Human Subjects' Protection

Paper Summary:

This paper discusses the role of The Office for Human Research Protections in the United States, which was expanded in 2000 to oversee not only federally funded tests, but all human-subject research. The paper describes the challenges of the changes that were introduced and how they can be addressed. It then discusses the Institutional Review Boards (IRB) and their role. The paper concludes by discussing the consequences of opposing the local IRB mandated training for researchers. The paper contains a large section of original source documents appended to the paper.

Table of Contents:
I. Introduction
From a Yelp to a Roar
II. Challenges to Changes
III. Either you be . . .

From the Paper:

"Institutional Review Boards (IRBs), created by universities and academic medical centers, establish committees called to review experimental protocols involving humans. Traditionally, as federal regulations were regarded as performance-based guidelines, IRBs discretionally acted on a protocol-by-protocol basis. Temporary shutdown of several academic IRBs during the past few years, along with the ensuing cessation of clinical research, encouraged administrators and researchers to begin to better protect subjects enrolled in trials, in order to move forward with their research projects. (Wynes, Martin, and Skorton)"

Sample of Sources Used:

• Callahan, Daniel. What Price Better Health? Hazards of the Research Imperative. Berkeley, CA: University of California Press, 2003.
• "House Bill Would Bolster Protection of Humans in Clinical Trials." Issues in Science and Technology Fall 2002: 24+.
• Hyslop, Margie. "Hopkins Sets Research Safety Training." The Washington Times 15 Nov. 2001: 1.
• "IRB Policy Highlights." Office of Research Subjects Protections, 2006. [09 September 2006]. http://www.evms.edu/research/protections/policies.html#Required.
• May, William F. Simpson's Contemporary Quotations. Boston: Houghton Mifflin, 1988. [09 September 2006]. http://www.bartleby.com/63/52/2852.html.

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• Term Paper # 46411 : "Political Pressure and Social Research"

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