These are just some of the many controversial and timely questions that Sheila Jasanoff asks in this study of the way science advisers shape federal policy.

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...) oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration. (shrink)

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed at (...) emerging technologies. This article reports on work funded by the National Science Foundation aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight. (shrink)