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  1. Phase 1 oncology trials and informed consent.Franklin G. Miller & Steven Joffe - 2013 - Journal of Medical Ethics 39 (12):761-764.
    Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they (...)
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  • Are therapeutic motivation and having one's own doctor as researcher sources of therapeutic misconception?Scott Y. H. Kim, Raymond De Vries, Sonali Parnami, Renee Wilson, H. Myra Kim, Samuel Frank, Robert G. Holloway & Karl Kieburtz - 2015 - Journal of Medical Ethics 41 (5):391-397.
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  • Gricean charity: The Gricean turn in psychology.Carole J. Lee - 2006 - Philosophy of the Social Sciences 36 (2):193-218.
    Psychologists' work on conversational pragmatics and judgment suggests a refreshing approach to charitable interpretation and theorizing. This charitable approach—what I call Gricean charity —recognizes the role of conversational assumptions and norms in subject-experimenter communication. In this paper, I outline the methodological lessons Gricean charity gleans from psychologists' work in conversational pragmatics. In particular, Gricean charity imposes specific evidential standards requiring that researchers collect empirical information about (1) the conditions of successful and unsuccessful communication for specific experimental contexts, and (2) the (...)
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  • Research participants'" irrational" expectations: common or commonly mismeasured?S. Y. Kim, R. de Vries, R. Wilson, S. Parnami, S. Frank, K. Kieburtz & R. G. Holloway - 2013 - IRB: Ethics & Human Research 35 (1):1-9.
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  • An Approach to Evaluating Therapeutic Misconception.Scott Y. H. Kim, Lauren Schrock, Renee M. Wilson, Samuel A. Frank, Robert G. Holloway, Karl Kieburtz & Raymond G. De Vries - 2009 - IRB: Ethics & Human Research 31 (5):7.
    Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition and measurement of the therapeutic misconception is a subject of continuing debate. Our qualitative pilot study of persons enrolled in a phase I trial of gene transfer for Parkinson disease suggests potential avenues for both measuring and preventing the therapeutic misconception. Building on earlier literature on the topic, we developed and (...)
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  • Unrealistic optimism in early-phase oncology trials.Lynn A. Jansen, Paul S. Appelbaum, William Mp Klein, Neil D. Weinstein, William Cook, Jessica S. Fogel & Daniel P. Sulmasy - 2011 - IRB: Ethics & Human Research 33 (1):1.
    Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participating in a clinical trial. In order to test for the prevalence of unrealistic optimism among participants of early-phase oncology trials, we (...)
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  • Therapeutic Misconception in Clinical Research: Frequency and Risk Factors.Paul S. Appelbaum, Charles W. Lidz & Thomas Grisso - 2004 - IRB: Ethics & Human Research 26 (2):1.
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