Healthy Skepticism Library item: 15641

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Publication type: Journal Article

Annas GJ.
Globalized Clinical Trials and Informed Consent
The New England Journal of Medicine 2009 May 14; 360:(20):2050-2053
http://content.nejm.org/cgi/content/full/360/20/2050

Abstract:

The increasing globalization of clinical research trials calls for more effective ethical and legal rules to protect both research subjects and scientific integrity.1 Some observers noted more than a decade ago that research was being conducted in developing countries without concern for adherence to the international ethical principles for human-subjects research contained in the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (see Codes Relied on by the Second Circuit).2 The situation has not improved. For example, late last year, the Food and Drug Administration (FDA) decided that research studies submitted to it for review need no longer be bound by the Declaration of Helsinki – they must only follow the industry-sponsored Guidelines for Good Clinical Practice outlined by the International Conference on Harmonisation.3

Notes:

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