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  1. Human and animal subjects of research: The moral significance of respect versus welfare.Rebecca L. Walker - 2006 - Theoretical Medicine and Bioethics 27 (4):305-331.
    Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is true. Without explicit (...)
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  • Beyond Primates: Research Protections and Animal Moral Value.Rebecca L. Walker - 2016 - Hastings Center Report 46 (4):28-30.
    Should monkeys be used in painful and often deadly infectious disease research that may save many human lives? This is the challenging question that Anne Barnhill, Steven Joffe, and Franklin G. Miller take on in their carefully argued and compelling article “The Ethics of Infection Challenges in Primates.” The authors offer a nuanced and even-handed position that takes philosophical worries about nonhuman primate moral status seriously and still appreciates the very real value of such research for human welfare. Overall, they (...)
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  • Role of the institutional animal care and use committee in monitoring research.Nicholas H. Steneck - 1997 - Ethics and Behavior 7 (2):173 – 184.
    During the 1980s, federal regulations transferred significant portions of the responsibility for monitoring the care and use of research animals from animal care programs to Institutional Animal Care and Use Committees (IACUCs). After a brief review of the history of the regulation of the use of animals in research preceding and during the 4 decades following World War 11, this article raises 4 problems associated with the role IACUCs currently play in monitoring the use of animals in research: (a) lack (...)
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  • (1 other version)Reading Trust between the Lines.Laura Stark - 2013 - Cambridge Quarterly of Healthcare Ethics 22 (4):391-399.
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  • (1 other version)Reading trust between the lines: "Housekeeping work" and Inequality in Human-Subject Review.Laura Stark - 2013 - Cambridge Quarterly of Healthcare Ethics 22 (4):391-399.
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  • The harm-benefit tradeoff in "bad deal" trials.Gillian Nycum & Lynette Reid - 2007 - Kennedy Institute of Ethics Journal 17 (4):321-350.
    : This paper examines the nature of the harm-benefit tradeoff in early clinical research for interventions that involve remote possibility of direct benefit and likelihood of direct harms to research participants with fatal prognoses, by drawing on the example of gene transfer trials for glioblastoma multiforme. We argue that the appeal made by the component approach to clinical equipoise fails to account fully for the nature of the harm-benefit tradeoff—individual harm for social benefit—that would be required to justify such research. (...)
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  • Human research protections:.Karen J. Maschke - 2008 - Hastings Center Report 38 (2):19-22.
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  • A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise.Lynn A. Jansen - 2005 - Hastings Center Report 35 (5):29.
    Some commentators have recently proposed that “clinical equipoise,” although widely accepted, is not necessary for morally acceptable research on human subjects. If this concept is rejected, however, we may find that trials not in the best medical interests of their subjects—”bad deal trials”—could be justified. To avoid exploiting participants, we must find a way to distribute the risks fairly, even if it means embracing radical changes in the way clinical research is conducted.
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  • A Belmont Report for Animals?Hope Ferdowsian, L. Syd M. Johnson, Jane Johnson, Andrew Fenton, Adam Shriver & John Gluck - 2020 - Cambridge Quarterly of Healthcare Ethics 29 (1):19-37.
    Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and (...)
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  • The benefit/risk ratio challenge in clinical research, and the case of HIV cure: an introduction.Nir Eyal - 2017 - Journal of Medical Ethics 43 (2):65-66.
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  • Redundant, Secretive, and Isolated: When Are Clinical Trials Scientifically Valid?Kirstin Borgerson - 2014 - Kennedy Institute of Ethics Journal 24 (4):385-411.
    Clinical research has at least three problematic features: it tends to be redundant, secretive, and isolated.1 Research with these features not only wastes resources and causes harm, it also fails to meet a basic ethical requirement of research: scientific validity. As bioethicists, we should be asking why, if research with these three features is ethically unjustified, it has been so routinely approved by research ethics committees over the past half century. In what follows, I provide one answer to this question. (...)
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  • Balancing Uncertain Risks and Benefits in Human Subjects Research.Richard Barke - 2009 - Science, Technology, and Human Values 34 (3):337-364.
    Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards in the United States—must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit ``sanguinity principle,'' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human subjects risks and (...)
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  • A framework for risk-benefit evaluations in biomedical research.Annette Rid & David Wendler - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  • Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009.[author unknown] - 2010
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  • An ethical framework for biomedical research.Ezekiel J. Emanuel, David Wendler & C. Grady - 2008 - In The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 123--135.
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  • Regulations for the Protection of Humans in Research in the United States.Joan P. Porter & Greg Koski - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 156.
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