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  1.  26
    How Do We Know That Research Ethics Committees Are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review.Carl H. Coleman & Marie-Charlotte Bouësseau - 2008 - BMC Medical Ethics 9 (1):6-.
    BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...)
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  2.  22
    Vulnerability as a Regulatory Category in Human Subject Research.Carl H. Coleman - 2009 - Journal of Law, Medicine and Ethics 37 (1):12-18.
    This article examines and critiques the use of the term “vulnerability” in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: “consent-based vulnerability,”“risk-based vulnerability,” and “justice-based vulnerability.”.
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  3.  7
    Vulnerability as a Regulatory Category in Human Subject Research.Carl H. Coleman - 2009 - Journal of Law, Medicine and Ethics 37 (1):12-18.
    The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding (...)
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  4.  5
    Introduction.Carl H. Coleman - 2019 - Journal of Law, Medicine and Ethics 47 (2):189-193.
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  5.  21
    Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human A Frican Trypanosomiasis.Carl H. Coleman, Chantal Ardiot, Séverine Blesson, Yves Bonnin, Francois Bompart, Pierre Colonna, Ames Dhai, Julius Ecuru, Andrew Edielu, Christian Hervé, François Hirsch, Bocar Kouyaté, Marie-France Mamzer-Bruneel, Dionko Maoundé, Eric Martinent, Honoré Ntsiba, Gérard Pelé, Gilles Quéva, Marie-Christine Reinmund, Samba Cor Sarr, Abdoulaye Sepou, Antoine Tarral, Djetodjide Tetimian, Olaf Valverde, Simon Van Nieuwenhove & Nathalie Strub-Wourgaft - 2015 - Developing World Bioethics 15 (3):241-247.
    Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs (...)
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  6.  4
    Rethinking the Regulatory Triggers for Prospective Ethics Review.Carl H. Coleman - 2019 - Journal of Law, Medicine and Ethics 47 (2):247-253.
    Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...)
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  7.  17
    The "Disparate Impact" Argument Reconsidered: Making Room for Justice in the Assisted Suicide Debate.Carl H. Coleman - 2002 - Journal of Law, Medicine and Ethics 30 (1):17-23.
    In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted (...)
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  8.  17
    Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators.Kate Greenwood, Carl H. Coleman & Kathleen M. Boozang - 2012 - Journal of Law, Medicine and Ethics 40 (3):500-510.
    In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, (...)
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  9.  6
    The “Disparate Impact” Argument Reconsidered: Making Room for Justice in the Assisted Suicide Debate.Carl H. Coleman - 2002 - Journal of Law, Medicine and Ethics 30 (1):17-23.
    In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted (...)
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  10.  26
    Guidelines for Physician-Assisted Suicide: Can the Challenge Be Met?Carl H. Coleman & Alan R. Fleischman - 1996 - Journal of Law, Medicine and Ethics 24 (3):217-224.
    The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...)
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  11.  15
    Guidelines for Physician-Assisted Suicide: Can the Challenge Be Met?Carl H. Coleman & Alan R. Fleischman - 1996 - Journal of Law, Medicine and Ethics 24 (3):217-224.
    The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...)
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  12.  44
    Do Physicians' Legal Duties to Patients Conflict with Public Health Values? The Case of Antibiotic Overprescription.Carl H. Coleman - 2009 - Journal of Bioethical Inquiry 6 (2):181-185.
    Among the many explanations for antibiotic overprescription, some doctors cite the risk of malpractice liability if they deny a patient's request for an antibiotic and the patient's condition worsens. In this paper, I examine the merits of this concern—i.e., whether physicians could, in fact, face malpractice liability for refusing to prescribe an antibiotic when, from a public health perspective, the use of the antibiotic would be considered inappropriate. I conclude that the potential for liability cannot be dismissed entirely, but the (...)
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  13.  15
    HIV, ARTs, and the ADA.Carl H. Coleman - 2003 - American Journal of Bioethics 3 (1):43-45.
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  14.  16
    Stemming the Tide: Assisted Suicide and the Constitution.Carl H. Coleman & Tracy E. Miller - 1995 - Journal of Law, Medicine and Ethics 23 (4):389-397.
    On November 8, 1994, Oregon became the first state in the nation to legalize assisted suicide. Passage of Proposition 16 was a milestone in the campaign to make assisted suicide a legal option. The culmination of years of effort, the Oregon vote followed on the heels of failed referenda in California and Washington, and other unsuccessful attempts to enact state laws guaranteeing the right to suicide assistance. Indeed, in 1993, four states passed laws strengthening or clarifying their ban against assisted (...)
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  15. A Request for ICSI.Carl H. Coleman - 2001 - Hastings Center Report 31 (4):6.
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  16.  69
    Is There a Constitutional Right to Preconception Sex Selection?Carl H. Coleman - 2001 - American Journal of Bioethics 1 (1):27 – 28.
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