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  1. 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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  • Research Ethics: Ethics and Methods in Surgical Trials.C. Ashton, N. Wray, A. Jarman, J. Kolman & D. Wenner - 2009 - Journal of Medical Ethics 35 (9):579-583.
    This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...)
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  • A Taxonomy of Multinational Ethical and Methodological Standards for Clinical Trials of Therapeutic Interventions.C. M. Ashton, N. P. Wray, A. F. Jarman, J. M. Kolman, D. M. Wenner & B. A. Brody - 2011 - Journal of Medical Ethics 37 (6):368-373.
    Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...)
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  • Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects.World Medical Association - 2009 - Jahrbuch für Wissenschaft Und Ethik 14 (1):233-238.
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  • The Inalienable Right to Withdraw From Research.Terrance McConnell - 2010 - Journal of Law, Medicine and Ethics 38 (4):840-846.
    Most codes of research ethics and the practice of Institutional Review Boards (IRBs) allow human subjects to withdraw from research at any time. Consent forms invariably make a statement to this effect. So understood, a subject's right to withdraw from research is inalienable; she cannot, through her consent, surrender this right. Recently critics have argued that in selected circumstances the right to withdraw from research is alienable; subjects have the moral authority, through their consent, to obligate themselves not to withdraw. (...)
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  • The Inalienable Right to Withdraw From Research.Terrance McConnell - 2010 - Journal of Law, Medicine and Ethics 38 (4):840-846.
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  • Placebo-Controlled Trials and the Logic of Scientific Purpose.B. Freedman - 1990 - IRB: Ethics & Human Research 12 (6):5.
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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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  • Incentives for Research Participants.Neal Dickert & Christine Grady - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 386.
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  • The Declaration of Helsinki.Richard Ashcroft - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 141--148.
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