An Extraterritorial FDA: Could the Food and Drug Administration Apply Its Informed Consent Requirement Abroad Consistent with International Law?

This paper addresses the regulatory challenges wrought by the increasing amount of human subject drug testing conducted in developing countries in support of new drug applications to the Food and Drug Administration. Specifically, it examines the difficulty of enforcing the “informed consent” requirement for ethical scientific research performed in foreign territory. In poorer regions, a lack of government oversight, lower regulatory standards, and barriers to communication have too frequently resulted in allegations of human experimentation performed without its participants’ informed consent. In order to solve this problem, some commentators have suggested that the FDA could apply its human subject protections to foreign clinical research, and enforce them through injunctions or criminal prosecutions. However, the international legal limits on states’ prescriptive jurisdiction may prohibit this exercise of extraterritoriality. After analyzing the proposed extraterritorial regulation of foreign drug testing under the traditional bases and limitations of prescriptive jurisdiction, this paper concludes that such regulation would likely violate international law. However, because nonconsensual clinical research has previously been regarded as a crime against humanity, the FDA might be able to bring criminal prosecutions under the principal of “universal jurisdiction” against investigators or sponsors who conducted studies without their subjects’ informed consent. This analysis offers both positive and normative conclusions regarding the international legal system and the human rights regime

Bulk nanostructured materials

This paper will address three topics of importance to bulk nanostructured materials. Bulk nanostructured materials are defined as bulk solids with nanoscale or partly nanoscale microstructures. This category of nanostructured materials has historical roots going back many decades but has relatively recent focus due to new discoveries of unique properties of some nanoscale materials. Bulk nanostructured materials are prepared by a variety of severe plastic deformation methods, and these will be reviewed. Powder processing to prepare bulk nanostructured materials requires that the powders be consolidated by typically combinations of pressure and temperature, the latter leading to coarsening of the microstructure. The thermal stability of nanostructured materials will also be discussed. An example of bringing nanostructured materials to applications as structural materials will be described in terms of the cryomilling of powders and their consolidation