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  1. Refuting the Net Risks Test: A Response to Wendler and Miller's "Assessing Research Risks Systematically".Charles Weijer & Paul B. Miller - 2007 - Journal of Medical Ethics 33 (8):487-490.
    Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) (...)
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  • Individual Risk and Community Benefit in International Research.Robert C. Hughes - 2012 - Journal of Medical Ethics 38 (10):626-629.
    It is widely agreed that medical researchers who conduct studies in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community, not only the subjects. The justification for this moral requirement has not been adequately examined. Most attempts to justify this requirement focus on researchers' interaction with the community as a whole, not on their relationship with their subjects. This paper argues that in some cases, research must benefit the broader host community (...)
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  • The Risk-Benefit Task of Research Ethics Committees: An Evaluation of Current Approaches and the Need to Incorporate Decision Studies Methods.D. L. C. Bernabe Rosemarie, J. M. W. van Thiel Ghislaine, A. M. Raaijmakers Jan & J. M. van Delden Johannes - 2012 - BMC Medical Ethics 13 (1):6.
    Background Research ethics committees are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit (...)
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  • An Ethical Justification for Research with Children.Ariella Binik - unknown
    This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...)
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  • News Media Coverage of Euthanasia: A Content Analysis of Dutch National Newspapers. [REVIEW]Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers & Johannes J. M. Van Delden - 2013 - Bmc Medical Ethics 2012 13 14 (1):6-.
    BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to (...)
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  • Can RESEARCH and CARE Be Ethically Integrated?Emily A. Largent, Steven Joffe & Franklin G. Miller - 2011 - Hastings Center Report 41 (4):37-46.
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  • Mehr Nutzen als Schaden?Angelika Hüppe & Heiner Raspe - 2011 - Ethik in der Medizin 23 (2):107-121.
    Forschung an und mit Menschen muss sich legitimieren, d. h. sie muss ihre wissenschaftliche Qualität, Rechtmäßigkeit und ethische Vertretbarkeit aufzeigen. Zu den Rechtfertigungsbedingungen zählt ein „günstiges“ Verhältnis von Nutzen- und Schadenpotenzialen des Forschungsvorhabens. Unabhängige Ethikkommissionen sind den Forschenden zur Seite gestellt, um sie bei der Prüfung und Sicherstellung der genannten Erfordernisse zu unterstützen. Eine zum Gebrauch durch Ethikkommissionen und Forschende entwickelte Nutzen- und Schadentaxonomie sowie ein Schema zur Systematisierung von Chancen-Risiken-Bewertungen wurde nachträglich auf alle Ethikanträge des Jahres 2006 an die (...)
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  • Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.David L. Evers, Carol B. Fowler, Jeffrey T. Mason & Rebecca K. Mimnall - 2015 - Science and Engineering Ethics 21 (4):1049-1064.
    Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are (...)
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  • The Risk-Benefit Task of Research Ethics Committees: An Evaluation of Current Approaches and the Need to Incorporate Decision Studies Methods. [REVIEW]Johannes J. M. Van Delden Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers - 2012 - BMC Medical Ethics 13 (1):6.
    BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...)
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  • Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent.Maxwell J. Mehlman & Jessica W. Berg - 2008 - Journal of Law, Medicine and Ethics 36 (3):546-549.
    The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay examines this question (...)
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  • Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent.Maxwell J. Mehlman & Jessica W. Berg - 2008 - Journal of Law, Medicine and Ethics 36 (3):546-559.
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  • Improving the Helsinki Declaration's Guidance on Research in Incompetent Subjects.A. E. Westra & I. de Beaufort - 2015 - Journal of Medical Ethics 41 (3):278-280.
    Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is expected to (...)
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