanomedicine? The Significance of the Mesoscale.George Khushf & Ronald A. Siegel - 2012 - Journal of Law, Medicine and Ethics 40 (4):780-794.
    In prominent funding and policy statements, a particle with at least one dimension in the 1-300 nm size range must have novel physicochemical properties to count as a “nanoparticle.” Size is thus only one factor. Novelty of a particle's properties is also essential to its “nano” classification. When particles in this size range are introduced into living systems, they often interact with their host in novel ways that require some modification of existing methods and models used by pharmaceutical scientists and (...)
    Direct download (4 more)  
     
    Export citation  
     
    Bookmark  
  • What Is Unique About Nanomedicine? The Significance of the Mesoscale.George Khushf & Ronald A. Siegel - 2012 - Journal of Law, Medicine and Ethics 40 (4):780-794.
    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.
    Direct download (6 more)  
     
    Export citation  
     
    Bookmark  
  • Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines.Jonathan Kimmelman - 2012 - Journal of Law, Medicine and Ethics 40 (4):841-847.
    Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation (...)
    Direct download (6 more)  
     
    Export citation  
     
    Bookmark  
  • Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines.Jonathan Kimmelman - 2012 - Journal of Law, Medicine and Ethics 40 (4):841-847.
    Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of (...)
    Direct download (4 more)  
     
    Export citation  
     
    Bookmark  
  • Synthetic Biology and the Translational Imperative.Raheleh Heidari Feidt, Marcello Ienca, Bernice Simone Elger & Marc Folcher - 2019 - Science and Engineering Ethics 25 (1):33-52.
    Advances at the interface between the biological sciences and engineering are giving rise to emerging research fields such as synthetic biology. Harnessing the potential of synthetic biology requires timely and adequate translation into clinical practice. However, the translational research enterprise is currently facing fundamental obstacles that slow down the transition of scientific discoveries from the laboratory to the patient bedside. These obstacles including scarce financial resources and deficiency of organizational and logistic settings are widely discussed as primary impediments to translational (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark  
  • Valuing Risk: The Ethical Review of Clinical Trial Safety.Jonathan Kimmelman - 2004 - Kennedy Institute of Ethics Journal 14 (4):369-393.
    : Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially (...)
    Direct download (6 more)  
     
    Export citation  
     
    Bookmark   9 citations  
  • Should Research Ethics Encourage the Production of Cost-Effective Interventions?Govind Persad - 2016 - In Daniel Strech & Marcel Mertz (eds.), Ethics and Governance of Biomedical Research: Theory and Practice. Springer. pp. 13-28.
    This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such as tissue (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark  
  • Designing a Disconnect?Gladys B. White - 2011 - American Journal of Bioethics 11 (5):20-22.
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   1 citation  
  • Dealing With the Long-Term Social Implications of Research.Jeremy Sugarman, Dale E. Hammerschmidt, Christine Grady, Lisa Eckenwiler, Carol Levine & Alan Fleischman - 2011 - American Journal of Bioethics 11 (5):5-9.
    Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   14 citations  
  • The Need for Topically Focused Efforts to Deal with the Long-Term Social Implications of Research.Frazier Benya - 2011 - American Journal of Bioethics 11 (5):19-20.
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   1 citation  
  • The Diverse Ethics of Translational Research.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):19-30.
    Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these features, translational research beyond approval (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   19 citations  
  • Improving Subject Safety in High-Risk Phase I Trials With Stem Cell-Based Candidate Therapies.Audrey R. Chapman - 2012 - American Journal of Bioethics Neuroscience 3 (2):18-20.
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark