11 found
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  1.  35
    Introduction: Sharing Data in a Medical Information Commons.Amy L. McGuire, Mary A. Majumder, Angela G. Villanueva, Jessica Bardill, Juli M. Bollinger, Eric Boerwinkle, Tania Bubela, Patricia A. Deverka, Barbara J. Evans, Nanibaa' A. Garrison, David Glazer, Melissa M. Goldstein, Henry T. Greely, Scott D. Kahn, Bartha M. Knoppers, Barbara A. Koenig, J. Mark Lambright, John E. Mattison, Christopher O'Donnell, Arti K. Rai, Laura L. Rodriguez, Tania Simoncelli, Sharon F. Terry, Adrian M. Thorogood, Michael S. Watson, John T. Wilbanks & Robert Cook-Deegan - 2019 - Journal of Law, Medicine and Ethics 47 (1):12-20.
    Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
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  2.  6
    Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.Mark A. Rothstein, John T. Wilbanks, Laura M. Beskow, Kathleen M. Brelsford, Kyle B. Brothers, Megan Doerr, Barbara J. Evans, Catherine M. Hammack-Aviran, Michelle L. McGowan & Stacey A. Tovino - 2020 - Journal of Law, Medicine and Ethics 48 (S1):196-226.
    Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...)
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  3.  15
    Who Owns the Data in a Medical Information Commons?Amy L. McGuire, Jessica Roberts, Sean Aas & Barbara J. Evans - 2019 - Journal of Law, Medicine and Ethics 47 (1):62-69.
    In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.
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  4.  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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  5.  5
    Parsing the Line Between Professional and Citizen Science.Barbara J. Evans - 2019 - American Journal of Bioethics 19 (8):15-17.
    Volume 19, Issue 8, August 2019, Page 15-17.
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  6.  3
    The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?Barbara J. Evans - 2020 - Journal of Law, Medicine and Ethics 48 (S1):74-81.
    The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how (...)
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  7.  1
    The Streetlight Effect: Regulating Genomics Where the Light Is.Barbara J. Evans - 2020 - Journal of Law, Medicine and Ethics 48 (1):105-118.
    Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.
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  8.  8
    Economic Regulation of Next-Generation Sequencing.Barbara J. Evans - 2014 - Journal of Law, Medicine and Ethics 42 (s1):51-66.
    The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 regulations and the Health Insurance Portability and Accountability Act Privacy Rule. This article explores the nature of these changes (...)
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  9.  13
    Patients' Choices for Return of Exome Sequencing Results to Relatives in the Event of Their Death.Laura M. Amendola, Martha Horike‐Pyne, Susan B. Trinidad, Stephanie M. Fullerton, Barbara J. Evans, Wylie Burke & Gail P. Jarvik - 2015 - Journal of Law, Medicine and Ethics 43 (3):476-485.
    The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.
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  10.  23
    Inconsistent Regulatory Protection Under the U.S. Common Rule.Barbara J. Evans - 2004 - Cambridge Quarterly of Healthcare Ethics 13 (4):366-379.
    U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration. This paper examines a deeper problem: Even when the regulations do apply, they still do not afford consistent standards of protection. The U.S. Common Rule and related FDA regulations lack a workable regulatory control mechanism.
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  11.  20
    Nancy Berlinger, Ph. D., M. Div., is Deputy Director and Associate for Religious Studies at The Hastings Center, Garrison, New York. Michael A. DeVita, MD, is Associate Professor of Critical Care Medicine and Internal Medicine and Chair of the UPMC Ethics Committee, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. [REVIEW]Barbara J. Evans, Sven Ove Hansson, Steve Heilig, Ana Smith Iltis, Kenneth V. Iserson, Anita F. Khayat, Greg Loeben, Jerry Menikoff & Rebecca D. Pentz - 2004 - Cambridge Quarterly of Healthcare Ethics 13:313-314.
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