14 found
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  1.  17
    Physician Autonomy and the Opioid Crisis.Nathan Guevremont, Mark Barnes & Claudia E. Haupt - 2018 - Journal of Law, Medicine and Ethics 46 (2):203-219.
    The scope and severity of the opioid epidemic in the United States has prompted significant legislative intrusion into the patient-physician relationship. These proscriptive regulatory regimes mirror earlier legislation in other politically-charged domains like abortion and gun regulation. We draw on lessons from those contexts to argue that states should consider integrating their responses to the epidemic with existing medical regulatory structures, making physicians partners rather than adversaries in addressing this public health crisis.
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  2.  6
    Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence.Holly Fernandez Lynch, Leslie E. Wolf & Mark Barnes - 2019 - Journal of Law, Medicine and Ethics 47 (2):213-231.
    The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to (...)
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  3.  2
    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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  4.  23
    Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies.Patrina Sexton, Katrina Hui, Donna Hanrahan, Mark Barnes, Jeremy Sugarman, Alex John London & Robert Klitzman - 2016 - Developing World Bioethics 16 (1):4-14.
    Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can (...)
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  5.  14
    Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts.Mark Barnes & Patrik S. Florencio - 2002 - Journal of Law, Medicine and Ethics 30 (3):390-402.
    In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and (...)
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  6.  18
    Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts.Mark Barnes & Patrik S. Florencio - 2002 - Journal of Law, Medicine and Ethics 30 (3):390-402.
    In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and (...)
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  7.  7
    The HIV-Infected Health Care Professional: Employment Policies and Public Health.Mark Barnes, Nicholas A. Rango, Gary R. Burke & Linda Chiarello - 1990 - Journal of Law, Medicine and Ethics 18 (4):311-330.
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  8.  12
    The HIV-Infected Health Care Professional: Employment Policies and Public Health.Mark Barnes, Nicholas A. Rango, Gary R. Burke & Linda Chiarello - 1990 - Journal of Law, Medicine and Ethics 18 (4):311-330.
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  9.  6
    Incorporating Ethical Principles Into Clinical Research Protocols: A Tool for Protocol Writers and Ethics Committees.Rebecca H. Li, Mary C. Wacholtz, Mark Barnes, Liam Boggs, Susan Callery-D'Amico, Amy Davis, Alla Digilova, David Forster, Kate Heffernan, Maeve Luthin, Holly Fernandez Lynch, Lindsay McNair, Jennifer E. Miller, Jacquelyn Murphy, Luann Van Campen, Mark Wilenzick, Delia Wolf, Cris Woolston, Carmen Aldinger & Barbara E. Bierer - 2016 - Journal of Medical Ethics 42 (4):229-234.
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  10.  6
    Research Misconduct Involving Noncompliance in Human Subjects Research Supported by the Public Health Service:Reconciling Separate Regulatory Systems.Barbara E. Bierer & Mark Barnes - 2014 - Hastings Center Report 44 (s3):S2-S26.
  11.  1
    " Exempt" Research After the Privacy Rule.Mark Barnes & Katherine E. Gallin - 2002 - IRB: Ethics & Human Research 25 (4):5-6.
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  12.  4
    HHS Draft Guidance on Financial Conflicts of Interest.Mark Barnes & Kate Gallin - 2002 - IRB: Ethics & Human Research 25 (5):15-16.
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  13.  3
    Research Subject Injury Compensation: The Ongoing Search for Fairness, Consistency and Clarity.Mark Barnes, Jamie Flaherty & Barbara E. Bierer - 2019 - Journal of Law, Medicine and Ethics 47 (4):748-750.
  14. MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. Guidance Document. Version 1.0, December 2016.Carmen Aldinger, Barbara Bierer, Rebecca Li, Luann Van Campen, Mark Barnes, Eileen Bedell, Amanda Brown-Inz, Robin Gibbs, Deborah Henderson, Christopher Kabacinski, Laurie Letvak, Susan Manoff, Ignacio Mastroleo, Ellie Okada, Usharani Pingali, Wasana Prasitsuebsai, Hans Spiegel, Daniel Wang, Susan Briggs Watson & Marc Wilenzik - 2016 - The Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center).
    I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...)
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