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Pilar N. Ossorio [11]Pilar Ossorio [4]
  1.  4
    How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?Barbara J. Evans, Gail Javitt, Ralph Hall, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan & Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):44-68.
    Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
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  2.  3
    FMT and Microbial Medical Products: Generating High-Quality Evidence Through Good Governance.Pilar N. Ossorio & Yao Zhou - 2019 - Journal of Law, Medicine and Ethics 47 (4):505-523.
    This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.
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  3.  22
    Clines Without Classes.Joan H. Fujimura, Deborah A. Bolnick, Ramya Rajagopalan, Jay S. Kaufman, Richard C. Lewontin, Troy Duster, Pilar Ossorio & Jonathan Marks - 2014 - Sociological Theory 32 (3):208-227.
    This article examines Shiao, Bode, Beyer, and Selvig’s (2012) arguments in their article “The Genomic Challenge to the Social Construction of Race” and finds that their claims are based on fundamentally flawed interpretations of current genetic research. We discuss current genomic and genetic knowledge about human biological variation to demonstrate why and how Shiao et al.’s recommendations for future sociological studies and social policy, based on their inadequate understanding of genomic methods and evidence, are similarly flawed and will lead sociology (...)
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  4.  10
    Letting the Gene Out of the Bottle: A Comment on Returning Individual Research Results to Participants.Pilar N. Ossorio - 2006 - American Journal of Bioethics 6 (6):24 – 25.
  5.  2
    Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.Susan M. Wolf, Pilar N. Ossorio, Susan A. Berry, Henry T. Greely, Amy L. McGuire, Michelle A. Penny & Sharon F. Terry - 2020 - Journal of Law, Medicine and Ethics 48 (1):69-86.
    Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
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  6.  7
    Fairness in Manufacturing Cellular Therapies.Amritava Das, Krishanu Saha & Pilar N. Ossorio - 2018 - American Journal of Bioethics 18 (4):68-70.
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  7.  19
    The Human Genome as Common Heritage: Common Sense or Legal Nonsense?Pilar N. Ossorio - 2007 - Journal of Law, Medicine and Ethics 35 (3):425-439.
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  8.  31
    The Human Genome as Common Heritage: Common Sense or Legal Nonsense?Pilar N. Ossorio - 2007 - Journal of Law, Medicine and Ethics 35 (3):425-439.
    This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.
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  9. Bodies of Data: Genomic Data and Bioscience Data Sharing.Pilar N. Ossorio - 2011 - Social Research: An International Quarterly 78 (3):907-932.
    The biosciences have become information sciences, in which knowledge is often produced in silica, by the manipulation and analysis of large datasets. Genomics has been at the forefront of the data explosion and is a model for bioscience as a large-scale endeavor. Large genome research datasets are frequently shared through research repositories. To protect the interests of people from whom the data were derived , human data are often shared through a controlled access mechanism, in which data repositories can, in (...)
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  10.  6
    The Ethics of Translating High-Throughput Science Into Clinical Practice.Pilar N. Ossorio - 2014 - Hastings Center Report 44 (5):8-9.
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  11.  18
    About Face: Forensic Genetic Testing for Race and Visible Traits.Pilar N. Ossorio - 2006 - Journal of Law, Medicine and Ethics 34 (2):277-292.
    Information from forensic genetic tests of crime scene samples has been used to make claims about suspects' race and appearance. This article discusses and critiques the techniques used to make such claims, and raises policy concerns about them.
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  12.  15
    About Face: Forensic Genetic Testing for Race and Visible Traits.Pilar N. Ossorio - 2006 - Journal of Law, Medicine and Ethics 34 (2):277-292.
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  13.  17
    Genotype-Driven Recruitment Without Deception.Pilar Ossorio & Marsha Mailick - 2017 - American Journal of Bioethics 17 (4):60-61.
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  14.  16
    Not Taking, Just Borrowing: Government Use of Patented Drugs.Pilar N. Ossorio - 2002 - American Journal of Bioethics 2 (3):51-52.