Public Health Practice vs Research: Implications for Preparedness and Disaster Research Review by State Health Department IRBs

ABSTRACTUnder the current US Department of Health and Human Services regulatory and ethical system for research involving human subjects, research is defined in terms of several key concepts: intent, systematic investigation, and generalizability. If an investigator engages in a systematic investigation designed or intended to contribute to generalizable knowledge, then he or she is engaged in research. If that research involves living individuals and the investigator will either interact or intervene with people or obtain their identifiable personal information, then the research must be prospectively reviewed by an institutional review board (IRB), a federally mandated committee that ensures the ethical and regulatory appropriateness of proposed research. In public health institutions, and especially at state departments of health, this definition of research may prove vexing for determining when particular public health activities must be reviewed by IRBs. This article outlines several reasons for such vexation and 2 key responses from major public health stakeholders. In the current climate of public health preparedness initiatives at state health departments for disasters and