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  1. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.Marlies van Lent, Gerard A. Rongen & Henk J. Out - 2014 - BMC Medical Ethics 15 (1):83.
    Submission of study protocols to research ethics committees constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials.
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  • Non-completion and informed consent.Alan Wertheimer - 2014 - Journal of Medical Ethics 40 (2):127-130.
    There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the ‘therapeutic misconception’, but has ignored the ‘completion misconception’. This article argues that, other things being equal, (...)
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  • The Social Value Misconception in Clinical Research.Jake Earl, Liza Dawson & Annette Rid - forthcoming - American Journal of Bioethics:1-17.
    Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to “misconceptions” about clinical research that can compromise participants’ decision-making, most notably the “therapeutic misconception.” These misconceptions typically involve false beliefs about a study’s purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving (...)
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