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Essay / Research Paper Abstract
A 6 page paper that explores the ethics of biomedical research, focusing on the key element of voluntary informed consent. Discussed are recent adverse events that have occurred in gene therapy research and the amendments and additions to federal regulations resulting from these events. Also included is a brief discussion of the history of the guidelines and regulations that safeguard human subject volunteers in medical and scientific research. Bibliography lists 8 sources.
Page Count:
6 pages (~225 words per page)
File: D0_LCBiomed.doc
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Unformatted sample text from the term paper:
gene therapy experiment at the University of Pennsylvania in the fall of 1999 (Henig, 2000; p. 17A). Jesse Gelsinger never had the opportunity to realize how little he really
knew about the relatively new medical science of gene therapy or, in fact, how little those conducting experiments in the field actually know about the process of genetic alteration.
Jesse Gelsinger died as a result of the infusion of altered cells introduced into his system during the therapy. This incident, among others, has prompted a series of recent investigations
and policy and regulation recommendations and amendments aimed at improving the protection and safety of persons volunteering their services as human research subjects. These investigations have uncovered regulation infractions
not only at the University of Pennsylvania, but also at Chicagos University of Illinois, the University of Colorado, and Duke University (Sciarra, 1999). Further probing turned up the fact
that, in gene therapy experiments similar to that participated in by Jesse Gelsinger, only 39 of the 691 seriously adverse results found had been reported to the National Institute of
Health by researchers without some degree of prompting (Henig, 2000; p. 17A). The results of these investigations have led to several Congressional Testimony hearings and a number of new
amendments to the regulations mandated by the U.S. Department of Health and Human Services as well as the U.S. Food and Drug Administration. II. The Nuremberg Code - A
Legacy Not Always Heeded Various types of human subject experimentation have been practiced in various sectors of the scientific and medical communities for as long as these communities have been
in existence. The majority of this research was conducted on a small scale due to the overall lack of funding, but recent probes into past practices have revealed that
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