ABSTRACT
These IRB considerations for review and informed consent presume that the project is research. What about projects that blur the line between pure research and pure public health practice? In contrast to IRB review and informed consent determinations, ascertaining the research status of an activity is not as straightforward. Ethical public health practices govern the latter projects.6 For research projects, there are several ethical and regulatory issues with which IRBs must deal.7 This article does not concentrate on these settled or debated issues. Rather, this article first examines the implications of making a research determination before IRB review or implementation of a purely public health intervention takes place. The author concludes by describing a specific, and confounding, type of determination and its implications-whether activities at state departments of health during times of emergency or disaster constitute research or public health practice. It is hoped that resolving this vexing determination can assist not only state health departments but also academically based researchers who either collaborate with those departments or whose research requires review by their IRBs.
