Human tissue is excised for either medical care or research. Demand for excised human tissue is increasing because of the realization of personalized medicine, which relies on excised human tissue to develop innovative tests for application in patient care. However, because excised human tissue is a limited, nonrenewable resource, increasing demand has stressed current institutional infrastructures. Excised human tissue consists of 2 classes -diagnostic and research - each with distinct rules governing collection, retention and use. Because of a dearth of published literature on the fundamental distinction between diagnostic and research tissue, there is confusion among institutions, physicians, researchers and patients regarding access to excised human tissue. Any meaningful future discourse and decisions about responsible access to excised human tissue therefore require definitional clarity surrounding this distinction.
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