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•U.S. National Research Act (1974)
prior to then only published regulations in the US were stated as NIH
policy.
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•Established a Commission to study issues related to human subject
research
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•Met over a four year period
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•Issued the Belmont Report – Became the basis for federal
regulations that followed
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•Took all the issues and
boiled them down to three simple principles
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Though stated differently
in each of the cornerstone documents express the same core principles
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•Respect for persons – dignity and autonomy of individuals must be
maintained and people should not be used as a means to an end
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•Beneficence – Subjects must be protected from harm
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•Justice – We should treat
people fairly and there should be a fair sharing of the burdens and benefits
of research (Should not burden one group with the risks in order to give the
benefits to another group e.g. prisoners, poor) Risks and benefits are
distributed evenly across the subject population.
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