United States regulations governing federally supported
research with human subjects derive in part from 2 international codes,
the Nuremberg Code and the Declaration of Helsinki. The Declaration of
Helsinki states that "concern for the interests of the subject must
always prevail over the interests of science and society." The
concept of minimal risk and the principle of informed consent are the
key means by which US federal regulations seek to protect the rights
and welfare of the individual in the research setting. Current trends
in medical research—including increased funding, ever-greater
capabilities of computers, development of new clinical tools that can
also be used in research, and new research tools developed through
research itself—are creating greater demand for human subjects, for
easier recruitment and conscription of these subjects, and for
unimpeded access to patient medical records and human biological
materials. Nationally and internationally, there are new pressures to
subordinate the interests of the subject to those of science and
society. The National Bioethics Advisory Commission, which is about to
undertake a comprehensive review of the US system of human subject
protections, faces a daunting task.
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