Principles for strengthening the integrity of clinical research.
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Biomedical subjects
Publications and source records attributed to David Korn.
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BACKGROUND TO THE DEBATE: In the United States, the passage of the Bayh-Dole Act in 1980 encouraged universities to license inventions for commercial development. Although this financial incentive can stimulate academic researchers to discover new drugs and devices, there is concern that the possibility of monetary reward could distort investigators' objectivity.
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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This paper examines the public policy value of looking at gambling from a public health perspective. The manner in which social issues are framed will either expand or curtail public policy debates. The existing and traditional frames for gambling (e.g. gambling as a matter of individual freedom, gambling as a form of recreation) fail to consider research on the social and economic impacts of gambling. Because a public health frame offers a broad viewpoint of society, it encompasses a number of social and economic impacts not considered in traditional frames. However, the existing gambling frames enjoy varying degrees of cultural, economic, and political support and, as a result, creating a higher profile for a public health framework will encounter a number of barriers. Research can play a decisive role in overcoming these barriers, as it has in a number of related fields (e.g., tobacco use, addiction and product liability, the epidemiology of AIDS). The paper concludes that research that identifies and quantifies the public health factors of gambling will substantially contribute to a public shift toward a public health frame.
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