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  1. From Genetics to Genomics: Facing the Liability Implications in Clinical Care.Gary Marchant, Mark Barnes, James P. Evans, Bonnie LeRoy & Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (1):11-43.
    Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...)
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  • 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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  • Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations.George J. Annas, Leonard H. Glantz & Patricia A. Roche - 1995 - Journal of Law, Medicine and Ethics 23 (4):360-366.
    Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to (...)
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  • Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations.George J. Annas, Leonard H. Glantz & Patricia A. Roche - 1995 - Journal of Law, Medicine and Ethics 23 (4):360-366.
    Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to (...)
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  • (1 other version)Smarter regulations.Victoria Sutton - 2009 - Science and Engineering Ethics 15 (3):303-309.
    In the United States a rapidly increasing regulatory burden for life scientists has led to questions of whether the increased burden resulting from the Select Agent Program has had adverse effects on scientific advances. Attention has focussed on the regulatory “fit” of the Program and ways in which its design could be improved. An international framework convention to address common concerns about biosecurity and biosafety is a logical next step.
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  • (1 other version)Smarter regulations commentary on “responsible conduct by life scientists in an age of terrorism”.Victoria Sutton - 2009 - Science and Engineering Ethics 15 (3):303-309.
    In the United States a rapidly increasing regulatory burden for life scientists has led to questions of whether the increased burden resulting from the Select Agent Program has had adverse effects on scientific advances. Attention has focussed on the regulatory “fit” of the Program and ways in which its design could be improved. An international framework convention to address common concerns about biosecurity and biosafety is a logical next step. Keywords Biosafety - Biosecurity law - Biosecurity regulations - Scientist - (...)
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