Abstract: This chapter describes bioethical problems related with the conduct of clinical research. Clinical research involving the human subjects helps in the development of generalize knowledge useful for understanding and improving human health and well being. Although clinical research has resulted in significant benefits for society, it continues to pose profound ethical questions. The major thrust of federal regulations and codes of research ethics is protection of subjects from the burdens of research and the possibility of exploitation. Throughout this history, several influential documents have helped to shape our sense of the contours of ethical research. Randomized clinical trials remain the principal method and “gold standard” for demonstrating safety and efficacy in the development of new drugs and biologics. The chapter has reviewed the three ethical principles most commonly accepted as underlying the conduct of research and their application, the historical basis of current guidance regarding the research on human subjects, and some unique features of randomized clinical trials. In addition to adherence to principles, codes of ethics, and regulations, the ethical conduct of human subjects' research depends on the integrity and sagacity of all involved.
Publication Year: 2002
Publication Date: 2002-01-01
Language: en
Type: book-chapter
Indexed In: ['crossref']
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Cited By Count: 7
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