11 found
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  1.  7
    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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  2.  3
    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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  3.  12
    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.
  4.  20
    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.
    In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization and the Council of Europe. The common heritage concept has played a prominent role in arguments against patenting the human genome or portions thereof. This (...)
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  5.  32
    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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  6.  21
    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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  7.  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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  8. 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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  9.  17
    About Face: Forensic Genetic Testing for Race and Visible Traits.Pilar N. Ossorio - 2006 - Journal of Law, Medicine and Ethics 34 (2):277-292.
    “DNAPrint Genomics, Inc. has applied the most recent advancements in human genomic technology for the deciphering of an individual's race. We are proud to introduce to the forensic community DNA WITNESS 2.0, a genetic test for the deduction of the heritable component of race, called Biogeographical Ancestry.”–Z. Gaskin“One definite and obvious consequence of the complexity of human demographic history is that races in any meaningful sense of the term do not exist in the human species.”–D. B. Goldstein and L. Chikhi.
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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.  17
    Not Taking, Just Borrowing: Government Use of Patented Drugs.Pilar N. Ossorio - 2002 - American Journal of Bioethics 2 (3):51-52.