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Progress in the development of human
subjects research standards in Latin America
Edward E. Bartlett
Introduction
Latin America has long been involved in the global effort to expand the
frontiers of research and contribute to scientific knowledge. Much of this
effort has revolved around drug clinical trials and other aspects of health-
care research. In order to assure the protection of human subjects and the
quality of data, countries throughout Latin America have established a
variety of laws, regulations, and guidelines, which are collectively referred
to as “standards” in this paper.
The purpose of this paper is four-fold:
Review the historical development of standards.
1.
Analyze the informed consent provisions of these standards.
2.
Summarize their current status.
3.
Describe current country-level research portfolios.
4.
Historical development
Global efforts to assure human subject projections began in the 1960s, fol-
lowing revelations of widespread human rights violations. The passage of
the first Declaration of Helsinki in 1964, followed by the 1966 publication
of Henry Beecher’s milestone article, “Ethics and Clinical Research,”
(1)
and subsequent revelations about the Tuskegee Study, all served to focus
and galvanize the attention of researchers, policy-makers, and the public
about the need to protect the rights and welfare of human subjects.
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