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Ethics in the design and conduct of clinical trials.by: J. Sugarman
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AbstractIn this article, I outline some of the important ethical issues in the design and conduct of clinical research. To set the appropriate context, I first sketch some of the most notorious examples of unethical research and explain how the ethics of research came to be recognized and articulated, especially in public declarations. Next I describe the basic ethical principles that can be of assistance in understanding the relevant ethical issues encountered in clinical research. I then outline the ethical implications associated with selected issues in research design: randomization, use of placebos, confidentiality, and selection of participants. Finally, I discuss some of the ethical considerations involved in the research process: obtaining valid informed consent, dealing with interim results, and the responsible conduct of research. Although the scope of this article does not permit a detailed analysis of any of these particular issues, I have attempted to provide a sense of the relevant concerns and to point the reader towards literature appropriate for further discussion of them.
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