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Ownership and Use of Tissue Specimens for Research
Rina Hakimian, JD, MPH;
David Korn, MD
JAMA. 2004;292:2500-2505.
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.
Author Affiliations: Division of Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, DC. Ms Hakimian is now with the Office for Human Research Protections, US Department of Health and Human Services, Rockville, Md.
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