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  1. Are Explanatory Trials Ethical? Shifting the Burden of Justification in Clinical Trial Design.Kirstin Borgerson - 2013 - Theoretical Medicine and Bioethics 34 (4):293-308.
    Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some (...)
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  • 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 (...)
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  • Guidelines to Prevent Malevolent Use of Biomedical Research.Shane K. Green, Sara Taub, Karine Morin & Daniel Higginson - 2006 - Cambridge Quarterly of Healthcare Ethics 15 (4):432-439.
    In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an end (...)
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  • The Social Value Requirement Reconsidered.Alan Wertheimer - 2015 - Bioethics 29 (5):301-308.
    It is widely assumed that it is ethical to conduct research with human subjects only if the research has social value. There are two standard arguments for this view. The allocation argument claims that public funds should not be devoted to research that lacks social value. The exploitation avoidance argument claims that subjects are exploited if research has no social value. The primary purpose of this article is to argue that these arguments do not succeed. The allocation argument has little (...)
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  • Why Reading the Title Isn’T Good Enough: An Evaluation of the 4S Approach to Evidence-Based Medicine.Kirstin Borgerson - 2009 - International Journal of Feminist Approaches to Bioethics 2 (2):152-175.
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  • A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review.Alex John London - 2012 - Journal of Law, Medicine and Ethics 40 (4):930-944.
    This paper offers a non-paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a “market” in which stakeholders working to advance diverse ends also advance the common good.
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  • The Role of Controversial Research in the IRB's Risk/Benefit Analysis.John Lunstroth - 2011 - American Journal of Bioethics 11 (5):14-16.
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  • Scientific Value and Validity as Ethical Requirements for Research: A Proposed Explication.Benjamin Freedman - 1987 - IRB: Ethics & Human Research.
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