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  1. Two dogmas of research ethics and the integrative approach to human-subjects research.Alex John London - 2007 - Journal of Medicine and Philosophy 32 (2):99 – 116.
    This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas are common to traditional articulations of the (...)
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  • Rethinking the Belmont Report?Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan - 2017 - American Journal of Bioethics 17 (7):15-21.
    This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...)
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  • De Minimis Risk: A Proposal for a New Category of Research Risk.Rosamond Rhodes - 2011 - American Journal of Bioethics 11 (11):1-7.
    In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.
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  • The clinician-investigator: Unavoidable but manageable tension.Howard Brody & Franklin G. Miller - 2003 - Kennedy Institute of Ethics Journal 13 (4):329-346.
    : The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...)
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  • The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.Nancy E. Kass, Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis & Tom L. Beauchamp - 2013 - Hastings Center Report 43 (s1):4-15.
    Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...)
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  • Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.Jake Earl - 2019 - American Journal of Bioethics 19 (6):7-18.
    Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of patients (...)
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  • De Minimis Risk: A Proposal for a New Category of Research Risk.Abraham Schwab - 2011 - American Journal of Bioethics 11 (11):1-7.
    In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.
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