The Limitations of Current Ethical Regulations

Part of the Studies in Regulation book series (STUDREG)


In this chapter, I chart the historical emergence of key international and national guidelines that govern medical research in general, and clinical drug trials in particular. The principle of informed consent, is central to these guidelines and has come to be seen as ‘the ethical solution’ to prevent the exploitation and abuse of human subjects. I present a critical examination of the central role accorded to this principle and challenge its emancipatory status. I draw upon a number of studies to illustrate the effects of the implementation of informed consent in various social contexts. Finally, I argue the central role accorded to informed consent obfuscates other ethical issues relating to the broader political and institutional setting


Research Participant Drug Trial Ethical Code Good Clinical Practice Guideline Clinical Drug Trial 
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© Palgrave Macmillan, a division of Macmillan Publishers Limited 2003

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