Chapter

Moral Traditions in an Era of Government Oversight

Sydney A. Halpern

in Lesser Harms

Published by University of Chicago Press

Published in print November 2004 | ISBN: 9780226314518
Published online February 2013 | e-ISBN: 9780226314532 | DOI: http://dx.doi.org/10.7208/chicago/9780226314532.003.0007
Moral Traditions in an Era of Government Oversight

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In the United States, human-subjects researchers conform to regulatory codes administered by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). The FDA oversees human testing of experimental drugs, biological materials, and medical devices, while the OHRP oversees a system of institutional review boards, committees that scrutinize human-subjects studies to be conducted at universities, hospitals, and other institutions that receive federal research support. This chapter argues that scientists' moral traditions have immediate relevance for current government oversight of medical research. It looks at two recent human experiments that resulted in research-induced fatalities. The issues these contemporary experiments raise are entirely compatible with the issues on human risk and research oversight. The fatalities were eighteen-year-old Jesse Gelsinger and twenty-four-year-old Ellen Roche, who participated in clinical trials at the University of Pennsylvania in 1999 and at Johns Hopkins University in 2001, respectively. These cases point to fundamental limitations of state-mandated oversight of medical research and show that the evaluative standards used by regulatory bodies have stinted the importance of the logic of lesser harms.

Keywords: Food and Drug Administration; Office for Human Research Protections; scientists; moral traditions; government oversight; clinical trials; human experiments; Jesse Gelsinger; Ellen Roche; lesser harms

Chapter.  9260 words. 

Subjects: Health, Illness, and Medicine

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