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  1.  17
    Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice.Gabriel Lázaro-Muñoz, John M. Conley, Arlene M. Davis, Marcia Van Riper, Rebecca L. Walker & Eric T. Juengst - 2015 - American Journal of Bioethics 15 (7):3-14.
    Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...)
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  2.  8
    Consent Forms and the Therapeutic Misconception.Nancy M. P. King, Gail E. Henderson, Larry R. Churchill, Arlene M. Davis, Sara Chandros Hull, Daniel K. Nelson, P. Christy Parham-Vetter, Barbra Bluestone Rothschild, Michele M. Easter & Benjamin S. Wilfond - 2005 - IRB: Ethics & Human Research 27 (1):1-7.
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  3.  3
    Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can Be Risky.Larry R. Churchill, Daniel K. Nelson, Gail E. Henderson, Nancy M. P. King, Arlene M. Davis, Erin Leahey & Benjamin S. Wilfond - 2003 - IRB: Ethics & Human Research 25 (3):1.
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  4.  22
    A Trade Secret Model for Genomic Biobanking.John M. Conley, Robert Mitchell, R. Jean Cadigan, Arlene M. Davis, Allison W. Dobson & Ryan Q. Gladden - 2012 - Journal of Law, Medicine and Ethics 40 (3):612-629.
    The current ethical norms of genomic biobanking creating and maintaining large repositories of human DNA and/or associated data for biomedical research have generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself (...)
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  5.  35
    Vulnerability to Influence: A Two-Way Street.Gail E. Henderson, Arlene M. Davis & Nancy M. P. King - 2004 - American Journal of Bioethics 4 (3):50 – 52.
  6.  5
    Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy.Rebecca L. Walker, Eric T. Juengst, Warren Whipple & Arlene M. Davis - 2014 - Journal of Law, Medicine and Ethics 42 (2):220-231.
    Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria, were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression program through the (...)
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  7.  17
    The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection.Arlene M. Davis, Sara Chandros Hull, Christine Grady, Benjamin S. Wilfond & Gail E. Henderson - 2002 - Journal of Law, Medicine and Ethics 30 (3):411-419.
    Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...)
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  8.  10
    The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection.Arlene M. Davis, Sara Chandros Hull, Christine Grady, Benjamin S. Wilfond & Gail E. Henderson - 2002 - Journal of Law, Medicine and Ethics 30 (3):411-419.
    Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...)
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  9.  10
    Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy.Rebecca L. Walker, Eric T. Juengst, Warren Whipple & Arlene M. Davis - 2014 - Journal of Law, Medicine and Ethics 42 (2):220-231.
    Recent advances in next generation sequencing along with high hopes for genomic medicine have inspired interest in genomic research with the newly dead. However, applicable law does not adequately determine ethical or policy responses to such research. In this paper we propose that such research stands at a crossroads between other more established biomedical clinical and research practices. In addressing the ethical and policy issues raised by a particular research project within our institution comparatively with these other practices, we illustrate (...)
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  10.  11
    Addressing “Difficult Patient” Dilemmas: Possible Alternatives to the Mediation Model.Arlene M. Davis, Michele Rivkin-Fish & Deborah J. Love - 2012 - American Journal of Bioethics 12 (5):13-14.
    The American Journal of Bioethics, Volume 12, Issue 5, Page 13-14, May 2012.
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  11.  4
    Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?Anya E. R. Prince, John M. Conley, Arlene M. Davis, Gabriel Lázaro-Muñoz & R. Jean Cadigan - 2015 - Journal of Law, Medicine and Ethics 43 (4):827-842.
    The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly (...)
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  12.  7
    Is Real-Time ELSI Realistic?John M. Conley, Anya E. R. Prince, Arlene M. Davis, Jean Cadigan & Gabriel Lazaro-Munoz - 2020 - Ajob Empirical Bioethics 11 (2):134-144.
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  13.  12
    Scientific Social Responsibility: Lessons From the Corporate Social Responsibility Movement.John M. Conley, Gabriel Lázaro-Muñoz, Anya E. R. Prince, Arlene M. Davis & R. Jean Cadigan - 2015 - American Journal of Bioethics 15 (12):64-66.
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  14.  10
    Exception From Informed Consent for Emergency Research: Drawing on Existing Skills and Experience.Arlene M. Davis - 1998 - IRB: Ethics & Human Research 20 (5):1.
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  15.  19
    Confidentiality: More Than a Linkage File and a Locked Drawer.Michele M. Easter, Arlene M. Davis & Gail E. Henderson - 2004 - IRB: Ethics & Human Research 26 (2):13.
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  16.  11
    Response to Open Peer Commentaries on “Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice”.Gabriel Lázaro-Muñoz, John M. Conley, Arlene M. Davis, Marcia Van Riper, Rebecca L. Walker & Eric T. Juengst - 2015 - American Journal of Bioethics 15 (12):6-9.
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  17.  6
    Reconsidering Scarce Drug Rationing: Implications for Clinical Research.Zev M. Nakamura, Douglas P. MacKay, Arlene M. Davis, Elizabeth R. Brassfield, Benny L. Joyner Jr & Donald L. Rosenstein - forthcoming - Journal of Medical Ethics:medethics-2020-106739.
    Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of (...)
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  18.  11
    Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?Anya E. R. Prince, John M. Conley, Arlene M. Davis, Gabriel Lázaro-Muñoz & R. Jean Cadigan - 2015 - Journal of Law, Medicine and Ethics 43 (4):827-842.
    The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly (...)
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  19.  6
    Exploring the Emotional Labor of Medical Trainees in the Setting of Ethics Education.Margaret Waltz, R. Jean Cadigan & Arlene M. Davis - 2019 - American Journal of Bioethics 19 (12):65-66.
    Volume 19, Issue 12, December 2019, Page 65-66.
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