40 found
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  1.  58
    Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine and Ethics 36 (2):219-248.
    No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...)
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  2.  25
    Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children.Ellen Wright Clayton - 2014 - American Journal of Bioethics 14 (3):3-9.
    American Academy of Pediatrics and American College of Medical Genetics recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and whether the guidelines conflict or come to different but (...)
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  3.  5
    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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  4.  19
    The Unbearable Requirement of Informed Consent.Ellen Wright Clayton - 2019 - American Journal of Bioethics 19 (5):19-20.
    Volume 19, Issue 5, May 2019, Page 19-20.
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  5.  25
    Informed Consent and Biobanks.Ellen Wright Clayton - 2005 - Journal of Law, Medicine and Ethics 33 (1):15-21.
    Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important (...)
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  6.  27
    Parents’ Attitudes Toward Consent and Data Sharing in Biobanks: A Multisite Experimental Survey.Armand H. Matheny Antommaria, Kyle B. Brothers, John A. Myers, Yana B. Feygin, Sharon A. Aufox, Murray H. Brilliant, Pat Conway, Stephanie M. Fullerton, Nanibaa’ A. Garrison, Carol R. Horowitz, Gail P. Jarvik, Rongling Li, Evette J. Ludman, Catherine A. McCarty, Jennifer B. McCormick, Nathaniel D. Mercaldo, Melanie F. Myers, Saskia C. Sanderson, Martha J. Shrubsole, Jonathan S. Schildcrout, Janet L. Williams, Maureen E. Smith, Ellen Wright Clayton & Ingrid A. Holm - 2018 - AJOB Empirical Bioethics 9 (3):128-142.
  7.  6
    Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions.Fook Yee Cheung, Lauren Clatch, Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2020 - Journal of Law, Medicine and Ethics 48 (1):87-104.
    The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to (...)
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  8.  6
    Informed Consent and Biobanks.Ellen Wright Clayton - 2005 - Journal of Law, Medicine and Ethics 33 (1):15-21.
    Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important (...)
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  9.  8
    The Past, Present, and Future of Informed Consent in Research and Translational Medicine.Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2018 - Journal of Law, Medicine and Ethics 46 (1):7-11.
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  10.  3
    Online Pediatric Research: Addressing Consent, Assent, and Parental Permission.Kyle B. Brothers, Ellen Wright Clayton & Aaron J. Goldenberg - 2020 - Journal of Law, Medicine and Ethics 48 (S1):129-137.
    This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.
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  11.  16
    Incidental Findings in Genetics Research Using Archived DNA.Ellen Wright Clayton - 2008 - Journal of Law, Medicine and Ethics 36 (2):286-291.
    Despite calls by some commentators for disclosing incidental fndings in genetics research, several factors weigh in favor of caution. The technology of genetics has the power to uncover a vast array of information. The most potent argument for restraint in disclosure is that much research is pursued without consent so that the individual participant may not know that research is being conducted at all. Often the work is done by investigators and at institutions with which the person has no prior (...)
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  12.  33
    “Human Non-Subjects Research”: Privacy and Compliance.Kyle Bertram Brothers & Ellen Wright Clayton - 2010 - American Journal of Bioethics 10 (9):15-17.
  13.  7
    Incidental Findings in Genetics Research Using Archived DNA.Ellen Wright Clayton - 2008 - Journal of Law, Medicine and Ethics 36 (2):286-291.
    There are countless variations on this theme. The call can come from one of your own physicians who was called by the investigator. Your physician may or may not be well informed on what the reported finding about Disease Y means or how to respond. DNA testing can reveal more than susceptibility to disease. People can learn that they do not have the biological connections — parentage or evidence of ethnic origin — that they thought they did.Colleagues who serve on (...)
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  14.  6
    Commercial Interests, the Technological Imperative, and Advocates: Three Forces Driving Genomic Sequencing in Newborns.Stacey Pereira & Ellen Wright Clayton - 2018 - Hastings Center Report 48 (S2):S43-S44.
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  15.  31
    So What Are We Going to Do About Research Using Clinical Information and Samples.Ellen Wright Clayton - 2004 - IRB: Ethics & Human Research 26 (6):14-15.
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  16.  3
    How Much Control Do Children and Adolescents Have Over Genomic Testing, Parental Access to Their Results, and Parental Communication of Those Results to Others?Ellen Wright Clayton - 2015 - Journal of Law, Medicine and Ethics 43 (3):538-544.
    Adolescents may often have opinions about whether they want genetic and genomic testing in both the clinic and research and about who should have access to the results. This legal analysis demonstrates that the law provides very little protection to minors' wishes.
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  17.  11
    Currents in Contemporary Ethics.Ellen Wright Clayton - 2010 - Journal of Law, Medicine and Ethics 38 (3):697-700.
    Parents, providers, policy makers, and the public need to talk about the implications of advances in genomic technologies for state run newborn metabolic screening programs. Technologies, such as highly multiplex testing and whole genome sequencing, are raising old issues with new urgency and are posing new challenges that threaten to overwhelm newborn screening programs.Newborn screening programs in their current form were born in the late 1960s. Robert Guthrie developed a screening test for phenylketonuria that could be performed on blood spots (...)
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  18.  1
    Currents in Contemporary Ethics.Ellen Wright Clayton - 2010 - Journal of Law, Medicine and Ethics 38 (3):697-700.
    Parents, providers, policy makers, and the public need to talk about the implications of advances in genomic technologies for state run newborn metabolic screening programs. Technologies, such as highly multiplex testing and whole genome sequencing, are raising old issues with new urgency and are posing new challenges that threaten to overwhelm newborn screening programs.Newborn screening programs in their current form were born in the late 1960s. Robert Guthrie developed a screening test for phenylketonuria that could be performed on blood spots (...)
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  19.  13
    A Time for Gratitude.Ellen Wright Clayton - 2000 - Journal of Law, Medicine and Ethics 28 (4):329-329.
  20.  7
    A Time for Gratitude.Ellen Wright Clayton - 2000 - Journal of Law, Medicine and Ethics 28 (4):329-329.
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  21.  26
    The Ethical Health Lawyer: An Empirical Assessment of Moral Decision Making.Joshua E. Perry, Ilene N. Moore, Bruce Barry, Ellen Wright Clayton & Amanda R. Carrico - 2009 - Journal of Law, Medicine and Ethics 37 (3):461-475.
    Writing in 1999, legal ethics scholar Brad Wendel noted that “[v]ery little empirical work has been done on the moral decision making of lawyers.” Indeed, since the mid-1990s, few empirical studies have attempted to explore how attorneys deliberate about ethical dilemmas they encounter in their practice. Moreover, while past research has explored some of the ethical issues confronting lawyers practicing in certain specific areas of practice, no published data exists probing the moral mind of health care lawyers. As signaled by (...)
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  22.  10
    The Complex Relationship of Genetics, Groups, and Health: What It Means for Public Health.Ellen Wright Clayton - 2002 - Journal of Law, Medicine and Ethics 30 (2):290-297.
    Genetics offers real opportunities for public health actors. Increased understanding of genetics will illuminate some of the factors that affect disease and, in many cases, will lead to more effective treatments. The recognition that phenylketonuria was caused by a metabolic defect that led to the accumulation of toxic levels of phenylalanine, an elevation that could largely be averted by adopting a low-phenylalanine diet, is an early example. Some cases of what was thought to be Sudden Infant Death Syndrome, a diagnosis (...)
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  23.  5
    The Complex Relationship of Genetics, Groups, and Health: What It Means for Public Health.Ellen Wright Clayton - 2002 - Journal of Law, Medicine and Ethics 30 (2):290-297.
    Genetics offers real opportunities for public health actors. Increased understanding of genetics will illuminate some of the factors that affect disease and, in many cases, will lead to more effective treatments. The recognition that phenylketonuria was caused by a metabolic defect that led to the accumulation of toxic levels of phenylalanine, an elevation that could largely be averted by adopting a low-phenylalanine diet, is an early example. Some cases of what was thought to be Sudden Infant Death Syndrome, a diagnosis (...)
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  24.  8
    Case Study: Baby Aaron and the Elders.Ellen Wright Clayton & Eric Kodish - 1999 - Hastings Center Report 29 (5):20.
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  25.  7
    Legal and Ethical Commentary: The Dangers of Reading Duty Too Broadly.Ellen Wright Clayton - 1997 - Journal of Law, Medicine and Ethics 25 (1):19-21.
    The term duty is used in philosophy and law to de scribe the obligation one person owes to another. Yet what these two disciplines mean by duty often differs. Perhaps even more important, a determination by the law that a duty exists has different social consequences than does a similar assessment by philosophy Moral or ethical obligations between individuals make living in society possible, but breach of these obligations usually results only in social opprobrium, personal guilt, or shame. A legal (...)
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  26.  3
    Foreword.Ellen Wright Clayton - 2001 - Journal of Law, Medicine and Ethics 29 (s2):1-2.
  27.  2
    Legal and Ethical Commentary: The Dangers of Reading Duty Too Broadly.Ellen Wright Clayton - 1997 - Journal of Law, Medicine and Ethics 25 (1):19-21.
    The term duty is used in philosophy and law to de scribe the obligation one person owes to another. Yet what these two disciplines mean by duty often differs. Perhaps even more important, a determination by the law that a duty exists has different social consequences than does a similar assessment by philosophy Moral or ethical obligations between individuals make living in society possible, but breach of these obligations usually results only in social opprobrium, personal guilt, or shame. A legal (...)
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  28.  16
    Index to Volume 22.Lisa Sowle Cahill, Mark J. Cherry, Ellen Wright Clayton, Francis Dominic Degnin, Kenneth DeVille, Robin S. Downie, Fiona Randall, Steven D. Edwards, Ruiping Fan & Kateryna Fedoryka - 1997 - Journal of Medicine and Philosophy 22:643-646.
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  29.  21
    A Ray of Light About Frozen Embryos.Ellen Wright Clayton - 1992 - Kennedy Institute of Ethics Journal 2 (4):347-359.
  30.  10
    Baby Aaron and the Elders.Ellen Wright Clayton & Eric Kodish - 1999 - Hastings Center Report 29 (5):20 - discussion.
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  31.  2
    Foreword.Ellen Wright Clayton - 2001 - Journal of Law, Medicine and Ethics 29 (S2):1-2.
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  32.  6
    The Dispersion of Genetic Technologies and the Law.Ellen Wright Clayton - 1995 - Hastings Center Report 25 (3):13-15.
  33.  4
    What Should We Be Asking of Informed Consent?Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):185-187.
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  34.  11
    Why the Use of Anonymous Samples for Research Matters.Ellen Wright Clayton - 1995 - Journal of Law, Medicine and Ethics 23 (4):375-377.
  35.  22
    Response.Ellen Wright Clayton - 2009 - Cambridge Quarterly of Healthcare Ethics 18 (3):320.
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  36.  3
    The Implementation Chasm Hindering Genome-Informed Health Care.Kevin B. Johnson, Ellen Wright Clayton, Justin Starren & Josh Peterson - 2020 - Journal of Law, Medicine and Ethics 48 (1):119-125.
    The promises of precision medicine are often heralded in the medical and lay literature, but routine integration of genomics in clinical practice is still limited. While the “last mile” infrastructure to bring genomics to the bedside has been demonstrated in some healthcare settings, a number of challenges remain — both in the receptivity of today's health system and in its technical and educational readiness to respond to this evolution in care. To improve the impact of genomics on health and disease (...)
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  37.  19
    The Ethical Health Lawyer: An Empirical Assessment of Moral Decision Making.Joshua E. Perry, Ilene N. Moore, Bruce Barry, Ellen Wright Clayton & Amanda R. Carrico - 2009 - Journal of Law, Medicine and Ethics 37 (3):461-475.
    The empirical literature exploring lawyers and their moral decision making is limited despite the “crisis” of unethical and unprofessional behavior in the bar that has been well documented for over a decade. In particular we are unaware of any empirical studies that investigate the moral landscape of the health lawyer’s practice. In an effort to address this gap in the literature, an interdisciplinary team of researchers at Vanderbilt University designed an empirical study to gather preliminary evidence regarding the moral reasoning (...)
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  38.  26
    Experimental Arrest of Cerebral Blood Flow in Human Subjects: The Red Wing Studies Revisited.Brian A. Smith, Ellen Wright Clayton & David Robertson - 2011 - Perspectives in Biology and Medicine 54 (2):121-131.
    Aircraft with increasingly high performance were important to the war effort in World War II. Changes in technology allowed aircraft to reach faster speeds and to complete missions at higher altitudes. With these changes came new obstacles for pilots who had to tolerate these stresses. Of primary concern to the U.S. War Department was the loss of consciousness that often occurred with high-speed maneuvers and especially during pull-up after dive-bombing missions. In some cases, pilots would experience up to 9G of (...)
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  39.  2
    Introduction: The Crucial Role of Law in Supporting Successful Translation of Genomics Into Clinical Care.Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2020 - Journal of Law, Medicine and Ethics 48 (1):7-10.
  40.  33
    What Is Really at Stake in Baby K?: A Response to Ellen Flannery.Ellen Wright Clayton - 1995 - Journal of Law, Medicine and Ethics 23 (1):13-14.
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