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  1. Risk Standards for Pediatric Research: Rethinking the Grimes Ruling.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
    In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). (...)
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  • Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can Be Risky.Larry R. Churchill, Daniel K. Nelson, Gail E. Henderson, Nancy M. P. King, Arlene M. Davis, Erin Leahey & Benjamin S. Wilfond - 2003 - IRB: Ethics & Human Research 25 (3):1.
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  • Risk standards for pediatric research: Rethinking the.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
    : In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective (...)
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  • Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. [REVIEW]Adam Nishimura, Jantey Carey, Patricia J. Erwin, Jon C. Tilburt, M. Hassan Murad & Jennifer B. McCormick - 2013 - BMC Medical Ethics 14 (1):28.
    Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
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  • Consent forms and the therapeutic misconception.Nancy M. P. King, Gail E. Henderson, Larry R. Churchill, Arlene M. Davis, Sara Chandros Hull, Daniel K. Nelson, P. Christy Parham-Vetter, Barbra Bluestone Rothschild, Michele M. Easter & Benjamin S. Wilfond - 2005 - IRB: Ethics & Human Research 27 (1):1-7.
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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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  • Genetic research involving human biological materials: a need to tailor current consent forms.Sara Chandros Hull, Holly Gooding, Alison P. Klein, Esther Warshauer-Baker, Susan Metosky & Benjamin S. Wilfond - 2004 - IRB: Ethics & Human Research 26 (3):1.
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  • An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics.Ruth R. Faden, Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis & Tom L. Beauchamp - 2013 - Hastings Center Report 43 (s1):16-27.
    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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