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  1. Money and Distorted Ethical Judgments about Research: Ethical Assessment of the TeGenero TGN1412 Trial. [REVIEW]Ezekiel J. Emanuel & Franklin G. Miller - 2007 - American Journal of Bioethics 7 (2):76-81.
    The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical (...)
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  • The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.R. K. Lie - 2004 - Journal of Medical Ethics 30 (2):190-193.
    The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that (...)
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  • The standard of care debate: against the myth of an "international consensus opinion".U. Schuklenk - 2004 - Journal of Medical Ethics 30 (2):194-197.
    It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by this author, (...)
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  • The ambiguity and the exigency: Clarifying 'standard of care' arguments in international research.Alex John London - 2000 - Journal of Medicine and Philosophy 25 (4):379 – 397.
    This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...)
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