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Volume 345:139-142 July 12, 2001 Number 2
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Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

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There has been considerable controversy about the ethics of clinical trials that are sponsored or conducted by groups in industrialized countries but carried out in developing countries.1,2,3,4,5,6,7,8 The National Bioethics Advisory Commission, of which we serve as chairman and executive director, respectively, has recently addressed these and related issues.9 International collaborative research covers a broad spectrum of methods, topics, and research strategies. In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. In particular, we focus on phase 3 and other drug trials that, if successful, can lead to the use of . . . [Full Text of this Article]

Exporting Ethical Standards

Specific Ethical Issues

The Process of Informed Consent

Research Design and Ethics Review

Post-Trial Benefits

Conclusions

References


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