Academic and industrial scientists have sharply increased their demand
for properly prepared and clinically annotated tissue samples that yield valuable
insights into the origins and expressions of human disease. Historically,
research on human tissue samples has been relatively unencumbered by federal
regulations and occurred without delineation of ownership rights to the specimens,
patient data, or research products. As regulations have become increasingly
restrictive, and because clear ownership interests have never been established,
the presumed right of researchers and institutions to collect, use, and dispose
of specimens and their associated patient data has remained undefined and
occasionally contentious. Recent examination of these issues by a US federal
court resulted in a ruling that individuals do not retain rights of ownership
or control of biological materials contributed for research, regardless of
whether commercial benefit accrues. This article examines the legal, regulatory,
and ethical framework within which human tissue research is currently conducted.
We contend that because the benefits of medical knowledge derived from tissue
research potentially accrue to all individuals and future generations (rather
than a single recipient), society may justify an expansive use of these valuable
resources for future studies.
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