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This article has been retrieved
times since November 24, 2004
Volume 12 Number 65
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November 24, 2004
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ISSN 1068-2341
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Tangible and Intangible Costs of "Protecting Human Subjects":
The Impact of the National Research Act of 1974 on
University Research Activities
Frederic Jacobs
Arina Zonnenberg
American University
Citation: Jacobs, F. & Zonnenberg, A. (2004, November 24). Tangible and intangible costs
of "protecting human subjects": The impact of the National Research Act of 1974 on
university research activities. Education Policy Analysis Archives, 12(65).
Retrieved [date] from http://epaa.asu.edu/epaa/v12n65/.
Abstract
This article (1) examines the overall structure of regulatory research oversight in the
United States; (2) details the origins and evolution of federal legislation pertaining to
the protection of human subjects in biomedical and behavioral treatment and
research; and (3) describes the expansion of oversight regulation from biomedical
and behavioral treatment areas to the social sciences. In addition, the paper describes
three areas identified by compliance administrators as susceptible to abuse: (1)
informed consent, (2) assessment of risks and benefits, and (3) equitable selection of
human subjects. There is a discussion of existing tensions in the implementation of
oversight policies and procedures. Finally, the paper identifies four issues for future
consideration: (1) scope of the mandate regarding protection of human subjects, (2)
impact on the nature of research being undertaken, (3) financial burden of
compliance and oversight activities, and (4) ethical standards, constraints, and
potential.
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Universidade do Estado do Rio de Janeiro
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Ministerio de Educación, Argentina
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Universidade de São Paulo,
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Ontario Institute for Studies in
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Instituto de Pedagogía Popular, Perú
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Social Science Research Council,
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Loyola University, Chicago, Illinois
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