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  1. Disclosure and Consent to Medical Research Participation.Danielle Bromwich & Joseph Millum - 2015 - Journal of Moral Philosophy 12 (2):195-219.
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  • A Framework for Risk-Benefit Evaluations in Biomedical Research.Wendler Annette Rid David - 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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  • Disclosure and Consent to Medical Research Participation.Danielle Bromwich & Joseph Millum - 2013 - Journal of Moral Philosophy 10 (4):195-219.
    Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...)
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  • The Quality of Informed Consent: Mapping the Landscape. A Review of Empirical Data From Developing and Developed Countries.A. Mandava, C. Pace, B. Campbell, E. Emanuel & C. Grady - 2012 - Journal of Medical Ethics 38 (6):356-365.
    Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...)
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  • Informed Consent Legal Theory and Clinical Practice.Paul S. Appelbaum, Charles W. Lidz & Alan Meisel - 1987
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  • A History and Theory of Informed Consent.William G. Bartholome - 1988 - Ethics 98 (3):605-606.
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  • An Empirical Study on the Preferred Size of the Participant Information Sheet in Research.E. E. Antoniou, H. Draper, K. Reed, A. Burls, T. R. Southwood & M. P. Zeegers - 2011 - Journal of Medical Ethics 37 (9):557-562.
    Background Informed consent is a requirement for all research. It is not, however, clear how much information is sufficient to make an informed decision about participation in research. Information on an online questionnaire about childhood development was provided through an unfolding electronic participant sheet in three levels of information. Methods 552 participants, who completed the web-based survey, accessed and spent time reading the participant information sheet (PIS) between July 2008 and November 2009. The information behaviour of the participants was investigated. (...)
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  • Are There Adverse Consequences of Quizzing During Informed Consent for HIV Research?J. Sugarman, A. Corneli, D. Donnell, T. Y. Liu, S. Rose, D. Celentano, B. Jackson, A. Aramrattana, L. Wei, Y. Shao, F. Liping, R. Baoling, B. Dye & D. Metzger - 2011 - Journal of Medical Ethics 37 (11):693-697.
    Introduction While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. Methods Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. Results 525 participants completed the informed consent survey (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was (...)
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  • Does Informed Consent to Research Require Comprehension?Gopal Sreenivasan - 2007 - The Proceedings of the Twenty-First World Congress of Philosophy 1:85-93.
    According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of many otherwise (...)
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  • Animal Derived Products May Conflict with Religious Patients' Beliefs.Axelina Eriksson, Jakob Burcharth & Jacob Rosenberg - 2013 - BMC Medical Ethics 14 (1):48.
    Implants and drugs with animal and human derived content are widely used in medicine and surgery, but information regarding ingredients is rarely obtainable by health practitioners. A religious perspective concerning the use of animal and human derived drug ingredients has not thoroughly been investigated. The purpose of this study was to clarify which parts of the medical and surgical treatments offered in western world-hospitals that conflicts with believers of major religions.
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  • Effectiveness of Multimedia Aids to Enhance Comprehension of Research Consent Information: A Systematic Review.Barton W. Palmer, Nicole M. Lanouette & Dilip V. Jeste - 2012 - IRB: Ethics & Human Research 34 (6):1-15.
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  • Disclosure and Consent to Medical Research Participation.Danielle Bromwich & Joseph Millum - 2014 - Journal of Moral Philosophy 11 (4).
    Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...)
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  • Harm to Self.Joel Feinberg - 1986
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  • The Fair Transaction Model of Informed Consent: An Alternative to Autonomous Authorization.Wertheimer Franklin G. Miller Alan - 2011 - Kennedy Institute of Ethics Journal 21 (3):201-218.
    Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...)
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  • Voluntariness of Consent to Research: A Preliminary Empirical Investigation.P. S. Appelbaum, C. W. Lidz & R. Klitzman - 2008 - IRB: Ethics & Human Research 31 (6):10-14.
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  • The Evolution of Consent Forms for Research: A Quarter Century of Changes.Ilene Albala, Margaret Doyle & Paul Appelbaum - 2010 - IRB: Ethics & Human Research 32 (3):7-11.
    Institutional review boards and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that (...)
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  • Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, & Therapeutic Optimism.Sam Horng & Christine Grady - forthcoming - IRB: Ethics & Human Research.
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  • Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial.Lindsay Sabik, Christine A. Pace, Heidi P. Forster-Gertner, David Wendler, Judith D. Bebchuk, Jorge A. Tavel, Laura A. McNay, Jack Killen, Ezekiel J. Emanuel & Christine Grady - 2004 - IRB: Ethics & Human Research 27 (5):13-18.
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  • Empirical Issues in Informed Consent for Research.James Flory, David Wendler & Ezekiel Emanuel - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 645--60.
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  • Voluntariness of Consent to Research: A Preliminary Empirical Investigation.P. S. Applebaum, C. W. Lidz & R. Klitzman - 2009 - IRB: Ethics & Human Research 31 (6):10-14.
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  • Ethics and Regulation of Clinical Research.Robert J. Levine - 1986 - Urban & Schwarzenberg.
    In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.
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